chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: had a mild, non severe reaction to the first dose of the vaccine/ She was told to go see an allergist; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "had a mild, non severe reaction to the first dose of the vaccine/ She was told to go see an allergist".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: having extreme pain in her thumb on the same hand from the same arm in which she was administered the second vaccine; This is a spontaneous report from a contactable consumer medical information team. This consumer reported for a female patient (Wife). A female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "having extreme pain in her thumb on the same hand from the same arm in which she was administered the second vaccine".  Additional information: Case narrative: Is Unspecified Vaccine a Pfizer product: Unspecified. Vaccine manufacturer was unspecified. Dates for Unspecified Vaccine was unspecified. NDC, Expiry Date and UPC number of Unspecified Vaccine was Unknown. Reason for no lot number: of Unspecified Vaccine: Not probed over call. Product: PFIZER-BIONTECH COVID-19 VACCINE. Additional Context: Reporter was Husband. Reporter mentioned " Reporter actually filed a report for his wife under the Pfizer reporting website, and she is having a problem with, after the second vaccine she is having extreme pain in her thumb on the same hand from the same arm in which she was administered the second vaccine. We wanted to kind of, like he said, he filled that report on the website and wanted to see what best next steps were.". Reporter mentioned "If its the same questions as he report he filled already, then he already did that."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First shot just a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 10:30 (Lot number: EW0151) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing); "beef allergy" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOESTRIN; BENADRYL. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "First shot just a sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient receive any other medications within 2 weeks of vaccination includes Lo-loestrin and benadryl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Painful respiration
Clinical narrative: His son experienced arm sore and it hurts when taking a deep breath.; His son experienced arm sore and it hurts when taking a deep breath.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PAINFUL RESPIRATION (non-serious) all with onset Apr2021, outcome "unknown" and all described as "His son experienced arm sore and it hurts when taking a deep breath.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was a little sore but that's nothing; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm was a little sore but that's nothing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Post herpetic neuralgia
Clinical narrative: After my first shot I noticed I was having more occurrences of problems with the PHN.; After my first shot I noticed I was having more occurrences of problems with the PHN.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 (Lot number: EN6206) at the age of 70 years as dose 1,single and administration date 01Apr2021 (Lot number: ER8737) as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POST HERPETIC NEURALGIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 18Mar2021, outcome "unknown" and all described as "After my first shot I noticed I was having more occurrences of problems with the PHN.".  Additional information: have suffered from post Hermetic neuralgia since having shingles in 2013. The episodes can be painful and erratic. I've gotten used to the pain. After my first shot I noticed I was having more occurrences of problems with the PHN. 10 days after the second shot I was in excruciating pain for 36 hours. It was like I had shingles all over again without the rash. The severe pain subsided within three days So I'm just back to my normal PHN issues. Covid prior vaccination No. Covid tested post vaccination No. Known allergies no. Other medical history none. other vaccine in four weeks No  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Extreme Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 19Feb2021 (Batch/Lot number: unknown) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 20Feb2021, outcome "recovered" (21Feb2021), described as "Extreme Pain".  Additional information: Extreme pain lasted about 24hrs had second shot on Feb 19th and was the next day when all this occurred.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: I was fine after the first shot but nine days later I felt like I had been hit by a sledgehammer - total exhaustion, some nausea and this lasted until right before time for the second shot three weeks; I was fine after the first shot but nine days later I felt like I had been hit by a sledgehammer - total exhaustion, some nausea and this lasted until right before time for the second shot three weeks; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 15:30 (Batch/Lot number: unknown) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "CAD" (unspecified if ongoing); "IBS" (unspecified if ongoing); "Costracontritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing); "known allergies: Cats" (unspecified if ongoing); "known allergies: Crabmeat" (unspecified if ongoing). Concomitant medication(s) included: CLOPIDOGREL; AMLODIPINE; SIMVASTATIN; ALPRAZOLAM. Past drug history included: Prednisone, reaction(s): "known allergies: Prednisone"; Iron injections, reaction(s): "known allergies: Iron Injections", notes: known allergies: Iron Injections. The following information was reported: NAUSEA (non-serious), FATIGUE (non-serious) all with onset 18Feb2021, outcome "recovering" and all described as "I was fine after the first shot but nine days later I felt like I had been hit by a sledgehammer - total exhaustion, some nausea and this lasted until right before time for the second shot three weeks". Therapeutic measures were not taken as a result of nausea, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was fine after the first shot but nine days later I felt like I had been hit by a sledgehammer - total exhaustion, some nausea and this lasted until right before time for the second shot three weeks later. Since the second shot, I have had more of the exhaustion and nausea - daily and the first couple of weeks were the worst - but it is now somewhat different as I have more energy and the nausea is not all day every day like it was but I'll have a day of being very nauseous and then a day or even two of not feeling that at all, which gets my hopes up, but then the next day it is back again. Better now than the first three weeks but this has been six weeks long and all I hear is that aftereffects last only 24-48 hours after the shot. I am very sensitive to medications (especially antibiotics, Prednisone, sulfa) and, consequently, kind of hard to treat but I thought you should have this information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 39 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) as dose 2,single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (1st Dose of COVID-19 Vaccine), for COVID-19 Immunisation. The following information was reported: HEADACHE (non-serious) with onset 15Apr2021, outcome "unknown", described as "headache".  Additional Information: Yesterday patient received the second dose of the Pfizer Covid 19 vaccine. Is it normal to have a headache today? Patient is 39-years-old.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; cold-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold-like symptoms".  Additional information: Caller received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 29Mar2021, she was scheduled to receive the second dose of the vaccine on 19Apr2021. The patient said that her mother had cold and she was catching cold too because she has a symptom. She would like to know if she could still receive the second dose of the vaccine while having a cold or cold-like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Vomiting
Clinical narrative: throwing up/vomiting; chills; aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset Apr2021, outcome "unknown", described as "throwing up/vomiting"; CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "aches".  Additional information: Caller explained she was 2 days without symptoms then "woke up throwing up, had chills, and mainly aches".  caller asked when should his wife's symptoms (vomiting, chills and aches) from the fist dose of the Pfizer-BioNTech COVID-19 vaccine subside. Received response as Side effects that you may experience throughout the rest of your body; (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter". from CONS -How long side effects last_final.Caller asked for general recommendations on getting a COVID-19 test for individuals with a recent vaccination with the first dose of the Pfizer-BioNTech COVID-19 vaccine received response as The Pfizer-BioNTech COVID-19 Vaccine does not contain SARS-CoV-2 and cannot give you COVID-19.1"; Per CDC "These interim considerations also state that if you currently have a COVID-19 (either before the first dose of vaccine or in between your first and second dose of vaccine), you should wait until you have recovered from the infection, show no symptoms and completed any required isolation.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Nausea
Clinical narrative: feel tired all the time; Headache; feel sick to my stomach; do not feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: ERC733) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "dizzy spells" (unspecified if ongoing). Concomitant medication(s) included: MECLIZINE [MECLOZINE HYDROCHLORIDE] taken for dizziness. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feel tired all the time"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "feel sick to my stomach"; MALAISE (non-serious), outcome "unknown", described as "do not feel good". Therapeutic measures were taken as a result of headache.  Additional information: Patient was also taking an unspecified blood pressure medicine as a concomitant medication. Patient took Rizatriptan as a result of headache.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Panic reaction, Tendonitis, Tinnitus
Clinical narrative: he developed tinnitus; he is panicking; Started having tendinitis in ear.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "he developed tinnitus"; PANIC REACTION (non-serious) with onset 14Apr2021, outcome "not recovered", described as "he is panicking"; TENDONITIS (non-serious) with onset 14Apr2021, outcome "not recovered", described as "Started having tendinitis in ear.". Additional information: Patient stated that he received the second dose of the pfizer covid 19 vaccine on Tuesday and on Wednesday he developed tinnitus describing it as a high pitch ringing in his head in his ears. Patient stated he was panicking now and wanted to know was this reported and will it go away. Patient stated it is continuing and does not stop. It was unknown if Reporter was a Healthcare Professional and prescribing HCP. Reporter's contact information was not available to a sub-contracted party.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph nodes/ Swollen lymph nodes on caller bone; Soreness under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 29Mar2021 (Lot number: ER8732) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient took concomitant medications.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset 31Mar2021, outcome "unknown", described as "Swollen lymph nodes/ Swollen lymph nodes on caller bone"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "unknown", described as "Soreness under arm". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity.  Additional information: It was reported that, no investigation assessment was done. When probed for the concern, consumer stated, "In the chart she was told that if she had to confirm about, she got an issue or some kind of something that she was having after the Covid shot, she had the first shot on 29Mar2021 that was to report it, side effect she guess. She asked that whether she was correct in certainly reporting them according to the paper. When probed to confirm the side effects, consumer stated, she had the swollen lymph nodes from the Pfizer shot, she had the swollen lymph nodes on the caller bone and the soreness under the arm from the Pfizer shot. When paraphrased the concern, consumer stated, yes. She doesn't want to share her body weight. When probed for second shot due date, she stated, 20Apr2021. When probed for concomitant medication, consumer stated, she was taking other medication, she don't have list in front of her, she had on high blood pressure, she took blood pressure medicine. She stated, about events still there it has changed (improved). When probed for outcome (event), she stated, it has been improved but it has not gone yet, she doesn't know, it has not gone away, it's still there. She did not receive any treatment. She was informed about Medical Information Department. She was provided with the number of Pfizer Medical Information and was requested to select option 3 and timings as 8 am to 11 pm from Monday to Friday as per (EST).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Increased headache; This is a spontaneous report received from contactable reporter (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program (60820). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 13Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Increased headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Nasopharyngitis
Clinical narrative: little uncomfortable feeling, like having a cold; little uncomfortable feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 13Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Jan2021, outcome "unknown", described as "little uncomfortable feeling, like having a cold"; DISCOMFORT (non-serious) with onset Jan2021, outcome "unknown", described as "little uncomfortable feeling".  Additional Information: Patient has taken second dose on 03Feb2021 and had no issues at all.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Consumer reported that she had this first shot 2 weeks ago and she is due for second dose next week. Consumer reported that the arm pain at injection site has not stopped.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Consumer reported that she had this first shot 2 weeks ago and she is due for second dose next week. Consumer reported that the arm pain at injection site has not stopped".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: She is now having floaters in her right vision of her right eye.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021417155 (Pfizer).  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Apr2021 04:45 (Lot number: EW0153) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot number=ER8730,, administration date=24Mar2021,, administration time=04:45 PM,, vaccine_ ocation=Right arm,, dose number=1.), for Covid-19 Immunization. The following information was reported: VITREOUS FLOATERS (non-serious) with onset 15Apr2021 10:30, outcome "unknown", described as "She is now having floaters in her right vision of her right eye.".  Clinical course: The vaccine was given in the right arm, and today her right eye was affected. The patient had multiple floaters, and some with a tail. The patient had an appointment today at 14:00 to see her optometrist. The patient never had this many floater in her eye before, especially with the tails. The patient reported that she did not saw a side effect about vision after the vaccine.  Additional information: The patient did not receive other vaccine within four weeks prior to COVID vaccine. Other medications in two weeks: Centrum silver multi vitamin. Adverse event resulted in: Doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received treatment for adverse event or not. The patient did not had COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. The patient did not had known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient developed  tinnitus/chronic ringing, with outcome of unknown. Additional information: Patient reported chronic ringing in her ear since the COVID-19 vaccine. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Felt nauseous; vomited once the evening of her second vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Felt nauseous"; VOMITING (non-serious), outcome "unknown", described as "vomited once the evening of her second vaccine".  Additional Information: Felt better after vomiting. Event took place after use of product.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: Sinus problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "Sinus problem".  Additional information: Patient had the first dose on 26Mar2021, scheduled her second dose on 15Apr2021 and patient had sinus problem which started last Sunday and caller wants to know if it is okay for her to have her second dose even though she had a sinus problem.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: Got 3 punctured wounds from an animal and had to go to the urgent care; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WOUND (non-serious), outcome "unknown", described as "Got 3 punctured wounds from an animal and had to go to the urgent care". Additional Information: Caller's daughter got the Covid vaccine yesterday and then after getting the vaccine she went to work and got 3 punctured wounds from an animal and had to go to the urgent care. They want to give her a tetanus shot, but wasn't sure they could so they told her to call Pfizer first.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: dizziness; sweating; feel like puking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating"; NAUSEA (non-serious), outcome "unknown", described as "feel like puking".  Additional information: Reporter stated that, patient received Pfizer-BioNTech COVID-19 vaccine this morning and after a couple of hours, patient experienced symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 04Jan2021 (Lot number: EK9231) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seizure disorder", start date: 2014 (ongoing); "reflux", start date: 2003 (unspecified if ongoing); "hypothyroidism", start date: 1989 (unspecified if ongoing); "arnold chiari malformation", start date: 1990 (ongoing); "hydrocephalus" (unspecified if ongoing); "hydromyelia" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "cervical fusion" (unspecified if ongoing); "latex allergy" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID (ongoing); PROZAC (ongoing); OMEPRAZOLE (ongoing); VIMPAT, start date: 14Oct2020 (ongoing); LAMOTRIGINE (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Back pain". Additional information: Patient was in a lot of back pain for two days, no other symptom at all, everything was fine. Patient was a healthy person.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm sore".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: We both had a sore arm around 3:30 in the afternoon; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Mar2021 15:30, outcome "unknown", described as "We both had a sore arm around 3:30 in the afternoon".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pollakiuria
Clinical narrative: Bladder is out of order; Going to bathroom every 10-15 minutes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Trouble hearing" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: POLLAKIURIA (non-serious), outcome "not recovered", described as "Bladder is out of order; Going to bathroom every 10-15 minutes". The event "bladder is out of order; going to bathroom every 10-15 minutes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pollakiuria. Additional information: The patient stated that treatment received was approved and prescribed by doctor and that the medication was not really working.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "allergic to ibuprofen" (unspecified if ongoing), notes: Verbatim: allergic to ibuprofen. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy".  Additional Information: Caller would like to know whether she can take Tylenol for her side effects from the covid vaccine. Caller said she just got the 2nd dose of the Pfizer covid vaccine today, 16Apr2021. She feels a little weak, has a headache, feels a little bit dizzy, but the 1st time it (dizziness) was worse. Caller also said she is allergic to ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm soreness; general fatigue for 2-3 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 , MANUFACTURER UNKNOWN, ), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness"; FATIGUE (non-serious), outcome "unknown", described as "general fatigue for 2-3 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, Ovulation delayed, Unintended pregnancy
Clinical narrative: Delayed ovulation; unplanned pregnancy; Is pregnant: No; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 06Apr2021 (Lot number: ER8729) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "gluten sensitivity" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, lot number: EP6955 , administration time: 04:00 PM, vaccine location: Right arm), administration date: 09Mar2021, when the patient was 38 years old, for Covid-19 immunisation. The following information was reported: OVULATION DELAYED (non-serious) with onset 08Apr2021, outcome "not recovered", described as "Delayed ovulation"; UNINTENDED PREGNANCY (non-serious) with onset 08Apr2021, outcome "not recovered", described as "unplanned pregnancy"; MATERNAL EXPOSURE BEFORE PREGNANCY (non-serious) with onset 06Apr2021, outcome "unknown", described as "Is pregnant: No". Therapeutic measures were not taken as a result of ovulation delayed, unintended pregnancy, maternal exposure before pregnancy.  Additional Information: The patient has no known allergies. The vaccine was administered to patient in a Pharmacy or Drug Store. The patient had no covid prior vaccination and not tested for covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and has no other medications received in 2 weeks of vaccination. The patient reported to have spoken to so many women about effects on menstrual cycle and delayed periods and was asking why this information was not disclosed. She had  heard of so many women where this was happening, and estrogen levels were so high. She will not give any of these vaccines to her kids after her experience and hearing from others as she did not want to mess with their hormones. She instructed the company to figure out what was going on and disclose it to the public because the company will risk losing credibility for the world on these shots. She further stated that she used to make fun of people who said it messed with fertility as a conspiracy theorist, and she felt like she got played.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: mild sore arm and hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 25 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "mild sore arm and hand".  Additional information: The patient asked if she can use a self-tanner like a mousse. She had 1st dose of Pfizer vaccine. Also mentioned had a mild sore arm and hand, nothing major.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Churning of stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Apr2021 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 19Apr2021, outcome "recovered" (2021), described as "Churning of stomach". Therapeutic measures were not taken as a result of nausea.  Additional information: It was unknown if the patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The reporter classified the events as non-serious. Since the vaccination, it was unknown if the patient has been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: light headed; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 (Lot number: Er8727) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaemia" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. Past drug history included: Doxycycline, reaction(s): "Known allergies: Doxycycline", notes: Known allergies: Doxycycline. The following information was reported: DIZZINESS (non-serious), outcome "recovering", described as "light headed"; PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "sore arm". Therapeutic measures were taken as a result of dizziness, pain in extremity.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Oligodipsia
Clinical narrative: Not Eating; Not drinking; Not Eating; Not drinking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DECREASED APPETITE (non-serious), OLIGODIPSIA (non-serious), outcome "unknown" and all described as "Not Eating; Not drinking".  Additional information: The reporter wanted to know that how long do the side effects last because her husband had all the side effects, they got the shot Sunday and he is not eating, he is not drinking, what she supposed to do. she can't take him to the hospital. Reporter clarified as her Husband was experiencing from the side effects, no he didn't wanna go to the hospital, we will got all the virus there.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got the shot and was sick for two hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "got the shot and was sick for two hours".  Additional information: Investigation Assessment: Not Provided. The reporter adds that she felt fine within a few hours. Her arm did not hurt. She was sick for like 2 and a half hours but then it completely went away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional Information: Getting a second covid shot. Took an aspirin last night. Inquiring if it would affect the vaccine. Clarified aspirin was not related to the first covid vaccine, called just had a headache. The patient had headache after getting the first vaccine.     No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: Shot 1 - arm pain at injection site/Shot 2 - arm pain at injection site; moderate headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: ER8729) at the age of 55 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. Vaccination history included: Bnt162b2 (Product:COVID 19, Lot number: ER8732, Lot unknown:False, Administration date:24Mar2021, Administration time:04:45 PM, Vaccine location: Left arm, Dose number:1, Shot 1 - arm pain at injection site), administration date: 24Mar2021, when the patient was 55 years old, for COVID-19 Immunisation, reaction(s): "Shot 1 - arm pain at injection site". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 15Apr2021 15:00, outcome "not recovered", described as "Shot 1 - arm pain at injection site/Shot 2 - arm pain at injection site"; HEADACHE (non-serious) with onset 15Apr2021 15:00, outcome "not recovered", described as "moderate headache". Therapeutic measures were not taken as a result of vaccination site pain, headache.   Additional information: Facility type vaccine was School or Student Health Clinic. There was Report about COVID vaccine. There was no other vaccine in four weeks. Reporter was not COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.