chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Peripheral coldness, SARS-CoV-2 test
Clinical narrative: had some pain in his arm and now pain has gone away; weakness; he has been feeling fatigue and tiredness in general for 3 days; dizziness; malaise in his whole body; feels his feet are cold; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing); "COVID-19", start date: Dec2020, stop date: Dec2020, notes: contracted the Covid 19 infection in DEC 2020. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "had some pain in his arm and now pain has gone away"; ASTHENIA (non-serious), outcome "unknown", described as "weakness"; FATIGUE (non-serious), outcome "unknown", described as "he has been feeling fatigue and tiredness in general for 3 days"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; MALAISE (non-serious), outcome "unknown", described as "malaise in his whole body"; PERIPHERAL COLDNESS (non-serious), outcome "unknown", described as "feels his feet are cold". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : Patient wants to know if the side effects that he is presenting are reported with the COVID-19 vaccine, he received the first dose on a Pharmacy, he is a diabetic patient, the day of the administration he presented pain in his arm that eventually went away (after 3 days), since 3 days ago until now the patient has presented weakness, fatigue and tiredness, dizziness y general body malaise similar to when he was infected with the COVID-19 virus (he had the infection in December), additionally he also developed cold feet, he is currently taking Tylenol. He also mentioned that he feels like he is "drugged with medications". Referred to his physician for treatment recommendation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Ultrasound therapy
Clinical narrative: she experienced severe lymphedema in arms and second dose was not as bad; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Chemo drugs for unknown indication. The following information was reported: LYMPHOEDEMA (non-serious), outcome "unknown", described as "she experienced severe lymphedema in arms and second dose was not as bad". Relevant laboratory tests and procedures are available in the appropriate section.  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
Clinical narrative: aches; 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: vertigo; tinnitus; 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 male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Relevant medical history included: "tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "vertigo"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Tremor
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient's parent). A 17-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 17, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced back pain/slight back pain and tremor (when she stands up, left leg keeps shaking), with outcome of unknown. Additional Information: The mother reported her 17-year-old daughter took the first vaccine dose at 9:30 am. Her daughter never had a flu shot or vaccine of this kind. She reported they waited the recommended 15 minutes after getting the vaccine. They went home and about 30 minutes after, her daughter started having back pain/slight back pain. When patient stood up her leg was shaking. Her left leg kept shaking alone. It came and went. The mother asked if this was normal or should she be concerned. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: I have a friend who said she felt like she was high on drugs. I didn't have control of my body. I had trouble getting into the garage; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) 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: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I have a friend who said she felt like she was high on drugs. I didn't have control of my body. I had trouble getting into the garage".  Additional information: It was reported that Caller was asking for her mom who is  due to get the vaccine tomorrow: verified inquiry is for the Pfizer vaccine her mom (age 79) has allergies to medications: sulfa, bactrim, amoxil, quinolones, cipro, zetia, levaquin rmadyne: lowered her blood pressure most dangerous for hercertain steroids imaging dye. She received the 2nd shot of the Pfizer vaccine last Friday. Everything was good until 2 and 3 hours into she was outside she felt like she was drugged, she was slow and was swaying. She had trouble getting her feet to step up into the garage. Through the rest of the night, stayed in bed, didn't like that feeling and didn't want to fall. 2 other friends the same thing happened to them (they too had the Pfizer vaccine). Everything was fine except that feeling. That lasted most of that day, that evening. when she woke up the next she felt ok. And no issues after that. She did not have control of my body. she had trouble getting into the garage. She had a friend who said she felt like she was high on drugs.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly male patient 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: Bnt162b2 (1st Dose), for Covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm".  Additional Information: consumer reported for a male patient (father) that: reporter worked in medical information and a friend from (state name) texted reporter at 13:00 on 13Apr2021 to tell reporter that her Dad (elderly male) received dose 2 of the Pfizer-BioNTech covid-19 vaccine and had a sore arm for 24 hours. Reporter have no other details to provide.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Laboratory test abnormal
Clinical narrative: lab work came back abnormal; This is a spontaneous report received from a non-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: LABORATORY TEST ABNORMAL (non-serious), outcome "unknown", described as "lab work came back abnormal". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The reporter stated that the patient had recent lab work came back abnormal after took the Pfizer COVID-19 Vaccine. The reporter wanted to know if the clinical trial showed these types of results.  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
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (115193). A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunization. The patient experienced pain ("she hurt all over"), with outcome of unknown. Additional information: Patient posted online she was "up all that day after the second Pfizer shot and she hurt all over." No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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. Other Case identifier(s): US-PFIZER INC-2021422152 (pfizer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "She has a Hx of pain" (unspecified if ongoing), notes: (unclear where) and takes pain medication for it. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: First, Lot no: Unknown), administration date: 22Mar2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional information: Patient reports she is feeling fine after receiving the second shot other than waking up this morning (as reported) with a sore arm. States the pain is not bad at all.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: felt sleepy/slept; Tired; 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 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 (Lot number: EN6206) at the age of 65 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: SOMNOLENCE (non-serious) with onset 13Mar2021, outcome "unknown", described as "felt sleepy/slept"; FATIGUE (non-serious) with onset 13Mar2021, outcome "recovered" (16Mar2021), described as "Tired".  Additional Information: Investigational assessment was done for dose 1. Patient stated that she was tired and slept. Tired adverse event started, the day after the first vaccine. Patient slept abnormally for 4 days and then she was okay. Sleeping and kept hoping it would go away like the first one but states it is going on 2 weeks now and it is so painful. Patient reported that she was on insurance and not everything recovered. Stated she wants to know if this is normal or if she should go to hospital.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021426776 same reporter/drug, different patient/AE
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: Hurting in arm with movement/in his right arm where he got his shot; his arm would bother him when he would lift it up or move it.; 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 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 06:12 (Lot number: ER8727) 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: LIMB DISCOMFORT (non-serious) with onset 25Mar2021, outcome "unknown", described as "his arm would bother him when he would lift it up or move it."; VACCINATION SITE PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "Hurting in arm with movement/in his right arm where he got his shot". Additional information: Caller is a 46 year old male patient who received his 1st dose of the Pfizer COVID Vaccine on 25/Mar/2021 and after a couple of days after, who noticed that his arm would bother him when he would lift it up or move it. He could not describe how it bothers him but he denied pain or weakness. He is schedule for his 2nd dose today and is asking if this would affect his 2nd dose. Caller stated he felt a pinch when getting the shot. After a few days, when he was sleeping and woke up, he was feeling a little pain in his arm but only with movement. He was wondering if there had been reports of pain in the arm. It was verified with caller pain location, in his right arm where he got his shot and only with movement. Why was the patient taking Covid shot, Pfizer (Verbatim): Everybody wanted to be safe. Other Products: No. Patient History: No. Investigation Assessment: Not Provided. History of all previous immunization with the Pfizer vaccine considered as suspect: No. Additional Vaccines Administered on Same Date of the Pfizer Suspect: No. Emergency Room: No. Physician Office: No. If the patient was hospitalized, how many days was the hospital stay: N/A. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: developed blurred  vision 30 minutes after the dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VISION BLURRED (non-serious), outcome "unknown", described as "developed blurred  vision 30 minutes after the dose".  Additional information: Mother Calling on behalf 18 old daughter who received the Pfizer Covid vaccine on 14 Apr 2021 and developed blurred  vision 30 minutes after the dose. The reporter asked if this was a common side effect that has been reported  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: long term fatigue beyond 4-5 days; 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 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: FATIGUE (non-serious), outcome "unknown", described as "long term fatigue beyond 4-5 days".  Additional information: The reporter enquired that if they were recommended patients who received their second dose of the vaccine if they had this type of reaction. The reporter stated all of the patients were older and immunocompromised and she did not think these were adverse reactions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021422097 Same reporter, event, product/ different patient;US-PFIZER INC-2021422098 Same reporter, event, product/ different patient
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), on Apr 13, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown, date of administration: unspecified), for immunization. The patient had a headache/dull headache, with outcome of unknown. Additional information: He called to ask if he can take Advil. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: He said that he doesn't feel very well after the first dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (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: MALAISE (non-serious) with onset 13Apr2021, outcome "unknown", described as "He said that he doesn't feel very well after the first dose.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Influenza
Clinical narrative: Fever; coldorflu; Cold or Flu; chill; dizziness; not feeling the best/not feeling well; headache; Nausea; 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 parent. Other Case identifier(s): PFIZER INC-2021405777 .  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold or flu"; INFLUENZA (non-serious), outcome "unknown", described as "Cold or Flu"; CHILLS (non-serious), outcome "unknown", described as "chill"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling the best/not feeling well"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional information: reporter stated her son (patient) was due for the second dose tomorrow (as reported). he has been experiencing chill, dizziness, nausea , fever, headache, and not feeling well. reporter thinks that he may have some cold or flu and its nothing to do with the vaccine. Reporter  wanted to know is it ok take the second dose. Reporter wanted to know about the timing for the second dose. Response: Spoke from the attached document. Reporter  was wondering if he can still receive the 2nd vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pyrexia
Clinical narrative: Fever; coldorflu; Cold or Flu; chill; dizziness; not feeling the best/not feeling well; headache; Nausea; 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 parent. Other Case identifier(s): PFIZER INC-2021405777 .  A 16 year-old male patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold or flu"; INFLUENZA (non-serious), outcome "unknown", described as "Cold or Flu"; CHILLS (non-serious), outcome "unknown", described as "chill"; DIZZINESS (non-serious), outcome "unknown", described as "dizziness"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "not feeling the best/not feeling well"; HEADACHE (non-serious), outcome "unknown", described as "headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional information: reporter stated her son (patient) was due for the second dose tomorrow (as reported). he has been experiencing chill, dizziness, nausea , fever, headache, and not feeling well. reporter thinks that he may have some cold or flu and its nothing to do with the vaccine. Reporter  wanted to know is it ok take the second dose. Reporter wanted to know about the timing for the second dose. Response: Spoke from the attached document. Reporter  was wondering if he can still receive the 2nd vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Infectious mononucleosis
Clinical narrative: Mononucleosis; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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: INFECTIOUS MONONUCLEOSIS (non-serious) with onset 05Mar2021, outcome "unknown", described as "Mononucleosis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pharyngitis streptococcal
Clinical narrative: strep throat; 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 male patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (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: PHARYNGITIS STREPTOCOCCAL (non-serious) with onset 2021, outcome "unknown", described as "strep throat".  Additional information: It was reported that, patient got his 1st dose of the vaccine on 27Mar2021 and scheduled for the 2nd dose on 17Apr2021. He said he got Strep throat after getting the 1st dose of the vaccine and his doctor prescribed him an antibiotic. He said he hasn't started taking in the antibiotic yet and is still waiting for a call from the pharmacy where he will get the antibiotic. He wants to know if he can still take the 2nd dose of the vaccine even if he still has Strep throat.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2021 16:30 (Lot number: EL3246) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "TIA" (unspecified if ongoing), notes: history of TIAs, occasional once a month migraines; "Migraine" (unspecified if ongoing), notes: history of TIAs, occasional once a month migraines. The patient took concomitant medications. Past drug history included: Flexeril, reaction(s): "Drug allergy", notes: Flexeril, developed a rash, that's it.; Flexeril, reaction(s): "Rash", notes: Flexeril, developed a rash, that's it. Vaccination history included: Bnt162b2 (Dose number=1, Lot number: EK5730, Administration time: 08:00 AM, Vaccine location=Right arm), administration date: 18Dec2020, when the patient was 51 years old, for Covid-19 immunisation. The following information was reported: MIGRAINE (non-serious) with onset 25Jan2021 19:00, outcome "not recovered", described as "migraines". The event "migraines" was evaluated at the physician office visit. Therapeutic measures were taken as a result of migraine.  Additional information: The patient had no other vaccine in four weeks. The patient had no other medications in two weeks. Migraines started January 26th, increased to 6-7 times a week in early February, had not decreased since though the patient tried multiple preventive medications. Had to go on medical leave from work, seeing a neurologist and still trying to get migraines under control. For adverse event the patient tried different abortive and preventive meds. The patient had no covid prior vaccination. The patient had not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: had diarrhea twice; vomiting all afternoon; 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 15Feb2021 (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: DIARRHOEA (non-serious), outcome "unknown", described as "had diarrhea twice"; VOMITING (non-serious), outcome "unknown", described as "vomiting all afternoon".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Has a sore throat; Stuffy nose; 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 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 was not reported. The patient took concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Has a sore throat"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Stuffy nose". Therapeutic measures were taken as a result of oropharyngeal pain, nasal congestion.  Additional information: Patent took Benadryl  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Fatigue, Hepatic enzyme increased, Limb discomfort, Mammoplasty
Clinical narrative: This is a spontaneous report received from non-contactable reporter(s) (Other HCP) for a Pfizer sponsored program. A 58 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for Covid-19 immunisation; palbociclib (IBRANCE), administration date 04Feb2020 (Batch/Lot number: unknown) as 125 mg, 1x/day for breast cancer. Relevant medical history included: "hard time sleeping with some bruising/swelling/irritated breast/chest/abdominal skin" (unspecified if ongoing); "tired" (unspecified if ongoing); "decreased appetite" (unspecified if ongoing); "weight stable" (unspecified if ongoing); "hip/back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 13Mar2021, for Covid-19 immunisation, reaction(s): "increased headache". The following information was reported: FATIGUE (non-serious), LIMB DISCOMFORT (non-serious), outcome "recovered" and all described as "she was more tired with sore arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient reports Ibrance on hold for 1 week 17Mar2021-24Mar2021. Patient reported that Ibrance manufactured by Pfizer. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling on his underarm; 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 male patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (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 (1st dose,manufacturer unknown), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 14Apr2021, outcome "unknown", described as "swelling on his underarm".  Additional information:Event Verbatim: Caller refused to provide last name. He mentioned that he received his 2nd dose of the Pfizer COVID Vaccine on Monday and last night he noticed that there was swelling on his underarm area on the arm he got the shot. On the papers he received, it does say something about injection swelling but nothing about underarm swelling. He mentioned that he searched the internet and saw that there was a possibility of lymph node swelling in the underarm. He is asking if this has been reported and for what to do.  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: Loss of personal independence in daily activities, Lymph node pain, Lymphadenopathy, Vaccination site pain, Vaccination site swelling
Clinical narrative: The pain is so bad it woke me up in the night; she has a ball under her armpit and the left arm was where the vaccine was administered; She is good if she sits still. Any movement kills her. She can't get comfortable.; severe swelling under my left armpit/Extremely swollen lymph nodes under the left armpit; Soreness of injection arm; 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), administered in arm left, administration date 13Apr2021 13:30 (Lot number: ER8733) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibroid cysts in chest" (unspecified if ongoing), notes: Verbatim: Fibroid cysts in chest: Diagnosed probably 8 years ago; "Flu and Pneumonia vaccines" (unspecified if ongoing); "soreness of the arm and fatigue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 14Apr2021 04:00, outcome "unknown", described as "severe swelling under my left armpit/Extremely swollen lymph nodes under the left armpit"; LYMPH NODE PAIN (non-serious), outcome "unknown", described as "The pain is so bad it woke me up in the night"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "she has a ball under her armpit and the left arm was where the vaccine was administered"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "She is good if she sits still. Any movement kills her. She can't get comfortable."; VACCINATION SITE PAIN (non-serious) with onset 13Apr2021, outcome "unknown", described as "Soreness of injection arm". Therapeutic measures were taken as a result of lymphadenopathy, lymph node pain, vaccination site swelling, loss of personal independence in daily activities, vaccination site pain.  Additional information: Extremely swollen lymph nodes under the left armpit happened again last night at 1AM on 15Apr2021 until 6AM. Treatment had been taking one Aspirin every day. Took one Aspirin late on 13Apr2021 and one at 4AM on 14Apr2021. After that, she took another Aspirin around 7AM. Then took two Ibuprofen. None of it is helping. Aspirin Lot number NAA6R06, EXP date Aug21, tablets as formulation and Dose was given at 325mg per tablet. Clarified Ibuprofen as Motrin and Lot number either 0KE2397A or OKE2397A is hard to see, Formulation in the form of caplets and Dose was given at 200mg per caplet. Prior vaccinations within 4 weeks was none. History of all previously immunizations was None. Family medical history was none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; 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), intramuscular, administered in arm left, administration date 15Feb2021 13:15 (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: Bnt162b2 (Dose number-1, Time-01:30 PM, Anatomical site of injection- Left arm, Route of administration: Intramuscular), administration date: 19Jan2021, for COVID-19 Immunization, reaction(s): "Fatigue".The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Feb2021, outcome "unknown", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information:Prior vaccinations within in 4 weeks and Relevant tests was none.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: stomach ache; diarrhea; 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 63 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: ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach ache"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  Additional information: Patient received first dose of the Pfizer BioNTech Covid 19 vaccine on Tuesday. She then developed a stomach ache then it went away, then the next day she had a stomach ache and diarrhea. Then "today" she was experiencing horrible pain in her stomach and diarrhea, similar to when she eats something with gluten (AE transmittal due to side effects, declined transfer to drug safety). Patient asked will her second dose be from the same Lot number. Patient asked if the vaccine contain gluten. Patient asked how does the vaccine work? How will be the second dose different from the first; How long will the diarrhea last; After getting vaccine, typically how soon the onset usually was; Will the side effects be worse than with the first dose?  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: developed headaches; 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 26 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: HEADACHE (non-serious), outcome "unknown", described as "developed headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Insomnia
Clinical narrative: Very tired; decreased appetite; sleeping less; less energy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), intramuscular (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: FATIGUE (non-serious), outcome "unknown", described as "Very tired"; DECREASED APPETITE (non-serious), outcome "unknown", described as "decreased appetite"; INSOMNIA (non-serious), outcome "unknown", described as "sleeping less"; ASTHENIA (non-serious), outcome "unknown", described as "less energy".  Additional Information: Patient received two doses of Pfizer vaccine. She was given appointments at 2 weeks (14 days) apart instead of three weeks apart. Patient reacted in a way that resembles Covid. She is very tired, have decreased appetite, sleeping less, and have less energy. She don't have a thermometer so don't know if she has a fever. She wants to know if she is protected if it was given too soon.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: pain from the fillings; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 11Apr2021 (Batch/Lot number: unknown) as dose 1,single for covid-19 immunisation. Relevant medical history included: "tooth cavities" (unspecified if ongoing), notes: She has since gone to the dentist to have cavities filled and has been experiencing pain from the fillings. Concomitant medication(s) included: TYLENOL; IBUPROFEN. The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "pain from the fillings".  Additional information:Caller states her daughter received the first Pfizer Covid vaccine on 11Apr2021. She has since gone to the dentist to have cavities filled and has been experiencing pain from the fillings. She wants to know how long does she need to wait before she takes Ibuprofen to treat the dental pain. Tylenol has not been working for her. Will e-transmit as potential AE. Response: Referred caller to HCP and spoke from attached document - use of fever reducing drugs and pain relievers (v2.0).She has since gone to the dentist to have cavities filled and has been experiencing pain from the fillings.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Off label use, Product use issue
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Apr2021 13:30 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes; "Rhinitis" (unspecified if ongoing), notes: Non-allergic rhinitis. Concomitant medication(s) included: CETIRIZINE; DIPHENHYDRAMINE; FLUNISOLIDE. The following information was reported: MYALGIA (non-serious) with onset 13Apr2021, outcome "recovering", described as "Myalgia"; HEADACHE (non-serious) with onset 13Apr2021, outcome "recovering", described as "Headache"; FATIGUE (non-serious) with onset 13Apr2021, outcome "recovering", described as "Tiredness"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 13Apr2021 13:30, outcome "unknown" and all described as "My nursing 8 month old infant developed symptoms of Upper Respiratory disease (nasal discharge, cough) the evening of the date I received my first dose". Therapeutic measures were not taken as a result of myalgia, headache, fatigue. Additional Information: Patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202101083251 maternal/child.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, SARS-CoV-2 antibody test
Clinical narrative: diarreaha for 3 days and then went away; 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) (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 (1st dose of covid vaccine), for Covid-19 immunization. The following information was reported: DIARRHOEA (non-serious), outcome "recovered", described as "diarreaha for 3 days and then went away". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She was also on immunosuppressant therapy. After second covax had diarreaha for 3 days and then went away.  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, Peripheral swelling
Clinical narrative: she noticed her arm was "slightly slightly" swollen; arm "sore" and it's given her a "little bit of pain".; 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 female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (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: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "she noticed her arm was "slightly slightly" swollen"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm "sore" and it's given her a "little bit of pain".".  Additional information: It was reported that she slept on that side mostly it could have made her arm "sore" and it's given her a "little bit of pain". She asked if she could exercise this arm and for treatment recommendations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to chemicals
Clinical narrative: Allegry to chemical compound; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "stroke" (unspecified if ongoing); "she had shortness of breath" (unspecified if ongoing), notes: they had to give her something for breathing. Concomitant medication(s) included: ASPIRIN (E.C.) taken for blood pressure measurement, blood cholesterol. Past drug history included: Streptomycin, reaction(s): "Allergic reaction", notes: 40 years ago. The following information was reported: ALLERGY TO CHEMICALS (non-serious), outcome "unknown", described as "Allegry to chemical compound".  Additional information: Her mother is scheduled to receive the Pfizer covid 19 vaccine in 2 days. She looked up the chemical compound and can't tell if is in the vaccine, it could be maybe related to penicillin. Patient had no problem with amoxicillin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.