chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt "terrible" for two 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 parent.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (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: MALAISE (non-serious) with onset 2021, outcome "recovering", described as "felt "terrible" for two days".  Additional information: The caller was concerned about taking the second dose of the vaccine due to the type of reaction that he experienced. He stated that his daughter was a Nurse Practitioner in Sweden, and she just received the second dose of the Pfizer COVID-19 vaccine last weekend and felt "terrible" for two days but now she felt fine. He stated that if he knew he would have that type of reaction he would move forward with receiving the second dose, however he was concerned about his blood pressure dropping and the dizziness. He would like to know if there are any recommendations on receiving the second dose of the Pfizer COVID-19 vaccine after experiencing this sort of reaction with the first dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "many allergies" (unspecified if ongoing); "allergy to sulfur" (unspecified if ongoing); "allergy to gatorade" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; NEXIUM [ESOMEPRAZOLE SODIUM]; MONTELUKAST; PRAVASTATIN; VALTREX. Vaccination history included: Bnt162b2 (Lot number: EN6200 in left arm at 16:00 as dose 1, single), administration date: 26Feb2021, when the patient was 71 years old, for COVID-19 immunisation, reaction(s): "Hives", "Swollen lymph nodes in neck", "Rash on legs". The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional information: Patient's medical history included "fibro" (as reported). The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Cystitis, Headache
Clinical narrative: Bladder infection; headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Mar2021 15:40 (Lot number: EN6205) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NITROFURANTOIN MACROCRYSTALS taken for cystitis, start date: 15Mar2021.  The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "headaches"; CYSTITIS (non-serious) with onset 10Mar2021, outcome "recovering", described as "Bladder infection". Therapeutic measures were taken as a result of headache, cystitis.   Additional information: Concomitant Medications: Caller reports that she thinks the previous antibiotic she was on, was probably the same thing that she was on now, the Nitrofurantoin macro, just a different dose, because they started her on a stronger dose and then lessened the dose. Patient had no prior vaccinations within 4 weeks of suspect administration. Patient had no family medical history relevant to adverse events. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). Caller states she had a little headache after the first dose of the vaccine. The headache lasted into the first week after the first dose of the vaccine; 11Mar2021 or 12Mar2021. Caller does not know start date of the headache and does not know exact end date. Patient took Ibuprofen headache.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fatigue, Migraine, Pain, SARS-CoV-2 test
Clinical narrative: Migraine; Body ache; Condiiton worsened; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 13:00 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, administration time: 10:00 AM, vaccine location: Left arm), administration date: 01Mar2021, when the patient was 42 years old, for COVID-19 Immunization, reaction(s): "migraine", "chills", "fatigue". The following information was reported: MIGRAINE (non-serious) with onset 22Mar2021 13:05, outcome "not recovered", described as "Migraine"; PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Body ache"; CONDITION AGGRAVATED (non-serious) with onset Mar2021, outcome "not recovered", described as "Condiiton worsened"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of migraine, pain, fatigue.  Additional information: Patient received most recent Covid-19 vaccine in Health Clinic facility. Patient did not received any other vaccines within 4 weeks prior to Covid-19 vaccine. Patient was not diagnosed with Covid-19 prior to vaccination. Patient was not tested for Covid-10 since vaccination. Patient did not have any known allergies to medications, food or other products.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder
Clinical narrative: He seen his lung specialist and they are putting him on Prednisone; 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-2021376985 (Pfizer).  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: LUNG DISORDER (non-serious), outcome "unknown", described as "He seen his lung specialist and they are putting him on Prednisone". Therapeutic measures were taken as a result of lung disorder.  Additional information: Patient got his 1st dose last week and today he seen his lung specialist and they are putting him on Prednisone. He wants to know if that would be an issue with the Covid vaccine. Again stated he was prescribed prednisone 20mg to take for 5 days. He wants to know if this will interact with the first dose or the upcoming second dose of Pfizer COVID-19 vaccine. Patient stated that he did tell his doctor he had received the first dose of the vaccine during his appointment. Patient stated he was going to call his doctor to find out whether or taking the prednisone was necessary right now because he did not want it to interfere with the Pfizer COVID-19 vaccine. He states, "I don't want to take this prednisone and mess up the vaccine, I want it to work."   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: my hands looked like they were mittens; swelling and pain; my hands looked like they were mittens; swelling and pain; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 55 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: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Mar2021, outcome "unknown" and all described as "my hands looked like they were mittens; swelling and pain".  Additional information: Patient sometimes feels discouraged mostly when dropping things and unable to perform daily tasks due to pain. She is under Xeljanz and reports being off of Xeljanz for one week when received first Covid vaccination as per her doctor instructions. Her fingers were like fat sausages which is very unpleasant and pains a lot. Usually it hurts more when she uses her hands more and then settles back down and again hurts more at night. She was using Xeljanz for Crohn's syndrome (the symptoms are tapering down).   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-2021388243
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal, Paraesthesia
Clinical narrative: tingling on the upper lip  under the nose area, all that area; she took her heart rate and it was 101. She stated her heart rate was in the 90's the rest of the evening; 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), administered in arm left, administration date 16Mar2021 14:15 (Lot number: EN6204) as dose 1, snigle for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 16Mar2021, outcome "unknown", described as "tingling on the upper lip under the nose area, all that area"; HEART RATE ABNORMAL (non-serious) with onset 16Mar2021, outcome "unknown", described as "she took her heart rate and it was 101. She stated her heart rate was in the 90's the rest of the evening". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient wondered if anyone or others have reported this reaction before. Confirmed reaction with the patient. The patient stated about 4 hours after receiving her vaccine she started having tingling on the upper lip, under the nose area, all that area. She stated she took her heart rate and it was 101. She stated her heart rate was in the 90's the rest of the evening and that was not her normal. Confirmed with the patient product was Pfizer vaccine, COVID 19. The patient did not provide further details for this report. The patient stated she had just spoke with someone a little while ago and thought that the questions were getting too personal, when asked about filling out a report for Safety, she declined the report. The patient did not have a follow up report reference number to provide. The patient stated she would provide her email again and she would also provided the vaccine information and symptoms for this report.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dry throat, Nausea
Clinical narrative: nauseated; very weak; very dry throat; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 12:00 (Lot number: Ft hood) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: NAUSEA (non-serious) with onset 07Apr2021 06:00, outcome "recovering", described as "nauseated"; ASTHENIA (non-serious) with onset 07Apr2021 06:00, outcome "recovering", described as "very weak"; DRY THROAT (non-serious) with onset 07Apr2021 06:00, outcome "recovering", described as "very dry throat". Therapeutic measures were not taken as a result of nausea, asthenia, dry throat.  Additional information: The patient has no known allergies. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was sore; 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), administered in arm right (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 IN EXTREMITY (non-serious), outcome "recovered", described as "arm was sore".  Additional information: Patient stated that her arm was sore for few days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contractions involuntary, Muscle spasms
Clinical narrative: right calf muscle started contracting, like spasming; right calf muscle started contracting, like spasming; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER8733) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "squamous cell carcinoma on right shin, lower down by ankle" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot number: EN6205 in left arm at 09:45 as dose 1, single), administration date: 08Mar2021, when the patient was 59 years old, for COVID-19 immunisation. The following information was reported: MUSCLE CONTRACTIONS INVOLUNTARY (non-serious), MUSCLE SPASMS (non-serious) all with onset 29Mar2021, outcome "not recovered" and all described as "right calf muscle started contracting, like spasming". Therapeutic measures were taken as a result of muscle contractions involuntary, muscle spasms.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. It was further reported that she received her second dose of the Pfizer Covid Vaccine last Monday, and a few hours afterwards she experienced a muscle contraction and spasms in right calf. Patient stated she was taking Mag Complex Magnesium since the symptoms began, but it did not help. Patient reported that she was going now to an urgent care or something because it was not going away. Patient was scheduled to have her squamous cell carcinoma removed and was unsure if this has anything to do with the event, since it was on the same leg.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Brain scan normal, Concussion, Dizziness, Ear, nose and throat examination, Feeling abnormal
Clinical narrative: concussion syndrome; dizzy; head fuzzy, vertigo; nauseous with a sore neck; nauseous with a sore neck; head fuzzy, vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 (Lot number: Unknown) at the age of 64 years as dose 2, single and administered in arm left, administration date 31Jan2021 13:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CONCUSSION (non-serious) with onset 01Feb2021, outcome "recovered" (2021), described as "concussion syndrome"; DIZZINESS (non-serious) with onset 01Feb2021, outcome "recovered" (2021), described as "dizzy"; VERTIGO (non-serious), FEELING ABNORMAL (non-serious) all with onset 01Feb2021, outcome "recovered" (2021) and all described as "head fuzzy, vertigo"; NAUSEA (non-serious), NECK PAIN (non-serious) all with onset 01Feb2021, outcome "recovered" (2021) and all described as "nauseous with a sore neck". The events "concussion syndrome", "dizzy", "head fuzzy, vertigo", "nauseous with a sore neck", "nauseous with a sore neck" and "head fuzzy, vertigo" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of concussion, dizziness, vertigo, nausea, neck pain, feeling abnormal.  Additional information: After the first vaccine, Patient came down with reported event and all got worse after the second vaccine, has been like this now for the past few weeks. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Allergies to medications, food, or other products: none. Seriousness was reported as: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Nausea, Neck pain, Specialist consultation, Vertigo
Clinical narrative: concussion syndrome; dizzy; head fuzzy, vertigo; nauseous with a sore neck; nauseous with a sore neck; head fuzzy, vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 (Lot number: Unknown) at the age of 64 years as dose 2, single and administered in arm left, administration date 31Jan2021 13:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: CONCUSSION (non-serious) with onset 01Feb2021, outcome "recovered" (2021), described as "concussion syndrome"; DIZZINESS (non-serious) with onset 01Feb2021, outcome "recovered" (2021), described as "dizzy"; VERTIGO (non-serious), FEELING ABNORMAL (non-serious) all with onset 01Feb2021, outcome "recovered" (2021) and all described as "head fuzzy, vertigo"; NAUSEA (non-serious), NECK PAIN (non-serious) all with onset 01Feb2021, outcome "recovered" (2021) and all described as "nauseous with a sore neck". The events "concussion syndrome", "dizzy", "head fuzzy, vertigo", "nauseous with a sore neck", "nauseous with a sore neck" and "head fuzzy, vertigo" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of concussion, dizziness, vertigo, nausea, neck pain, feeling abnormal.  Additional information: After the first vaccine, Patient came down with reported event and all got worse after the second vaccine, has been like this now for the past few weeks. Patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Other medications the patient received within 2 weeks of vaccination: No. Prior to vaccination, the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. Allergies to medications, food, or other products: none. Seriousness was reported as: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: Dizziness; Funny feeling in my head; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 11:00 (Batch/Lot number: unknown) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Kidney stones" (unspecified if ongoing), notes: other medical history: Kidney stones, anxiety; "Anxiety" (unspecified if ongoing), notes: other medical history: Kidney stones, anxiety; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: TYLENOL; ATIVAN. The following information was reported: DIZZINESS (non-serious) with onset 20Mar2021 04:00, outcome "not recovered", described as "Dizziness"; FEELING ABNORMAL (non-serious) with onset 20Mar2021 04:00, outcome "not recovered", described as "Funny feeling in my head". The events "dizziness" and "funny feeling in my head" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, feeling abnormal.  Additional information: The patient was not received other vaccine in four weeks. The patient was not tested for covid post vaccination. The patient not had known allergies.  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, Hyperhidrosis
Clinical narrative: it made her extremely weak; sweated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 11:00 (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: HYPERHIDROSIS (non-serious) with onset 06Apr2021, outcome "recovered" (Apr2021), described as "sweated"; ASTHENIA (non-serious) with onset 07Apr2021, outcome "unknown", described as "it made her extremely weak".  Additional information: In the afternoon (06Apr2021), patient sweated which lasted through the night.   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, Dry throat, Paraesthesia, Paraesthesia oral
Clinical narrative: dry throat; Dizziness; Tingling of the tongue, roof of the mouth, around the lips, and on the face; Tingling of the tongue, roof of the mouth, around the lips, and on the face; Tingling of the tongue, roof of the mouth, around the lips, and on the face; Tingling of the tongue, roof of the mouth, around the lips, and on the face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 60 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: DIZZINESS (non-serious) with onset 25Mar2021, outcome "unknown", described as "Dizziness"; PARAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious), PARAESTHESIA ORAL (non-serious), PARAESTHESIA (non-serious) all with onset 25Mar2021, outcome "unknown" and all described as "Tingling of the tongue, roof of the mouth, around the lips, and on the face"; DRY THROAT (non-serious), outcome "unknown", described as "dry throat".  Additional Information: Caller mentioned that the young gentleman next to her experienced similar symptoms right after getting the Covid 19 Vaccine on 25 Mar 2021. They both had dizziness and tingling of the tongue, roof of the mouth, around the lips, and on the face. She also said that he had a dry throat. Up on Follow up on PRD/SRD 07Apr2021 A contactable 60 year old female reporter (patient) reported for herself that: Caller stated she already reported AE and was transferred. Caller is a consumer, (Withheld) "had first dose of the Pfizer COVID vaccine, after the first got really dizzy and had tingling around my mouth and tongue, around mouth and the roof of the mouth, especially the face and lips. It did go away, but She worried about a possibly worse reaction with second dose. There was also a young man that had same reaction. Responded per documents attached and referred back to her HCP for medical advice. Responded per Fact Sheet for Recipients and Caregivers, section: WHAT ARE THE RISKS OF THE PFIZER-BIONTECH COVID-19 VACCINE? As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. They refer her to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision.  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) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 08Apr2021 12:30 (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) with onset 08Apr2021, outcome "unknown", described as "Headache".  Additional Information: The reporter reported on behalf of patient (daughter) that, the patient had vaccine (Covid Vaccine) and had some headache, little bit of headache. The reporter wanted to know that can the patient could be given Tylenol or Ibuprofen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site paraesthesia
Clinical narrative: had tingling arm in the arm he had the shot in; tingling in his fingers that felt like pin and needles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Lot number: ER8729) 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 PARAESTHESIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "had tingling arm in the arm he had the shot in"; PARAESTHESIA (non-serious) with onset 07Apr2021, outcome "not recovered", described as "tingling in his fingers that felt like pin and needles".  Additional information: It was reported that right after when he received the shot he stayed a little longer and experienced the events. The pharmacist said to hangout a little longer so he stayed a half an hour and was now (day of report) driving home but was still experiencing the pin and needles.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Batch/Lot number: unknown) at the age of 74 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Bladder cancer" (unspecified if ongoing), notes: Verbatim: Bladder cancer, I don't know exact date but you can take a year.; "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for blood pressure abnormal. The following information was reported: HEADACHE (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: This report was not related to a study or programme. ATENOLOL (Pill, 25mg, once a day). He had Covid shot on 25Mar2021 and for a last two days had been having headache. He took Advil and 2 Tylenol last night (guessed it was 250 but took 2 so its 500 mg, yesterday, he took a twice yesterday and had not taken any today) for it but the same still lingering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Pain
Clinical narrative: body aches; Fatigue; diarrhea; headache; 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 24Mar2021 (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 (non-serious) with onset Mar2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "Fatigue"; DIARRHOEA (non-serious) with onset Mar2021, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache".  Additional information: The patient got his 1st dose on 24Mar2021 and 2 days after, he experienced adverse events such as fatigue, diarrhea, headache, and body aches. He wanted to know if he should still get the 2nd dose and or what will be the efficacy of the vaccine if he did not take the 2nd dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: Chills; Not feeling good; 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 02Apr2021 (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: CHILLS (non-serious) with onset Apr2021, outcome "unknown", described as "Chills"; MALAISE (non-serious) with onset Apr2021, outcome "unknown", described as "Not feeling good".  Additional information: Patient received first dose of the Pfizer vaccine on Friday and was told not to take any Advil and completely forgot and took couple of doses of Advil and "camkingi" (word not clarified) that have ruined the vaccine now. When paraphrased the concern, consumer stated, "Not Tylenol Advil. Patient was told to avoid Advil and should take Tylenol and forgot. Patient have been having chills, not feeling good and couples of doses of Advil between 03Apr2021 and 04Apr2021 and suddenly remember that patient was not supposed to take it. Patient asked was that going to ruin the efficacy of the vaccine or was it okay because patient reading the articles, they are saying it was perfectly ok.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Communication disorder, Condition aggravated, Toothache
Clinical narrative: toothache ever since that has gotten worse/left upper dental pain; toothache ever since that has gotten worse; He is having trouble talking; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 10:20 (Lot number: EW0150) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: He takes medicine for high blood pressure. The patient took concomitant medications.  The following information was reported: TOOTHACHE (non-serious) with onset 08Apr2021 10:00, outcome "not recovered", described as "toothache ever since that has gotten worse/left upper dental pain"; CONDITION AGGRAVATED (non-serious) with onset 08Apr2021 10:00, outcome "unknown", described as "toothache ever since that has gotten worse"; COMMUNICATION DISORDER (non-serious) with onset 08Apr2021 10:00, outcome "unknown", described as "He is having trouble talking".  Additional information: No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No patient's medical history (including any illness at time of vaccination). No relevant tests. Patient took the Pfizer Covid 19 vaccine on 7Apr2021 at 10:20 and on 08Apr2021, he developed a toothache ever since that has gotten worse/toothache in the upper left of his pallet. It is severe. The pain started on 08Apr2021 at 10:00 and has worsened through the night and is bad today. He is having trouble talking because of it. He has an appointment to see a dentist today, but he wanted to know has anyone reported a toothache when taking the vaccine. He has a dental appointment today at 11:20. He was recommended to consult with his HCP for further guidance. His physician knows nothing about this, so he hasn't contacted him. He takes medicine for high blood pressure but doesn't think it has anything to do with what he's experiencing.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Burning sensation, Fatigue
Clinical narrative: burning pain in her thigh; weakness; tiredness; back pain; 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 03Apr2021 (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: BURNING SENSATION (non-serious) with onset Apr2021, outcome "unknown", described as "burning pain in her thigh"; ASTHENIA (non-serious) with onset Apr2021, outcome "unknown", described as "weakness"; FATIGUE (non-serious) with onset Apr2021, outcome "unknown", described as "tiredness"; BACK PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "back pain".  Additional information: Verbatim and Event Description: Caller (Withheld) is reporting adverse events after getting the first dose on Saturday 03APRIL2021, she's experiencing burning pain in her thigh, weakness, tiredness, and back pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Chills, Dry skin, Fatigue
Clinical narrative: muscular pain; tiredness; his vaccination site is also very sore; Nervous; achy body; chills; Feeling sick; feeling rough; Shaky; Achy lower back like in the liver or kidney area; headache; not being able to sleep well; anxious 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 56 year-old male patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Lot number: EW0158) at the age of 56 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 (Manufacturer Unknown, Dose 1.), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "achy body"; MYALGIA (non-serious), outcome "unknown", described as "muscular pain"; HEADACHE (non-serious) with onset 08Apr2021, outcome "unknown", described as "headache"; INSOMNIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "not being able to sleep well"; ANXIETY (non-serious) with onset 08Apr2021, outcome "unknown", described as "anxious feeling"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; CHILLS (non-serious) with onset 08Apr2021, outcome "unknown", described as "chills"; MALAISE (non-serious) with onset 08Apr2021, outcome "unknown", described as "Feeling sick"; DRY SKIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "feeling rough"; NERVOUSNESS (non-serious) with onset 08Apr2021, outcome "unknown", described as "Shaky"; BACK PAIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "Achy lower back like in the liver or kidney area"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "his vaccination site is also very sore"; NERVOUSNESS (non-serious) with onset 08Apr2021, outcome "unknown", described as "Nervous".  Additional Information: The information provided as per medical information requested and there was no product complaint, no other conditions and investigations to report. NDC number and expiry date for Lot number was not provided. Patient administered 2 Alka-Seltzer tablets with about 8 ounces of water to treat adverse events headache, chills, feeling sick, achy all over, anxious which helped the patient. For events insominia and back pain patient administered Ibuprofen and Gabapentin. Patient was injured previously and took therapeutic measures for pain in his back.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Malaise, Myalgia, Nervousness
Clinical narrative: muscular pain; tiredness; his vaccination site is also very sore; Nervous; achy body; chills; Feeling sick; feeling rough; Shaky; Achy lower back like in the liver or kidney area; headache; not being able to sleep well; anxious 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 56 year-old male patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Lot number: EW0158) at the age of 56 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 (Manufacturer Unknown, Dose 1.), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "achy body"; MYALGIA (non-serious), outcome "unknown", described as "muscular pain"; HEADACHE (non-serious) with onset 08Apr2021, outcome "unknown", described as "headache"; INSOMNIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "not being able to sleep well"; ANXIETY (non-serious) with onset 08Apr2021, outcome "unknown", described as "anxious feeling"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; CHILLS (non-serious) with onset 08Apr2021, outcome "unknown", described as "chills"; MALAISE (non-serious) with onset 08Apr2021, outcome "unknown", described as "Feeling sick"; DRY SKIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "feeling rough"; NERVOUSNESS (non-serious) with onset 08Apr2021, outcome "unknown", described as "Shaky"; BACK PAIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "Achy lower back like in the liver or kidney area"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "his vaccination site is also very sore"; NERVOUSNESS (non-serious) with onset 08Apr2021, outcome "unknown", described as "Nervous".  Additional Information: The information provided as per medical information requested and there was no product complaint, no other conditions and investigations to report. NDC number and expiry date for Lot number was not provided. Patient administered 2 Alka-Seltzer tablets with about 8 ounces of water to treat adverse events headache, chills, feeling sick, achy all over, anxious which helped the patient. For events insominia and back pain patient administered Ibuprofen and Gabapentin. Patient was injured previously and took therapeutic measures for pain in his back.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: muscular pain; tiredness; his vaccination site is also very sore; Nervous; achy body; chills; Feeling sick; feeling rough; Shaky; Achy lower back like in the liver or kidney area; headache; not being able to sleep well; anxious 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 56 year-old male patient received bnt162b2 (BNT162B2), administration date 08Apr2021 (Lot number: EW0158) at the age of 56 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 (Manufacturer Unknown, Dose 1.), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "achy body"; MYALGIA (non-serious), outcome "unknown", described as "muscular pain"; HEADACHE (non-serious) with onset 08Apr2021, outcome "unknown", described as "headache"; INSOMNIA (non-serious) with onset 08Apr2021, outcome "unknown", described as "not being able to sleep well"; ANXIETY (non-serious) with onset 08Apr2021, outcome "unknown", described as "anxious feeling"; FATIGUE (non-serious), outcome "unknown", described as "tiredness"; CHILLS (non-serious) with onset 08Apr2021, outcome "unknown", described as "chills"; MALAISE (non-serious) with onset 08Apr2021, outcome "unknown", described as "Feeling sick"; DRY SKIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "feeling rough"; NERVOUSNESS (non-serious) with onset 08Apr2021, outcome "unknown", described as "Shaky"; BACK PAIN (non-serious) with onset 08Apr2021, outcome "unknown", described as "Achy lower back like in the liver or kidney area"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "his vaccination site is also very sore"; NERVOUSNESS (non-serious) with onset 08Apr2021, outcome "unknown", described as "Nervous".  Additional Information: The information provided as per medical information requested and there was no product complaint, no other conditions and investigations to report. NDC number and expiry date for Lot number was not provided. Patient administered 2 Alka-Seltzer tablets with about 8 ounces of water to treat adverse events headache, chills, feeling sick, achy all over, anxious which helped the patient. For events insominia and back pain patient administered Ibuprofen and Gabapentin. Patient was injured previously and took therapeutic measures for pain in his back.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Albumin urine, Nausea, Pain in extremity, Vomiting
Clinical narrative: Nauseated; Threw up once, maybe twice; Soreness in right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 14:15 (Lot number: EW0158, Expiration Date: 31Jul2021) at the age of 80 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Verbatim: Arthritis in hands; "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (First dose:, NDC: Unknown, Lot: EN620X, Exp: 30Jun2021, Received in left arm), for COVID-19 Immunization, reaction(s): "I wasn't feeling so great so I did get sick", "Get sick to my stomach", "threw up one time two hours after the first shot". The following information was reported: NAUSEA (non-serious) with onset 28Apr2021, outcome "recovering", described as "Nauseated"; PAIN IN EXTREMITY (non-serious) with onset 27Apr2021, outcome "recovering", described as "Soreness in right arm"; VOMITING (non-serious) with onset 28Apr2021, outcome "unknown", described as "Threw up once, maybe twice". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She had the first shot on 01Apr2021. She got sick to her stomach and threw up one time two hours after the first shot. She got her second shot yesterday, 27Apr2021 at 14:15. She did not get sick yesterday, just had a sore arm. Ten minutes before 08:00 she had to thrown up one time. It wasn't a lot, but it happened just a short time ago. At 07:50 this morning she had not had any breakfast yet. Was getting ready to put breakfast together when she felt this feeling come over her. She dashed to the bathroom and threw up once, maybe twice, it wasn't much. She didn't have any food in her. She had taken a couple of pills earlier and doesn't know if those pills came up or not. The throwing up stopped and she thought that was probably it since she only threw up once after the first shot. Caller did not provide product names of pills she took earlier this morning.  No follow-up attempts are possible. No further information is expected.