chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  An elderly male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "EPISTAXIS (nose bleeds)", start date: Dec2021 (unspecified if ongoing), notes: nose bleeds.; "Allergy" (unspecified if ongoing), notes: (pneumonia shot). The patient's concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-platelet factor 4 antibody test, Asthenia, Biopsy muscle, Musculoskeletal discomfort, SARS-CoV-2 test
Clinical narrative: Jan and Feb I got the 1st 2 shots in my left shoulder, within a month I begin to get extreme weakness in my both shoulders; Jan and Feb I got the 1st 2 shots in my left shoulder, within a month I begin to get extreme weakness in my both shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 25Jan2021 (Lot number: EH9899) at the age of 73 years as dose 1, single and administered in deltoid left, administration date 15Feb2021 (Lot number: EN9581) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Graves disease", start date: 1970 (unspecified if ongoing), notes: Stop date: Only took meds one year for Graves. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), ASTHENIA (non-serious) all with onset 2021, outcome "unknown" and all described as "Jan and Feb I got the 1st 2 shots in my left shoulder, within a month I begin to get extreme weakness in my both shoulders". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: consumer stated, "You have the dates out of order, Jan and Feb I got the 1st 2 shots in my left shoulder, within a month I begin to get extreme weakness in my both shoulders.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200038441 same reporter/SD, different patient
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Physician).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; lenvatinib mesilate (LENVIMA), since 27Dec2021 (ongoing) (Batch/Lot number: unknown) at 10 mg. Relevant medical history included: "Endometrial Cancer" (unspecified if ongoing), notes: Medical History. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". The action taken for lenvatinib mesilate was unknown.  Additional Information: The action taken for bnt162b2 and lenvatinib mesilate was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Investigation
Clinical narrative: Felt a little bit fluey; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 08:00 (Lot number: EN6204) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mast cell activation syndrome" (ongoing); "Several autoimmune situations" (ongoing), notes: The tissue autoimmune to thyroid, bone, liver and nerve to sheath. Patient has had for many years. There were no concomitant medications. Vaccination history included: Flu vaccine, for Immunization, reaction(s): "little bit fluey"; Rabies booster (the rabies booster was a good 20 years ago), for Immunization, reaction(s): "little bit fluey". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 11Mar2021, outcome "recovered" (12Mar2021), described as "Felt a little bit fluey". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Vaccine was not administered at special Facility. No additional vaccines administered on same date of Pfizer suspect. No other vaccines received within 4 weeks prior to Pfizer vaccine. Patient felt a little bit fluey after receiving first dose Adult Pfizer Vaccine. The patient stated feeling a little bit fluey began on 11Mar2021, the day after receiving the first dose and went away within 24 hours and the caller recovered 100% completely. Investigation Assessment was reported.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Nipple disorder
Clinical narrative: benign growth on my left nipple; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Lot number: EW0177) 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: NIPPLE DISORDER (non-serious), outcome "unknown", described as "benign growth on my left nipple". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: Patient was also Reporter. COVID-19 Vaccine is a Pfizer product. About Height and weight of Pharmacist, Pharmacist stated that her height is 5 (feet) 3 (inches) or 5 (feet) 4 (inches) and her weight is, Patient do not dare to weight herself, she is so fat, she think she is in like 170 or 173 (pounds)." Pharmacist stated, "No, the card does not provide that page and she is a pharmacist, nobody is writing and she also participated on vaccination, that information is not given on the patient card and the Pfizer does not provide that information. Pharmacist stated that she was not sure that the registry to the CDC might give that information but not at the level of patient on the vaccination card that information is not there". Pharmacist stated, "No, they did not put that. They are only putting the name and the LOT number using the CDC card and just the day it was administered, there is no information of the vaccine expiration date or what so ever. The CDC card does not annotate that". Pharmacist stated, "In her case, she got it on the left arm and actually two days after he got a reaction on her nipple and we do not know, she got black a reaction and had to have a biopsy on her nipple and that came two days after she got her first vaccine, it came out as benign growth, but it was very interesting that she got that immediately two days after the vaccination and my son, she think he also because we are right handed so got vaccinated on the left hand, on the left arm." She got a growth a benign growth on her left nipple which was not there it's invisible and she got a biopsy done." Patient got the same EW0177 for the first dose.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101870644 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; 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 14May2021 (Lot number: EW0182, Expiration Date: 31Aug2021) 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, single, lot EW0172 and expiry date 31Aug2021), administration date: 23Apr2021, for COVID-19 immunization. The following information was reported: DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath".  Additional Information: She received her second dose and experienced shortness of breath over the summer. It seemed weird that the patient never had shortness of breath and after the shot she did. She Reporter wanted to know whether anyone else reported residual side effects of shortness of breath with Pfizer Covid vaccine. The patient needs to get a booster shot but should she because she did not want to have the shortness of breath. She wanted to know if she should tell about the event to her general doctor or cardiologist. She wanted to know if she get the booster, would she have the same problem or not.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm; Fever; Exhausted; Achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Jan2022 (Lot number: FJ5683) at the age of 12 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0185, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 02Jun2021, when the patient was 11 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 12May2021, when the patient was 11 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Jan2022, outcome "recovered" (11Jan2022), described as "sore arm"; PYREXIA (non-serious) with onset 10Jan2022, outcome "recovered" (11Jan2022), described as "Fever"; FATIGUE (non-serious) with onset 10Jan2022, outcome "recovered" (11Jan2022), described as "Exhausted"; PAIN (non-serious) with onset 10Jan2022, outcome "recovered" (11Jan2022), described as "Achy". Therapeutic measures were not taken as a result of pain in extremity, pyrexia, fatigue, pain.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Facility type vaccine was Public Health Clinic/Administration facility.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the back of his lower right leg.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 6 year-old male patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Lot number: FK5127) at the age of 6 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1st , Lot Number / Expiry Date: FK5127/unknown, Route, Anatomical Location: unknown), administration date: 18Dec2021, when the patient was 6 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Jan2022, outcome "not recovered", described as "pain in the back of his lower right leg.".  Additional information: Caller calling on behalf of his friend's son. He reports his friend's 7 y/o son received their first Pfizer pediatric Covid vaccine dose on 07Jan2022 at 3 or 4 pm. The following day, 08Jan2022 he developed pain in the back of his lower right leg. He wants to know if this could be because of the vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Headache, Pyrexia
Clinical narrative: fever; Headache; Stated that at night time a fever gets worst so she is wondering if she can take something for the fever; 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 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 (Lot number: SL3198) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 11Jan2022, outcome "not recovered", described as "fever"; HEADACHE (non-serious) with onset 11Jan2022, outcome "recovering", described as "Headache"; CONDITION AGGRAVATED (non-serious) with onset 11Jan2022, outcome "not recovered", described as "Stated that at night time a fever gets worst so she is wondering if she can take something for the fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: The body temperature was measured as 102 degree Celsius and sometimes 100 degree Celsius Stated that now it is 101.8 degree Celsius to her forehead. Stated that she noticed two hours ago and it was 99.5 degree Celsius. The reporter stated that she had the Covid 19 yesterday. Stated that it was her first dose. Stated that today she had a fever. Wanted to know if this normal. Wanted to know if can take Alka Seltzer plus for fever. Wanted to know if can take Tylenol. Stated that she was checking the papers she received after the first dose and receiving the side effects. Stated that she does not see fever as the side effects. Wanted to know if she should go to be tested. Stated that this is the first time that she had the vaccine. Unable to clarify details. Multiple attempts made to redirect caller. Stated that at night time a fever gets worst so she is wondering if she can take something for the fever. Stated that her husband got the shot about a month ago and she is taking her kids on the weekend. Stated that she just went and got it. Does not provide a physicians name. Occupation/specialty, consent to contact, address, phone number and email address not provided. The patient was treated with Excedrin just for the headache.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: vaginal spotting; 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 20Apr2021 14:45 (Lot number: EW0170) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 01 at 02:45 PM (Lot Number: ER8730) Anatomical location: Left arm), administration date: 23Mar2021, when the patient was 27 years old, for Covid-19 immunization. The following information was reported: VAGINAL HAEMORRHAGE (non-serious) with onset 2021, outcome "unknown", described as "vaginal spotting".  Additional information: No other vaccine in four weeks. No prior covid vaccination. No known allergies. Patient had vaginal spotting for 3-4 days after her second dose.  Follow-up attempts are completed. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: one dose of undiluted vaccine, 0.2ml, was administered; one dose of undiluted vaccine, 0.2ml, was administered; Arm pain; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Jan2022 (Lot number: FL0007, Expiration Date: 21Feb2022) as dose number unknown, 0.2ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 08Jan2022, outcome "unknown" and all described as "one dose of undiluted vaccine, 0.2ml, was administered"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Arm pain".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Overdose, Product preparation error, Pyrexia
Clinical narrative: one dose of undiluted vaccine, 0.2ml, was administered; one dose of undiluted vaccine, 0.2ml, was administered; Mild Fever; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Jan2022 (Lot number: FL0007, Expiration Date: 21Feb2022) as dose number unknown, 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 08Jan2022, outcome "unknown" and all described as "one dose of undiluted vaccine, 0.2ml, was administered"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Mild Fever". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: One dose of undiluted vaccine, 0.2ml, was administered 3 times to 3 different patients. It was reported that an event in which the vaccine was administered undiluted and was looking for recommendations and guidelines in that situation.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: his left upper arm/shoulder, he got a severe pain when he was just doing normal things and he had never had that problem before; his left upper arm/shoulder, he got a severe pain when he was just doing normal things and he had never had that problem before/Both shoulders are pretty sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 (Lot number: EN6199, Expiration Date: 28Feb2022) at the age of 81 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Rotator Cuff surgery", start date: 2010 (unspecified if ongoing), notes: on right side; they replaced the joint; "blood pressure" (ongoing), notes: takes medication for blood pressure; "cholesterol" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single; Lot number: EN9581; Anatomical site: right arm), administration date: 12Feb2021, when the patient was 80 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "not recovered", described as "his left upper arm/shoulder, he got a severe pain when he was just doing normal things and he had never had that problem before"; ARTHRALGIA (non-serious) with onset Jul2021, outcome "not recovered", described as "his left upper arm/shoulder, he got a severe pain when he was just doing normal things and he had never had that problem before/Both shoulders are pretty sore".  Additional information: States that he has something going on with his upper arms where he got the vaccinations. It didn't start immediately. He got his 1st dose on 12Feb2021, 2nd dose on 05Mar2021, and booster dose on 22Oct2021. The symptoms started around mid-July; his left upper arm/shoulder, he got a severe pain when he was just doing normal things and he had never had that problem before. Then after the booster he had an intense pain from that one and it was still painful in the shoulder joint. His right arm, in 2010, he had surgery for the rotator cuff where they replaced the joint, and it was doing very good with no problems, but all the sudden about 2 weeks ago he was throwing something for his dog and he pulled something loose in there and now it was very painful. States that he was going to try to see an orthopedic surgeon. He was reading all that he was supposed to do within a year of getting the vaccines to report this stuff, so he was starting by reporting it to Pfizer. Something has changed since he had these shots. Both shoulders were pretty sore, but he was most worried about the right one; he cannot hardly use this right arm right now because he has really intense pain in his shoulder. It was reported as he did get a flu shot but he thinks it was more than 4 weeks before the booster dose.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hyperacusis, Hypoacusis, Tinnitus
Clinical narrative: I have never had ringing in my ears and when I had this, Its like a bad case of tinnitus; I can't hear; I hear like music very strange; now it's getting worse. In the afternoon I hear a motor, a constant noise in my ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Feb2021 (Lot number: EN5318) as dose 1, single and administered in arm left, administration date 25Feb2021 (Lot number: EN6203) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Patient history: Blood pressure; "Stenosis" (unspecified if ongoing); "back condition" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "Pain" (unspecified if ongoing); "antidepressant" (unspecified if ongoing). Concomitant medication(s) included: OXYCODONE taken for back disorder; ENALAPRIL taken for blood pressure abnormal; VENLAFAXINE taken for blood cholesterol; HYDROCODONE taken for pain; BUPROPION taken for antidepressant therapy. The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "I have never had ringing in my ears and when I had this, Its like a bad case of tinnitus"; HYPOACUSIS (non-serious), outcome "unknown", described as "I cant hear"; HYPERACUSIS (non-serious), outcome "unknown", described as "I hear like music very strange"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "now its getting worse. In the afternoon I hear a motor, a constant noise in my ear". Therapeutic measures were not taken as a result of tinnitus, hypoacusis, hyperacusis, condition aggravated.  Additional information:  Consumers have a back condition. So, patient took medicine for my back and patient had a blood pressure medicine but other than that healthy, active, walk every day, no problems, no heart condition, no cancer in family. patient very healthy.For my back a pain, one medication was called Oxycodone, patient took Oxycodone 10mg. daily for back, patient had stenosis unfortunately but any case, blood pressure medicine was, well this, its Enalapril 10mg and then lets see, this was another one guess this was for my, Venlafaxine, patient think thats for Cholesterol (Further clarification unknown) so, this was the other one, this one says 150mg. and patient also, this was another pain medication this one patient think was called Hydrocodone for her back, this one was 10-325mg. Yes, patient have a condition called Stenosis. There was another one for an antidepressant and this one called Bupropion and this one was 300mg, once a day." Prior Vaccination (4 Weeks): no vaccinations. Vaccination facility type: Consumer stated, "It was like a big gymnasium. Time of vaccination: afternoon like from 12 to 2 something like that."   No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain approximately 5 minutes post vaccination; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 14 year-old female patient received bnt162b2 (BNT162B2), administration date 07Jan2022 (Lot number: FD0809, Expiration Date: 10Jan2022) at the age of 14 years 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: CHEST PAIN (non-serious) with onset 07Jan2022, outcome "unknown", described as "Chest pain approximately 5 minutes post vaccination".  Additional information: The reporter stated that vaccine was administered at one of their specific fixed vaccination site and that particular day, 3 of their individuals between ages of 14 and 16 had adverse reaction, 3 which were 'about the 10% reactive' for that day'. The reporter stated the vaccine was administered for provision not for treatment. Further stated that 1st patient was a 14 years old female which reported chest pain approximately 5 minutes post vaccination. The reporter stated that immediately after vaccination on 07Jan2022, these vaccines were pulled '"from use" to "for do not use". The reporter stated that 2 of the 3 did seek emergency room care and was unaware of the outcome and for evaluation yes for the 2 that had chest pain for both of them.  Follow-up attempts completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased
Clinical narrative: chest tightness; shortness of breath; rapid heartbeat; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Jan2022 18:30 (Lot number: 33025BD) at the age of 39 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: other medical history: Ulcerative Colitis, known allergies: Note that I am aware of; "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: LIALDA; VYVANSE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Right, Vaccine Administration Time: 05:30 PM), administration date: 02Nov2021, when the patient was 39 years old, for COVID-19 Immunization, reaction(s): "numbness and tingling in both arms n hands, entire arms fall asleep", "numbness and tingling in both arms n hands, entire arms fall asleep". The following information was reported: CHEST DISCOMFORT (non-serious) with onset 10Jan2022, outcome "not recovered", described as "chest tightness"; DYSPNOEA (non-serious) with onset 10Jan2022, outcome "not recovered", described as "shortness of breath"; HEART RATE INCREASED (non-serious) with onset 10Jan2022, outcome "not recovered", described as "rapid heartbeat". The events "chest tightness", "shortness of breath" and "rapid heartbeat" were evaluated at the physician office visit and emergency room visit.  Additional information: The patient did not receive any other vaccines within 4 weeks. Other medications in two weeks were Prescribed Lialda & Vyvanse. The patient was waiting to see a doctor today (11Jan2022). Post vaccination, the patient had not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: Stomach upset; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (COMIRNATY) (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: ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Stomach upset".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Pain in jaw, Peripheral swelling
Clinical narrative: swelling under my left arm; throbbing pain in my jaw and my ears for about 3 days; throbbing pain in my jaw and my ears for about 3 days; joint pain; 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 male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15May2021 13:00 (Lot number: EW0167) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (ongoing). Concomitant medication(s) included: ALLEGRA-D 24 HOUR taken for hypersensitivity (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: ER8731, Anatomical site: Left upper arm, Route of administration: Intramuscular, Time of administration: 13:00), administration date: 22Apr2021, when the patient was 48 years old, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 16May2021, outcome "recovered", described as " swelling under my left arm"; PAIN IN JAW (non-serious), EAR PAIN (non-serious) all with onset 16May2021, outcome "recovered" and all described as "throbbing pain in my jaw and my ears for about 3 days"; ARTHRALGIA (non-serious) with onset 16May2021, outcome "recovered", described as "joint pain".  Additional information: Patient received the second dose in left upper arm. Prior Vaccinations (within 4 weeks) were reported as None. Patient's Medical History (including any illness at time of vaccination), Relevant Tests and Specific relevant test for thromboembolic events with thrombocytopenia reported as None. For the 2nd and 3rd doses I experienced swelling under my left arm. The swelling was approx. the size of a softball. I also had joint pain and a throbbing pain in my jaw and my ears for about 3 days. Patient received Dose 3 (Lot no FH8030 Expiry date not provided) on 21Nov2021 at 17:00 via intramuscular route of administration in left upper arm. For the 3rd booster only, I also had in my going area for about 2 days after my vaccination.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101649158 same reporter/patient/product, different dose and similar events
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The first two shots it took a day or so before his arm got sore.; 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 63 year-old male patient received bnt162b2 (BNT162B2) (Lot number: EW0183) at the age of 63 years as dose 2, single and administration date 21Jun2021 (Lot number: EW0183) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The first two shots it took a day or so before his arm got sore.".  Additional information: Caller denied any other medications, medical conditions, labs, testing, or treatments relevant to these events. The first two shots it took a day or so before his arm got sore. Investigation assessment was reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test
Clinical narrative: started developing a rash on his stomach, back, and legs/the rash was on his body, tummy, legs and back; his hands and legs were itchy/there were patches which were itchy also; 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 9 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 (Lot number: FL8095) at the age of 9 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 07Jan2022, outcome "recovered" (2022), described as "started developing a rash on his stomach, back, and legs/the rash was on his body, tummy, legs and back"; PRURITUS (non-serious) with onset 07Jan2022, outcome "unknown", described as "his hands and legs were itchy/there were patches which were itchy also". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash, pruritus.  Additional information: Reporter was stated that Pediatric Covid vaccine first dose. Stated that his twin sons got the first dose 05Jan2022 in the evening at withheld. Stated that one twin was fine. Stated that the other twin had rashes two days after the vaccine. Stated that on 07Jan2022 or 08Jan2022 that he had rashes on his body and tummy. Stated that he got itchy legs and had rashes in middle of night and applied coconut oil. Stated that he was itchy because of the weather. Stated that he was in the cold and snow and two the three hours later his son showed him some rashes and he thought maybe the temperature could be causing the itchiness. Stated that later in the night that his hands and legs were itchy and it went away. Stated that there were patches which were itchy also. Stated that he was talking to friends and they reported similar rashes and hives with the booster dose of Moderna. Wanted clarification if his son should get the second dose which is scheduled for the last week of Jan2022. Provided the lot: FL8095. Stated that it was administered at withheld. Later clarified that it was Pfizer Pediatric Covid vaccine (5-11). Stated that he had Covid testing before the vaccine on 29Dec2021 or 30Dec2021. Height was 48 to 50 inches. Weight was 80 pounds plus or minus two or three pounds. Reporter was stated that the rashes started on 07Jan2022 or 08Jan2022. Later clarified that the rash was on his body, tummy, legs and back. Stated that the rash on his body subsided in 8-10 hours. Stated that the rash on his legs subsided in a couple of hours. Stated that the rash on his tummy and back started first and subsided the same day. Treatment was stated that he applied coconut oil to the rashes on his legs and body.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: tingling; numbness; pain in the feet/pain in her feet and ankles; pain in her feet and ankles; arthritis; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 13Jan2022 11:30 (Lot number: FJ5683) at the age of 62 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: PARAESTHESIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "tingling"; HYPOAESTHESIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "numbness"; PAIN IN EXTREMITY (non-serious) with onset 13Jan2022, outcome "unknown", described as "pain in the feet/pain in her feet and ankles"; ARTHRALGIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "pain in her feet and ankles"; ARTHRITIS (non-serious) with onset 13Jan2022, outcome "unknown", described as "arthritis".  Additional Context: Caller was a pharmacist at # that was calling about a patient who received her 1st adult gray cap Pfizer BioNTech Covid-19 vaccine this morning at around 11:30 AM. Caller stated the patient called her later today and states she was experiencing tingling, numbness and pain in the feet. Caller stated the patient was treated for arthritis already and this seems coincidental.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes virus test, Herpes zoster
Clinical narrative: tested positive for herpes.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "tested positive for herpes.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Called in because his sexual partner recently got the Pfizer covid-19 vaccine 6 or 8 months ago and tested positive for herpes. He wants to know if vaccines trigger dormant herpes in somebody's body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Cough, Dry throat, Pruritus
Clinical narrative: bone pain; itching on the side of her heart; dry throat; cough; 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 48 year-old female patient received bnt162b2 (BNT162B2) (Lot number: 331308A) as dose 3 (booster), 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; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: BONE PAIN (non-serious), outcome "unknown", described as "bone pain"; PRURITUS (non-serious), outcome "unknown", described as "itching on the side of her heart"; DRY THROAT (non-serious), outcome "unknown", described as "dry throat"; COUGH (non-serious), outcome "unknown", described as "cough".  Additional information: Caller got her third dose of Comirnaty on Wednesday.  Yesterday, she had the following side effects begin itching on the side of her heart (further clarified that it was a sudden sensation on the left side of her chest, next to her breast).  She reported that it comes and goes. She had a blood clot last year, and she was asking what she should do about this.  She also reported a dry throat, a cough, and a lot of bone pain.    Follow-up attempts completed. No further information expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea". Additional information: Device Date: 14Jan2022 No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: experiences nauseous; threw up; headache; temperature of 102; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (COMIRNATY), administration date 13Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: METHYLPHENIDATE taken for attention deficit hyperactivity disorder; GUANFACINE taken for attention deficit hyperactivity disorder. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 14Jan2022, outcome "not recovered", described as "experiences nauseous"; VOMITING (non-serious) with onset 14Jan2022, outcome "unknown", described as "threw up"; HEADACHE (non-serious) with onset 14Jan2022, outcome "unknown", described as "headache"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "temperature of 102". 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.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: Headaches; sweating; fever; nausea; tremors-chest and body; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Jan2022 18:00 (Lot number: FL3198) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Brain stenosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRINTELLIX; LOSARTAN taken for blood pressure measurement; ROSUVASTATIN taken for blood cholesterol; ASPIRIN; LAMICTAL. Past drug history included: Fosamax, reaction(s): "Known allergies: Fosamax"; Lipitor, reaction(s): "Known allergies: Lipitor"; Atorvastatin, reaction(s): "Known allergies: Atorvastatin". Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Route of Administration: Intramuscular, lot number=331308A,, administration time=10:30 AM,), administration date: 17Dec2021, when the patient was 56 years old, for COVID-19 Immunization; Flu (other vaccine 4weeks product=Pfizer,, other vaccine 4weeks vaccine date=17Dec2021,, other vaccine 4weeks lot number=331308A,, other vaccine 4weeks dose number=1,), administration date: 17Dec2021, when the patient was 56 years old, for Immunization. The following information was reported: HEADACHE (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "Headaches"; HYPERHIDROSIS (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "sweating"; PYREXIA (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "fever"; NAUSEA (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "nausea"; TREMOR (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "tremors-chest and body"; FATIGUE (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "fatigue". The events "headaches", "sweating", "fever", "nausea", "tremors-chest and body" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, hyperhidrosis, pyrexia, nausea, tremor, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tremor
Clinical narrative: Headaches; sweating; fever; nausea; tremors-chest and body; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Jan2022 18:00 (Lot number: FL3198) at the age of 56 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "Stroke" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Brain stenosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: TRINTELLIX; LOSARTAN taken for blood pressure measurement; ROSUVASTATIN taken for blood cholesterol; ASPIRIN; LAMICTAL. Past drug history included: Fosamax, reaction(s): "Known allergies: Fosamax"; Lipitor, reaction(s): "Known allergies: Lipitor"; Atorvastatin, reaction(s): "Known allergies: Atorvastatin". Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Route of Administration: Intramuscular, lot number=331308A,, administration time=10:30 AM,), administration date: 17Dec2021, when the patient was 56 years old, for COVID-19 Immunization; Flu (other vaccine 4weeks product=Pfizer,, other vaccine 4weeks vaccine date=17Dec2021,, other vaccine 4weeks lot number=331308A,, other vaccine 4weeks dose number=1,), administration date: 17Dec2021, when the patient was 56 years old, for Immunization. The following information was reported: HEADACHE (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "Headaches"; HYPERHIDROSIS (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "sweating"; PYREXIA (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "fever"; NAUSEA (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "nausea"; TREMOR (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "tremors-chest and body"; FATIGUE (non-serious) with onset 11Jan2022 23:00, outcome "not recovered", described as "fatigue". The events "headaches", "sweating", "fever", "nausea", "tremors-chest and body" and "fatigue" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, hyperhidrosis, pyrexia, nausea, tremor, fatigue.  No follow-up attempts are possible. No further information is expected.