chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypoaesthesia, Pain in extremity, Somnolence
Clinical narrative: arm get a little sore / feels a little sore; numbing sensation under her underarm that went up to the right side of her neck / right side jaw felt a little bit number; kind of sleepy; a little tired like you just want to lie down and sleep / a little fatigue; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm get a little sore / feels a little sore"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbing sensation under her underarm that went up to the right side of her neck / right side jaw felt a little bit number"; SOMNOLENCE (non-serious), outcome "unknown", described as "kind of sleepy"; FATIGUE (non-serious), outcome "unknown", described as "a little tired like you just want to lie down and sleep / a little fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Dizziness, Hypoaesthesia, Pain in extremity, Somnolence
Clinical narrative: arm get a little sore / feels a little sore; numbing sensation under her underarm that went up to the right side of her neck / right side jaw felt a little bit number; kind of sleepy; a little tired like you just want to lie down and sleep / a little fatigue; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm get a little sore / feels a little sore"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "numbing sensation under her underarm that went up to the right side of her neck / right side jaw felt a little bit number"; SOMNOLENCE (non-serious), outcome "unknown", described as "kind of sleepy"; FATIGUE (non-serious), outcome "unknown", described as "a little tired like you just want to lie down and sleep / a little fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in arm; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 02Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; 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 74 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left, administration date 27Feb2021 12:15 (Lot number: EN6202) at the age of 74 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (Received first COVID-19 vaccine on 06Feb2021 in the right arm, Lot# looks like an "L" EL3248), administration date: 06Feb2021, for COVID-19 immunisation, reaction(s): "No adverse effect". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 28Feb2021, outcome "not recovered", described as "sore throat". Therapeutic measures were taken as a result of oropharyngeal pain.  Additional Information: The patient had other medical conditions but they have been going on for a long time and she did not think they were relevant. The patient did not receive other vaccines on same date with the Pfizer vaccine considered as suspect. The patient did not undergo any relevant tests. The event did not result to emergency room or physician's office visit. The patient received: Chloraseptic spray, 2 sprays every couple of hours, helps a little but, not much. Lot/expiry not seen on the bottle.  She then took Acetaminophen extra strength for adults 500 mg, 2 or 3 at a time which helped more Expiration Sep2020, ALV2304 was located right above the expiration date, there was a number below that, A8085 2E F4).  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain
Clinical narrative: Severe left-sided neck and head pain; Severe left-sided neck and head pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2021 13:00 (Batch/Lot number: unknown) at the age of 74 years as single dose for covid-19 immunisation. Relevant medical history included: "no" (unspecified if ongoing), notes: Structured information(Patient episode name): No. The patient's concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (1st dose of vaccination), when the patient was 74 years old. The following information was reported: NECK PAIN (non-serious), HEADACHE (non-serious) all with onset 28Feb2021, outcome "not recovered" and all described as "Severe left-sided neck and head pain". The event "severe left-sided neck and head pain" and "severe left-sided neck and head pain" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of neck pain, headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain
Clinical narrative: lot of pain; bad headache; nauseated; muscle pain; This is a spontaneous report received from contactable reporter(s) (Physician).  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 02Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing); "Headache" (ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: TYMLOS taken for osteoporosis. The following information was reported: MYALGIA (non-serious) with onset 02Feb2021, outcome "not recovered", described as "muscle pain"; PAIN (non-serious) with onset 03Feb2021, outcome "not recovered", described as "lot of pain"; HEADACHE (non-serious) with onset 03Feb2021, outcome "not recovered", described as "bad headache"; NAUSEA (non-serious) with onset 03Feb2021, outcome "not recovered", described as "nauseated". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: she is afraid she might die; 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.  An 87-year-old female patient received bnt162b2 (BNT162B2; Formulation: Solution for Injection), administration date 03Feb2021 (Batch/Lot number: unknown) as single dose for covid-19 immunization. Relevant medical history included: "aneurysm" (unspecified if ongoing), notes: has an aneurysm. The patient's concomitant medications were not reported.  The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "she is afraid she might die". Action taken for bnt162b2 (BNT162B2) was not applicable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Feeling abnormal, Headache, Vomiting
Clinical narrative: vomiting; diarrhea; severe chills; headache; Last night I had everything were horrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 09:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose of Pfizer-BioNTech COVID-19 Vaccine), administration date: 09Feb2021, for Covid-19 immunisation. The following information was reported: VOMITING (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "vomiting"; DIARRHOEA (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "diarrhea"; CHILLS (non-serious) with onset 04Mar2021, outcome "recovered" (Mar2021), described as "severe chills"; HEADACHE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "headache"; FEELING ABNORMAL (non-serious) with onset 04Mar2021, outcome "unknown", described as "Last night I had everything were horrible".  Additional information: She reported: "last night (around two and a half days later) I had symptoms/reaction; I had vomiting, diarrhea, severe chills, and a headache". Did not attempt warm transfer to Safety because caller stated she still had the headache (all other symptoms had resolved, except for headache) and to avoid her from waiting too long on hold, due to high call volume. Transferring agent stated, "I have a caller here on the other line and she received the second dose on Tuesday, (02Mar2021). She mentioned that she experienced chills, vomiting, diarrhea and headache after receiving the second dose." When paraphrased the concern to confirm, consumer transferring agent stated, "Yes, chills, vomiting, diarrhea and headache." When paraphrased the concern, consumer stated, "Yes, I mean, I had it during the night, I had it like since the vaccine is on Tuesday, so was during the night, last night I had everything the headache, the vomiting, the diarrhea and chills were horrible but that's okay I just have a remaining like headache, I just want see was it normal, you guys expect (incomplete sentence), I have a reaction. I could have a reaction within the 24 hours."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Gait disturbance, Hunger, Irregular sleep wake rhythm disorder
Clinical narrative: still didn't feel 100%/doesn't feel 100% back to what she was before she had the second shot; shivers and shaking all night long; shivers and shaking all night long; She slept on and off; hungry all the time; a little dizzy; she is not steady on her feet; she gained weight making the comment "roly-poly"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 88 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACICNE), intramuscular, administered in arm left, administration date 23Feb2021 (Batch/Lot number: unknown) at the age of 88 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical Location: Left arm, Route: Intramuscular), administration date: 02Feb2021, for COVID-19 immunisation, reaction(s): "no adverse effect". The following information was reported: CHILLS (non-serious), TREMOR (non-serious) all with onset 23Feb2021, outcome "recovered" (2021) and all described as "shivers and shaking all night long"; IRREGULAR SLEEP WAKE RHYTHM DISORDER (non-serious) with onset 23Feb2021, outcome "recovered" (2021), described as "She slept on and off"; MALAISE (non-serious) with onset 24Feb2021, outcome "unknown", described as "still didn't feel 100%/doesn't feel 100% back to what she was before she had the second shot"; HUNGER (non-serious) with onset 2021, outcome "unknown", described as "hungry all the time"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "a little dizzy"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "she is not steady on her feet"; WEIGHT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "she gained weight making the comment "roly-poly"".  Additional information: The vaccination was given between 10-11am. The patient confirmed she no longer was shivering and shaking at night. She slept okay at night, other that getting up to go the bathroom. She did not have the shivers and shakes any longer. She just did not feel steady on her feet. The events did not result to emergency or physician's office visit. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient did not receive prior vaccinations (within 4 weeks). The patient did not undergo any relevant tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Tremor, Weight increased
Clinical narrative: still didn't feel 100%/doesn't feel 100% back to what she was before she had the second shot; shivers and shaking all night long; shivers and shaking all night long; She slept on and off; hungry all the time; a little dizzy; she is not steady on her feet; she gained weight making the comment "roly-poly"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 88 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-9 VACICNE), intramuscular, administered in arm left, administration date 23Feb2021 (Batch/Lot number: unknown) at the age of 88 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Anatomical Location: Left arm, Route: Intramuscular), administration date: 02Feb2021, for COVID-19 immunisation, reaction(s): "no adverse effect". The following information was reported: CHILLS (non-serious), TREMOR (non-serious) all with onset 23Feb2021, outcome "recovered" (2021) and all described as "shivers and shaking all night long"; IRREGULAR SLEEP WAKE RHYTHM DISORDER (non-serious) with onset 23Feb2021, outcome "recovered" (2021), described as "She slept on and off"; MALAISE (non-serious) with onset 24Feb2021, outcome "unknown", described as "still didn't feel 100%/doesn't feel 100% back to what she was before she had the second shot"; HUNGER (non-serious) with onset 2021, outcome "unknown", described as "hungry all the time"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "a little dizzy"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "not recovered", described as "she is not steady on her feet"; WEIGHT INCREASED (non-serious) with onset 2021, outcome "unknown", described as "she gained weight making the comment "roly-poly"".  Additional information: The vaccination was given between 10-11am. The patient confirmed she no longer was shivering and shaking at night. She slept okay at night, other that getting up to go the bathroom. She did not have the shivers and shakes any longer. She just did not feel steady on her feet. The events did not result to emergency or physician's office visit. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient did not receive prior vaccinations (within 4 weeks). The patient did not undergo any relevant tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy/lightheaded; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional).  A male patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "dizzy/lightheaded".  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-2021247682 Same reporter and drug; similar event, different patient.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Nausea
Clinical narrative: stomach has been upset; had diarrhea and had 2 loose stools; Queasy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 01Mar2021, outcome "unknown", described as "stomach has been upset"; DIARRHOEA (non-serious) with onset 01Mar2021, outcome "unknown", described as "had diarrhea and had 2 loose stools"; NAUSEA (non-serious) with onset 01Mar2021, outcome "unknown", described as "Queasy".  Additional Information: The patient was taking unspecified medication but she did not think anything would be related. The patient's next appointment/ second dose was scheduled on 31Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: Had pain in the arm where I got the shot and the pain goes from my shoulder and my arm and that is basically six days after I got the shot; Had pain in the arm where I got the shot and the pain goes from my shoulder and my arm and that is basically six days after I got the shot; Had pain in the arm where I got the shot and the pain goes from my shoulder and my arm and that is basically six days after I got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 23Feb2021 (Batch/Lot number: unknown) at the age of 79 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: VACCINATION SITE PAIN (non-serious), ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 01Mar2021, outcome "unknown" and all described as "Had pain in the arm where I got the shot and the pain goes from my shoulder and my arm and that is basically six days after I got the shot". Therapeutic measures were taken as a result of vaccination site pain, arthralgia, pain in extremity.  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: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: has been diagnosed a while, at least 10-12 years; "Rheumatoid arthritis", start date: 2007 (unspecified if ongoing), notes: on a medication for this ; "Psoriatic arthritis", start date: Jan2020 (unspecified if ongoing); "Diabetes" (unspecified if ongoing), notes: was diagnosed when she was in her 40s, somewhere around 1990-1998.; "sleeps with a CPAP" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 02Mar2021, outcome "unknown", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: It was reported that the patient was vaccinated at 12:30PM to 13:00PM, since her appointment was at 12:00PM. The patient had diarrhea 2.5 hours after she got the shot, she has had it a couple times today. The patient doesn't know yet if that was getting better or worse, she has gone twice within a short period of time within less than an hour, and her stomach still felt like she needed to go to the bathroom. The patient was on unspecified medication for rheumatoid arthritis. The patient has had no other recent vaccinations or started any new medications.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the first shot, the girl didn't get it in the muscle very well, its hard to do in her skinny arms, her arm was very sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 08Feb2021 (Lot number: EN5318) at the age of 65 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Takes medicine for it; Situational, known to have panic attacks, heart races, she gets dizzy.; "panic attacks" (unspecified if ongoing); "heart races" (unspecified if ongoing); "gets dizzy" (unspecified if ongoing); "cholesterol is still high" (unspecified if ongoing), notes: had blood work done prior to vaccine; going to start the statins soon; "red count is on the high side" (unspecified if ongoing), notes: had blood work done prior to vaccine; not too high to be alarmed about. Family history included: "High blood pressure" (unspecified if ongoing), notes: Takes medicine for it; diagnosed 10 years ago and runs in the family. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "the first shot, the girl didn't get it in the muscle very well, its hard to do in her skinny arms, her arm was very sore". Additional information: Concomitant medications included unspecified treatments for high blood pressure and anxiety. The patient doesn't think she got the first dose of the vaccine the right way. The patient was going to take naproxen sodium (ALEVE) but thought it might interfere with the vaccine. She doesn't want to wear a mask anymore and was previously reluctant to get the vaccine but thought she needed it.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: a little shooting headache every now and then; Dizziness/lightheaded; This is a spontaneous report received from 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 right, administration date 01Mar2021 08:35 (Lot number: EN6202) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "Blood cholesterol increased" (unspecified if ongoing); "low carb diet" (ongoing). Concomitant medication(s) included: LOSARTAN "AGP" taken for hypertension; ATORVASTATIN CALCIUM. The following information was reported: DIZZINESS (non-serious) with onset 01Mar2021, outcome "not recovered", described as "Dizziness/lightheaded"; HEADACHE (non-serious) with onset 02Mar2021, outcome "unknown", described as "a little shooting headache every now and then". Therapeutic measures were not taken as a result of dizziness, headache.  Additional information: Patient was also taking an unspecified over the counter heart burn medication as a concomitant medication. There were no additional vaccines administered on same date of the Pfizer Suspect. Events did not result to physician and emergency room visit. Patient was asking if she needs to see a doctor and if there was any information on low carb diet and the vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021247362 Same reporter and drug; similar event, different patient.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: wiped out and felt tired; arm hurt; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  An 82 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 26Feb2021 10:00 (Batch/Lot number: unknown) at the age of 82 years, as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "atrial fibrillation" (ongoing); "high blood pressure" (ongoing). Concomitant medication included: METOPROLOL taken for atrial fibrillation, hypertension, start date: 2018 (ongoing). The following information was reported: FATIGUE (non-serious) with onset 26Feb2021, outcome "recovered" (27Feb2021), described as "wiped out and felt tired"; PAIN IN EXTREMITY (non-serious) with onset 26Feb2021, outcome "recovered" (27Feb2021), described as "arm hurt". Therapeutic measures were taken as a result of pain in extremity. Additional information: Paracetamol (TYLENOL) was taken for the event "arm hurt".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was more sore than after the first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Feb2021 09:15 (Lot number: EM9810, Expiration Date: 30Jun2021) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes 2" (unspecified if ongoing), notes: The caller takes pills and watches diet to control it. The caller was diagnosed over 10 years ago.; "Blood pressure high" (unspecified if ongoing), notes: The caller takes pills to control it. The caller was diagnosed over 10 years ago. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "her arm was more sore than after the first shot".  Additional information: There were no additional vaccines administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events did not result to physician and emergency room visit.   No follow up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: After 2nd dose, slept for most of day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 23Feb2021 09:00 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN. Vaccination history included: Bnt162b2 (Dose 1; administration time: 01:30 PM; vaccine location: Left arm), administration date: 04Feb2021, when the patient was 55 years old, for COVID-19 immunisation, reaction(s): "Very sore arm for approx. 48 hours". The following information was reported: HYPERSOMNIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "After 2nd dose, slept for most of day". Therapeutic measures were not taken as a result of hypersomnia. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination.  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, Headache
Clinical narrative: got up real dizzy; slight headache; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 28Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "problems with vertigo" (unspecified if ongoing), notes: she has a spell every three to four years. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 02Mar2021, outcome "unknown", described as "got up real dizzy"; HEADACHE (non-serious) with onset 02Mar2021, outcome "unknown", described as "slight headache".  Additional information: The reporter stated that when she got her vaccine, the people told her that if she had side effects, she could take paracetamol (TYLENOL). She has medicine prescribed to her for her history of vertigo, and she was just calling to seek information on if the medicine she takes for vertigo is contraindicated with the COVID vaccine at all, before she takes it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: bladder infection; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: CYSTITIS (non-serious), outcome "not recovered", described as "bladder infection". Therapeutic measures were taken as a result of cystitis. Additional information: Clinical course: The patient currently has a bladder infection and has taken Cephalexine for 8 days as treatment. She started taking this medication on 27Jan2021 and has already completed it. But she felt like still having trouble with her bladder, so she went to Urgent care and was confirmed that there was still a bladder infection. The patient wanted to know if she can take her second COVID vaccine today with the bladder infection. She said that she was feeling fine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: muscle pain and soreness; muscle pain and soreness; 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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in deltoid left, administration date 17Feb2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: DPT booster shot, administration date: 03Jul2017, for immunisation, reaction(s): "Mild reaction"; BNT162B2 (dose number=1, vaccine location=Deltoid left, lot number=EJ1686), administration date: 27Jan2021, when the patient was 42 years old, for COVID-19 immunisation, reaction(s): "I experienced sharp pain laterally through my deltoid muscle", "Ached/painful/ douloureux", "Higher than normal blood sugar". The following information was reported: MYALGIA (non-serious), PAIN (non-serious) all with onset 17Feb2021, outcome "unknown" and all described as "muscle pain and soreness". Therapeutic measures were taken as a result of myalgia, pain.  Additional information: The patient had no known allergies and have never had an allergic reaction to any vaccine or medication. On 17Feb2021 more than 3.5 hour after receiving the second dose, the patient took one Tylenol that had an expiration date of Apr2020.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: extra exhaustion; Soreness at site of injection for two days; 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) (Lot number: EL3248) 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: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Soreness at site of injection for two days"; FATIGUE (non-serious), outcome "unknown", described as "extra exhaustion".  Additional Information: Events took place after use of product.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired the day following the second COVID vaccine dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Tired the day following the second COVID vaccine dose".  Additional Information: The event lasted about a day and a half.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tooth impacted
Clinical narrative: impacted tooth; 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 male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: TOOTH IMPACTED (non-serious), outcome "unknown", described as "impacted tooth". Additional information: The patient asked if it was okay for him to get his second dose of the COVID-19 vaccine on 03Mar2021 instead of 02Mar2021. The patient had just been to his dentist due to impacted tooth and his dentist wanted to put him to an antibiotic which is Penicillin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 2nd shot tiny soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Lot number: , LN-S PF) at the age of 80 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "No adverse effect- not even any redness". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "2nd shot tiny soreness". Additional information: Time at vaccination for the 2nd dose was reported at 08:30 AM. The patient wanted to know if taking 81 mg aspirin and that if having a "Crest" would preclude her from getting the vaccine.  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: Bone disorder, Discomfort
Clinical narrative: felt her bones weighed more; felt her bones weighed more; This is a spontaneous report received from contactable consumer for a Pfizer sponsored program (143231). The reporter is the patient.  A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 71 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: DISCOMFORT (non-serious), BONE DISORDER (non-serious) all with onset 26Feb2021, outcome "recovering" and all described as "felt her bones weighed more".  Additional information: The patient stated that couple times she felt her bones weighed more, an hour or so, two days, 26Feb2021 & 28Feb2021 or 01Mar2021. The patient felt better after resting, she has had no diarrhea, and would inform her doctor of new symptoms on 04Mar2021 during her next infusion.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after she got the 1st vaccine; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) for a Pfizer sponsored program (159558). The reporter is the parent.  An 85-year-old female patient received bnt162b2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, solution for injection), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after she got the 1st vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: had some swelling in that area; 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 (PFIZER-BIONTECH COVID-19 VACICNE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "had some swelling in that area".  Additional information: The report was received from a Pfizer sponsored program. The patient also received the 2nd dose on an unspecified date and they angled the needle and it entered into her deltoid and she wanted to know about the efficacy of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: sinus; 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) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cold" (unspecified if ongoing), notes: before his 1st dose. The patient's concomitant medications were not reported. The following information was reported: SINUS DISORDER (non-serious), outcome "unknown", described as "sinus".  Additional Information: It was reported that when the patient already received his 1st dose, he was asking if he can take an OTC guaifenesin (MUCINEX) for his "sinus."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after first dose; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after first dose".  Additional information: The patient was querying on storage and stability of the covid-19 vaccination; stated when he was at the facility to receive the vaccine, he was watching the providers, questioning deep freeze, temperature gauge on a box and how long syringe was good for after the freezer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: has a Bladder surgery 23Mar; This case has been considered invalid as the AE was unspecified. This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient that: Is the Reporter a Healthcare Professional (HCP): Unknown Occupation/Specialty: UNKNOWN Is the reporter the prescribing HCP: UNKNOWN. Is the reporter's contact information available to you or a sub-contracted party: Yes. Verbatim and Event Description: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Consumer husband Received first covid vaccine on the 27Feb- Also has a Bladder surgery 23Mar- Second dose is the 20th- Can it be extended until after surgery- if so how long- Clarified it was scheduled before first dose- Transferred after 1 min- faxed possible AE. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Flatulence
Clinical narrative: severe gas; diarrhea; stomach swelled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 (Lot number: EN6205) at the age of 76 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 (Date of start of drug: 9Feb2021, Batch/lot number: EL9264, Dosage text: First dose in Left), administration date: 09Feb2021, when the patient was 76 years old, for COVID-19 immunisation, reaction(s): "severe gas", "dirrhea".  The following information was reported: FLATULENCE (non-serious) with onset 06Mar2021, outcome "unknown", described as "severe gas"; DIARRHOEA (non-serious) with onset 06Mar2021, outcome "unknown", described as "diarrhea"; ABDOMINAL DISTENSION (non-serious) with onset 06Mar2021, outcome "unknown", described as "stomach swelled".  Addition information: The patient previously took BNT162B2 (Lot Number: EL9264) via on an unspecified route of administration, administrated in left arm on 09Feb2021 (age at vaccination 76 years) for COVID-19 immunisation and experienced severe gas and dirrhea on 13Feb2021. It was reported that 4 days after the second vaccine she reported that the gas attack happened again and the diarrhea has continued on since and is reported to be intermittent. After the second dose, about 4 days later she had the same gas effect. Caller mentioned her stomach swelled and had loud gas which was shocking to her. She continues to state that she is basically a vegetarian that eats well and does not normally have diarrhea issues. Caller reports she had a gas attack last night and then the diarrhea started. It stopped but then started again 30 minutes later, it just goes on and on. Caller reports that she continues to say it is intermittent and still ongoing which surprises her. It is explained that it has to be something with her body and the vaccine as she never has diarrhea. Caller remarked her husband had the shot at the same time and he didn't have any symptoms.The patient was wondering if she needed antibiotics, do we have any advice to provide. She continued to state that she was basically a vegetarian that eats well and does not normally have diarrhea issues. It was intermittent and still ongoing which surprises her. It is explained that it has to be something with her body and the vaccine as she never has diarrhea.   No follow-up attempts are possible; No further information is expected.