chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Large intestinal stenosis, Myalgia, Nightmare, Procedural pain, Pyrexia
Clinical narrative: Colon stenosis; Unspecified disorder of intestine; Post-procedural pain; Surgical scar; Laceration; Wound healing delayed; Bruise; Nighmare; Chills; Muscle aches; Fever; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LARGE INTESTINAL STENOSIS (Colon stenosis) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (Colon stenosis) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), PROCEDURAL PAIN (Post-procedural pain), SCAR (Surgical scar), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (Bruise), NIGHTMARE (Nighmare), CHILLS (Chills), MYALGIA (Muscle aches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, LARGE INTESTINAL STENOSIS (Colon stenosis), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), PROCEDURAL PAIN (Post-procedural pain), SCAR (Surgical scar), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed) and CONTUSION (Bruise) had not resolved and NIGHTMARE (Nighmare), CHILLS (Chills), MYALGIA (Muscle aches), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information were reported.   Action taken with the drug in response to events was not applicable.  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fatigue, chills, pyrexia, and myalgia.   This case was linked to (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fatigue, chills, pyrexia, and myalgia.
Age: 56.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Scar, Skin laceration
Clinical narrative: Colon stenosis; Unspecified disorder of intestine; Post-procedural pain; Surgical scar; Laceration; Wound healing delayed; Bruise; Nighmare; Chills; Muscle aches; Fever; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LARGE INTESTINAL STENOSIS (Colon stenosis) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced LARGE INTESTINAL STENOSIS (Colon stenosis) (seriousness criterion medically significant), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), PROCEDURAL PAIN (Post-procedural pain), SCAR (Surgical scar), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed), CONTUSION (Bruise), NIGHTMARE (Nighmare), CHILLS (Chills), MYALGIA (Muscle aches), PYREXIA (Fever) and FATIGUE (Fatigue). At the time of the report, LARGE INTESTINAL STENOSIS (Colon stenosis), GASTROINTESTINAL DISORDER (Unspecified disorder of intestine), PROCEDURAL PAIN (Post-procedural pain), SCAR (Surgical scar), SKIN LACERATION (Laceration), IMPAIRED HEALING (Wound healing delayed) and CONTUSION (Bruise) had not resolved and NIGHTMARE (Nighmare), CHILLS (Chills), MYALGIA (Muscle aches), PYREXIA (Fever) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported. No treatment information were reported.   Action taken with the drug in response to events was not applicable.  Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fatigue, chills, pyrexia, and myalgia.   This case was linked to (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities. A causal relationship cannot be excluded for the events of fatigue, chills, pyrexia, and myalgia.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diverticulitis
Clinical narrative: diverticulitis; sick in his stomach; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIVERTICULITIS (diverticulitis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DIVERTICULITIS (diverticulitis) (seriousness criteria hospitalization and medically significant). On 04-May-2021, the patient experienced ABDOMINAL DISCOMFORT (sick in his stomach). The patient was hospitalized for 3 days due to DIVERTICULITIS. At the time of the report, DIVERTICULITIS (diverticulitis) and ABDOMINAL DISCOMFORT (sick in his stomach) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The patient's diverticulitis did not have anything to do with the vaccine and he had no history of diverticulitis. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Eyelid ptosis, IIIrd nerve paralysis
Clinical narrative: CN#3 palsy; left eye ptosis; double vision; This spontaneous case was reported by a physician and describes the occurrence of IIIRD NERVE PARALYSIS (CN#3 palsy) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced IIIRD NERVE PARALYSIS (CN#3 palsy) (seriousness criteria disability and medically significant), EYELID PTOSIS (left eye ptosis) and DIPLOPIA (double vision). At the time of the report, IIIRD NERVE PARALYSIS (CN#3 palsy), EYELID PTOSIS (left eye ptosis) and DIPLOPIA (double vision) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  The reporter is the brother of the patient and reported that there were no adverse events after the first dose of the vaccine. On an unspecified date, an ophthalmologist was consulted who confirmed the diagnosis of cranial nerve 3 palsy.  Treatment information was not provided.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Pruritus, Rash erythematous
Clinical narrative: Has a "pimply thing" on his wrist/ couple of little pimples; Itching like crazy/itching  "started in his hand", extended to his "chest, stomach, lower abdomen area/ woke up itching /mostly itching in his hands; Had a "red rash on the bottom of his right wrist and a little bit on his chest"/ small, light, red, rash on bottom of right wrist; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. A 70-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 27Jan2021 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included cholesterol, BPH (benign prostatic hyperplasia), blood pressure. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and unspecified medications. Caller stated there were no relevant medications, history or investigations to report, states that he knows they say not to take over the counter medications prior to the vaccine, states that he does take a baby aspirin but has for 20 years. States he takes other prescription medications, for cholesterol, BPH, blood pressure, states these are all under control, takes blood pressure every day. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) as a single dose for COVID-19 immunisation. It was reported that, caller, 70-year-old, stated he received the second dose of the COVID-19 vaccine this past Wednesday morning, on 27Jan2021, on the left arm. He explained during the middle of that night (27Jan2021), he was "itching like crazy" and had a "red rash on the bottom of his right wrist and a little bit on his chest". He specified the itching "started in his hand" and extended to his "chest, stomach and lower abdomen area". Today, he said the "itching has not gone away, there was not much of a rash," he just has a "pimply thing" on his wrist on 28Jan2021, but "the rash comes and goes", it might be there "in 2-3 hours". He mentioned he had no reaction to the first dose. He added that he could not reach his doctor and asked for our recommendations. He also asked if his experience was reported as a side effect of the vaccine. Caller stated that he had his second shot, clarifies of the Pfizer COVID vaccine, on Wednesday, 27Jan2021, states when he got his first shot, he had no problems, states with this second shot he woke up itching like crazy, no rash, no issues or swelling, mostly itching in his hands. Caller wants to know if he should be concerned. Caller clarifies he did have a small, light, red rash on the bottom of right wrist that also has a couple of little pimples, states this rash would come and go. States the itching has now spread from his hands to his shoulders and neck. States he got the vaccine in his left arm. The events were considered as non-serious by the consumer. The outcome of the events was not recovered.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: dizzy; the whole room began to spin/he was still wobbly; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, Expiration Date: 31May2021) via intramuscular on 31Jan2021 16:15 on right arm as single dose for covid-19 immunisation. Medical history included mesothelioma from Aug2019 and ongoing. The patient concomitant medications were not reported. Prior Vaccinations (within 4 weeks) reported as none. Patient took the first dose of the Pfizer covid vaccine shot yesterday at 4:15 pm. Everything was fine till about 10:30 at night when he was ready to go to bed. patient got up from his recliner, patient was dizzy and the whole room was spinning so he sat down again and tried again 5 minutes later, and he was still wobbly on 31Jan2021 22:30. Then after he sat there for a while, he was ok. patient did not have an immediate reaction. Patient asks if his reaction was serious what would they have treated him with for the dizziness. Patient asks if he should take the second dose and if the dizziness is normal. Last night patient was thinking about going to the hospital since he got panicky but then it passed. patient did not go to the hospital since there was a snowstorm. Patient did not visit emergency room and physician office. Treatment was declines any, he was drinking plenty of fluids. The outcome of the event dizzy was recovered on 31Jan2021 and unknown for another event.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left on 18Jan2021 08:00 (Batch/Lot Number: EL3247; Expiration Date: 18Feb2021) as single dose for covid-19 immunisation. There were no medical history and concomitant medications. Family history included: older brother had shingles in his early to mid 30's and had mild symptoms. Patient previously had flu shot on 2020. The patient developed shingles on 31Jan2021. Patient was asking if it was okay to take the second dose on 08Feb2021 as she was taking valacyclovir 1gm 3 times a day by mouth for 7 days, started on 02Feb2021 for shingles. Event resulted to a physician's office visit. Outcome of the event was not recovered
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: Headache; fatigue; muscle and extreme joint pain; muscle and extreme joint pain; This is a spontaneous report received from a contactable other health care professional (HCP). A 21-years-old non pregnant female patient received bnt162b2 (BNT162B2, Solution for injection ), via an unspecified route of administration, administered on arm left on 26Jan2021 10:30 (at the age of 21-year-old) as single dose for covid-19 immunization. Medical history included fibromyalgia and postural orthostatic tachycardia syndrome (POTS). The patient had no covid prior to vaccination and no covid tested post vaccination. Concomitant medication included ibuprofen and fluoxetine hydrochloride (PROZAC). On 27Jan2021 03:00, the patient experienced headache, fatigue and muscle and extreme joint pain. The patient did not received any treatment for the event. The outcome of the events were recovering.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: pain at injection site; redness and swelling at injection site/1.5 inch swelling circle on her left arm; redness and swelling at injection site; This is a spontaneous report from a contactable consumer (patient's husband) via medical information team. A (Age: 83; Unit: unknown) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration as a single dose on 26Jan2021 for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that he and his wife had their first injection for the Covid-19 vaccine. About 6 hours later patient developed at the injection site, redness and swelling and it was still there today along with some pain in the injection site on 26Jan2021. Patient developed a 1.5 inch swelling circle on her left arm and pain that goes with that. He has a few questions. Reporter wanted to know could that be the vaccine under the red swollen area. Would that swelling be the vaccine where it's staying in place under the skin and will this dissolve over time and does this affect the effectiveness of the vaccine. Since this is the first shot, he assumes this won't interfere with her getting the second shot and asks if that is true. Reporter wanted to know if his wife should get the second dose of the covid vaccine since she had a reaction to the first dose. The outcome of the events were unknown.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Tiredness; brain fog; headache; Day 1 Sore arm; This is a spontaneous report from a non-contactable Other Health Professional, the patient. A 59-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EK5730), via an unspecified route of administration as a single dose on 30Dec2020 for COVID-19 immunisation. The patient medical history was not reported. No allergies to medications, food, or other products reported. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), calcium/magnesium/ vitamin d nos (CAL MAG), calcium carbonate/colecalciferol/phytomenadione (Vit D+K), fish oil (OMEGA 3) and multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Dec2020, the patient experienced sore arm on day 1 of vaccination and on 31Dec2020 experienced tiredness, brain fog and headache. No treatment was received for the events. The outcome of the events were recovered on an unknown date.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed in-clinic with shingles; This is a spontaneous report from a contactable other hcp (patient herself). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982, expiration date not reported), via an unspecified route of administration, administered on the right arm on 14Jan2021 15:00 (at the age of 40-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma (allergy-related asthma), drug hypersensitivity (Penicillin allergy), allergy to animal (pet dander), seasonal allergy (hay-fever), and seasonal allergy (pollen). The patient was reported to be taking other medications (unspecified) in the last two weeks prior vaccination. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. On 26Jan2021 09:30, two weeks following the first dose vaccination, the patient was diagnosed in-clinic with shingles. The event resulted to a physician office visit. Patient received anti-viral medication as a result of the event. The outcome of the event was recovered on an unspecified date.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Considering a plausible temporal relationship , a possible contributory role of suspect vaccine BNT162B2 to the reported event shingles cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: some soreness in the arm; was exhausted; and sleep after the shot; This is a spontaneous report from a contactable consumer (patient).    This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included slow growing blood cancer. Concomitant medications were not reported. On an unspecified date, the patient experienced some soreness in the arm, was exhausted and sleep after the shot with outcome of unknown.    Follow-up attempts completed, information on batch number can not be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received the vaccine and had little shingles above the waist line on an unspecified date and didn't know if it was a side effect, and wanted to know if she can take Benadryl. Outcome of the event was unknown.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Throat irritation, Upper respiratory tract congestion
Clinical narrative: scratchy throat; runny nose; stuffy head; This is a spontaneous report from a contactable consumer or other non hcp (patient himself). A male patient of an unspecified age (reported as age of 72) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date not reported), via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. Medical history included suspected COVID-19. The patient's concomitant medications were not reported. Patient saw his son six days ago (31Jan2021) who has since tested positive. The patient experienced scratchy throat, runny nose, and stuffy head on an unspecified date in Feb2021. Patient was going to get a COVID test and was inquiring if receiving a vaccine two days ago (04Feb2021) would cause a false positive. Events were assessed as non-serious. The outcome of the events reported was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal pain, Hangover, Pain, Pain in extremity
Clinical narrative: diarrhea; digestive pain; sluggish; felt like a hangover; normal throbbing pain in my arm; tingling down my arm to my fingers; throbbing pain in my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 04Feb2021 16:15 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and cetirizine hydrochloride (ZYRTEC) (reported as allergy medicine), both taken for unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. It was reported that 4 hours after the administration of the vaccine (04Feb2021 20:15), the patient experienced normal throbbing pain in my arm and tingling down my arm to my fingers. The next morning (05Feb2021), the patient was sluggish and felt like a hangover. From 24 hours after the administration of the vaccine (05Feb2021 16:15), the patient experienced digestive pain. The patient also experienced diarrhea on 05Feb2021 19:45. It was reported that the digestive pain started with normal bowel movements then it turned into diarrhea. The diarrhea was in different forms, from a little solid to water (this is not normal for the patient). The patient was not sure if it was the vaccine. But, the food intake was normal and the patient had not eaten any different. The patient wanted to share just in case others had experience the same thing. Therapeutic measures were taken as a result of the event diarrhea included over the counter anti-diarrhea medicine. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Sluggishness
Clinical narrative: diarrhea; digestive pain; sluggish; felt like a hangover; normal throbbing pain in my arm; tingling down my arm to my fingers; throbbing pain in my arm; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9269, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 04Feb2021 16:15 (at the age of 44-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient has no known allergies. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) and cetirizine hydrochloride (ZYRTEC) (reported as allergy medicine), both taken for unspecified indication, start and stop dates were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. It was reported that 4 hours after the administration of the vaccine (04Feb2021 20:15), the patient experienced normal throbbing pain in my arm and tingling down my arm to my fingers. The next morning (05Feb2021), the patient was sluggish and felt like a hangover. From 24 hours after the administration of the vaccine (05Feb2021 16:15), the patient experienced digestive pain. The patient also experienced diarrhea on 05Feb2021 19:45. It was reported that the digestive pain started with normal bowel movements then it turned into diarrhea. The diarrhea was in different forms, from a little solid to water (this is not normal for the patient). The patient was not sure if it was the vaccine. But, the food intake was normal and the patient had not eaten any different. The patient wanted to share just in case others had experience the same thing. Therapeutic measures were taken as a result of the event diarrhea included over the counter anti-diarrhea medicine. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Headache, Muscle tightness
Clinical narrative: 16 hours after the vaccination I woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees.  These symptoms lasted between 20 and 24 hours.; 16 hours after the vaccination I woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees.  These symptoms lasted between 20 and 24 hours.; 16 hours after the vaccination I woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees.  These symptoms lasted between 20 and 24 hours.; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in the right arm on 04Feb2021 at 11:00 AM (batch/lot number: EM9810) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took clindamycin and experienced allergies; and BNT162B2 first dose on 14Jan2021 at 10:30 AM (batch/lot number: EL3248) administered in the right arm for COVID-19 immunisation. Facility type vaccine was public health clinic/administration facility. No other vaccine in four weeks. No COVID prior to vaccination and was not COVID tested post vaccination. On 05Feb2021 at 03:00 AM, 16 hours after the vaccination, the patient woke to a medium headache, tight muscles and a slight temperature elevation of about 1.5 degrees. These symptoms lasted between 20 and 24 hours. Treatment was received for the events which included over the counter acetaminophen. The outcome of the events was recovered on Feb2021.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Tired; Low energy; Chills; Headache; Nausea; Feel unwell; This is a spontaneous report from a contactable healthcare professional (other HCP; patient himself). A 65-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported) via an unspecified route of administration in the left arm on an unspecified date (at the age of 65-years-old) at a single dose for COVID-19 immunization at a hospital. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took levofloxacin (LEVAQUIN), ciprofloxacin (CIPRO) and amikacin sulfate (BIOCIN) and experienced allergies (drug hypersensitivity). No other vaccine was given in four weeks. The patient has not been tested positive for Covid prior vaccination. The patient has not been tested for Covid post vaccination. On 23Jan2021 09:45AM, the patient was tired and experienced low energy, chills, headache, nausea and felt unwell. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Tired; Low energy; Chills; Headache; Nausea; Feel unwell; This is a spontaneous report from a contactable healthcare professional (other HCP; patient himself). A 65-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and expiration date were not reported) via an unspecified route of administration in the left arm on an unspecified date (at the age of 65-years-old) at a single dose for COVID-19 immunization at a hospital. Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took levofloxacin (LEVAQUIN), ciprofloxacin (CIPRO) and amikacin sulfate (BIOCIN) and experienced allergies (drug hypersensitivity). No other vaccine was given in four weeks. The patient has not been tested positive for Covid prior vaccination. The patient has not been tested for Covid post vaccination. On 23Jan2021 09:45AM, the patient was tired and experienced low energy, chills, headache, nausea and felt unwell. No treatment was given for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass, Pain in extremity
Clinical narrative: had a little of a sore arm; a little lump on the arm; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 20Jan2021 as a single dose for COVID-19 immunisation. The patient also reported that the shot was a "breeze". The patient's medical history and concomitant medications were not reported. On 21Jan2021, the next day (as reported), the patient experienced little of a sore arm and a little lump on the arm. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fevers; This is a spontaneous report from a contactable consumer (parent). This consumer reported same events for two patients. This is the first of two reports. A male patient of an unspecified age received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fevers on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021168417 Same reporter, drug, event; different patient
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Sever body chills with uncontrollable shivering for about 1.5 hours; Sever body chills with uncontrollable shivering for about 1.5 hours; This is spontaneous report from a non-contactable other-HCP.  A 31-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EL9261) at the age of 31 years as SINGLE DOSE for COVID-19 immunization. The patient medical history was unknown. Concomitant medication included contraceptive drug unspecified. Pregnant: no. Facility type vaccine: Hospital. On 02Feb2021 the patient experienced sever body chills with uncontrollable shivering for about 1.5 hours with outcome of recovered and no treatment received. No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Decreased appetite, Headache, Pain in extremity
Clinical narrative: Headache; stomach cramps; pain in legs and weakness; pain in legs and weakness; not hungry; arm pain; This is a spontaneous report from a contactable consumer.   An 82-Year-old female patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EM9809) on 05Feb2021 at 12:30  at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history included hypertension. Concomitant medication included  lisinopril. On 05Feb2021 at 21:00 patient started experiencing headache, stomach cramps, pain in legs and weakness, not hungry, arm pain. The patient did not received treatment for the events. At the time of the reporting the patient had not yet recovered from the events.    Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Shortness of breath; Dizziness; A fast heartbeat; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El9269) on 05Feb2021 18:15 at left arm at single dose for COVID-19 immunization. Medical history included known allergies was Dust, mold, cat. Patient is not pregnant. Concomitant medication was not reported. Patient experienced shortness of breath, dizziness and a fast heartbeat, all on 05Feb2021 10:30 PM. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Patient was recovered from the events in Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Migraine, Nausea, Pain
Clinical narrative: Fever; Chills; Body aches; Migraine; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9269) at 13:15 at single dose for COVID-19 immunisation. The relevant medical history included fibromyalgia. Concomitant medications included spironolactone. The patient previously received the first dose of BNT162B2 on 13Jan2021 (lot number: EL3249, administration time: 12:45PM, vaccine location: Left arm) at the age of 27 years old for COVID-19 immunisation. The patient experienced fever, chills, body aches, migraine, nausea, dizziness on 04Feb2021 at 09:00 AM. No treatment received for the events. The outcome of the events was recovered on an unspecified date in Feb2021.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Chills; Body aches; Migraine; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient (pregnant: No) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 03Feb2021 (lot number: EL9269) at 13:15 at single dose for COVID-19 immunisation. The relevant medical history included fibromyalgia. Concomitant medications included spironolactone. The patient previously received the first dose of BNT162B2 on 13Jan2021 (lot number: EL3249, administration time: 12:45PM, vaccine location: Left arm) at the age of 27 years old for COVID-19 immunisation. The patient experienced fever, chills, body aches, migraine, nausea, dizziness on 04Feb2021 at 09:00 AM. No treatment received for the events. The outcome of the events was recovered on an unspecified date in Feb2021.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Fatigue, Headache
Clinical narrative: Fever tmax 102; chills; muscle aches; fatigue; sore throat; headache; cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 02Feb2021 14:00 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history included anxiety, allergy to sulfa drugs and Scallops. Patient didn't have COVID prior vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported, in two weeks. No other vaccines were administered in four weeks. The patient previously received the first dose of bnt162b2 on 13Jan2021 01:00 PM at 32 years old, on Right arm for covid-19 immunization. The patient experienced fever tmax 102, chills, muscle aches, fatigue, sore throat, headache, cough, all from 02Feb2021 08:00 PM. No treatment was received for the events. The patient underwent lab tests and procedures which included COVID test (Nasal Swab): negative on 05Feb2021. The outcome of the events was recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever tmax 102; chills; muscle aches; fatigue; sore throat; headache; cough; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 02Feb2021 14:00 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history included anxiety, allergy to sulfa drugs and Scallops. Patient didn't have COVID prior vaccination. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported, in two weeks. No other vaccines were administered in four weeks. The patient previously received the first dose of bnt162b2 on 13Jan2021 01:00 PM at 32 years old, on Right arm for covid-19 immunization. The patient experienced fever tmax 102, chills, muscle aches, fatigue, sore throat, headache, cough, all from 02Feb2021 08:00 PM. No treatment was received for the events. The patient underwent lab tests and procedures which included COVID test (Nasal Swab): negative on 05Feb2021. The outcome of the events was recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: After recieving the second dose of Pfizer-BioNtech COVID-19 vaccine 48 hours ago; My sensitivity to test and smell has significantly decreased. I still cannot smell food or other scents from a distanc; I cannot taste the food as well as before the vaccination; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 24-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9264) via an unspecified route of administration on Arm Right on 04Feb2021 10:30AM at single dose for COVID-19 immunization. The patient Medical history included patient cannot taste the food before vaccination. 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 had no allergies. The patient's concomitant medications were not reported. The Patient did not receive other vaccines in four weeks. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3248) via an unspecified route of administration on Arm Right on 14Jan2021 05:30 PM at single dose for COVID-19 immunization. On 05Feb2021 09:00AM, after receiving the second dose of pfizer-biontech covid-19 vaccine 48 hours ago; the patient experienced sensitivity to test and smell has significantly decreased and still cannot smell food or other scents from a distance and have to smell up close. Patient cannot taste the food as well as before the vaccination. The patient did not receive any treatment for the events. The Outcome of the events was recovering.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Pain of skin
Clinical narrative: Hot spot (literally hot to the touch, palpably different than the rest of my scalp); emanating from scalp/with severe pain lasting less than 30 seconds each episode; Mild strange headache/multiple times in 36 hours; This is a spontaneous report from a contactable other health professional (patient). A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and expiration was not reported) via an unspecified route of administration on 05Feb2021 at 15:00 as single dose for Covid-19 immunization at Fairgrounds (the patient was not pregnant). Medical history included depression from an unknown date and unknown if ongoing. No known allergies, no other vaccine was administered in four weeks. No covid prior vaccination and no covid tested post vaccination. Concomitant medication(s) included bupropion (medication taken within in two weeks). On unspecified date, the patient experienced mild strange headache (just wanted you to know). It came and went quickly, but multiple times 36 hours, the patient had brief hot spot (literally hot to the touch, palpably different than the rest of my scalp) emanating from scalp - mostly top left but sometimes EOP right- with severe pain lasting less than 30 seconds each episode. No therapeutic measures were taken for any of the event. Outcome of the events was recovered.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Head ache; This is a spontaneous report from contactable consumer. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Number: EN6201), via an unspecified route of administration, administered in Arm Left on 06Feb2021 17:30 as SINGLE DOSE for covid-19 immunization (Age at vaccination: 52 years). Medical history included known Allergies: Sulfa. The patient's concomitant medications were not reported. The patient experienced head ache on 06Feb2021 02:00. The patient did not received any treatment for the event. The patient was not pregnant. Outcome of the event was not recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus
Clinical narrative: Dull headache; Extreme Itching skin; This is a spontaneous report from a non-contactable other healthcare professional (HCP, patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 28Jan2021 11:45 AM, at single dose for COVID-19 immunization. Medical history included High blood pressure, known allergies to Sulfa drugs, shellfish. Patient is not pregnant. Concomitant medication included other medications in two weeks. No other vaccine in four weeks. Patient experienced dull headache for exactly 1 week. Extreme Itching skin from 1 week after and ongoing. Mostly in evening. event start date was 04Feb2021 07:00 PM. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Patient was not recovered from the events.   No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: developed a dull headache; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient (pregnant: No) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration in left arm on 04Feb2021 (lot number: EL9264) at 14:15 at single dose for COVID-19 immunisation. The relevant medical history was reported as none. Concomitant medications included l-methylfolate, venlafaxine, cyanocobalamin (VIT B12), ascorbic acid (VIT C) and ergocalciferol (VIT D). For the first 24 hours the patient felt fine. Around 24 hours later she developed a dull headache on 05Feb2021 at 3:30 PM. This lasted from 05Feb2021 to 06Feb2021. She medicated with one dose of Advil on 06Feb2021. It was alleviated totally by 07Feb2021 at 7:00 AM. No covid prior vaccination. The patient underwent lab test included Nasal Swab and PCR on 05Feb2021, which were both pending. The outcome of the event was recovered on 07Feb2021.