chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Cough, Dysphonia, Erythema, Exposure to SARS-CoV-2
Clinical narrative: Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold.  The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Injection site pain, Injection site swelling, Lower respiratory tract infection
Clinical narrative: Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold.  The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be 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.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Fatigued; Sore in her throat; Lost her voice (hoarse); Reddish nose; Intermittent coughs; she went to work to a COVID unit which she usually didn't do; described her symptoms as a chest cold; Feeling strange like coming down; swelling and soreness in the injection site for a day or two; swelling and soreness in the injection site for a day or two; This is a spontaneous report from a contactable nurse reported for self. This 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 07Jan2021 13:30 PM at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) for COVID-19 immunization on an unspecified date. On 07Jan2021 after second dose vaccination, the patient started experiencing swelling and soreness in the injection site for a day or two. On 08Jan2021 the next day, she went to work to a COVID unit which she usually didn't do. On 08Jan2021 the next day after her shift at 15:00 PM, she started feeling strange like coming down. On 09Jan2021, she felt totally fatigued. The symptom that bothered her the most is the sore in her throat which has gone 10Jan2021, she said she lost her voice (hoarse). She was also experiencing a reddish nose and intermittent coughs. She described her symptoms as a chest cold.  The patient also stated she didn't have fever or chills. She's afraid she might be sick. The outcome of event the sore in her throat was resolved on 10Jan2021. The outcome of other events was unknown.   Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported chest cold cannot be 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.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Right side of face including lips are numb starting at 11:55 a.m. Have phone call into associates PCP. In care of co workers. Associate is alert and oriented. Appointment with associates allergist at 4:00 p.m. today
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: She is still freezing to death; Sick as a dog; Fever; Chills; cannot eat and have no appetite; nauseous; This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received first dose of bnt162b2 (also reported as Pfizer Covid vaccine, lot number: EK4176), intramuscular into left arm on 05Jan2021 16:00 at single dose indicated as presentation because she is a nurse/Covid-19 immunization. Medical history included Type 2 Diabetes, about 2 years ago in 2019 in which she takes metformin 1,000mg twice daily. Concomitant medication included metformin on unspecified date at 1,000mg twice daily for Type 2 Diabetes. There was no history of all previous immunization with the Pfizer vaccine nor there were additional vaccines administered on same date of the Pfizer Covid vaccine. The patient received the Pfizer COVID vaccine last Tuesday and since 06Jan2021 at 06:00, she has been sick as a dog. She is running a fever, has chills, can't eat and has no appetite because she is nauseous; all on 06Jan2021 at 06:00. This is the third day of it.  She would like to know what she can she do. She said that it all started Wednesday morning when she got up. It just gets worse every day.  It looks like it would get better by now, but it hasn't.  She never runs a temperature, but she has now (unspecified date).  She is still freezing to death on unspecified date. She usually has a good appetite.  Even the thought of food makes her sick. She further reported that she has had nothing but chills, fever, and nausea and states it will not go away. She is treating it with ibuprofen. She confirms she already talked to a nurse in this department to report this and she was transferred to see what she could do and states they never answered. This is her first dose and she does not know if she should get the second dose. The patient can't calm down since she has been sick since last Wednesday. She stated that she needed some help because she is so sick. She was suggested to call again calling Pfizer medical information department. She stated that she had called back three times, but there is no such number. The events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous were considered serious (Other medically important condition). The outcome of the events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous was not recovered, and the outcome of the remaining event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completed based on known safety profile and a compatible temporal relation between vaccination and onset of events.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: She is still freezing to death; Sick as a dog; Fever; Chills; cannot eat and have no appetite; nauseous; This is a spontaneous report from a contactable nurse (patient). A 79-year-old female patient received first dose of bnt162b2 (also reported as Pfizer Covid vaccine, lot number: EK4176), intramuscular into left arm on 05Jan2021 16:00 at single dose indicated as presentation because she is a nurse/Covid-19 immunization. Medical history included Type 2 Diabetes, about 2 years ago in 2019 in which she takes metformin 1,000mg twice daily. Concomitant medication included metformin on unspecified date at 1,000mg twice daily for Type 2 Diabetes. There was no history of all previous immunization with the Pfizer vaccine nor there were additional vaccines administered on same date of the Pfizer Covid vaccine. The patient received the Pfizer COVID vaccine last Tuesday and since 06Jan2021 at 06:00, she has been sick as a dog. She is running a fever, has chills, can't eat and has no appetite because she is nauseous; all on 06Jan2021 at 06:00. This is the third day of it.  She would like to know what she can she do. She said that it all started Wednesday morning when she got up. It just gets worse every day.  It looks like it would get better by now, but it hasn't.  She never runs a temperature, but she has now (unspecified date).  She is still freezing to death on unspecified date. She usually has a good appetite.  Even the thought of food makes her sick. She further reported that she has had nothing but chills, fever, and nausea and states it will not go away. She is treating it with ibuprofen. She confirms she already talked to a nurse in this department to report this and she was transferred to see what she could do and states they never answered. This is her first dose and she does not know if she should get the second dose. The patient can't calm down since she has been sick since last Wednesday. She stated that she needed some help because she is so sick. She was suggested to call again calling Pfizer medical information department. She stated that she had called back three times, but there is no such number. The events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous were considered serious (Other medically important condition). The outcome of the events sick as a dog, fever, chills, can't eat and has no appetite, and nauseous was not recovered, and the outcome of the remaining event was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be completed based on known safety profile and a compatible temporal relation between vaccination and onset of events.  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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Myalgia, Pain
Clinical narrative: BODY ACHES; MUSCLE ACHES; LOWER BACK PAIN; HEADACHE. TOOK TYLENOL
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Hot flush, Nausea, Pharyngeal swelling, Rash
Clinical narrative: palms of my hands were bright red; very warm flush feeling; nausea; swelling of the throat; rash on my arms and abdomen; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899 and expiration date not provided), intramuscular in the left arm on 06Jan2021 16:00 (at the age of 49 years old) at a single dose for COVID-19 immunization. Medical history included psoriasis, microscopic colitis, allergies to shellfish, and coconut. The patient's concomitant medications were not reported. The patient previously took estrogen patch, etanercept (ENBREL) and sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies to all. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine and did not take any other medications with 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 06Jan2021 16:15, the patient experienced a very warm flush feeling, nausea started and by 15 minutes, she had swelling of the throat and rash on her arms and abdomen and the palms of her hands were bright red. The events resulted in Emergency room/department or urgent care visit. The patient was treated with diphenhydramine hcl (BENADRYL), steroids (unspecified), famotidine (PEPCID) and ondansetron (ZOFRAN) in response to the events. The patient assessed the events as non-serious. The outcome of the events was recovered with sequel on an unspecified date in Jan2021. The patient has not been tested for COVID-19 since the vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be 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: Unevaluable event
Clinical narrative: glaucoma; This is spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first shot and was scheduled to receive the second dose on 27Jan2021 however, she has an eye surgery for glaucoma scheduled on 22Jan2021 and 25Jan2021. The patient wanted to know if she re-schedule the eye surgery. The outcome of the event glaucoma was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin exfoliation, Stevens-Johnson syndrome
Clinical narrative: Stevens Johnson Syndrome; rash was starting to peel; developed a rash all over her neck/ the rash has spread to face eyes, cheek; developed a rash all over her neck, "looks like its peeling and taut"; developed a rash all over her neck, "looks like its peeling and taut"; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (Age: 48, Unit unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 at single dose for covid-19 immunization. Medical history included she had an allergic reaction to sulfa and developed Stevens Johnson syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Stevens Johnson Syndrome, developed a rash all over her neck/ the rash has spread to face eyes, cheek; "looks like its peeling and taut"; and the rash was starting to peel, all in Jan2021. The patient received 1st dose of vaccine on 10Jan2021, developed a rash all over her neck, "looks like its peeling and taut". She had an allergic reaction to sulfa and developed Stevens Johnson syndrome, this looks similar to that (Experience of Stevens Johnson Syndrome). The patient was asking if she did take the steroid dose pack from her dermatologist for the skin rash will it prohibit her from taking the second dose of the vaccine. She called yesterday and reported a rash after receiving the first dose of the COVID-19 vaccine. She stated that she went to her Dermatologist this morning because the rash has spread to face eyes, cheek and the rash was starting to peel. She stated that the dermatologist wanted to know if it was safe to treat her with a prednisone dose pack after receiving the vaccine. Her rash was worsening so she went to her dermatologist for treatment. She was asking if she should get the second dose. The outcome of events for developed a rash all over her neck/ the rash has spread to face eyes, cheek was not resolved, for other events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of suspect Stevens Johnson Syndrome presented as skin reactions cannot be excluded, considering the plausible temporal relationship.  Severe allergic reaction is the known risk for the vaccine. The underlying predisposing condition of an allergic reaction to sulfa developed Stevens Johnson syndrome may put the patient at high risk of the similar occurrence. 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
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Flushing, Heart rate increased, Lip swelling
Clinical narrative: following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covid vaccine face flushing; increased HR about 45 mins. went away on its own; hours later left eye swollen; This is a spontaneous report from a contactable Nurse (patient). A 31-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Known allergies: Shellfish, IV contrast dye, Penicillin. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced after first dose of covid vaccine face flushing; increased hr about 45 mins. went away on its own since 06Jan2021 16:00; hours later left eye swollen on 06Jan2021; following day around 7pm lip swelling, tongue tingling, body hives, chills on 07Jan2021 19:00. The patient underwent lab tests and procedures which included heart rate: increased on Jan2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: Steroids, IV fluids, Benadryl. No COVID prior vaccination. No COVID tested post vaccinate. This report was reported non-serious. The event outcome of increased hr about 45 mins. went away on its own was recovered on 06Jan2021 16:45, outcome of other events were not recovered.; Sender's Comments: Based on the compatible time association, the serious events are possibly related to suspect BNT162B2 administration. 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.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Urticaria
Clinical narrative: following day around 7pm lip swelling; tongue tingling; body hives; chills; After first dose of Covid vaccine face flushing; increased HR about 45 mins. went away on its own; hours later left eye swollen; This is a spontaneous report from a contactable Nurse (patient). A 31-years-old female patient received first dose of bnt162b2 (BNT162B2, Lot number: EK9231), via an unspecified route of administration on 06Jan2021 15:00 at single dose on Left arm for covid-19 immunisation. Medical history included Known allergies: Shellfish, IV contrast dye, Penicillin. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient experienced after first dose of covid vaccine face flushing; increased hr about 45 mins. went away on its own since 06Jan2021 16:00; hours later left eye swollen on 06Jan2021; following day around 7pm lip swelling, tongue tingling, body hives, chills on 07Jan2021 19:00. The patient underwent lab tests and procedures which included heart rate: increased on Jan2021. Ae resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Ae treatment: Steroids, IV fluids, Benadryl. No COVID prior vaccination. No COVID tested post vaccinate. This report was reported non-serious. The event outcome of increased hr about 45 mins. went away on its own was recovered on 06Jan2021 16:45, outcome of other events were not recovered.; Sender's Comments: Based on the compatible time association, the serious events are possibly related to suspect BNT162B2 administration. 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.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Computerised tomogram normal, Diarrhoea, Dizziness
Clinical narrative: Severe abdominal cramps,  syncope feeling, sweating, nausea, migraine, vision impairment, loose bowel movement, chills, muscle cramps
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Hyperhidrosis, Migraine, Muscle spasms, Nausea
Clinical narrative: Severe abdominal cramps,  syncope feeling, sweating, nausea, migraine, vision impairment, loose bowel movement, chills, muscle cramps
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis normal, Visual impairment, White blood cell count
Clinical narrative: Severe abdominal cramps,  syncope feeling, sweating, nausea, migraine, vision impairment, loose bowel movement, chills, muscle cramps
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Dizziness, Feeling abnormal, Malaise, Renal disorder
Clinical narrative: kidneys weren't acting/kidney issues; not having the feeling to urinate; Light-headed; This is a spontaneous report from a contactable consumer (reported for herself). A 91-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3248; expiration date: not known), via an unspecified route of administration in the left arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure and blood thinner. Concomitant medication included apixaban (ELIQUIS) for blood thinner. The patient is asking if there were any reports of adverse events with kidneys and the vaccine. She received the 1st shot last Thursday (07Jan2021) and told that yesterday (10Jan2021), she had an episode where kidneys weren't acting. She also mentioned that she is on a blood thinner, ELIQUIS. She is due to receive the 2nd shot on 28Jan2021. She said that she wouldn't want to receive the 2nd dose if this was related to her adverse reaction. The issue with the kidney started after on 10Jan2021, yesterday she was really having problems, she went to church then came home by that time she would have to go to the bathroom, but she did not go, she ended up cooking dinner which was 3 hours later, she was noticing that she was not urinating. She drank some Gatorade and that made it little better, she is wondering if it's a side effect. On 10Jan2021, when she noticed the kidney issues, she did not know for certain if it started before that, she didn't pay attention. Also, yesterday (10Jan2021), she got sick in which she had to grab the counter, she felt bad, she wasn't dizzy, but felt light-headed. The symptom of not having the feeling to urinate had improved a little today but she is concerned and wanted to know if this was a side effect. Her being light-headed only occurred on 10Jan2021, it was a onetime occurrence yesterday. However, she was also just sitting around, laying around, after that yesterday. The outcome of the event 'light-headed' was unknown; while outcome of other events was recovering.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary retention
Clinical narrative: kidneys weren't acting/kidney issues; not having the feeling to urinate; Light-headed; This is a spontaneous report from a contactable consumer (reported for herself). A 91-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL3248; expiration date: not known), via an unspecified route of administration in the left arm on 07Jan2021 at single dose for COVID-19 immunization. Medical history included high blood pressure and blood thinner. Concomitant medication included apixaban (ELIQUIS) for blood thinner. The patient is asking if there were any reports of adverse events with kidneys and the vaccine. She received the 1st shot last Thursday (07Jan2021) and told that yesterday (10Jan2021), she had an episode where kidneys weren't acting. She also mentioned that she is on a blood thinner, ELIQUIS. She is due to receive the 2nd shot on 28Jan2021. She said that she wouldn't want to receive the 2nd dose if this was related to her adverse reaction. The issue with the kidney started after on 10Jan2021, yesterday she was really having problems, she went to church then came home by that time she would have to go to the bathroom, but she did not go, she ended up cooking dinner which was 3 hours later, she was noticing that she was not urinating. She drank some Gatorade and that made it little better, she is wondering if it's a side effect. On 10Jan2021, when she noticed the kidney issues, she did not know for certain if it started before that, she didn't pay attention. Also, yesterday (10Jan2021), she got sick in which she had to grab the counter, she felt bad, she wasn't dizzy, but felt light-headed. The symptom of not having the feeling to urinate had improved a little today but she is concerned and wanted to know if this was a side effect. Her being light-headed only occurred on 10Jan2021, it was a onetime occurrence yesterday. However, she was also just sitting around, laying around, after that yesterday. The outcome of the event 'light-headed' was unknown; while outcome of other events was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy, Rash erythematous, Rash pruritic
Clinical narrative: Rt arm axillary swelling and pain. Pain is radiating down rt arm to hand. Red rash itchy rash around torso. And achy joints.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Injection site induration
Clinical narrative: concern for injection to the subcutaneous tissue/concerned about improper administration/patient has a mark where you can see the vaccine and it's higher up where you expect it to be; induration at the injection site; felt induration was moving down his/her arm/can feel it migrated down her arm, 7 inches below injection site; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176), subcutaneous (reported as injection to the subcutaneous tissue to deltoid) on 09Jan2021 at 0.3 mL, single to prevent from getting COVID. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. On 09Jan2021, within a couple hours after, the patient experienced induration at the injection site. The patient felt induration was moving down his/her arm with concern for injection to the subcutaneous tissue. The patient can feel it migrated down his/her arm, 7 inches below injection site. The reporter assessed that the causality was yes for the suspect drug and the patient was concerned about improper administration. The reporter was unsure if it is administration or vaccine, the patient has a mark where you can see the vaccine and it's higher up where you expect it to be. Outcome of the vaccination site induration and induration was not recovered. The events were considered medically significant by the reporter.; Sender's Comments: Based on the available information a causal relationship between reported events induration at the injection site / induration and incorrect route (subcutaneous) of BNT162B2 vaccine administration cannot be excluded. The case will be reevaluated should additional information become available. 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.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Headache
Clinical narrative: Patient noticed her left arm started to get swollen around 7pm, the area around the injection site was raised to approximately (at least) 1 1/2 inch; redness around the injection site was approximately 5 inches. Patient also noticed rash on the area where was red.  A little later on the same day patient started to have fever, terrible body ache all over the body, joints pain, Chills, terrible headache, sore throat, cough and extreme pain on the injection site, Patient described that she was exhausted.   Patient didn't take any med on 1/13/21. Patient took Motrin x 2 dose on 1/14/21 and 1 dose on 1/15/21 with no improve in all her symptoms above. Approximately in the early afternoon of 1/15/21 patient started to feel better.  Patient stated she was 50% improved in her symptoms on Saturday.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Oropharyngeal pain
Clinical narrative: Patient noticed her left arm started to get swollen around 7pm, the area around the injection site was raised to approximately (at least) 1 1/2 inch; redness around the injection site was approximately 5 inches. Patient also noticed rash on the area where was red.  A little later on the same day patient started to have fever, terrible body ache all over the body, joints pain, Chills, terrible headache, sore throat, cough and extreme pain on the injection site, Patient described that she was exhausted.   Patient didn't take any med on 1/13/21. Patient took Motrin x 2 dose on 1/14/21 and 1 dose on 1/15/21 with no improve in all her symptoms above. Approximately in the early afternoon of 1/15/21 patient started to feel better.  Patient stated she was 50% improved in her symptoms on Saturday.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Patient noticed her left arm started to get swollen around 7pm, the area around the injection site was raised to approximately (at least) 1 1/2 inch; redness around the injection site was approximately 5 inches. Patient also noticed rash on the area where was red.  A little later on the same day patient started to have fever, terrible body ache all over the body, joints pain, Chills, terrible headache, sore throat, cough and extreme pain on the injection site, Patient described that she was exhausted.   Patient didn't take any med on 1/13/21. Patient took Motrin x 2 dose on 1/14/21 and 1 dose on 1/15/21 with no improve in all her symptoms above. Approximately in the early afternoon of 1/15/21 patient started to feel better.  Patient stated she was 50% improved in her symptoms on Saturday.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Facial paresis, Paraesthesia, Paraesthesia oral, SARS-CoV-2 test negative
Clinical narrative: Slight left sided facial weakness/droop 4 days post vaccination; Slight left sided facial weakness/droop 4 days post vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination/Tingling to lower extremities; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; Tingling in injected arm and facial tingling in cheeks/lips same day of vaccination; This is a spontaneous report from a contactable consumer (patient herself).  A 36-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EK9231), via an unspecified route of administration in the left arm on 04Jan2021 13:00 at single dose, for Covid-19 immunisation. The vaccine was given in a Nursing Home/Senior Living Facility. Medical history was none. No known drug allergies. No other vaccine in four weeks. No Covid-19 prior vaccination. Concomitant medication included naproxen sodium (ALEVE). The patient experienced tingling in injected arm and facial tingling in cheeks/lips same day of vaccination (04Jan2021). Tingling to lower extremities the day after vaccination (still continuing). Slight left sided facial weakness/droop 4 days post vaccination (04Jan2021). Tingling to left arm continuing on and off. No treatment reported. On 04Jan2021, she was negative to PCR covid test post vaccination. She went to the Emergency room/department or urgent care. The outcome of events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Mass, Skin warm
Clinical narrative: 1 week out symptoms started - hard lump, red, swollen, hot to touch, spread to about a 2 inch diameter
Sex: U
Vaccine: COVID19
Symptoms: Brain natriuretic peptide normal, Chest X-ray abnormal, Dyspnoea, Eosinophil count normal, Leukocytosis
Clinical narrative: SOB; leukocytosis; acute onset of fever (101.2); CXR = bilateral vascular congestion; This is a spontaneous report from a contactable consumer. An elderly NH resident patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced shortness of breath (SOB), leukocytosis (17,800), acute onset of fever (101.2), bilateral vascular congestion. The patient was admitted with acute onset of fever (101.2), leukocytosis (17,800, no eosinophilia) and SOB, all beginning 3-4 hours after BNT162B2 administration. CXR showed bilateral vascular congestion. No facial or SQ edema. No evidence of myocardial damage or CHF based on BNP and troponin, respectively. The patient was treated with brief (3 days) pulse of methylprednisolone sodium succinate (SOLUMEDROL) with improvement. Chalking it up to acute capillary leak syndrome 2^2 vaccine. The final events outcome was unknown. Information on lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary congestion, Pyrexia, Troponin normal, White blood cell count increased
Clinical narrative: SOB; leukocytosis; acute onset of fever (101.2); CXR = bilateral vascular congestion; This is a spontaneous report from a contactable consumer. An elderly NH resident patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced shortness of breath (SOB), leukocytosis (17,800), acute onset of fever (101.2), bilateral vascular congestion. The patient was admitted with acute onset of fever (101.2), leukocytosis (17,800, no eosinophilia) and SOB, all beginning 3-4 hours after BNT162B2 administration. CXR showed bilateral vascular congestion. No facial or SQ edema. No evidence of myocardial damage or CHF based on BNP and troponin, respectively. The patient was treated with brief (3 days) pulse of methylprednisolone sodium succinate (SOLUMEDROL) with improvement. Chalking it up to acute capillary leak syndrome 2^2 vaccine. The final events outcome was unknown. Information on lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Cough, Injection site erythema, Injection site pruritus
Clinical narrative: Temp off 100.8 at 0430 on 1-12-2021. Chills at that time, body aches. No appetite at 0900 on 1-12-2021 and no energy for rest of the day. Nauseated thru out day. Muscle aches thru out day. No further temp by 1700 on that day. On 1-15-2021 noticed redness and itching at injection site...prior to that arm was just sore-also had cough worsen on 1-12-2021. I have had cough off and on since my positive Covid in December
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: Temp off 100.8 at 0430 on 1-12-2021. Chills at that time, body aches. No appetite at 0900 on 1-12-2021 and no energy for rest of the day. Nauseated thru out day. Muscle aches thru out day. No further temp by 1700 on that day. On 1-15-2021 noticed redness and itching at injection site...prior to that arm was just sore-also had cough worsen on 1-12-2021. I have had cough off and on since my positive Covid in December
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Migraine
Clinical narrative: The following two days, I had a migraine. I also had swelling and tenderness at the vaccination site for 6 days afterwards.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: 1/15/2021 minor aches, Saturday 1/16 started with chills, fever, headache and low grade fever  around 6AM.  Body aches and fatigue on Sunday  1/17and Monday 1/18
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chest pain, Dyspnoea, Headache
Clinical narrative: Vaccine at 10:45 am.  At 2 am patient awoke with severe chest, left arm, back of the head, neck, stomach and shoulder pain and was breathing heavily, in a panic attack.  Said he feared he was having a heart attack.  I gave him an extra strength tylenol, rubbed his neck, back of head, shoulders and suggested he was having a vaccine reaction.  After about an hour, he fell asleep. He awoke around 8:30 am with a slight headache but otherwise feeling fine.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Panic attack
Clinical narrative: Vaccine at 10:45 am.  At 2 am patient awoke with severe chest, left arm, back of the head, neck, stomach and shoulder pain and was breathing heavily, in a panic attack.  Said he feared he was having a heart attack.  I gave him an extra strength tylenol, rubbed his neck, back of head, shoulders and suggested he was having a vaccine reaction.  After about an hour, he fell asleep. He awoke around 8:30 am with a slight headache but otherwise feeling fine.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Head discomfort, Headache, Influenza like illness
Clinical narrative: A rash appeared on the upper left leg about 5-10 minutes after the vaccine was administered. A slight burning/stinging sensation was experienced during the 15 minute observation period after vaccine administration; however, at the time, this was attributed to warmth from sitting in the sun. After return to work, the rash was noticed during a bathroom break, which spanned the entirety of the front of the upper left leg. A significant amount of nausea was also experienced about an hour after vaccine administration; however, it stopped short of vomiting. The rash lessened throughout the day and was nearly gone by the end of the night. The nausea also subsided around 6 pm. Only mild flu-like symptoms were experienced the following day (headache, fatigue, head congestion), which were ameliorated 48 hrs post vaccine administration. Pain in the left arm was also experienced, which peaked 24 hours after vaccine administration and subsided 48 hours after.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Rash
Clinical narrative: A rash appeared on the upper left leg about 5-10 minutes after the vaccine was administered. A slight burning/stinging sensation was experienced during the 15 minute observation period after vaccine administration; however, at the time, this was attributed to warmth from sitting in the sun. After return to work, the rash was noticed during a bathroom break, which spanned the entirety of the front of the upper left leg. A significant amount of nausea was also experienced about an hour after vaccine administration; however, it stopped short of vomiting. The rash lessened throughout the day and was nearly gone by the end of the night. The nausea also subsided around 6 pm. Only mild flu-like symptoms were experienced the following day (headache, fatigue, head congestion), which were ameliorated 48 hrs post vaccine administration. Pain in the left arm was also experienced, which peaked 24 hours after vaccine administration and subsided 48 hours after.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: diagnosed with covid after close exposure realized- sitter tested positive
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Palpitations, Tachycardia
Clinical narrative: 17 minutes after injection, .  Moved to a clinical room.  BP initially elevated and tachycardic.  Respiratory rate and pulse ox normal.  Patient given oral Benadryl, IM epi and IV Solu-medrol.  HR slowed and patient became hypotensive.  IV fluids initiated.  Patient observed for a couple of hours and discharged home.  Patient called her allergist who initiated steroids and continuous histamine blockers.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Blood pressure increased, Cardiac stress test, Chest pain, Chills
Clinical narrative: 17 minutes after injection, .  Moved to a clinical room.  BP initially elevated and tachycardic.  Respiratory rate and pulse ox normal.  Patient given oral Benadryl, IM epi and IV Solu-medrol.  HR slowed and patient became hypotensive.  IV fluids initiated.  Patient observed for a couple of hours and discharged home.  Patient called her allergist who initiated steroids and continuous histamine blockers.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Echocardiogram, Heart rate increased, Neurological examination abnormal, Tachycardia
Clinical narrative: 17 minutes after injection, .  Moved to a clinical room.  BP initially elevated and tachycardic.  Respiratory rate and pulse ox normal.  Patient given oral Benadryl, IM epi and IV Solu-medrol.  HR slowed and patient became hypotensive.  IV fluids initiated.  Patient observed for a couple of hours and discharged home.  Patient called her allergist who initiated steroids and continuous histamine blockers.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test, Urticaria
Clinical narrative: 17 minutes after injection, .  Moved to a clinical room.  BP initially elevated and tachycardic.  Respiratory rate and pulse ox normal.  Patient given oral Benadryl, IM epi and IV Solu-medrol.  HR slowed and patient became hypotensive.  IV fluids initiated.  Patient observed for a couple of hours and discharged home.  Patient called her allergist who initiated steroids and continuous histamine blockers.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain
Clinical narrative: TOOK IBUPROFEN BEFORE GETTING VACCINE AND AROUND 0230 AM WOKE UP WITH CHILLS THAT LASTED UNTIL MORNING AND AS THE DAY WENT ON HAD GENERAL MALAISE/BODY ACHES.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Rotator cuff syndrome
Clinical narrative: Shoulder tendinitis
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: There is a red lump.  1 1/2 inches wide and 1 inch tall.  It feels warm to the touch.  No treatment has been administered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Chills, Headache, Injection site pain
Clinical narrative: At 1:00 - 3:00 in morning - 100.3 temperature and chills and headache. Headache became severe - 7:00 in morning. Really severe joint pain and headache - not quite a migraine - no aura but very severe headache. Had to medicate with 1000 mg Tylenol and 600 of Advil. Headache for days. Pain at injection site and that has been with every vaccine I've ever had. Headache went away within three or four days.  Joint pain was there for about two days. Only medicated the headache the first couple of days then it slowly got better. Didn't get vertigo and didn't get flushed after the vaccine. Didn't have the fainting feeling.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: fever 101.3, chills, headache, extreme fatigue, soreness at injection site