chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Temperature of 99.9; Body aches; Frequent headaches; Nauseated; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Lot Number: EW0151) via unknown route of administration in left arm on 17Apr2021 at 11:24 (at the age of 21 years old) as DOSE 2, SINGLE for covid-19 immunisation. Vaccine Administered At Military Facility: No, But There Were Military People And Police There. People Administering Covid Shots Were Regular Nurses. The patient medical history included severe depression with psychosis, Diagnosed a little bit over a year. Has always been a struggle since she was a child, but never knew what it was. Since taking the medications she had been feeling better and was more productive. The patient family medical history included diabetes, either high or low blood pressure and cervical cancer. Concomitant medication included hydroxyzine 25 mg thrice daily (lot number: ED6351089 and expiry date: 10Nov2021) via orally for anxiety, depression and psychosis, had been taking for a little over a year. Dose would increase to either 50mg or 100mg and quetiapine 25 mg tablet daily (two tablets for bedtime) for psychosis and sleep, doctor would up her dose to either 50mg or 100mg, had been taking a little over a year. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Lot Number: ER8727) via unknown route of administration in left arm on 27Mar2021 as DOSE 1, SINGLE for covid-19 immunization and had no reaction from the first COVID shot. The patient did not receive any other vaccine prior vaccination within 4 Weeks. On 17Apr2021, the patient had body aches, has been nauseated, and had frequent migraines. Had not actually thrown up or anything like that. Apparently she had a fever, but didn't know it. Had her temperature checked for work and it was 99.9. Her job sent her home. Had no reaction from the first COVID shot. Body aches began between 17:00-18:00. Had some last night and just thought she would try to get rest. Woke up with a headache and body pain. Was a little bit nauseated last night. Would stop for a minute and come right back on. Felt like a soreness after a workout. It was clarified she would instead classify it as headaches and not migraines, had been constant since 17Apr2021, had been turning down the TV volume and staying in quiet environments. Comes and goes, but never lasts long. had not thrown up and was not nauseated this morning. At 08:46, temperature was taken at her work and she was told it was too high and considered risky to go to work. She was sent home. On 08May2021, written on her card, she was not sure what that means or if she had to come back for another shot. The outcome of the event Frequent headaches was not recovered and other events was unknown.  No follow-up attempts were needed. No further information was expected.
Age: 92.0
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Chills, Circumstance or information capable of leading to medication error, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non health- care professional.  A 93-year-old patient of an unspecified gender received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Left Arm on 30Mar2021 (at 92-year-old age)  as dose 1, single for covid-19 immunization.  Patients Medical history included Atrial fibrillation, Thyroid, anxiety, COVID-19 from Jan2021 to an unknown date. Concomitant medication(s) included apixaban (ELIQUIS) taken for atrial fibrillation, levothyroxine sodium taken for hypothyroidism, lorazepam taken for anxiety, start and stop date were not reported.  The patient experienced chills, fever, nausea on an unspecified date. Patient stated he/she was afraid and worried about getting the second shot because patient was on blood thinner Eliquis, Patient asks is that going to make any difference? can patient get the second vaccine?  The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on Jan2021. Outcome of events was unknown.    No follow-up attempts needed or possible. No further information expected.
Age: 92.0
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: This is a spontaneous report from a contactable consumer or other non health- care professional.  A 93-year-old patient of an unspecified gender received BNT162B2 (BNT162B2 Formulation: Solution for injection Batch/Lot Number: ER8732; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in Left Arm on 30Mar2021 (at 92-year-old age)  as dose 1, single for covid-19 immunization.  Patients Medical history included Atrial fibrillation, Thyroid, anxiety, COVID-19 from Jan2021 to an unknown date. Concomitant medication(s) included apixaban (ELIQUIS) taken for atrial fibrillation, levothyroxine sodium taken for hypothyroidism, lorazepam taken for anxiety, start and stop date were not reported.  The patient experienced chills, fever, nausea on an unspecified date. Patient stated he/she was afraid and worried about getting the second shot because patient was on blood thinner Eliquis, Patient asks is that going to make any difference? can patient get the second vaccine?  The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on Jan2021. Outcome of events was unknown.    No follow-up attempts needed or possible. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Pruritus, Rash, Skin burning sensation, Urticaria
Clinical narrative: Itching; Skin burning sensation; red welts; About 3-4 hours afterward her 1st COVID-19 Vaccine, she had a rash start on the back of her left leg that then spread allover her body on 18Apr2021; bad back; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0153, Expiry date was not reported) via an unspecified route of administration, administered in Arm Right on 17Apr2021 16:00 (at the age of 49-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication(s) included prednisone (PREDNISONE) (60mg tablet per day) taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. The reporter reported that she had her first dose of the Pfizer COVID-19 Vaccine on Saturday, 17Apr2021. She said about 3-4 hours afterwards, she had a rash start on the back of her (left) leg. She said at the time, she didn't think anything of the rash because she had received her COVID-19 Vaccine in her in right arm. She said the rash was on the back of her left leg, behind her left knee. She said by the next day (Sunday, 18Apr2021), the rash had spread all over her body. She said the rash was itching and burning with red welts. She said she went to immediate Care (an urgent care) yesterday (18Apr2021), when the rash started to spread up to her neck. She said she was concerned when the rash started to spread to her neck because she was told if she had a reaction to the COVID-19 Vaccine, the reaction could close off her breathing. As a treatment patient has received steroid injection at the urgent care, and told to start Benadryl, and to take the Benadryl 25mg tablet, every 4-5 hours. She said she was also given a steroid prescription to take for the next 5 days. The outcome for the events Rash starts on the back of her left leg that then spread all over her body, itching, skin burning sensation, red welts was not recovered. And for the event bad back was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Confusional state, Fatigue, Feeling abnormal, Pain
Clinical narrative: was confused and tired; was confused and tired; it feels weird in her abdomen; lot of pain; would go to urinate and she had light blood; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:00 pm (age of vaccination was 62 years) as dose 2, single for COVID-19 immunization. The patient's medical history included asthma that was fine, inflammation and cysts (it was reported that they had took out her uterine, it was removed for cysts and it was so many years ago, 5 years and now she didn't bleed). Concomitant medications included vitamin C [ascorbic acid], vitamin D NOS and zinc all taken for an unspecified indication. The patient took an inhaler for asthma sometimes if she had one, she took 5 mg for inflammation and asked what was inside the tube of the inhaler. She didn't have anything else. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8730, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 25Mar2021 at 14:00 pm (age of vaccination was 62 years) as dose 1, single for COVID-19 immunization and experienced lot of pain, hot flashes and it was so like burning. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient provided that with the 2nd one it was the same thing continued but more intense. She stated that she did not have a fever. On 15Apr2021, Thursday, the patient would go to urinate and she had light blood and it freaked her out, that was the 2nd day after and she thought ok 2nd day. The patient clarified that by the night after the 2nd dose she started having light blood and it was the same color and she thought it was going to go away and it didn't worry her and she didn't know what to think. On an unspecified date, the patient was very tired and very confused, airy head like go out of herself at work and just didn't want to move and she was still very tired and was feeling a lot of pain. The patient was confused and tired and woke up fine in the afternoon and had very light blood and she thought it was from taking a lot of vitamins, she always took Vitamin C, Vitamin D, and Zinc and it was not a big deal. She stated that it then continued and it felt weird in her abdomen. The patient was scared and she didn't know what to do. She wanted to know if that was a side effect.The adverse did not require a visit to Emergency Room or Physician Office. No relevant tests were done. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rhinorrhoea, Swelling, Swelling face
Clinical narrative: face got swollen and got red; face got swollen and got red; I got wet nose right there swelling a little bit same time; I got wet nose right there swelling a little bit; This is a spontaneous report from a contactable consumer (patient reported for herself). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727 and Expiration date was unknown) via an unspecified route of administration, on 18Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included cardiovascular disease, anxiety, depression. Patient had open heart surgery, a double bypass when she was 44 and she was only 53 now though. The patient concomitant medications included acetylsalicylic acid (ASPIRIN ANALGESIC); atorvastatin; midodrine; metoprolol; clopidogrel; ronalazine; duloxetine taken for anxiety depression; meclozine hydrochloride (MECLIZINE HCL); hydrocortisone; glyceryl trinitrate (NITROGLYCERIN); zinc sulfate (ZINC SULPHATE); gabapentin; vitamin d nos; paracetamol (ACETAMINOPHEN) additional Information for acetaminophen: 1000mg each time and alprazolam (XANAX). On 18Mar2021, patient stated at the first she got the reaction, but they were gone after 30 minutes her air way did not get stopped but her face got swollen and got red and she thought she got wet nose right there swelling a little bit same time. Patient stated that was the first time she got a vaccine on March 18th and experienced face swollen but she was fine after that. When probed for the concern, Patient stated, "she may have call it one symptom she guessed adverse and adverse reaction to her second dosage of vaccine, and she need somebody about it. Patient had her first dosage on 18Mar2021 and had her second dosage on 08Apr2021 that April 8th on Tuesday really did not have reaction, did not get any nauseous, headache but her right was feeling like sinusy whatever but she do not have any sinus issues and then she was feeling little nauseas and then her right hand for some reason she got bruise on the top of her hand and then that bruise moved to left part of upper hand and gotten a big knot there and now it was black and blue and it was also like ball and her husband and she thought that could be a blood clot. she probably got headache and had a headache every single day with sickness and felt like little vomit and not having a very good appetite not at all. Patient stated she got the second reaction, it was 5 days later, it was 13Apr2021." Patient stated that she had Xanax if she was having the anxiety attack and that was alprazolam, 0.5 mg tablet. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anxiety, Arthralgia, Irritable bowel syndrome, Paraesthesia
Clinical narrative: tingling in face and arms; joint pain; constantly throwing up; anxiety; stomach pain; something for IBS; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date: Not reported), via an unspecified route of administration, on 18Apr2021 (at the age of 37-year-old) (at 15:00), in Arm Right, as dose 1, single for COVID-19 immunization. Medical history included, diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) obesity, ongoing chronic nausea. Concomitant medication(s) included ondansetron taken for chronic nausea, start and stop date were not reported. The patient previously took promethazine (PHENERGAN) for allergy. The patient went to the hospital last night because got so sick an hour after getting the vaccine. Reporter stated that the patient was experiencing tingling in her face and arms, severe joint pain and was constantly throwing up. The patient cannot keep anything down. The reporter took patient to the emergency room. In emergency room the patient was given with rehydration in IV fluids, something for IBS and to calm stomach pain that caller doesn't remember, as well as Zofran, Benadryl and Ativan because patient's anxiety shot through the roof. Patient's labs all came back normal so the emergency room decided to send her home, which the reporter was not very happy about, but he could not do anything about. The reporter stated that these symptoms were all ongoing and consistent. He confirmed the anxiety has not gotten any better. The reporter reported that patient had chronic nausea but it did not usually come on like this did, usually Zofran stops the nausea but it had not worked so far. Patient went to emergency room as a result of AE. Treatment was taken with rehydration in IV fluids, something for IBS, Zofran, Benadryl and Ativan. The clinical outcome of events anxiety, abdominal pain, nausea were unknown while remaining events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: tingling in face and arms; joint pain; constantly throwing up; anxiety; stomach pain; something for IBS; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and expiration date: Not reported), via an unspecified route of administration, on 18Apr2021 (at the age of 37-year-old) (at 15:00), in Arm Right, as dose 1, single for COVID-19 immunization. Medical history included, diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) obesity, ongoing chronic nausea. Concomitant medication(s) included ondansetron taken for chronic nausea, start and stop date were not reported. The patient previously took promethazine (PHENERGAN) for allergy. The patient went to the hospital last night because got so sick an hour after getting the vaccine. Reporter stated that the patient was experiencing tingling in her face and arms, severe joint pain and was constantly throwing up. The patient cannot keep anything down. The reporter took patient to the emergency room. In emergency room the patient was given with rehydration in IV fluids, something for IBS and to calm stomach pain that caller doesn't remember, as well as Zofran, Benadryl and Ativan because patient's anxiety shot through the roof. Patient's labs all came back normal so the emergency room decided to send her home, which the reporter was not very happy about, but he could not do anything about. The reporter stated that these symptoms were all ongoing and consistent. He confirmed the anxiety has not gotten any better. The reporter reported that patient had chronic nausea but it did not usually come on like this did, usually Zofran stops the nausea but it had not worked so far. Patient went to emergency room as a result of AE. Treatment was taken with rehydration in IV fluids, something for IBS, Zofran, Benadryl and Ativan. The clinical outcome of events anxiety, abdominal pain, nausea were unknown while remaining events were not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Rash
Clinical narrative: Full body rash; head hurts; fast heart rate; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced full body rash, head hurts, fast heart rate on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Myalgia
Clinical narrative: chills; Muscle ache; supraclavicular lymphadenopaty/lymph node swell; This is a spontaneous report from a contactable other hcp. A 32-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3246; Expiration Date: Apr2021), dose 1 intramuscular, administered in Arm Left on 08Jan2021 as SINGLE DOSE and dose 2 intramuscular, administered in Arm Left on 29Jan2021 (Batch/Lot Number: EN5318) as DOSE 2 SINGLE for covid-19 immunisation. Medical history included back pain from an unknown date and unknown if ongoing. The patient's concomitant medications were Drospirenone and ethinyl estradiol (Birth control pills). Patient did not receive other vaccine in four weeks of vaccination. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events.The patient experienced supraclavicular lymphadenopathy on 13Jan2021, chills 02Feb2021, muscle ache on 02Feb2021. The outcome of the event supraclavicular lymphadenopathy was recovering, chills and muscle ache was recovered. No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: 2 hours later I developed a rash on the inside of my left elbow that itched for a few days.; 2 hours later I developed a rash on the inside of my left elbow that itched for a few days.; This is a spontaneous report from a contactable consumer or other non-HCP (patient) via Pfizer sales representative. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 01Apr2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On 01Apr2021 patient took first shot in left arm. Approximately 2 hours later patient developed a rash on the inside of left elbow that itched for a few days. Event took place after use of product. The outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Nausea, Pain, Pyrexia
Clinical narrative: body aches; frequent headache; I felt nauseous; temperature was 99.6; This is a spontaneous report from a contactable consumer (patient) via from Pfizer sponsored. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 17Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her second shot on the 17th and had some body aches. The patient underwent lab tests and procedures which included body temperature increased: 99.6 on an unspecified date. The patient had a frequent headache and when the patient went to work today (19Apr2021) and had temperature was 99.6 so the patient could not go and felt nauseous. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Gingival pain, Paraesthesia oral, Pharyngeal swelling, Tongue disorder
Clinical narrative: my tongue feels weird/tingling above my lip; bumps all over the back of my tongue; throat swell a bit; hard to swallow; tremendous pain in my gums, like I was biting down on nails; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number er8735 & Expiry date not reported)  via an unspecified route of administration, administered in  Left arm  on 19Apr2021 at 12:45 (at age of 41-years-old) as dose 2,single for COVID-19 immunisation .Patient medical history include allergic to all nuts except peanuts, seasonal allergy, allergic to bees, Oral allergy to many fruits and vegetable.  Concomitant medication(s) includes epinephrine (EPIPEN) taken for an unspecified indication, start and stop date were not reported; levocetirizine dihydrochloride (XYZAL) taken for an allergy nose spray, start and stop date were not reported. Patient previously took sulfites and experienced allergic to sulfites (lip swell).Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number er8733, & Expiry date not reported)  via an unspecified route of administration in left arm on Mar2021 at 12:45 as single dose for COVID-19 immunisation.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 19Apr2021 at 13:00 (15 mins after vaccination) Patient experienced events. It was reported that at the 15-minute mark my husband and I left the clinic.  As we left, I remarked to him, my tongue feels weird. When I got in the car, I removed my mask and saw bumps all over the back of my tongue. A few minutes after that I felt my throat swell a bit.I am allergic to all nuts (except peanuts) and have felt my throat swell before.If I had not had this allergic reaction in the past, I would have been very scared. But I carry an EpiPen and felt that if things got worse, I'd use the EpiPen. Since this was not as severe so we did not return to the clinic.Shortly after that it was hard to swallow. I drank about 12 oz of water to help my system process everything.Within an hour these symptoms subsided.About an hour after that I felt tingling above my lip.Shortly after that I felt tremendous pain in my gums, like I was biting down on nails.(I am also allergic to sulfites and have oral food allergic reactions to most raw fruits and some vegetables.) Patient did not receive any treatment for the events. The Outcome of the events was recovered on unspecified day in Apr2021.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer. This female consumer reported a female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown, expiry date: unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation.  The patient's medical history not reported. There were no concomitant medications. The patient experienced dizziness, extremely weak, sore arm and chills on an unspecified date. Caller stated that the second Pfizer COVID-19 shot was due on Tuesday. With the first shot within some minutes of getting it, caller felt a little dizzy. It passed quickly. Then, 4-5 hours later experienced extreme dizziness, caller family walked her to the bed. Caller got to the bed in time was extremely weak and dizzy. The dizziness was still there the next morning, and  was mildly dizzy a couple of days later. Caller also had the common side effects like pain in her arm and chills, but consumer expected that. The dizziness was listed as more of a less common side effect. It was not one of the common ones or an allergic issue. It was not a common side effect. Caller was not sure if she would  get the second shot. The initial dizziness was immediately within minutes following the injection. So this worried her for the second. The outcome of events: unknown. No follow-up attempts possible. Information on lot/batch cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Disorientation, Fatigue, Pharyngeal swelling, Sinusitis
Clinical narrative: tongue and throat feels puffy; extreme vertigo; Depleted energy; blurred vision; confusion; disoriented; sinuses feel inflamed; tongue and throat feels puffy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 44-year-old-female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ep7533, expiry date: unknown, Age at vaccination: 44-year-old) via an unspecified route of administration in arm left on 09Apr2021 05:00 PM as dose 2, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included MECLIZINE HCL, PREDNISONE. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: en6206, expiry date: unknown) via an unspecified route of administration in arm left on 12Mar2021 08:45 AM as dose 1, single for COVID-19 immunisation. On 10Apr2021 23:00, patient experienced tongue and throat feels puffy (throat swelling and swelling of tongue), extreme vertigo, Depleted energy, blurred vision, confusion, disoriented sinuses feel inflamed. Patient has been to the ER three times with in one week. Facility where the most recent COVID-19 vaccine was administered was pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event result in doctor or other healthcare professional office/clinic visit. Adverse event result in emergency room/department or urgent care. Treatment received for the adverse event as Meclizine and prednisone. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Allergies to medications, food, or other products none. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue, Vertigo, Vision blurred
Clinical narrative: tongue and throat feels puffy; extreme vertigo; Depleted energy; blurred vision; confusion; disoriented; sinuses feel inflamed; tongue and throat feels puffy; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 44-year-old-female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ep7533, expiry date: unknown, Age at vaccination: 44-year-old) via an unspecified route of administration in arm left on 09Apr2021 05:00 PM as dose 2, single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included MECLIZINE HCL, PREDNISONE. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: en6206, expiry date: unknown) via an unspecified route of administration in arm left on 12Mar2021 08:45 AM as dose 1, single for COVID-19 immunisation. On 10Apr2021 23:00, patient experienced tongue and throat feels puffy (throat swelling and swelling of tongue), extreme vertigo, Depleted energy, blurred vision, confusion, disoriented sinuses feel inflamed. Patient has been to the ER three times with in one week. Facility where the most recent COVID-19 vaccine was administered was pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event result in doctor or other healthcare professional office/clinic visit. Adverse event result in emergency room/department or urgent care. Treatment received for the adverse event as Meclizine and prednisone. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Allergies to medications, food, or other products none. The outcome of events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A 21-year-old male patient received BNT162B2 (Comirnaty, solution for injection, batch/lot# 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 not reported.  The patient experienced rashes and welts on an unspecified date; with outcome of unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP reporting for herself (patient). A 34-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiration date: unknown), via an unspecified route of administration, on Apr 19, 2021, at 10:50, single dose, for COVID-19 immunization. Patient's medical history included migraine headache. Concomitant medications not reported. Approximately 11 hours later on Apr 19, 2021, patient had a raised non-itchy rash on her upper back above her bra line about the size of an adult hand. The patient also had a headache and took Motrin around 5 pm as treatment. The rash began to resolve around 2 am on Apr 20, 2021. The outcome of event recovered on Apr 20, 2021. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Oropharyngeal pain, Pharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: throat infection; sore throat; swelling in her eyes; fever; This is a spontaneous report from a contactable consumer (patient's mother) via Medical Information Team. A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 01Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She said that her daughter had a fever and a little bit of a throat infection and was prescribed to take antibiotics, it's her 3rd day of taking it. Last week she was prescribed antibiotics for a sore throat and swelling in her eyes. She reported she was negative for Covid and strep throat. She stated her 19 y/o daughter was due to receive her second Pfizer Covid vaccine dose tomorrow 23Apr2021. She was asking if she should continue getting the 2nd dose today or should they wait a week or 2. She wanted to know if she can safely take the second dose of the vaccine while on antibiotics. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of all the events and included treatment with antibiotics. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Clarified that she is currently experiencing allergies.; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support a contactable consumer (Patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 17Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications was not reported. Clinical course reported as caller has taken the 1st dose on 17Apr and wants to know if she is cleared to take allergy pills. On 19Apr2021, Clarified that she is currently experiencing allergies. The outcome for the event was not recovered.  No follow-up attempts are possible; Information related to batch/Lot number could not be requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased activity, Headache, Pyrexia
Clinical narrative: Bad headache; low grade fever; bed rest for 24 hours; This is a spontaneous report from a contactable consumer reported for herself. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EL9241; Expiration date was not reported), via intramuscular on 11Feb2021 11:30 (at the age of 77-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history, concomitant medications, prior vaccination within 4 weeks included none. Historical vaccines included first dose of BNT162B2 (Lot number: EL0142) via intramuscular rout on 21Jan2021 11:30 as DOSE 1, SINGLE for covid-19 immunisation and had no problem, went well. The patient experienced bad headache, low grade fever, bed rest for 24 hours on 11Feb2021 23:30. Onset time stated as 12 hrs later. After second injection, patient was ok for first 12 hours. Then had bad headache, low grade Fever, bed rest for 24hours. Next day, felt fine. The events did not require the initiation of new medication/other treatment/procedure. Had no problems. Relevant tests included none. The events were not serious. Clinical outcome of events was recovered on 12Feb2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pyrexia, Throat irritation
Clinical narrative: cough; fever; I got a tickle in my throat; This is a spontaneous report from a contactable consumer (patient). A 21-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on 19Apr2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Tuesday, 20Apr2021, she got a tickle in her throat, and on Wednesday, 21Apr2021, cough started along with fever. The fever went away but cough was not going away. She woke up and she voice was a little worse today. She don't feel completely sick, feel like body is fighting it. She don't feel like dying or anything. Outcome of the event was unknown. Overall Safety Summary section and per attached documents and VR noting cough is not listed as a common side in our trials and listed as a possible symptom of Covid 19. Referred to HCP for further discussion/guidance, based on medical history; unfortunately, we are unable to make specific recommendations. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Vaccination site pain
Clinical narrative: Diarrhea, feeling stomach sick like i was going to vomit; Diarrhea, feeling stomach sick like i was going to vomit; very tired; usual sore arm at the site; This is a spontaneous report from a contactable consumer (patient herself). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6200), via intramuscular route on 04Mar2021 09:15 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6200), via intramuscular route on 11Feb2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation. On an unknown date, the patient experienced diarrhea, feeling stomach sick like she was going to vomit, very tired and usual sore arm at the site. The patient took 1 ammodium went to bed morning till noon started to feel better and was very tired for 3-4 days. Nothing but the usual sore arm at the site that night and next one then nothing. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash that break out over her body; Itching; This is a spontaneous report from a contactable consumer or other non HCP. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection in pre-filled syringe, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2 SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection in pre-filled syringe, Batch/Lot number was not reported), dose 1, via an unspecified route of administration on an unspecified date as DOSE 1 SINGLE for covid-19 immunization. On an unknown date, reporter mentioned that she got yesterday the second dose of the Pfizer covid vaccine and at night after dinner she got some rash that break out over her body and gave her itching. She would like to know if this was an adverse event of the vaccine and what could she do about it. She mentioned that she took an allergy pill. Therapeutic measures were taken as a result of rash that break out over her body, itching. The outcome of all events was unknown.   No follow-up attempts are needed: information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue; Body aches; Chills; Fever; Headache; This is a spontaneous report from a contactable consumer. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. On an unspecified date, patient experienced fatigue, body aches, chills, fever, and headache and Symptoms improving after 48 hours. Outcome of the events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Acute diarrhea that came on suddenly about 5 hours after the vaccine was administered; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: ER8736; Expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 22Apr2021 10:30 (at the age of 68-years-old) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Medical history included hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medications or other medications in two weeks included methimazole (METHIMAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took norco and experienced drug allergy (known allergies). No other vaccine in four weeks. No covid prior vaccination. Covid was not tested post vaccination. The patient experienced acute diarrhea that came on suddenly about 5 hours after the vaccine was administered on 22Apr2021 12:00. Therapeutic measures were taken as a result of the event or treatment was received for AE (details unspecified). AE resulted in none of the above (details unspecified). If patient recovered stated as not recovering. Clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Swelling
Clinical narrative: neck getting inflamed; he has a little ball on top of her collar bone; This is a spontaneous report from a contactable consumer or other non hcp (patients caregiver). A 49-years-old female patient (reporters mother) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced neck getting inflamed and has a little ball on top of her collar bone. The reporter reported on the behalf of her Mother (Patient). The patient received the first dose of the Pfizer-BioNTech COVID-19 Vaccine, and her neck getting inflamed, she had a little ball on top of her collar bone. The reporter asked what to do about that side effect. The outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: she developed hives on her right arm, but received shot in theleft arm.Now she has some on her arms and face.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 30-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered in left arm, on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot was not reported), via an unspecified route of administration, administered anatomical location not reported, on an unspecified date as dose 1, single for COVID-19 immunization. The patient stated she received second dose about an hour and ten minutes ago, about twenty minutes ago she developed hives on her right arm (on unspecified date). The patient stated but she received the dose in the left arm. The patient stated now she has some on her arms and face (on unspecified date). The patient stated she had no reaction with the first dose. The patient asked is this a side effect of the vaccine. The patient asked can she take a BENDADRYL. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: And got a large bruise (at the COVID-19 Vaccine injection site); This is a spontaneous report from a contactable nurse. An 80-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: ELV0158), dose 1 in the left arm on 13Apr 2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccination was 80-year-old). The patient medical included she had COPD, Sinusitis, Bronchial infection and Doxycycline. The patient said she was a bad smoker. The patient reported that she got her first Shingles Vaccine in 2017. XARELTO was reported as concomitant medication. The patient reported that a couple years ago her Xarelto dose was upped from 15mg to 20mg. The patient had not visited emergency room or physician office due to the event and patient had not received any other vaccinations within 4 weeks. On 13-APR-2021 the patient got a large bruise (at the COVID-19 Vaccine injection site). She had her first COVID-19 shot on Tuesday (13Apr2021) and got a large bruise at the COVID-19 Vaccine injection site. She said she never had a bruise from a vaccination before. She said the bruise was over 2" in diameter, and there was no redness, or swelling. She said the bruising didn't hurt, and she did not even have to take Tylenol.  She said her left arm did not hurt. She said the COVID-19 Vaccine injection site bruising was dissipating now. She said she just had a large bruise on her left arm. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.