chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeding disorder, Hyperhidrosis, Movement disorder, Pain
Clinical narrative: severe body pain/every movement painful; fever with chills for 2 days/feverish; Cannot lie down, shivering/fever with chills for 2 days; She was sweating a lot; Cannot even move around; cannot eat; This is a spontaneous report from a non-contactable pharmacist (patient).  An adult female patient (not pregnant) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on right arm on 21Jan2021 at single dose for covid-19 immunisation.  Medical history included Covid prior vaccination from an unknown date. Covid was not tested post vaccination. The patient's concomitant medications were not reported. Historical Vaccine included she received her first dose on 31Dec2020 for covid-19 immunization and gave her mild body ache and feverish for 2 days. The patient took second dose Pfizer vaccine. It was terrible. She stated the first dose gave her mild body ache and feverish for 2 days. On 21Jan2021, the second dose gave her severe body pain, fever with chills for 2 days. Today was the third day. She cannot even move around, cannot eat, every movement painful. She can not lie down, shivering. They told her to take Tylenol 24 hours. She woke up at 2 am last night feverish. She took Ibuprofen 400 mg. She was sweating a lot. She was taking lemon with tea. She was feeling much better. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: severe body pain/every movement painful; fever with chills for 2 days/feverish; Cannot lie down, shivering/fever with chills for 2 days; She was sweating a lot; Cannot even move around; cannot eat; This is a spontaneous report from a non-contactable pharmacist (patient).  An adult female patient (not pregnant) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on right arm on 21Jan2021 at single dose for covid-19 immunisation.  Medical history included Covid prior vaccination from an unknown date. Covid was not tested post vaccination. The patient's concomitant medications were not reported. Historical Vaccine included she received her first dose on 31Dec2020 for covid-19 immunization and gave her mild body ache and feverish for 2 days. The patient took second dose Pfizer vaccine. It was terrible. She stated the first dose gave her mild body ache and feverish for 2 days. On 21Jan2021, the second dose gave her severe body pain, fever with chills for 2 days. Today was the third day. She cannot even move around, cannot eat, every movement painful. She can not lie down, shivering. They told her to take Tylenol 24 hours. She woke up at 2 am last night feverish. She took Ibuprofen 400 mg. She was sweating a lot. She was taking lemon with tea. She was feeling much better. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Itchy rash at vaccine location that appeared 8 days after vaccine.  Itching lasted 4 days. Used hydrocortisone cream for relief.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Headache, SARS-CoV-2 test negative
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.  A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced first symptoms of headache, vertigo, loss of smell and taste on 08Jan2021. The patient tested positive for covid-19 on 10Jan2021. The patient reported the Saturday before the Pfizer-BioNTech vaccine was administered, he tested negative for COVID-19 disease with a rapid test, but felt it was possible he had COVID-19 disease but it was so recent that the rapid test may have not been accurate. He reported being mostly recovered from his symptoms at this time with some tiny headache remaining. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vertigo
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program.  A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced first symptoms of headache, vertigo, loss of smell and taste on 08Jan2021. The patient tested positive for covid-19 on 10Jan2021. The patient reported the Saturday before the Pfizer-BioNTech vaccine was administered, he tested negative for COVID-19 disease with a rapid test, but felt it was possible he had COVID-19 disease but it was so recent that the rapid test may have not been accurate. He reported being mostly recovered from his symptoms at this time with some tiny headache remaining. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: Had a pain in my arm; Flu like symptoms; Chills; Body aches; Runny nose; This is a spontaneous report from a contactable consumer reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The caller stated "I had the first dose of the vaccine yesterday on 24Jan2021 around 10:00 and I am having more side effects and want to know how long it is going to last. I was fine and had a pain in my arm. Not until maybe midnight, I started feeling more flu like symptoms and took Tylenol and helped, I woke up this morning on 25Jan2021, with chills, body aches, runny nose, and not wanting to do anything. I came to work and pushed myself. Feeling like this, I know it's not covid but what do you suggest." Outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Hypersomnia, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: I went to sleep for four hours when I woke up I had a hard time walking.  My legs were sore for about 24-36 hours.  I was very tired for about 7 days all I did was sleep.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: extreme fatigue; chills; This is a spontaneous report from a contactable other HCP (patient). A 58-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3247) via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (lot number: ER9231) on 29Dec2020 for COVID-19 immunization. The patient experienced extreme fatigue and minor chills 24 hours after 2nd dose of vaccine. Took Tylenol, felt better after 8 hours or so. This is a non-serious report per reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was recovered in Jan2021.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Rash erythematous
Clinical narrative: reddish, flat rash on my right abdomen and chest; Dose 1 administration date 05Jan2021, Dose 2 administration date 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 32-year-old female patient received second single dose of BNT162B2 (Solution for injection, lot number: EL9262, exp date not reported), intramuscular (vaccine location: Left arm) on 22Jan2021 16:15 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included asthma, and penicillin allergy. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient previously took first single dose of BNT162B2 (Pfizer, lot number: unknown) intramuscularly (vaccine location: Left arm) on 05Jan2021 for COVID-19 immunization. The patient noticed on 22Jan2021 at 9:00 pm reddish, flat rash on right abdomen and chest. Treatment received for the adverse event included diphenhydramine (BENADRYL) 50 mg. The events went away. Since the vaccination, the patient has not been tested for COVID-19. The events were considered as non-serious by the reporter. The patient recovered from the event on an unspecified date in Jan2021.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Vision blurred
Clinical narrative: left eye became swollen; aching in the eye socket and eye ball; vision was clouded; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: DL9263), via an unspecified route of administration at the site of left arm at 12:15 on 24Jan2021 at single dose for COVID-19 immunization. Medical history included cancer survivor, penicillin allergy and aspirin allergy. Concomitant medication included ibrutinib (IMBRUVICA), testosterone, cyanocobalamin (VITAMIN B-12) and vitamin d3 (VITAMIN D3), all received within 2 weeks of vaccination. The patient's left eye became swollen and aching in the eye socket and eyeball and vision was "clouded" at 19:00 on 25Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse reactions did not result in any serious consequences. Case assessed as non-serious by reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Rash
Clinical narrative: Body rash and redness
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: mild body ache; feverish; This is a spontaneous report from a Non-contactable Pharmacist. An adult female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Intramuscular in left arm at single dose on 31Dec2020 for COVID-19 immunization. Medical history and concomitant medications were not reported. 1st dose gave mild body ache and feverish for 2 days. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. The outcome of both events was resolved.  No follow-up attempts are possible, information about lot/batch cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site swelling
Clinical narrative: Start Date/Time: [pfizer] 19-JAN-2021 01:00 PM/Start Date/Time: [pfizer] 23-DEC-2020 01:00 PM; right arm swelling; This is a spontaneous report from a contactable other HCP (patient). This 48-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 19Jan2021 13:00 at single dose on the right arm for covid-19 immunization. The patient medical history included diabetes mellitus (DM), hypertension (HTN), depression, obesity, known allergies: TB serum and hair dye. Patient took other medications the patient received within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 via intramuscular on 23Dec2020 13:00 on the right arm for covid-19 immunization, took lisinopril and experienced drug allergy. Patient was not pregnant at the time of vaccination. Facility the most recent COVID-19 vaccine administered was public health clinic/veterans administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced right arm swelling in Jan2021. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No treatment received for the adverse event. Outcome of right arm swelling was recovering. The event was assessed as non-serious.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer reporting for herself. This consumer reported 2 reports for herself and her husband. This is the 1st of 2 reports. A 71-year-old female patient received the first dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 16Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Jan2021, shortly after the first dose, the patient experienced COVID-19 virus test positive. Therapeutic measures were taken as a result of the event and included treatment with monoclonal antibodies on 24Jan2021. She was scheduled for the second dose on 09Feb2021.  The information on the Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021092581 Same reporter/drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site pain
Clinical narrative: she felt the nurse gave the vaccine via subcutaneous instead of intramuscular; tenderness at the injection site; This is a spontaneous report from a contactable consumer repported for self via from a Pfizer sponsored program. This female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via subcutaneous in Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. The patient reported that she felt the nurse gave the vaccine via subcutaneous instead of intramuscular. The nurse squeezed her arm but did not pull the skin taut. The nurse pinched arm and it just didn't feel like it went into muscle. She had no reaction except tenderness at the injection site. The patient asked if she should get another dose. The outcome of event was unknown.   Information about lot/batch number has been requested.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lymphadenopathy
Clinical narrative: 2/9 1pm swelling of rt lymph nodes in neck           8pm 100.4 temp - tylenol & difficulty breathing when laying down - albuterol inhaler, humidifier   02 at 97-99
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Immediate dysosmia and dysgeusia; Immediate dysosmia and dysgeusia; This is a spontaneous report from a contactable other health professional (patient herself). A 47-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: 31Mar2021), via intramuscular route of administration in the left arm on 28Dec2020 17:00 at a single dose for covid-19 immunization. The patient was diagnosed with COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced immediate dysosmia and dysgeusia on 28Dec2020 17:30. The events were reported as non-serious and no treatment was received for the events. The outcome of the events was unknown. The patient had not been tested for COVID-19 since the vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site movement impairment, Vaccination site pain
Clinical narrative: could not lift or move arm; Shoulder was hurting from the injection site; This is a spontaneous report from a contactable consumer reported for herself. A 35-year-old female patient received first dose of bnt162b2 (report as PFIZER COVID-19 VACCINE, Lot number: E11284, Vaccine location: Left arm), via an unspecified route of administration on 08Jan2021 11:30 AM  at single dose for COVID-19 immunization.  The patient did not have allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination.  The patient medical history was not reported.  Concomitant medication included methylphenidate hydrochloride (CONCERTA) from an unspecified date to an unspecified date, influenza vaccine (FLU SHOT) on 18Dec2020 for immunization. The patient reported Friday evening (08Jan2021 06:00 PM) her shoulder was hurting from the injection site. When she woke up Saturday 09Jan2021, she could not lift or move her arm. This followed into Monday. It was now 25Jan2021 and she was still not able to life her arm all the way and she still had a constant pain in her shoulder. It was unknown if patient received treatment for the events. These events did not result in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, was not congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient did not have been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Facility. The outcome of the events was not resolved.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Following day fever (102.7) chills, exhaustion, weakness, achy, body pain soreness, head ache, redness swelling extending 4 in diameter aroung injection site
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Pain, Pyrexia
Clinical narrative: Following day fever (102.7) chills, exhaustion, weakness, achy, body pain soreness, head ache, redness swelling extending 4 in diameter aroung injection site
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Computerised tomogram, Electrocardiogram, Vaccination site pain
Clinical narrative: after 1st immunization mild injection site pain; This is a spontaneous report from a contactable nurse (patient). A 67-year-old female patient received first single dose of BNT162B2 (Pfizer, Solution for injection, lot number: EJ1686, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 30Dec2020 for COVID-19 immunization. Facility type vaccine: Hospital. Medical history included hypothyroidism, arthritis, chronic neck R shoulder pain, migraines, submaxillary gland removal, and tubal ligation. The patient had COVID prior vaccination. The patient was not pregnant at the time of reporting. Concomitant medications/other medications within two weeks included levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN), ibuprofen, amitriptyline hydrochloride (AMITRIP) and vitamin D3. There was no other vaccine within four weeks of vaccination. The patient previously took amoxicillin, cefadroxil (DURICEF), meloxicam (MOBIC), and esomeprazole magnesium (NEXIUM) and experienced allergies to all. On an unspecified date, after 1st immunization, the patient experienced mild injection site pain. Reported labs performed included chest xray, CT head neck, and EKG with unknown results on an unspecified date. The patient was not Covid tested post vaccination. The outcome of event was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing
Clinical narrative: Deep red Flush Began in cheeks And spread down to jaw line; This is a spontaneous report from a contactable consumer (patient).  A 75-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration at Left arm on 25Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization. Medical history included Penicillin allergy, no other medical history. Concomitant medication included simvastatin. The patient was not pregnant. The patient developed a deep red flush that started in her cheeks and went down to her jaw line on 25Jan2021 on 14:00. Stated that flush seemed to be abating but if it came back and/or other reactions occur she could go to Emergency Room. She had electrical shocks going down her left side. Stated that she read through everything on fact sheet but did not see that a flush might occur, it had been 8 hours. This was her first shot, had an appointment for three weeks for her second shot. No COVID prior to vaccination, no COVID tested post vaccination. The outcome of the event was recovering.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Fatigue, body aches, fever
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Petechiae, Purpura, Rash
Clinical narrative: abdominal pain; rash on legs; Rash continues 1 weeks later with purpura, petechiae with no itching or pain; Rash continues 1 weeks later with purpura, petechiae with no itching or pain; This is a spontaneous report from a contactable 34-year-old female nurse (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EK9231), via an unspecified route of administration at left arm on 11Jan2021 08:00 AM at single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine administered was hospital. The patient medical history and concomitant medication was none. Historical vaccine included the first dose of BNT162B2 (lot number=EK5730) on 21Dec2020 08:00 AM at left arm for COVID-19 immunization. Not pregnant at the time of vaccination. On 19Jan2021 12:00 AM, the patient developed abdominal pain and rash on legs; rash continued 1 weeks later with purpura and petechiae (Jan2021) with no itching or pain. Doctor or other healthcare professional office/clinic visit was reported. It was reported as non-serious. Unknown if treatment was received for the events. Outcome of events was not recovered. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: diagnosed with shingles; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received his first dose of the Pfizer COVID-19 vaccine three weeks ago. The patient was diagnosed with shingles on an unspecified date. The patient wanted to know if he is eligible to receive the second dose of the vaccine. The outcome of the event was unknown.   information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness; vertigo; This is a spontaneous report from a contactable consumer (patient).  A 40-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on 24Jan2021, the patient experienced dizziness and vertigo and stated that it gets worse when she tries to get up or turn her head. She wanted to know if this is a normal side effect of the vaccine. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Body temperature increased, Chills
Clinical narrative: Intense back pain, lower back pain above buttocks, similar to contractions all day, joint aches everywhere, chills, temp 99.9, no appetite, head pounding, at 15 hours later, back pain continued and wrapped around quads and down to shins and calf?s, aches stopped but stayed strong at jaw. Neck pain stopped the following morning 7am, headache persude  lethargy, and weakness rest of day, more appetite but not back to normal, light headed rest of day.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Headache, Lethargy, Neck pain
Clinical narrative: Intense back pain, lower back pain above buttocks, similar to contractions all day, joint aches everywhere, chills, temp 99.9, no appetite, head pounding, at 15 hours later, back pain continued and wrapped around quads and down to shins and calf?s, aches stopped but stayed strong at jaw. Neck pain stopped the following morning 7am, headache persude  lethargy, and weakness rest of day, more appetite but not back to normal, light headed rest of day.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw
Clinical narrative: Intense back pain, lower back pain above buttocks, similar to contractions all day, joint aches everywhere, chills, temp 99.9, no appetite, head pounding, at 15 hours later, back pain continued and wrapped around quads and down to shins and calf?s, aches stopped but stayed strong at jaw. Neck pain stopped the following morning 7am, headache persude  lethargy, and weakness rest of day, more appetite but not back to normal, light headed rest of day.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Overdose, Pain in extremity, Product preparation issue, Product use issue
Clinical narrative: Rash more like itchy area above the injection site; Rash more like itchy area above the injection site; Sore arm; reconstitution problem / 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS; patient received approximately "double strength dose"/ 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS,  the recommended 0.3ml dose was then administered to the patient; medical history included rheumatoid arthritis; medical history included rheumatoid arthritis; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, exp. date May2021) via unspecified route of administration on 25Jan2021 at 11:45am at 0.3 mL single dose in right deltoid for COVID-19 immunization. The patient's medical history included ongoing rheumatoid arthritis. The patient's concomitant medications included ongoing hydroxychloroquine for rheumatoid arthritis. The patient experienced sore arm on 26Jan2021, rash more like itchy area above the injection site on 27Jan2021. The patient had no treatment. Pharmacist stated is was a reconstitution problem. He did not have a syringe bigger than 1 ml so he put 0.8 ml, got distracted and forgot to put the rest of the diluent. 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS. The recommended 0.3ml dose was then administered to the patient. The patient received approximately "double strength dose". After applying the vaccine, he remembered that he did finish the preparation of the vaccine. The patient is a co-worker and they have been checking on her to see if she developed any adverse effect. The event was reported as non-serious. The patient recovered from sore arm. The patient was covering from rash more like itchy area above the injection site.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Rash more like itchy area above the injection site; Rash more like itchy area above the injection site; Sore arm; reconstitution problem / 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS; patient received approximately "double strength dose"/ 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS,  the recommended 0.3ml dose was then administered to the patient; medical history included rheumatoid arthritis; medical history included rheumatoid arthritis; This is a spontaneous report from a contactable pharmacist. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, exp. date May2021) via unspecified route of administration on 25Jan2021 at 11:45am at 0.3 mL single dose in right deltoid for COVID-19 immunization. The patient's medical history included ongoing rheumatoid arthritis. The patient's concomitant medications included ongoing hydroxychloroquine for rheumatoid arthritis. The patient experienced sore arm on 26Jan2021, rash more like itchy area above the injection site on 27Jan2021. The patient had no treatment. Pharmacist stated is was a reconstitution problem. He did not have a syringe bigger than 1 ml so he put 0.8 ml, got distracted and forgot to put the rest of the diluent. 0.8ml saline diluent was added to the vaccine vial, instead of 1.8ml NS. The recommended 0.3ml dose was then administered to the patient. The patient received approximately "double strength dose". After applying the vaccine, he remembered that he did finish the preparation of the vaccine. The patient is a co-worker and they have been checking on her to see if she developed any adverse effect. The event was reported as non-serious. The patient recovered from sore arm. The patient was covering from rash more like itchy area above the injection site.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 05Jan2021, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test positive (medically significant) on 07Jan2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 07Jan2021.  The information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling
Clinical narrative: Swelling throat; BP 120/74, pulse 74, O2 sat 99%. Benadryl 25 mg PO given, then Benadryl 50 mg IM. Patient stabilized.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: chills; headache; This is a spontaneous report from a non-contactable consumer (reported for herself). An adult female patient (Pregnant at the time of vaccination) received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Hospital. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced chills and headache for a couple days following vaccination. No treatment was received for the adverse events. The events were non-serious per the reporter. It was unknown prior to vaccination, if the patient was diagnosed with COVID-19. It was also unknown since the vaccination, if the patient had been tested for COVID-19. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: received the first dose of the Pfizer vaccine on 05Jan2021 and was diagnosed with covid on 10Jan2021; received the first dose of the Pfizer vaccine on 05Jan2021 and was diagnosed with covid on 10Jan2021; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2) at single dose on 05Jan2021 for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was diagnosed with Covid on 10Jan2021. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 10Jan2021. She has been back to work on 25Jan2021 and was currently Covid free. The outcome of events was unknown. She was scheduled to take the second dose of the vaccine on 26Jan2021 and wanted to know if she can receive it or would need to wait considering her situation. Filing potential AE report for review.  Lot and batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rectal discharge
Clinical narrative: an oily, anal discharge that looks orange in the toilet bowl, and bright yellow on toilet paper; This is a spontaneous report from a contactable consumer (patient).  This 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on unknown date at a single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. After vaccination, in the evening, the patient has had an oily, anal discharge that looks orange in the toilet bowl, and bright yellow on toilet paper. The patient also stated she must wear a pad, as the discharge is persistent, and happens even when she is not having a bowel movement. The outcome of the event was unknown.  Information about Lot/batch number has been requested.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pruritus
Clinical narrative: Injection site still itches.  Like a very large mosquito bite.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Vaccination site pain, White blood cell count, White blood cell count decreased
Clinical narrative: arm hurt a little bit after the shot; low white blood cell count; medical history included multiple myeloma for 5 years and compromised immune system; medical history included multiple myeloma for 5 years and compromised immune system; This is a spontaneous report from a contactable consumer reported for self. This male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on 14Jan2021 at single dose in arm for COVID-19 immunization. The patient's medical history included multiple myeloma for 5 years and compromised immune system (at least he assumed he did). The patient's concomitant medications were not reported. The patient previously received lenalidomide (REVLIMID) 5mg for about 15 days during a month for multiple myeloma. The patient had no other side effects to the vaccine other than arm hurt a little bit after the shot, which he stated was good in his book because it may indicate that had reaction to the vaccine. The patient stated that he had had a compromised immune system, and had a low white blood cell count on an unspecified date. The patient asked for information if he should stop lenalidomide and information with regards to using ibuprofen, paracetamol (TYLENOL), or acetylsalicylic acid (ASPIRIN) after the vaccine. The patient asked about alcohol, any dos and don'ts after the vaccination. The patient also asked how proved that the vaccine worked in old people and if any difference between the results in young and old people. The outcome of events was unknown. The patient is due for the second dose on 04Feb2021.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fear, Feeling cold, Headache
Clinical narrative: she was sleeping; dizziness; she said that she had a reaction that scared her; She was sleeping and she got dizzy and felt like she was going to fall; She said that she had nausea.; She said that she felt very cold and felt her heart beating; She said that she felt very cold and felt her heart beating; Headaches; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included she was on radiotherapy treatment and had it on Thursday and Friday prior to the vaccine. The patient's concomitant medications were not reported. On 24Jan2021, she said that she had a reaction that scared her, she said she was sleeping and felt dizziness. She was sleeping and she got dizzy and felt like she was going to fall. She said that she thought she was dreaming at first until she opened her eyes and realized that she was still dizzy. When she opened her eyes, she still felt dizzy and it wouldn't go away no matter which way she looked. She states dizziness has resolved. She also reports having nausea. She said that she felt very cold and felt her heart beating. She said that everywhere that she turned her head she would get dizzy, even when her eyes were open or closed. She is on radiotherapy treatment and had it on Thursday and Friday prior to the vaccine. The patient was also receiving radiotherapy treatments. She was scheduled for hormone treatments starting 9Feb2021. She has Zofran for nausea and told her doctor about what happened and her oncologist told her to take Tylenol for headaches, but she said that she did not have a headache. She said that the Zofran relieved the nausea, but she still had the dizziness. She said that every movement would cause dizziness. She said that she was wondering if it is safe for her to get the second dose. She states that she does not take immunosuppressant medications. The outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Palpitations, Somnolence
Clinical narrative: she was sleeping; dizziness; she said that she had a reaction that scared her; She was sleeping and she got dizzy and felt like she was going to fall; She said that she had nausea.; She said that she felt very cold and felt her heart beating; She said that she felt very cold and felt her heart beating; Headaches; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 09:15 at single dose for COVID-19 immunization. Medical history included she was on radiotherapy treatment and had it on Thursday and Friday prior to the vaccine. The patient's concomitant medications were not reported. On 24Jan2021, she said that she had a reaction that scared her, she said she was sleeping and felt dizziness. She was sleeping and she got dizzy and felt like she was going to fall. She said that she thought she was dreaming at first until she opened her eyes and realized that she was still dizzy. When she opened her eyes, she still felt dizzy and it wouldn't go away no matter which way she looked. She states dizziness has resolved. She also reports having nausea. She said that she felt very cold and felt her heart beating. She said that everywhere that she turned her head she would get dizzy, even when her eyes were open or closed. She is on radiotherapy treatment and had it on Thursday and Friday prior to the vaccine. The patient was also receiving radiotherapy treatments. She was scheduled for hormone treatments starting 9Feb2021. She has Zofran for nausea and told her doctor about what happened and her oncologist told her to take Tylenol for headaches, but she said that she did not have a headache. She said that the Zofran relieved the nausea, but she still had the dizziness. She said that every movement would cause dizziness. She said that she was wondering if it is safe for her to get the second dose. She states that she does not take immunosuppressant medications. The outcome was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pain, Malaise, Pain, Pyrexia
Clinical narrative: dizzy; achy; her eyes began to ache; she felt feverish but she did not have a fever; she just felt lousy; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and exp date not reported), via an unspecified route of administration on 20Jan2021 11:00 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient felt fine right after receiving it at approximately 11:00 am. On 21Jan2021, the next day around 11:30 am, she began to feel dizzy and achy and her eyes began to ache. On an unspecified date in Jan2021, she felt feverish, but she did not have a fever and she just felt lousy. The patient states on an unspecified date (Friday) she felt better but still a little dizzy and achy. Patient was instructed to call the number listed on the FactSheet to report her experience. She would like to know if her symptoms were normal and would like to know what she should do about her symptoms. She asked if she should receive the second dose of the vaccine. She was scheduled to receive second dose on 10Feb2021. She just wanted to call so that her symptoms can go on record for what people are experiencing after receiving the Pfizer COVID vaccine. Caller states the fact that everyone gets the same dosage no matter their size was amazing to her. She had been bragging to her neighbors and others how the first dose of the vaccine was a piece a cake and then she started to experience side effects 24 hours after receiving the vaccine. The outcome of events was unknown.  Information on the lot/ batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 1ml instead of 0.5ml
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Migraine, Vaccination site pain
Clinical narrative: Soreness at shot site; fatigue; migraine; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date: unknown) via an unspecified route of administration, on 12Jan2021 at 14:30 at a single dose, for COVID-19 immunization. Relevant medical history included allergies to sulfa drugs. Concomitant medications included escitalopram, alprazolam, paracetamol (TYLENOL), simethicone (GAS X), and vitamin D. The patient previously took aspirin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the Facility. On 12Jan2021, at 14:30, the patient experienced soreness at shot site, fatigue, and migraine. The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was unknown. The patient has not been tested for COVID-19 since vaccination.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID19 after getting the first shot and wanted to know if doctor will proceed with his second dose. Event outcome was unknown. Information on the lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal uterine bleeding, Haemoglobin normal, Pregnancy test negative, Pyrexia
Clinical narrative: Heavy, abnormal uterine bleeding, home temperature reported as 103 off and on x 2 days. Fever resolved, bleeding currently persisting.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: a huge swollen lymph nodes under her left armpit on the same side where she received the injection; This is a spontaneous report from a contactable Pharmacist(patient). A female patient of an unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 16Jan2021 at single dose, in left arm for covid-19 immunization. The patient received first dose of BNT162B2 on 26Dec2020 for covid-19 immunization. The lot number from her first dose was EL0140. The patient's medical history and concomitant medications were not reported. She got the second shot on 16Jan2021. The next day she experienced a huge swollen lymph nodes under her left armpit on the same side where she received the injection and she still had them. She was asking what she should do. The patient was wondering if she should be concerned if her lymph node was still swollen after 10 days. The outcome of the event was not recovered.    Information on the Lot/Batch Number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: patient was diagnosed with COVID-19; patient was diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (patient's mother).   A 23-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was diagnosed with COVID-19 on an unspecified date with outcome of unknown (as reported).  The event was described by reporter as follows: her son who received the first dose of the Pfizer vaccine, and is due for the second dose this weekend. Between the two doses the son was diagnosed with Covid, but currently is already doing fine according to the caller. She wanted to know if her son can take the second dose of the Covid vaccine as intended.  The information on the Lot/Batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Pt remained near pharmacy for observation and developed a rash while waiting.  We observed for an additional 30 minutes without further worsening of rash.