chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Had no side effects yesterday. This was my second dose. Tonight I noticed my arm felt a little itchy around where the shot was given. I had not removed the band-aid before tonight but when I did under; Red Rash; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration in right arm on 13Feb2021 at 14:00 (age at vaccination was 66 years non pregnant)) as dose 2, single for COVID-19 immunization. Medical history included, gastroesophageal reflux disease from an unknown date. Concomitant medication included rabeprazole sodium DR 20 MG (RABEPRAZOLE SODIUM), colecalciferol (VITAMIN D 3) and vitamins. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot number and expiration dates were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient had no known allergies. On 14Feb2021 at 22:00 after second dose same night the patient noticed her arm felt a little itchy around where the shot was given. She had not removed the Band-Aid before tonight but when she did under where the sticky wings of the Band-Aid were, there was a little raised red rash on both sides but just at the outline of the Band-Aid and not in the center where the white part was located on the Band-Aid. she removed the Band-Aid tonight, washed the area with warm water, it did not seem to itch now. No treatment was received for the event. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.  Follow-up (21May2021): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Vision blurred
Clinical narrative: blood pressure stayed really elevated for 36 hours. It's usually 150's over 88 or something like; Blurred vision; This is a spontaneous report from a contactable consumer. A 74-year-old female received first dose of BNT162B2 (Pfizer COVID-19 vaccine, Solution for Injection, Batch/lot number: EM9810, Expiration date: Unknown), via an intramuscular route in the left upper arm, near the shoulder on 06Feb2021 at 15:08, as a single dose for covid-19 immunization. Medical history included multiple sclerosis since 1991 (ongoing), Hashimoto's disease since 1998 (ongoing), hyperthyroidism (patient had radioactive iodine for hyperthyroidism) and allergic to Penicillin, Shellfish and monosodium glutamate (MSG). The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Feb2021, patient blood pressure skyrocketed. It was 107/99. Her blood pressure stayed really elevated for 36 hours. It's usually 150's over 88 or something like. She also experienced blurred vision. Therapeutic measures taken as a result of the events included low dose of blood pressure medication Lisinopril 10mg. She normally just takes it once in the morning, but she finally resorted to taking it again in the evening. She has continued to take it twice a day until her blood pressure goes down. She confirms she is currently still taking the Lisinopril twice daily. The caller verifies her Lisinopril is dispensed in an orange pharmacy bottle. She only sees a DEA number. No NDC, Lot number or expiry date is seen. Adverse events did not result in visit to emergency room or physician office. She has scheduled an appointment with cardiologist. The caller wanted to get some feedback as to what precautions she should take or what could she take, if it is an allergic reaction can she take Benadryl? The patient underwent lab test and procedure which included blood pressure was 107/99 and from 06Feb2021 it's usually 150's over 88 or something like that. The clinical outcome of blood pressure was not recovered (still having issues, it got below 100 over 90 something but it just stayed elevated for a long time) and of the blurred vision was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: itching; tingling; This is a spontaneous report from a contactable consumer. A 49-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: E19226), via an unspecified route of administration on arm right on 14Feb2021 14:15 PM at single dose for COVID-19 immunisation. The Facility type vaccine was reported as Hospital. The patient medical history included elevated blood pressure and had known allergies to penicillin, Bactrim, shrimp. There was no Covid prior vaccination and had no Covid tested post vaccination. There was no other vaccine in four weeks. The patient Concomitant medications in two weeks included hydrochlorothiazide; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) take n for unspecified indication from an unknown date. On 14Feb2021 03:00 PM, About 45 minutes after vaccine my arms began itching and my face was tingling. Both were mild and last about 15 - 20 min. The patient did not receive any treatment for the events. The outcome of the events was resolved on 14Feb2021 .  No follow up attempts are Possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle soreness; fatigue; This is a spontaneous report from a contactable consumer (the patient) received via a Pfizer sales representative. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL9269), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle soreness and fatigue. Symptoms resolved within 12 hours. 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: Breast pain, Lymphadenopathy
Clinical narrative: breasts were sore; swollen lymph nodes in her neck area and armpits; This is a spontaneous report from a contactable consumer (the patient) received via a sales representative. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 16Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient noticed that by day 4 post shot (20Feb2021), her breasts were sore, and she was experiencing swollen lymph nodes in her neck area and armpits. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Nausea, Paraesthesia
Clinical narrative: Hand tingling; nausea; Medicine head feel; This is a spontaneous report from a contactable other Healthcare Professional (patient).  A 42 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9261), via intramuscular route, administered in Right Arm on 28Jan2021 at 13:00 (42-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. The patients medical history included Penicillin and Sulfonamide allergy, milk and egg intolerance. The patient concomitant medications were not reported. The patient did not receive any other vaccine within in four weeks prior to vaccination. The patient was not infected with Covid prior to vaccination. On an unknown date in 2021, the patient had experienced hand tingling and medicine head feel for 30 mins with nausea occurring 2 days later. Since vaccination the patient was not tested for Covid. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Heart rate increased
Clinical narrative: Heart is racing all day. 144/82; Heart is racing all day. 144/82; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL3247) via an unspecified route of administration on 23Feb2021 at 14:00 (at age of 49-year-old), as dose 1, single in left arm for COVID-19 Immunization. Patient's medical history includes Penicillin allergy. Concomitant medications include omega-3-acid ethyl ester (LOVAZA); Atorvastatin; and ascorbic acid, biotin, calcium pantothenate, cellulose microcrystalline, copper sulfate, folic acid, magnesium stearate, nicotinamide, pyridoxine hydrochloride, riboflavin, silicon dioxide, thiamine disulfide, vitamin b12 nos, vitamin e nos, zinc oxide (CENTRUM B); all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Feb2021, 1 day and 10 hours after vaccination, patient's heart was racing all day 144/82. Patient received treatment for event with beta blocker Metoprolol. Patient had to visit health professional office due to events. The patient underwent lab tests and procedures performed on 25Feb2021 included blood pressure measurement: 144/82, increased; and heart rate: increases. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of all the events was not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: paresthesia, moderate; This is a spontaneous report from a contactable other hcp (patient). A 38-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0142 and expiry date: unknown), dose 2 via an unspecified route of administration on 18Jan2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient received first dose of bnt162b2 on 28Dec2020 at 08:00 AM for covid-19 immunisation (Lot No: EH9899, Administrator route: Intramuscular, Vaccine location: Right arm). Medical history included sinusitis and seasonal allergy. The patient had no known allergies. The patient had no known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced paresthesia, moderate on 31Jan2021 at 12:00. The patient experienced event at doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not take treatment for the event. Outcome of the event was not recovered.  No follow-up attempts are possible; No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Diarrhoea, Eye pain, Headache
Clinical narrative: back pain; eye pain; sensitive to lights and sounds; sensitive to lights and sound; aches; Chills; excruciating headache; diarrhea; nausea; This is a spontaneous report from a contactable Other HCP. This 50-year-old female Other HCP (patient) reported that: A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via unspecified route of administration in left arm on 12Feb2021 at 16:00 (at the age of 50-years old) as dose 2, single for COVID-19 immunization. The patient medical history included Epstein bar virus (at 18 years old), pneumonia and disc herniations. The patient had known allergy to Sulfa. The patient did not receive other vaccine in four weeks of vaccination. The patient had not had COVID-19 prior to vaccination. Concomitant medications received within two weeks included xantofyl (LUTEIN), xanthine, Multivitamin and nortriptyline. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via unspecified route of administration in left arm on 22Jan2021 at 16:00 as dose 1, single for COVID-19 immunization. On 13Feb2021 at 02:00 AM, the patient experienced chills, aches, back pain, excruciating headache, eye pain, sensitive to light and sounds, nausea and diarrhea. The patient had not been tested for COVID-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperacusis, Nausea, Pain, Photophobia
Clinical narrative: back pain; eye pain; sensitive to lights and sounds; sensitive to lights and sound; aches; Chills; excruciating headache; diarrhea; nausea; This is a spontaneous report from a contactable Other HCP. This 50-year-old female Other HCP (patient) reported that: A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via unspecified route of administration in left arm on 12Feb2021 at 16:00 (at the age of 50-years old) as dose 2, single for COVID-19 immunization. The patient medical history included Epstein bar virus (at 18 years old), pneumonia and disc herniations. The patient had known allergy to Sulfa. The patient did not receive other vaccine in four weeks of vaccination. The patient had not had COVID-19 prior to vaccination. Concomitant medications received within two weeks included xantofyl (LUTEIN), xanthine, Multivitamin and nortriptyline. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3249), via unspecified route of administration in left arm on 22Jan2021 at 16:00 as dose 1, single for COVID-19 immunization. On 13Feb2021 at 02:00 AM, the patient experienced chills, aches, back pain, excruciating headache, eye pain, sensitive to light and sounds, nausea and diarrhea. The patient had not been tested for COVID-19 post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Headache, Oropharyngeal pain, Throat tightness
Clinical narrative: tightness in the throat; Headache; chest pain; sore throat; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 27Jan2021 for COVID-19 immunisation. It was reported on 21Feb2021, 4 days after receiving the second dose of the vaccine, consumer started experiencing headache, chest pain, sore throat and tightness in the throat. Consumer still experiencing these symptoms 11 days after receiving the second dose. Consumer stated  that consumer went to the ER several days ago and got an EKG and all done. They told her everything looked okay and that they didn't think it was a reaction to the vaccine. Consumer also added that consumer read on the internet from people receiving the vaccine that they were experiencing lingering chest pain. The outcome of events was not recovered.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Tenderness
Clinical narrative: tenderness in left armpit and left inside elbow/palpate lymph gland/lymph gland in armpit still tender and more pronounced; Tingling down left arm, across shoulders and back of neck; Achy in same area; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: 4145741-16036), via an unspecified route of administration, in arm left on 25Feb2021 at 09:15 (at the age of 61-year-old) as dose 1, single for COVID-19 immunisation. Medical history included Raynaud, Hashimotos hypothyroid, sinusitis, achalasia, undifferentiated connective tissue disease, osteoarthritis and known allergies: penicillin, sulfa drugs and Mastisol surgical glue. Concomitant medications include allergy shot weekly (3 days prior on 22Feb2021) and plaque. The patient did not receive any other vaccine in four weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. On 25Feb2021, 8-10 hours after the shot, the patient experienced tingling down left arm, across shoulders and back of neck and achy in same area. The patient took 2 Tylenol as treatment. On 27Feb2021 at 08:00,  the patient experienced tenderness in left armpit and left inside elbow, can palpate lymph gland and 4 days later (on the day of reporting), lymph gland in armpit still tender and more pronounced. The patient took 2 Tylenol. The outcome of all the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia, Paraesthesia, Sensitive skin, Skin striae
Clinical narrative: Face tingling and numbness; Face tingling and numbness; flushed face; sensitive skin on fingertips; feeling that face and neck were stretching my skin; This is a spontaneous report from a Non-contactable consumer, the patient. A 42-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Dn6203), via an unspecified route of administration, administered in left arm on 26Feb2021 15:15 (at the age of 42-years-old) as a single dose for covid-19 immunization. Medical history included blood pressure abnormal, hypersensitivity. Concomitant medication(s) in two weeks included hydrochlorothiazide, multivitamins, Vitamin D. The patient had sensitivity but no confirmed allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 15:45, the patient experienced face tingling and numbness, flushed face, sensitive skin on fingertips, feeling that face and neck were stretching my skin. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: She has more tingling; This is a spontaneous report from a Pfizer sponsored program COVAX US Support. A contactable consumer reported for a 56-year-old female patient (mother) that: A 56-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history included ongoing neuropathy and was having neuropathy from trauma long ago. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced more tingling. The patient was a teacher and need to go back to school. The patient was not diabetic. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingle or feeling on my neck to the base of the scull; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 25Feb2021 at 16:45 (Batch/Lot Number: EN6200) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were reported as none. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6200) 1st dose on 03Feb2021 at 11:00 (at the age of 77-year-old), administered in left arm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had not taken any other medicine in last two weeks. The patient did not have COVID prior vaccination and had no known allergies. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced tingle or feeling on her neck to the base of the scull on an unspecified date. This is felt on the same side of the neck that the shot was administered. COVID Pfizer vaccine was administered on 03Feb201 and was still present as of 02Mar2021. Patient did not receive any treatment. The clinical outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Paraesthesia
Clinical narrative: Chest pain; Tingling Pins and Needles All Over his body/pins and needles all over his skin; This is a spontaneous report from contactable consumer via Medical Information Team. A 76-year-old male patient (Husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on 17Feb2021 09:00 (at the age of 76-year-old) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Feb2021, the patient experienced tingling pins and needles all over his body, pins and needles all over his skin. On an unspecified date, the patient experienced chest pain. Reporter stated that this morning it was only on his left arm where he got his vaccine. February 2021. She explained her husband had "pins and needles all over his skin", and in the morning it was limited to his left arm, where he received the vaccine. She added she experienced "chest pain" the Friday following the injection, which lasted for 4 days. She had a phone consultation with her cardiologist who said it was "fine and muscle pain". She mentioned their second dose was scheduled on 10Mar2021 and asked if they should receive it. She also reported 3 females died post vaccination with the Pfizer-BioNTech COVID-19 vaccine. She explained: one died after the vaccine; the second, in her sixties, died of a heart after the vaccine; and the third, in her fifties, died after experiencing chest pain for 2 weeks post vaccination. She explained she had no additional details on these adverse events. Her husband had pins and needles all over his skin the day after, and it was just in left arm where he had the COVAX. She said he tried to ask the HCP about it, but the HCP would not answer them and told them to call. She had chest pain 4 days after receiving the COVAX and her cardiologist told her it was just muscle pain. She did not have it. Patient was not visited to Emergency Room and physician Office. No vaccine was administered Prior Vaccinations (within 4 weeks). No treatment was given for the events. Outcome of the event chest pain was recovered on an unspecified date, and tingling pins and needles all over his body and pins and needles all over his skin was recovering.  Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Groin pain, Headache, Menstruation delayed, Nausea
Clinical narrative: period is now eight days late; body feels like she was menstruating (cramps, groin area soreness and aches); nausea; Head pain; body feels like she was menstruating (cramps, groin area soreness and aches); feeling more run down; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 36-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9266 and Expiration date not reported), via an unspecified route of administration in left arm on 13Feb2021 13:00 (at the age of 36-year-old) as single dose for COVID-19 immunisation in workplace clinic. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccine in four weeks. Patient had not been tested for COVID-19 post vaccination. On 28Feb2021, patient reported that her period was eight days late. Patient stated that she gets very regular periods consistently. Patient stated that her body feels like she was menstruating (cramps, groin area soreness and aches) even though she was not. Patient also had some nausea, head pain and feeling more run down in the last two days. Patient is due for her second shot this Saturday (06Mar2021) and patient was wondering if she should get it due to these symptoms and them potentially becoming worse. Patient did not receive any treatment for the events. Patient had taken two pregnancy tests that were negative on an unspecified date of 2021. The outcome of all the events was not resolved.  Follow up activity have been closed and no further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pregnancy test, Premenstrual pain
Clinical narrative: period is now eight days late; body feels like she was menstruating (cramps, groin area soreness and aches); nausea; Head pain; body feels like she was menstruating (cramps, groin area soreness and aches); feeling more run down; This is a spontaneous report from a contactable consumer or other non health care professional (patient). A 36-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL9266 and Expiration date not reported), via an unspecified route of administration in left arm on 13Feb2021 13:00 (at the age of 36-year-old) as single dose for COVID-19 immunisation in workplace clinic. The patient medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced allergy. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccine in four weeks. Patient had not been tested for COVID-19 post vaccination. On 28Feb2021, patient reported that her period was eight days late. Patient stated that she gets very regular periods consistently. Patient stated that her body feels like she was menstruating (cramps, groin area soreness and aches) even though she was not. Patient also had some nausea, head pain and feeling more run down in the last two days. Patient is due for her second shot this Saturday (06Mar2021) and patient was wondering if she should get it due to these symptoms and them potentially becoming worse. Patient did not receive any treatment for the events. Patient had taken two pregnancy tests that were negative on an unspecified date of 2021. The outcome of all the events was not resolved.  Follow up activity have been closed and no further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Paraesthesia, Swelling face
Clinical narrative: Tingling of the face; swelling of the face; loss of strength in left arm, hand,ring finger, and pinky finger.; This is a spontaneous report from a contactable consumer. A 39-years-old non pregnant 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, administered in Right arm on 26Feb2021 at 16:30 (At the age of 39 years old) as Dose number, Unknown, Single for COVID-19 immunization. The patient's medical history included mastocytosis, mast cell activation syndrome from an unknown date and unknown if ongoing. The patient previously took histamine and experienced drug hypersensitivity, gluten and experienced drug hypersensitivity, soy bean and experienced drug hypersensitivity, dairy care and experienced hypersensitivity. Concomitant medications were not reported. Other medications in two weeks includes antihistamines store bought allergy meds. On 26Feb2021 the patient experienced Tingling of the face, swelling of the face, loss of strength in left arm, hand, ring finger, and pinky finger. Outcome of the events was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: tingling on top of tongue about 1 to 10 minutes post injection (during the 15 min wait post vaccination). tongue was not scratchy, just tingled for a few minutes.; This is a spontaneous report from a contactable consumer(patient). A 38-year-old male patient received bnt162b2 (BNT162B2, Batch/Lot Number: EJ1685) via an unspecified route of administration, administered in left arm on 02Mar2021 at 16:45 PM (age at vaccination 38 years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included egg allergy from an unknown date and unknown if ongoing. He did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 02Mar2021 at 16:45, the patient experienced tingling on top of tongue about 1 to 10 minutes post injection (during the 15 min wait post vaccination). Tongue was not scratchy, just tingled for a few minutes. The reporter stated that this is likely not related to the vaccine but as a Pfizer employee he wanted to record this event. Patient did not receive treatment for adverse event. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Insomnia
Clinical narrative: Insomnia; increase in bp; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity (Known allergies: Penicillin). The patient's concomitant medications were not reported. 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. The patient experienced insomnia and increase in bp on 04Feb2021. The patient underwent lab tests and procedures which included blood pressure measurement: increase in bp on an unknown date. The patient received the treatment (Xanax/bp med). Outcome of both the events was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Recurring tingling sensation in muscle at the back of the shoulder; This is a spontaneous report from a contactable consumer (patient). A 32-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3247), via an unspecified route of administration on 23Feb2021 (age at the vaccination 32-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient received Multivitamins as other medications within 2 weeks of vaccination. Concomitant medication(s) included betacarotene, bioflavonoids nos, biotin, calcium ascorbate, calcium pantothenate, calcium phosphate, choline bitartrate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, folic acid, hesperidin, inositol, iron amino acid chelate, lycopene, lysine hydrochloride, magnesium oxide, manganese sulfate, molybdenum trioxide, nicotinamide, phytomenadione, potassium iodide, potassium sulfate, pyridoxine hydrochloride, retinol acetate, riboflavin, selenomethionine, silicon dioxide, colloidal, sodium borate decahydrate, thiamine mononitrate, tocopheryl acid succinate, ubidecarenone, zinc oxide (MULTIVITAMIN & MINERAL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination patient was not tested for covid-19. The patient experienced recurring tingling sensation in muscle at the back of the shoulder on 25Feb2021. Treatment was not received for the adverse event. The outcome was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: elevated blood pressure 202/102; This is a spontaneous report from a non-contactable consumer (patient). A 70-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 26Feb2021 at 08:00 (at the age of 70-years-old) as dose 1 single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no COVID prior vaccination. On 26Feb2021, in evening around 20:00, the patient had elevated blood pressure 202/102. The patient received treatment for adverse event. Patient was not tested for COVID post vaccination. The outcome of the adverse event was recovered on an unspecified date in 2021.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: she received the 2nd dose on 24Feb2021 and both ofher legs are swollen; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program.   A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 24Feb2021 as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included warfarin taken for an unspecified indication from an unspecified start date and ongoing. Patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot number was not reported), via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Reporter stated that she received the 2nd dose on 24Feb2021, and both of her legs were swollen. She mentioned that she was taking Warfarin every day. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoaesthesia, Throat tightness
Clinical narrative: Throat became tight; Was still able to breath, but not comfortable; Left side of face became numb.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not provided, Unable to locate or read the details), via an unspecified route of administration, administered in right arm on 06Feb2021, at 11:15 as dose 1, single (age at vaccination: 49-year-old), for COVID-19 immunization. Medical history included thyroid cancer and breast cancer, both from unknown dates and unknown if ongoing and known allergy to penicillin. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported. The patient previously took dextropropoxyphene (Darvocet), alprazolam (Xanax), acetaminophen;hydrocodone and venlafaxine and had known allergies to these medications. The patient stated that, on 06Feb2021, at 11:45 AM, her throat became tight, was still able to breath, but not comfortable and her left side of face became numb. She took Benadryl and that helped relieve her symptoms. Reportedly, no other vaccine was administered within four weeks. Covid was not diagnosed prior vaccination and post vaccination, she was not tested for Covid. The outcome of the events was recovered on unknown dates in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling, Paraesthesia oral
Clinical narrative: tingling in the center right above her upper lip; swollen with some redness in the same area; swollen with some redness in the same area; This is the spontaneous report from a contactable consumer.   A 72-year-old female consumer reported that: This patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 17:20 (Batch/Lot Number: EN6205) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Contrast media allergy, urticaria and Dyspnoea from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced Tingling in the centre right above her upper lip on 03Mar2021, swollen with some redness in the same area on 03Mar2021, swollen with some redness in the same area on 03Mar2021. The Outcome of event was unknown for event Tingling in the centre right above her upper lip, the outcome of event for swollen with some redness in the same area was recovering and the outcome of swollen with some redness in the same area (Redness) was recovered on 04Mar2021. Upon follow up received on 05Mar2021 Investigation Assessment was not provided. Vaccine was not Administered at  and there was no history of all previous immunization with the Pfizer vaccine considered as suspect, there was no Additional Administered Vaccines. AE(s) did not require a visit to Emergency Room or Physician Office.   Follow up (05Mar2021): This is the spontaneous report from a contactable consumer. This report included: Height and weight, Outcome of events, Dosage details and clinical information.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Elevated blood pressure by 20-30 points; This is a spontaneous report from a contactable consumer (reported for herself).   A 74-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN 6205/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 03Mar2021 at 09:00 (at the age of 74-years-old) as dose 1, single for covid-19 immunisation at Hospital. Medical history included hypertension, blood cholesterol increased, drug hypersensitivity (Penicillin allergy) and mycotic allergy. Concomitant medication(s) included norvasc (AMLODIPINE BESILATE), timolol maleate (TIMOLOL MALEATE) and latanoprost (LATANOPROST). The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took bactrin and experienced drug hypersensitivity, statins and experienced drug hypersensitivity. On 04Mar2021 at 07:00, the patient experienced elevated blood pressure by 20-30 points. The patient underwent lab tests and procedures which included blood pressure measurement: elevated on 04Mar2021 (elevated blood pressure by 20-30 points). At the time of reporting, the outcome of the event was resolving.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: This is a spontaneous report based on the information received by Pfizer from Sanofi PVPortal, (Local reference no: 20210222000002). A contactable consumer reported for herself. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced tingling in both legs and feet 2-3 days later. She stated to neurologist. They are aware. Neurologist stated it was patient decision, as to whether she chooses to get 2nd COVID-19 (Pfizer) vaccine. (Patient stated she has opted not to get). The patient did not receive any treatment for event. The outcome of event was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: allergic reaction; Hard to swallow and to catch breath; Throat started closing; Hard to swallow and to catch breath; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: Number: EL9263), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced hard to swallow and to catch breath, throat started closing on 16Feb2021 and allergic reaction on an unspecified date. The patient was treated with 2 Benadryl to help calm this down. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Headache, Lymphadenopathy
Clinical narrative: lymph nodes swollen under her neck, arm pits, and the back of arms; problems breathing; a lot of headaches; joint pain particularly in her hips/a lot of joint pains especially in the hips; This is a spontaneous report from a contactable consumer (patient).   A 71-years-old female patient reported that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202, Expiry Date, NDC number: Unknown), via an unspecified route of administration in Arm Left on 05Mar2021 at 16:00 as DOSE 2, SINGLE for Covid-19 Immunisation. Medical history included asthma, arthritis, diabetes, cholesterol, reflux, and allergies. Concomitant medications included glipizide for diabetes, liraglutide (VICTOZA) for diabetes, lisinopril taken for diabetes to keep her kidneys healthy, rosuvastatin for cholesterol; Fenosibric Acid and mometasone furoate (NASONEX) for unspecified indications; cyanocobalamine injection taken once a month for vitamin d, VITAMIN D [VITAMIN D NOS] taken 5000mg once a day for an unspecified indication, montelukast for allergies, meloxicam for arthritis. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318, Expiry Date, NDC number: Unknown), via an unspecified route of administration, administered in Arm Left on 30Jan2021 at 16:00 as DOSE 1, SINGLE for covid-19 immunization, she had no problem except tenderness around the shot site, it made a scab, and it came off. It was not healing. The patient had flu shot on 11Sep2020. Fluadquad 2020 2021 syringe (HARX: 120345300, lot number: unknown, expiry: unknown). She had a lot of side effects. The worst was she had a lot of joint pains especially in the hips. The joint pain got really bad on Saturday 06Mar2021. She got out of bed and it was hard to walk without pain. She got up probably about 5:30 am and 6:00am. She had lymph nodes swollen under her neck, arm pits, and the back of arms. It was odd. It said the reaction would be within an hour, but it was 2 to 2.5 hours when she had problems breathing. She came home and used the nebulizer and then used her emergency inhaler. She had Albuterol Sulfate 0.083 percent 2.5mg/3ml (lot number and expiry date: unknown) in the nebulizer and albuterol emergency inhaler (lot number: DAD24A, expiry: Oct2019). Nebulizer came in clear tubes. It eased it a little bit but not much. She had a lot of headaches. She wondered the amount of time before the joint pain went away. The events did not result in Emergency Room or Physician Office. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.