chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Paraesthesia
Clinical narrative: Had severe tingling and muscle tightening in left arm; Had severe tingling and muscle tightening in left arm; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System. This 51-year-old female patient received dose 2 BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0172) via an unspecified route of administration on 28Apr2021 at 08:45 (at the age of 51-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included allergies, anxiety disorder, gastroesophageal reflux disease (GERD), hysterectomy, and allergy to sulfa drugs. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included omeprazole, estradiol patch, fexofenadine hydrochloride, and duloxetine hydrochloride (CYMBALTA) from unknown dates for unknown indications. The patient previously received bupropion (WELLBUTRIN) and clarithromycin (BIAXIN) from unknown dates for unknown indications and experienced allergy and "shingles" on an unknown date and had a similar experience. The patient previously received dose 1 of BNT162B2 on 07Apr2021 at 09:00 (lot number EW0150) as a single dose in the right arm for COVID-19 immunization. On 30Apr2021 at 00:30 the patient experienced severe tingling and muscle tightening in her left arm which felt like possible heart attack. The event was reported as non-serious. The patient visited the emergency room (ER) as a result of the events and it was confirmed negative for thus but discussed that it felt similar to her "shingles experience" which was also in her left arm. The patient did not receive any treatment for the events. The outcomes of tingling and muscle tightening were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Tongue blistering, Tongue discomfort, Tongue disorder, Urticaria
Clinical narrative: hives like on side of my neck and under my chin/ hives down my throat and left side of my face; I got blisters and burning sensation on my tongue; I got blisters and burning sensation on my tongue; redness; It's just little bumps; This is a spontaneous report from a contactable consumer (patient). This 56-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0176) via an unspecified route of administration on 30Apr2021 at 23:30 (at the age of 56-years-old) as a single dose in the right arm for COVID-19 immunization. Medical history included thyroid condition. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 (lot number EW0151) on 08Apr2021. Seven hours after dose 2 of the vaccine (01May2021), the patient experienced hives like on side of her neck and under her chin. She put water on it and it went away. Around 12 midnight that night she started to get the hives down her throat and left side of her face. She got blisters and burning sensation on her tongue. She did not know what to do. The patient received treatment with diphenhydramine (BENADRYL). The hives went down and redness went away but she still had a little bit of hives. Her tongue still had bumps and like a burning sensation. The hives were still there but it was not red or itchy. It was just little bumps. Her tongue was still burning. It felt like when you drank something really hot and burned your tongue. She guessed she was allergic to it. The outcome of redness was recovered. The outcomes of hives and tongue still had bumps and burning sensation were not recovered. The outcome of blisters on tongue was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Vasculitis
Clinical narrative: swelling and tenderness in lower right leg / vasculitis; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the right arm) on 03Apr2021 10:15 (at the age of 34-years-old) as 1st dose, single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included alprazolam (XANAX) and propranolol both taken for an unspecified indication, start and stop date were not reported.  The patient previously took PERCOCET and experienced mild allergy. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient experienced swelling and tenderness in lower right leg / vasculitis on 06Apr2021 15:00. It was reported that 3 days after vaccination the patient experienced swelling and tenderness in lower right leg and was initially misdiagnosed as infection. After symptoms persisted for 1.5 weeks and antibiotics had no effect, it was diagnosed as vasculitis. No rheumatological issues in blood test or blood clot. PCP determined likely an immune response to the vaccine. The adverse event resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event included antibiotics and antiinflamttories. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was recovering.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (parent) reporting for the patient (son).  A 19-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in deltoid left on 01Apr2021 (Lot Number: ER8737) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. It was reported that the patient tested positive for COVID on 11Apr2021. The patient did not receive any treatment for the event. The event did not result in emergency room/department visit and physician office visit. The patient underwent COVID-19 test with positive result on 11Apr2021. The patient is scheduled for the second dose 1 day shy of 7 weeks from getting the first which later on clarified the appointment had to be rescheduled for the second dose of the vaccine. The outcome of the event was recovered in Apr2021.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program, . This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 11Apr2021 as a singe dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she had her first dose on 11Apr2021, and her second dose was scheduled "today" (as of 02May2021). She reported experiencing a migraine and was not sure if it was okay to take the second dose. The clinical outcome of migraine was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Erythema, Feeling hot
Clinical narrative: my feet are very red and have large water blisters; my feet are very red and have large water blisters; feel very hot on feet; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration in Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had the vaccine a week ago (Apr2021) and now the feet were very red and had large water blisters and felt very hot on feet. The outcomes of feet were very red, large water blisters, and very hot on feet were unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Muscle twitching, SARS-CoV-2 test
Clinical narrative: twitching in the muscle in his right arm, which is the arm he got the shot in; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for different doses. This is the first of two reports. A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 02Apr2021 reported as at 1600 or 1700 (Batch/Lot Number: ER8732) at the age of 50 years old as 1st dose, single dose for COVID-19 immunization. Medical history was none.  There were no concomitant medications. The patient received the 1st and 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE. He experienced twitching in the muscle on Apr2021. It has not gone away. He received both doses of the vaccine. With the first dose, the patient experienced positive covid-19 test with symptoms. He had headache and diarrhea on Apr2021, fever and tired/fatigue on 05Apr2021, muscle aches and pains on 06Apr2021. He had the first dose on 02Apr2021 (Friday). He tested positive for COVID on 09Apr2021. One of the side effects that he has been getting and still has is twitching in the muscle in his right arm, which is the arm he got the shot in. He was asking if this has been reported in anyone else and wanted to know what the timeframe is before it wears off. Headache started Monday or Tuesday and recovered by Friday (Apr2021). Diarrhea started Thursday or Wednesday and recovered by Friday (Apr2021). Fever started Monday night (05Apr2021) and recovered by Friday (09Apr2021). The twitching in his right arm started two weeks after the first shot (Apr2021) and has been more steady the last couple of days - it had worsened. He recovered completely from COVID about a week after symptoms started. No additional vaccines administered on same date. No visit to Emergency Room not Physician Office required. Prior Vaccinations (within 4 weeks) was none. Outcome of event positive covid-19 test with symptoms was recovered on Apr2021, while other event was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503563 same patient, similar event; different dose
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Skin discolouration
Clinical narrative: I got one dark spot on both legs then I touch it, it was rough to touch then I got another, another and now another; I got one dark spot on both legs then I touch it, it was rough to touch then I got another, another and now another; This is a spontaneous report from a contactable consumer (patient). A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: EW0153) as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient previously received first dose of bnt162b2 (Lot number: EN6208). It was reported that the patient received second vaccine on 07Apr2021. She stated she had dark spots on her back; and they were 1, 2, 3,4. She just noticed that she got one dark spot on both legs then she touch it, it was rough to touch then she got another, another and now another. She wanted to know how it would go away and stated she need treatment. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Ear pain, Muscle tightness
Clinical narrative: Slur of words; tightness R jaw; ear pain; This is a spontaneous report from a contactable Nurse. A 48-Year-old Non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot number & expiry date not reported) dose 1 via unspecified route of administration on 12Feb2021 (at age of 48years) as 1st dose single for COVID-19 Immunization. Patient medical history and concomitant medications are not reported. Patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Formulation: Solution for injection, Lot number & expiry date not reported) dose 2 via unspecified route of administration on 03May2021 as 2nd dose single for Covid-19 immunization.Patient didnt receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was unknown On 12Feb2021, (On day of vaccination),Patient experienced Slur of words, tightness R jaw, Ear Pain. Patient received treatment for the adverse events by Depomedrol shot. Patient had to visit clinic for adverse events. The Clinical outcome of all events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of slurred speech,tightness of jaw muscles,ear pain cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Essential tremor, Head discomfort, Pain in extremity, Tremor, Walking disability
Clinical narrative: little bit of arm soreness in his left arm where he got his shot; little more shaking in his left hand than normal but his left hand always shakes; his walking has also been affected; head is also bobbing up and down more than normal; essential tremors; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer BioNTech Covid 19 vaccine three weeks ago as of tomorrow. He was calling to report his side effects from the vaccine. He tried calling Reporting hotline but was unable to talk to someone. He had a little bit of arm soreness in his left arm where he got his shot, and a little sore the next morning. He also got DBS (deep brain stimulation) for his essential tremors and he had noticed a little more shaking in his left hand than normal but his left hand always shakes. He says his walking had also been affected but was getting better. His head was also bobbing up and down more than normal but that was separate from his essential tremor according to his doctor. He wanted to know if he can take tylenol before the vaccine. His friend said he should take it before the vaccine but he had heard you can only take it after the vaccine but not before. He cannot take ibuprofen because he's on a blood thinner. The seriousness of the events was reported as non-serious. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Burning sensation, Feeling abnormal, Nervous system disorder
Clinical narrative: burning in fingers; back pain; all kinds of neurological problems; she is scared; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced burning in fingers, back pain, all kinds of neurological problems and she is scared. The outcome of event was unknown.  Follow up (14May2021): New Information received from the contactable consumer includes updated events and dates and questions regarding events.  Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Back pain, Burning sensation, Fatigue, Gait disturbance
Clinical narrative: burning in fingers; back pain; all kinds of neurological problems; she is scared; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced burning in fingers, back pain, all kinds of neurological problems and she is scared. The outcome of event was unknown.  Follow up (14May2021): New Information received from the contactable consumer includes updated events and dates and questions regarding events.  Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Myalgia, Neck pain, Paraesthesia, Pelvic pain
Clinical narrative: burning in fingers; back pain; all kinds of neurological problems; she is scared; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced burning in fingers, back pain, all kinds of neurological problems and she is scared. The outcome of event was unknown.  Follow up (14May2021): New Information received from the contactable consumer includes updated events and dates and questions regarding events.  Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Blood calcium, Blood calcium abnormal, Bone pain, Fatigue
Clinical narrative: burning in fingers; back pain; all kinds of neurological problems; she is scared; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced burning in fingers, back pain, all kinds of neurological problems and she is scared. The outcome of event was unknown.  Follow up (14May2021): New Information received from the contactable consumer includes updated events and dates and questions regarding events.  Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypersensitivity, Myalgia, Neuralgia, Pain, Pain in extremity
Clinical narrative: burning in fingers; back pain; all kinds of neurological problems; she is scared; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced burning in fingers, back pain, all kinds of neurological problems and she is scared. The outcome of event was unknown.  Follow up (14May2021): New Information received from the contactable consumer includes updated events and dates and questions regarding events.  Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pelvic pain, Skin burning sensation
Clinical narrative: burning in fingers; back pain; all kinds of neurological problems; she is scared; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as 1st dose, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced burning in fingers, back pain, all kinds of neurological problems and she is scared. The outcome of event was unknown.  Follow up (14May2021): New Information received from the contactable consumer includes updated events and dates and questions regarding events.  Follow up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Lip dry
Clinical narrative: a metallic taste in their mouth; His lips also feel dry; This is a spontaneous report from a contactable other hcp.A male patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN,SINGLE for covid-19 immunisation.The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date,the patient experienced a metallic taste in their mouth and his lips also feel dry.He does not have any tingling in his lips and she (nurse) suggested to stay hydrated. He took a Tylenol about an hour ago. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Waking up multiple times throughout the night; This is a spontaneous report from a contactable consumer reported for a patient (mother in law). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: Not Provided), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, his mother-in-law did get the Pfizer COVID vaccine in a different town, and she has had the same issue where she is waking up multiple times throughout the night but she is taking it like it is part of her new normal and she is not complaining about it. Probed if caller would like to complete a safety report for his mother in law and he declined. He said that he would let her know about this and he also did let her know about the VAERS system and he is just leaving it up to her if she wants to report on her own behalf. On an unspecified date, the patient experienced waking up multiple times throughout the night. Outcome of the event was unknown.  Additional Context: Caller is a 43 y/o male. Reports he received his first Pfizer Covid vaccine dose on 27Mar2021. On 31Mar2021, he woke up with a shock in his chest and has woken up every night since then with a shock. He states he falls asleep and then wakes up an hour later every night. He also reports this "shock" sensation in his intestinal area. He reports his limbs have been twitching, he has a headache that feels like vibrating inside of his head. He also reports a vibrating sensation in his chest and abdomen. He did not receive the second dose of the vaccine. He reports a loss of sensation in his penis. He wants to know if these side effects have been reported before and what to do about them. Will e-transmit as duplicate AE. He reports his mother-in-law has also experienced wakefulness after receiving the Pfizer Covid vaccine. Response: Referred to HCP and spoke from attached document FACT SHEET FOR HCPs ADMINISTERING VACCINE; FULL EUA PI (v1.0) (LAB-1450-8.0 Revised: 10 May 2021) section 6.1 Clinical Trials Experience and from VR Consumer Inquiry Management (Off-Label or No Info) (v15.0).  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: unusually heavier menstrual flow; This is a spontaneous report from a non-contactable consumer (patient). A 35-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Left Arm on 12May2021 15:00, at the age of 35-years-old, (Lot Number: RHTSFD) as 2ND DOSE, SINGLE for Covid-19 immunization. Medical history included Fibroids. Historical vaccine includes first dose of BNT162B (lot number: ER8731) on 19Apr2021, left arm. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient's concomitant medications were not reported. On 14May2021, patient experienced unusually heavier menstrual flow with outcome of not recovered. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the event.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Some pain and soreness in his arm; This is a spontaneous report from a non-contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 (Batch/Lot number was not reported, expiry date not reported) as second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date at first dose, single for COVID-19 immunization. The patient experienced some pain and soreness in his arm on 15May2021, and asked if it was safe to take Tylenol. Clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes/lymph nodes enlarged in right arm pit; This is a spontaneous report from a contactable consumer (patient).  A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on the right arm on 05Feb2021 (17:00) as a 2nd dose, single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included breast cancer; clot in the right leg; factor V deficiency; clotting blood disorder; and bilateral mastectomy. Concomitant medications included warfarin sodium (COUMADIN), amlodipine and acetylsalicylic acid (ASPIRIN 81). The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on the right arm on 15Jan2021 (10:00) (when the patient was 78 years old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On an unspecified date, the patient had swollen lymph nodes/lymph nodes were enlarged in the right armpit. The patient did not receive any treatment for the event. The outcome of the event was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash pruritic, SARS-CoV-2 test
Clinical narrative: I started getting rashes 2 weeks after the first vaccine, very itchy bumps on my leg then my side; Shingles; This is a spontaneous report received from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 13:15 (Batch/Lot Number: ER8727) (at the age of 55 years old) as 1st dose, single for COVID-19 immunisation. The patient is not pregnant at the time of vaccination. Medical history included healthy (as reported), allergic to latex, little overweight, asthma and acid reflux. Concomitant medications included levothyroxine sodium (LEVOXYL); famotidine (PEPCID AC); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); and cyclobenzaprine hydrochloride (CYCLOBENZAPRIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously took Vicodin and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient started getting rashes on 08Apr2021 (also reported as2  weeks after the first vaccine), very itchy bumps on leg then side. The patient thought it was shingles and contacted the doctor. They went away with Benadryl and time. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included covid test type post vaccination= Nasal Swab: negative on 19Apr2021. The outcome of the events was recovered in Apr2021.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headache; sore arm; very tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0150) in the left arm, on 24Apr2021, at 12:15 PM, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  Relevant medical history and concomitant medications were unknown. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. On 02May2021, at 06:00 AM, the patient experienced fever, headache, sore arm and he was very tired. No treatment was received. Post the vaccination, the patient has not been tested for COVID-19. The patient did not recover from the events at time of this report. The case was assessed as non-serious. Then, on 15May2021, at 09:45 AM, the patient received the second dose of BNT162B2 (COMIRNATY, Lot. EW0179) in the left arm, at single dose, for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Pain in her arm; Chills; his is a spontaneous report from a contactable consumer (patient's husband). A female patient (wife) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15May2021 (Batch/Lot number and expiry date were not reported) as second dose single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date at first dose, single for COVID-19 immunization. The patient experienced pain in her arm on 15May2021 with outcome of unknown, and chills on 15May2021 with outcome of unknown.  The events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Migraine
Clinical narrative: Cholesterol was high; Migraine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ENG208; Expiration date was not reported) on 30Mar2021 as a 1st dose, single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On an unspecified date in 2021, after the first dose of vaccination, the patient's cholesterol was high; and had migraine. The outcome of the events was unknown. The patient had received the second dose of vaccination on 12May2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 test
Clinical narrative: random  itchy bumps now near armpit and on stomach; This is a spontaneous report from a contactable consumer (patient).  A 55-years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 13:15 (Batch/Lot Number: ER8T35), age at vaccination of 56-years-old, as single dose,for covid-19 immunisation. Medical history included overweight from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOXYL) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID AC) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE ALLERGY RELIEF) taken for an unspecified indication, start and stop date were not reported; cyclobendazole (CYCLOBENDAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took vicodin for drug hypersensitivity, BNT162B2 dose 1, administered in Arm Left on 26Mar2021 13:15 (Batch/Lot Number: ER8727) for covid-19 immunisation and experienced rash pruritic and herpes zoster.  On 08May2021 (3 weeks after the 2nd dose) the patient kept getting these random itchy bumps now near armpit and on stomach. No treatment was given for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 19Apr2021 Nasal Swab. The patient had not recovered from the event.  No follow-up attempts are needed. No further information is expected
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gingival bleeding, Noninfective gingivitis, Oral herpes
Clinical narrative: EXTREMELY inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth; EXTREMELY inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth; EXTREMELY inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth; vomiting; diarrhea; 10 pound weight loss in a week; Extreme fatigue.; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 09Apr2021 16:00 (at 72 years old, not pregnant) (Batch/Lot Number: ER8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included blood cholesterol, hypertension, both from an unknown date. The patient was taking unspecified concomitant medications. The patient had her first dose of bnt162b2 on 14Mar2021 16:00 at 72 years old for covid-19 immunisation, on left arm, lot number EP6955. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021, patient experienced extremely inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth, vomiting, diarrhea, 10 pound weight loss in a week, Extreme fatigue. No treatment received for the events. The outcome of the events was recovered on 2021. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known allergies.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting, Weight, Weight decreased
Clinical narrative: EXTREMELY inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth; EXTREMELY inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth; EXTREMELY inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth; vomiting; diarrhea; 10 pound weight loss in a week; Extreme fatigue.; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 09Apr2021 16:00 (at 72 years old, not pregnant) (Batch/Lot Number: ER8735) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included blood cholesterol, hypertension, both from an unknown date. The patient was taking unspecified concomitant medications. The patient had her first dose of bnt162b2 on 14Mar2021 16:00 at 72 years old for covid-19 immunisation, on left arm, lot number EP6955. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Apr2021, patient experienced extremely inflamed and bleeding gums,  sore similar to a cold sore outer part of mouth, vomiting, diarrhea, 10 pound weight loss in a week, Extreme fatigue. No treatment received for the events. The outcome of the events was recovered on 2021. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known allergies.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Illness, Pain in extremity, Vomiting
Clinical narrative: Arm was hurting; got sick; Throwing up; This is a spontaneous report from a contactable consumer (patient). A 55-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0185, Expiry date not reported), via an unspecified route of administration, administered in deltoid left on 13May2021 (age at vaccination was 55 years) as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced arm was hurting on 14May2021 with outcome of recovering, got sick on 14May2021 with outcome of recovering, and throwing up on 14May2021 with outcome of recovering. The patient underwent lab tests and procedures which included blood for TB test: unknown results on 13May2021. The events were reported as non-serious.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Feeling abnormal, Heart rate increased, Palpitations
Clinical narrative: Fast heart beat; Palpitations; it make me feel real bad and it is going; Stress; Tired; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 22Mar2021 (Batch/Lot Number: ER8727) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure high, asthma, thyroid, cholesterol, allergy. Patient stated "I take medications. I have high blood pressure. I am asthmatic, I have asthma and allergy. I take lot of medications. I take thyroid medicines, I take inhaler for my asthma (Captured as per verbatim), I have eye drop latanoprost (not spelled, further clarification unknown) and I take cholesterol medicine." Patient stated "I had rapid, fast heart beat the same day. They gave me a paper and I took it that if I have any of these features then I should not have the second vaccine. I had one of those, I had palpitations and it made me feel real bad and it is going, I don't know what is going on so when I had after an hour I had the shot, I still had the palpitations. I drive back home I live by myself so I feel really bad I didn't know what happened so finally the next day I went to the emergency care because I figured out that I might be having palpitations they say yeah you have and there is nothing we could do about so finally after 3 days they stopped they used to come off and on right after the shot like three 3 days in a row and then it finally stopped, then I went to the Cardiology, they telling me I guess I have age but now I have the real stress and tired. So the shot, I guess, it started it for this started to happen to me when I had the shot. So, I would not take the shot but I have my doctors, and when I called them to talk, they would tell me just take the second shot. When I read the CDC guidelines, I should not take it, and then there are my doctors. I am trying to say that I wouldn't take it and my doctors, some of my family members, so what do I do? I don't want to go through that again and it was really bad, I thought like I was going die. I didn't take my second shot and my doctor, they were little upset with me and my children that if you have that bad reaction and you feel that bad then you should try to take it anyway I guess the second one would kill me so it's okay, I don't have to worry about the virus because I won't be there. I had a EKG right after because of my heart palpitation. No, I had no treatment. They are trying to find out if I have a heart problem. So I had EKG which shows that I had the palpitations and then I am scheduled to have echocardiogram, another heart test next week." Outcome of events fast heart beat, palpitations, and 'it make me feel real bad and it is going' was recovered, of remaining events was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Fast heart beat; Palpitations; it make me feel real bad and it is going; Stress; Tired; This is a spontaneous report from a contactable consumer (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 22Mar2021 (Batch/Lot Number: ER8727) as 1st dose, single for COVID-19 immunisation. Medical history included blood pressure high, asthma, thyroid, cholesterol, allergy. Patient stated "I take medications. I have high blood pressure. I am asthmatic, I have asthma and allergy. I take lot of medications. I take thyroid medicines, I take inhaler for my asthma (Captured as per verbatim), I have eye drop latanoprost (not spelled, further clarification unknown) and I take cholesterol medicine." Patient stated "I had rapid, fast heart beat the same day. They gave me a paper and I took it that if I have any of these features then I should not have the second vaccine. I had one of those, I had palpitations and it made me feel real bad and it is going, I don't know what is going on so when I had after an hour I had the shot, I still had the palpitations. I drive back home I live by myself so I feel really bad I didn't know what happened so finally the next day I went to the emergency care because I figured out that I might be having palpitations they say yeah you have and there is nothing we could do about so finally after 3 days they stopped they used to come off and on right after the shot like three 3 days in a row and then it finally stopped, then I went to the Cardiology, they telling me I guess I have age but now I have the real stress and tired. So the shot, I guess, it started it for this started to happen to me when I had the shot. So, I would not take the shot but I have my doctors, and when I called them to talk, they would tell me just take the second shot. When I read the CDC guidelines, I should not take it, and then there are my doctors. I am trying to say that I wouldn't take it and my doctors, some of my family members, so what do I do? I don't want to go through that again and it was really bad, I thought like I was going die. I didn't take my second shot and my doctor, they were little upset with me and my children that if you have that bad reaction and you feel that bad then you should try to take it anyway I guess the second one would kill me so it's okay, I don't have to worry about the virus because I won't be there. I had a EKG right after because of my heart palpitation. No, I had no treatment. They are trying to find out if I have a heart problem. So I had EKG which shows that I had the palpitations and then I am scheduled to have echocardiogram, another heart test next week." Outcome of events fast heart beat, palpitations, and 'it make me feel real bad and it is going' was recovered, of remaining events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss; This is a spontaneous report from a non-contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 16Apr2021 (age at vaccination was 36 years) as unknown, single for COVID-19 immunization. Medical history was none. The 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 patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient experienced hair loss on 26Apr2021 with outcome of recovering. No therapeutic measure was taken as a result of the event. The event was reported as non-serious. No follow-up attempts are needed; information about lot/batch number cannot be obtained.