chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Throat irritation, Urticaria
Clinical narrative: scratchy throat; flushed feeling; beginning of hives (raised welts); This is a spontaneous report from a contactable consumer (patient).  A 40-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 28Jan2021 14:00 (Batch/Lot number was not reported) as single dose at the age of 40-year-old for COVID-19 immunisation .  Medical history included congenital heart defects, Eegs allergy. The patient's concomitant medications in two weeks were none. Patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID-19. The patient previously took phenergan, demerol and hydrocodone and experienced drug hypersensitivity. No other vaccine in four weeks.  Within 5-10 minutes the patient experienced scratchy throat, flushed feeling and beginning of hives on 28Jan2021 02:15. Patient received treatment with Benadryl for the events. COVID was not tested post vaccination. The outcome of events was recovered in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Myalgia
Clinical narrative: Myalgia, flu-like symptoms lasting 6hours, took 800mg ibuprofen for the relief
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Around 3:30am (13 hours after vaccination), I started a fever, intense chills, body aches, and headache. These symptoms lasted for about 4 hours, and then slowly went away.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Contusion, Flank pain, Hyperhidrosis, Pain
Clinical narrative: First shot, bruise on arm with pain, profuse sweating with fever. Side pain. Second shot, side ache, after about 5 days both arms were really sore like arthritis but  I dont have arthritis in my elbows or wrists and my arms dont normally hurt. Took naproxen, tried Tylenol but got a side ache.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: First shot, bruise on arm with pain, profuse sweating with fever. Side pain. Second shot, side ache, after about 5 days both arms were really sore like arthritis but  I dont have arthritis in my elbows or wrists and my arms dont normally hurt. Took naproxen, tried Tylenol but got a side ache.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Petechiae, Rash
Clinical narrative: Developed severe skin rash throughout body.  Went to Emergency Room and was diagnosed as Petechiae.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Oropharyngeal pain, Throat tightness
Clinical narrative: Within just a couple minutes, I felt tightness in my chest.  A few minutes later I felt tightness in my throat.  This is the same affect I have when I breath in cooked, steaming mushrooms on pizza or other cooked foods. I informed a nurse nearby about it and she had another nurse  come over and talk to me.  They asked  me if I wanted to go to the Emergency Room at the hospital and I declined, thinking it would subside, and because I was there with a woman whom I am one of her home care providers.. I did relaxation exercises and drank water to relax and it helped a little but after leaving, I went to a pharmacy and purchased Benadryl and took a 20ml dose.  Within about 30 minutes I was feeling better and the next day my chest felt fine but my throat still bothered me; I assumed my throat muscles were still sore from the swelling.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Fatigue, Headache
Clinical narrative: at around noon the day following my shot, I started feeling soreness all over my body. I took aleve. I felt some chills and a slight headache. These lasted until Sunday. Monday I started feeling very tired, very week, and still sore in my arms and a little in my legs. I took aleeve. Tuesday I still felt lingering soreness but no headache. I started feeling anxiety towards the end of my workday. At around 4pm I started to feel my legs quivering as if I had just run several miles and my muscles were week. This gave me anxiety as I was still working and assisting clients. at around 4:15 I started feeling like I was going to break out in hives around my neck area, which does sometimes happen to me. I got home and around 7pm I took a Zyrtec, but by that point hives started forming on my neck and head. I felt my lip start to swell. I woke up at about 3am on Wednesday to find both of my lips swollen and I took a Benadryl and went back to bed. I woke up at about 7am and my eyes were both swollen almost completely shut and my lips were swollen. I could feel itchiness from incoming hives around my neck and shoulders. I took two Benadryl and rested all day. The swelling mostly went down by the end of the day and I continued to nurse the Benadryl. I saw my doctor on the 15th. He advised how to proceed and prepare  with the second dose and referred me to an allergist.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Muscular weakness, Pain, Pain in extremity, Pruritus
Clinical narrative: at around noon the day following my shot, I started feeling soreness all over my body. I took aleve. I felt some chills and a slight headache. These lasted until Sunday. Monday I started feeling very tired, very week, and still sore in my arms and a little in my legs. I took aleeve. Tuesday I still felt lingering soreness but no headache. I started feeling anxiety towards the end of my workday. At around 4pm I started to feel my legs quivering as if I had just run several miles and my muscles were week. This gave me anxiety as I was still working and assisting clients. at around 4:15 I started feeling like I was going to break out in hives around my neck area, which does sometimes happen to me. I got home and around 7pm I took a Zyrtec, but by that point hives started forming on my neck and head. I felt my lip start to swell. I woke up at about 3am on Wednesday to find both of my lips swollen and I took a Benadryl and went back to bed. I woke up at about 7am and my eyes were both swollen almost completely shut and my lips were swollen. I could feel itchiness from incoming hives around my neck and shoulders. I took two Benadryl and rested all day. The swelling mostly went down by the end of the day and I continued to nurse the Benadryl. I saw my doctor on the 15th. He advised how to proceed and prepare  with the second dose and referred me to an allergist.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling of eyelid, Tremor, Urticaria
Clinical narrative: at around noon the day following my shot, I started feeling soreness all over my body. I took aleve. I felt some chills and a slight headache. These lasted until Sunday. Monday I started feeling very tired, very week, and still sore in my arms and a little in my legs. I took aleeve. Tuesday I still felt lingering soreness but no headache. I started feeling anxiety towards the end of my workday. At around 4pm I started to feel my legs quivering as if I had just run several miles and my muscles were week. This gave me anxiety as I was still working and assisting clients. at around 4:15 I started feeling like I was going to break out in hives around my neck area, which does sometimes happen to me. I got home and around 7pm I took a Zyrtec, but by that point hives started forming on my neck and head. I felt my lip start to swell. I woke up at about 3am on Wednesday to find both of my lips swollen and I took a Benadryl and went back to bed. I woke up at about 7am and my eyes were both swollen almost completely shut and my lips were swollen. I could feel itchiness from incoming hives around my neck and shoulders. I took two Benadryl and rested all day. The swelling mostly went down by the end of the day and I continued to nurse the Benadryl. I saw my doctor on the 15th. He advised how to proceed and prepare  with the second dose and referred me to an allergist.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: Shingles - intense internal left abdominal and side pain, followed by skin rash on left side a week later. Treated with pain medication, and anti-virus medication. Still experiencing some pain and some rash 2 months later, at the time of this report. Currently continuing pain medication.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: New onset joint pain to distal joints (wrists, ankles); This is a spontaneous report from a contactable physician (patient). This 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 intramuscular, administered in Arm Left on 13Jan2021 14:00 (at the age of 25-year-old) (Batch/Lot Number: EK5730) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included Congenital spinal stenosis causing RUE pain and headache. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL3246) on 22Dec2020 at 15:30 intramuscular in the left arm for COVID-19 immunisation; the patient was allergic to ranitidine hydrochloride (ZANTAC) and povidone iodine (BETADINE). Concomitant medications included gabapentin taken for an unspecified indication, start and stop date were not reported and ibuprofen, start and stop date were not reported, intermittent for headache. In Jan2021, the patient experienced new onset joint pain to distal joints (wrists, ankles), lasting almost 1 month since vaccination. Corrective treatments included OTC pain medication. The patient did not have COVID-19 prior to vaccination; the patient underwent nasal swab in Jan2021 with negative result. The patient had not recovered from the event.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Off label use, Pain
Clinical narrative: Extreme fatigue; headache; body aches; patient received the first dose of BNT162B2 on 19Jan2021 and the second dose on 02Feb2021; patient received the first dose of BNT162B2 on 19Jan2021 and the second dose on 02Feb2021; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in the left arm on 02Feb2021 10:15 AM (batch/lot number: EL9263) at 42 years old as 2ND DOSE, SINGLE for COVID-19 immunization. The patient received the vaccine at a Health Clinic. The patient's medical history included hypertension and hypothyroidism, both from an unknown date and unknown if ongoing. Patient had no known allergies. The patient was not pregnant.  Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included labetalol (LABETALOL) and levothyroxine (LEVOTHYROXINE), therapy dates and indications for both were not reported. The patient received these medications within two weeks of vaccination. The patient has not received other vaccines in four weeks prior to BNT162B2. The patient previously received BNT162B2 via an unspecified route of administration, administered in the left arm on 19Jan2021 01:15 PM (batch/lot number: EL1283) at 42 years old as 1ST DOSE, SINGLE for COVID-19 immunization. The patient received the first dose of BNT162B2 on 19Jan2021 and the second dose on 02Feb2021. On 03Feb2021 05:00 AM, the patient experienced extreme fatigue, headache, and body aches. The patient did not receive treatment for the events extreme fatigue, headache, and body aches. Outcome of the events extreme fatigue, headache, and body aches was recovered on Feb2021.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: had nausea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer vaccine and felt fine however 2h later (on an unspecified date) she had nausea nothing to throw up only nausea. The outcome of the event was unknown.    Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: a little sore; This is a spontaneous report from a contactable consumer (patient herself) via medical information team. A female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as first dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer vaccine on 09Feb2021 and noted that it felt just a little sore that's all. The outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: Fatigue; sore injection site and arm; sore injection site and arm; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 09Feb2021 at 17:30 (at the age of 38 years old) (Lot Number: em9809, unknown expiration) as 1st dose, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced fatigue and sore injection site and arm on 10Feb2021. No other vaccine in four weeks. The patient did not receive treatment for the events. The patient was not diagnosed with COVID prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Vaccination site erythema, Vaccination site mass
Clinical narrative: injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; chills; nausea; diarrhea; site remains red swollen and little soreness area below injection site.; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (non-pregnant) received second dose of BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 13:15 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose in left arm (Lot number: EL3302) at 1.00pm on 20Jan2021 for COVID-19 Immunisation. COVID was not found prior vaccination. Medical history included hypertension. The patient's concomitant medications were not reported. Other medications were received in two weeks but not specified. The patient experienced injection site became red swollen and firm and warm within 24 hours of injection, chills, nausea, diarrhea and site remains red swollen and little soreness area below injection site. Treatment was not received. The outcome of the events was recovering for chills, nausea and diarrhea whereas not recovered for the other events.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; chills; nausea; diarrhea; site remains red swollen and little soreness area below injection site.; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (non-pregnant) received second dose of BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 13:15 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose in left arm (Lot number: EL3302) at 1.00pm on 20Jan2021 for COVID-19 Immunisation. COVID was not found prior vaccination. Medical history included hypertension. The patient's concomitant medications were not reported. Other medications were received in two weeks but not specified. The patient experienced injection site became red swollen and firm and warm within 24 hours of injection, chills, nausea, diarrhea and site remains red swollen and little soreness area below injection site. Treatment was not received. The outcome of the events was recovering for chills, nausea and diarrhea whereas not recovered for the other events.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Nausea
Clinical narrative: Flu like symptoms; Headaches; Nauseous; This is a spontaneous report from a contactable other health professional (patient). A 46-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number EL9261) via unspecified route of administration in left arm on 13Feb2021 at 10:00 (age at vaccination 46-year-old) as single dose for Covid-19 immunization. The patient medical history included migraines, vertigo, high blood pressure, gastrointestinal and covid-19, prior to vaccination, patient was the diagnosed with COVID-19. Concomitant medication received within 2 weeks of vaccination included ascorbic acid (VIT C) and zinc. The patient previously received tetanus shot, toradol and had experienced allergy. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. On 14Feb2021 at 05:00, the patient experienced flu like symptoms, headaches and nauseous. Patient received treatment with advil and acetaminophen for pain. Since the vaccination, patient was not tested for COVID-19. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches; This is a spontaneous report from a contactable consumer (patient).  An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that she took the Covid shot number one and a couple days later I got headaches. The outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a Pfizer sponsored program, received from a contactable female consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 05Feb2021 at 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  On 10Feb2021, the patient experienced diarrhea. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: backache; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (Patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was taking Tylenol and Hydrocodone for his backache. The patient was scheduled to receive his second dose of Pfizer-Biontech Covid19 vaccine tomorrow. He takes hydrocodone for chronic back pain. Will this affect the efficacy of the vaccine? The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Acne, Chills, Herpes zoster, Illness, Pain
Clinical narrative: shingles; very sick; pimp bumps; big rash on above my chest; pain; chills; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that she took a first dose of Pfizer COVID-19 vaccine on Saturday (unspecified date). That night, she was very sick. The next day, she got pimp bumps, then the next day afternoon, she got a big rash on above her chest, all from unspecifiefd dates. Then, she talked to her dermatologist and told her that she got shingles. She did not know what to do with that.  At the time of report, she was sick, took terrible pain, and felt some chills. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: shingles; very sick; pimp bumps; big rash on above my chest; pain; chills; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient reported that she took a first dose of Pfizer COVID-19 vaccine on Saturday (unspecified date). That night, she was very sick. The next day, she got pimp bumps, then the next day afternoon, she got a big rash on above her chest, all from unspecifiefd dates. Then, she talked to her dermatologist and told her that she got shingles. She did not know what to do with that.  At the time of report, she was sick, took terrible pain, and felt some chills. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Back pain, Chills, Diarrhoea, Dyspepsia
Clinical narrative: mild dyspepsia; bloating; loose stools; mild bilateral LBP; Fatigue; chills; body ache; low grade fever; This is a spontaneous report received from a contactable physician. A 50-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL0140), via an unspecified route of administration, administered in arm left on 15Jan2021 at 12:00 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose on 28Dec2020. The patient medical history was not reported. Concomitant medications included varicella zoster vaccine rge (SHINGRIX) taken for an unspecified indication from 14Dec2020 to an unspecified stop date, Escitalopram (ESCITALOPRAM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), MVI, ergocalciferol (VIT D) and calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. On 16Jan2021 at 11:00 patient experienced fatigue, chills, body ache and low-grade fever. Symptoms were significant enough that he remained in bed and missed planned activities. Second set of symptoms began on 06Feb2021. Patient says the second set of symptoms is most likely unrelated to his Pfizer COVID vaccine. However, sharing this might be helpful in the event other recipients describe similar symptoms and timing. Symptoms began at 03:00 AM as mild dyspepsia, bloating and loose stools and mild bilateral LBP. Pepcid relieved my dyspepsia which slowly resolved over 24 hours. The bloating has resolved but I have persistent loose stools and mild LBP. During this time patient have had no fever or symptoms of URI. All the symptoms have been mild and have not prevented him from participating in planned activities. Again, doubtful this is related to vaccine but curious to know if anyone else has reported this. The outcome of the events was not recovered with diarrhea and backpain whereas recovered for the other events.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: mild dyspepsia; bloating; loose stools; mild bilateral LBP; Fatigue; chills; body ache; low grade fever; This is a spontaneous report received from a contactable physician. A 50-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL0140), via an unspecified route of administration, administered in arm left on 15Jan2021 at 12:00 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose on 28Dec2020. The patient medical history was not reported. Concomitant medications included varicella zoster vaccine rge (SHINGRIX) taken for an unspecified indication from 14Dec2020 to an unspecified stop date, Escitalopram (ESCITALOPRAM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), MVI, ergocalciferol (VIT D) and calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. On 16Jan2021 at 11:00 patient experienced fatigue, chills, body ache and low-grade fever. Symptoms were significant enough that he remained in bed and missed planned activities. Second set of symptoms began on 06Feb2021. Patient says the second set of symptoms is most likely unrelated to his Pfizer COVID vaccine. However, sharing this might be helpful in the event other recipients describe similar symptoms and timing. Symptoms began at 03:00 AM as mild dyspepsia, bloating and loose stools and mild bilateral LBP. Pepcid relieved my dyspepsia which slowly resolved over 24 hours. The bloating has resolved but I have persistent loose stools and mild LBP. During this time patient have had no fever or symptoms of URI. All the symptoms have been mild and have not prevented him from participating in planned activities. Again, doubtful this is related to vaccine but curious to know if anyone else has reported this. The outcome of the events was not recovered with diarrhea and backpain whereas recovered for the other events.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Nausea, Pain
Clinical narrative: Moderate Nausea; Body Aches; Lethargy; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 08Feb2021 at 11:30 AM (at the age of 36 years old) (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation.  Medical history included asthma.  No known allergies. The patient has unspecified concomitant medication. The patient also received first dose of BNT162B2 on 18Jan2021 at 11:00 AM (unknown lot number and expiration) via intramuscular in left arm for COVID-19 immunization at the age of 36 years old.  The patient experienced moderate nausea and body aches on 08Feb2021 at 15:00; and lethargy within 12-16 hours following 2nd shot on 08Feb2021 that lasted for 24 hours. The patient did not receive treatment for the events. The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. No other vaccine in four weeks. The patient recovered from lethargy on 09Feb2021; and recovered from nausea and body aches in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in my head and my face; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL9269; Expiration Date: May2021), via an unspecified route of administration on 06Feb2021 02:06 as SINGLE DOSE for covid-19 immunisation. Patient received diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date (Batch/Lot Number: SMF011; Expiration Date: May2022) to an unspecified date for hypersensitivity. Medical history Patient was allergic to shellfish, shrimp, flowering and allergic to vegetable asparagus. The patient's concomitant medications were not reported. The patient previously took novocaine and experienced feeling abnormal. Patient had first covid vaccine shot on 06Feb2021 (Saturday) on 02:06 and it was the Pfizer and she had a reaction each day that have caused patient to take a Benadryl, they asked her, when she signed up to get the shot. We found out through them but when we get there to get the shot they said they had switched over to her charts and all of her information was not transferred over so they asked the patient little bit about her allergies and they asked her if she was allergic to polyethylene apparently that was something that was in the Pfizer shot. Patient told them she did not know but she had reactions apparently to that she was not sure but she don't know what to do about having the second shot and she don't know if there was something else beside the Benadryl that she could take because Benadryl has that product in it. Patient stated, that she don't know that she was allergic to that she don't know if she had a problem but she had an allergic reaction to that shot. Patient had numbness in her head and her face, it feels like when she go to a dentist and you get a shot of Novacaine and she was feeling in your mouth. Patient stated that she was coming back that sort of feeling in her head and her face feels. At the time of this report event outcome was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, Inflammation, Rash, Scab
Clinical narrative: Inflammation; redness; scabs; Shingles; Developed a rash on left hip into abdomen area about 5 days after vaccine; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 09:30 (Batch/Lot Number: EMA10) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included psoriasis from 2020, Allergies to medications, food, or other products:Latex, Verbatim: She has had spine surgery  before. She has issues with her lower back and inflammation with twitches. The patient's concomitant medications were not reported. She developed a rash 4-5 days after getting the vaccine. She has psoriasis and thought it was that. She used a cream that she has for psoriasis and the rash faded. After the inflammation and redness faded she noticed she had bumps on it like they were scabs. She held off seeing her doctor but did go see him yesterday. She was diagnosed with shingles. Therapeutic measures were taken as a result of the events. The outcome of the event rash, and Inflammation was recovering, while unknown for the other events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Herpes zoster, Investigation, Pruritus, Rash
Clinical narrative: like shingles; rash; rash began as an itch/itch is on the hairline of her tummy going into her vaginal area between and down her legs, on either side of her genital area.; foot is red; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Batch/Lot Number: EN6207) as 1st dose, single for COVID-19 immunization. Medical history included prolapsed bladder. Concomitant medication included estriol (ESTRIOL) taken for bladder prolapse, start and stop date were not reported. The patient have not had any other recent vaccinations or started any new medications other than since she was supposed to have bladder surgery for her prolapsed bladder and they did some kind of tests a couple weeks ago in her doctor's office, they prescribed her with Estriol vaginal cream. She says she happened to think that might have been why, but she came out there this morning and she has rash on her on her left ankle under that protruding bone there and that and her foot was red, it looks like there was a little bit of dotting, the other one didn't. She says she doesn't know what shingles looked like but she imagines this was what shingles looks like. On 24Feb2021, the patient experienced bumps down leg, looks like shingles. It was reported that the patient had rash after she spent 3 hours waiting for someone last night. She says that she put in two items in the little thing and it wouldn't take all of it as far as listing her meds, it wouldn't let her put anything more. She says she was curious to find out what was happening to her, and she has not spoken to her doctor yet about the rash, not even the pharmacist could help her with her questions. She stated that her friend said to take Benadryl, but she didn't even know if she can take that medication with the meds she takes. She was afraid to take anything that might help her without talking to someone first. The rash began as an itch after she went home instead of staying there at the drug store since she lives one block away. She says that the itch was on the hairline of her tummy going into her vaginal area between and down her legs, on either side of her genital area. The events rash, itch and erythema started on 23Feb2021. The outcome of the events was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Headache, Hypoacusis, Neck pain
Clinical narrative: difficulty hearing; headache; pain in neck/shoulder area; pain in neck/shoulder area; unusual severe pressure around upper rib cage increasing over two days; This is a spontaneous report from a contactable consumer (patient).   An 82-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on an unknown date in Feb2021 at 15:45 as single dose for COVID-19 immunization. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered on an unknown date in Jan2021 at 03:45 PM, as single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medications included furosemide (LASIX [FUROSEMIDE]) and omeprazole (PROTONIX [OMEPRAZOLE]). The patient had reported allergy with shingles vaccine. Patient not received other vaccines within 4 weeks prior to the COVID vaccine. The patient not tested for COVID-19 since the vaccination. On 07Feb2021 at 09:00 the patient experienced difficulty hearing, headache, pain in neck/shoulder area and unusual severe pressure around upper rib cage increasing over two days. The outcome of event was recovered on an unknown date in 2021. No treatment received for the adverse event.  Information on the lot/batch number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Chills, Dyspnoea, Illness
Clinical narrative: harder to breathe; smell of food made me sick later that day; blood pressure went down; cold chills; Shaking; This is a spontaneous report from a contactable consumer (patient reported for herself). A 78-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982) administered in left arm via an unspecified route of administration on 27Feb2021 at 10:00AM as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, known allergies to sulfa and Tetanus shots. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration on 06Feb2021 at 10:00 am as SINGLE DOSE for covid-19 immunization and experienced no adverse event. Other historical vaccine in 4 weeks included Prolia on 21Jan2021 in doctor office. On 28Feb2021 at 12:30 am, the patient was harder to breathe, smell of food made me sick later that day, blood pressure went down, cold chills and shaking. The patient reported as Shaking was so hard as she could not hold glass of water or get the pills out of the bottle because they flew all over the place. This lasted for 2 hours. Then smell of food made the patient sick later that day and then with the cold chills. It took heating pad and other heating products to stop from shaking. patient blood pressure went down to 98/60 and harder to breathe for just a short time. Treatment received for the event shaking and no treatment received for other events. The outcome of the events was recovering.   No follow up attempts were possible. No further information was expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: harder to breathe; smell of food made me sick later that day; blood pressure went down; cold chills; Shaking; This is a spontaneous report from a contactable consumer (patient reported for herself). A 78-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982) administered in left arm via an unspecified route of administration on 27Feb2021 at 10:00AM as SINGLE DOSE for covid-19 immunization. Medical history included arthritis, known allergies to sulfa and Tetanus shots. The patient's concomitant medications were not reported. The patient previously took first dose of historical vaccine of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration on 06Feb2021 at 10:00 am as SINGLE DOSE for covid-19 immunization and experienced no adverse event. Other historical vaccine in 4 weeks included Prolia on 21Jan2021 in doctor office. On 28Feb2021 at 12:30 am, the patient was harder to breathe, smell of food made me sick later that day, blood pressure went down, cold chills and shaking. The patient reported as Shaking was so hard as she could not hold glass of water or get the pills out of the bottle because they flew all over the place. This lasted for 2 hours. Then smell of food made the patient sick later that day and then with the cold chills. It took heating pad and other heating products to stop from shaking. patient blood pressure went down to 98/60 and harder to breathe for just a short time. Treatment received for the event shaking and no treatment received for other events. The outcome of the events was recovering.   No follow up attempts were possible. No further information was expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Skin disorder
Clinical narrative: Developed some type of skin condition on her back and has a fear/concern that it may be shingles; Developed some type of skin condition on her back and has a fear/concern that it may be shingles; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's husband) reported that a 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN9581) via an unspecified route of administration on 04Feb2021 as 1st dose, single for COVID-19 immunisation. Medical history included thyroid condition (she takes a medication for thyroid condition, but she was always done that). Concomitant medication included medication for thyroid condition. On 26Feb2021 the patient developed some type of skin condition on her back and has a fear/concern that it may be shingles. She was due for her second dose on 02Mar2021. On 26Feb developed skin condition that she fears might be shingles. She is not certain, but her concern was that it might be and she worried that it might be a conflict with the second dose which is scheduled for 02Mar2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Insomnia, Pain in extremity, Rash
Clinical narrative: shingles; rash on right inner thigh; leg was painful and tender to the touch; didn't sleep well; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6203; Expiration Date: Jun2021) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included surgery in the fall for cervical disc and cholesterol. Concomitant medication included simvastatin taken for cholesterol, start and stop date were not reported. On 25Feb2021 (reported as "the next day"), the patient noticed on her inner right thigh it felt like a rash but there was nothing there, but it felt like there was. The leg was painful and tender to the touch. The patient also didn't sleep well and talked to someone on 27Feb2021 (reported as Saturday) and said it sounds like shingles to them. The patient talked to the doctor and they felt like it was shingles. The doctor put the patient on medication which has really helped a lot. The rash was not getting worse, it has just stayed a little better and the same. The doctor prescribed her prednisone and valacyclovir, 1mg three times a day. The rash seemed to get worse in the evening, it was painful all around her leg, she thought it was a blood clot, but then realized no because the pain was on the outside it doesn't feel like it was on the inside. The rash wasn't red, Friday late afternoon it started being raised. The pain in her leg was sensitive but not like it was. The patient has kept her leg covered, its impossible to do this because of where it was on her leg. The pain was worse Friday night, the patient was able to sleep Saturday night, it was still sensitive. The outcome of the event didn't sleep well was recovered on 27Feb2021 while the outcome of the other events were recovering.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint stiffness, Pain, Vaccination site pain
Clinical narrative: Pain and soreness in my arm around the  injection site; Body aches and tiredness; Body aches and tiredness; Pain and stiffness in ankle joint where I had a previous injury.; Pain and stiffness in ankle joint where I had a previous injury; This is a spontaneous report from a contactable Nurse. A 42-year male patient received (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot Number: EL3247; Expiry Date: Unknown) dose 1, on an unspecified date on 01Mar2021 at 15:00 (at the age of 42-years-old) into Arm left as a single dose for COVID-19 immunization. Medical history included Amoxicillin for allergy and Pain and stiffness in ankle joint where I had a previous injury. It was reported that the patient had no allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not received list of any other medications the patient received within 2 weeks of vaccination. On 01Mar2021 18:00 patient experienced pain and soreness in his arm around the injection site, body aches and tiredness, pain and stiffness in ankle joint where he had a previous injury. The patient did not receive any treatment for adverse event. The outcome of the events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Patient has developed shingles on back and legs within 7 - 10 days of receiving 2nd dose of Pfizer COVID-19 Vaccine.; This is a spontaneous report from a contactable consumer.  A non-pregnant 68- year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as 2nd dose, single (at the age of 68 years old) for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 for COVID-19 immunisation.  The patient has developed shingles on back and legs within 7 - 10 days of receiving 2nd dose of Pfizer COVID-19 Vaccine on Feb2021. It was unknown if the patient received treatment. The outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles diagnosis Left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 07Feb2021 11:15 (Batch/Lot Number: EM9810) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included omeprazole, and lisinopril. No other vaccines received within 4 weeks. The patient experienced shingles diagnosis left shoulder on 26Feb2021 17:00. Event resulted in physician's clinic visit and was given VALTREX as treatment. Outcome of the event was recovering. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination. The second dose was received on 28Feb2021 (lot number: EN6202) on the left arm.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chillblains, Myalgia, Nausea
Clinical narrative: Severe stomach ache; muscle and joint aches and pains; Chilblains; muscle and joint aches and pains; nausea; fever; injection site pain; Vertigo; vomiting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 03Mar2021 at 03:00 PM (at the age of 65 years old) as single dose, for COVID-19 immunisation. The patient's medical history included hypothyroidism, MZ on Serpina1 (as reported) and known allergies to shrimp. The patient had no COVID prior vaccination and she was not tested for COVID post-vaccination. The patient also did not receive other vaccine in four weeks. Concomitant medications included levothyroxine, thyroid (ARMOUR THYROID) and ibuprofen (ADVIL); all were taken for an unspecified indications, start and stop dates were not reported. On 03Mar2021 at 11:00 PM, it was reported that the patient experienced severe stomachache with nausea and vomiting about 12 hours post injection (as reported). She also experienced chilblains, fever, muscle and joint aches, injection site pain 8 hours post injection and vertigo. The patient did not received treatment for the adverse events. The outcome of the events was not recovered.