chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Pain, Rib fracture
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 86-years-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Lot number and Expiration date was not reported), via an unspecified route of administration, in Right Arm on 11Feb2021 at 13:15 (at the age of 86-years-old) as first dose, single for COVID-19 immunization. The patient medical history included ongoing type 2 diabetes mellitus. The patient concomitant medications were not reported. It was reported that, patient got 1st dose of vaccine on 11Feb2021. "Had a major fall" on 28Feb2021, patient went to the hospital and was diagnosed with broken rib, "plus other junk". patient says she was supposed to go back 8Mar2021 for 2nd dose, but was not able to go because of her injuries. patient is asking if she is able to get 2nd dose after the original scheduled date, and asking for assistance with scheduling. She was in so much pain from her fall, she couldn't even get out of bed. Patient reported she broke a rib when she had a major fall at home. She said her broken rib was very painful, and from her waistline down to her hips, she had pain. she went to the Emergency Room, and her doctor gave her a shot. She said she did not remember what the shot was, and cannot provide the NDC, Lot, and Expiration Date. She said the doctor wanted to admit her to the hospital, but she declined. She said she was kept in the Emergency Room overnight, and sent home the next day. She stated that 2 years ago she was in the hospital for 51 days. The outcome for the events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Pharyngeal swelling, Pyrexia
Clinical narrative: swelling of the throat which caused difficulty breathing; Fever; Chills; swelling of the throat which caused difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6207, Expiration date was not reported), via an unspecified route of administration, administered in left arm on Mar2021 at 14:30 hours, as 1st dose, single (age at the time of vaccine 51-year-old) for covid-19 immunisation. Patient had no medical history. Patient had no other vaccine in four weeks. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included ibuprofen (Advil) and cetirizine hydrochloride, pseudoephedrine hydrochloride (Zyrtec-D) (taken for an unspecified indication, start and stop date were not reported). On an unspecified date of Mar2021 at 12:00 hours, patient had fever and chills, swelling of the throat which caused difficulty breathing. Patient took 1 dose of cetirizine hydrochloride, pseudoephedrine hydrochloride (Zyrtec-D), as treatment. Patient was not COVID tested post vaccination. The outcome of the events was resolved on Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles after the first dose of the vaccine; This is a spontaneous report from a contactable consumer or other non-health care professional. A patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on Feb2021 (reported as last week of February) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Mar2021, the patient was diagnosed with shingles after the first dose of the vaccine. The patient's second dose was scheduled on 18Mar2021. Patient was concerned about the second dose because of the shingles or are there any recommendations on how long she should wait. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. Follow-up attempts have been completed and no further information is expected.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Sinus operation
Clinical narrative: fever 4 days after vaccine; This is a spontaneous report received from a contactable 56-year-old female physician (patient) who reported in response to HCP letter, received pneumococcal 13-val conj vac (dipht crm197 protein (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN), Unknown formulation, Batch/Lot number was not reported), via an unspecified route of administration on 01Nov2015 at an unspecified dosage for an unspecified indication. The patient's medical history included chronic sinusitis from 01Jan1980 and ongoing Sinus surgery 09Feb2019, migraine from 01Jan1980 and ongoing, hypertension from 01Jan1994 and ongoing, sinus operation from 09Feb2019 to an unknown date. The concomitant medications included hydrochlorothiazide, losartan potassium started from 2005 and ongoing for hypertension at most recent dose of 50mg/12.5mg and esomeprazole sodium (NEXIUM MUPS) started from 2010 and ongoing for prevention of gastritis at most recent dose of PRN prior to Asprin or NSAID product. The patient took PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) Vaccine on 01Nov2015, and on 05Nov2015, four days after the vaccination, the patient developed fever, with no source of infection. The action taken in response to the event for pneumococcal 13-val conj vac (dipht crm197 protein) was not applicable. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Tooth injury, Toothache
Clinical narrative: cracked a molar/cracked her tooth/broken tooth; she had pain in her tooth so she took Tylenol beginning 14Mar2021; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient received the 1st dose of Covid vaccine and then cracked a molar and needs to have this fixed. She heard that you were not supposed to have any surgery before taking the Covid vaccine so she is calling to see if it is ok. She asked that whether she could have her inflamed tooth pulled out today by her dentist. She was inquiring whether it was okay to took antibiotics prior to the said procedure (as prescribed by her dentist). She received her first dose last 27Feb2021 and her second dose is being scheduled on 20Mar2021. What happened was, she unknowingly cracked her tooth a few days ago. She had pain in her tooth, so she took Tylenol beginning 14Mar2021. The treatment was received for the events with Tylenol. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Swelling face, Throat tightness
Clinical narrative: face began to swell and throat felt tight about 40 minutes after the injection; face began to swell and throat felt tight about 40 minutes after the injection; This is a spontaneous report from a contactable consumer who reported for herself, a 71-year-old female patient who received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: 588727), via an unspecified route of administration, administered in right arm (also reported as left arm), on 12Mar2021 at 12:30 at the age of 71 years old (also reported as on 25Mar2021), as first dose, single dose for COVID-19 immunization. Medical history included hypertension and cholesterol. The patient was not pregnant at the time of vaccination. Concomitant medications included latanoprost; amlodipine; HCTZ; rosuvastatin; and estrogens conjugated, medroxyprogesterone acetate (PREMPRO). The patient previously received the Shingles vaccine for immunization and she had an allergy to it. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient's face began to swell, and her throat felt tight about 40 minutes after the injection, on 12Mar2021 at 13:15. The patient went to a walk-in clinic and was told to take Benadryl. She was given scripts for a Medrol Dosepak and epi pens. Three days later (15Mar2021), after taking the Benadryl the first two days and stopping, her face began to swell, her throat was feeling tight again. She took Benadryl and monitored herself and went to bed. In the morning (16Mar2021), her face seemed worse, so she started the Medrol Dosepak. Her throat was again tight and eating bread was like swallowing a boulder. She decided to use an epi pen and did. The pen said to get immediate medical attention. She got the shakes from the epinephrine and went to the emergency room. Her blood pressure was very high, which she believed was from the epi pen. Blood work was done on 16Mar2021 and all checked out okay. The epi pen did its job. She was watched for over 4 hours and was released. She has had some continuing face swelling/puffiness on 16Mar2021, 4 days after the vaccine. They added famotidine to the mix. The events were reported as non-serious. The events were reported to have resulted in emergency room/department or urgent care. Therapeutic measures taken as a result of the events included patient was told to take Benadryl, steroid and epi pen. The outcome of the events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection.; This is a spontaneous report from a contactable consumer (Patient, self-reported). A (Age: 62, unit: unknown, as reported) female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1, via an unspecified route of administration on 03Mar2021 as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Reportedly, Caller got 1st dose on 03Mar2021. Today, being treated for a urinary tract infection. Caller is prescribed Nitrofurantoin (Macrobid). Caller asked if the antibiotic will interact/cause issues with the vaccine working. On an unspecified date, the patient experienced urinary tract infection. Therapeutic measures were taken as a result of urinary tract infection. Outcome of the event was unknown.    No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Pruritus
Clinical narrative: short of breath; I got dizzy; I got itchy; This is a spontaneous report from a contactable consumer (Patient). A 57-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203 and expiration date was not reported), first dose via an unspecified route of administration, administered in arm Left on 10Mar2021 11:30 (at the age of 57 years) as 1st DOSE, SINGLE for covid-19 immunisation (57years old when vaccinated). Medical history included asthma allergies, hypertension. Concomitant medication(s) included levothyroxine sodium (SYNTHROID), valsartan, amoxicillin, Montelukast sodium (SINGULAIR). Patient did have known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. On 10Mar2021 06:30 the patient got dizzy and itchy followed by short of breath around 23:30, so patient took a Benadryl and fell asleep and woke up without those symptoms. Reporter assessed the event as non-serious. The outcome of the events were resolved on 11Mar2021.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure diastolic, Blood pressure measurement, Blood pressure systolic, Cerebrovascular accident, Hypertension
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 70-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Feb 2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient stated that had the Pfizer COVID-19 Vaccine three weeks ago (in Feb 2021) and Two days ago (12Mar2021) woke up with severe vertigo and took blood pressure started out about 152 and then it went up to 205 within 3 hours, and that was systolic but the diastolic 112. It was also reported that patient do not have high blood pressure and blood pressure is usually around at most 140, generally it is 126/76 and this was very scary. Patient took Aspirin because, was worried about the stroke and questioned can that be contributed to vaccine? It was 19 days later. Outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient, self-reported). A 70-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on an unknown date in Feb 2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. Patient stated that had the Pfizer COVID-19 Vaccine three weeks ago (in Feb 2021) and Two days ago (12Mar2021) woke up with severe vertigo and took blood pressure started out about 152 and then it went up to 205 within 3 hours, and that was systolic but the diastolic 112. It was also reported that patient do not have high blood pressure and blood pressure is usually around at most 140, generally it is 126/76 and this was very scary. Patient took Aspirin because, was worried about the stroke and questioned can that be contributed to vaccine? It was 19 days later. Outcome of the events was unknown. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This is a spontaneous report from a contactable consumer. A (age: 61; unit: unknown) female pa-tient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration on 14Mar2021 as single dose for Covid-19 Immunization. Patients medical history include menstrual disorder, rheumatoid arthritis. Patient concomitant medications include hydrocortisone acetate (ANUCORT-HC) used for menopause complications in vagina and estradiol (vaginal cream) used for unspecified indication and unknown if ongoing. On 2Apr2021 patient experienced urinary tract infection. It was reported that she has rheumatoid arthritis and gets infusion shots every 6 months of methylprednisolone sodium succinate to 125 mg and rituximab 10 mg and she is due to get them this year. After the verbal response the caller stated she sees her Rheumatologist tomorrow and then has the appointment that day for the infusion so she will ask him before she goes. Additionally, she had a mammogram scheduled on Monday and they told her to cancel that [because she got the shot on Sunday]. She queried if rituximab 10 mg would interact with the vaccine. She had the initial dose on Sunday 14Mar2021 but she has Rheumatoid Arthritis and needs to be infused. Caller is asking if she can cancel the infusion for her to take the 2nd dose. Her address is (address withheld) and her phone number is (phone no. withheld). She queried Getting ready to take 3 medicines, but going to get 2nd shot of Pfizer covid vaccine tomorrow, is there any problem with taking these medications. Bactrim - urinary tract infection (New medication, just got diagnosed today). She queried she is taking Bactrim, is there any contraindication with taking this with the Pfizer covid 19 vaccine. I am taking Bactrim and Estradiol, is there any contraindication with taking this with the Pfizer covid 19 vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dysphagia, Dyspnoea, Fatigue, Hypersomnia
Clinical narrative: broke out in hives real bad and they itch; broke out in hives real bad and they itch; pain in her chest between her boobs, felt like someone sitting on her chest and when she took a deep breath it hurt; hard to swallow; difficulty of breathing /hasn't been breathing real good; slept 36 or more hours, extremely tired; slept 36 or more hours, extremely tired; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206 and expiry date: unknown), via an unspecified route of administration, administered on Arm Left on 11Mar2021 11:45(age at vaccination: 75 years) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus, asthma and osteoporosis. There was no previous immunization with the Pfizer vaccine considered as suspect. There were no concomitant medications. Prior Vaccinations (within 4 weeks) On 24Feb201 she received the shingles shot and there was no Adverse events following prior vaccinations The patient On 11Mar2021, the patient experienced difficulty of breathing /hasn't been breathing real good (She hasn't been breathing real good, her throat isn't right. She has an inhaler (albuterol) to get her breath going), slept 36 or more hours, extremely tired, pain in her chest between her boobs, felt like someone sitting on her chest and when she took a deep breath it hurt, hard to swallow. On 13Mar2021, the patient experienced broke out in hives real bad and they itch and this time the hives were great big welts. She states she had a problem with hives prior to vaccine but not this bad. And they itch. When querying her weight she states she's overweight and her weight doesn't bother her, her weight only bothers her doctor. She reports it's hard to lose weight now. She reported that she gets the second Covid 19 vaccine on 02Apr2021 she's been told that the second one is worse than the first one. She reported that she slept for 36 hours or more, she states when she got home after the Covid 19 injection she wanted coffee but she laid down and went to sleep. She woke up periodically to use the bathroom and get something to drink but every time she woke up it was dark so she just kept going to sleep. She was extremely tired. She woke up on Saturday morning on 13Mar2021.The events has not resulted in Emergency Room or Physician Office visit. The relevant lab test was reported as none. Treatment: Hydroxyzine 25mg tablet, she takes 2 or more if she's itching. The outcome of the events difficulty of breathing /hasn't been breathing real good, hard to swallow and pain in her chest between her boobs, felt like someone sitting on her chest and when she took a deep breath it hurt was Not recovered, slept 36 or more hours, extremely tired was recovered, broke out in hives real bad and they itch was recovering.  No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: broke out in hives real bad and they itch; broke out in hives real bad and they itch; pain in her chest between her boobs, felt like someone sitting on her chest and when she took a deep breath it hurt; hard to swallow; difficulty of breathing /hasn't been breathing real good; slept 36 or more hours, extremely tired; slept 36 or more hours, extremely tired; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 75-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6206 and expiry date: unknown), via an unspecified route of administration, administered on Arm Left on 11Mar2021 11:45(age at vaccination: 75 years) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus, asthma and osteoporosis. There was no previous immunization with the Pfizer vaccine considered as suspect. There were no concomitant medications. Prior Vaccinations (within 4 weeks) On 24Feb201 she received the shingles shot and there was no Adverse events following prior vaccinations The patient On 11Mar2021, the patient experienced difficulty of breathing /hasn't been breathing real good (She hasn't been breathing real good, her throat isn't right. She has an inhaler (albuterol) to get her breath going), slept 36 or more hours, extremely tired, pain in her chest between her boobs, felt like someone sitting on her chest and when she took a deep breath it hurt, hard to swallow. On 13Mar2021, the patient experienced broke out in hives real bad and they itch and this time the hives were great big welts. She states she had a problem with hives prior to vaccine but not this bad. And they itch. When querying her weight she states she's overweight and her weight doesn't bother her, her weight only bothers her doctor. She reports it's hard to lose weight now. She reported that she gets the second Covid 19 vaccine on 02Apr2021 she's been told that the second one is worse than the first one. She reported that she slept for 36 hours or more, she states when she got home after the Covid 19 injection she wanted coffee but she laid down and went to sleep. She woke up periodically to use the bathroom and get something to drink but every time she woke up it was dark so she just kept going to sleep. She was extremely tired. She woke up on Saturday morning on 13Mar2021.The events has not resulted in Emergency Room or Physician Office visit. The relevant lab test was reported as none. Treatment: Hydroxyzine 25mg tablet, she takes 2 or more if she's itching. The outcome of the events difficulty of breathing /hasn't been breathing real good, hard to swallow and pain in her chest between her boobs, felt like someone sitting on her chest and when she took a deep breath it hurt was Not recovered, slept 36 or more hours, extremely tired was recovered, broke out in hives real bad and they itch was recovering.  No follow-up attempts are possible. Information on Batch number, Lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: his finger on his right hand were numb and tingly; his finger on his right hand were numb and tingly; tiredness, fever and headache; tiredness, fever and headache; tiredness, fever and headache; This is a spontaneous report from a contactable consumer (patient's daughter). An 87 year-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that her father received the Pfizer COVID-19 vaccine and experienced the normal side effects of tiredness, fever and headache (onset date unknown). She also reported that on the morning of the report the patient's finger on his right hand were numb and tingly but had gone away at the time of this call. Caller reported the vaccine was given on his left side. At the time of the report the events finger on his right hand were numb and tingly had resolved on an unknown date, whereas the outcome of the events tiredness, fever and headache was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: itchy or burning on different spots of back, neck, arms, upper thighs, face; mild allergic reaction; 19 mRNA VACCINE; Lot number: er2613) as a single dose via unspecified route on 17Mar2021 at 15.30 (at the age of 57-year-old) for COVID-19 immunisation. The patient medical history included spasmodic dysphonia, acid reflux. Concomitant medications included omeprazole (MANUFACTURE UNKNOWN) delay release 20milligram, vitamin c (MANUFACTURE UNKNOWN), calcium d3(MANUFACTURE UNKNOWN), muti. Prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested positive for COVID-19 since the vaccination. The patient was allergic to pistachio nuts from Spain or the red dye in it. Patient previously took benadryl in the past to relieve allergy symptoms. The patient experienced mild allergic reaction on 17Mar2021 at 15.30., itchy or burning on different spots of back, neck, arms, upper thighs, face, felt burning at 11:30 PM, but better than that first hour. Patient had taken treatment for the reported events. The clinical outcome of mild allergic reaction, and itchy was recovered .   No follow-up attempts are needed. No further information is expected..
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Lethargy, Nausea, Pain
Clinical narrative: Body aches (across entire body); Lethargy/Need to sleep; Fever (100-101F); Pain at injection site; Headache; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247] via an unspecified route of administration in left arm on 16Mar2021 at 08:30 (at the age of 49-year-old) as a single dose, for COVID-19 immunisation. Medical history included hypertension, since unknown dates. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in left arm on 23Feb2021 at 08:30 as a single dose for COVID-19 immunisation. The patient experienced fever (100-101F), body aches (across entire body) (general body pain), pain at injection site (vaccination site pain), lethargy/need to sleep, headache and nausea on 17Mar2021 at 08:00. The patient underwent lab tests and procedures, which included body temperature on 17Mar2021 and the result was 100-101F. The patient did not receive any treatment for the events. The clinical outcome of events fever, general body pain, vaccination site pain, lethargy, headache and nausea were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Body aches (across entire body); Lethargy/Need to sleep; Fever (100-101F); Pain at injection site; Headache; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old male patient received his second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247] via an unspecified route of administration in left arm on 16Mar2021 at 08:30 (at the age of 49-year-old) as a single dose, for COVID-19 immunisation. Medical history included hypertension, since unknown dates. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within two weeks prior to the vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration in left arm on 23Feb2021 at 08:30 as a single dose for COVID-19 immunisation. The patient experienced fever (100-101F), body aches (across entire body) (general body pain), pain at injection site (vaccination site pain), lethargy/need to sleep, headache and nausea on 17Mar2021 at 08:00. The patient underwent lab tests and procedures, which included body temperature on 17Mar2021 and the result was 100-101F. The patient did not receive any treatment for the events. The clinical outcome of events fever, general body pain, vaccination site pain, lethargy, headache and nausea were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Arm hurt; got bad chills; slightly nausea; low grade headache; This is a spontaneous report received from a contactable consumer, the patient.  A 72-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in right arm on 04Mar2021 at 09:45 hours (at the age of 72-year-old) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure and cholesterol. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medications included unspecified medication.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL926), via an unspecified route of administration in left arm on 11Feb2021 at 09:00 hours, as a single dose for COVID-19 immunisation.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination patient had not been tested for COVID-19.  On 04Mar2021 at 16:00 hours, the patients arm was hurt, that night she got bad chills, felt slightly nausea and low-grade headache.  The patients arm hurt for about 3 days, got bad chills for about 4 hours, felt slightly nausea for 2 days and low-grade headache for 2 days. The patient did not receive any treatment for events.  The clinical outcome of the event chills was resolved on 04Mar2021 at 21:00 hours, for events nausea and headache were resolved on 06Mar2021 and whereas for event arm hurt was resolved on 07Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes; Painful swollen lymph nodes; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in left arm on 03Mar2021, at 09:30 hours (at the age of 58-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic fatigue and epstein Barr virus. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), norvasc (MANUFACTURER UNKNOWN) and acebutolol (MANUFACTURER UNKNOWN), for an unknown indication. Prior to vaccination the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination patient had not been tested for COVID-19. The patient had penicillin allergies. On 14Mar2021, the patient experienced very painful swollen lymph nodes under arm and up to shoulder (4 days after shot and not much relief). The patient did not receive any treatment for events. The clinical outcome of the events swollen lymph nodes under arm and up to shoulder and painful lymph node was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain
Clinical narrative: Body aches; Sore throat; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on left arm on 16Mar2021 at 13:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient medical history was not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on left arm on 23Feb2021 at 13:30 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. No allergies to medications, food, or other products. Concomitant medications were not reported. On 17Mar2021 the patient experienced body aches, sore throat, headache. No treatment was received for the events. The clinical outcome of body aches, sore throat, headache was recovering at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Aches; Headache; Chills; Joint pain; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL8982) via unspecified route to left arm on 15Mar2021 at 12:45 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included Ambien and multivitamins for unspecified indications received on unknown dates and unknown if ongoing. On 15Mar2021 at 21:00, patient experienced headache, chills, aches, joint pain and tiredness. The patient did not receive any treatment for the events. The clinical outcome of headache, chills, aches, joint pain and tiredness were recovered on unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Headaches; Nausea; This is a spontaneous report  from a contactable consumer, the patient. A 45-year-old  male patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198)  via an unspecified route of administration in the right arm, on 09Mar2021 at 12:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The patient had a medical history of diabetes, blood pressure high (high blood pressure) and high cholesterol. Concomitant medications include simvastatin  (MANUFACTURER UNKNOWN), hydrochlorothiazide  (MANUFACTURER UNKNOWN), glipizide (MANUFACTURER UNKNOWN) and metfor (MANUFACTURER UNKNOWN). The patient had no allergy to medications, food, or other products. The patient had not received any vaccine within four weeks prior to the COVID-19 vaccine. Prior to vaccination and since the vaccination the patient had not been diagnosed with COVID-19. On 14Mar2021,the  patient experienced headache and nausea.  The patient had not received any therapeutic measure or treatment taken for the resulted adverse event. The clinical outcome of headache and nausea was not resolved. No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable health care professional. A 43-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6200), via an intramuscular route of administration in the left arm on 15Mar2021 at 15:45 (at the age of 43-years-old), as a second single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included calcium (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), BIOTIN, Vitamin D (MANUFACTURER UNKNOWN), Vitamin B (MANUFACTURER UNKNOWN), LEXAPRO, BUSPAR, RESTASIS, FLEXERILL for an unknown indication from an unspecified date and unknown if ongoing. Patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient was not pregnant. The patient had not tested positive for COVID-19 since the vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN5318), via an unspecified route of administration in the left arm on 22Feb2021 at 15:45 (at the age of 43-years-old), as a single dose for COVID-19 immunisation. On 17Mar2021 at 00:00, the patient experienced left lower bicep with redness, swelling, pain. This was approximately 1-2 inches below the injection site. Patient did not receive any treatment for the events. The clinical outcome of the events vaccination site pain, vaccination site redness and vaccination site redness were not recovered. No follow-up attempts are needed. No further information is expected
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pseudofolliculitis
Clinical narrative: Bumps raised on legs after taking a shower and shaving my legs; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH mRNA COVID-19 VACCINE; Lot number: EL9269) via unspecified route of administration on the left arm as a single dose on 03Mar2021 at 9:45 am for COVID-19 immunisation. Relevant Medical history included Atrial Fibrillation, Atrial Tachycardia and Meniere's Disease. The patient was allergic to the drug Tramadol. Concomitant medications included Eliquis (MANUFACTURER UNKNOWN) 5 milligram, Sotalol HCL (MANUFACTURER UNKNOWN) 80 milligram and Triam/HCTZ 37.5 25 unspecified units for unknown indication on an unknown date and unknown if ongoing. The patient had not taken any vaccines in past four weeks before vaccination. The patient had not infected with COVID-19, prior vaccination. The patient has not tested for COVID-19, post vaccination. On 18Mar2021 at 12pm, after taking the shower and shaving her legs, the patient noticed that her legs had raised bumps and they appeared as full of blood. She informed that she had never encountered this response after shaving her leg. The patient has not received any treatment for the event. Clinical outcome of the event was unknown at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Dizziness, Dry throat, Dysphonia
Clinical narrative: Hot flash; Heart rate increased; Dizzy; Nauseated; Stomach pain; throat felt hoarse; Dry throat; Rash/hives left side of face and arm,entirety of chest; Rash/hives left side of face and arm,entirety of chest; Tightening of chest; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 08Mar2021 at 10.30 (age at vaccination was 39-year-old), as single dose of COVID-19 immunisation. Medical history was not reported. Patient was allergic to sulfa medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), and Daily Vitamin (MANUFACTURER UNKNOWN) for unknown indication. On 8Mar2021 at 10.30, patient experienced hot and cold flash over entire body, heart rate increased rapidly and immediately, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest through to neck and face and Rash/hives left side of face and arm, entirety of chest. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measure was taken as a result of events hot and cold flash, heart rate increased rapidly, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest, Rash/hives and treatment included IV antihistamine (50mg Benadryl injection) Pepcid. The clinical outcome of the events hot and cold flash over entire body, heart rate increased rapidly and immediately, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest through to neck and face and Rash/hives left side of face and arm, entirety of chest was recovered with lasting effects. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hot flush, Nausea, Rash
Clinical narrative: Hot flash; Heart rate increased; Dizzy; Nauseated; Stomach pain; throat felt hoarse; Dry throat; Rash/hives left side of face and arm,entirety of chest; Rash/hives left side of face and arm,entirety of chest; Tightening of chest; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 08Mar2021 at 10.30 (age at vaccination was 39-year-old), as single dose of COVID-19 immunisation. Medical history was not reported. Patient was allergic to sulfa medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), and Daily Vitamin (MANUFACTURER UNKNOWN) for unknown indication. On 8Mar2021 at 10.30, patient experienced hot and cold flash over entire body, heart rate increased rapidly and immediately, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest through to neck and face and Rash/hives left side of face and arm, entirety of chest. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measure was taken as a result of events hot and cold flash, heart rate increased rapidly, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest, Rash/hives and treatment included IV antihistamine (50mg Benadryl injection) Pepcid. The clinical outcome of the events hot and cold flash over entire body, heart rate increased rapidly and immediately, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest through to neck and face and Rash/hives left side of face and arm, entirety of chest was recovered with lasting effects. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hot flash; Heart rate increased; Dizzy; Nauseated; Stomach pain; throat felt hoarse; Dry throat; Rash/hives left side of face and arm,entirety of chest; Rash/hives left side of face and arm,entirety of chest; Tightening of chest; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 08Mar2021 at 10.30 (age at vaccination was 39-year-old), as single dose of COVID-19 immunisation. Medical history was not reported. Patient was allergic to sulfa medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), and Daily Vitamin (MANUFACTURER UNKNOWN) for unknown indication. On 8Mar2021 at 10.30, patient experienced hot and cold flash over entire body, heart rate increased rapidly and immediately, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest through to neck and face and Rash/hives left side of face and arm, entirety of chest. Patient visited Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measure was taken as a result of events hot and cold flash, heart rate increased rapidly, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest, Rash/hives and treatment included IV antihistamine (50mg Benadryl injection) Pepcid. The clinical outcome of the events hot and cold flash over entire body, heart rate increased rapidly and immediately, dizzy, nauseated, stomach pains throat felt hoarse and dry, General tightening feeling from chest through to neck and face and Rash/hives left side of face and arm, entirety of chest was recovered with lasting effects. Information about lot/batch number cannot be obtained. No further information is expected.