chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: experiencing bronchitis; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported, expiry date: unknown) via an unspecified route of administration on 27Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced experiencing bronchitis. She had an appointment for the second dose; however, she experienced bronchitis and her doctor said she needs to cancel the second dose and had it rescheduled for at least 1 or 2 weeks. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 96.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: patient already received his first vaccine and developed a fever; This is a spontaneous report from the Pfizer sponsored program received from a contactable consumer or other non hcp.  A 96-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single (age at vaccination was 96 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient already received his first vaccine and developed a fever (unspecified date). It was reported the patient is scheduled to receive is second vaccine tomorrow. Dr. told him to wait and receive his vaccine 2 weeks later due to fever, wanted to cancel appointment and was questioning is this okay. The outcome of fever was unknown.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient experienced chest pain on an unspecified date. It was reported that Caller had the first dose of the Pfizer Covid-19 vaccine and experienced chest pain. Caller is afraid to get the second dose and wants to know if she can still get it. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: little bit rash; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program  Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 12Apr2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received her 1st dose on last Monday 12Apr2021. In Apr2021, after her 1st dose she experienced a little bit rash. The patient was scheduled to have her mammogram and pap smear on 21Apr2021. She asked if it's safe to get these procedures after her 1st dose. Outcome of the events was unknown.  No follow up attempts are possible. Information on lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 45 minutes after vaccine developed mild rash under both eyes and on tip nose patient; This is a spontaneous report from a non-contactable consumer or other non hcp. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified after 45 minutes of vaccine patient developed mild rash under both eyes and on tip nose patient reported to pharmacy they were not concerned. The patient applied soolantra ointment he had at home as therapeutic measures and seems to be resolving. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: fever of 100.3; chills; body aches; runny nose; sinus drainage; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (age at time of vaccination 45 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication included vitamins number (VITAMINS NOS), fish oil (FISH OIL), vitamin D [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and zinc (ZINC) all taken for an unspecified indication, start and stop date were not reported. The patient developed fever of 100.3, chills, body aches, runny nose and sinus drainage on an unspecified date. The events were assessed as non-serious. Event was around 12 hrs after vaccine administration. Event took place after use of product. The patient underwent lab tests and procedures which included body temperature: 100.3 on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus disorder
Clinical narrative: fever of 100.3; chills; body aches; runny nose; sinus drainage; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (age at time of vaccination 45 years) as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medication included vitamins number (VITAMINS NOS), fish oil (FISH OIL), vitamin D [vitamin d nos] (VITAMIN D [VITAMIN D NOS]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and zinc (ZINC) all taken for an unspecified indication, start and stop date were not reported. The patient developed fever of 100.3, chills, body aches, runny nose and sinus drainage on an unspecified date. The events were assessed as non-serious. Event was around 12 hrs after vaccine administration. Event took place after use of product. The patient underwent lab tests and procedures which included body temperature: 100.3 on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Lethargy, Pyrexia
Clinical narrative: Extremely weak; lethargic; chills; fever of 101.2; very sensitive to light and touch; This is a spontaneous report from a contactable other hcp (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 16:30 (Batch/Lot Number: EW0158) as dose 2, single (age at vaccination 26-year-old) for covid-19 immunisation. Medical history included rheumatoid arthritis and covid-19 from an unknown date and unknown if ongoing (If covid prior vaccination: Yes). There were no concomitant medications. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 29Mar2021, administration site (Left arm), administered at 04:30 PM (age at vaccination 26-year-old), lot number ER8727 for covid-19 immunisation. On 19Apr2021 21:00, the patient experienced extremely weak, lethargic, chills, fever of 101.2, very sensitive to light and touch. Adverse event: Extremely weak and lethargic, having chills and running a fever of 101.2 very sensitive to light and touch. Missed two days of work. The patient underwent lab tests and procedures which included body temperature: 101.2 on 19Apr2021(fever of 101.2). The patient did not received treatment. The outcome for all events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: Extremely weak; lethargic; chills; fever of 101.2; very sensitive to light and touch; This is a spontaneous report from a contactable other hcp (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Apr2021 16:30 (Batch/Lot Number: EW0158) as dose 2, single (age at vaccination 26-year-old) for covid-19 immunisation. Medical history included rheumatoid arthritis and covid-19 from an unknown date and unknown if ongoing (If covid prior vaccination: Yes). There were no concomitant medications. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient did not receive other medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 29Mar2021, administration site (Left arm), administered at 04:30 PM (age at vaccination 26-year-old), lot number ER8727 for covid-19 immunisation. On 19Apr2021 21:00, the patient experienced extremely weak, lethargic, chills, fever of 101.2, very sensitive to light and touch. Adverse event: Extremely weak and lethargic, having chills and running a fever of 101.2 very sensitive to light and touch. Missed two days of work. The patient underwent lab tests and procedures which included body temperature: 101.2 on 19Apr2021(fever of 101.2). The patient did not received treatment. The outcome for all events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Limb discomfort, Myalgia, Nausea
Clinical narrative: pain; injection site is painful, puffy & hot; Both my arms feel like they weigh a 1000 lbs; aching from my neck down to my navel with severe muscle aches; aching from my neck down to my navel with severe muscle aches; shortness of breath; nauseous; diarrhea; This is a spontaneous report from contactable consumer(Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Mar2021, patient had first Pfizer shot. Patient's left arm hurt for 4 weeks, so patient got second shot in right arm on 26Mar2021.That day patient ended up in the ER in horrible pain. Patient was put in a sling and given pain meds. 22 days later patient was still in pain. Patient had injection site pain,  injection site was puffy & hot. Both arms felt like they weigh a 1000 lbs. Patient was aching from neck down to navel with severe muscle aches. Patient experienced shortness of breath when talk and patient was nauseous every time patient eat and had diarrhea since 2nd dose. The 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: Neck pain, Pain, Vaccination site pain
Clinical narrative: pain; injection site is painful, puffy & hot; Both my arms feel like they weigh a 1000 lbs; aching from my neck down to my navel with severe muscle aches; aching from my neck down to my navel with severe muscle aches; shortness of breath; nauseous; diarrhea; This is a spontaneous report from contactable consumer(Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Right on 26Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Mar2021, patient had first Pfizer shot. Patient's left arm hurt for 4 weeks, so patient got second shot in right arm on 26Mar2021.That day patient ended up in the ER in horrible pain. Patient was put in a sling and given pain meds. 22 days later patient was still in pain. Patient had injection site pain,  injection site was puffy & hot. Both arms felt like they weigh a 1000 lbs. Patient was aching from neck down to navel with severe muscle aches. Patient experienced shortness of breath when talk and patient was nauseous every time patient eat and had diarrhea since 2nd dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills; Fever; Headache; muscle pain; Joint pain; This is a spontaneous report from contactable 70-year-old female consumer (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EWU153) via an unspecified route of administration on 14Apr2021 at 1300 hours (70-year-old) on left arm, as dose 2, single for COVID-19 immunization. Prior Vaccinations (within 4 weeks) Iwithin four weeks prior to the first administration date of the suspect vaccine, events following prior vaccinations, patient's medical history, family medical history relevant to event, relevant tests, additional vaccines administered on same date of the pfizer suspect were reported as none. No investigation assessment was done. The patient's concomitant medications were not reported. The patient previously received the first received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date (70-year-old) as dose 1, single for COVID-19 immunization. On 14 Apr2021 at 22:00 hours the patient had chills, fever, headache, muscle pain and joint pain. She wanted to know if it was okay to take Tylenol or Aleve for her symptoms. Treatment was reported as none. The patient did not require emergency room and physician office visit. The event chills, muscle and joint pain were ongoing. On 15 Apr2021 headache recovered. On 16 Apr2021 fever recovered. PSCC Communication: Advised caller that they may speak with Medical Information and they may be able to provide them with medical information based on literature from research or studies. They cannot provide recommendations. They may refer them to the healthcare provider that is medically overseeing them. Caller declined transfer.   No follow-up attempts were needed. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruise; This is a spontaneous report from a contactable consumer. This consumer reported for the female patient. A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 09Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. She said that she got a bruise after it and the bruise had just gone away. She had said that she wanted to get someone else this time. The patient experienced bruise on an unspecified date in 2021. The outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Scratch
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband). A 74-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8730, patient was 74-year-old at the time of vaccination), via an unspecified route of administration on 24Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cerebrovascular accident in September, back pain. Concomitant medication(s) included atorvastatin (ATORVASTATIN); oxybutynin hcl (OXYBUTYNIN HCL); morphine sulfate (MORPHINE SULPHATE); ondansetron hydrochloride (EMITIVA); lisinopril (LISINOPRIL); mirabegron (MYRBETRIQ); lactulose (ENULOSE); etoposide (ETOPOSIDE); duloxetine hydrochloride (DULOXETINE HYDROCHLORIDE); varenicline tartrate (CHANTIX); diclofenac sodium (DICLOFENAC SODIUM); ibandronate sodium (IBANDRONATE SODIUM); gabapentin (GABAPENTIN). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6198, patient was 74-year-old at the time of vaccination), via an unspecified route of administration on 25Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Reported that patient was like a puppy with leash. I mean we change sheets over maybe something, I don't know, just it's continuously, just won't stop. On 25Apr2021, the patient experienced itchy, on 24Mar2021 at 17:00, patient experienced scratching. Therapeutic measures were taken as a result of itchy, scratching with Benadryl from super market and keep an eye again same thing so I wasn't happy about so doctor said these are severe about anybody could have so Benadryl liquids she has been drinking it. The outcomes of events were not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Small Rash; Itchiness; This is spontaneous report received from a contactable female consumer or other non-health care professional (Patient). A female patient of an unspecified age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 16Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 07May2021 as dose 2, single for covid-19 immunization. On an unspecified date, the patient reported that she had experienced small rash and itchiness. The patient wanted to know if she could take Benadryl for the reported events. The outcome of events was unknown.  No Follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (reported for herself). A female patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection), via an unspecified route of administration, on Apr 16, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection), on an unspecified route of administration, on a unspecified date, single dose, for COVID-19 immunisation. She felt very bad after receiving her second dose of vaccine yesterday. She experienced chills, fever, aching and there is a nodule on her clavicle, which is painful/swollen lymph node on an unspecified date. The outcome of the events: unknown. No follow-up attempts needed. Information about batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching in belly and above my chest; Slight rash like on my stomach and over my chest; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 24Mar2021 at 17:00 as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not provided. on 25Mar2021, patient experienced slight rash like on my stomach and over my chest, itching in belly and above my chest. patient had little bit itching in belly and above his chest that was about a day or two and that was minimal. The outcome of the event slight rash like on his stomach and over my chest was reported as unknown and outcome of events itching in belly and above my chest was recovered on an unspecified date.  No follow-up attempts are needed. Information out batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Itchy; He did broke up hives; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration on 25Feb2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included cerebrovascular accident from an unknown date and unknown if ongoing, back pain from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin (ATORVASTATIN) taken for an unspecified indication, start and stop date were not reported; oxybutynin hydrochloride (OXYBUTYNIN HCL) taken for an unspecified indication, start and stop date were not reported;  (MORHINE SULPHATE ER) taken for an unspecified indication, start and stop date were not reported; ondansetron hydrochloride (EMITIVA) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported;  (MYBETRIQ) taken for an unspecified indication, start and stop date were not reported; lactulose (ENULOSE) taken for an unspecified indication, start and stop date were not reported; etoposide (ETOPOSIDE) taken for an unspecified indication, start and stop date were not reported; duloxetine hydrochloride (DULOXETINE HYDROCHLORIDE) taken for an unspecified indication, start and stop date were not reported; varenicline tartrate (CHANTIX) taken for an unspecified indication, start and stop date were not reported; diclofenac sodium (DICLOFENAC SODIUM) taken for an unspecified indication, start and stop date were not reported; ibandronate sodium (IBANDRONATE SODIUM) taken for an unspecified indication, start and stop date were not reported; gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported. Patient received Benadryl as treatment after the second dose of vaccination. The patient experienced itchy on an unspecified date, he did broke up hives on an unspecified date. The outcome of the events pruritus, urticaria was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: she is having another knot to the right side of her neck.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER8731, Expiry date: unknown), dose 2 via an unspecified route of administration, administered in right arm on 18Apr2021 (age at time of vaccination 58 years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP6955), via an unspecified route of administration, administered in left arm on 27Mar2021 as dose 1, single for covid-19 immunisation. The patient reported she is having another knot to the right side of her neck on an unspecified date. Caller reports that since then she has received her second vaccine dose yesterday, 18Apr to her right arm. Caller reports that now she is having another knot to the right side of her neck. The outcome of event was unknown.  No Follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Swollen tongue
Clinical narrative: I had something I had tongue swollen; then I cannot drink; something like different side effects; My tongue is getting swollen/I had something I had tongue swollen; This is a spontaneous report from a contactable consumer. A 33-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EW0158), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: EW0158) as dose 1, single for covid-19 immunisation (at the age of 33 years). The patient medical history and concomitant medications were not reported. Consumer stated, I got the paperwork here. I just got my vaccine on Wednesday and this is my first time not a second. I took 30 minutes, and I didn't get home back and I had something I had tongue swollen and then I cannot drink and then and something like different side effects. No follow-up attempts are needed. No further information is expected. My tongue is getting swollen. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An adult female patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Apr2021 as dose 1, single for covid-19 immunisation. Medical history included, prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date in Jan2021. The patient's concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. The patient stated, on 13Apr2021, tuesday after the monday vaccination she was having a fever and body aches. On an unspecified date in 2021, outcome of the events were recovered .    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: shoulder is still sore; Legs hurt, in the morning time both legs hurt when getting up; when wakes up every morning joints, just hurting all over; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration in Arm Left on 27Mar2021 17:00 (age at vaccination: 78 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination. The patient medical history and patient's concomitant medications were not reported. The patient experienced shoulder is still sore on an unspecified date with outcome of unknown, legs hurt, in the morning time both legs hurt when getting up on an unspecified date with outcome of unknown, when wakes up every morning joints, just hurting all over on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of shoulder is still sore, legs hurt, in the morning time both legs hurt when getting up, when wakes up every morning joints, just hurting all over was Tramadol 50mg. Relevant tests were reported as none The outcome of the events arthralgia, pain in extremity was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Hypoaesthesia, Inflammation, Mass, Mobility decreased
Clinical narrative: Rash: her cheek is completely red.; Mass on left arm; Fingers losing sensation; mass is inflamed, raised, and warm to the touch.; she couldn't lift her arm.; Body itching; Became a little dehydrated; Arm sore; rash is very itchy; This is a spontaneous report from a Pfizer sponsored program support. A contactable 28-year-old female consumer (patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Unknown) via an unspecified route of administration on 12Apr2021 (age at vaccination: 28 years-old) as dose 1,single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Apr2021 the patient became a little dehydrated and arm sore, that she spoke with her grandmother who is a nurse, and grandmother informed her to rub her arm to make sure that the vaccine dispersed. She rubbed her arm some more to make sure that the Covid-19 vaccine was spread out. On 13Apr2021, her body became very itchy. She reported that the itching started in her arm and then went into her legs, but was nothing major and on the same day it was reported that she couldn't lift her arm. Patient reported that on 16Apr2021, from her right cheek all the way down to her left arm on a diagonal, she is covered in a rash, that her cheek is completely red. She reported that the rash is very itchy. The patient reported that at time of call on 16Apr2021, she was still experiencing body itching. she took a shower and put cortisone cream on the rash, but the rash is still very red and inflamed. She reported that she has a hard mass on her lower left arm between the wrist and elbow, that the mass is inflamed, raised, and warm to the touch, the mass is about the size of her fist and it feels like there is a hard piece of tissue in there. The fingers in her left arm are losing sensation, she reported that it felt a little like arthritis, but she doesn't have a history of arthritis. She reported that she was healthy and does not have a primary care physician, so she contacted her gynecologist and her gynecologist informed her that they weren't able to assist her. Afraid to get second dose of Covid-19 vaccine. The reporter reported that she could deal with the itching, but the rash and mass developing 5 days later is concerning to her. The outcome of the events mobility decreased ,rash pruritic and hypoaesthesia was unknown and all other events were not recovered.  No follow-up attempts are needed. No further information is expected.~
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Rash: her cheek is completely red.; Mass on left arm; Fingers losing sensation; mass is inflamed, raised, and warm to the touch.; she couldn't lift her arm.; Body itching; Became a little dehydrated; Arm sore; rash is very itchy; This is a spontaneous report from a Pfizer sponsored program support. A contactable 28-year-old female consumer (patient) received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EP7534, Expiry date: Unknown) via an unspecified route of administration on 12Apr2021 (age at vaccination: 28 years-old) as dose 1,single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Apr2021 the patient became a little dehydrated and arm sore, that she spoke with her grandmother who is a nurse, and grandmother informed her to rub her arm to make sure that the vaccine dispersed. She rubbed her arm some more to make sure that the Covid-19 vaccine was spread out. On 13Apr2021, her body became very itchy. She reported that the itching started in her arm and then went into her legs, but was nothing major and on the same day it was reported that she couldn't lift her arm. Patient reported that on 16Apr2021, from her right cheek all the way down to her left arm on a diagonal, she is covered in a rash, that her cheek is completely red. She reported that the rash is very itchy. The patient reported that at time of call on 16Apr2021, she was still experiencing body itching. she took a shower and put cortisone cream on the rash, but the rash is still very red and inflamed. She reported that she has a hard mass on her lower left arm between the wrist and elbow, that the mass is inflamed, raised, and warm to the touch, the mass is about the size of her fist and it feels like there is a hard piece of tissue in there. The fingers in her left arm are losing sensation, she reported that it felt a little like arthritis, but she doesn't have a history of arthritis. She reported that she was healthy and does not have a primary care physician, so she contacted her gynecologist and her gynecologist informed her that they weren't able to assist her. Afraid to get second dose of Covid-19 vaccine. The reporter reported that she could deal with the itching, but the rash and mass developing 5 days later is concerning to her. The outcome of the events mobility decreased ,rash pruritic and hypoaesthesia was unknown and all other events were not recovered.  No follow-up attempts are needed. No further information is expected.~
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Irritability, Oropharyngeal pain, Pyrexia
Clinical narrative: Tired; Cranky; Fever/took his temperature and it was 100.3; Throwing Up; Sore throat; This is a spontaneous report from a contactable consumer (patients mother). A 29-year-old male patient (reporters son) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was unknown, expiration date was not reported), via an unspecified route of administration, administered in left arm on 15Apr2021 11:00 (at the age of 29-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccinations were received within 4 weeks. It was reported that, reporter is calling about the Pfizer Covid19 Vaccine. Reporter states he is calling for his son, that is 30 years old. States he got the vaccine yesterday and he has side effects. He has a fever and throwing up and a really bad sore throat. Reporter asks if those are normal side effects. Reporter clarifies these events were after the first dose of the Covid vaccine. Reporter states it started at 17:30 15APR 2021, he was tired and cranky, and she took his temperature and it was 100.3 then he went downhill from there. The patient underwent lab tests and procedures which included body temperature: 100.3 Fahrenheit on 15Apr2021. The adverse events did not result in emergency room visit or in physician office visit. Treatment includes Tylenol. Therapeutic measures were taken for all events. The outcome of the events was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Tired; Cranky; Fever/took his temperature and it was 100.3; Throwing Up; Sore throat; This is a spontaneous report from a contactable consumer (patients mother). A 29-year-old male patient (reporters son) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was unknown, expiration date was not reported), via an unspecified route of administration, administered in left arm on 15Apr2021 11:00 (at the age of 29-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. No prior vaccinations were received within 4 weeks. It was reported that, reporter is calling about the Pfizer Covid19 Vaccine. Reporter states he is calling for his son, that is 30 years old. States he got the vaccine yesterday and he has side effects. He has a fever and throwing up and a really bad sore throat. Reporter asks if those are normal side effects. Reporter clarifies these events were after the first dose of the Covid vaccine. Reporter states it started at 17:30 15APR 2021, he was tired and cranky, and she took his temperature and it was 100.3 then he went downhill from there. The patient underwent lab tests and procedures which included body temperature: 100.3 Fahrenheit on 15Apr2021. The adverse events did not result in emergency room visit or in physician office visit. Treatment includes Tylenol. Therapeutic measures were taken for all events. The outcome of the events was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Neck pain
Clinical narrative: Fever over 100 F for 1 day; Headache; Muscle/joint pain; Muscle/joint pain; Neck Pain; Fatigue; Full Body Rash, worse on left shoulder; Full Body Rash, worse on left shoulder; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EW0151 and expiry date was not reported), via an unspecified route of administration at left arm, on 12Apr2021 at 03:45 PM (age at vaccination: 38 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes psoriasis and allergies to almond. The patient concomitant medications was not reported. Reportedly the patient was not pregnant at the time of vaccination. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also did not receive any other medications within 2 weeks of vaccination. Reportedly prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ER8730 and expiry date was not reported), via an unspecified route of administration at left arm, on 25Mar2021 at 12:45 AM, as a dose 1, single for COVID-19 immunization. On 12Apr2021 at 09:00 PM the patient experienced fever over 100 F for 1 day, headache, muscle/joint pain, neck Pain, fatigue, full Body Rash, worse on left shoulder. The patient did not receive treatment for the adverse event. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: Fever over 100 F for 1 day; Headache; Muscle/joint pain; Muscle/joint pain; Neck Pain; Fatigue; Full Body Rash, worse on left shoulder; Full Body Rash, worse on left shoulder; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: EW0151 and expiry date was not reported), via an unspecified route of administration at left arm, on 12Apr2021 at 03:45 PM (age at vaccination: 38 years), as a dose 2, single for COVID-19 immunization. The patient's medical history includes psoriasis and allergies to almond. The patient concomitant medications was not reported. Reportedly the patient was not pregnant at the time of vaccination. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also did not receive any other medications within 2 weeks of vaccination. Reportedly prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient was not tested for COVID-19. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot/batch number: ER8730 and expiry date was not reported), via an unspecified route of administration at left arm, on 25Mar2021 at 12:45 AM, as a dose 1, single for COVID-19 immunization. On 12Apr2021 at 09:00 PM the patient experienced fever over 100 F for 1 day, headache, muscle/joint pain, neck Pain, fatigue, full Body Rash, worse on left shoulder. The patient did not receive treatment for the adverse event. Outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: I was itchy above my belly button; This is a spontaneous report from a contactable consumer or other non-HCP.   A 74-years-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Feb2021 as a DOSE 1, SINGLE dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced I was itchy above my belly button. Caller called earlier and reported the information about his wife's problem. Ever since she had the vaccine she's had been extremely itchy. Her first shot was on 24Feb2021 and then they postponed the second to 24Mar2021. After the first shot she was itchy and was itchy for 2 weeks. I told them that, but they gave her the second shot and she got itchy again. They told him to go to pharmacy to get Benadryl. Caller went to a doctor instead but all the doctors were gone. He got her some children's Benadryl. She's was like a puppy with fleas. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash on right arm. Very itchy. Spread to left arm.; Rash on right arm. Very itchy. Spread to left arm.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 01Apr2021 15:00 (at the age of 45-year-old) as dose number unknown, single for covid-19 immunisation. Medical history included eosinophilic oesophagitis from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLOVENT) taken for an unspecified indication, start and stop date were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 04:00, the patient experienced rash on right arm, very itchy, spread to left arm. Clinical course: Rash on right arm. Very itchy. Spread to left arm. Topical steroid (clobetasol) not providing relief. Rash ongoing for 13+ days. Won't go away. Prescribed oral steroid (prednisone): also not working. Therapeutic measures were taken as a result of events included topical: clobetasol; oral: prednisone. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Limb discomfort, Ocular hyperaemia, Pain in extremity
Clinical narrative: My arm felt heavy late that night and sore all the next day. My arm was normal by Monday.; My arm felt heavy late that night and sore all the next day. My arm was normal by Monday.; my eye felt sore and the next day I noticed it was red; my eye felt sore and the next day I noticed it was red; This is a spontaneous report from a non-contactable consumer (patient). A 58-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 10Apr2021 at 10:45 (Batch/Lot Number: EW0153) as dose 1, single (at the age of 58-year-old) for covid-19 immunisation. Medical history included cancer survivor since 2003. The patient's concomitant medications includes unspecified medications. Patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient experienced her arm felt heavy late that night and sore all the next day on 11Apr2021 at 20:00. It was also reported that the patient eye felt sore and the next day she noticed it was red on 11Apr2021 20:00. The patient did not receive treatment for the events. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other unspecified medications within 2 weeks of vaccination. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The outcome of all the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Blood test, Contusion, Dizziness, Feeling abnormal
Clinical narrative: Pressure on head, Fog head; Pressure on head, Fog head; Dizzy tiny bit; Bruise on left arm, where shot was; Twitching in the left eyelid, eyebrow; Sore arm, were shot was, left; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8737) via an unspecified route of administration, administered in Arm Left on 03Apr2021 10:50 (age at vaccination 47-years-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing seasonal allergy. The patient's concomitant medication: everything she took was over the counter. No investigation assessment was performed. No additional vaccines were administered. On 03Apr2021, the patient experienced a sore left arm at the shot site. On 04Apr2021, the patient experienced twitching in the left eyelid, eyebrow. It lasted all day long. For 4 days in a row it was noticeable. Then it went away, but came back. It was not as strong, not as noticeable, not continuous but frequent. She could still feel it even today she had it. She had it now for 12 days. On 05Apr2021, the patient had bruise on left arm, where shot site was. She confirmed the bruise was not there anymore but did not know when it went away. On an unspecified date, she felt pressure on the head, fog head. She felt dizzy tiny bit. Dizzy over a week even a couple of days ago. She stated she did have seasonal allergies so was unsure if that was related. No emergency room and physician office visit. The patient underwent lab tests and procedures on an unspecified date which included blood test and physical examination and results were normal. The outcome of the event bruise on left arm, where shot site was unknown. The outcome of the event twitching in the left eyelid, eyebrow, pressure on head, fog head and dizzy tiny bit was recovering. The outcome of the event sore arm, were shot was, left was recovered on 05Apr2021.  No follow-up attempts are needed. No further information is expected.