chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Musculoskeletal stiffness
Clinical narrative: dizziness; felt stiff; This is a spontaneous report from a contactable consumer.  A male patient in the 90's received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The consumer reported that she is reporting about her friend. He got his first covid vaccine and afterwards experienced dizziness on unspecified date. He also did yard work for about 6 hours felt stiff so he took some acetaminophen and oxycodone (PERCOCET) and she wonders if that could have interfered with the vaccine effectiveness. The consumer was asking if taking acetaminophen and oxycodone after getting the covid vaccine will nullify the vaccine. Outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient).  A 60-year-old male patient, who was also 60-year-old at the time of vaccination, received first dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration on left arm from 15Jan2021 14:00 as dose for COVID-19 immunisation.  The patient medical history was not reported.  There were no concomitant medications.  The patient received second dose of BNT162B2 on 05Feb2021 at 02:00 PM on left arm. On 18Jan2021 10:00, patient experienced diarrhea with outcome of not recovered. Therapeutic measures were taken as a result of diarrhea which includes Imodium.  Information regarding the lot/batch number has been requested.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Insomnia
Clinical narrative: Insomnia; 103 Fever; Chills; Muscle and Total body pain; Muscle and Total body pain; Profuse vomiting; Migraine; Tiredness; Stomach pain; Diarrhea; This 37- year-old male patient contactable consumer (reported for himself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot El3247), via an unspecified route of administration, on 31Jan2021 at 10:00 AM (at the age of 37-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines on the same day or in the past 4 weeks. The patient has allergy to Ceclor and Cephalosporin. The patient has no relevant medical history and is not taking any concomitant medications. On 04Feb2021 at 5:00PM, the patient experienced 103 Fever, Chills, Muscle and Total body pain, Profuse vomiting, Migraine, Tiredness, Stomach pain and Diarrhea, Insomnia. The patient did not receive treatment for the events. The clinical outcome of the events 103 Fever, Chills, Muscle and Total body pain, Profuse vomiting, Migraine, Tiredness, Stomach pain and Diarrhea, Insomnia was not recovered. It was reported that since the vaccination, the patient had been tested for COVID-19 via nasal swab on 05Feb2021 with a negative result.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Insomnia; 103 Fever; Chills; Muscle and Total body pain; Muscle and Total body pain; Profuse vomiting; Migraine; Tiredness; Stomach pain; Diarrhea; This 37- year-old male patient contactable consumer (reported for himself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot El3247), via an unspecified route of administration, on 31Jan2021 at 10:00 AM (at the age of 37-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines on the same day or in the past 4 weeks. The patient has allergy to Ceclor and Cephalosporin. The patient has no relevant medical history and is not taking any concomitant medications. On 04Feb2021 at 5:00PM, the patient experienced 103 Fever, Chills, Muscle and Total body pain, Profuse vomiting, Migraine, Tiredness, Stomach pain and Diarrhea, Insomnia. The patient did not receive treatment for the events. The clinical outcome of the events 103 Fever, Chills, Muscle and Total body pain, Profuse vomiting, Migraine, Tiredness, Stomach pain and Diarrhea, Insomnia was not recovered. It was reported that since the vaccination, the patient had been tested for COVID-19 via nasal swab on 05Feb2021 with a negative result.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Insomnia; 103 Fever; Chills; Muscle and Total body pain; Muscle and Total body pain; Profuse vomiting; Migraine; Tiredness; Stomach pain; Diarrhea; This 37- year-old male patient contactable consumer (reported for himself) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot El3247), via an unspecified route of administration, on 31Jan2021 at 10:00 AM (at the age of 37-years-old) as a single dose for COVID-19 immunization, in left arm. The facility where COVID-19 vaccine was administered was at a Hospital. She has had no other vaccines on the same day or in the past 4 weeks. The patient has allergy to Ceclor and Cephalosporin. The patient has no relevant medical history and is not taking any concomitant medications. On 04Feb2021 at 5:00PM, the patient experienced 103 Fever, Chills, Muscle and Total body pain, Profuse vomiting, Migraine, Tiredness, Stomach pain and Diarrhea, Insomnia. The patient did not receive treatment for the events. The clinical outcome of the events 103 Fever, Chills, Muscle and Total body pain, Profuse vomiting, Migraine, Tiredness, Stomach pain and Diarrhea, Insomnia was not recovered. It was reported that since the vaccination, the patient had been tested for COVID-19 via nasal swab on 05Feb2021 with a negative result.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: I got shingles after both my first and second dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE) at 63-year-old vaccination age for the first dose via an unspecified route of administration in the left arm on 13Jan2021 18:30 (unknown lot number and expiration date) at a single dose and at 63-year-old vaccination age for the second dose via an unspecified route of administration in the left arm on 03Feb2021 (unknown lot number and expiration date) at a single dose for covid-19 immunisation. The patient's medical history was none. The patient has no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccine in four weeks and did not have other medication in two weeks. The patient received vaccine in the hospital. On 20Jan2021, the patient had shingles after both the first and the second dose of the vaccine. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient received treatment which included valacyclovir (VALTREX) medication and antiviral cream. The patient has been COVID tested (nasal swab) post vaccination with unknown results on an unspecified date. The outcome of the event was not recovered.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: redness underneath her opposite (non-injection arm) armpit and on both sides of her opposite elbow; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route in arm on 06Feb2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 VACCINE for Covid-19 immunization and didn't have any reaction. Patient reported a redness underneath her opposite (non-injection arm) armpit and on both sides of her opposite elbow, but nothing at the vaccination site.  She stated that it was "not itchy or anything". She stated redness under armpit and fleshy side of the elbow, but nothing at the vaccine, opposite from injection site. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Sensation of foreign body
Clinical narrative: her throat felt like she had something stuck/she felt like she had a lump in her throat; This is a spontaneous report received from a contactable pharmacist. An unspecified aged female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient relevant medical history and concomitant medications were not reported. On an unspecified date it was reported that patient got the COVID vaccine and her throat felt like she had something stuck that lasted for a few minutes. Stated that it started two hours after the vaccine. Stated that she felt like she had a lump in her throat for about four days and then it went away. Stated that the nurse is worried about her mom getting the second one if this one is that bad. Wanted to know if her mom should get the second shot. Outcome of event was unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Hypersensitivity
Clinical narrative: I have allergies/ My Mom has same thing happen; allergy induced asthma/  My Mom has same thing happen; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age (mother) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The physician has allergies and allergy induced asthma. It started slowly and became worse. The physician had to take allergy pills and double the steroid inhalent. It's the middle of winter this never happens. The physician's mom has same thing happen and she had vaccine near the same time. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021122699 Same reporter/product/event, different patient
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Herpes zoster
Clinical narrative: shingles; he started feeling strange; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261), via an unspecified route of administration on the left arm, at the age of 71 years, on 20Jan2021 at 0.3 mL, single for covid-19 immunisation. Medical history included white blood cell count decreased from an unknown date and unknown if ongoing. The patient stated that his white blood cell count was usually on the low side and his doctor sends him to a hematologist to do whatever, then they say he was fine. Concomitant medication included an unspecified flu shot. The patient said that he had his first Pfizer COVID-19 shot 20Jan2021, and this coming Wednesday he was supposed to have his second shot, but unfortunately in the interim he found out he has shingles. He says he would like to know if he can get a second shot or would he need to hold off. He says that developed shingles 9 days later after getting first COVID-19 vaccine shot (31Jan2021), and he doesn't want to do something that will be a problem. He says that he was on an antiviral to treat the shingles. No further details provided about the antiviral. He says he didn't go see his doctor until last Wednesday, he thinks he has been suffering from shingles since 07Feb2021 or a little before that when he started feeling strange. The patient clarified he meant 31Jan2021 since he began dealing with this. The patient said when he was diagnosed with shingles they didn't do any tests, the doctor walked into the room and looked at him, though he didn't have a lot then, over the days it has gotten worse. Therapeutic measures were taken as a result of shingles (herpes zoster). The outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Subjects has COVID-19; Subjects has COVID-19; This is a spontaneous report received from a contactable consumer. A 42-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route pf administration on 07Jan2021 at single dose for Covid-19 immunization. Patient medical history and concomitant medications were not reported. Lab data was reported as patient was tested post vaccination and results was reported as unknown. On an unspecified date in Jan2021 it was reported as subjects has COVID-19. Outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Herpes zoster, Neuralgia, Rash
Clinical narrative: shingles; rash; shoulder pain; little nerve pain thing; This is a spontaneous report from a contactable consumer (patient). A 42-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: from vaccine card: EL then either 0 or O 142), via an unspecified route of administration by injection once to left arm on 13Jan2021 at single dose for prevention (covid-19 immunisation).  Medical history was none.  There were no concomitant medications. Patient was diagnosed with shingles about 3 weeks after receiving his first injection of the Pfizer covid-19 vaccine. This male consumer received his first injection of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021. He reported being diagnosed with shingles last Thursday (04Feb2021) and stated his symptoms started that same week (Feb2021), which were described as rash and shoulder pain. He reported his shingles are improved and are scabbing over. The consumer was prescribed and was taking valacyclovir for treatment of the shingles. Shingles was now (base on 09Feb2021) healing. Shingles occurred after the first dose, he was not blaming the vaccine, he did fine, he had no reaction, his first dose was on 13Jan2021, and shingles came up last week (on 04Feb2021). The consumer's second dose of the covid-19 vaccine was supposed to be last week (base on 09Feb2021) but this physician recommended he delay due to the shingles. Currently on an antiviral, getting better, feels great, wondering if he can proceed with second dosage. The consumer was wanting to get his second dose this week (base on 09Feb2021). No investigation Assessment. Outcome: he scabbed up, he never had fever, just a rash and the little nerve pain thing (Feb2021), that's it. Stated he had no reaction to the vaccine whatsoever. The outcome of shingles was recovering, of other events was unknown.   Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Malaise, Nausea, Pain
Clinical narrative: Feeling sick; Headache; Fever; Body aches; Nausea; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 02Feb2021 at 15:00 as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 vaccination. On 03Feb2021 at 06:00 the patient woke up feeling sick with headache, fever, body aches, nausea, and lethargy. The patient was asking how long do side effects normally last. The clinical outcome of the feeling sick with headache, fever, body aches, nausea, and lethargy was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Feeling sick; Headache; Fever; Body aches; Nausea; Lethargy; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on 02Feb2021 at 15:00 as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown), via an unspecified route of administration on an unknown date as a single dose for COVID-19 vaccination. On 03Feb2021 at 06:00 the patient woke up feeling sick with headache, fever, body aches, nausea, and lethargy. The patient was asking how long do side effects normally last. The clinical outcome of the feeling sick with headache, fever, body aches, nausea, and lethargy was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: First time occurrence of shingles on right shoulder, arm pit and scapula area; This is a spontaneous report from a contactable nurse (patient). A 47-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on right arm at 10:00 on 19Jan2021 (at 47 years old) at single dose for COVID-19 immunization. Medical history included hypertension (HTN). The patient's concomitant medications included: fingolimod hydrochloride (GILENYA), baclofen, mirabegron (MYRBETRIQ), bupropion hydrochloride (WELLBUTRIN), and hydroxyzine hydrochloride (HYDROXIN). The patient previously took his first dose of BNT162B2 (Lot number: EK5730) on Left Arm at 10:00 AM on 29Dec2020 for COVID-19 immunization, Ceftin and experienced drug allergies, erythromycin and experienced allergies. The patient experienced first time occurrence of shingles on right shoulder, arm pit and scapula area on 07Feb2021. The patient underwent lab tests and procedures which included Nasal Swab (PCR): negative on 05Feb2021. The patient received Valcyclovir as treatment. The outcome of event was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bone disorder, Pain in extremity
Clinical narrative: big bump that came on her right thumb/ It is on the hand right below the thumb where there is a normal bone, but on the side of the thumb it is enlarged./ she has a bump on her bone on the bottom of her thumb that is on the same arm as the vaccine; arm pain the next day and sore while sleeping the night of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1283, Expiry date: unknown), via an unspecified route of administration on 22Jan2021 at 01:30 (age at the time of vaccination was 58-years-old) on right arm at single dose to prevent from getting COVID. Medical history was none. The patient reported that, she is calling because she had her vaccination for COVID on the 22Jan2021. She has a big bump that came on her right thumb. She doesn't know if that is side effect. It is on the hand right below the thumb where there is a normal bone, but on the side of the thumb it is enlarged on 22Jan2021. She works in health facility. she is on two medications. One is a topical medication. The reporter did not provide the medication names. She doesn't think it is relevant. History of all previous immunization with the Pfizer vaccine considered as suspect were one. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No adverse event requires a visit to Emergency Room or Physician Office. No Prior Vaccinations (within 4 weeks). The patient stated that she has a bump on her bone on the bottom of her thumb that is on the same arm as the vaccine she reported arm pain the next day and sore while sleeping the night of the vaccine on 22Jan2021. she wanted to know if this is a side effect. Potential duplicate AE. She was provided information from the attached documents and referred her to HCP. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: felt tired; This is a spontaneous report from a sponsored program. A contactable nurse (patient) reported that a 34-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She felt tired after getting the first dose of the vaccine on unspecified date. The outcome of the event was unknown.  Information on the lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Hypoaesthesia
Clinical narrative: headache; Joint pain in fingers; numbness in hand; This is a spontaneous report from a sponsored program. A contactable consumer reported for self. A female patient of an unknown age received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 05Feb2021 for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient got the vaccine on 05Feb2021 and on 06Feb2021 she was experiencing a headache, numbness in hand and joint pain in fingers. Outcome of the events was  unknown.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingly sensation in my chin area; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284), via an unspecified route of administration on 15Jan2021 15:30 on left arm at single dose for covid-19 immunization. The facility type vaccine was hospital. Patient was not pregnant. Medical history included type 1 diabetes mellitus from an unknown date, Raynaud's from an unknown date. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included insulin glargine (LANTUS), insulin lispro (HUMALOG), lansoprazole. The patient experienced tingly sensation in chin area in Jan2021 with outcome of unknown.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Disorientation, Dysstasia, Gait disturbance
Clinical narrative: chills; couldn't stand; disoriented; wobbly/he had to hold on to sink to keep from falling; skin was acting crazy all over body; sweating horribly; heart beat was racing; felt unwell; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 09Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included surgeries (38 surgeries in his lifetime), arthritis and pain. Concomitant medication included temazepam (MANUFACTUTERE UNKNOWN, 15mg Capsule) and diphenhydramine hydrochloride/naproxen sodium (ALEVE PM, 220mg); both to help him sleep. The patient stated he received his first dose of the Pfizer COVID Vaccine yesterday (09Feb2021) at 4 pm and felt perfectly fine afterwards. The patient stated at night before bed he usually takes a prescribed sleeping pill called Temazepam capsule 15 mg, Aleve PM 220 mg and a couple drinks. The patient stated he has had 38 surgeries in his lifetime, and he has a lot of arthritis and pain, so he takes those medications and drinks every night to help him sleep. The patient stated he took his nightly routine of medicines at 7:30 pm last night and went to bed at 10 pm and he felt fine when he went to bed. The patient woke up at 1:50 am and he was disoriented and very wobbly, was going to the bathroom and he had chills and he couldn't stand to urinate. The patient skin was acting crazy all over body. While he was washing hands, he had to hold on to sink to keep from falling. The patient made his way back to the bed he put one hand to right and one hand to left and his pillow was wet and down below was wet and stated he was sweating horribly and did not want to lay down on the bed so he laid on the floor. The patient heartbeat was racing, and he just felt unwell. He laid on the floor from 2-4 am because his phone was not near, and he could not get to the phone until after 4 am. The patient stated at 4 am he got up and felt much better and he was able to tale his temperature and it was 97.8°F. The patient started feeling back normal and he has been feeling well ever since. The patient thought he did something wrong by taking his night medications and alcohol after receiving the vaccine and this caused him to have a reaction. The patient just wanted to report his adverse reaction. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Hyperhidrosis, Malaise, Palpitations, Skin disorder
Clinical narrative: chills; couldn't stand; disoriented; wobbly/he had to hold on to sink to keep from falling; skin was acting crazy all over body; sweating horribly; heart beat was racing; felt unwell; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 09Feb2021 16:00 as a single dose for covid-19 immunisation. Medical history included surgeries (38 surgeries in his lifetime), arthritis and pain. Concomitant medication included temazepam (MANUFACTUTERE UNKNOWN, 15mg Capsule) and diphenhydramine hydrochloride/naproxen sodium (ALEVE PM, 220mg); both to help him sleep. The patient stated he received his first dose of the Pfizer COVID Vaccine yesterday (09Feb2021) at 4 pm and felt perfectly fine afterwards. The patient stated at night before bed he usually takes a prescribed sleeping pill called Temazepam capsule 15 mg, Aleve PM 220 mg and a couple drinks. The patient stated he has had 38 surgeries in his lifetime, and he has a lot of arthritis and pain, so he takes those medications and drinks every night to help him sleep. The patient stated he took his nightly routine of medicines at 7:30 pm last night and went to bed at 10 pm and he felt fine when he went to bed. The patient woke up at 1:50 am and he was disoriented and very wobbly, was going to the bathroom and he had chills and he couldn't stand to urinate. The patient skin was acting crazy all over body. While he was washing hands, he had to hold on to sink to keep from falling. The patient made his way back to the bed he put one hand to right and one hand to left and his pillow was wet and down below was wet and stated he was sweating horribly and did not want to lay down on the bed so he laid on the floor. The patient heartbeat was racing, and he just felt unwell. He laid on the floor from 2-4 am because his phone was not near, and he could not get to the phone until after 4 am. The patient stated at 4 am he got up and felt much better and he was able to tale his temperature and it was 97.8°F. The patient started feeling back normal and he has been feeling well ever since. The patient thought he did something wrong by taking his night medications and alcohol after receiving the vaccine and this caused him to have a reaction. The patient just wanted to report his adverse reaction. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Pruritus, Rash macular, Vaccination site pain, Vaccination site pruritus
Clinical narrative: hives on the injected arm/ diagnosed by his physician as shingles; experienced pain and itching near the injection site; experienced pain and itching near the injection site; red splotches under his arm and on his chest; chest that were itching; This is a spontaneous report from a contactable consumer (patient).A 77-year-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 29Jan2021 (vaccine location: right arm) at single dose for COVID-19 immunisation. The patient's medical history was included Prediabetes. The concomitant medications were reported as metformin at 1000mg by mouth for Prediabetes and blood pressure medication. Patient got his first shot on 29Jan2021, about 3-4 days later (in Feb2021) it started hurting/ pain and itching near the injection site, he found red splotches under his arm and on his chest and chest that were itching. Later, patient developed hives on the injected arm, he was able to get to the doctor today to see him, doctor diagnosed him with shingles and gave him some medicine. Patient wanted to know if it is safe to proceed with the next dose since it was scheduled 20Feb2021. The outcome of red splotches on arm and chest that were itching was recovering. The outcome of other events was unknown.  Information on the batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: feeling bad; fever; cough; muscle pain; joint pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the vaccine and started feeling bad, had fever cough, muscle pain and joint pain all on an unspecified date in 2021. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pain; This is a spontaneous report from a Pfizer-. A contactable consumer (patient) reported that a female patient of an unknown age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 05Feb2021 via an unknown route for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient got the second dose yesterday and she was experiencing chest pain. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient)via Pfizer Sponsored Program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced headache on an unspecified date with outcome of unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: First dose last 20Jan2021 and tested positive after the vaccine; First dose last 20Jan2021 and tested positive after the vaccine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program, . A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 20Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced a positive COVID-19 test on an unknown date after the vaccine. The clinical outcome of the event COVID-19 was unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report from a non-contactable consumer from a sponsored program. A male patient of an unknown age received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient took ibuprofen same day as his second dose schedule due to pain related issue. Outcome of the event was unknown.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: Injection site pain; Headache; Muscle pain; Tiredness; This is a spontaneous report from a Sponsored Program. A non-contactable consumer reported for self. A male of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history and concomitant drug were not provided. Patient reported injection site pain, headache, muscle pain, and tiredness on an unknown date. Outcome of the events was unknown.    No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rashes on face; This is a spontaneous report from a sponsored program.  A contactable consumer reported for a female (wife) patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration single dose on an unspecified date for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rashes on face on an unspecified date, 11 hours after 1st dose, took Benadryl. The outcome was unknown.    Information on the lot/batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: got covid after receiving 1st dose of vaccine; got covid after receiving 1st dose of vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced had COVID-19 on an unknown date after receiving the first dose of vaccine. The clinical outcome of the event COVID-19 was unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever 100.4; sore arm; aches; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of unspecified age received BNT162B2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received Covid vaccine and was good for first 12 hours, then developed sore arm, aches, fever 100.4 and chills on an unspecified date. She wanted to know if her family is susceptible because she had a fever. She was fever free today (06Feb2021). The patient recovered from fever on 06Feb2021 while the outcome of other events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19 after the vaccine; tested positive for COVID-19 after the vaccine; This is a spontaneous report from a contactable consumer, the patient, via the Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: not reported), via an unspecified route of administration on 20Jan2021 (also reported as 18Jan2021, pending clarification) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient tested positive for COVID-19 after the vaccine. She queried if she still needed the second dose and when she can have it administered. The clinical outcome of "tested positive for COVID-19 after the vaccine" was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Myalgia, Pyrexia
Clinical narrative: Inappropriate schedule of vaccine administered; headache; muscle pain; chills; fever; This is a spontaneous report from a Pfizer sponsored program "Pfizer First Connect" from a non-contactable consumer (patient's husband).   A female patient of an unspecified age received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on 05Feb2021, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. The patient received, on 19Jan2021, the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, for COVID-19 immunisation. On an unspecified date, in Feb2021, the patient experienced headache, muscle pain, chills and fever. He is asking if her wife can take naproxen sodium or ibuprofen. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible, information about lot number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Ear swelling, Headache, Herpes zoster
Clinical narrative: Blisters/Shingles/positive for Varicella zoster virus DNA, PCR; rash; ear started swelling; lymph node swelling under her ear/lymph swelling increased to quarter size; shooting pain in my right ear; Headache; chills; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) intramuscular on 27Jan2021 15:30 in left arm at single dose for COVID-19 immunization. The patient did not have Covid prior vaccination. The patient did not have covid tested post vaccination. No known drug allergies and no other medical history. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced headache and chills 3 days after Covid vaccine on 30Jan2021. On 03Feb2021, she had shooting pain in her right ear. On 04Feb2021, her ear started swelling, she also noticed her lymph node swelling under her ear. On 05Feb2021, chills, lymph swelling increased to quarter size with a rash under her jaw line and earlobe; she made an appointment with her PCP and was given Ceftin 500 mg two times a day for 7 days. She had blisters on the back of her earlobe on 07Feb2021. On 07Feb2021, she noticed more blisters in front of her right earlobe and on the rash under her jaw line. On 07Feb2021, she went to urgent care and was diagnosed of shingles, given valacyclovir (VALTREX) 1 mg three times a day for 7 days. On 10Feb2021, culture came back positive for Varicella zoster virus DNA, PCR. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Rash, Varicella virus test
Clinical narrative: Blisters/Shingles/positive for Varicella zoster virus DNA, PCR; rash; ear started swelling; lymph node swelling under her ear/lymph swelling increased to quarter size; shooting pain in my right ear; Headache; chills; This is a spontaneous report from a non-contactable healthcare professional (patient). A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249) intramuscular on 27Jan2021 15:30 in left arm at single dose for COVID-19 immunization. The patient did not have Covid prior vaccination. The patient did not have covid tested post vaccination. No known drug allergies and no other medical history. The patient was not pregnant. The patient's concomitant medications were not reported. The patient experienced headache and chills 3 days after Covid vaccine on 30Jan2021. On 03Feb2021, she had shooting pain in her right ear. On 04Feb2021, her ear started swelling, she also noticed her lymph node swelling under her ear. On 05Feb2021, chills, lymph swelling increased to quarter size with a rash under her jaw line and earlobe; she made an appointment with her PCP and was given Ceftin 500 mg two times a day for 7 days. She had blisters on the back of her earlobe on 07Feb2021. On 07Feb2021, she noticed more blisters in front of her right earlobe and on the rash under her jaw line. On 07Feb2021, she went to urgent care and was diagnosed of shingles, given valacyclovir (VALTREX) 1 mg three times a day for 7 days. On 10Feb2021, culture came back positive for Varicella zoster virus DNA, PCR. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced shingles on an unspecified date with outcome of unknown. Patient had shingles for 10 days and query if patient should get the second COVID shot Friday.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Dermatitis acneiform, Herpes zoster, Pruritus, Rash
Clinical narrative: it looked like pimples all over her back/they looked like blisters; painful and was like Shingles; pimple-like dot; itching on her back and shoulder; rash on the armpit inside the arm; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable nurse (patient) reported that a female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunization.  The medical history was not reported. The concomitant medications were unspecified pain medicines. The patient got the first Pfizer Covid-19 vaccine on Saturday morning on 06Feb2021. On Saturday night 06Feb2021 she noticed a pimple-like dot and it was itching on her back and shoulder and this was about 10-12 hours later after getting the vaccine. It spread very fast. Yesterday 07Feb2021 when she looked in the mirror, it looked like pimples all over her back. During the night, they looked like blisters and were down in the armpit area and painful. Were large blisters in the armpit and much bigger, but flat and is spread down inside of arms and were red and slightly raised and painful. Within 48 hours from time of injection, it is now flat, bigger, red, raised, and painful and it had gone down to her arm. They are tolerable and she doesn't have to take anything like pain medicines or anything. Thought it might be shingles on 07Feb2021 and she went online and they are not localized in one area of the back of shoulder. It happens to be on the same side she got the shot and spread down into the armpit and gone down the arm.  She also had a rash on the armpit inside the arm on 06Feb2021.  The rash was painful and was like Shingles and it happened instantly. Again mentions it all happened really fast within 48 hours. Wants to know if there are any reports of this or should she have gone to doctor or dermatologist to be looked at. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported a male patient with unknown age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient had received 1st dose of Covid vaccine and developed shingles about 17 days later. He is wondering if he should wait to get the Covid vaccine until after he in recovered from Shingles. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Headaches; Nausea; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL3248) via an unspecified route of administration in the left arm on 09Feb2021 at 07:00 (at the age of 23-year-old) as a single dose for COVID-19 immunisation. The patient relevant medical history and concomitant medication were not reported. The patient previously took historical vaccine, first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3248) in the left arm on 19Jan2021 at 07:00 for COVID-19 immunisation. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced headaches, nausea, soreness at injection site on 09Feb2021 at 20:00. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events headaches, nausea, soreness at injection site was recovered on an unknown date in Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: chills; felt extremely unwell; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for COVID-19 immunization on an unspecified date. The patient received her 2nd Pfizer COVID-19 vaccine on Wednesday (unknown date). She experienced chills and felt extremely unwell on Thursday and Friday (unknown date). She recovered completely by yesterday morning (05Feb2021). The patient recovered from both events on 05Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.