chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Vaccination site pain
Clinical narrative: soreness around the injection point; Severe migraine on the right side of my head; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "soreness around the injection point"; MIGRAINE (non-serious), outcome "unknown", described as "Severe migraine on the right side of my head".  Additional info: Patient stated, that the patient didn't get any serious side effects other than a soreness around the injection point, it went away the next day. But there's been something patient never experienced before, 5-6 days after, anything that requires certain amount of physical strength, gives a severe migraine on the right side of head. The first time patent got very concerned, patient didn't think of the vaccine, and this, sharp, sudden pain, patient  thought was having a stroke or something, but after a little bit of a research found due to the nature and suddenness, it's a migraine. it's a persistent thing that gets triggered by anything that it's stimulating or physically demanding, none of this was present pre-vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: shivers/chills; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "shivers/chills".  Additional information: It was reported that, the patient day after the vaccine, she experienced shivers and chills for the next day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  Additional information: The patient had two doses of the Pfizer-BioNTech vaccine. One symptom the patient had both time, but more pronounced after the second dose, was a sore throat.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Apr2021 15:00 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing); "Type 2 sugar diabetes" (ongoing); "high blood pressure" (ongoing); "lower lumbar sciatica" (ongoing); "COVID-19", start date: 11Mar2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04Apr2021, outcome "recovered" (05Apr2021), described as "sore arm".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. It was reported that with the first Covid 19 vaccine, she just had a sore arm the day after she received it and it only lasted a day.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Soreness in my arm like some flu shot; Pain; After she received the first dose she experienced an achy sore arm on the injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 (Lot number: EW0182) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ARIPIPRAZOLE taken for contraception. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in my arm like some flu shot"; PAIN (non-serious), outcome "unknown", described as "Pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "After she received the first dose she experienced an achy sore arm on the injection site.".  Additional information: second dose is scheduled on 01Jun2021. After she received the first dose she experienced an achy sore arm on the injection site. She was asking as well if it was okay to take medication or Tylenol.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: arms were swollen, very painful and she can't barely lift her arms; arms were swollen, very painful and she can't barely lift her arms; arms were swollen, very painful and she can't barely lift her arms; very tired and is having fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 10May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious), MOBILITY DECREASED (non-serious) all with onset 10May2021, outcome "unknown" and all described as "arms were swollen, very painful and she can't barely lift her arms"; FATIGUE (non-serious) with onset 10May2021, outcome "unknown", described as "very tired and is having fatigue". Additional Information: It was reported that, patient experienced sore arms immediately after receiving the 1st dose of the vaccine yesterday, 10May2021. Patient would like to know what she needed to put on her arms whether a warm or cold compress to lessen the swelling of it on injection site or forearm, but particularly on injection site. Was very tired and was having fatigue.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Peripheral swelling
Clinical narrative: left foot swollen; Slight numbness in left shin area; right foot swollen and puffy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 17:15 (Batch/Lot number: unknown) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 25Mar2021, outcome "recovered" (2021), described as "left foot swollen"; HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "Slight numbness in left shin area"; PERIPHERAL SWELLING (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "right foot swollen and puffy". The action taken for bnt162b2 was unknown.  Additional information: Patient reported out of everyone she had talked to, some people didn't had any symptoms and some had more flu like symptoms. Her symptoms were different. Her left foot swollen was started after the first dose, the next day, about 24 hours later. It was not swollen anymore. It might had lasted around 4 days. She reported above the area, in the shin, noticed a little bit of a slight numbness feeling. It was the next day after the foot was swollen. It lasted about the same time, 4 or 5 days. Her right foot swollen and puffy was not really in any pain, just swollen and puffy. It was started the day after the left foot and went down 2 days later. No visit to emergency room or physician office was required. Patient called her physician after the first dose when the foot was swollen. They hadn't heard anything and didn't give any suggestions. Her sister is a nurse and said that it may be lymph nodes and drainage. That might be why her foot had swollen up. No prior vaccinations (within 4 weeks). No family medical history relevant to adverse events reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Myalgia
Clinical narrative: Chills; back pain; muscle / painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: EW0173, Expiration Date: 31Aug2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset May2021, outcome "not recovered", described as "Chills"; BACK PAIN (non-serious) with onset May2021, outcome "not recovered", described as "back pain"; MYALGIA (non-serious) with onset May2021, outcome "not recovered", described as "muscle / painful". Therapeutic measures were taken as a result of chills, back pain, myalgia.  Additional information: It was further reported that 2 days after the shot he was okay, nothing was happening or doing for few days. Two days ago, he thought like he felt chills and he had back pain. It's like the muscle and the back it was so painful it was been like 2 or 3 days already. Patient has been given some pain medicine and some cream to put on. Patient was scheduled to have his second shot this month on 22May2021.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; super tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 32-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 10May2021 (Lot number: EW0168) at the age of 32 years as dose 1, single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10May2021, outcome "not recovered", described as "Sore arm"; FATIGUE (non-serious) with onset 10May2021, outcome "unknown", described as "super tired".  Additional information: Patients Medical History (including any illness at time of vaccination) was none. Family Medical history was none. History of all previous immunization with the Pfizer vaccine was none. No additional vaccines were Administered on Same Date of the Pfizer Suspect. The patient did not receive any Prior Vaccinations (within 4 weeks). The patient received Vaccination on 10May2021 between at 9:40 am to 9:55 am. The patient took the nap and then woke up and fell back asleep at the same time. She confirmed that the tiredness and sore arm started yesterday. She explains the arm soreness did not happen right way after the vaccine, it started between 4 and 5 PM yesterday. No relevant tests were performed.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: Only local pain; little bit of dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 07Apr2021 17:45 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "Only local pain"; DIZZINESS (non-serious), outcome "unknown", described as "little bit of dizziness".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient did not have COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Malaise, Pain
Clinical narrative: being tired and having pain; After 2 weeks she has not been well at all, she has been unwell, she is in so much pain at back of part of her body; being tired and having pain; After 2 weeks she has not been well at all, she has been unwell, she is in so much pain at back of part of her body; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (Batch/Lot number: unknown) as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose:1, Manufacturer unknown), for Covid-19 immunisation. The following information was reported: PAIN (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "being tired and having pain"; MALAISE (non-serious), BACK PAIN (non-serious), outcome "unknown" and all described as "After 2 weeks she has not been well at all, she has been unwell, she is in so much pain at back of part of her body".  Additional information: Patient received the Pfizer vaccine, the second one, on 14Mar2021 and she had the first reactions of being tired and having pain. After 2 weeks she has not been well at all, she has been unwell, she is in so much pain at back of part of her body. She is wondering what she could do. Does this have to do with the Pfizer COVID vaccine. She saw her doctor and he said that it is probably from the vaccine. She says that there are two types of vaccines, there is one in a tube and one in a syringe and her one came in the syringe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: She experienced 36-48 hours of pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 08:30 (Lot number: EW0151) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Vitamin d, notes: Started 2 years ago; Folic acid, notes: Started couple years ago, recommended by doctor; Armour thyroid for Thyroid, notes: Started 3-4 yrs ago. Vaccination history included: Shingles vaccine (She had a vaccine about 6-8 weeks before the Covid-19 vaccine, it was the Shingles vaccine.). The following information was reported: PAIN (non-serious) with onset 06Apr2021, outcome "recovered" (08Apr2021), described as "She experienced 36-48 hours of pain". Therapeutic measures were taken as a result of pain.   Additional Information: After the first dose: She experienced 36-48 hours of pain and then it went away with the Ibuprofen, 800 mg every 12 hours. After 48 hours she was fine. she started taking Armour Thyroid because the thyroid it had dipped down, it is controlled good with medicine. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no.   No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema
Clinical narrative: Pretty dark hard red area around where like just below where she got the shot; It's almost like her left node is puffy and hard in her armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09May2021 (Lot number: EW0170) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Blind" (unspecified if ongoing), notes: Blind in her left eye; "Deaf" (unspecified if ongoing), notes: Deaf in her left ear. Concomitant medication(s) included: SEROQUEL; CYMBALTA. Vaccination history included: Bnt162b2 (Dose 1, Lot number: EW0158, Anatomical site of injection: Left arm), administration date: 18Apr2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Pretty dark hard red area around where like just below where she got the shot"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "It's almost like her left node is puffy and hard in her armpit".  Additional information: Patient had her second dose on 09May on Sunday and then she has a pretty dark hard red area around where like just below where she got the shot and like puffy it is almost like her left node is puffy and hard in her armpit. Patient is blind and deaf on her right side or her left side. She is blind and deaf on the left side. She is blind in her left eye and she is deaf in her left ear.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Chills, Depressed mood, Fatigue, Thinking abnormal
Clinical narrative: mind was bad and clouded; depressed; Tiredness; Vivid dreams; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02May2021 (Lot number: EW0182) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "she has thin blood, things like that, nothing else besides that, which she clarified to being low platelets", start date: 2018 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEPRESSED MOOD (non-serious) with onset 02May2021, outcome "recovered", described as "depressed"; FATIGUE (non-serious) with onset 02May2021, outcome "recovered", described as "Tiredness"; ABNORMAL DREAMS (non-serious) with onset May2021, outcome "recovered", described as "Vivid dreams"; THINKING ABNORMAL (non-serious) with onset 06May2021, outcome "recovered", described as "mind was bad and clouded"; CHILLS (non-serious) with onset May2021, outcome "unknown", described as "Chills". Therapeutic measures were taken as a result of chills.  Additional information: Patient stated that she had no other vaccinations 02May2021 or in the four weeks prior to getting the Pfizer COVID-19 vaccine. She stated she had started no new medications. Patient got the shot Sunday 02May2021 and as she had that shot, she got depressed but she was tired, it made her tired, she was having wild vivid dreams. She said it got progressively worse almost like she just declining, and the getting depressed went on from Monday-Wednesday, then she hit Thursday which was the absolute worst day, a terrible day, something was so off, and her mind was so bad and clouded. She says it was awful, but she made it through that day, and then Friday she was fine, everything was back to normal. She said she wanted to report this because she doesn't know if others have experienced something similar or if it even could be from that. She said it was scary the way it got worse and worse, then hit bottom, then the next day it was just gone. She said she was having chills too, and that is why she took a bit of paracetamol (TYLENOL). She said she bought a TYLENOL powdered packet of quick dissolve 500mg, and she took half of that, so 250mg.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia
Clinical narrative: I was feeling like a shocking pain and feels like in my nerves; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 (Lot number: ER8736) at the age of 19 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, lot number:ER8731, Anatomical location: left arm), administration date: 14Apr2021, when the patient was 19 years old, for COVID-19 immunization. The following information was reported: NEURALGIA (non-serious), outcome "not recovered", described as "I was feeling like a shocking pain and feels like in my nerves". Therapeutic measures were not taken as a result of neuralgia.  Additional information: Consumer stated, He was calling for a possible side effects from the Pfizer shot. He got the shot about a week ago on the 5May2021 and the day after he was feeling like a shocking pain and feels like in my nerves for few days so, he still has it. He does not know what the issue could have been or could be. Next day of the vaccine it started, after the second shot. Expiration date: Consumer stated, he does not saw expiration date, he saw just the day that he got the shot."  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Patient was sick after COVID-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Patient was sick after COVID-19 vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Product dose omission issue, Vomiting
Clinical narrative: scheduled to get her second dose on 30Apr2021. However, that day, she experienced vomiting due to stomach problems and missed her appointment; vomiting; stomach problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 09Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 30Apr2021, outcome "unknown", described as "vomiting"; ABDOMINAL DISCOMFORT (non-serious) with onset 30Apr2021, outcome "unknown", described as "stomach problems"; PRODUCT DOSE OMISSION ISSUE (non-serious) with onset 30Apr2021, outcome "unknown", described as "scheduled to get her second dose on 30Apr2021. However, that day, she experienced vomiting due to stomach problems and missed her appointment".  Additional Information: Patient got the first dose on 09Apr2021. She was scheduled to get her second dose on 30Apr2021. However, that day, she experienced vomiting due to stomach problems and missed her appointment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, SARS-CoV-2 test
Clinical narrative: I slept for a full day after the 2nd dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 31Mar2021 11:58 (Lot number: ER8732, Expiration Date: Jul2021) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "heartburn" (ongoing); "Allergies" (ongoing); "blood pressure" (ongoing). Concomitant medication(s) included: TENORMIN taken for blood pressure abnormal, start date: 03Mar2021 (ongoing); HYDROCHLOROTHIAZIDE taken for blood pressure abnormal, start date: 03Mar2021 (ongoing); CLARITINE taken for hypersensitivity (ongoing); PROTONIX [OMEPRAZOLE] taken for dyspepsia, start date: 03Mar2021 (ongoing). Vaccination history included: Bnt162b2 (Anatomical site of injection: Left upper arm, Route of administration: Intramuscular, Batch/Lot number: EN6202, Expiration Date: Jun2021, Time: 11:52 AM), administration date: 10Mar2021, when the patient was 59 years old, for COVID-19 immunization, reaction(s): "Both sides of her Face, lips and tongue went numb", "Both sides of her Face, lips and tongue went numb", "Tongue tingled". The following information was reported: HYPERSOMNIA (non-serious), outcome "unknown", described as "I slept for a full day after the 2nd dose". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Got completely better from all pre-existing illnessess; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 71-year-old female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "crest syndrome" (unspecified if ongoing), notes: She has connective tissue disease crest syndrome; "fybromyalgia" (unspecified if ongoing), notes: She no longer has fybromyalgia. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Single, (Lot # not provided)), for covid-19 immunisation, reaction(s): "sick". The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Got completely better from all pre-existing illnessess".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541072 same patient/drug, different dose/events.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in my arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in my arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count decreased
Clinical narrative: WCB low; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WHITE BLOOD CELL COUNT DECREASED (non-serious), outcome "unknown", described as "WCB low". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ear pain, Headache
Clinical narrative: Headache; ear pain, almost like a shooting pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Jan2021 09:30 (Lot number: E23247) as dose 1, single and intramuscular, administered in arm left, administration date 16Feb2021 14:00 (Lot number: E23247) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR PAIN (non-serious) with onset 27Jan2021 10:15, outcome "recovered" (Jan2021), described as "ear pain, almost like a shooting pain"; HEADACHE (non-serious) with onset 27Jan2021 18:00, outcome "recovered" (Jan2021), described as "Headache". Therapeutic measures were not taken as a result of ear pain, headache.  Additional information: Prior Vaccinations, concomitant drugs, patient medical history and relevant tests were reported as None. Ear pain almost like a shooting pain about 3 times ober a few minute period shortly after 1st vaccination. It resolved and did not return the headache started in the evening after 1st vaccination and resolved the following day.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021176741 same reporter/patient/drug, different dose
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: Second shot my arm barely hurt at all compared to the the first one; She was fine with the first dose, felt a little yucky; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic leukopenia" (unspecified if ongoing); "COVID-19", start date: Dec2020 (unspecified if ongoing), notes: sick with Covid for 4 months, has "long haulers symptoms"; "chemotherapy" (unspecified if ongoing), notes: 33 months of chemo. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Second shot my arm barely hurt at all compared to the the first one"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "She was fine with the first dose, felt a little yucky".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nausea
Clinical narrative: I also got sick after second shot; I was Nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Lot number: ER8755) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Lot: ER8737), administration date: 09Apr2021, for Covid-19 immunisation. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I also got sick after second shot"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "I was Nauseous". Therapeutic measures were not taken as a result of illness, nausea.  Additional information: Patient got badly sick this happened all at the above on the day after the covid vaccine it lasted about a week on and some days she felt good , others not so good. She also got sick after the second shot and it was and suddenly this has happened it was nauseous , no material treatment for either one.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Throat irritation, Tinnitus, Vaccination site reaction
Clinical narrative: problem with her throat/ felt an intense heat in her throat and chest; problem with her throat/ felt an intense heat in her throat and chest; ringing in her ears; at the vaccination site, they applied ice pack; This is a spontaneous report received from a contactable nurse from medical information team. The reporter is the parent.  A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 10May2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "sensitivity to latex" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Methyl-chloro-isolthiazolinone, reaction: "alergy to a preservative". The following information was reported: THROAT IRRITATION (non-serious), FEELING HOT (non-serious) all with onset May2021, outcome "recovered" (May2021) and all described as "problem with her throat/ felt an intense heat in her throat and chest"; TINNITUS (non-serious) with onset May2021, outcome "recovered" (May2021), described as "ringing in her ears"; VACCINATION SITE REACTION (non-serious) with onset May2021, outcome "recovered" (May2021), described as "at the vaccination site, they applied ice pack". Therapeutic measures were taken as a result of throat irritation, feeling hot, tinnitus, vaccination site reaction.  Additional information: The reporter stated she and her daughter are nurses. She explained her daughter had problem with her throat after vaccination and then resolved one hour after taking diphenhydramine hydrochloride (BENADRYL). She later described that her daughter felt an intense heat in her throat and chest, with ringing in her ears. She explained at the vaccination site, they applied ice pack for one hour behind her neck and her chest and it resolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: has  a head ache; body ache; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 43 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12May2021 (Lot number: EW0168, Expiration Date: Aug2021) at the age of 43 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: BUSPAR. Vaccination history included: BNT162B2 (Dose: 1), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 13May2021, outcome "unknown", described as "has  a head ache"; PAIN (non-serious) with onset 13May2021, outcome "unknown", described as "body ache"; CHILLS (non-serious) with onset 13May2021, outcome "unknown", described as "chills".  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 16:30 (Lot number: EW0153) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "samter's syndrome" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Aspirin, reaction(s): "Known allergies". The following information was reported: MYALGIA (non-serious), outcome "recovered", described as "muscle soreness".  Additional information: The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not been diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The first shot only gave the patient muscle soreness for 3 to 4 days then went away.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: severe vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for COVID-19 immunisation. The following information was reported: VERTIGO (non-serious), outcome "unknown", described as "severe vertigo". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling slightly ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "chest tightness", "difficulty breathing", "almost fainted ". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feeling slightly ill".  Additional information: The consumer was concerned because her daughter (patient) had chest tightness, difficulty breathing, and almost fainted with her first shot. She went ahead and got her second shot anyway and only had "normal reactions" like feeling slightly ill. She was concerned if there are boosters because she has not heard of anyone else having these effects.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy".  Additional information: Caller was querying if her husband was supposed to feel dizzy after getting his second covid vaccine today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: had swollen lymph nodes on my second vaccine.It was quite painful; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Apr2021 11:00 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1; Anatomical Location: Arm Right;  time:at 11:00 AM), administration date: 16Mar2021, when the patient was 55 years old, for covid-19 immunization, reaction(s): "covid". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 06Apr2021 21:00, outcome "recovered" (Apr2021), described as "had swollen lymph nodes on my second vaccine.It was quite painful".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021491217 same reporter/ product/ patient, seperated doses
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Slightly more tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 79-year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Feb2021 13:30 (Lot number: EM9810) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart murmur", start date: 1999 (ongoing); "Hypertension", start date: 1999 (ongoing); "High Cholesterol", start date: 1999 (ongoing); "Arthritis knee" (ongoing), notes: Replacements in 2012, 2013; "Diabetes Type 2", start date: 2000 (ongoing); "Kidney stones", start date: 2000 (ongoing), notes: lithotripsy in 2006, 2010, 2011; "IBS", start date: 2000 (ongoing). Concomitant medication(s) included: ATACAND COMB taken for hypertension, start date: 2001 (ongoing); LIPITOR [ATORVASTATIN] taken for blood cholesterol increased, start date: 1999 (ongoing); METFORMIN taken for type 2 diabetes mellitus, start date: 2002 (ongoing); ALLOPURINOL taken for nephrolithiasis, start date: 1980 (ongoing). Past drug history included: Glipizide, start date: 2018, reaction(s): "Bruising"; Glipizide, reaction(s): "Bleeding". Vaccination history included: Bnt162b2 (1st Dose), administration date: 27Jan2021, for COVID-19 Immunisation, reaction(s): "tenderness arm". The following information was reported: FATIGUE (non-serious) with onset 17Feb2021, outcome "unknown", described as "Slightly more tired". Therapeutic measures were taken as a result of fatigue (extra fluid). No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Extreme fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Extreme fatigue"; HEADACHE (non-serious), outcome "unknown", described as "headache". Additional information: The patient's age was reported "44" (unit not specified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Somnolence
Clinical narrative: extreme headache; extreme tiredness; muscle soreness; need to nap often even though I've slept 8-10 hours; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 79-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Endoscopy", start date: Sep2020 (unspecified if ongoing), notes: This was on late September.; "Stomach bleed", start date: Sep2020 (unspecified if ongoing), notes: This was on late September. The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (Dose 1 (Lot Number: Not provided)), for COVID-19 immunisation, reactions: "Headache", "Tiredness", "Dizziness", "Nausea". The following information was reported: HEADACHE (non-serious), outcome "not recovered", described as "extreme headache"; FATIGUE (non-serious), outcome "not recovered", described as "extreme tiredness"; MYALGIA (non-serious), outcome "not recovered", described as "muscle soreness"; SOMNOLENCE (non-serious), outcome "unknown", described as "need to nap often even though I've slept 8-10 hours".  Additional information: The patient experienced extreme headache within 10 minutes, extreme tiredness within 1 hour lasting a full week, muscle soreness in the next day - no pain from the shot. Milder headaches continued as well as muscle soreness. Tiredness continued and needed to nap often even though slept 8-10 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021138669 Same patient and drug, different dose and events
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: only arm pain I feel like in my where shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (left shoulder), administration date 07Apr2021 (Lot number: ER8729) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "only arm pain I feel like in my where shot".  No follow-up attempts are possible. No further information is expected.