chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Computerised tomogram, Dizziness, Electrocardiogram
Clinical narrative: Dizziness; Headaches/little headache; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 12:15 (Lot number: EW0153) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; HEADACHE (non-serious), outcome "unknown", described as "Headaches/little headache"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness". The event "headaches/little headache" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took a medication for depression. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After her first vaccine dose on 07Apr2021, the patient experienced headaches with episodes of dizziness and weakness. The patient wanted to know what she could do for her side effects following vaccination and needed recommendations for what she could do about these symptoms, she needed medical advice. With the first COVID-19 vaccine, the patient experienced a little headache, dizziness and weakness. She didn't think her side effects were from the vaccine. When she got the second COVID-19 vaccine, she had a headache and she knew it was definitely the vaccine. She received her second COVID-19 vaccine on Thursday, 29Apr2021. When she received her second COVID-19 vaccine she was still experiencing side effects from the first COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Dizziness; Headaches/little headache; Weakness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 12:15 (Lot number: EW0153) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; HEADACHE (non-serious), outcome "unknown", described as "Headaches/little headache"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness". The event "headaches/little headache" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took a medication for depression. There was no history of any previous immunization with the Pfizer vaccine considered as suspect. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After her first vaccine dose on 07Apr2021, the patient experienced headaches with episodes of dizziness and weakness. The patient wanted to know what she could do for her side effects following vaccination and needed recommendations for what she could do about these symptoms, she needed medical advice. With the first COVID-19 vaccine, the patient experienced a little headache, dizziness and weakness. She didn't think her side effects were from the vaccine. When she got the second COVID-19 vaccine, she had a headache and she knew it was definitely the vaccine. She received her second COVID-19 vaccine on Thursday, 29Apr2021. When she received her second COVID-19 vaccine she was still experiencing side effects from the first COVID-19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Dizziness; Headache; His son is still very ,very fatigued/feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 33 year-old male patient received bnt162b2 (BNT162B2), administration date 27Apr2021 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mercury poisoning", start date: 2013 (unspecified if ongoing); "Chelation Therapy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 27Apr2021, outcome "not recovered", described as "His son is still very ,very fatigued/feeling tired"; DIZZINESS (non-serious), outcome "recovering", described as "Dizziness"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fear, Nervousness, Pain in extremity
Clinical narrative: terrified; nervous wreck; sore arm after receiving the first dose; 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 58 year-old female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Lot number: ER8737) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FEAR (non-serious), outcome "unknown", described as "terrified"; NERVOUSNESS (non-serious), outcome "unknown", described as "nervous wreck"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm after receiving the first dose".  Additional information: Patient had COVID and then she had the first shot. Patient is a nervous wreck over taking the shot because nobody knows what is going on.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blepharospasm, Muscle twitching, SARS-CoV-2 test false negative
Clinical narrative: Twitching of my left upper eyelid, if Iclose my eyes or sneeze my uppereyelid spasm and shaking left and right; Twitching of my left upper eyelid, if Iclose my eyes or sneeze my uppereyelid spasm and shaking left and right; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 17:45 (Lot number: ER8729) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Season allergies" (unspecified if ongoing), notes: Verbatim: Season allergies; "Known Allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa drugs" (unspecified if ongoing); "Known allergies: wheat, gluten, tree nuts, peanuts, soy" (unspecified if ongoing). Concomitant medication(s) included: TRI LO MARZIA; XYZAL; NASACORT. Past drug history included: Tetracycline, reaction(s): "Known allergies: tetracycline", notes: Verbatim: Known allergies; Zythromax, reaction(s): "Known allergies: Zythromax", notes: Verbatim: Known allergies; Erythromycin, reaction(s): "Known allergies: erythromycin", notes: Verbatim: Known allergies. The following information was reported: MUSCLE TWITCHING (non-serious), BLEPHAROSPASM (non-serious) all with onset 12Apr2021 20:00, outcome "not recovered" and all described as "Twitching of my left upper eyelid, if Iclose my eyes or sneeze my uppereyelid spasm and shaking left and right". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle twitching, blepharospasm.  Additional Information: Patient had no other vaccine in four weeks .Patient had no covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Sinusitis
Clinical narrative: suffered sinusitis; dizziness; 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 (BNT162B2), administration date 24Apr2021 (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: SINUSITIS (non-serious) with onset 2021, outcome "unknown", described as "suffered sinusitis"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness".  Additional information: Patient states, she want to know if Pfizer's covid-19 vaccine might cause the symptoms (sinusitis and nausea) that she experienced and also wants to know how long would this side effects last.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left Arm Pain; arm is still sore and underneath it is like spasming/someone was punching and punching her; 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 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: ER8737) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. Vaccination history included: Measles vaccine (as a kid, she had the German Measles vaccine and then after that she got the German Measles.), for Immunisation, reaction(s): "German Measles". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Apr2021, outcome "recovered" (04Apr2021), described as "Left Arm Pain; arm is still sore and underneath it is like spasming/someone was punching and punching her".  Additional information: Caller stated that she had her first shot in her right arm, and it was sore, but it went away after 3 days. Prior Vaccinations (within 4 weeks): Patient had received both doses of the Pfizer Covid Vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Hurt in the arm after receiving both doses; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 25Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date 15Feb2021 (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Hurt in the arm after receiving both doses".  Additional information: Patient mentioned that she experienced minor adverse events like hurt in the arm after receiving both doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; 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 11Apr2021 (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: LYMPHADENOPATHY (non-serious) with onset 2021, outcome "not recovered", described as "swollen lymph nodes".  Additional information: It was reported that, the patient still experiencing lymph nodes before getting the second dose. She still feels swollen lymph nodes. Patient wanted to know if she could take the second dose with a lymph node. No unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Flatulence
Clinical narrative: Watery diarrhea; Gas; Bloating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Apr2021 08:30 (Lot number: EW0151) at the age of 73 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: EP7534, Anatomical location: Arm right), administration date: 19Mar2021, when the patient was 73 years old, for Covid-19 Immunization, reaction(s): "Sore arm". The following information was reported: DIARRHOEA (non-serious) with onset Apr2021, outcome "recovering", described as "Watery diarrhea"; FLATULENCE (non-serious) with onset Apr2021, outcome "recovering", described as "Gas"; ABDOMINAL DISTENSION (non-serious) with onset Apr2021, outcome "recovering", described as "Bloating".  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain on her heal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cortisone for swelling. The following information was reported: PAIN (non-serious) with onset May2021, outcome "unknown", described as "pain on her heal".  Additional information: Patient has a condition in her foot heal  (before getting Pfizer Vaccine), like an arthritis condition that causes inflammation and she usually receives a shot of cortisone to reduce the swelling.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Started hurting during the hold.; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 65 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: PAIN (non-serious), outcome "unknown", described as "Started hurting during the hold."  Additional Information: Patient reported after start of therapy he got his covid vaccine and stopped taking his medication sometime in Mar2021. Patient reported he does not remember how long patient stopped taking his medication but started hurting during the hold. md aware. Patient answered some of the time to the question how often patient forget to take his medicines. Patient reported after start of therapy he forgets to take his medication once a month. md unaware. Advised patient to notify patient mg. No adverse reactions reported. Patient answered some of the time to the question how often patient runs out of medicine. Patient reported after start of therapy patient ran out of his medication due to changing pharmacies. md aware and gave patient samples. No adverse reactions reported. Patient did not report any side effects. No further information reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: 1st dose just sore arm where the injection took place; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 18:00 (Lot number: ER8734) at the age of 27 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "1st dose just sore arm where the injection took place".  Additional Information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: energy level dropped to zero; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient in his 40's 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: Covid-19 vaccine (1st dose), for Covid-19 immunisation. The following information was reported: ASTHENIA (non-serious) with onset 26Apr2021, outcome "unknown", described as "energy level dropped to zero".  Additional Information: The patient was in his 40s. His energy level dropped to zero yesterday after he received his 2nd Pfizer Covid vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Myalgia
Clinical narrative: His ankle has been swollen; He is got some in like ankle and in wrist have muscle ache; he is really feeling terrible; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 46 year-old 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 immunization. The following information was reported: JOINT SWELLING (non-serious), outcome "unknown", described as "His ankle has been swollen"; MYALGIA (non-serious), outcome "unknown", described as "He is got some in like ankle and in wrist have muscle ache; he is really feeling terrible".  Additional information: The patient got his second dose of the Pfizer vaccine several days ago and his ankle has been swollen and he is got some in like ankle and in wrist have muscle ache and he was really feeling terrible and this was the thing that ever happened and just wanted to help with this.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Taste disorder
Clinical narrative: very bad taste in his mouth and numbness in his throat; very bad taste in his mouth and numbness in his throat; 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), administration date 06Apr2021 (Lot number: Not Provided) as dose 1 single for covid-19 immunisation. Relevant medical history included: "bronchitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious), HYPOAESTHESIA (non-serious), outcome "unknown" and all described as "very bad taste in his mouth and numbness in his throat".  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: After 1st dose there was a metallic taste in my mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 12:30 (Lot number: EN6202) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLONASE ALLERGY RELIEF; LIPITOR [ATORVASTATIN]; TYLENOL PM; CBD OIL. The following information was reported: DYSGEUSIA (non-serious), outcome "recovered", described as "After 1st dose there was a metallic taste in my mouth". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: The patient did not suffered from COVID prior to vaccination. The patient did not have COVID post vaccination. The patient also have no known allergies. The patient was also having Claritin as a concomitant drug.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills
Clinical narrative: unspecified side effects; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (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, Batch/Lot Number: Unknown, Route of administration: Unknown), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 28Apr2021 05:00, outcome "unknown", described as "Chills"; ADVERSE DRUG REACTION (non-serious), outcome "unknown", described as "unspecified side effects".  Additional information: The caller called in regards to the Pfizer COVID vaccine that she received at the (Name with held). She has received both vaccines. She received the second vaccine on 18Mar2021. She had some side effects; she took that Friday off and was fine by Saturday. She has been doing everything that she is supposed to masking, sanitizing, she sanitizes the carts when she goes to the supermarket. However, she woke up at 5AM this morning with chills. She had no headache, no temperature. Caller wanted to know can there be a side effect this late after receiving the vaccine.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Malaise, Nausea
Clinical narrative: Nausea; Stomach problems; Feeling sick; Weak; This is a spontaneous report received from a 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: NAUSEA (non-serious), outcome "unknown", described as "Nausea"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "Stomach problems"; MALAISE (non-serious), outcome "unknown", described as "Feeling sick"; ASTHENIA (non-serious), outcome "unknown", described as "Weak".  Additional information: Reported that, Patient got vaccinated on Saturday at 26th or 27th some like that and can not remember and confirmed it as first shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Limb discomfort, Movement disorder, Off label use, Skin discolouration
Clinical narrative: Second dose: Patient has a big purple circle around her arm. It looks like patient got hit by a baseball.; Second dose: Patient has a big purple circle around her arm. It looks like patient got hit by a baseball.; Patient told reporter that it was hard for her to get up and get around for the first week. Patient had to force herself to get up.; Reporter states that patient received second dose two weeks after first dose; Reporter states that patient received second dose two weeks after first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: Verbatim: Breast cancer; "Open heart surgery" (unspecified if ongoing), notes: Verbatim: Open heart surgery; "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes. Concomitant medication(s) included: COUMADIN. Vaccination history included: Covid-19 vaccine (Dose number: 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: SKIN DISCOLOURATION (non-serious), outcome "recovering", LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "Second dose: Patient has a big purple circle around her arm. It looks like patient got hit by a baseball."; MOVEMENT DISORDER (non-serious), outcome "recovering", described as "Patient told reporter that it was hard for her to get up and get around for the first week. Patient had to force herself to get up."; OFF LABEL USE (non-serious), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown" and all described as "Reporter states that patient received second dose two weeks after first dose".  Additional information: Patient had a big purple circle around her arm. It looked like patient got hit by a baseball: Patient sent reporter pictures of her arm. Reporter believes that patient's big purple circle around her arm began the day after she received the covid vaccine. Patient told reporter earlier on the phone today that it was getting better, but the spot was still there. Patient told reporter that it was hard for her to get up and get around for the first week. Patient was taking care of the grandkids. Patient had to force herself to get up. Patient was feeling better now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This morning and today his arm was sore.; Slightly tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 28Apr2021 (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) with onset 28Apr2021, outcome "unknown", described as "This morning and today his arm was sore."; FATIGUE (non-serious) with onset 28Apr2021, outcome "unknown", described as "Slightly tired".  Additional information: Received Vaccine at Site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 33-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Lot number: ER8731, Expiration Date: 16Apr2021) at the age of 33 years as single dose for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose, right arm injection, Batch/Lot number: EP6955), administration date: 25Mar2021, when the patient was 33 years old, for COVID-19 Immunization. Reactions with first dose included flu-like symptoms, temperature was 102-103 degrees, and would lower to 100 degrees at times.   The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 16Apr2021, outcome recovered (17Apr2021), described as Flu-like symptoms. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of influenza like illness. Additional information: The patient reporting on self in regard to the Pfizer COVID-19 vaccine. He took the second shot of the vaccine 10 days ago. After the first shot, he experienced adverse reaction that started about 10 days after on 04Apr2021, which lasted for 3 days. It is approximately 10 days after the second shot, and he is having the exact same symptoms as he did after the first shot. He clarifies with the second shot, the day after he had a long 24 hours still of experiencing flu-like symptoms, but he got over that after 24 hours. Now, it is like 10 days after, and he is experiencing similar flu-like symptoms as he did with the first shot. The patient mentioned when he recently moved back, he had blood work done. He just wanted to get a screening and all his levels came back normal, everything looked great, even with his size. The patient had no treatment besides over the counter medications. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the pfizer suspect.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: vaccine aggravated issues she already had; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 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: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "vaccine aggravated issues she already had".  Additional Information: The report not related to a study or program. the patient also the reporter. Covid Vaccine a Pfizer product. Caller states she had her first shot and was scheduled to come back 25Mar2021, but she had to cancel it because she was having some issues and she went to see her primary care doctor today and he said it was okay to take the shot. States she got her first shot at Facility. Caller was asking to schedule her second vaccine. Caller clarified she was having some health issues, they weren't from the vaccine, but the vaccine aggravated what she already had.  Caller declined to answer additional questions or complete a safety report at this time. Further details unable to be obtained.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypersomnia, Pain in extremity
Clinical narrative: Sharp pain in her arm where the vein is near her wrist, it goes into her hand; Woke up and the next day she couldn't move; Sleeping a lot more; Sharp pain in her arm where the vein is near her wrist, it goes into her hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 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), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Sharp pain in her arm where the vein is near her wrist, it goes into her hand"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Woke up and the next day she couldn't move"; HYPERSOMNIA (non-serious), outcome "unknown", described as "Sleeping a lot more".  Additional information: It was reported that, Had a really bad experience with it, which she hears a lot of people do. No further details provided. Has that real sharp pain in her arm like where the vein was. Didn't have it the day of the COVID shot but has had it since. She doesn't know when it started because she has had so many side effects. She woke up the next day and couldn't even move. On that arm, she doesn't know whether anybody else has had it. Wants to know should she called her doctor. Clarified the sharp pain on her arm near the vein was down towards her wrist and goes into her hand. She drops things once in a while, but not all of the time. She woke up in the middle of the night crying because the pain was so sharp. It eased up and went back to sleep. It happened three times. It happens all day. She was sleeping a lot more. A lot of people say they are sleeping more for the first week and then it goes away. No further details provided. Stated this was not going away. She was having a hard time hearing this agent because she was outside and it was windy. She walked in from outside and got blinded. Caller declined to complete report. Full details not obtained. Loud background noise was present and caller was difficult to hear at times. Attempted to clarify details with caller. Advised caller to follow up with her primary care physician for medical advice and treatment recommendations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Peripheral swelling
Clinical narrative: Slight headache; Arm swollen; Arm hurt for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Mar2021 12:45 (Lot number: ER8734) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. Concomitant medication(s) included: AMLODIPINE taken for hypertension. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 30Mar2021, outcome "recovered" (31Mar2021), described as "Arm swollen"; PAIN IN EXTREMITY (non-serious) with onset 30Mar2021, outcome "recovered" (01Apr2021), described as "Arm hurt for a couple of days"; HEADACHE (non-serious) with onset 01Apr2021, outcome "recovered" (03Apr2021), described as "Slight headache".  Additional information: No additional vaccines administered. No prior vaccinations within 4 weeks. Patient (Pt) reported that she began taking amlodipine about 2 years ago and that she took a different medication prior to amlodipine. Pt was diagnosed with high blood pressure when she was 37, about 11 years ago. Patient was calling to report a side effect, reported that when she got the first dose of the Covid-19 vaccine, her arm was swollen and hurt for a couple of days and reported that everyone was saying that the sore arm was happening to them and she didn't think that she needed to report the event to Pfizer. Pt arm started hurting real bad when she went to drive off from the vaccination facility on 30Mar2021. Pt experienced a nagging headache, the pain was right between her nose and states that she saw that a headache was listed as a side effect. Later Pt got the second dose of the Covid-19 vaccine in her left arm because her right arm had hurt so badly after the first dose. No Emergency Room or Physician Office visit. No details provided on the other patients that reported a sore arm after receiving the Covid-19 vaccine. Pt reported that she took the vaccine first because her parents are 70. Pt reported that her parents did not want to get the Covid-19 vaccine, so said that she would get it first so her parents would see that it was fine. Pt reported that if she tells her parents about her side effects, they will not get the Covid-19 vaccine. Pt reported that she is not going to tell her parents about her side effects because she wants her parents to get the Covid-19 vaccine. Pt reported that she does not like needles and was not going to be getting any more shots than she needs to.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Fatigue, Headache, Influenza like illness, Mental disorder
Clinical narrative: Flu like symptoms; mental health issue; Fatigue; Ache/Pain; She got very angry and tried to convince her husband to get a divorce/She also sent angry emails to companies and individuals that have wronged her some how; Headache; 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 female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 12Apr2021 13:30 (Lot number: EW0153) at the age of 42 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 (lot number:EN6208, Dose Number:1, Anatomical site of injection: Left Shoulder), administration date: 22Mar2021, for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 13Apr2021, outcome "recovered" (15Apr2021), described as "Flu like symptoms"; MENTAL DISORDER (non-serious) with onset 13Apr2021, outcome "recovered" (14Apr2021), described as "mental health issue"; FATIGUE (non-serious) with onset 13Apr2021, outcome "recovered" (15Apr2021), described as "Fatigue"; PAIN (non-serious) with onset 13Apr2021, outcome "recovered" (15Apr2021), described as "Ache/Pain"; ANGER (non-serious) with onset 13Apr2021, outcome "recovered" (15Apr2021), described as "She got very angry and tried to convince her husband to get a divorce/She also sent angry emails to companies and individuals that have wronged her some how"; HEADACHE (non-serious) with onset 13Apr2021, outcome "recovered" (15Apr2021), described as "Headache".  Additional info: She had flu like symptoms for 2 days like many other people have had. She had side effect of the vaccine. The symptoms were the worst the 13Apr2021 and 14Apr2021. She was worried something was wrong with her brain. She doesnt understand why that happened. She has had no further episodes like that. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Flu like symptoms; mental health issue; Fatigue; Ache/Pain; She got very angry and tried to convince her husband to get a divorce/She also sent angry emails to companies and individuals that have wronged her some how; Headache; 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 female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 12Apr2021 13:30 (Lot number: EW0153) at the age of 42 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 (lot number:EN6208, Dose Number:1, Anatomical site of injection: Left Shoulder), administration date: 22Mar2021, for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 13Apr2021, outcome "recovered" (15Apr2021), described as "Flu like symptoms"; MENTAL DISORDER (non-serious) with onset 13Apr2021, outcome "recovered" (14Apr2021), described as "mental health issue"; FATIGUE (non-serious) with onset 13Apr2021, outcome "recovered" (15Apr2021), described as "Fatigue"; PAIN (non-serious) with onset 13Apr2021, outcome "recovered" (15Apr2021), described as "Ache/Pain"; ANGER (non-serious) with onset 13Apr2021, outcome "recovered" (15Apr2021), described as "She got very angry and tried to convince her husband to get a divorce/She also sent angry emails to companies and individuals that have wronged her some how"; HEADACHE (non-serious) with onset 13Apr2021, outcome "recovered" (15Apr2021), described as "Headache".  Additional info: She had flu like symptoms for 2 days like many other people have had. She had side effect of the vaccine. The symptoms were the worst the 13Apr2021 and 14Apr2021. She was worried something was wrong with her brain. She doesnt understand why that happened. She has had no further episodes like that. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional Vaccines Administered on Same Date of the Pfizer Suspect.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Mouth ulceration
Clinical narrative: friend and he had the same thing with the oral mouth ulcers occur.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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: MOUTH ULCERATION (non-serious), outcome "unknown", described as "friend and he had the same thing with the oral mouth ulcers occur."  Additional information: NDC number, batch/lot number and expiry date was not provided. Other products was not provided. Patient history not provided. Investigation assessment was not provided  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Expired product administered
Clinical narrative: Her shot was expired and had turned into water; Dehydrated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Lot number: EW1062) at the age of 62 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing), notes: Caller says that it has been diagnosed for years, maybe 40 years ago., ; "Blood pressure high" (unspecified if ongoing), notes: Caller says that it has been diagnosed for years, maybe 40 years ago., . The patient's concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset Apr2021, described as "Her shot was expired and had turned into water"; DEHYDRATION (non-serious) with onset Apr2021, described as "Dehydrated".  Additional Information: Speakerphone recording notification given. Consumer calling about the Pfizer COVID-19 vaccine who said she got her first dose at Walgreens 3 weeks ago and sat there for 15 minutes, then when she was going out the door they said her shot was expired and had turned into water and she should take it again. She says she just went to a clinic to get one and was told she has got to talk to her doctor first, but no one has ever heard of something like this, that if it is expired that it would turned into water. Caller says that her vaccine card information was handwritten, and they did not provide the NDC/EXP of her dose. Caller says that the date the dose was given was hard to read the way it was written, it could have been either 11Apr2021 or 17Apr2021, it was two weeks ago. She says the dose was injected into her left arm around 11:00-11:30AM. Caller says that she did not get any other vaccinations the day. she got the Pfizer COVID-19 vaccine or start any new medications recently. Caller said that she tried to get labs done the other day but they could not get a vein and said that she was dehydrated, they weren't able to get blood .Is there a Product Complaint: Yes.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Lethargy
Clinical narrative: Weakness; Lethargy; hands and fingers are numb; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Lot number: Not Provided) 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: ASTHENIA (non-serious), outcome "unknown", described as "Weakness"; LETHARGY (non-serious), outcome "unknown", described as "Lethargy"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "hands and fingers are numb".  Additional information included: Caller was calling about the Pfizer COVID 19 vaccine. She said she had the first one on Thursday seem to be ok after and Friday and Saturday but then she started feeling like she was having a reaction, she was having some weakness, lethargy and just today her hands were numb, her fingers were numb. She asked that, was something that had been reported with the vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: 5 days later and my husband got the shot same exact time ended up with a incapacitating bout of vertigo; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male 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: VERTIGO (non-serious), outcome "unknown", described as "5 days later and my husband got the shot same exact time ended up with a incapacitating bout of vertigo".  Additional information: This consumer reported for a male patient (husband). After the vaccine one, Pfizer 1st vaccination 6 days later in evening of the first shot she awoke about 7 hours later after she went to sleep at night she couldn't breath like someone put a pillow on her face and she couldn't get air and it woke her from a sound sleep, 5 days later she ended up not feeling, meaning that is she had her symptom 5 days later and her husband got the shot same exact time ended up with a incapacitating bout of vertigo and she was calling to see if we had any other report of these kind (side effects)."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.