chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: After the first dose, I had a terrible migraine.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "After the first dose, I had a terrible migraine.". Therapeutic measures were taken as a result of migraine.  Additional information included: The patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA), via an unspecified route of administration. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included butalbital; caffeine; paracetamol (FIORICET) for an unknown indication from an unspecified date and unknown if ongoing.The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in 2021, after the first dose, the patient experienced a terrible migraine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event migraine and included treatment with unspecified medication. The patient reported that the medication did not work. The clinical outcome of the event terrible migraine was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea, Pain, SARS-CoV-2 test
Clinical narrative: Nausea; Diahrrea; Severe body pain; Mild headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) via database. The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 11:00 (Lot number: ep6955) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing); "Osteoarthritis" (unspecified if ongoing); "If covid prior vaccination - Yes" (unspecified if ongoing). Concomitant medication(s) included: CELEBREX. The following information was reported: NAUSEA (non-serious) with onset 22May2021 14:00, outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious) with onset 22May2021 14:00, outcome "unknown", described as "Diahrrea"; PAIN (non-serious) with onset 22May2021 14:00, outcome "unknown", described as "Severe body pain"; HEADACHE (non-serious) with onset 22May2021 14:00, outcome "unknown", described as "Mild headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of nausea, diarrhoea, pain, headache.  Additional information: Report about covid vaccine- Yes. Reporter type  Patient. Patient occupation - None of the above. Other vaccine same date product= NA. Other vaccine same date lot number= NA. If other vaccine in four weeks: No. Other medications in two weeks: High blood pressure meds, Celebrex. Adverse event - nausea, diahrrea, severe body pain, mild headache, 3rd day after vaccination, previous positive covid 21Jan2021. If covid prior vaccination - Yes. If covid tested post vaccination - No. Known allergies - no. Other medical history - high blood pressure, osteoarthritis. Device timestamp - 22May2021.  Follow-up attempts completed. No further information expected.
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little soreness in my arm at 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 84 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 05Mar2021 13:30 (Lot number: EN6205) as dose 1, single and intramuscular, administered in deltoid right, administration date 26Mar2021 13:10 (Lot number: EN6204) 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: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "little soreness in my arm at the injection site". Additional information: A patient did not receive any other vaccine in 4 weeks prior vaccination. A patients concomitant medication, medical history and relevant test was unknown. Patient stated "received my Pfizer shot for covid-19, I didn't have hardly any side effects except for a little soreness in my arm at the injection site."  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: Feeling dizziness after 3 days of vaccine 2nd shot.; imbalance feeling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).   A 34-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19May2021 16:00 (Lot number: EW0185) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose number 1, lot number: EW0173, administration time: 16:00, vaccine location: Left arm), administration date: 28Apr2021, when the patient was 34 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 22May2021 09:00, outcome "not recovered", described as "Feeling dizziness after 3 days of vaccine 2nd shot."; BALANCE DISORDER (non-serious) with onset 22May2021, outcome "unknown", described as "imbalance feeling". Therapeutic measures were not taken as a result of dizziness.  Additional information: There was no other vaccine in four weeks. There was no other vaccine in two weeks. The patient was not diagnosed with Covid, prior vaccination. The patient was not diagnosed with Covid, post vaccination. There were no known allergies and no relevant tests. After 3 days of second dose of covid vaccine, patient started feeling dizziness never had any such experience before in his life. Contacted physician & explained his imbalance feeling. He concluded it may be due to age (34) covid vaccine could not have such impact. Looking for an answer for why felt such dizziness after second dose (3 days after).  No follow up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Sore neck; Stiff neck; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 15:00 (Batch/Lot number: unknown) at the age of 33 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic to cats" (unspecified if ongoing); "Grass allergy" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "allergies Opiates" (unspecified if ongoing), notes: allergies Opiates. The patient's concomitant medications were not reported. Past drug history included: Rye, reaction(s): "Drug allergy". The following information was reported: NECK PAIN (non-serious) with onset 22May2021, outcome "not recovered", described as "Sore neck"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 22May2021, outcome "not recovered", described as "Stiff neck". Therapeutic measures were not taken as a result of neck pain, musculoskeletal stiffness.  Additional Information: The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, SARS-CoV-2 test
Clinical narrative: Insomnia, couldn't fall asleep until 4am that night.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Mar2021 11:15 (Lot number: En5318) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: Known allergies: Yes; "GERD" (unspecified if ongoing), notes: GERD; "HTN" (unspecified if ongoing), notes: HTN. The patient took concomitant medications. The following information was reported: INSOMNIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Insomnia, couldn't fall asleep until 4am that night.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID -19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 03:30 (Batch/Lot number: unknown) at the age of 16 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anorexia" (unspecified if ongoing); "Anemia" (unspecified if ongoing). Concomitant medication(s) included: PROZAC; IRON; VITAMIN D [VITAMIN D NOS]; MULTI VITAMIN [ASCORBIC ACID;FOLIC ACID;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;VITAMIN B1 NOS;VITAMIN B12 NOS;VITAMIN D NOS;VITAMIN E NOS]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "recovering", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 51-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 51, single dose, for COVID-19 immunisation. Medical history included vertigo, start date: 2019 (not ongoing), notes: had a bout of vertigo around 2019 that lasted weeks. The patient's concomitant medications not reported. The patient had pain in extremity (sore arm), onset 2021, with outcome of not recovered. No therapeutic measures taken as a result of pain in extremity. Additional information: The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit/emergency room/department or urgent care. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Menstruation delayed
Clinical narrative: period was late; bad headache for a week; fatigue; overall not feeling well for a week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 12:00 (Lot number: EW0167) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Irritable bowel syndrome" (unspecified if ongoing), notes: IBS; "Hypothyroidism" (unspecified if ongoing); "Hashimoto's disease" (unspecified if ongoing), notes: Hashimotos. The patient took concomitant medications.  The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 2021, outcome "unknown", described as "period was late"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "bad headache for a week"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "overall not feeling well for a week". Therapeutic measures were not taken as a result of menstruation delayed, headache, fatigue, malaise.  Additional Information: The patient had no known allergies to medications, food or other products. The patient received unspecified medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EWOL 76) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: EMGALITY [GALCANEZUMAB]; GABAPENTIN; VALACYCLOVIR HCL; TYLENOL; BENADRYL. The following information was reported: MIGRAINE (non-serious) with onset 26Apr2021, outcome "recovered" (2021), described as "Migraines". Therapeutic measures were not taken as a result of migraine.  Additional information: Patient was not pregnant at the time of Vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was reported as Emgality, Gabapentin, Valacyclovir, Tylenol, Benad. Reported Event: It seems like my Emgality shot that I had the same day did not work. I had nearly migraines for a month after the shot that could not be relieved until time for my next Emgality shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She had no problems except injection site soreness with the first one; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Apr2021 (Lot number: EW0161) at the age of 67 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "She had no problems except injection site soreness with the first one". No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021585244 same patient, different drug/event
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: redness at injection site/ location of vaccination still a little red, slightly blotchy 12 days later; soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 18May2021 (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 ERYTHEMA (non-serious) with onset May2021, outcome "not recovered", described as "redness at injection site/ location of vaccination still a little red, slightly blotchy 12 days later"; VACCINATION SITE PAIN (non-serious) with onset May2021, outcome "unknown", described as "soreness at injection site". Additional information: The patient was reported as 12 (age unit was unspecified).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: More frequent or extended migraine headaches; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (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: MIGRAINE (non-serious), outcome "unknown", described as "More frequent or extended migraine headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: I have a cold, little bit cold; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 11May2021, outcome "unknown", described as "I have a cold, little bit cold".  Additional information: patient would like to report that, he currently had this cold and then he was due to get his second dose by the day after the present report (22May2021). Other question he had, if it was okay for him to get the second dose tomorrow even though he was experiencing that type of adverse event something like that. Patient had a cold, little bit cold. It started on 11May2021. He took vaccine first dose on 01May2021 but the cold started on 11May2021 or something on that prior week (as reported) and he still felt it little bit but he just wanted to say whether he had to go for the day after dose or he needed to stay until he fully recovered from that. He stated, "no mam sorry I mean".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: 1st dose, I had fatigue and projectile diarrhoea for 24 hrs.  Thought it was a fluke.  2nd dose gave me the same effects.; 1st dose, I had fatigue and projectile diarrhoea for 24 hrs.  Thought it was a fluke.  2nd dose gave me the same effects.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 01May2021 12:30 (Lot number: EW0158) as dose 1, single and intramuscular, administered in arm left, administration date 22May2021 12:30 (Lot number: ER8736) as dose 2, single for covid-19 immunisation. Relevant medical history included: "type 2 diabetes" (ongoing); "COPD" (ongoing); "cholesterol" (ongoing); "BP" (ongoing); "acid reflux" (ongoing); "Allergies" (ongoing). Concomitant medication(s) included: ATORVASTATIN taken for blood cholesterol (ongoing); VICTOZA taken for diabetes mellitus (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); PANTOPRAZOL [PANTOPRAZOLE] taken for gastrooesophageal reflux disease (ongoing); MONTELUKAST taken for hypersensitivity (ongoing). Past drug history included: Demeral, reaction(s): "known allergies: demeral"; Soma complex, reaction(s): "known allergies:soma complex". The following information was reported: FATIGUE (non-serious), DIARRHOEA (non-serious) all with onset 01May2021, outcome "recovered" (25May2021) and all described as "1st dose, I had fatigue and projectile diareha for 24 hrs.  Thought it was a fluke.  2nd dose gave me the same effects.". Therapeutic measures were not taken as a result of fatigue, diarrhoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. 1.Diarrhoea, onset date:01May2021, onset time: next day, lasted 2 days. seriousness criteria: not serious.AE outcome: recovered. Date of recovery:04May2021. Treatment: No 2.Diarrhoea; onset date:22May2021.onset time: next day, lasted 2 days. seriousness criteria: not serious. AE outcome: recovered. Date of recovery:25May2021.Treatment: No Ended up with projectile diarrhoea the day after each dose, that lasted 2 days and then went away on its own. Been fine since then.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Loss of personal independence in daily activities, Pain, Somnolence, Vertigo
Clinical narrative: Achy; Flu like symptoms; Vertigo; Went to bed; Couldn't empty dishwasher; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Achy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; SOMNOLENCE (non-serious), outcome "unknown", described as "Went to bed"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Couldn't empty dishwasher".  Additional information: Post Dose 2 adverse events to COVID 19 vaccine. Within 24 hours of second dose felt Achy, Flu like symptoms, Vertigo, Went to bed and Couldn't empty dishwasher. Called into her work meeting and a colleague in the call was having symptoms as well post his second dose.  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-2021586056 same reporter/ drug , different AE/ patient
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: I got dizzy after the Pfizer vaccine; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Apr2021 (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: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "I got dizzy after the Pfizer vaccine". Additional information:Patient got dizzy after the Pfizer vaccine, patient didn't realize it was a severe adverse reaction. This happened 11 days after patient got the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait inability, Hyperhidrosis, Pain
Clinical narrative: profusely sweating non stop; Unable to walk around; Exhausted; Shivering / Cold; Intense pain all over /  her entire body was hurting / not one part of me wasn't hurting; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 18May2021 12:00 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Factor V Leiden homozygote" (unspecified if ongoing), notes: Factor v Leiden homozygous. The patient took concomitant medications. Vaccination history included: BNT162B2 (DOSE 1, SINGLE  (Lot number: UNKNOWN), Location of injection: Arm Left, Administration time: 18:00), administration date: 27Apr2021, when the patient was 39 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 19May2021 03:00, outcome "recovering", described as "Shivering / Cold"; PAIN (non-serious) with onset 19May2021 03:00, outcome "recovering", described as "Intense pain all over /  her entire body was hurting / not one part of me wasn't hurting"; GAIT INABILITY (non-serious) with onset 20May2021, outcome "recovering", described as "Unable to walk around"; FATIGUE (non-serious) with onset 20May2021, outcome "recovering", described as "Exhausted"; HYPERHIDROSIS (non-serious) with onset 21May2021, outcome "not recovered", described as "profusely sweating non stop". Therapeutic measures were not taken as a result of chills, pain, gait inability, fatigue, hyperhidrosis.  Additional Information: The patient did not have any allergies to medications, food, or other products. Concomitant medication included unspecified anxiety medication since an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient reported that on 19May2021 at 03:00, the night she took the second vaccine, she woke up shivering in intense pain all over from how cold she was and her entire body was hurting. She stated that she was unable to walk around on 20May2021, the following day and not one part of her was not hurting. She clarified that on 20May2021, the next day her symptoms were improved but she was exhausted and its currently 21May2021, day three now and was profusely sweating non-stop. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Electric shock sensation, Fatigue, Hyperacusis, Myalgia, Tinnitus
Clinical narrative: Have found like electricity in my ears; I am hearing like an electricity all the time in my ears; I am hearing like a 'zoom', like an electricity; tiredness; her muscles in all of her neck and all parts of her neck and shoulder are hurting; sound of electricity inside her ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18May2021 11:00 (Lot number: EW0176) as dose 2, single and administered in arm left, administration date 27Apr2021 (Lot number: EW0176) 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: ELECTRIC SHOCK SENSATION (non-serious) with onset 2021, outcome "not recovered", described as "Have found like electricity in my ears; I am hearing like an electricity all the time in my ears"; HYPERACUSIS (non-serious) with onset 2021, outcome "unknown", described as "I am hearing like a 'zoom', like an electricity"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "tiredness"; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "her muscles in all of her neck and all parts of her neck and shoulder are hurting"; TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "sound of electricity inside her ear".  Additional information: She says after the first vaccine she got a zoom in her ear, like the sound of electricity. She says it started two days after the vaccine but she is not sure the date or the time of onset. She says she went to the doctor because she had her shot in 3 weeks from the second shot. She said they made a sound test and told her ears are fine. She says she told them she is still hearing this; it wasn't that strong that strong like now. She says they sent her home, she was seen by a nurse practitioner because it was for an emergency. She says the doctor didn't see her. She says she decided to go get the second shot because it was about to pass.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Nasopharyngitis, Pain in extremity, Vomiting
Clinical narrative: Barely can move arm and having pain in arm; Barely can move arm and having pain in arm; Severe cold like symptoms; Vomiting; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient's son.  A 53-year-old male patient received the second dose of bnt162b2 (BNT162B2) via an unspecified route of administration, administered on the right arm on 21May2021 (batch/lot number: unknown) at the age of 53 years old, as DOSE 2, SINGLE for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (first dose (manufacturer unknown) via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown" and all described as "Barely can move arm and having pain in arm"; NASOPHARYNGITIS (non-serious), outcome "unknown" described as "Severe cold like symptoms"; VOMITING (non-serious), outcome "unknown" described as "Vomiting." The clinical course was reported as follows: The reporter stated that his father got the second vaccine yesterday (21May2021). He can barely move his arm and having severe cold like symptoms. He is vomiting. He wanted to know how much are these normal? He has (severe) pain in his arm."  No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site erythema
Clinical narrative: Arm swelling and where they put the shot is red; Arm swelling and where they put the shot is red; 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), administered in arm left, administration date 21May2021 (Lot number: EW0170) 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), administration date: 29Apr2021, for Covid-19 Immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset May2021, outcome "unknown" and all described as "Arm swelling and where they put the shot is red".  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: Arm is very sore, I cannot lift it; Have feel the pain with first one, but with this one they put in the injection and I can feel the pain right away; Nausea; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old patient received bnt162b2 (BNT162B2), administration date 19May2021 (Batch/Lot number: unknown) at the age of 60 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 (Dose:1), for COVID-19 immunization, reaction(s): "Headache", "Sore arm"; Bnt162b2 (Dose:1, Verbatim:When confirmed if it was the first Pfizer COVID shot, Consumer stated, "Yes It was for COVID shot the first shot, for two days I have like nausea, like headache and my arm I cannot lift it,), for COVID-19 immunization, reaction(s): "Naussea". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 19May2021, outcome "not recovered", described as "Arm is very sore, I cannot lift it"; VACCINATION SITE PAIN (non-serious) with onset 19May2021, outcome "unknown", described as "Have feel the pain with first one, but with this one they put in the injection and I can feel the pain right away"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache".  Addition information:I think I am not able to go work today because my arm cannot lift things which are heavy. I just need a note so that I can take it tomorrow because I work from Saturday to Wednesday, I work at nights. So if you can email or notes, so that they can see that because they ask me for the mail after two days, three days. I have felt the pain with first one like that, but with this one they put in the injection and I can feel the pain right away."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm started to get pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old 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 "Arm started to get pain".  Additional information:  At the time of reporting patient don't have lot number. Patient stated got the first dose of covid-vaccine of Pfizer reported as yesterday and patient arm started to get pain at last night. Patient was just wondering can take Tylenol or something they just want to confirm?.  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 pain upper
Clinical narrative: She woke up and she has a short pain in her stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 19May2021 (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: ABDOMINAL PAIN UPPER (non-serious) with onset May2021, outcome "unknown", described as "She woke up and she has a short pain in her stomach".  Additional Information: Reporter  stated,  His girlfriend got the shot yesterday or the other day and she woke up and she had a short pain in her stomach .I mean is thats one of the side effect but the paper didnt say. As  reporter was unwilling to share further information. Hence further probing could not be done. Limited information available over the call. 6:26 PM.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck; 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), administration date 21May2021 (Lot number: EW0183) as dose 1, single for covid-19 immunisation. Relevant medical history included: "down syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset May2021, outcome "unknown", described as "Stiff neck".  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 21May2021 (Lot number: EW0183) at the age of 51 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "down syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "Stiff neck".  Additional information: Reporter stated, "My son, had the Pfizer shot and I wanted to know, he has a stiff neck, I wanted to know if that is a symptom of getting the shot or if it could be something else. Reporter stated, "He got a shot on Friday, yes it's Pfizer and the LOT he got is EW0183.When confirmed if the reporter wanted to report this or have some questions, Reporter further stated, "Is that a side effect of it, stiff neck. Reporter was again informed about the role of Pfizer Drug Safety and requested to probe. Reporter stated, "No, I'm just trying to get information about the side effects. I really don't want to do a survey. We are concerned about this. No further probing was done as the reporter was unwilling to share any further information. Hence limited information available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: arm tenderness/ soreness; arm tenderness/ soreness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 12 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: TENDERNESS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "arm tenderness/ soreness".  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: Headache, SARS-CoV-2 test
Clinical narrative: headache X 3 days after 1st and 2nd vaccines; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 16:00 (Lot number: EN6205) at the age of 59 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Perennial allergies" (unspecified if ongoing), notes: Other medical history: Perennial allergies; "horseradish allergy" (unspecified if ongoing), notes: Known allergies: Seldane, horseradish. Concomitant medication(s) included: CLARITIN; FLONASE; NEXIUM; MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]. Past drug history included: Seldane, reaction(s): "Allergies: Seldane", notes: Known allergies: Seldane, horseradish. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache X 3 days after 1st and 2nd vaccines". The event "headache x 3 days after 1st and 2nd vaccines" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: The patient had headache X 3 days after 1st and 2nd vaccines. No COVID prior vaccination. No other vaccine in four weeks.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, SARS-CoV-2 test, Toxicity to various agents
Clinical narrative: My heart med became toxic; Nodule on left side of my neck apoearrd; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Feb2021 (Lot number: EL9264) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing), notes: known allergies: Yes; "Afib" (ongoing); "Thyroid" (ongoing); "Asthma" (ongoing). Concomitant medication(s) included: SYNTHROID taken for thyroid disorder (ongoing); BETAPACE taken for atrial fibrillation, stop date: 24Mar2021. Vaccination history included: Bnt162b2 (Dose 1, Time:11:00pm, Batch/Lot number: EL9264), administration date: 28Jan2021, when the patient was 76 years old, for Covid-19 immunization. The following information was reported: TOXICITY TO VARIOUS AGENTS (hospitalization) with onset 24Mar2021 13:00, outcome "not recovered", described as "My heart med became toxic"; NODULE (non-serious) with onset 24Mar2021 13:00, outcome "not recovered", described as "Nodule on left side of my neck apoearrd". The patient was hospitalized for toxicity to various agents (hospitalization duration: 3 day(s)). The events "my heart med became toxic" and "nodule on left side of my neck apoearrd" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Mar2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of toxicity to various agents. It was unknown if therapeutic measures were taken as a result of nodule.  Additional Information: It was reported that, the patient received other medications within 2 weeks of vaccination. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes. Prior Vaccinations: None. After receiving vaccine my neck nodule for 2-4 day called Physician didnt get appointment for 26Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal discomfort, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: bilateral stiffness in all knuckles; swelling in the ring and pinky fingers on both hands and just under the fingers on the palm sides are puffy; there is no pain, only slight discomfort when he "push it in"; He feels more resistance to close his hand; swelling around knuckles; 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. Other Case identifier(s): US-PFIZER INC-2021592715 (Pfizer).  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18May2021 15:30 (Lot number: EW0178) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset May2021, outcome "not recovered", described as "swelling around knuckles"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "bilateral stiffness in all knuckles"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in the ring and pinky fingers on both hands and just under the fingers on the palm sides are puffy"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "there is no pain, only slight discomfort when he "push it in""; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "He feels more resistance to close his hand". Therapeutic measures were not taken as a result of peripheral swelling, musculoskeletal stiffness, peripheral swelling, musculoskeletal discomfort, muscular weakness.  Additional information: Patient had no known allergies not even Penicillins. He states he noticed something different 3-4 days before when starting a leaf blower. He had difficulty getting it started. On an unknown date, he noticed bilateral stiffness in all knuckles, swelling in the ring and pinky fingers on both hands and just under the fingers on the palm sides are puffy. He states there was no pain, only slight discomfort when he "push it in". He feels more resistance to close his hand. It got a little bit worse last night. He felt it started late since he had read that most side effects occur within a day or two and go away. He wants to know would it go down eventually and is this normal. There was no emergency room or physician office visit. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. No other vaccine was administered on same date of the Pfizer suspect.  Follow-up attempts are completed. No further information is expected.