chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Nasopharyngitis
Clinical narrative: soreness in arm; extreme fatigue; Headache; chills; cold symptoms; sore throat; felt like I got hit by a truck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 10Nov2021 09:15 (Lot number: FF8841) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN; ADVIL [IBUPROFEN]; TYLENOL. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EE3247, prev dose lot unknown: False, prev dose administrator route: Intramuscular, prev dose administration date: 18Feb2021, prev dose administration time: 10:00 AM, prev dose number: 2, prev dose vaccine location: Right arm), administration date: 18Feb2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL3247, prev dose lot unknown: False, prev dose administrator route: Intramuscular, prev dose administration date: 28Jan2021, prev dose administration time: 10:30 AM, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 28Jan2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "soreness in arm"; FATIGUE (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "extreme fatigue"; HEADACHE (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "Headache"; CHILLS (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "chills"; NASOPHARYNGITIS (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "cold symptoms"; OROPHARYNGEAL PAIN (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "sore throat"; MALAISE (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "felt like I got hit by a truck". Therapeutic measures were not taken as a result of pain in extremity, fatigue, headache, chills, nasopharyngitis, oropharyngeal pain, malaise.  Additional information: No other vaccine in four weeks. No covid-19 prior vaccination. Not tested positive covid-19 post vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity
Clinical narrative: soreness in arm; extreme fatigue; Headache; chills; cold symptoms; sore throat; felt like I got hit by a truck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 63 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 10Nov2021 09:15 (Lot number: FF8841) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN; ADVIL [IBUPROFEN]; TYLENOL. Vaccination history included: Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EE3247, prev dose lot unknown: False, prev dose administrator route: Intramuscular, prev dose administration date: 18Feb2021, prev dose administration time: 10:00 AM, prev dose number: 2, prev dose vaccine location: Right arm), administration date: 18Feb2021, when the patient was 63 years old, for Covid-19 Immunization; Bnt162b2 (prev dose product: COVID 19, prev dose brand: Pfizer, prev dose brand unknown: False, prev dose lot number: EL3247, prev dose lot unknown: False, prev dose administrator route: Intramuscular, prev dose administration date: 28Jan2021, prev dose administration time: 10:30 AM, prev dose number: 1, prev dose vaccine location: Left arm), administration date: 28Jan2021, when the patient was 63 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "soreness in arm"; FATIGUE (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "extreme fatigue"; HEADACHE (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "Headache"; CHILLS (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "chills"; NASOPHARYNGITIS (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "cold symptoms"; OROPHARYNGEAL PAIN (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "sore throat"; MALAISE (non-serious) with onset 10Nov2021 05:00, outcome "recovered with sequelae", described as "felt like I got hit by a truck". Therapeutic measures were not taken as a result of pain in extremity, fatigue, headache, chills, nasopharyngitis, oropharyngeal pain, malaise.  Additional information: No other vaccine in four weeks. No covid-19 prior vaccination. Not tested positive covid-19 post vaccination. No known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Headache, SARS-CoV-2 test, Vision blurred
Clinical narrative: During my first two rounds, I noticed blurred vision. I thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong.; During my first two rounds, I noticed blurred vision. I thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong.; During my first two rounds, I noticed blurred vision. I thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Jan2021 10:00 (Lot number: EL3247) at the age of 33 years as dose 1, single and administered in arm left, administration date 17Feb2021 10:30 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DIFFERIN; CLINDAMYCIN. The following information was reported: HEADACHE (non-serious), VISION BLURRED (non-serious), DRY EYE (non-serious) all with onset 22Feb2021, outcome "recovering" and all described as "During my first two rounds, I noticed blurred vision. I thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong.". The event "during my first two rounds, i noticed blurred vision. i thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong.", "during my first two rounds, i noticed blurred vision. i thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong." and "during my first two rounds, i noticed blurred vision. i thought it was due to contacts, dry eyes, etc. and went to my eye doctor but he said nothing was wrong." was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, vision blurred, dry eye.  Additional information: Patient did not receive other vaccines in four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient took Differin, Clindamycin medications in two weeks. During her first two rounds, she noticed blurred vision. She thought it was due to contacts, dry eyes, etc. and went to her eye doctor but he said nothing was wrong. It eventually went away but seemed to take several weeks of slightly blurred vision leading to headaches. A day or two after getting her booster, she had noticed the same slight blurred vision. Post vaccination, the patient had been tested for COVID-19 (COVID test post vaccination: Nasal Swab, covid test result: Negative). The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: leg started to hurt; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (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 "leg started to hurt".  Additional information: After received the first shot of pfizer covid vaccine, his leg started to hurt.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she had a slight headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 (Lot number: EN531B) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number- EN531B, Expiration Date- UNKNOWN, Anatomical Location- may have received in left arm by injection), administration date: 04Feb2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "she had a slight headache". Additional information: Vaccination facility type was reported as Pharmacy/drug store. Patient did not receive the vaccine at a facility. Patient has diabetes, rheumatoid arthritis, and breathing issues. Patient called about the Pfizer Covid Vaccine. Stated that she has had all 3 doses. She had the booster on the 04Nov2021, last Thursday. The paper did not say this was one of the common side effects, so she wanted to know if it could still be a side effect of the vaccine. First dose, she had no side effects. Second dose, she had a slight headache for about a week. Patient received the second dose on 25Feb2021 may have received in left arm (as reported).  The adverse events did not result in the emergency room or physician office visit. She got the flu shot 34 days before the third booster dose.   No follow-up attempts are needed. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vomiting
Clinical narrative: Vomitting and chills; Vomitting and chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 7 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in leg right, administration date 10Nov2021 16:30 (Lot number: FK5127) at the age of 7 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: FOCALIN [DEXMETHYLPHENIDATE HYDROCHLORIDE]. The following information was reported: CHILLS (non-serious), VOMITING (non-serious) all with onset 11Nov2021 16:45, outcome "not recovered" and all described as "Vomitting and chills". Therapeutic measures were not taken as a result of chills, vomiting.  Additional information: Facility type vaccine was given as hospital. There was no other vaccine administration in four weeks. Other medications in two weeks reported as focalin. Patient had no covid prior vaccination or tested covid post vaccination. No known allergies were reported.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
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 23-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21May2021 (Lot number: ew0177) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21May2021, outcome "recovered" (2021), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility type vaccine was Pharmacy or Drug Store. No other vaccine was administered in four weeks. Post vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: Tired; Soreness in her inner arm; Sleepy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 (Lot number: EL8982, Expiration Date: 31May2021) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing); "Nodules on lung" (unspecified if ongoing), notes: She has had these nodules for about 3 years and they haven't grown any.; "compromised immune system" (unspecified if ongoing), notes: She clarifies she does have a compromised immune system. Concomitant medication(s) included: REPATHA taken for blood cholesterol increased, start date: 03Oct2021 (ongoing). Vaccination history included: Bnt162b2 (Dose:1, Lot: EK9231, Expiration Date: 30Apr2021, Anatomical location: Right arm), administration date: 12Jan2021, when the patient was 72 years old, for COVID-19 Immunization, reaction(s): "Arm was sore", "Slight fever". The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tired"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Soreness in her inner arm"; SOMNOLENCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sleepy".  Additional information: NDC number of COVID-19 Vaccine was unknown. It was reported that patient was calling about the booster she had. Patient was clarified that she had the two vaccines before. She explains she had side effects from all three vaccines, but usually the side effects are gone in three days. No side effects were reported and at one time she was having problems with nausea, she doesn't remember what she had going on, but her gastroenterologist gave her some medication that she takes off and on as needed. She hadn't had to take any in about 6 months when she just had a little nausea before. No additional vaccines administered on same date of the Pfizer Suspect. Patient did not visit emergency room and physician office. No prior vaccinations and no other vaccinations were reported within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 7 year-old male patient received bnt162b2 (BNT162B2), administration date 09Nov2021 09:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset 10Nov2021 03:00, outcome "recovered" (10Nov2021), described as "vomiting".  Additional information: At 3am that night woke up with one strong short episode of vomiting. Normal behavior after the shot until 3am. No other symptoms and returned to normal after vomiting once. Have 2 older sisters (9 and 11 years old). Received COVID-19 vaccine the same visit and showed no symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug intolerance, Eczema
Clinical narrative: 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) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INTOLERANCE (non-serious), outcome "recovering", described as "My system over reacts to the vaccine"; ECZEMA (non-serious), outcome "unknown", described as "Eczema flared". Therapeutic measures were taken as a result of drug intolerance. Additional information: Reporter stated that, her system overreacts to the vaccine. Patient used medication for that, and it has been worked for her. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: urinary incontinence (peed herself) while awake; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 16:00 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: Patient had covid prior vaccination. The patient's concomitant medications were not reported. The following information was reported: URINARY INCONTINENCE (non-serious) with onset 12Nov2021, outcome "unknown", described as "urinary incontinence (peed herself) while awake". Therapeutic measures were not taken as a result of urinary incontinence.  Additional information: The Lot was not available/provided to reporter at the time of report completion. The facility type vaccine was pharmacy or drug Store. Patient did not take other vaccine in four weeks.  Daughter (age 5) received first vaccine on 11Nov2021. This morning (12Nov2021) she experience urinary incontinence (peed herself) while awake. Patient did not tested Covid post vaccination. Patient had no known allergies.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he had side effect like arm pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). This consumer reported for a male patient (husband). A male patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Lot number: FG3527) 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 "he had side effect like arm pain".  Additional information (Narrative case summary and further information): Batch/lot number, number, number and Expiry Date of COVID-19 Vaccine were Unknown. Reporter stated, "Oh, I am calling this in behalf of my husband. Yes, he have a vaccine the first one, he have a vaccine on 12Nov2021, he had side effect like arm pain, you have somebody speak to me." Reporter was informed about the role of the Pfizer drug safety. Reporter stated, "I actually, I don't want to say what you say I do but he had a vaccine on my husband you want my husband name first." Patient initials: Reporter stated, "the last name, First name. "(not alphabetically spelled hence patient initial captured as Unknown). Name: Reporter stated, "My name (not alphabetically spelled hence not captured in tab), I have got the vaccine the third one the number Pfizer but I am okay, my husband not okay." LOT# of Pfizer covid-19 vaccine: Reporter stated, "The LOT number the Pfizer number you mean, Pfizer FG3527."(not appropriately clarified). Permission to probe further questions: Reporter stated, "You speak so fast. I cannot understand, can you get someone else speak with me please, I will call back." Further probing could not be done as Reporter hung up the call abruptly. Hence,limited information was available over the call.  No follow-up attempts are possible. No further information was expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Lethargy, Productive cough, Vomiting
Clinical narrative: sick; lethargic; throwing up; woke up and had some phlegm and couldn't get it up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Nov2021 (Lot number: FK52A) at the age of 5 years as dose 1 , single for covid-19 immunisation. Relevant medical history included: "Febrile seizure" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Flu vaccine. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sick"; LETHARGY (non-serious) with onset 12Nov2021, outcome "not recovered", described as "lethargic"; VOMITING (non-serious) with onset 10Nov2021, outcome "not recovered", described as "throwing up"; PRODUCTIVE COUGH (non-serious) with onset 10Nov2021, outcome "unknown", described as "woke up and had some phlegm and couldn't get it up". Therapeutic measures were not taken as a result of illness, lethargy, vomiting, productive cough.  Additional Information: Caregiver was Calling on the behalf of her son (male, 5 and half years old) who got a pediatric Pfizer Covid19 vaccine, has been feeling very lethargic, throwing up, initially he was sick on Wednesday was fine yesterday and sick again this morning. Reporter states she is calling regarding the Pediatric Covid shot, clarified that she is referring to the Pfizer pediatric Covid shot. She states that her 5-and-a-half-year-old son got his shot Monday.  On Wednesday, he had one episode where he threw up, then he was fine. Today, he woke up at pone point and threw up and was quite a bit lethargic. He has no fever. He woke up about 6:00am and he tried to eat breakfast, which did not go over very well. He is still sleeping and has been waking up and then he threw up and fell back asleep. He threw up twice Wednesday morning and they kept him home from school. Then, by lunch time, he looked like a new kid, and he went to school Thursday. It started back up this morning.  He looks worse now. She thought on Wednesday, it was just the flu. He woke up and had some phlegm and couldn't get it up. He only had a little episode in the morning, and they thought it was congestion. Treatment was no, they were going to give him some Guaifenesin, but he looked fine Wednesday and they didn't worry.  They haven't given him anything. The Vaccination Facility Type was Pharmacy/Drug Store  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: both of her biceps have been hurting; This is a spontaneous report received from a non-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 Oct2021 (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: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "both of her biceps have been hurting".  Additional Information: Patient stated that she had second Pfizer vaccine a month ago, last 5 days both biceps have been hurting. She declines to provide any contact information and a report. She wants to know what medications Pfizer recommends to treat her symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: running fevers around 104-105 beginning 8 hours/ hovering around 101-102; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 11Nov2021 15:00 (Lot number: FK5127) at the age of 5 years as dose 1, single and intramuscular, administered in arm right, administration date 02Dec2021 15:30 (Lot number: FK5127) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: MELATONIN taken for sleep disorder. The following information was reported: PYREXIA (non-serious) with onset 11Nov2021 23:00, outcome "recovered", described as "running fevers around 104-105 beginning 8 hours/ hovering around 101-102". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: No other vaccine in four weeks. Other medication in 2 weeks included Natural Sleep with Melatonin. No covid prior to vaccination and not tested for covid post vaccination. No known allergies and no other medical history. Approximately 8 hours after initial vaccine fever was marked at 104.8. Reporter gave alternating Advil (children's) plus Tylenol (children's) age-appropriate dose every 4 hours and her fever was consistently between 101-102 degree for 2days. After her second dose of the vaccine on 02Dec2021 her fever spilled to 103 degree and with the same regime her fever hovered around 100-101 degree for 24degree. No other issues noted. Spoke with her physician and was told if it goes higher to being her in. They had suggested a slightly larger dose of Advil to help combat the fever.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
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).  A 9 year-old male patient received BNT162B2, administration date Nov2021 (Batch/Lot number: unknown, Expiry date: Unknown) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Foods" (unspecified if ongoing), notes: known allergies: Foods. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  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-202101579093 same reporter/drug/event, different patient
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First two shots no reaction except sore arm was on non-prescription vitamins.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: ER2613) as dose 1, single and administered in arm left, administration date 12Apr2021 (Lot number: EW0162) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa Drugs" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; ZINC. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "First two shots no reaction except sore arm was on non-prescription vitamins.". Therapeutic measures were taken as a result of pain in extremity.  Additional Information :Prior to vaccination,the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood test, Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Have pain like I can''t move my arm, my shoulder area of my armpit, it just hurts like I can''t move/It is my arm where I got the injection/Injection site hurts; Have pain like I can''t move my arm, my shoulder area of my armpit, it just hurts like I can''t move/It is my arm where I got the injection/Injection site hurts; The pain just started all of sudden 3-4 hours later, you know the whole under the armpit; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Oct2021 (Lot number: FF2588) at the age of 57 years as dose 2, single and administration date 11Sep2021 (Lot number: FC3181) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer" (unspecified if ongoing), notes: Verbatim: Thyroid cancer; "Thyroidectomy" (unspecified if ongoing), notes: Verbatim: Thyroidectomy. Concomitant medication(s) included: SYNTHROID taken for thyroid cancer. The following information was reported: VACCINATION SITE PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 02Oct2021, outcome "unknown" and all described as "Have pain like I can''t move my arm, my shoulder area of my armpit, it just hurts like I can''t move/It is my arm where I got the injection/Injection site hurts"; AXILLARY PAIN (non-serious) with onset 02Oct2021, outcome "unknown", described as "The pain just started all of sudden 3-4 hours later, you know the whole under the armpit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: When probed for any lab result, Nurse stated, "That was follow up for my Endocrinology for, seems in every 6 months, every 3 months that I have history of thyroid cancer, I just need follow up."  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: The doctor suggested Ibuprofen and Tylenol and that helped me feel better. I am fine now; 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 received bnt162b2 (BNT162B2), administration date 10Nov2021 (Lot number: FE3592) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose of covid-19 vaccine), for Covid-19 immunization; Bnt162b2 (Second dose of Covid-19 vaccine), for Covid-19 Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 10Nov2021, outcome "recovered" (2021), described as "The doctor suggested Ibuprofen and Tylenol and that helped me feel better. I am fine now". Therapeutic measures were taken as a result of feeling abnormal. Additional information: It was stated that doctor suggested Ibuprofen and Tylenol and that helped him feel better. he is fine now."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Not feeling well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NVSC2021US235393.  A 53 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; secukinumab (COSENTYX), first regimen details not provided (Batch/Lot number: unknown) and second regimen details not provided (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Not feeling well".  Additional information: Patient had taken 2 doses of Cosentyx. She stated she had taken the 2 doses of inconsistently because she received the Covid vaccine. Her healthcare provider wanted her to wait taking her Cosentyx so she held back dose after receiving the Covid vaccine. Patient stated she was not feeling well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Lethargy, Pain in extremity
Clinical narrative: Sore arm; Very lethargic 24 hours after injection; Tired; no appetite; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Nov2021 16:15 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Food allergies" (unspecified if ongoing); "environmental allergies" (unspecified if ongoing); "egg allergy" (unspecified if ongoing); "tree nuts allergy" (unspecified if ongoing); "sesame allergy" (unspecified if ongoing); "garlic allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 06Nov2021 15:00, outcome "recovered" (2021), described as "Sore arm"; LETHARGY (non-serious) with onset 06Nov2021 15:00, outcome "recovered" (2021), described as "Very lethargic 24 hours after injection"; FATIGUE (non-serious) with onset 06Nov2021 15:00, outcome "recovered" (2021), described as "Tired"; DECREASED APPETITE (non-serious) with onset 06Nov2021 15:00, outcome "recovered" (2021), described as "no appetite". Therapeutic measures were not taken as a result of pain in extremity, lethargy, fatigue, decreased appetite.  Additional information: Patient did not receive other vaccine in four weeks and other medications in two weeks. Patient did not receive covid prior vaccination and covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Dizziness, Nausea, Vomiting
Clinical narrative: nauseous; dizzy; Threw up 3 times; could not get out of bed for 24 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Nov2021 15:30 (Lot number: FH8027) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date 01Oct2021; ALIGN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FF2590, Vaccine Administration Time: 03:30 PM), administration date: 19Oct2021, when the patient was 12 years old, for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 13Nov2021 03:00, outcome "recovering", described as "nauseous"; DIZZINESS (non-serious) with onset 13Nov2021 03:00, outcome "recovering", described as "dizzy"; VOMITING (non-serious) with onset 13Nov2021 03:00, outcome "recovering", described as "Threw up 3 times"; BEDRIDDEN (non-serious) with onset 13Nov2021 03:00, outcome "recovered" (14Nov2021), described as "could not get out of bed for 24 hours". Therapeutic measures were not taken as a result of nausea, dizziness, vomiting, bedridden.  Additional Information: Facility type vaccine was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Other medications in two weeks were OTC Accentrate. Known allergies: Not that we are aware.  No follow-up attempts are possible. No further information is expected.
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Rhinorrhoea, Vomiting
Clinical narrative: runny nose; nausea; feeling unwell; vomiting; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 10:00 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU taken for immunisation, administration date 16Oct2021; VITAMIN D [VITAMIN D NOS]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PROBIOTIC [BIFIDOBACTERIUM LACTIS].  The following information was reported: RHINORRHOEA (non-serious) with onset 14Nov2021 06:00, outcome "recovering", described as "runny nose"; NAUSEA (non-serious) with onset 14Nov2021 06:00, outcome "recovering", described as "nausea"; MALAISE (non-serious) with onset 14Nov2021 06:00, outcome "recovering", described as "feeling unwell"; VOMITING (non-serious) with onset 14Nov2021 06:00, outcome "recovering", described as "vomiting". Therapeutic measures were not taken as a result of rhinorrhoea, nausea, malaise, vomiting.  Additional information: The patient had no Known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient received other vaccine in four weeks included Flu vaccine. The patient received within 2 weeks of vaccination included vitamin D, Zyrtec, multi, probiot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Mar2021 (Lot number: ER8727) at the age of 64 years as dose 1, single and administered in arm left, administration date 12Apr2021 (Lot number: EW0153) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood Pressure high" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Coedine, reaction(s): "Known_allergies: Coedine"; Pyridium, reaction(s): "Known_allergies: Pyridium"; Sulfur, reaction(s): "Known_allergies: Sulfur". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Sore arm".  Additional information:  The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Lethargy, Vaccination site pain
Clinical narrative: Sore arm at injection site; lethargic; Decreased appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 7 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Nov2021 (Lot number: FK5618) at the age of 7 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Nov2021, outcome "recovering", described as "Sore arm at injection site"; LETHARGY (non-serious) with onset 12Nov2021, outcome "recovering", described as "lethargic"; DECREASED APPETITE (non-serious) with onset 12Nov2021, outcome "recovering", described as "Decreased appetite". Therapeutic measures were taken as a result of vaccination site pain, lethargy, decreased appetite.  Additional Information: Seriousness criteria not Results in death/Life threatening/Caused/prolonged hospitalization/Disabling/Incapacitating/Congenital anomaly/birth defect. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drugstore. 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 had not been tested for COVID-19. No covid prior vaccination was reported. Patient not tested covid post vaccination. No known allergies were reported. Treatment received for the adverse event was with motrin. Awareness Date was and device timestamp was reported as 12Nov2021.  No follow-up attempts are possible. No further information is expected.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 9 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Foods" (unspecified if ongoing), notes: known allergies: Foods. The patient's concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  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-202101577003 same reporter/drug/event, different patient
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Headache
Clinical narrative: There was also noticeable pain, like a headache behind my left eye; I had double vision when I looked up out of the top half of my eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 13:00 (Lot number: FF8839) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing), notes: Sulfa, barley; "known allergies: barley" (unspecified if ongoing), notes: Sulfa, barley. The patient's concomitant medications were not reported. Vaccination history included: Pfizer (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 26Mar2021, when the patient was 50 years old, for Covid-19 Vaccination; Pfizer (Dose Number: 1, Batch/Lot No: EN6199, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 04Mar2021, when the patient was 50 years old, for Covid-19 Vaccination. The following information was reported: DIPLOPIA (non-serious) with onset 11Oct2021 03:00, outcome "recovered" (2021), described as "I had double vision when I looked up out of the top half of my eyes"; HEADACHE (non-serious) with onset 11Oct2021 13:00, outcome "recovered" (2021), described as "There was also noticeable pain, like a headache behind my left eye". The events "i had double vision when i looked up out of the top half of my eyes" and "there was also noticeable pain, like a headache behind my left eye" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of diplopia, headache.  Additional information: Beginning 2.5 days after the booster shot, she had double vision when she looked up out of the top half of her eyes. The images were one on top of the other. There was also noticeable pain, like a headache behind my left eye. The double vision finally went away after about 4.5 weeks. She had gone in to her eye doctor twice and found no abnormalities to explain her double vision. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient did not receive any other vaccines within 4 weeks and received other unspecified medications within 2 weeks to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced sharp pain bottom ocher foot same side of vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered" (2021), described as "experienced sharp pain bottom ocher foot same side of vaccine".  Additional information: Patient experienced sharp pain bottom ocher foot same side of vaccine after a few hours of taking vaccine lasted less 24 hours nothing since. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.