chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after the Pfizer Covid Vaccines; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm after the Pfizer Covid Vaccines".  Additional information: Reporter stated that he works in an emergency room and a couple of patients had raised this concern. States he already called the CDC, and they gave him the numbers to call for Pfizer and Moderna. Reporter stated that he has had a couple of people with the alpha-gal reaction to a tick bite, which is where they develop a reaction to the dextrose molecule that gets injected and then when they eat red meat, they become anaphylactic per the caller. Reporter stated that he has heard from a few of them that they read on the internet that if you have the alpha-gal reaction and you get the Covid 19 Vaccine you will develop anaphylaxis and die. Reporter stated that the CDC told him they have no information on this, and no one has reported such a reaction. Reporter stated the CDC said they recommend taking the vaccine. Reporter stated he is just trying to find out more information on this, since he has been asked about it more than once. Caller verifies that no patients have received the Covid Vaccine and then had this reaction that he is aware of; they are just worried it could happen since they heard about it on the internet. Reporter stated that he is an advocate for the Pfizer vaccine. Stated that he had both doses of the Pfizer Covid Vaccine himself and then had the Moderna Vaccine for his booster dose. Reporter stated that with the Pfizer vaccines he had no issues, just a sore arm. Caller says the Moderna is the one that kicked his butt and had him sick as hell. Stated that he always tries to push people who ask him about the vaccines towards getting the Pfizer Covid Vaccine. Reporter stated that a sore arm is normal with any vaccine. Says the Moderna he had a 102-degree fever and felt like he had a bad flu. Reporter stated that as a Registered nurse in the emergency room the patient's often look to him for information and guidance more so than the doctors; he is just trying to do some research for this question.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: My lymph nodes enlarged and didn't go down for many weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 03Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "recovered" (2021), described as "My lymph nodes enlarged and didn't go down for many weeks".  Additional Information: Patient received her 1st vaccine for Covid 03Aug2021. Her lymph nodes enlarged and didn't go down for many weeks so I never received my second shot. It is over the 42 days so should I start over again or get the second shot? When should I attempt this again? I'm so confused and nervous. Patient have issues with my lymph nodes going up and down for about 10 months now and doctors are not sure why. The vaccine made them go up for months but seems to going down a bit now. Any suggestions are appreciated. No, other important information available.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Blood pressure measurement, Hypertension, SARS-CoV-2 test
Clinical narrative: his blood pressure is too high / his blood pressure spiked up; loss of sense of taste and smell; loss of sense of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "lost taste and smell" (unspecified if ongoing), notes: nearly a year and a half ago, then it back at 5% at the most; "lost taste and smell" (unspecified if ongoing), notes: he also lost taste and smell, that was nearly a year and a half ago, then after this it came out and his sense of taste and smell was back at 5% at the most. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose was last April, Dates for Pfizer COVID-19 vaccine: (Start: Apr2021 Stop: Unspecified)), administration date: Apr2021, for COVID-19 immunisation. The following information was reported: HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "his blood pressure is too high / his blood pressure spiked up"; AGEUSIA (non-serious), ANOSMIA (non-serious) all with onset 2021, outcome "unknown" and all described as "loss of sense of taste and smell". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient reported his age to be above 50 and he could not receive booster dose as his blood pressure was too high. He said he also lost taste and smell, that was nearly a year and a half ago, then after this it came out and his sense of taste and smell was back at 5% at the most. He says there was a chance he had COVID to lose sense of taste and smell, for it to come back, but he was tested 6 times with negatives. He got the Pfizer COVID-19 vaccine back in April, then got his second in May. He said his blood pressure had been getting worse, he wondered if getting the booster shot had to do with it. He said if he had COVID-19 it could have had to do with it, but he had bad health and wouldn't have known it. He said his blood pressure has gotten lower, it is 94-95 most of the time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: tiredness; headache; muscle pain; chills; joint pain; fever; diarrhea; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Nov2021 13:15 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medications included: acetylsalicylic acid (ASPIRIN); levothyroxine sodium (LEVOTHYROXIN); simvastatin (SIMVASTAT); ascorbic acid; ergocalciferol; nicotinamide; retinol; riboflavin; thiamine hydrochloride (VITAMINS). The following information was reported: FATIGUE (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "tiredness"; HEADACHE (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "headache"; MYALGIA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "muscle pain"; CHILLS (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "chills"; ARTHRALGIA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "joint pain"; PYREXIA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "fever"; DIARRHOEA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "diarrhea". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, chills, arthralgia, pyrexia, diarrhoea.  Additional Information: The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: tiredness; headache; muscle pain; chills; joint pain; fever; diarrhea; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Nov2021 13:15 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medications included: acetylsalicylic acid (ASPIRIN); levothyroxine sodium (LEVOTHYROXIN); simvastatin (SIMVASTAT); ascorbic acid; ergocalciferol; nicotinamide; retinol; riboflavin; thiamine hydrochloride (VITAMINS). The following information was reported: FATIGUE (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "tiredness"; HEADACHE (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "headache"; MYALGIA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "muscle pain"; CHILLS (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "chills"; ARTHRALGIA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "joint pain"; PYREXIA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "fever"; DIARRHOEA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "diarrhea". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, chills, arthralgia, pyrexia, diarrhoea.  Additional Information: The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Product administered to patient of inappropriate age
Clinical narrative: he is 5 years old; Having little chills; 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 male patient received bnt162b2 (BNT162B2), administration date 10Nov2021 (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: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 10Nov2021, outcome "unknown", described as "he is 5 years old"; CHILLS (non-serious) with onset 10Nov2021, outcome "unknown", described as "Having little chills".  Additional Information: my son is having little chills and he is sleeping.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Vaccination site erythema
Clinical narrative: Clarified that he is referring to the booster for the Pfizer Covid-19 vaccine.; sore arm; redness on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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 (dose 1), for COVID-19 immunisation; Bnt162b2 (dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Clarified that he is referring to the booster for the Pfizer Covid-19 vaccine."; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "redness on the injection site". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: Extreme headache for a day after the 2nd vaccine.Chronic headaches for 8 months following second vaccine, still occurring.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 (Lot number: Em6198) at the age of 25 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Past drug history included: No, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Em9810, Location of injection: Arm Left), administration date: 04Feb2021, when the patient was 24 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Extreme headache for a day after the 2nd vaccine.Chronic headaches for 8 months following second vaccine, still occurring.". The event "extreme headache for a day after the 2nd vaccine.chronic headaches for 8 months following second vaccine, still occurring." 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:Prior vaccinations within 4 weeks and other medications within 2 weeks were reported as none. Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination patient has been tested for COVID-19. The patient had no known allergies. Extreme headache for a day after the 2nd vaccine. Chronic headaches for 8 months following second vaccine, still occurring. Device Date: 13Nov2021  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Headache, Immunisation, Pain in extremity
Clinical narrative: I have side effects; it was pain in the back of my head closer to the neck behind my right ear; Needle in the right arm; had the needle in the right arm, in the shoulder in the right arm; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101587242 (Pfizer).  A 71-year-old female patient received bnt162b2 (BNT162B2), administration date 28Oct2021 (Lot number: 301258A) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization, reaction(s): "No reaction on previous exposure to vaccine"; Bnt162b2 (2nd Dose), for COVID-19 immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: IMMUNISATION (non-serious) with onset 28Oct2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 15Nov2021, outcome "unknown", described as "I have side effects; it was pain in the back of my head closer to the neck behind my right ear"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2021, outcome "unknown", described as "Needle in the right arm"; ARTHRALGIA (non-serious) with onset 15Nov2021, outcome "unknown", described as "had the needle in the right arm, in the shoulder in the right arm". The events "i have side effects; it was pain in the back of my head closer to the neck behind my right ear", "needle in the right arm" and "had the needle in the right arm, in the shoulder in the right arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any prior vaccinations. Lab Test: blood work, X-ray and Urine test and that was for rheumatology (Further clarifications unknown). Treatment: Consumer stated that she went to a doctor, and he said use something cold on head that was it (Further not clarified). Vaccination facility was a food store.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, X-ray
Clinical narrative: I have side effects; it was pain in the back of my head closer to the neck behind my right ear; Needle in the right arm; had the needle in the right arm, in the shoulder in the right arm; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101587242 (Pfizer).  A 71-year-old female patient received bnt162b2 (BNT162B2), administration date 28Oct2021 (Lot number: 301258A) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization, reaction(s): "No reaction on previous exposure to vaccine"; Bnt162b2 (2nd Dose), for COVID-19 immunization, reaction(s): "No reaction on previous exposure to vaccine". The following information was reported: IMMUNISATION (non-serious) with onset 28Oct2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 15Nov2021, outcome "unknown", described as "I have side effects; it was pain in the back of my head closer to the neck behind my right ear"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2021, outcome "unknown", described as "Needle in the right arm"; ARTHRALGIA (non-serious) with onset 15Nov2021, outcome "unknown", described as "had the needle in the right arm, in the shoulder in the right arm". The events "i have side effects; it was pain in the back of my head closer to the neck behind my right ear", "needle in the right arm" and "had the needle in the right arm, in the shoulder in the right arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient did not receive any prior vaccinations. Lab Test: blood work, X-ray and Urine test and that was for rheumatology (Further clarifications unknown). Treatment: Consumer stated that she went to a doctor, and he said use something cold on head that was it (Further not clarified). Vaccination facility was a food store.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Asthenia, Dizziness, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: She states that she originally had a J & J shot and was told that she could have the Pfizer booster, she preferred to have the Pfizer booster; She states that she originally had a J & J shot and was told that she could have the Pfizer booster, she preferred to have the Pfizer booster; received the Pfizer covid vaccine booster 05Nov2021; Weakness; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 05Nov2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation; cortisone (CORTISONE), since 15Nov2021 (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J&j covid-19 vaccine (Dose 2), for COVID-19 immunization; J&j covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "She states that she originally had a J & J shot and was told that she could have the Pfizer booster, she preferred to have the Pfizer booster"; IMMUNISATION (non-serious) with onset 05Nov2021, outcome "unknown", described as "received the Pfizer covid vaccine booster 05Nov2021"; ASTHENIA (non-serious) with onset Nov2021, outcome "unknown", described as "Weakness"; DIZZINESS (non-serious) with onset Nov2021, outcome "unknown", described as "Dizziness". The action taken for cortisone was unknown. Additional Information: The caller received her booster shot 5Nov2021 and had a few side effects from the shot, including dizziness and weakness. 10 days after she had the booster shot, she went to her knee doctor, because she has knee problems, and he gave her a cortisone shot. She had the same type of symptoms. She was wondering if the Cortisone and the booster shot were similar. The caller has been referring to the Pfizer booster shot. She states that she originally had a J & J shot and was told that she could have the Pfizer booster, she preferred to have the Pfizer booster. Clarified that she was referring to the Pfizer Covid booster shot.  The lot number for bnt162b2 was not provided and will be requested during follow up. .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: had a sore arm / her arm hurt worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administration date 14Feb2021 (Lot number: EL9266) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "had a sore arm / her arm hurt worse". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia
Clinical narrative: Stomach cramps; I have not energy to do anything/feels weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 09Nov2021 (Lot number: FD7220) at the age of 55 years as dose 2, single (time the vaccination was given: little before or after 7:00am) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose, Lot Number / Expiry Date: FF8841, Route, Anatomical Location: Left arm, First dose: had a cold), administration date: 19Oct2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "had a cold", "stomach pain", "arm was sore too, couldn't hardly lift it", "hoarse, couldn't hardly talk", "couldn't hardly talk". The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset Nov2021, outcome "not recovered", described as "Stomach cramps"; ASTHENIA (non-serious) with onset Nov2021, outcome "unknown", described as "I have not energy to do anything/feels weak".  Additional information: Patients details included height: 5'6 or 5'7, weight: 240 something. Patient did not received any other vaccine within 4 weeks before the vaccination. Since she took the second vaccine, she keeps having stomach cramps and she was not having stomach cramps in 8 years. The patient stated that she was trying to get an appoint but her stomach keeps nagging her and she was drained. The events did not require any emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Immunisation, Myalgia, Pain, Pain in extremity
Clinical narrative: Pain at injection site; Sore arm; Slight body aches; muscle aches; Chills; Booster; 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 (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 13:30 (Lot number: FH8028) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Many fruits" (unspecified if ongoing), notes: Known allergies: Many fruits (e.g., apples, pears, cherries). Concomitant medication(s) included: ALPRAZOLAM; SUMATRIPTAN. Vaccination history included: Bnt162b2 (Dose number: 1, Prev dose Product: COVID 19, Prev dose Brand: Pfizer-BioNTech, Prev dose Lot number: EL3248, Prev dose Administration date: 03Mar2021, Prev dose administrator route: Intramuscular), administration date: 03Mar2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose number: 2, Prev dose Product: COVID 19, Prev dose Brand: Pfizer-BioNTech, Prev dose Lot number: EL3248, Prev dose Administration date: 23Mar2021, Prev dose administrator route: Intramuscular), administration date: 23Mar2021, when the patient was 38 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021 05:00, outcome "recovered" (18Nov2021), described as "Pain at injection site"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 05:00, outcome "recovered" (18Nov2021), described as "Sore arm"; PAIN (non-serious) with onset 17Nov2021 05:00, outcome "recovering", described as "Slight body aches"; MYALGIA (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "muscle aches"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Chills". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, pain, myalgia, chills.  Additional information: Patient had no illness at time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 and since the vaccination, patient had not been tested for COVID-19. The events did not result in hospitalization or any other seriousness criteria. Morning after receiving shot, wake up with the reported events, they lasted about 1 day and then fully recovered. No longing effects. No relevant tests were performed with respect to the events.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; Sore arm; Slight body aches; muscle aches; Chills; Booster; 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 (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Nov2021 13:30 (Lot number: FH8028) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Many fruits" (unspecified if ongoing), notes: Known allergies: Many fruits (e.g., apples, pears, cherries). Concomitant medication(s) included: ALPRAZOLAM; SUMATRIPTAN. Vaccination history included: Bnt162b2 (Dose number: 1, Prev dose Product: COVID 19, Prev dose Brand: Pfizer-BioNTech, Prev dose Lot number: EL3248, Prev dose Administration date: 03Mar2021, Prev dose administrator route: Intramuscular), administration date: 03Mar2021, when the patient was 38 years old, for COVID-19 Immunization; Bnt162b2 (Dose number: 2, Prev dose Product: COVID 19, Prev dose Brand: Pfizer-BioNTech, Prev dose Lot number: EL3248, Prev dose Administration date: 23Mar2021, Prev dose administrator route: Intramuscular), administration date: 23Mar2021, when the patient was 38 years old, for COVID-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious) with onset 17Nov2021 05:00, outcome "recovered" (18Nov2021), described as "Pain at injection site"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 05:00, outcome "recovered" (18Nov2021), described as "Sore arm"; PAIN (non-serious) with onset 17Nov2021 05:00, outcome "recovering", described as "Slight body aches"; MYALGIA (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "muscle aches"; CHILLS (non-serious) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Chills". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, pain, myalgia, chills.  Additional information: Patient had no illness at time of vaccination. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19 and since the vaccination, patient had not been tested for COVID-19. The events did not result in hospitalization or any other seriousness criteria. Morning after receiving shot, wake up with the reported events, they lasted about 1 day and then fully recovered. No longing effects. No relevant tests were performed with respect to the events.  Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pain, Somnolence
Clinical narrative: Dose 1 / Dose 2 Moderna; Dose 1 / Dose 2 Moderna; Booster; sleepy (slept from 11:30 pm on 16th to 2:00 pm on 17th; body is so achy, like not just arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 22 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: Moderna (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 09Feb2021, when the patient was 21 years old, for Covid-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 12Jan2021, when the patient was 21 years old, for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 16Nov2021, outcome "unknown" and all described as "Dose 1 / Dose 2 Moderna"; IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster"; SOMNOLENCE (non-serious) with onset 16Nov2021, outcome "recovering", described as "sleepy (slept from 11:30 pm on 16th to 2:00 pm on 17th"; PAIN (non-serious) with onset 16Nov2021, outcome "recovering", described as "body is so achy, like not just arms". Therapeutic measures were not taken as a result of somnolence, pain.  Additional Information: Patient was sleepy (slept from 11:30 pm on 16th to 2:00 pm on 17th body was so achy, like not just arms). Prior to vaccination, patient was not diagnosed with COVID-19. The patient was not COVID tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Off label use, Pain, Pain in extremity, Product use issue
Clinical narrative: patient received pfizer covid-19 dose 3 on 17Nov2021 and FLU vaccine also on 17Nov2021; patient received pfizer covid-19 dose 3 on 17Nov2021 and FLU vaccine also on 17Nov2021; dose number 3; Very sore arm; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Nov2021 (Lot number: FF8841) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm left, administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer,, Previous dose brand unknown: False,, Previous dose lot number: EP-6955,, Previous dose lot unknown: False,, Previous dose administrator route: Intramuscular, Previous dose administration date: 01Apr2021, Previous dose number: 2, Previous dose Vaccine location: Left arm), administration date: 01Apr2021, when the patient was 41 years old, for Covid-19 immunization; Bnt162b2 (Previous dose details:, Previous dose Product: COVID 19,, Previous dose brand=Pfizer,, Previous dose brand unknown: False,, Previous dose lot number: EL3247,, Previous dose lot unknown: False,, Previous dose administrator route: Intramuscular, Previous dose administration date: 11Mar2021, Previous dose number: 1, Previous dose Vaccine location: Left arm), administration date: 11Mar2021, when the patient was 41 years old, for Covid-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "dose number 3"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "recovered", described as "Very sore arm"; PAIN (non-serious) with onset 17Nov2021, outcome "recovered", described as "Body aches"; PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 17Nov2021, outcome "unknown" and all described as "patient received pfizer covid-19 dose 3 on 17Nov2021 and FLU vaccine also on 17Nov2021". Therapeutic measures were not taken as a result of pain in extremity, pain.  Additional information: Facility type vaccine: Workplace clinic. Other vaccine in four weeks: No. It was reported that patient had no COVID prior vaccination nor been tested for COVID post vaccination. Known allergies, other medical history: NA.  Follow-Up (24Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Pain in extremity, Vaccination site joint movement impairment
Clinical narrative: underarm/lymph nodes became swollen; lifting arm was painful; same as injection arm. On day 2 after the injection, the lymph nodes were so swollen that lifting arm was painful.; 3rd Dose/booster of Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 18:15 (Lot number: FG3527) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ew0153, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 28Apr2021, when the patient was 32 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Right, Vaccine Administration Time: 01:00 PM), administration date: 07Apr2021, when the patient was 32 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021 18:15, outcome "unknown", described as "3rd Dose/booster of Pfizer covid vaccine"; LYMPHADENOPATHY (non-serious) with onset 17Nov2021 12:00, outcome "not recovered", described as "underarm/lymph nodes became swollen"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 12:00, outcome "recovering", described as "lifting arm was painful"; VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious) with onset 17Nov2021 12:00, outcome "recovering", described as "same as injection arm. On day 2 after the injection, the lymph nodes were so swollen that lifting arm was painful.". Therapeutic measures were not taken as a result of lymphadenopathy, pain in extremity.  Additional information: Other vaccine same date product: none. Facility type vaccine: Pharmacy or Drug Store. Patient received no other vaccine in four weeks. No COVID prior vaccination, no COVID tested post vaccination. Known allergies: None.  Follow-Up (25Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Influenza like illness, Pain, Vaccination site pain
Clinical narrative: Pain at injection site; flu like symptoms; body ache; headache; Dose number= 3; This is a spontaneous report received from a contactable Consumer or other non-HCP. The reporter is the patient.  A 48-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Nov2021 10:30 (Lot number: EWW0196) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPITOR. Vaccination history included: Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose Lot number= #EL3247, Previous dose administrator route: Intramuscular, Previous dose Dose number= 1, Previous dose vaccine location= left arm), administration date: 24Feb2021, when the patient was 48 years old, for COVID-19 Immunization; Bnt162b2 (Previous dose Product= Covid 19, Previous dose brand= Pfizer, Previous dose Lot number= #EL3247, Previous dose administrator route: Intramuscular, Previous dose Dose number= 2, Previous dose vaccine location= left arm), administration date: 17Mar2021, when the patient was 48 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 10:30, outcome "unknown", described as "Dose number= 3"; VACCINATION SITE PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Pain at injection site"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021, outcome "not recovered", described as "flu like symptoms"; PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "body ache"; HEADACHE (non-serious) with onset 19Nov2021, outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of vaccination site pain, influenza like illness, pain, headache.  Additional information: No other vaccine administered in four weeks. No known allergies reported for the patient. The patient had not diagnosed with covid prior vaccination. And post vaccination, patient had not tested with covid.   Follow-up attempts are completed. No further information is expected.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Pain, Pain in extremity, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased
Clinical narrative: Severe leg pain; body pain; He had elevated sendimentation rate via blood work; Prevented our son from being able to walk properly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Nov2021 12:30 (Lot number: FK5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TENEX. Past drug history included: Known allergies: amoxicillin, reaction(s): "Drug allergy", notes: Known allergies: Amoxicillin. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Nov2021 21:00, outcome "not recovered", described as "Severe leg pain"; PAIN (non-serious) with onset 14Nov2021 21:00, outcome "not recovered", described as "body pain"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious) with onset 14Nov2021 21:00, outcome "not recovered", described as "He had elevated sendimentation rate via blood work"; GAIT DISTURBANCE (non-serious) with onset 14Nov2021 21:00, outcome "not recovered", described as "Prevented our son from being able to walk properly". The events "severe leg pain", "body pain", "he had elevated sendimentation rate via blood work" and "prevented our son from being able to walk properly" were 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 pain in extremity. Therapeutic measures were not taken as a result of pain, red blood cell sedimentation rate increased, gait disturbance.  Additional Information: Prior to vaccination patient was not diagnosed with COVID-19 and since the vaccination patient has not been tested for COVID-19. Severe leg pain that has lasted over 4 days that has prevented our son from being able to walk properly- he could not go to school, have a backpack etc. due to his body pain. He had elevated sedimentation rate via blood work taken by his Pediatrician. Leg pain still not resolved. Taking both Motrin and Tylenol and still no improvement. Device Date : 19Nov2021  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Arthralgia, Chills, Fatigue
Clinical narrative: experienced most of these same symptoms after being inoculated three times with your vaccine; experienced most of these same symptoms after being inoculated three times with your vaccine; Debilitating fatigue; Extreme chills; Headaches; Joint pain; Loss of taste and smell; Loss of taste and smell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Contracted covid", start date: Dec2020 (unspecified if ongoing), notes: contracted covid last December. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, Debilitating fatigue), for Covid-19 immunization, reaction(s): "Debilitating fatigue"; Bnt162b2 (DOSE: 1, Extreme chills), for Covid-19 immunization, reaction(s): "Extreme chills"; Bnt162b2 (DOSE: 1, Headaches), for Covid-19 immunization, reaction(s): "Headaches"; Bnt162b2 (DOSE: 1), for Covid-19 immunization, reaction(s): "Joint pain"; Bnt162b2 (DOSE: 1, Loss of taste and smell for 3 weeks), for Covid-19 immunization, reaction(s): "Loss of taste and smell", "Loss of taste and smell"; Bnt162b2 (DOSE: 2, Debilitating fatigue), for Covid-19 immunization, reaction(s): "Debilitating fatigue"; Bnt162b2 (DOSE: 2, Extreme chills), for Covid-19 immunization, reaction(s): "Extreme chills"; Bnt162b2 (DOSE: 2, Headaches), for Covid-19 immunization, reaction(s): "Headaches"; Bnt162b2 (DOSE: 2), for Covid-19 immunization, reaction(s): "Joint pain"; Bnt162b2 (DOSE: 2, Loss of taste and smell for 3 weeks), for Covid-19 immunization, reaction(s): "Loss of taste and smell", "Loss of taste and smell". The following information was reported: IMMUNISATION (non-serious), OFF LABEL USE (non-serious), outcome "unknown" and all described as "experienced most of these same symptoms after being inoculated three times with your vaccine"; FATIGUE (non-serious), outcome "unknown", described as "Debilitating fatigue"; CHILLS (non-serious), outcome "unknown", described as "Extreme chills"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Loss of taste and smell".  Additional information: patient who, having contracted Covid last December and experienced symptoms of debilitating fatigue, extreme chills, headaches, joint pain, loss of taste and smell for 3 weeks, has experienced most of these same symptoms after being inoculated three times with your vaccine. Each time I have gotten the vaccine, the side effects have gotten worse. I hate to think that if I have to get a booster twice a year, I will have to experience more severe side effects.   The lot number for bnt162b2 was not provided and will be requested during follow up.