chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Headache, Insomnia
Clinical narrative: Hips and knees pain; knees pain; muscle pain; joint pain; muscle twitching; headaches; stiffness; Body aches; fever; no enery  for 3days; Insomnia; Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administration date 17Apr2021 (Lot number: ER8731) 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:1st, Site and Route of injection:, Route of administration: Intramuscular, Batch/Lot number: ER8730), administration date: 28Mar2021, for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "muscle twitching"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "stiffness"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body aches"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "no enery  for 3days"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "Insomnia"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown", described as "Tachycardia"; ARTHRALGIA (non-serious) with onset Jul2021, outcome "unknown", described as "Hips and knees pain"; ARTHRALGIA (non-serious) with onset Jul2021, outcome "unknown", described as "knees pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was all healthy prior to covid vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Muscle twitching, Musculoskeletal stiffness, Myalgia, Pain, Pyrexia
Clinical narrative: Hips and knees pain; knees pain; muscle pain; joint pain; muscle twitching; headaches; stiffness; Body aches; fever; no enery  for 3days; Insomnia; Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administration date 17Apr2021 (Lot number: ER8731) 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:1st, Site and Route of injection:, Route of administration: Intramuscular, Batch/Lot number: ER8730), administration date: 28Mar2021, for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "muscle twitching"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "stiffness"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body aches"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "no enery  for 3days"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "Insomnia"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown", described as "Tachycardia"; ARTHRALGIA (non-serious) with onset Jul2021, outcome "unknown", described as "Hips and knees pain"; ARTHRALGIA (non-serious) with onset Jul2021, outcome "unknown", described as "knees pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was all healthy prior to covid vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Hips and knees pain; knees pain; muscle pain; joint pain; muscle twitching; headaches; stiffness; Body aches; fever; no enery  for 3days; Insomnia; Tachycardia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), intramuscular, administration date 17Apr2021 (Lot number: ER8731) 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:1st, Site and Route of injection:, Route of administration: Intramuscular, Batch/Lot number: ER8730), administration date: 28Mar2021, for COVID-19 Immunization. The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "muscle pain"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "unknown", described as "muscle twitching"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "stiffness"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Body aches"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "no enery  for 3days"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "Insomnia"; TACHYCARDIA (non-serious) with onset 2021, outcome "unknown", described as "Tachycardia"; ARTHRALGIA (non-serious) with onset Jul2021, outcome "unknown", described as "Hips and knees pain"; ARTHRALGIA (non-serious) with onset Jul2021, outcome "unknown", described as "knees pain". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient was all healthy prior to covid vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Sweating; Numbing of arms and legs; Rapid heart beat; Trouble breathing.; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 13Mar2022 at 17:00 (Lot number: FJ9943) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication included: FISH OIL.  The following information was reported: HYPERHIDROSIS (non-serious) with onset 13Mar2022 at 17:00, outcome "recovered with sequelae" (an unknown date in Mar2022), described as "Sweating"; HYPOAESTHESIA (non-serious) with onset 13Mar2022 at 17:00, outcome "recovered with sequelae" (an unknown date in Mar2022), described as "Numbing of arms and legs"; HEART RATE INCREASED (non-serious) with onset 13Mar2022 at 17:00, outcome "recovered with sequelae" (an unknown date in Mar2022), described as "Rapid heart beat"; DYSPNOEA (non-serious) with onset 13Mar2022 at 17:00, outcome "recovered with sequelae" (an unknown date in Mar2022), described as "Trouble breathing". The events "Sweating", "Numbing of arms and legs", "Rapid heart beat" and "Trouble breathing" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hyperhidrosis, hypoaesthesia, heart rate increased and dyspnoea.  Additional Information: It was reported that the patient didn't take any medications to know about allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Treatment taken as a result of the reported events included 50mg Benadryl. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Hyperhidrosis, Hypoaesthesia
Clinical narrative: Sweating; Numbing of arms and legs; Rapid heart beat; Trouble breathing.; This is a spontaneous report from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 13Mar2022 at 17:00 (Lot number: FJ9943) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication included: FISH OIL.  The following information was reported: HYPERHIDROSIS (non-serious) with onset 13Mar2022 at 17:00, outcome "recovered with sequelae" (an unknown date in Mar2022), described as "Sweating"; HYPOAESTHESIA (non-serious) with onset 13Mar2022 at 17:00, outcome "recovered with sequelae" (an unknown date in Mar2022), described as "Numbing of arms and legs"; HEART RATE INCREASED (non-serious) with onset 13Mar2022 at 17:00, outcome "recovered with sequelae" (an unknown date in Mar2022), described as "Rapid heart beat"; DYSPNOEA (non-serious) with onset 13Mar2022 at 17:00, outcome "recovered with sequelae" (an unknown date in Mar2022), described as "Trouble breathing". The events "Sweating", "Numbing of arms and legs", "Rapid heart beat" and "Trouble breathing" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of hyperhidrosis, hypoaesthesia, heart rate increased and dyspnoea.  Additional Information: It was reported that the patient didn't take any medications to know about allergies. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Treatment taken as a result of the reported events included 50mg Benadryl. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 0.25
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5, RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; Patient was administered ROTATEQ when Patient was 15 Weeks, 5 Days Old on 02/14/2022.; This spontaneous report was received from a registered nurse and refers to a 15-week-old patient of unspecified gender. Concomitant medications, concurrent conditions and medical history were not reported.  On 14-FEB-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered orally (strength, dose, frequency, lot # and expiration date were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse events reported (no adverse event).
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in the ears .. Comes and goes. Never had it before ever,  but now it is constant and unpredictable; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 10:00 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev_dose_product=COVID 19,, prev_dose_brand=pfizer biotech,, prev_dose_brand_unknown=False,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, prev_dose_administration_date=18May2021,, prev_dose_administration_time=03:00, PM, prev_dose_dose_number=1,, prev_dose_vaccine_location=Left arm), administration date: 18May2021, when the patient was 16 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Oct2021, outcome "not recovered", described as "Ringing in the ears .. Comes and goes. Never had it before ever, but now it is constant and unpredictable". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. Additional information: No other vaccine in four weeks.No other medications in two weeks. No covid prior vaccination. No known allergies and No medical history  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Ringing in the ears .. Comes and goes. Never had it before ever,  but now it is constant and unpredictable; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jun2021 10:00 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev_dose_product=COVID 19,, prev_dose_brand=pfizer biotech,, prev_dose_brand_unknown=False,, prev_dose_lot_unknown=True,, prev_dose_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, prev_dose_administration_date=18May2021,, prev_dose_administration_time=03:00, PM, prev_dose_dose_number=1,, prev_dose_vaccine_location=Left arm), administration date: 18May2021, when the patient was 16 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Oct2021, outcome "not recovered", described as "Ringing in the ears .. Comes and goes. Never had it before ever, but now it is constant and unpredictable". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus. Additional information: No other vaccine in four weeks.No other medications in two weeks. No covid prior vaccination. No known allergies and No medical history  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Lymphadenopathy, Wrong product administered
Clinical narrative: accidentally administered 0.1cc of the Pfizer Covid Vaccine (grey cap) intradermally.; Instead of grabbing a TB solution to do a TB Skin test, he grabbed a Pfizer vaccine and gave 0.1 cc intradermally; She has redness at site, but it is not warm to the touch; axillary swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 20 year-old female patient received bnt162b2 (BNT162B2), intradermal, administered in arm left, administration date 21Mar2022 13:10 (Lot number: FK9729, Expiration Date: 31May2022) at the age of 20 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: J&j vaccine (She had J&J Vaccine previously.), for COVID-19 Immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Mar2022 13:10, outcome "unknown", described as "accidentally administered 0.1cc of the Pfizer Covid Vaccine (grey cap) intradermally."; WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Mar2022 13:10, outcome "unknown", described as "Instead of grabbing a TB solution to do a TB Skin test, he grabbed a Pfizer vaccine and gave 0.1 cc intradermally"; VACCINATION SITE ERYTHEMA (non-serious) with onset Mar2022, outcome "unknown", described as "She has redness at site, but it is not warm to the touch"; SWELLING (non-serious) with onset Mar2022, outcome "unknown", described as "axillary swelling".  Additional information: Investigations: No. History of all previous immunization with the Pfizer vaccine considered as suspect: none. AE did not require to visit Emergency Room and Physician Office. Prior Vaccinations within 4 weeks: none. AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): unknown. Relevant Tests: None  No follow-up attempts are possible. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect route of product administration, Swelling, Vaccination site erythema, Wrong product administered
Clinical narrative: accidentally administered 0.1cc of the Pfizer Covid Vaccine (grey cap) intradermally.; Instead of grabbing a TB solution to do a TB Skin test, he grabbed a Pfizer vaccine and gave 0.1 cc intradermally; She has redness at site, but it is not warm to the touch; axillary swelling; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 20 year-old female patient received bnt162b2 (BNT162B2), intradermal, administered in arm left, administration date 21Mar2022 13:10 (Lot number: FK9729, Expiration Date: 31May2022) at the age of 20 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: J&j vaccine (She had J&J Vaccine previously.), for COVID-19 Immunization. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Mar2022 13:10, outcome "unknown", described as "accidentally administered 0.1cc of the Pfizer Covid Vaccine (grey cap) intradermally."; WRONG PRODUCT ADMINISTERED (non-serious) with onset 21Mar2022 13:10, outcome "unknown", described as "Instead of grabbing a TB solution to do a TB Skin test, he grabbed a Pfizer vaccine and gave 0.1 cc intradermally"; VACCINATION SITE ERYTHEMA (non-serious) with onset Mar2022, outcome "unknown", described as "She has redness at site, but it is not warm to the touch"; SWELLING (non-serious) with onset Mar2022, outcome "unknown", described as "axillary swelling".  Additional information: Investigations: No. History of all previous immunization with the Pfizer vaccine considered as suspect: none. AE did not require to visit Emergency Room and Physician Office. Prior Vaccinations within 4 weeks: none. AE(s) following prior vaccinations: None. Family Medical History Relevant to AE(s): unknown. Relevant Tests: None  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia, Alopecia areata, Injection
Clinical narrative: Alopecia Areata; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: ALOPECIA AREATA (non-serious), outcome "not recovered", described as "Alopecia Areata". Therapeutic measures were taken as a result of alopecia areata.  Additional Information: The patient reported that "I am contacting you because I am interested in the studies regarding your Covid vaccine and Alopecia. I am currently suffering with Alopecia Areata. My symptoms presented after receiving the booster and I would like to inquire about being included in any studies and to ask if there are any other treatments available if I am not responding to traditional methods. Thank you and I appreciate any further information you may have regarding the above."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Alopecia areata
Clinical narrative: Alopecia Areata; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number Unknown, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: ALOPECIA AREATA (non-serious), outcome "not recovered", described as "Alopecia Areata". Therapeutic measures were taken as a result of alopecia areata.  Additional Information: The patient reported that "I am contacting you because I am interested in the studies regarding your Covid vaccine and Alopecia. I am currently suffering with Alopecia Areata. My symptoms presented after receiving the booster and I would like to inquire about being included in any studies and to ask if there are any other treatments available if I am not responding to traditional methods. Thank you and I appreciate any further information you may have regarding the above."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Herpes zoster, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; Shingles; hypochondriac; 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 79 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "deaf" (ongoing), notes: The caller is deaf too. Concomitant medication(s) included: LISINOPRIL; VIT D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (Dose 1), administration date: 30Apr2021, when the patient was 79 years old, for COVID-19 immunization, reaction(s): "tingling in her face, hands and feet, primarily on the left side."; Shingles vaccine (The caller got the shingles vaccine 10-12 years ago), for Immunization. The following information was reported: PARAESTHESIA (non-serious), DISEASE PROGRESSION (non-serious), PARAESTHESIA (non-serious), outcome "not recovered" and all described as "tingling in her face, hands and feet, primarily on the left side./these symptoms became worse"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles"; ILLNESS ANXIETY DISORDER (non-serious) with onset May2021, outcome "unknown", described as "hypochondriac". The event "tingling in her face, hands and feet, primarily on the left side./these symptoms became worse" was evaluated at the physician office visit. Therapeutic measures were taken as a result of paraesthesia, disease progression.  Additional information: Reporter states patient had been prescribed Gabapentin by her doctor for the tingling, but it is not helping. The caller doesn't take anything and has become a hypochondriac since May2021. The caller had the two Pfizer shots, and she has talked to her doctor multiple times and decided not to get the booster. Caller states she has spoken to and seen her doctor and neurologist about these side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, SARS-CoV-2 test
Clinical narrative: tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; Shingles; hypochondriac; 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 79 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "deaf" (ongoing), notes: The caller is deaf too. Concomitant medication(s) included: LISINOPRIL; VIT D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (Dose 1), administration date: 30Apr2021, when the patient was 79 years old, for COVID-19 immunization, reaction(s): "tingling in her face, hands and feet, primarily on the left side."; Shingles vaccine (The caller got the shingles vaccine 10-12 years ago), for Immunization. The following information was reported: PARAESTHESIA (non-serious), DISEASE PROGRESSION (non-serious), PARAESTHESIA (non-serious), outcome "not recovered" and all described as "tingling in her face, hands and feet, primarily on the left side./these symptoms became worse"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles"; ILLNESS ANXIETY DISORDER (non-serious) with onset May2021, outcome "unknown", described as "hypochondriac". The event "tingling in her face, hands and feet, primarily on the left side./these symptoms became worse" was evaluated at the physician office visit. Therapeutic measures were taken as a result of paraesthesia, disease progression.  Additional information: Reporter states patient had been prescribed Gabapentin by her doctor for the tingling, but it is not helping. The caller doesn't take anything and has become a hypochondriac since May2021. The caller had the two Pfizer shots, and she has talked to her doctor multiple times and decided not to get the booster. Caller states she has spoken to and seen her doctor and neurologist about these side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease progression, Herpes zoster, Illness anxiety disorder, Paraesthesia
Clinical narrative: tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; tingling in her face, hands and feet, primarily on the left side./these symptoms became worse; Shingles; hypochondriac; 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 79 year-old female patient received bnt162b2 (BNT162B2), administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "deaf" (ongoing), notes: The caller is deaf too. Concomitant medication(s) included: LISINOPRIL; VIT D [COLECALCIFEROL]; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (Dose 1), administration date: 30Apr2021, when the patient was 79 years old, for COVID-19 immunization, reaction(s): "tingling in her face, hands and feet, primarily on the left side."; Shingles vaccine (The caller got the shingles vaccine 10-12 years ago), for Immunization. The following information was reported: PARAESTHESIA (non-serious), DISEASE PROGRESSION (non-serious), PARAESTHESIA (non-serious), outcome "not recovered" and all described as "tingling in her face, hands and feet, primarily on the left side./these symptoms became worse"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles"; ILLNESS ANXIETY DISORDER (non-serious) with onset May2021, outcome "unknown", described as "hypochondriac". The event "tingling in her face, hands and feet, primarily on the left side./these symptoms became worse" was evaluated at the physician office visit. Therapeutic measures were taken as a result of paraesthesia, disease progression.  Additional information: Reporter states patient had been prescribed Gabapentin by her doctor for the tingling, but it is not helping. The caller doesn't take anything and has become a hypochondriac since May2021. The caller had the two Pfizer shots, and she has talked to her doctor multiple times and decided not to get the booster. Caller states she has spoken to and seen her doctor and neurologist about these side effects.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Severe hives; rash itching; inflammation; dry peeling skin located on my face eyes lips neck and the outside of both hands; dry peeling skin located on my face eyes lips neck and the outside of both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 04:00 (Lot number: FD0810) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE MAGNESIUM]. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline/ erythromycin"; Erythromycin, reaction(s): "Known allergies: Tetracycline/ erythromycin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 08Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 15Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: URTICARIA (life threatening) with onset 14Oct2021, outcome "not recovered", described as "Severe hives"; RASH PRURITIC (life threatening) with onset 14Oct2021, outcome "not recovered", described as "rash itching"; INFLAMMATION (life threatening) with onset 14Oct2021, outcome "not recovered", described as "inflammation"; DRY SKIN (life threatening), SKIN EXFOLIATION (life threatening) all with onset 14Oct2021, outcome "not recovered" and all described as "dry peeling skin located on my face eyes lips neck and the outside of both hands". The events "severe hives", "rash itching", "inflammation", "dry peeling skin located on my face eyes lips neck and the outside of both hands" and "dry peeling skin located on my face eyes lips neck and the outside of both hands" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) positive. Therapeutic measures were taken as a result of urticaria, rash pruritic, inflammation, dry skin, skin exfoliation. Clinical course: 4 rounds Steroids / Pepcid Zyrtec Allegra etc. event included Severe hives rash itching inflammation dry peeling skin located on my face eyes lips neck and the outside of both hands.  No follow-up attempts are possible. No further information is expected.  Follow-up (25Mar2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200463650 Same reporter/SD, Different potential/AE
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry skin, Inflammation, Rash pruritic, SARS-CoV-2 test, Skin exfoliation
Clinical narrative: Severe hives; rash itching; inflammation; dry peeling skin located on my face eyes lips neck and the outside of both hands; dry peeling skin located on my face eyes lips neck and the outside of both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 04:00 (Lot number: FD0810) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE MAGNESIUM]. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline/ erythromycin"; Erythromycin, reaction(s): "Known allergies: Tetracycline/ erythromycin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 08Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 15Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: URTICARIA (life threatening) with onset 14Oct2021, outcome "not recovered", described as "Severe hives"; RASH PRURITIC (life threatening) with onset 14Oct2021, outcome "not recovered", described as "rash itching"; INFLAMMATION (life threatening) with onset 14Oct2021, outcome "not recovered", described as "inflammation"; DRY SKIN (life threatening), SKIN EXFOLIATION (life threatening) all with onset 14Oct2021, outcome "not recovered" and all described as "dry peeling skin located on my face eyes lips neck and the outside of both hands". The events "severe hives", "rash itching", "inflammation", "dry peeling skin located on my face eyes lips neck and the outside of both hands" and "dry peeling skin located on my face eyes lips neck and the outside of both hands" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) positive. Therapeutic measures were taken as a result of urticaria, rash pruritic, inflammation, dry skin, skin exfoliation. Clinical course: 4 rounds Steroids / Pepcid Zyrtec Allegra etc. event included Severe hives rash itching inflammation dry peeling skin located on my face eyes lips neck and the outside of both hands.  No follow-up attempts are possible. No further information is expected.  Follow-up (25Mar2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200463650 Same reporter/SD, Different potential/AE
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Severe hives; rash itching; inflammation; dry peeling skin located on my face eyes lips neck and the outside of both hands; dry peeling skin located on my face eyes lips neck and the outside of both hands; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Oct2021 04:00 (Lot number: FD0810) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: PRILOSEC [OMEPRAZOLE MAGNESIUM]. Past drug history included: Tetracycline, reaction(s): "Known allergies: Tetracycline/ erythromycin"; Erythromycin, reaction(s): "Known allergies: Tetracycline/ erythromycin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 08Mar2021, when the patient was 66 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 15Feb2021, when the patient was 66 years old, for COVID-19 immunization. The following information was reported: URTICARIA (life threatening) with onset 14Oct2021, outcome "not recovered", described as "Severe hives"; RASH PRURITIC (life threatening) with onset 14Oct2021, outcome "not recovered", described as "rash itching"; INFLAMMATION (life threatening) with onset 14Oct2021, outcome "not recovered", described as "inflammation"; DRY SKIN (life threatening), SKIN EXFOLIATION (life threatening) all with onset 14Oct2021, outcome "not recovered" and all described as "dry peeling skin located on my face eyes lips neck and the outside of both hands". The events "severe hives", "rash itching", "inflammation", "dry peeling skin located on my face eyes lips neck and the outside of both hands" and "dry peeling skin located on my face eyes lips neck and the outside of both hands" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Nov2021) positive. Therapeutic measures were taken as a result of urticaria, rash pruritic, inflammation, dry skin, skin exfoliation. Clinical course: 4 rounds Steroids / Pepcid Zyrtec Allegra etc. event included Severe hives rash itching inflammation dry peeling skin located on my face eyes lips neck and the outside of both hands.  No follow-up attempts are possible. No further information is expected.  Follow-up (25Mar2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200463650 Same reporter/SD, Different potential/AE
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: slight fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (slight fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (slight fever) and CHILLS (Chills). At the time of the report, PYREXIA (slight fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. It was reported by reporter that her son and sister who had a slight fever and chill which lasted the afternoon they got the vaccine. No treatment medications were reported.   This case was linked to MOD-2022-524342 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2022: Follow-up received contains no new information.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT ADMINISTERED VACCINE 1 DAY AFTER THE BEYOND USE DATE OF 03/27/2022.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT WAS ADMINISTERED VACCINE ONE DAY AFTER ITS BEYOND USE DATE OF 3/27/2022
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT WAS ADMINISTERED VACCINE ONE DAY AFTER ITS BEYOND USE DATE OF 03/27/2022
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vertigo
Clinical narrative: I suffered vertigo 2 weeks later and a related pain in the lower right base of the neck. The pain and vertigo occurred for 2-3 months. I had 4 visits to a vestibular physical therapist to help with symptoms.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired day before (3/25/22)  administration.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing
Clinical narrative: Flushing on both the hands.(Palms turned red )Lasted for 20 minutes,subsided after 20 minutes.
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired day before (3.26.22) administration.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis acneiform, Dizziness, Rash pruritic, Scar
Clinical narrative: There was a Pimple like rash on neck, ears and left hand. Scarring is still present. The pimples were tiny about the size of a pen head filled with clear fluid and very itchy. After the vaccination I felt dizzy for a moment like a head rush.i reported the incident to a friend who is a pharmacist technician.
Age: 21.0
Sex: M
Vaccine: HEPAB, HPV9
Symptoms: Bradycardia, Dizziness, Fall, Heart rate decreased, Hypotension
Clinical narrative: After the vaccines were administered to the patient, they left and in about 2 minutes were found to have fallen down on one of the aisles. The patient was conscious but dizzy. Paramedics were then called, upon assessment, he was found to have bradycardia and dizziness. he was then transported to the hospital for further evaluation
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired day before (3/25/22) administration.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine expired day before (03/25/2022) administration.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Feeling of body temperature change, Headache, Nausea
Clinical narrative: I am experiencing headache, nausea, hotness but i feel cold and cant stop shivering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Arthritis, Asthenia, Axillary pain, Dyspnoea
Clinical narrative: within the first 24hrs I experienced soreness and swollen armpits and inflammation in my joints (hands, wrists, hips, knees, ankles etc.) That subsided along with injection site soreness and general fatigue. Almost exactly 10 days later, I experienced severe hives, swollen hands and feet, bloating, and tightness in my throat and chest. I was seen in the ER and prescribed allergy medication and a steroid. It has been 2 months and I can only go a day or two without allergy medication before hives reappear, hands swell and bloating returns. I have gained over 15lbs in the last 2 months with no other lifestyle or diet changes. Exercise and previously enjoyed physical activities have become difficult (harder to breathe/hr raises higher sooner, loss of endurance, low energy, etc.) and I get headaches easily.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Exercise tolerance decreased, Fatigue, Headache, Heart rate increased, Inflammation
Clinical narrative: within the first 24hrs I experienced soreness and swollen armpits and inflammation in my joints (hands, wrists, hips, knees, ankles etc.) That subsided along with injection site soreness and general fatigue. Almost exactly 10 days later, I experienced severe hives, swollen hands and feet, bloating, and tightness in my throat and chest. I was seen in the ER and prescribed allergy medication and a steroid. It has been 2 months and I can only go a day or two without allergy medication before hives reappear, hands swell and bloating returns. I have gained over 15lbs in the last 2 months with no other lifestyle or diet changes. Exercise and previously enjoyed physical activities have become difficult (harder to breathe/hr raises higher sooner, loss of endurance, low energy, etc.) and I get headaches easily.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Peripheral swelling, Urticaria, Weight increased
Clinical narrative: within the first 24hrs I experienced soreness and swollen armpits and inflammation in my joints (hands, wrists, hips, knees, ankles etc.) That subsided along with injection site soreness and general fatigue. Almost exactly 10 days later, I experienced severe hives, swollen hands and feet, bloating, and tightness in my throat and chest. I was seen in the ER and prescribed allergy medication and a steroid. It has been 2 months and I can only go a day or two without allergy medication before hives reappear, hands swell and bloating returns. I have gained over 15lbs in the last 2 months with no other lifestyle or diet changes. Exercise and previously enjoyed physical activities have become difficult (harder to breathe/hr raises higher sooner, loss of endurance, low energy, etc.) and I get headaches easily.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives/Urticaria that started approximately 2 weeks after his third Moderna injections. No prior symptoms. He was initially treated with antihistamines but did nor respond well, instead got worse. Was given course of oral steroids but still did not have completed resolution. He was finally referred to allergist who initiated Xolair hots. He has has 2 shots and all his symptoms have resolved.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test normal, Chest pain, Dyspnoea, Echocardiogram
Clinical narrative: - First dose of phzier vaccine, on April 21, 2021 no severe symptoms.  - Second dose of Phizer on May 18, 2021,  gradually felt increasing fatigue, which became severe enough that I was unable to move or work as I normally do.  I was sleeping more than 11 hours per night and napping during the day without feeling rested. I am full time engineer and life-long endurance athlete, my resting HR is 30-40 bpm.  - June 27, I was experiencing weakness and fatigued and collapsed at home.  - June 28, I went to urgent care with shortness of breath and chest pain and weakness, near fainting.  I was brought to the hospital and saw MD who did ultrasound of my heart and found some pericardial effusion. No other issues we found at hospital with blood tests and examinations.  - June 28, I was dismissed from ER and told to return if I have more issue -June 29-July 11 continued to have extreme fatigue, shortness of breath, chest pain near my heart, heart palpitations, ongoing headaches and
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypersomnia, Impaired work ability, Mobility decreased
Clinical narrative: - First dose of phzier vaccine, on April 21, 2021 no severe symptoms.  - Second dose of Phizer on May 18, 2021,  gradually felt increasing fatigue, which became severe enough that I was unable to move or work as I normally do.  I was sleeping more than 11 hours per night and napping during the day without feeling rested. I am full time engineer and life-long endurance athlete, my resting HR is 30-40 bpm.  - June 27, I was experiencing weakness and fatigued and collapsed at home.  - June 28, I went to urgent care with shortness of breath and chest pain and weakness, near fainting.  I was brought to the hospital and saw MD who did ultrasound of my heart and found some pericardial effusion. No other issues we found at hospital with blood tests and examinations.  - June 28, I was dismissed from ER and told to return if I have more issue -June 29-July 11 continued to have extreme fatigue, shortness of breath, chest pain near my heart, heart palpitations, ongoing headaches and