chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Axillary pain, Breast swelling, Breast tenderness, Swelling, Tenderness
Clinical narrative: Soreness under arm; Slight swelling/ tenderness on left side near breast; Slight swelling/ tenderness on left side near breast; This spontaneous case was retrieved on 23-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 890574-1) reported by other health professional and concerned 71-year-old, female patient.  The patient's concurrent condition included allergy to codeine and non-steroidal anti-inflammatory drug (NSAID). The patient's concomitant medications were not reported.   On 15-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular; anatomical location: left arm; dose and indication not reported). The batch number reported was 279822.  On the same day, after receiving Fluad Quadrivalent, the patient experienced soreness under arm and slight swelling/ tenderness on left side near breast, but no soreness/swelling at injection site. Patient was contacting her primary care doctor.  The outcome of the event was unknown.  The reporter did not provide a causality assessment, as she was unsure if it was related to vaccine.   The case was assessed as non-serious.  Additional information received on 19-Jan-2021 form Product Technical Complaint (PTC) reporting: Regulatory Authority removed from intermediary field. Report sent to Regulatory Authority by reporter was marked as unknown. Per batch number mapping, the reported batch number corresponded to Fluad Quadrivalent. Therefore the suspect vaccine was recoded from Fluad (TIV) to Fluad Quadrivalent. The narrative was amended accordingly.   Company comment: A 71-year-old patient developed axillary pain, local swelling and tenderness on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related.; Reporter's Comments: Unsure if related to vaccine.; Sender's Comments: A 71-year-old patient developed axillary pain, local swelling and tenderness on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related.
Age: 71.0
Sex: M
Vaccine: FLUA4, PPV
Symptoms: Lymphadenopathy, Product administration error
Clinical narrative: Swelling from armpit to elbow; Fluad Quadrivalent and Pneumovax were administered in right arm; This spontaneous case was retrieved on 24-Nov-2020 from (reference number: 892304-1), reported by other health professional and concerned a 71-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 20-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, route of administration: intramuscular, anatomical location: right arm, dose: reported as '1' and indication: not reported). The batch number reported was 282539.   On the same day, the patient was vaccinated with non-company co-suspect vaccine, Pneumovax (pneumococcal vaccine polysacch 23v, route of administration: intramuscular, anatomical location: right arm, dose: reported as '1' and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was S036495.  On 21-Oct-2020, one day after receiving Fluad Quadrivalent and Pneumovax, the patient experienced swelling from armpit to elbow.   On an unspecified date in Oct-2020, the patient visited Doctor's Office. The patient stated prescriber placed them on an antibiotic.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Additional information received on 19-Jan-2021 via Seqirus' manufacturing quality assurance : After batch number mapping, suspect product was re-coded from 'Fluad (TIV) ' to 'Fluad Quadrivalent'. The narrative was amended accordingly.  Company comment: On the same day, the patient was vaccinated with Fluad Quadrivalent and Pneumovax. One day after receiving vaccines, the patient experienced swelling from armpit to elbow. Causality is assessed as possibly related for peripheral swelling. Product administration error is assessed as unrelated per company's conventions.; Sender's Comments: On the same day, the patient was vaccinated with Fluad Quadrivalent and Pneumovax. One day after receiving vaccines, the patient experienced swelling from armpit to elbow. Causality is assessed as possibly related for peripheral swelling. Product administration error is assessed as unrelated per company's conventions.
Age: 88.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Pain in extremity, Swelling
Clinical narrative: This spontaneous case was retrieved on 21-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 896446-1), reported by other health professional and concerned an 88-year-old, female patient.  The patient's medical history was not reported. The patient had no known drug allergy. The patient's concomitant medications included metoprolol succinate 25, Synthroid 25 (levothyroxine sodium), albuterol sulfate nebulizer solution (reported as 'neb.soln. ') and atorvastatin 40, all used for an unreported indication.  On 03-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: reported as 'one', route of administration: intramuscular, anatomical location: left arm and indication: not reported) (explicitly coded as 'Product administration error'). The batch number reported was 282538.  On the same day, the patient was vaccinated with a non-company co-suspect vaccine Pneumovax (pneumococcal vaccine polysacch 23v; dose: reported as 'one', route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was T016159.  On 06-Nov-2020, three days after receiving Fluad Quadrivalent and non-company co-suspect vaccine Pneumovax, the patient experienced left arm pain and swelling.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Additional information received on 14-Jan-2021 via Product Technical Complaint (PTC) group: After batch number mapping, suspect product was re-coded from 'Fluad (TIV) ' to 'Fluad Quadrivalent'. Event left arm pain and swelling code changed from 'arm swelling' to 'extensive swelling of vaccinated limb'. The narrative was amended accordingly.  Company comment: The patient developed extensive swelling of vaccinated limb and pain in extremity after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. Reportedly, Fluad Quadrivalent and Pneumovax were administered into the same (left) arm on the same day. Causality may have been confounded by co-suspect vaccine, Pneumovax. Considering all above mentioned, causal relationship for both events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes). Product administration error is not related per company's conventions.  Sender's Comments: The patient developed extensive swelling of vaccinated limb and pain in extremity after vaccination with the suspect product, Fluad Quadrivalent. Chronology is plausible. Reportedly, Fluad Quadrivalent and Pneumovax were administered into the same (left) arm on the same day. Causality may have been confounded by co-suspect vaccine, Pneumovax. Considering all above mentioned, causal relationship for both events is assessed as possibly related (defaults to ''related'' in the safety database for reporting purposes). Product administration error is not related per company's conventions.
Age: 89.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and tenderness around injection site; Redness and tenderness around injection site; This spontaneous case was retrieved on 22-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 897202-1), reported by other health professional and concerned an 89-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 26-Oct-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as two, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 282540.  On the same day, in the night after receiving Fluad Quadrivalent, the patient developed redness and tenderness around injection site.  On an unspecified date in Oct-2020, the patient visited physician's office, however further details were not provided.  The outcome of the events was unknown.  The reporter did not provide causality assessment.   The case was assessed as non-serious.  Additional information received on 19-Jan-2021 from Seqirus' manufacturing quality assurance department: Suspect vaccine was re-coded to from 'Fluad TIV' to 'Fluad Quadrivalent' based on batch number mapping. Start date of events amended. The narrative was amended accordingly.  Company comment: The events of 'vaccination site erythema' and 'vaccination site tenderness' are assessed as related to Fluad Quadrivalent.; Sender's Comments: The events of 'vaccination site erythema' and 'vaccination site tenderness' are assessed as related to Fluad Quadrivalent.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Site of injection is red, hard, swollen; Site of injection is red, hard, swollen; Site of injection is red, hard, swollen; This spontaneous case was retrieved on 22-Dec-2020 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 898514-1) reported by other health professional and concerned 69-year-old, female patient.  The patient's medical history and concomitant medications were not reported.  On 24-Nov-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one; route of administration: intramuscular; anatomical location: left arm; indication: not reported). The batch number reported was 282539.  On 25-Nov-2020, one day after receiving Fluad Quadrivalent, the patient's site of injection was red, hard, swollen (oblong, about two inches in size). Patient had no pain or fever.  At the time of initial reporting, the patient had not recovered from events.   The reporter did not provide a causality assessment.  The case was assessed as non-serious.   Additional information received on 19-Jan-2021 from Product Technical Complaint (PTC) reporting: Regulatory Authority removed from intermediary field. Report sent to Regulatory Authority by reporter was marked as unknown. Per batch number mapping, the reported batch number corresponded to Fluad Quadrivalent. Therefore, the suspect vaccine was recoded from Fluad (TIV) to Fluad Quadrivalent. The narrative was amended accordingly.   Company comment: The events 'vaccination site swelling', 'vaccination site erythema' and 'vaccination site induration' are considered to be related to Fluad Quadrivalent.; Sender's Comments: The events 'vaccination site swelling', 'vaccination site erythema' and 'vaccination site induration' are considered to be related to Fluad Quadrivalent.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Can't move up/down; Pain to arm throbbing; Pain to arm throbbing; This spontaneous case was retrieved on 12-Jan-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 901661-1), reported by other health professional and concerned a 65-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 07-Dec-2020, the patient was vaccinated with Fluad Quadrivalent vaccine (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; route of administration: intramuscular, dose, indication and anatomical location: not reported). The batch number reported was 290706.  On the same day, the patient was vaccinated with non-company co-suspect Pneumovax (pneumococcal vaccine polysacch 23v; route of administration: intramuscular, batch number: T032003, dose, indication and anatomical location: not reported). The batch number reported was T032003.  On the same day, after receiving Fluad Quadrivalent vaccine, the patient developed severe pain to arm throbbing, cannot move up or down. Unrelieved by pain meds.  At the time of initial reporitng, the patient had not recovered from the events. Discrepant information were provided, event info states recovered: yes, but adverse event description states unrelieved by pain meds.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 65-year-old patient was vaccinated with Fluad Quadrivalent vaccine and non-company co-suspect Pneumovax. On the same day, after receiving vaccines, the patient developed pain in extremity, throbbing pain and mobility decreased. Causal role of the suspect vaccine is assessed as possibly related for all events.; Sender's Comments: A 65-year-old patient was vaccinated with Fluad Quadrivalent vaccine and non-company co-suspect Pneumovax. On the same day, after receiving vaccines, the patient developed pain in extremity, throbbing pain and mobility decreased. Causal role of the suspect vaccine is assessed as possibly related for all events.
Age: 69.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site swelling
Clinical narrative: Bump at site of flu vaccine injection well below deltoid muscle; This spontaneous case was retrieved on 14-Jan-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 902156-1), reported by other health professional and concerned a 69-year-old, female patient.   The patient's medical history and concomitant medications were not reported.   On 15-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, anatomical location: left arm, route of administration, dose and indication: not reported). The batch number reported was 279802.   On an unspecified date in 2020, an unknown amount of time after receiving Fluad Quadrivalent, the patient developed bump at site of flu vaccine injection. The pharmacist noticed that the bump was below deltoid muscle. The patient denied pain associated with bump.   On an unspecified date in 2020, the patient recovered from the event.  The reporter did not provide a causality assessment.   This case was assessed as non-serious.  Company Comment: A 69-year-old, female patient developed mass after vaccination with the suspect product, Flucelvax Quadrivalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Although chronology needs more clarification, causality of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: A 69-year-old, female patient developed mass after vaccination with the suspect product, Flucelvax Quadrivalent. There is lack of information regarding the vaccination date and event onset date. Therefore, chronology is unassessable. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Although chronology needs more clarification, causality of the suspect product cannot be totally excluded and is assessed as possibly related.
Age: 75.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash
Clinical narrative: Rash over entire body; This spontaneous case was retrieved on 15-Jan-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 903111-1), reported by other health professional and concerned a 75-year-old female patient.  The patient's concurrent conditions included allergy to quinolones, nitrofurantoin and lincosamides. The patient's concomitant medications included Keppra (levetiracetam), rosuvastatin and metoprolol, all used for an unreported indication.   On 18-Aug-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose reported as one, route of administration: intramuscular, anatomical location: right arm and indication: not reported). The batch number reported was 279782.  On 19-Aug-2020, one day after receiving Fluad Quadrivalent, the patient developed rash over entire body and had to take a course of oral and topical steroids.   On an unspecifed date in 2020, the patient visited physician's office, however no further information was provided.   On an unspecified date in 2020, the patient recovered from the event.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Comapny comment: The event of 'rash generalised' ia assessed as related to Fluad Quadrivalent.; Sender's Comments: The event of 'rash generalised' ia assessed as related to Fluad Quadrivalent.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Balance disorder, Fall, Pain in extremity, Parkinson's disease, Syncope
Clinical narrative: Lost her balance when reaching for the wall/door to help stabilize her; Possible syncope/ did not complain of loss of consciousness; Pain in her arm; Fell when exiting the store; Broken arm; This spontaneous case was retrieved on 01-Feb-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 905640-1), reported by other health professional and concerned a 71-year-old, female patient.   The patient's concurrent conditions included Parkinson's disease. The patient had no known allergies. The patient's concomitant medications were not reported.   On 18-Dec-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location: left arm, dose reported as one, route of administration: intramuscular and indication: not reported). The batch number reported was 279823.  On the same day, after receiving Fluad Quadrivalent, the patient experienced possible syncope. The patient lost her balance when reaching for the wall/door to help stabilize her and fell when exiting the store. The patient did not complain of shortness of breath or loss of consciousness, but only on pain in her arm. The patient was taken to the clinic.   On 21-Dec-2020, it was confirmed with the caregiver, that the patient had a broken arm.  At the time of initial reporting, the patient had not recovered from the events.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 71-year-old, female patient was administered Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced pain in extremity and possible syncope (did not complain of loss of consciousness). The patient lost her balance and fell. Three days later, it was confirmed with the caregiver, that the patient had a broken arm. Causality is assessed as possible for presyncope, balance disorder and pain in extremity, while fall and Upper limb fracture are assessed as not related to the suspect vaccine.; Sender's Comments: A 71-year-old, female patient was administered Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced pain in extremity and possible syncope (did not complain of loss of consciousness). The patient lost her balance and fell. Three days later, it was confirmed with the caregiver, that the patient had a broken arm. Causality is assessed as possible for presyncope, balance disorder and pain in extremity, while fall and Upper limb fracture are assessed as not related to the suspect vaccine.
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Upper limb fracture
Clinical narrative: Lost her balance when reaching for the wall/door to help stabilize her; Possible syncope/ did not complain of loss of consciousness; Pain in her arm; Fell when exiting the store; Broken arm; This spontaneous case was retrieved on 01-Feb-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 905640-1), reported by other health professional and concerned a 71-year-old, female patient.   The patient's concurrent conditions included Parkinson's disease. The patient had no known allergies. The patient's concomitant medications were not reported.   On 18-Dec-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; anatomical location: left arm, dose reported as one, route of administration: intramuscular and indication: not reported). The batch number reported was 279823.  On the same day, after receiving Fluad Quadrivalent, the patient experienced possible syncope. The patient lost her balance when reaching for the wall/door to help stabilize her and fell when exiting the store. The patient did not complain of shortness of breath or loss of consciousness, but only on pain in her arm. The patient was taken to the clinic.   On 21-Dec-2020, it was confirmed with the caregiver, that the patient had a broken arm.  At the time of initial reporting, the patient had not recovered from the events.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 71-year-old, female patient was administered Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced pain in extremity and possible syncope (did not complain of loss of consciousness). The patient lost her balance and fell. Three days later, it was confirmed with the caregiver, that the patient had a broken arm. Causality is assessed as possible for presyncope, balance disorder and pain in extremity, while fall and Upper limb fracture are assessed as not related to the suspect vaccine.; Sender's Comments: A 71-year-old, female patient was administered Fluad Quadrivalent. On the same day, after receiving Fluad Quadrivalent, the patient experienced pain in extremity and possible syncope (did not complain of loss of consciousness). The patient lost her balance and fell. Three days later, it was confirmed with the caregiver, that the patient had a broken arm. Causality is assessed as possible for presyncope, balance disorder and pain in extremity, while fall and Upper limb fracture are assessed as not related to the suspect vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: The day after, I had pain in my arm. Then a week afterward, I had a large red, swollen spot that was also itchy. It was the size of a 20 oz soda bottle. It lasted four days. I had use of arm. The nurse at health department I took Benadryl. Doctor visit was January 7th. No other treatment except ice.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site warmth
Clinical narrative: The day after, I had pain in my arm. Then a week afterward, I had a large red, swollen spot that was also itchy. It was the size of a 20 oz soda bottle. It lasted four days. I had use of arm. The nurse at health department I took Benadryl. Doctor visit was January 7th. No other treatment except ice.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: The day after, I had pain in my arm. Then a week afterward, I had a large red, swollen spot that was also itchy. It was the size of a 20 oz soda bottle. It lasted four days. I had use of arm. The nurse at health department I took Benadryl. Doctor visit was January 7th. No other treatment except ice.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: The day after, I had pain in my arm. Then a week afterward, I had a large red, swollen spot that was also itchy. It was the size of a 20 oz soda bottle. It lasted four days. I had use of arm. The nurse at health department I took Benadryl. Doctor visit was January 7th. No other treatment except ice.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Swelling
Clinical narrative: The day after, I had pain in my arm. Then a week afterward, I had a large red, swollen spot that was also itchy. It was the size of a 20 oz soda bottle. It lasted four days. I had use of arm. The nurse at health department I took Benadryl. Doctor visit was January 7th. No other treatment except ice.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac stress test, Palpitations
Clinical narrative: Immediately after vaccination (10min) patient developed heart palpations that are still ongoing (6 weeks later). It was worst the first 2 days. Doctor put patient on a beta blocker which helped some.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Cardiac flutter, Cardiac monitoring, Electrocardiogram, Extrasystoles
Clinical narrative: Immediately after vaccination (10min) patient developed heart palpations that are still ongoing (6 weeks later). It was worst the first 2 days. Doctor put patient on a beta blocker which helped some.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: Immediately after vaccination (10min) patient developed heart palpations that are still ongoing (6 weeks later). It was worst the first 2 days. Doctor put patient on a beta blocker which helped some.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Palpitations
Clinical narrative: Immediately after vaccination (10min) patient developed heart palpations that are still ongoing (6 weeks later). It was worst the first 2 days. Doctor put patient on a beta blocker which helped some.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Audiogram normal, Tinnitus
Clinical narrative: ringing in my ears; This case was reported by a consumer and described the occurrence of ringing in ears in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had constant ringing in ears since getting the first dose of Shingrix vaccine.  The information provided to patient suggested that if this occurred to contact doctor, which patient did.  Unfortunately, there was nothing posted on the CDC web site regarding this particular side effect other than it was rare.  The patient looking for any information on this particular adverse reaction, especially any indication if this would now be a permanent occurrence life.  The patient concerned about getting second dose.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Tinnitus, Vaccination complication
Clinical narrative: ringing in my ears; This case was reported by a consumer and described the occurrence of ringing in ears in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th December 2020, the patient received Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unknown.   It was unknown if the reporter considered the ringing in ears to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient had constant ringing in ears since getting the first dose of Shingrix vaccine.  The information provided to patient suggested that if this occurred to contact doctor, which patient did.  Unfortunately, there was nothing posted on the CDC web site regarding this particular side effect other than it was rare.  The patient looking for any information on this particular adverse reaction, especially any indication if this would now be a permanent occurrence life.  The patient concerned about getting second dose.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Intense Itching and swelling; Intense Itching and swelling; Pain but not severe, moderate; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3247), via an unspecified route of administration on 18Jan2021 17:30 at a single dose on left arm for COVID-19 immunization. Medical history included itchiness from fake eyelash glue. There were no concomitant medications. The patient previously received flu vaccine for immunization and experienced itchiness. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. On 20Jan2021, the patient experienced intense itching and swelling and pain but not severe, moderate. The events resulted in visit to emergency room/department or urgent care. The patient was treated with antihistamine for the events. The patient was recovering from the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Intense Itching and swelling; Intense Itching and swelling; Pain but not severe, moderate; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL 3247), via an unspecified route of administration on 18Jan2021 17:30 at a single dose on left arm for COVID-19 immunization. Medical history included itchiness from fake eyelash glue. There were no concomitant medications. The patient previously received flu vaccine for immunization and experienced itchiness. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no any other medications received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. On 20Jan2021, the patient experienced intense itching and swelling and pain but not severe, moderate. The events resulted in visit to emergency room/department or urgent care. The patient was treated with antihistamine for the events. The patient was recovering from the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events were reported as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dysphonia, Dyspnoea, Flushing, Hypoaesthesia
Clinical narrative: Within 5 minutes of vaccine I  developed a tight cough. By 10 minutes I was wheezing, coughing and it was difficult to inhale deeply, was itchy with few hives, lips and tongue were tingling and I became dizzy. I was sent to the ER and received IV Benadryl, IV pepcis and an IV steroid along with an Albuterol breathing treatment.  Heartrate 110-115 pulse ox 94% prior to meds and breathing treatment. BP not done. Symptoms resolved but by 1200 were all back. At that time I was given Epinepherine IM. Symptoms resolved by 1pm. Discharged from hospital by 4pm.  By 5pm face numb and tingling from cheekbones to mandible. Resolved within 24hrs. Since then, I have had episodes of facial numbness and tingling, hives and overall itching, lip/tongue tingling and bronchoconstriction(not with exercise)
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Wheezing
Clinical narrative: Within 5 minutes of vaccine I  developed a tight cough. By 10 minutes I was wheezing, coughing and it was difficult to inhale deeply, was itchy with few hives, lips and tongue were tingling and I became dizzy. I was sent to the ER and received IV Benadryl, IV pepcis and an IV steroid along with an Albuterol breathing treatment.  Heartrate 110-115 pulse ox 94% prior to meds and breathing treatment. BP not done. Symptoms resolved but by 1200 were all back. At that time I was given Epinepherine IM. Symptoms resolved by 1pm. Discharged from hospital by 4pm.  By 5pm face numb and tingling from cheekbones to mandible. Resolved within 24hrs. Since then, I have had episodes of facial numbness and tingling, hives and overall itching, lip/tongue tingling and bronchoconstriction(not with exercise)
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure normal, Cough, Dizziness, Dyspnoea, Full blood count normal
Clinical narrative: Within 5 minutes of vaccine I  developed a tight cough. By 10 minutes I was wheezing, coughing and it was difficult to inhale deeply, was itchy with few hives, lips and tongue were tingling and I became dizzy. I was sent to the ER and received IV Benadryl, IV pepcis and an IV steroid along with an Albuterol breathing treatment.  Heartrate 110-115 pulse ox 94% prior to meds and breathing treatment. BP not done. Symptoms resolved but by 1200 were all back. At that time I was given Epinepherine IM. Symptoms resolved by 1pm. Discharged from hospital by 4pm.  By 5pm face numb and tingling from cheekbones to mandible. Resolved within 24hrs. Since then, I have had episodes of facial numbness and tingling, hives and overall itching, lip/tongue tingling and bronchoconstriction(not with exercise)
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral, Pruritus, Urticaria, Wheezing
Clinical narrative: Within 5 minutes of vaccine I  developed a tight cough. By 10 minutes I was wheezing, coughing and it was difficult to inhale deeply, was itchy with few hives, lips and tongue were tingling and I became dizzy. I was sent to the ER and received IV Benadryl, IV pepcis and an IV steroid along with an Albuterol breathing treatment.  Heartrate 110-115 pulse ox 94% prior to meds and breathing treatment. BP not done. Symptoms resolved but by 1200 were all back. At that time I was given Epinepherine IM. Symptoms resolved by 1pm. Discharged from hospital by 4pm.  By 5pm face numb and tingling from cheekbones to mandible. Resolved within 24hrs. Since then, I have had episodes of facial numbness and tingling, hives and overall itching, lip/tongue tingling and bronchoconstriction(not with exercise)
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Paraesthesia oral, Pruritus, Urticaria
Clinical narrative: Within 5 minutes of vaccine I  developed a tight cough. By 10 minutes I was wheezing, coughing and it was difficult to inhale deeply, was itchy with few hives, lips and tongue were tingling and I became dizzy. I was sent to the ER and received IV Benadryl, IV pepcis and an IV steroid along with an Albuterol breathing treatment.  Heartrate 110-115 pulse ox 94% prior to meds and breathing treatment. BP not done. Symptoms resolved but by 1200 were all back. At that time I was given Epinepherine IM. Symptoms resolved by 1pm. Discharged from hospital by 4pm.  By 5pm face numb and tingling from cheekbones to mandible. Resolved within 24hrs. Since then, I have had episodes of facial numbness and tingling, hives and overall itching, lip/tongue tingling and bronchoconstriction(not with exercise)
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: I have been diagnosed with Afib but do not have daily episodes.  Within 2 hours after receiving the vaccine I began to have regular episodes throughout the day and night and they have continued.; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELB982), via an unspecified route of administration on the left arm on 25Jan2021 11:15 at a single dose for COVID-19 immunization. Medical history included heart disease, hypothyroidism and Afib (Atrial fibrillation). The patient is not pregnant. Concomitant medication included levothyroxine, acetylsalicylic acid (BABY ASPIRIN) and cetirizine hydrochloride (ZYRTEC). It was reported that the patient was diagnosed with Afib but do not have daily episodes. Within 2 hours after receiving the vaccine (25Jan2021 13:30), the patient began to have regular episodes throughout the day and night and they have continued. Her cardiologist is out of town and was referred by his office to go to the ER if she felt she should. The patient do not think it is bad enough to go to the ER so she is just monitoring on her smart Watch. No treatment was received for the event. The outcome of the event was not recovered.
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Electrocardiogram ST segment elevation, Hypoaesthesia, Magnetic resonance imaging heart, Myocarditis
Clinical narrative: Acute myocarditis after 2nd vaccine dose
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Troponin increased
Clinical narrative: Acute myocarditis after 2nd vaccine dose
Age: 36.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: Acute myocarditis after 2nd vaccine dose
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Injection site induration, Injection site pain, Pain
Clinical narrative: sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection; about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of paiin where injection was given; hardness where injection was given; slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302, expiry date not reported), via an unspecified route of administration on 26Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included gastric bypass on an unknown date, pseudotumor cerebri (no attacks in over 4 years) from an unknown date to an unspecified date. Concomitant medication included cefprozil (CEFZIL), cetirizine hydrochloride (ZYRTEC), lisinopril. The patient previously took codeine and fluoride [sodium fluoride] and experienced allergies. The patient experienced slight headache on 26Jan2021 14:00, sore arm from shoulder to finger tips barely able to move it on 27Jan2021 05:00, sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection on 27Jan2021 05:00, about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of pain where injection was given on 27Jan2021 05:00, hardness where injection was given on 27Jan2021 05:00. The patient reported that hey had slight headache an hour after injection which went away a couple hours later. On morning after injection they work at 5am with sore arm from shoulder to finger tips barely able to move it. At 8:30 they got up and the pain was still pretty intense but read they needed to move it around started to do that and about an hour later the pain was just in the shoulder and site of injection. Hours later it is still a grapefruit size area of pain and hardness where injection was given. The patient recovered from slight headache on 26Jan2021, was recovering from pain in extremity, shoulder pain, vaccination site pain and vaccination site induration.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection; about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of paiin where injection was given; hardness where injection was given; slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302, expiry date not reported), via an unspecified route of administration on 26Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included gastric bypass on an unknown date, pseudotumor cerebri (no attacks in over 4 years) from an unknown date to an unspecified date. Concomitant medication included cefprozil (CEFZIL), cetirizine hydrochloride (ZYRTEC), lisinopril. The patient previously took codeine and fluoride [sodium fluoride] and experienced allergies. The patient experienced slight headache on 26Jan2021 14:00, sore arm from shoulder to finger tips barely able to move it on 27Jan2021 05:00, sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection on 27Jan2021 05:00, about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of pain where injection was given on 27Jan2021 05:00, hardness where injection was given on 27Jan2021 05:00. The patient reported that hey had slight headache an hour after injection which went away a couple hours later. On morning after injection they work at 5am with sore arm from shoulder to finger tips barely able to move it. At 8:30 they got up and the pain was still pretty intense but read they needed to move it around started to do that and about an hour later the pain was just in the shoulder and site of injection. Hours later it is still a grapefruit size area of pain and hardness where injection was given. The patient recovered from slight headache on 26Jan2021, was recovering from pain in extremity, shoulder pain, vaccination site pain and vaccination site induration.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Headache, Pain in extremity, Vaccination site induration, Vaccination site pain
Clinical narrative: sore arm from shoulder to finger tips barely able to move it; sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection; about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of paiin where injection was given; hardness where injection was given; slight headache; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received their first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: El3302, expiry date not reported), via an unspecified route of administration on 26Jan2021 13:00 at single dose for covid-19 immunisation. Medical history included gastric bypass on an unknown date, pseudotumor cerebri (no attacks in over 4 years) from an unknown date to an unspecified date. Concomitant medication included cefprozil (CEFZIL), cetirizine hydrochloride (ZYRTEC), lisinopril. The patient previously took codeine and fluoride [sodium fluoride] and experienced allergies. The patient experienced slight headache on 26Jan2021 14:00, sore arm from shoulder to finger tips barely able to move it on 27Jan2021 05:00, sore arm from shoulder/about an hour later the pain was just in the shoulder and site of injection on 27Jan2021 05:00, about an hour later the pain was just in the shoulder and site of injection/a grapefruit size area of pain where injection was given on 27Jan2021 05:00, hardness where injection was given on 27Jan2021 05:00. The patient reported that hey had slight headache an hour after injection which went away a couple hours later. On morning after injection they work at 5am with sore arm from shoulder to finger tips barely able to move it. At 8:30 they got up and the pain was still pretty intense but read they needed to move it around started to do that and about an hour later the pain was just in the shoulder and site of injection. Hours later it is still a grapefruit size area of pain and hardness where injection was given. The patient recovered from slight headache on 26Jan2021, was recovering from pain in extremity, shoulder pain, vaccination site pain and vaccination site induration.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: tongue and lip tingling; subjective swelling; This is a spontaneous report from a contactable physician reported that a 37-years-old female patient first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) intramuscularly on 27Jan2021 at single dose for covid-19 immunisation. Medical history included anaphylaxis; nightshade vegetable allergy; Food allergy, migraine, Attention deficit hyperactivity disorder, anxiety, former smoker. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), alprazolam (XANAX), escitalopram oxalate (LEXAPRO), ethinylestradiol, norethisterone acetate (JUNEL), amitriptyline (AMITRIPTYLINE). The patient previously took atropine had anaphylaxis and known allergies. On 27Jan2021, patient developed tongue and lip tingling and subjective swelling within 10 minutes after vaccine administration. No angioedema. The patient was received treatment with benadryl, pepcid, IVF and solumedrol. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on vaccine-event chronological association a causal relationship between events "tongue and lip tingling and subjective swelling" and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.