chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; ccines were previously short dated for 1 month after excursion and then were administered after the short date; This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 22-OCT-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T032321, expiration date 22-SEP-2022 (short expiration date reported as 15-OCT-2021) for prophylaxis (dose, anatomical location and route of administration were not reported). It was reported that that vaccines were previously short dated for 1 month after excursion and then were administered after the short date.  The vaccine was stored at the temperature that was reported as 55.9 degrees of Fahrenheit for 30 minutes. There was no previous temperature excursion reported. The date of excursion was provided as 15-SEP-2021.  No additional adverse event reported.
Sex: U
Vaccine: VARZOS
Symptoms: Decreased appetite, Herpes zoster, Pain
Clinical narrative: This spontaneous report was received from a consumer refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug or allergy history. No concomitant therapies were reported.   The reporter patient said "I had the shingle shot - zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, lot #, expiration date and indication were not reported) approximately in 2010 (reported as about 11 years ago) then it was only 50% active that was why I got it a fourth time, I received two shots earlier this year (2021) both were 95% active."     It was reported that in the fourth time the patient said: "I had it on my face and in my mouth on the right side gosh was I in pain (herpes zoster) and I could not eat for two weeks it was that painful" (appetite decreased) on an unspecified date in 2021.   The outcome of herpes zoster and decreased appetite was not reported. Causality assessment was not provided.; Sender's Comments:  US-009507513-2111USA005096:
Sex: F
Vaccine: PPV
Symptoms: Antibody test negative, Asthma
Clinical narrative: a lot of infections; titers for 21 out of the 23 serotypes; This spontaneous report was received from a pharmacist referring to a female patient of unknown age.  The patient's concurrent conditions included asthma. Her historical conditions and concomitant medications were not reported.  On an unknown date, presumably, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, frequency, route, anatomical location, lot # and expiration date not reported) for prophylaxis.  On an unknown date, the patient had an immunology test that showed she had titers for 21 out of the 23 serotypes in pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (antibody test negative). Additionally, the patient got a lot of unspecified infections. At the time of the report, the outcome of antibody test negative and infection was unknown.  The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), antibody test negative and infection was not reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event reported; GARDASIL 9 vaccine that underwent a temperature excursion was administered to a patient; This spontaneous report as received from a Registered nurse refers to a patient of unknown age and gender .  There was no information about the patient's medical history, concurrent conditions or concomitant medication.    On 05-NOV-2021, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that underwent a temperature excursion , Lot number/batch number: T026234, expiration date reported as: 22-FEB-2023 is an invalid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9). Lot number: T026234 does not match any Company product as confirmed, for prophylaxis (dose, route of administration, were not reported). There was no adverse effect reported. No product quality complaint was involved.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 15-NOV-2021, the patient was vaccinated with incorrect storage haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S036821 with expiration date 21-APR-2022, to prevent Haemophilus Influenza B infection (strength, dose, route of administration nd anatomical location were not reported). No additional adverse event (AE) was reported. The temperature of exposure and the duration were not reported.
Age: 47.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neoplasm malignant, Vaccination failure
Clinical narrative: Now I have cancer; getting shingles regularly after receiving shingles vaccines; getting shingles regularly after receiving shingles vaccines; This spontaneous report was received from a consumer referring to himself a currently 58 years-old male patient of unknown race. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 18-FEB-2010, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dose, frequency, route, lot number and expiration date were not privided) for prophylaxis.  The patient wanted to have a refund for the vaccines he had paid for. He stated that he and his wife were in disablility income and could barely afford the cost of shingles vaccines. The patient reported that on an unspecified date (reported as ''now''), he had cancer (neoplasm malignant) and this was costy. And that even after getting the shot, to this day, he had still get shingles and have gotten them regularly (vaccination failure, herpes zoster). He had paid two shots and he wondered if the price was fair. Action taken with the vaccine was not appplicable. The outcome of neoplasm malignant, vaccination failure and herpes zoster was unknown.  The causal relationship between the events and the zoster vaccine live (ZOSTAVAX) vaccine was not provided.  Upon internal review, the event of neoplasm malignant was considered to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: patient was "diagnosed with shingles, but had received the old shingles vaccine"; This spontaneous report has been received from a physician concerning to a female patient on her 70s. Her concomitant therapies included mepolizumab (NUCALA). There was no information about patient's concurrent conditions, drug allergy and pertinent medical history.   On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, lot # and expiration date were not provided).      On an unspecified date the patient experienced herpes zoster. The outcome was not reported.   Causality assessment between the event and the suspect therapy was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Scar
Clinical narrative: multiple outbreaks of herpes zoster; postherpetic neuralgia; scarring; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, and scarring. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of multiple outbreaks of herpes zoster, postherpetic neuralgia and scarring was considered as not recovered and causal relationship was assessed as related.  These events multiple outbreaks of herpes zoster, postherpetic neuralgia and scarring were considered as disability by the lawyer.
Age: 57.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a doctor of osteopathy and refers to a 57-year-old male patient. There was no information regarding his medical history, concurrent conditions nor concomitant therapies provided. On 23-NOV-2021, the patient was inadvertently vaccinated with an expired dose of Hepatitis A vaccine, inactivated (VAQTA) lot # T017179, expiration date 26-OCT-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (expired product administered). The patient did not have any symptoms from receiving the expired vaccine (no adverse event). The reporter inquired was there any danger to the patient. This is one of two reports from the same reporter. Due to system limitations, the case # US-009507513-2111USA009083 was copied to case # US-009507513-2111USA009741 to correct the aware date to 23-NOV-2021. Therefore, the case # US-009507513-2111USA009083 is being voided. All the information was merged in case # US-009507513-2111USA009741. Sender's Comments: US-009507513-2111USA009175: US-009507513-2111USA009083:
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt horrible, pretty awful; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful. On an unknown date, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient just got the shingles vaccine and felt horrible for several days. The patient never had have such a bad reaction to a shot.  The patient did not want shingles either, but the shot was pretty awful! The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: UNK
Symptoms: Condition aggravated, Ligament sprain, Pain, Rheumatoid arthritis, Walking aid user
Clinical narrative: RA flare/significant flare; all over" body pain / unmanageable; twisted her knee; This case was reported by a physician via other manufacturer and described the occurrence of rheumatoid arthritis flare up in a 73-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   Co-suspect products included etanercept (Enbrel) unknown for rheumatoid arthritis.   Concurrent medical conditions included rheumatoid arthritis and pain.   In October 2021, the patient received Hz/su + AS01B and Enbrel 50 mg at an unknown frequency. On an unknown date, less than 2 months after receiving Hz/su + AS01B, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant and other: serious as per reporter), general body pain (serious criteria other: serious as per reporter) and twisted knee (serious criteria other: serious as per reporter). The subject was treated with steroids nos (Steroids). Enbrel was continued with no change. On an unknown date, the outcome of the rheumatoid arthritis flare up and twisted knee were unknown and the outcome of the general body pain was not recovered/not resolved.   The reporter considered the rheumatoid arthritis flare up, general body pain and twisted knee to be possibly related to Hz/su + AS01B.  Additional details were reported as follows: The age at vaccination was not reported. No concomitant medications were provided. The patient received Enbrel with Single Dose Prefilled Autoinjector with co-suspect medication included Shingrix (varicella zoster vaccine RGE (cho)) on an unknown date in 2021. The patient had been on Enbrel for about seven weeks. On an unknown date in 2021, the patient twisted her knee and was using a walker to assist her when walking. The patient had Flare of RA (rheumatoid arthritis). It was reported that event of pain (RA pain) was prior to her Enbrel start. The patient also experienced body pain that described as  unmanageable. The patient was told by health care professional the benefits of the Enbrel may take up to six months to work for her. Treatment medication for event rheumatoid arthritis includes unspecified steroids.  The physician reported that the event rheumatoid arthritis were not related to Enbrel. The causal relationship between the event rheumatoid arthritis and Single Dose Prefilled Autoinjector was not provided by the physician. The reporter declined consent for follow up with physician. No follow up attempts was possible.  No further information was expected.
Sex: M
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Administration following temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 26-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 5S945, expiry date 6th April 2023) for prophylaxis.   In November 2021, the patient received Boostrix (intramuscular). On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient inadvertently received the Boostrix via intramuscular route in the left deltoid after being exposed to below freezing temperatures, which led to incorrect storage of drug. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Overdose
Clinical narrative: been given two doses of Shingrix on 21Nov2021; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 21st November 2021, the patient received the 1st dose of Shingrix (unknown) 3. On 21st November 2021, unknown after receiving Shingrix and Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.  Additional details were reported as follows: At the time of reporting, the patient was in her 70s (specific age not provided since pharmacist did not had information at hand). The age at vaccination was not reported. The pharmacist reported that the patient had been given two doses of Shingrix on the same day, which led to overdose. The reporter did not agree nor declined follow-up since they wanted to consult with patient first.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: FEELING BLAH; SORE ARM; CHILLS; MILD FEVER; FEELING TIRED; MUSCLE ACHES LEFT LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) (series 1), administered in MAR-2021 for prophylactic vaccination. The patient received a booster dose (series 2) with non-company suspect vaccine MRNA 1273 (form of admin, route of admin, and batch number were not reported) on 23-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, when the patient initially received the Janssen vaccine after vaccination on an unspecified date, the patient experienced feeling blah, sore arm, chills, mild fever, and feeling tired. When the patient received the Modern booster vaccine on 23-OCT-2021, the patient experienced muscle aches in left leg. Laboratory data included: Body temperature 100.1, 99.7, 98.7, 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, was recovering from sore arm, had not recovered from mild fever, feeling tired, and feeling blah, and the outcome of muscle aches left leg was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: FEELING BLAH; SORE ARM; CHILLS; MILD FEVER; FEELING TIRED; MUSCLE ACHES LEFT LEG; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) (series 1), administered in MAR-2021 for prophylactic vaccination. The patient received a booster dose (series 2) with non-company suspect vaccine MRNA 1273 (form of admin, route of admin, and batch number were not reported) on 23-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, when the patient initially received the Janssen vaccine after vaccination on an unspecified date, the patient experienced feeling blah, sore arm, chills, mild fever, and feeling tired. When the patient received the Modern booster vaccine on 23-OCT-2021, the patient experienced muscle aches in left leg. Laboratory data included: Body temperature 100.1, 99.7, 98.7, 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, was recovering from sore arm, had not recovered from mild fever, feeling tired, and feeling blah, and the outcome of muscle aches left leg was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: FEVER; TIRESOME; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (unspecified manufacturer). (Dose number in series 1)  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 23-OCT-2021 for prophylactic vaccination. The batch number was not reported.(Dose number in series 2) The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 24-OCT-2021, the patient experienced fever that had  lasted for 3 days, its tolerable just tiresome.(Dose number in series 2)   The patient had no side effects from the first covid-19 vaccine. (Dose number in series 1)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the fever and tiresome was not reported.  This report was non-serious
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia
Clinical narrative: LOW GRADE FEVER; MILD HEADACHE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (Dose number in series: 1). She reported that she did not have any reaction or fever to the first shot.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822811 expiry: 20-MAR-2022) dose (dose number in series: 2) was not reported, 1 total, administered in left deltoid on 27-OCT-2021 10:15 for prophylactic vaccination. No concomitant medications were reported.   On 27-OCT-2021, the patient had a mild headache last night. Do not normally get headaches, but it went away. It was so mild it was not an issue this. (Dose number in series: 2)  On 28-OCT-2021, about 5pm, the patient had a low grade fever (caller very specific it was low grade). Laboratory data included: Body temperature (NR: not provided) 99.1 F. (Dose number in series: 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from mild headache on 28-OCT-2021, and had not recovered from low grade fever.  This report was non-serious.  This case, from the same reporter is linked to 20211059158.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Headache, Hyperhidrosis
Clinical narrative: COULD NOT MOVE ON; FELT TERRIBLE; SWEATING; COUGH; FEELING SICK; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of administration not reported, and batch number: JNJ041A21A and expiry: Unknown) dose was not reported, administered in right arm on 07-APR-2021 for prophylactic vaccination. On unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1), The patient experienced chills and headache on 07-APR-2021 and events cough, could not move on, feeling sick, felt terrible, fever and sweating on 08-APR-2021 (all events dose number in series 1) . The patient received of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-OCT-2021, After receiving the booster dose of JNJ the patient experienced same effects as (dose number series 1). On unspecified date he could not move on, felt terrible, sweating, cough, feeling sick, chills, fever and headache(all events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Outcome on events could not move on, felt terrible, sweating, cough, feeling sick, chills, fever, and headache was unknown. This report was non-serious. This case, involving the same patient is linked to 20210421476.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia, Malaise, Pyrexia
Clinical narrative: COULD NOT MOVE ON; FELT TERRIBLE; SWEATING; COUGH; FEELING SICK; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of administration not reported, and batch number: JNJ041A21A and expiry: Unknown) dose was not reported, administered in right arm on 07-APR-2021 for prophylactic vaccination. On unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1), The patient experienced chills and headache on 07-APR-2021 and events cough, could not move on, feeling sick, felt terrible, fever and sweating on 08-APR-2021 (all events dose number in series 1) . The patient received of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-OCT-2021, After receiving the booster dose of JNJ the patient experienced same effects as (dose number series 1). On unspecified date he could not move on, felt terrible, sweating, cough, feeling sick, chills, fever and headache(all events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Outcome on events could not move on, felt terrible, sweating, cough, feeling sick, chills, fever, and headache was unknown. This report was non-serious. This case, involving the same patient is linked to 20210421476.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: BODY ACHES; LITTLE SORE ARM; FEVER; VERY TIRED; This spontaneous report received from a patient concerned a 59 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: fibromyalgia, depression, anxiety, pollen allergy, and sulfa allergy. The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination with no side effects, dose series 1.   The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 182A09 expiry: UNKNOWN) dose was not reported, 1 total, dose series 2,  administered at right arm on 06-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in NOV-2021, the patient experienced body aches, little sore arm, fever and was very tired after getting the booster dose. Laboratory data included: Body temperature (NR: not provided) 102 F. On 12-NOV-2021, Laboratory data included: Body temperature (NR: not provided) 100 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little sore arm on NOV-2021, and had not recovered from fever, body aches, and very tired. This report was non-serious.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Urinary tract infection
Clinical narrative: URINARY TRACT INFECTION; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced slight headache and urinary tract infection (both events dose number in series 1) when treated with covid-19 vaccine ad26. cov2.s for prophylactic vaccination on /MAR-2021 (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855194 expiry: UNKNOWN) dose was not reported, 1 total, administered in left arm on 12-NOV-2021 (dose number in series 2) for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in NOV-2021, the patient experienced urinary tract infection and slight headache from the booster dose ( both events dose number in series 2). The patient did not have sore arm, so she slept on it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of urinary tract infection and slight headache was unknown. (also mentioned recovered from slight headache) This report was non-serious. This case, involving the same patient is linked to 20211137085.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: TIRED; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s in /APR-2021 ( dose number in series 1)for prophylactic vaccination with no side effects. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 12-NOV-2021 (dose number in series 2) for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 13-NOV-2021, the patient experienced tired and headache from the booster dose (both events dose number in series). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tired and headache was unknown. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 69 year old female with unspecified race. Initial information was processed along with the additional information received on 23-NOV-2021 and 24-NOV-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808020, expiry: UNKNOWN) 0.5 ml dose, (Dose Number in Series: 1),1 total, administered to right arm on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in AUG-2021 (5 months after primary vaccination with covid-19 vaccine ad26.cov2.s), the patient found to have no antibodies on test (coded to confirmed immunological vaccine failure). Laboratory data included: Antibody test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000203438. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. This case, involving the same patient is linked to 20211150258.; Sender's Comments: V0: 20211149833-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 69 year old female with unspecified race. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 1808020, expiry: unknown) dose was not reported, 01 total, dose series 1, administered to right arm on 10-MAR-2021 for prophylactic vaccination.  In AUG-2021, following vaccination with covid-19 vaccine ad26.cov2.s, patient had done SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) antibody test which was found negative (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. On 25-OCT-2021, the patient received additional company suspect vaccine covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: 20-MAR-2022) dose was not reported, 01 total, dose series 2, administered on right arm for prophylactic vaccination. No concomitant medications were reported.  On 22-NOV-2021, patient had done SARS-CoV-2 antibody test which was found negative (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This case, involving the same patient is linked to 20211149833.; Sender's Comments: V0:20211150258-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: MAJOR BLOOD CLOTS; This spontaneous report received from a patient via a company representative via a social media  concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s ((suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced major blood clots and never had them before. The patient was on blood thinner and reported a clot in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of major blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211152736- Covid-19 vaccine ad26.cov2.s-major blood clots. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blepharospasm, Headache, Influenza like illness, Muscle spasms, Muscle twitching
Clinical narrative: This spontaneous report received from a consumer concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On NOV-2021, the patient experienced legs and hand twitching. On NOV-2021, the patient experienced eye twitching. On NOV-2021, the patient experienced more than flu like symptoms. On NOV-2021, the patient experienced cramps of extremities. On NOV-2021, the patient experienced headache. On an unspecified date, the patient experienced lesions on scalp, and skin rashes.The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported.The outcome of the lesions on scalp, legs and hand twitching, eye twitching, headache, skin rashes, more than flu like symptoms and cramps of extremities was not reported.This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Rash, Skin lesion
Clinical narrative: This spontaneous report received from a consumer concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On NOV-2021, the patient experienced legs and hand twitching. On NOV-2021, the patient experienced eye twitching. On NOV-2021, the patient experienced more than flu like symptoms. On NOV-2021, the patient experienced cramps of extremities. On NOV-2021, the patient experienced headache. On an unspecified date, the patient experienced lesions on scalp, and skin rashes.The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported.The outcome of the lesions on scalp, legs and hand twitching, eye twitching, headache, skin rashes, more than flu like symptoms and cramps of extremities was not reported.This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: NEUROPATHY IN MY FEET AFTER THE SECOND SHOT; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age and sex unknown race and ethnicity.    The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency 1 total for prophylactic vaccination (Dose number series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, 1 total, start therapy date were not reported for prophylactic vaccination. (Booster dose, Dose number series 2). The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.   On an unspecified date, the patient experienced neuropathy in feet after the second shot (Dose number series 2). Patient reported that "I have it in my feet after the second shot".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of neuropathy in my feet after the second shot was not reported.  This report was serious (Other Medically Important Condition).  This case, from the same reporter is linked to 20211143298.; Sender's Comments: V0: 20211157009-covid-19 vaccine ad26.cov2.s-neuropathy in my feet after the second shot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: M
Vaccine: COVID19
Symptoms: Multi-organ disorder, Nervous system disorder, Weight, Weight increased
Clinical narrative: POSSIBLE ORGAN DAMAGE; SEVERE NEUROLOGICAL ISSUES; WEIGHT GAIN; This spontaneous report received from a consumer via a company representative concerned a 29 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced possible organ damage, severe neurological issues, and weight gain. Laboratory data (dates unspecified) included: Weight (NR: not provided) Weight gain. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe neurological issues, and the outcome of weight gain and possible organ damage was not reported. This report was non-serious.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 36 year old female of unknown race and ethnicity. The patient's weight was 75.9 kilograms, and height was not reported. The patient's concurrent conditions included: primary pulmonary hypertension. The patient received selexipag (tablet, oral, batch number: 031542202 expiry: 31-AUG-2022) 1600 mcg orally 2 times daily, therapy dates were not reported for primary pulmonary hypertension.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported , batch number: Unknown and expiry: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included tadalafil.  On 18-NOV-2021, the patient diagnosed with covid-19 infection and suspected clinical vaccination failure. Patient stated that  she was fully vaccinated and symptoms have been fairly mild.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20211161711-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS  20211161711-UPTRAVI- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: ARM HURT A LONG TIME AFTER THE ORIGINAL SHOT IN LEFT ARM, COULD FEEL THE NEEDLE STICKING IN ARM; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-MAR-2021, the patient experienced arm hurt a long time after the original shot in left arm, could feel the needle sticking in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm hurt a long time after the original shot in left arm, could feel the needle sticking in arm was not reported. This report was non-serious. This case, involving the same patient is linked to 20211124742.
Sex: U
Vaccine: COVID19
Symptoms: Eye colour change
Clinical narrative: EYES TURNED THAT COLOR AFTER JNJ JAB; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced eyes turned that color after JNJ jab. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of eyes turned that color after JNJ jab was not reported. This report was non-serious.