chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: were more than 6 months apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th September 2018, Batch number- EH9z7 and expiration date- 8th March 2021, intramuscularly on an unknown arm), Flu vaccine (received a dose on 24th September 2018) and Prevenar (received a dose on 24th September 2018).   On 5th January 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 5th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: This case was reported by the retails pharmacist. The patient received the 2nd dose of Shingrix on an unknown arm, later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up. This case is one of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022002784:same reporter US-GLAXOSMITHKLINE-US2022002782:same reporter
Age: 84.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got both doses in 2018, now has shingles\ suspected Vaccination failure; Shingles, not as bad; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number Jc92p, expiry date 22nd November 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (prior to the vaccine).   On 23rd August 2018, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 24th April 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received both doses of the Shingrix vaccine and at the time of reporting had a case of shingles. The patient reports that the case of shingles they had now was not as bad as the case they had prior to the vaccine. The pharmacist was asking about giving a 3rd dose or series of the Shingrix vaccine. Referred the patient to health care professional and transferred the pharmacist to MI for further discussion. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th June 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No further events were reported.  The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient got a havrix expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 34-year-old female patient who received HAV (Havrix) (batch number E9G4E, expiry date 29th December 2021) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 7th January 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th January 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received a Havrix expired dose, which led to expired vaccine used. The reporter consented to follow up.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) (batch number T2F4Z, expiry date 20th November 2022) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Engerix B adult with an associated reaction of product administered to patient of inappropriate age (received 1st dose on an unknown date, refer case US2022AMR003832). On 16th September 2021, the patient received the 2nd dose of Engerix B adult and Engerix B Pre-Filled Syringe Device. On 16th September 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Manager informed that the patient received two first doses of Engerix B adult instead of pediatric, which led to overdose and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.; Sender's Comments: US-GLAXOSMITHKLINE-US2022AMR003832:Same patient. 1st dose.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 INFECTION; This spontaneous report received from a patient male. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received bnt 162 (Dose number in series was 1) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on an unspecified date in APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with bnt 162 (Pfizer). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 2) (suspension for injection, route of admin not reported, batch number: 1855191 and expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-DEC-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced covid-19 infection (Dose number in series was 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint 90000210119. The suspected product quality complaint has been confirmed to be voided (did not meet Regulatory Authority criteria since infection occurred less than 14 days after receiving the booster shot) based on the Regulatory Authority evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: 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 (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 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 murdered me for 3 days (dose number in series 1). The action taken with covid-19 vaccine was not applicable. The patient recovered from murdered me for 3 days. This report was non-serious. This case, involving the same patient is linked to 20220107322 (dose number in series 2).
Sex: M
Vaccine: COVID19
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 22 year old Asian male of unknown ethnicity. 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: 1808978 expiry: 11-SEP-2021) 1 total, administered on 07-JUN-2021 for prophylactic vaccination (Dose number in series 1). No concomitant medications were reported.  On an unspecified date, the patient was exposed in the household and had symptoms of covid including runny nose, cough and a headache (suspected covid-19 infection and suspected clinical vaccination failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. 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 is associated with regularity authority: 90000210990.; Sender's Comments: V0: 20220109975-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
Sex: U
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: 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 (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown), dose was not reported, administered 1 in total on APR-2021 for prophylactic vaccination. The patient did not experience any pain following covid-19 vaccine (dose number in series: 1). The patient received covid-19 vaccine (dose number in series: 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 04-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-JAN-2022, following vaccination with covid-19 vaccine, the patient experienced quite a bit of discomfort which had nothing to do with the way the vaccine was administered (dose number in series: 2). The action taken with covid-19 vaccine was not applicable. The outcome of discomfort was unknown. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Insomnia, Pain
Clinical narrative: 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 (suspension for injection, route of admin, and batch number were not reported) 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 woke up shaking like it was having a seizure, sick, could not sleep, woke up shaking, soreness, and headache. The action taken with covid-19 vaccine was not applicable. The outcome of the sick, could not sleep, woke up shaking, woke up shaking like it was having a seizure, soreness and headache was not reported. This report was non-serious.  Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: 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 (suspension for injection, route of admin, and batch number were not reported) 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 woke up shaking like it was having a seizure, sick, could not sleep, woke up shaking, soreness, and headache. The action taken with covid-19 vaccine was not applicable. The outcome of the sick, could not sleep, woke up shaking, woke up shaking like it was having a seizure, soreness and headache was not reported. This report was non-serious.  Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Pain, Vomiting
Clinical narrative: This spontaneous report received from a patient concerned a 30-year-old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JAN-2022, the patient experienced severe cough, body pain, vomiting from coughing, and headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from severe cough, body pain, vomiting from coughing, and headache. This report was non-serious. This report was associated with a product quality complaint: 90000210540 The suspected product quality complaint has been confirmed to be voided (did not meet RA criteria as reported complaints were adverse events, and there was no report of a covid infection or statement indicating the vaccine did not work) based on the RA evaluation/investigation performed.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Testicular pain
Clinical narrative: TESTICULAR PAIN; BACK PAIN/BACK FELT LIKE IT HAD NEEDLES IN IT; JOINT PAIN; This spontaneous report received from a patient concerned an 18 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: 1855191, expiry: unknown) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. No concomitant medications were reported.  On 06-JAN-2022, the patient experienced joint pain, back pain/back felt like it had needles in it and testicular pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint pain, back pain/back felt like it had needles in it and testicular pain. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Pain, Sleep disorder due to general medical condition, insomnia type
Clinical narrative: BELLS PALSY; TOO MUCH PAIN; TOO MUCH PAIN TO SLEEP; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included immunocompromised and polyethylene glycol (PEG) allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number unknown and expiry: unknown) dose, start therapy date were not reported with dose number in series was 1, frequency 1 total used for prophylactic vaccination. The batch number was not reported. The company unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced bells palsy, too much pain and too much pain to sleep (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bells palsy, and the outcome of too much pain to sleep and too much pain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220112396 -Covid-19 vaccine ad26.cov2.s- Bell's palsy. 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.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral venous sinus thrombosis, Thrombosis
Clinical narrative: CEREBRAL VENOUS SINUS THROMBOSIS; BLOOD CLOT IN BRAIN; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. 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) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced cerebral venous sinus thrombosis, and blood clot in brain. Patient stated that she believe she had a reaction to the vaccine CVST(cerebral venous sinus thrombosis), blood clots in the brain. She is working with her medical providers who have not been much help and believe that there is no way to make a determination. The patient visited to Physician office and Her primary care physician recommended her to email for any further guidance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cerebral venous sinus thrombosis and blood clot in brain was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220112522-COVID-19 VACCINE AD26.COV2.S- Cerebral venous sinus thrombosis, Blood clot in brain. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation
Clinical narrative: BURPING RIGHT AFTER SHE RECEIVED THE VACCINE (WHEN SHE TALK, SHE DIDN'T BURP AND WHEN SHE DIDN'T TALK, SHE BURP); This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroid, high cholesterol, asthma, auto-immune deficiency, penicillin allergy, abstain alcohol, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-MAR-2021, the patient experienced burping right after she received the vaccine (when she talk, she didn't burp and when she didn't talk, she burp). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from burping right after she received the vaccine (when she talk, she didn't burp and when she didn't talk, she burp). This report was non-serious.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Bedridden, Gastrointestinal haemorrhage, Haemoglobin, Haemoglobin decreased, Impaired quality of life
Clinical narrative: IRON PUTS IN HOSPITAL WITH BLEEDING IN GI; UNABLE TO MAINTAIN A NORMAL HEMOGLOBIN LEVEL; BEDRIDDEN; RUINED LIFE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. 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, batch number: unknown, expiry: unknown) dose was not reported, dose number in series was 1, 01 total was administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: iron (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for hemoglobin abnormal. No concomitant medications were reported. It was reported that, on an unspecified date, the patient was bedridden since the vaccine in APR-2021, the patient was unable to maintain a normal hemoglobin level and was taking iron puts the patient in hospital with bleeding in gastro intestine (GI), It ruined the patient's life  (dose number in series was 1), and was hospitalized on an unspecified date. Number of days hospitalized and discharge information was not reported   The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with iron was not reported. The outcome of the bedridden, unable to maintain a normal hemoglobin level, iron puts in hospital with bleeding in gi and ruined life was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220112751-COVID-19 VACCINE AD26.COV2.S-iron puts in hospital with bleeding in GI, bedridden, unable to maintain a normal hemoglobin level. 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: Demyelination, Myelitis transverse, Paralysis, Spinal cord injury
Clinical narrative: SPINAL CORD RUPTURED; PARALYZED; TRANSVERSE MYELITIS; DEMYELINATION OF THE SPINAL CORD; This spontaneous report received from a consumer via social media via a company representative concerned a male of unspecified age, race and ethnic origin. 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, expiry: unknown) dose and start therapy date were not reported, 1 total administered 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 spinal cord ruptured, paralyzed, transverse myelitis, and demyelination of the spinal cord, and was hospitalized (date unspecified). It was reporter that "one of the guys who spoke out, had a really severe reaction to the Johnson and Johnson vaccine and it caused transverse myelitis, which was basically the demyelination of the spinal cord, and so what happened to him was his spinal cord ruptured and now he was paralyzed and he spent 30 days in the hospital and the first 30 days in the hospital cost him 1.2 million dollars." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paralyzed, and the outcome of transverse myelitis, spinal cord ruptured and demyelination of the spinal cord was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220112025.; Sender's Comments: V0: This spontaneous report received from a consumer via social media via a company representative concerned a man of unspecified age, race and ethnic origin who experienced transverse myelitis and demyelination on an unspecified day after vaccination. The patient's medical history, concomitant medications, treatment, lab work and diagnostics were not reported. On an unspecified date, the patient experienced spinal cord rupture, paralysis, transverse myelitis, demyelination of the spinal cord, and spent 30 days in the hospital. However, the patient had not recovered from paralysis and the outcome of transverse myelitis, spinal cord rupture and demyelination of the spinal cord was not reported. Information regarding other potential etiologies was insufficient, and the occurrence of such events could represent background incidence in the general population. Considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Eructation, Nausea
Clinical narrative: CHRONIC AND PERSISTENT DIARRHEA (PASSES DARK BROWN LIQUID 15 TIMES A DAY); NAUSEA; BELCHING; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight was 254 pounds, and height was 73.5 inches. 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) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JAN-2022, the patient experienced belching, and nausea. Treatment medications included: loperamide hydrochloride. On 07-JAN-2022, the patient experienced chronic and persistent diarrhea (passes dark brown liquid 15 times a day). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chronic and persistent diarrhea (passes dark brown liquid 15 times a day), and the outcome of belching and nausea was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Muscle twitching, Paraesthesia, Pyrexia, Restless legs syndrome
Clinical narrative: TINGLING SENSATION IN RANDOM AREAS OF THE BODY, INCLUDING  FEET, ANKLE AND SPECIFICALLY LEFT HAND; NUMBNESS SENSATION IN RANDOM AREAS OF THE BODY, INCLUDING  FEET, ANKLE AND SPECIFICALLY LEFT HAND; FEVER; TWITCHING A LOT IN LEGS; RESTLESS/MOVING LEGS; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 06-JAN-2022 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JAN-2022, the patient experienced twitching a lot in legs, and restless/moving legs. Treatment medications included: dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol. On 06-JAN-2022, the patient experienced fever. On 08-JAN-2022, the patient experienced tingling sensation in random areas of the body, including feet, ankle and specifically left hand. On 08-JAN-2022, the patient experienced numbness sensation in random areas of the body, including feet, ankle and specifically left hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on JAN-2022, and had not recovered from tingling sensation in random areas of the body, including feet, ankle and specifically left hand, numbness sensation in random areas of the body, including feet, ankle and specifically left hand, restless/moving legs, and twitching a lot in legs. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: This spontaneous report received from a patient 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 (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced chills, felt sick, high fever, weak, and fatigued. The action taken with covid-19 vaccine was not applicable. The patient recovered from chills, felt sick, high fever, weak, and fatigued. This report was non-serious.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Sneezing
Clinical narrative: ITCHY EYE; SNEEZING; This spontaneous report received from a patient concerned a 59 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: 1855101 expiry: 11-APR-2022) dose was not reported, administered on 30-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced itchy eye, and sneezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy eye and sneezing was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Poor quality product administered, Product storage error
Clinical narrative: This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 03-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. On 03-JAN-2022, the patient experienced vaccine given 29 hours after being punctured for 6 hours, incorrect vaccine storage, and off label use. The action taken with covid-19 vaccine was not applicable. The outcome of the vaccine given 29 hours after being punctured for 6 hours, incorrect vaccine storage and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220116011.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced initially took the Janssen and Janssen vaccine and had severe allergies. The action taken with covid-19 vaccine was not applicable. The outcome of initially took the Janssen and Janssen vaccine and had severe allergies was not reported. This report was non-serious.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; Lack of efficacy; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 08FEB2021 and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Dec-2021, the patient experienced COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. COMPANY COMMENT: This is a spontaneous case concerning a 37-year-old female patient with no clinical history who experienced the unexpected events of COVID-19 (AESI) and DRUG INEFFECTIVE The events occurred 324 days after 2nd dose of mRNA-1273. The rechallenge was not applicable since only information about 2nd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    This case was linked to MOD-2021-432829 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Dec-2021: follow-up received and contains non-significant information; Sender's Comments: COMPANY COMMENT: This is a spontaneous case concerning a 37-year-old female patient with no clinical history who experienced the unexpected events of COVID-19 (AESI) and DRUG INEFFECTIVE The events occurred 324 days after 2nd dose of mRNA-1273. The rechallenge was not applicable since only information about 2nd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested positive for COVID-19 in the rapid test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (she tested positive for COVID-19 in the rapid test) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced COVID-19 (she tested positive for COVID-19 in the rapid test). At the time of the report, COVID-19 (she tested positive for COVID-19 in the rapid test) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Dec-2021, SARS-CoV-2 test: positive (Positive) She tested positive for COVID-19 in the rapid test.         No concomitant medications were reported.   No treatment details were reported.   Reporter did not allow further contact; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred 2 days after the third dose of mRNA-1273 vaccine administration. Causality for the event of COVID-19 was not applicable to the product administration. The rechallenge was not applicable since the event occurred after the third dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test
Clinical narrative: She took rapid Covid test on Sunday 11/28 and the results were positive.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She took rapid Covid test on Sunday 11/28 and the results were positive.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 mcg. On 28-Nov-2021, the patient experienced COVID-19 (She took rapid Covid test on Sunday 11/28 and the results were positive.). At the time of the report, COVID-19 (She took rapid Covid test on Sunday 11/28 and the results were positive.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2021, Body temperature: 102 (High) 102 Fahrenheit. On 28-Nov-2021, SARS-CoV-2 test: positive (Positive) positive.   No concomitant medications were reported  No treatment medications were reported Company comment: This is a spontaneous case concerning a 58-year-old, female patient with no medical history reported, who experienced the non- serious unexpected, according CCDS, AESI of COVID-19. The event COVID-19 occurred approximately five days after the third dose of mRNA-1273 vaccine.  The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-399707 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Follow up received contains patient initial ,DOB and new event  and lab data.; Sender's Comments: This is a spontaneous case concerning a 58-year-old, female patient with no medical history reported, who experienced the non- serious unexpected, according CCDS, AESI of COVID-19. The event COVID-19 occurred approximately five days after the third dose of mRNA-1273 vaccine.  The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Cough, Diarrhoea, Suspected COVID-19
Clinical narrative: horrible cough; ran a temperature; diarrhea; all the symptoms of Covid; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (horrible cough), BODY TEMPERATURE INCREASED (ran a temperature), DIARRHOEA (diarrhea) and SUSPECTED COVID-19 (all the symptoms of Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (horrible cough), BODY TEMPERATURE INCREASED (ran a temperature), DIARRHOEA (diarrhea) and SUSPECTED COVID-19 (all the symptoms of Covid). At the time of the report, COUGH (horrible cough), BODY TEMPERATURE INCREASED (ran a temperature), DIARRHOEA (diarrhea) and SUSPECTED COVID-19 (all the symptoms of Covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported. Consumer states that had the Moderna shot in Mar2021 and Apr2021 She mentioned that after the 1st one; the day after the shot had a horrible cough, went downhill from there. She ran a temperature, had diarrhea and all the symptoms of Covid. Company comment This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious events of COUGH, BODY TEMPERATURE INCREASED, DIARRHOEA and SUSPECTED COVID-19. The events occurred om the following day after the administration of the first dose of mRNA-1273 vaccine. She ran a temperature, had diarrhea and all the symptoms of Covid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the unexpected non-serious events of COUGH, BODY TEMPERATURE INCREASED, DIARRHOEA and SUSPECTED COVID-19. The events occurred om the following day after the administration of the first dose of mRNA-1273 vaccine. She ran a temperature, had diarrhea and all the symptoms of Covid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: breakthrough case of CoVid; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (breakthrough case of CoVid) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (breakthrough case of CoVid). At the time of the report, COVID-19 (breakthrough case of CoVid) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Company comment: This is a spontaneous case concerning a unknown age and gender patient with no  medical history reported, who experienced the non- serious unexpected , according CCDS, AESI of COVID-19. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-403259 (Patient Link). Sender's Comments: This is a spontaneous case concerning a unknown age and gender patient with no  medical history reported, who experienced the non- serious unexpected , according CCDS, AESI of COVID-19. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable since the event happened after the second dose and no information on additional dosing is available. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Periarthritis, Vaccination site movement impairment
Clinical narrative: Experienced frozen shoulder; Unable to raise arm; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PERIARTHRITIS (Experienced frozen shoulder), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to raise arm) and PAIN IN EXTREMITY (Arm pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIARTHRITIS (Experienced frozen shoulder), VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to raise arm) and PAIN IN EXTREMITY (Arm pain). The patient was treated with Physical therapy for Periarthritis and Physical therapy for Pain in extremity. At the time of the report, PERIARTHRITIS (Experienced frozen shoulder) and VACCINATION SITE MOVEMENT IMPAIRMENT (Unable to raise arm) outcome was unknown and PAIN IN EXTREMITY (Arm pain) was resolving.            Concomitant information was not provided.  It was reported pain is resolving but is still there.  The patient was treated with steroid injection.  Company Comment: This case refers to a male patient with no known medical history who experienced the unexpected adverse event of special interest (AESI) of Periarthritis at an unspecified interval of time after receiving the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This case refers to a male patient with no known medical history who experienced the unexpected adverse event of special interest (AESI) of Periarthritis at an unspecified interval of time after receiving the second dose of mRNA-1273 vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: he contracted covid in September.; Med Info Agent:  He had both Moderna COVID-19 vaccine shots then he contracted covid in September. After that he had a Moderna COVID-19 booster shot and then on 22Nov2021 he had another positive test. So he had covid twice now? How common is this? Patient denied any other information about his case.; Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the non-serious unexpected AESI event of COVID-19. The event occurred unknown date after the second dose of mRNA-1273 vaccine administration. Causality for the event of COVID-19 was not applicable to the product administration. The rechallenge was not applicable since the event occurred after the second dose and no further dosing is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.