chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; shingles were very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingrix vaccine, the patient got shingles.  The patient stated that, evidently vaccine didn't work on him/her. The patient's shingles were very painful. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Just got my second shingle shot yesterday. I was sore for a day or so; This case was reported by a consumer via interactive digital and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On 15th July 2021, the patient received the 2nd dose of Shingles vaccine. In July 2021, less than a day after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and was sore for a day. The patient was glad he/she received it.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; she got em.; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 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 Shingles vaccine.  Additional details were provided as follows The reporter was the patient's husband. The age at vaccination was not reported. The reporter reported that the patient got the shingles shot, it worked she got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Herpes zoster, Loss of personal independence in daily activities, Nerve injury, Vaccination failure
Clinical narrative: Suspected vaccination failure; had permanent neurological damage to her legs and had to learn to walk again; GOT shingles; had to learn to walk again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 vaccination failure (serious criteria GSK medically significant), nerve damage (serious criteria disability), shingles and activities of daily living impaired. On an unknown date, the outcome of the vaccination failure, nerve damage, shingles and activities of daily living impaired were unknown.   It was unknown if the reporter considered the vaccination failure, nerve damage, shingles and activities of daily living impaired to be related to Shingles vaccine.  Additional details were provided as follows The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles.  The reporter stated that, the patient had permanent neurological damage to her legs and had to learn to walk again.  This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.    This case had been linked with case US2021AMR156165, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156165:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the shot to protect myself from Shingles and landed up with them within 7 days; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingles vaccine and landed with Shingles within 7 days.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster in dermatomes; This case was reported by a physician via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporting physician was the patient's husband. The reporter and the patient were both on the phone with medical information and both shared details for this report. The age at vaccination was not reported. The patient received Shingrix about two years before the date of reporting. Six to 8 months after receiving 1st dose of Shingrix, the patient developed herpes zoster in dermatomes which was treated with Acyclovir but reoccurred.  Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix series due to the occurrence of herpes zoster. No further details were shared at time of call. The consent to follow up was granted since the contact details of the healthcare professional were available.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient/ administered on Jul 15th 2021 with an adult dose from Havrix; pediatric patient/ administered on Jul 15th 2021 with an adult dose from Havrix; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 1-year-old female patient who received HAV (Havrix adult) (batch number X9A9B, expiry date 14th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th July 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 15th July 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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 reported as follows: A female pediatric patient who was administered on 15th July 2021 with an adult dose from Havrix which led to overdose and adult product administered to child. The reporter consented to follow up.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: booster/ should have been INFANRIX/PEDIARIX was administered; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 1st dose on an unknown date at 2 months of age), Pediarix (received 2nd dose on an unknown date at 4 months of age) and Pediarix (received 3rd dose on an unknown date at 6 months of age).   On 7th July 2021, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 7th July 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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: Historical medication included first three doses of Pediarix at 2, 4 and 6 months of age. The patient received the fourth dose of Pediarix instead of Infanrix, which led to wrong vaccine administered. The health care professional's office had not yet contacted the patient/ parent of patient, resolution unknown. This case was linked with US2021152840, US2021152836 and US2021152833, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152840:same reporter US-GLAXOSMITHKLINE-US2021152836:same reporter US-GLAXOSMITHKLINE-US2021152833:same reporter
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received both Shingrix doses in 2018/broke out in Shingles in September 2020/for a second time/July 14, 2021/suspected Vaccination failure; broke out in Shingles in September 2020/ for a second time/July 14, 2021; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and the 1st dose of Shingrix. On 14th July 2021, less than 2 years after receiving Shingrix and Shingrix, the patient experienced shingles. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant). The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The reporter was the patient.   The patient received both Shingrix doses in 2018 on an unknown deltoid and broke out in Shingles in September 2020 along her waistline.   The patient was able to start taking Valtrex and the symptoms were resolved in 2 weeks and reported that the patient broke out in shingles for a second time which started a day before reporting on 14th July 2021. The symptoms continue and had not resolved.   The lot number and expiration dates for the vaccines were unknown.   The HCP contact information was provided and listed in call notes. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: vaccinated on Sept 12 2020 / second dose is not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th September 2020, batch number 5KM49, expiry date 26th November 2021).   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 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up. This case was linked with case US2021152856 and US2021152861, reported by same reporter for different patients. The VAERS details were provided for 1st dose of Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021152861:Same reporter US-GLAXOSMITHKLINE-US2021152856:Same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blindness unilateral, Herpes zoster, Musculoskeletal discomfort, Myalgia
Clinical narrative: almost blind in left eye; I am obviously getting shingles; massive lesions on right and left buttocks/ mild lesions on left shoulder; Back is bothering me; Back discomfort; developed itching; muscles aches night after / vaccine; This case was reported by a nurse via call center representative and described the occurrence of blind in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of hospitalisation (received 1st dose in 2019 and was hospitalized, refer case- US2021AMR155494), Valtrex with an associated reaction of neutropenia (received doses on an unknown date and experienced neutropenia, refer case- US2021AMR155432) and Covid vaccine (received both doses on an unknown date and did well). Concomitant products included lidocaine.   On 10th July 2021, the patient received Shingrix. On 10th July 2021, less than a day after receiving Shingrix, the patient experienced pruritus and muscle pain. On 16th July 2021, the patient experienced blind (serious criteria GSK medically significant), shingles, skin lesion, back pain and back discomfort. On 16th July 2021, the outcome of the blind, shingles, pruritus, muscle pain, skin lesion, back pain and back discomfort were recovered/resolved.   It was unknown if the reporter considered the blind, shingles, pruritus, muscle pain, skin lesion, back pain and back discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by nurse for herself. The patient did not give any specifics around the hospitalization in 2019, left eye blindness (if this was a new occurrence).  The patient also reported being on lidocaine, not identified as a new medication therapy.  The patient developed itching and muscles aches night after Shingrix vaccine.  On 16th July 2021, 6 day after receiving Shingrix, the patient developed massive lesions on right and left buttocks, mild lesions on left shoulder and almost blind in left eye.  The patient stated that, 6 day after receiving Shingrix, she was obviously getting shingles and back was bothering her.  The patient stated she was definitely reporting a side effect on Shingrix. The reporter consented to follow up. This was 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR155432:Same reporter US-GLAXOSMITHKLINE-US2021AMR155494:Same reporter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Skin lesion
Clinical narrative: almost blind in left eye; I am obviously getting shingles; massive lesions on right and left buttocks/ mild lesions on left shoulder; Back is bothering me; Back discomfort; developed itching; muscles aches night after / vaccine; This case was reported by a nurse via call center representative and described the occurrence of blind in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of hospitalisation (received 1st dose in 2019 and was hospitalized, refer case- US2021AMR155494), Valtrex with an associated reaction of neutropenia (received doses on an unknown date and experienced neutropenia, refer case- US2021AMR155432) and Covid vaccine (received both doses on an unknown date and did well). Concomitant products included lidocaine.   On 10th July 2021, the patient received Shingrix. On 10th July 2021, less than a day after receiving Shingrix, the patient experienced pruritus and muscle pain. On 16th July 2021, the patient experienced blind (serious criteria GSK medically significant), shingles, skin lesion, back pain and back discomfort. On 16th July 2021, the outcome of the blind, shingles, pruritus, muscle pain, skin lesion, back pain and back discomfort were recovered/resolved.   It was unknown if the reporter considered the blind, shingles, pruritus, muscle pain, skin lesion, back pain and back discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by nurse for herself. The patient did not give any specifics around the hospitalization in 2019, left eye blindness (if this was a new occurrence).  The patient also reported being on lidocaine, not identified as a new medication therapy.  The patient developed itching and muscles aches night after Shingrix vaccine.  On 16th July 2021, 6 day after receiving Shingrix, the patient developed massive lesions on right and left buttocks, mild lesions on left shoulder and almost blind in left eye.  The patient stated that, 6 day after receiving Shingrix, she was obviously getting shingles and back was bothering her.  The patient stated she was definitely reporting a side effect on Shingrix. The reporter consented to follow up. This was 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR155432:Same reporter US-GLAXOSMITHKLINE-US2021AMR155494:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient had missed dose.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on an unknown date).   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 provided were as follows: Age at vaccination was not applicable for this report. The Agent was called to state that previous caller had reported an adverse event. Caller was no longer on the call. Agent stated that patient had missed the dose. The agent did not provide any other information about patient or event.
Sex: M
Vaccine: MEN
Symptoms: Seizure
Clinical narrative: experienced a brief convulsion; This case was reported by a consumer via call center representative and described the occurrence of convulsion in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, less than a day after receiving Meningococcal B vaccine, the patient experienced convulsion (serious criteria GSK medically significant). On an unknown date, the outcome of the convulsion was unknown.   It was unknown if the reporter considered the convulsion to be related to Meningococcal B vaccine.  Additional details were provided as follows: The case was reported by the patient's parent. The age at vaccination was not reported. The reporter stated that, the patient received a Meningococcal B vaccine and after that experienced a brief convulsion at the doctor's office. No other contact details or patient details were reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Gastrointestinal disorder
Clinical narrative: GI symptoms / began shortly after receiving dose; This case was reported by a consumer via call center representative and described the occurrence of gastrointestinal disorder in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2021, the patient received the 1st dose of Shingrix. On 15th July 2021, immediately after receiving Shingrix, the patient experienced gastrointestinal disorder. On an unknown date, the outcome of the gastrointestinal disorder was unknown.   It was unknown if the reporter considered the gastrointestinal disorder to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The age at vaccination was not reported. The patient received 1st dose of Shingrix and she currently experiencing gastrointestinal symptoms, that began shortly after receiving dose. No demographics were provided. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: experiencing some tiredness, fatigue; feeling achy, pain, in body throughout; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and pain. On an unknown date, the outcome of the fatigue and pain were recovered/resolved.   It was unknown if the reporter considered the fatigue and pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the consumer for herself. The age at vaccination was not reported. The patient received dose of Shingrix vaccine, after receiving the vaccine, the patient reported that she experienced some tiredness, fatigue, and feeling achy, pain, in body throughout.  The symptoms were resolved without intervention from health care professional. The patient disconnected the call, no other information was reported. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: vaccinated on 03/06/2020 / second dose is not administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received on 6th March 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 to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The health care professional gave consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Daughter only had a sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. This case was reported for reporter's daughter. The daughter only had a sore arm from Shingrix vaccine. The reporter did not want to provide her address or any additional information. The reporter did not consent to follow up. This case has been linked with US2021156443, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156443:Same reporter. Son in law case.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscular weakness, Nervousness, Pain, Pain in extremity
Clinical narrative: BLURRY VISION; NERVOUSNESS; PAIN DURING SLEEP; WEAKNESS IN MUSCLES/ARM/CANNOT LIFT MILK JUG; PAIN IN ELBOW; PAIN IN ARM AND SHOULDER; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced pain during sleep. On 04-MAY-2021, the subject experienced weakness in muscles/arm/cannot lift milk jug. On 04-MAY-2021, the subject experienced pain in elbow. On 04-MAY-2021, the subject experienced pain in arm and shoulder. On 09-MAY-2021, the subject experienced nervousness. On 09-JUN-2021, the subject experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nervousness, pain in arm and shoulder, weakness in muscles/arm/cannot lift milk jug, pain during sleep, blurry vision, and pain in elbow. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: BLURRY VISION; NERVOUSNESS; PAIN DURING SLEEP; WEAKNESS IN MUSCLES/ARM/CANNOT LIFT MILK JUG; PAIN IN ELBOW; PAIN IN ARM AND SHOULDER; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced pain during sleep. On 04-MAY-2021, the subject experienced weakness in muscles/arm/cannot lift milk jug. On 04-MAY-2021, the subject experienced pain in elbow. On 04-MAY-2021, the subject experienced pain in arm and shoulder. On 09-MAY-2021, the subject experienced nervousness. On 09-JUN-2021, the subject experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nervousness, pain in arm and shoulder, weakness in muscles/arm/cannot lift milk jug, pain during sleep, blurry vision, and pain in elbow. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: VACCINE INJURY/VAXX INJURY; This spontaneous report received from a consumer concerned multiple patients. 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) dose, start therapy date were not reported 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 an unspecified date, the subject experienced vaccine injury/vaxx injury. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injury/vaxx injury was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Retinal detachment, Suicidal ideation
Clinical narrative: PATIENT FELT TO KILL HIMSELF; RETINAL DETACHMENT,  LOOSING VISION, BLINDNESS OF LEFT EYE; SORENESS/PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included bilateral cataract surgery a few years ago, and concurrent conditions included glaucoma, COPD (Chronic obstructive pulmonary disease), smoker (a little less than a pack a day), and alcohol user (about 1 drink a day). The patient had allergies to some of previous COPD medications (but the patient could not recall which).  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A31A, expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced soreness, pain at injection site after vaccination. On 13-APR-2021, 3-4 days after vaccination the patient started losing vision in his left eye. He visited his physician's office- primary care provider (PCP). He was referred to a specialist and was diagnosed with retinal detachment. It was reported that there was a slight vision improvement in his left eye since symptoms started. It was also reported that the patient was going blind from retinal detachment. The patient felt to kill himself (captured as suicidal thoughts), if he did not receive help for his condition. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from retinal detachment, loosing vision, blindness of left eye, and soreness/pain at injection site, and the outcome of patient felt to kill himself was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738594-Covid-19 vaccine ad26.cov2.s- Retinal detachment, Patient felt to kill himself. 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).
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blindness unilateral
Clinical narrative: PATIENT FELT TO KILL HIMSELF; RETINAL DETACHMENT,  LOOSING VISION, BLINDNESS OF LEFT EYE; SORENESS/PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's past medical history included bilateral cataract surgery a few years ago, and concurrent conditions included glaucoma, COPD (Chronic obstructive pulmonary disease), smoker (a little less than a pack a day), and alcohol user (about 1 drink a day). The patient had allergies to some of previous COPD medications (but the patient could not recall which).  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A31A, expiry: unknown) dose was not reported, 1 total, administered on left arm on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021, the patient experienced soreness, pain at injection site after vaccination. On 13-APR-2021, 3-4 days after vaccination the patient started losing vision in his left eye. He visited his physician's office- primary care provider (PCP). He was referred to a specialist and was diagnosed with retinal detachment. It was reported that there was a slight vision improvement in his left eye since symptoms started. It was also reported that the patient was going blind from retinal detachment. The patient felt to kill himself (captured as suicidal thoughts), if he did not receive help for his condition. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from retinal detachment, loosing vision, blindness of left eye, and soreness/pain at injection site, and the outcome of patient felt to kill himself was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210738594-Covid-19 vaccine ad26.cov2.s- Retinal detachment, Patient felt to kill himself. 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).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Lethargy, Myocardial infarction, Pyrexia
Clinical narrative: HEART ATTACK; SEVERE LETHARGY; FEVER LIKE TEMPERATURE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug or non-drug allergies, no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808962, expiry: 23-JUN-2021) dose was not reported, 1 total, administered on 18-MAY-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On 18-MAY-2021, Patient experienced severe lethargy, fever-like temperature. On 23-MAY-2021 at about 09:40 pm, she began to severe chest pain from breast and upward. She was taken to emergency room with Electrocardiogram readings off the chart, that lead to a heart attack. She received double stent placement in her heart. Several weeks later, she was on several medications. Patient's coworker mentioned that it had to do with J&J/Janssen vaccine. Her lifestyle had detrimentally changed from healthy to living with a comorbid condition. She was treated by a cardiologist in hospital. On 27-May-2021, she was discharged from hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever like temperature, recovered with sequelae from heart attack, and had not recovered from severe lethargy. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0 20210738717 covid-19 vaccine ad26.cov2.s -Heart attack. 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: Therapeutic response unexpected
Clinical narrative: CHRONIC BRONCHITIS WAS CURED AFTER 2-3 WEEKS AFTER TAKING VACCINATION; This spontaneous report received from a patient concerned a male 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chronic bronchitis was cured after 2-3 weeks after taking vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chronic bronchitis was cured after 2-3 weeks after taking vaccination was not reported. This report was non-serious.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pyrexia, Vision blurred
Clinical narrative: BLURRED VISION; FEELING GENERALLY UNWELL; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned an 18 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 14-JUL-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 JUL-2021, treatment medications included: paracetamol. On 14-JUL-2021, the subject experienced blurred vision. On 14-JUL-2021, the subject experienced feeling generally unwell. On 14-JUL-2021, the subject experienced low grade fever. On 14-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, low grade fever, headache, and feeling generally unwell. This report was non-serious.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Cerebrovascular accident, Contusion, Loss of personal independence in daily activities, Peripheral swelling
Clinical narrative: URINARY TRACT INFECTION; SPINAL NERVE STIMULATOR IMPLANTATION; POSSIBLE STROKE; ARM TURNING BLACK; LEFT ARM SWOLLEN; EYES NOT FOCUSING; UNABLE TO DO DAILY FUNCTIONS; ISSUES WITH BOWEL MOVEMENT; This spontaneous report received from a consumer concerned an 85 year old,male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included non-alcohol user, non-smoker, and drug allergy not specified, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) frequency one total, dose was not reported, administered on left arm on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-JUN-2021, the patient experienced eyes not focusing, unable to do daily functions and issues with bowel movement, and was hospitalized. On 21-JUN-2021, the patient experienced left arm swollen and arm turning black. On an unspecified date, the subject experienced possible stroke, urinary tract infection and spinal nerve stimulator implantation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left arm swollen, and arm turning black, had not recovered from eyes not focusing, unable to do daily functions, and issues with bowel movement, and the outcome of urinary tract infection, possible stroke and spinal nerve stimulator implantation was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210740972-Covid-19 Vaccine Ad26.Cov2.S -Possible stroke, Issues with bowel movement, Arm turning black, Urinary tract infection, Spinal nerve stimulator implantation, Left arm swollen, Eyes not focusing, Unable to do daily functions. 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).
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal nerve stimulator implantation, Urinary tract infection, Vision blurred
Clinical narrative: URINARY TRACT INFECTION; SPINAL NERVE STIMULATOR IMPLANTATION; POSSIBLE STROKE; ARM TURNING BLACK; LEFT ARM SWOLLEN; EYES NOT FOCUSING; UNABLE TO DO DAILY FUNCTIONS; ISSUES WITH BOWEL MOVEMENT; This spontaneous report received from a consumer concerned an 85 year old,male. The patient's weight was 215 pounds, and height was 71 inches. The patient's concurrent conditions included non-alcohol user, non-smoker, and drug allergy not specified, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) frequency one total, dose was not reported, administered on left arm on 18-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 20-JUN-2021, the patient experienced eyes not focusing, unable to do daily functions and issues with bowel movement, and was hospitalized. On 21-JUN-2021, the patient experienced left arm swollen and arm turning black. On an unspecified date, the subject experienced possible stroke, urinary tract infection and spinal nerve stimulator implantation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from left arm swollen, and arm turning black, had not recovered from eyes not focusing, unable to do daily functions, and issues with bowel movement, and the outcome of urinary tract infection, possible stroke and spinal nerve stimulator implantation was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210740972-Covid-19 Vaccine Ad26.Cov2.S -Possible stroke, Issues with bowel movement, Arm turning black, Urinary tract infection, Spinal nerve stimulator implantation, Left arm swollen, Eyes not focusing, Unable to do daily functions. 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: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: VACCINE DID NOT WORK; COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a white and not Hispanic/Latino male of an 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 not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 19-MAR-2021 for prophylactic vaccination to left arm. No concomitant medications were reported.  On 18-JUL-2021, the patient tested positive for COVID-19 rapid POC test through the nostril (covid-19 test positive). It was also reported that, the vaccine did not work. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive and vaccine did not work was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000186473. The suspected product quality complaint has been confirmed to be not voided (meet product quality complaint (PQC) criteria) based on the product quality complaint (PQC) evaluation/investigation performed.; Sender's Comments: V0: 20210741048-Covid-19 vaccine ad26.cov2.s-Vaccine did not work. 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: M
Vaccine: COVID19
Symptoms: Culture stool, Diarrhoea, Frequent bowel movements, Weight decreased
Clinical narrative: LOST A LITTLE BIT OF WEIGHT; BOWEL MOVEMENTS HAD BECOME MORE FREQUENT; BOWEL IS VERY LOOSE BATHROOM 7 TIMES BEFORE NOON/DIARRHOEA; This spontaneous report received from a patient concerned a 49 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207AZ1A, and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced bowel movements had become more frequent. On 27-MAY-2021, the subject experienced bowel is very loose bathroom 7 times before noon/diarrhoea. On an unspecified date, the subject experienced lost a little bit of weight. Laboratory data (dates unspecified) included: Stool culture (NR: not provided) Negative. Treatment medications (dates unspecified) included: bismuth subsalicylate, and loperamide hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bowel movements had become more frequent, and bowel is very loose bathroom 7 times before noon/diarrhoea, and the outcome of lost a little bit of weight was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Malaise, Pain
Clinical narrative: DRY COUGH; SNEEZING; FEELING REALLY CRUDDY; PAIN IN MY ARM; LOW GRADE FEVER; HEADACHE; CHILLS; CONGESTED; CLEAR MUCOUS; BODY ACHE; This spontaneous report received from a patient concerned a 38 year old male. The patient's weight was 209 pounds, and height was 67 inches. The patient's past medical history included covid-19, got really sick, fever, body ache, dry cough, and mucus was really green, and concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 14-JUL-2021, the subject experienced body ache. On 14-JUL-2021, the subject experienced congested. On 14-JUL-2021, the subject experienced clear mucous. On 14-JUL-2021, the subject experienced chills. On 14-JUL-2021, the subject experienced pain in my arm. On 14-JUL-2021, the subject experienced low grade fever. On 14-JUL-2021, the subject experienced headache. On 15-JUL-2021, the subject experienced dry cough. On 15-JUL-2021, the subject experienced sneezing. On 15-JUL-2021, the subject experienced feeling really cruddy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Not Provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, body ache, headache, dry cough, congested, clear mucous, chills, feeling really cruddy, pain in my arm, and sneezing. This report was non-serious.