chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: late for shingrix 2nd dose; This case was reported by a pharmacist 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 (received 1st dose on 27th December 2019).   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. The patient received 1st dose of Shingrix at primary reporter's facility. The registered pharmacist reported that the patient was late for shingrix 2nd dose. Till the time of reporting, the patient did not receive 2nd dose which led to incomplete course of vaccination.  The reporter asked if patient should be revaccinated. No other vaccine details were provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: have not received second dose of Shingrix vaccine within the 6 month; This case was reported by a nurse via and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 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 were provided as follows: The age at vaccination was not applicable for this report. The patients received 1st dose of Shingrix at primary reporter's facility. The nurse reported that approximately 50 patients in their practice had not received second dose of Shingrix vaccine within the 6 month window for various reasons, and many were now approaching 12 months.   The nurse did not have specific patient identifiers or lot numbers at time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received their first dose of Shingrix 3 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, 3 years ago).   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 was inquiring if the patient should receive second dose now or restart the series.  The reporter did not consent to follow-up. No additional details provided by reporter.
Age: 83.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Erythema, Flushing, Pruritus
Clinical narrative: Redness on both of arms; Itching on both of arms; Flushing on both of arms; This case was reported by a nurse and described the occurrence of erythema in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included niacin tablet for product used for unknown indication.   The patient's past medical history included skin breakout (usually breakout or have side effects when takes tablets).   On 19th October 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started niacin at an unknown dose and frequency. On 20th October 2021, 1 days after receiving Shingrix, the patient experienced erythema, pruritus and flushing. Niacin was discontinued (Dechallenge was positive). On an unknown date, the outcome of the erythema, pruritus and flushing were recovered/resolved.   It was unknown if the reporter considered the erythema, pruritus and flushing to be related to Shingrix.   Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine intramuscularly on right deltoid and on the following day, she experienced flushing, redness, and itching. The patient was also taking Niacin tablet during that time. The patient was unsure whether the side effects came from Shingrix or Niacin. The patient mentioned that this time Niacin that she received was tablet form and not capsule.  The patient also stated that she usually breakout or had side effects when she took tablets. The patient discontinued taking tablets and the side effects was disappeared. The reporter did not provide lot number, expiry date and dose. The reporter did not give a consent to follow-up. It was unknown if the reporter considered the erythema, pruritus and flushing to be related to Niacin.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not return within the recommended time frame; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date 18 months ago).   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. The pharmacist reported that the patient did not return within the recommended time frame to receive the second dose, which led to incomplete course of vaccination. The patient did not receive the Shingrix at the pharmacy, so lot number, expiration date, and site of injection was unknown. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got Shingrix shot #2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in July 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 reporter was the patient. The age at vaccination was not applicable for this report. The patient received dose 1 of Shingrix at her doctor's office but never got Shingrix shot 2, which led to incomplete course of vaccination.  The patient did not have the lot number or expiration date of Shingrix shot 1.  The reporter did not want to share her medical doctor contact information. The reporter did not consent to follow-up.
Age: 15.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix-B given; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 15-year-old male patient who received HBV (Engerix B) (batch number YL2L3, expiry date 14th October 2021) for prophylaxis.   On 28th October 2021, the patient received Engerix B. On 28th October 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharmacist reported that patient was administered Engerix B which was expired on 14th October 2021, which led to expired vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Hernia, Herpes zoster, Scab
Clinical narrative: shingles from trauma of hernia surgery; scabs on back and chest; Hernia; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male 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 shingles, scab and hernia. The action taken with Shingrix was unknown. On an unknown date, the outcome of the shingles and hernia were unknown and the outcome of the scab was recovering/resolving.   It was unknown if the reporter considered the shingles, scab and hernia to be related to Shingrix.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient received first dose of Shingrix (date unknown) and developed shingles (date unknown).  The reporter mentioned he developed shingles from the trauma of hernia surgery.  He developed scabs on his back and had a small scab on his chest.  He stated that he was 85 percent done with the scabs on his back, and it had not fully yet resolved. The patient denied consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with sterile water instead of supplied adjuvant; reconstituted with sterile water instead of supplied adjuvant; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) (batch number DC439, expiry date 3rd February 2023) and (batch number ASO1B, expiry date unknown) for prophylaxis.   On 29th October 2021, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On 29th October 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse supervisor reported that a nurse administered a Shingrix vaccine to a patient, however the vaccine was reconstituted with sterile water instead of the supplied ASO1B adjuvant which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have patient details at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: Negative HepB titer result after being immunized; This case was reported by a physician via call center representative and described the occurrence of therapy non-responder in an unspecified number of patients who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, every semester a few nursing students would have a negative Hepatitis B titer result even though they had been immunized. The reporter could not quantify number of students with negative results or provide vaccine details. It was not known if the students were dosed with Engerix-B or a vaccine from a different manufacturer. The reporter consented to follow up.
Age: 29.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of on 26-Apr-2021, not gotten third dose yet; first dose on 26-Apr-2021, second on 16-Jul-2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 29-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 26th April 2021).   On 16th July 2021, the patient received the 2nd dose of Twinrix (intramuscular) and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 16th July 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination 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: The age at vaccination was not applicable for 3rd dose of Twinrix. The patient received 2nd dose of Twinrix late than athe recommended time interval, which led to lengthening of vaccination schedule. Till the time of reportingt, the patient did not receive 3rd dose of Twinrix , which led to incomplete course of vaccination. The reporter did not have the following information, lot or exp date of both doses, dosage, and whether the vaccine was administered on left or right arm. The reporter gave a consent to follow-up, However, he did not have a fax number or an email address to health care professional.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: exceeded six-month for their second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about a year ago).   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. The reporter asked, if the patient have exceeded the six month window for their second dose of Shingrix. 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 US2021AMR227820, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR227820:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inquire if pt can take the 2nd dose, had the first in 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   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 did not consent to follow up. This case was linked with case US2021227978, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021227978:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the first dose in 2018; This case was reported by a pharmacist  and described the occurrence of incomplete course of vaccination in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018).   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 did not consent to follow up. This case was linked with case US2021227965, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021227965:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First shot 2 years ago without getting the second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   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 reporter was the retail pharmacist. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Pt forgot to get the second injection; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 10 months ago, 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 were provided as follows: The age at vaccination was not applicable for this report. The patient forgot to get the second injection of shingrix. The patient was now10 months late. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked should the patient take the series again or just get the second injection 10 months late. The reporter consented to follow up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 26Nov2019 received first dose, 08Aug2021 received the second; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 26th November 2019).   On 8th August 2021, the patient received the 2nd dose of Shingrix. On 8th August 2021, 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: The patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Inflammation, Multisystem inflammatory syndrome, Platelet disorder, Vasculitis
Clinical narrative: MULTISYSTEM INFLAMMATORY SYNDROME; INFLAMMATORY SYNDROME; VASCULAR INFLAMMATION; PLATELET ACTIVATION; This spontaneous report received from a consumer and concerned multiple patients (4 patients) The patient's weight, height, and medical history were not reported. The patient's received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805031, expiry date: 24-AUG-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date a consumer called in with specific questions about lot number 1805031. The consumer stated that in the local area there were 4 patients who received this specific lot number and experienced symptoms of: inflammatory syndrome, vascular inflammation, multisystem inflammatory syndrome, platelet activation. This was not limited to women under 50 (2 women over 60, 1 man over 60 and 1 unknown).  The consumer was trying to rule out lack of training, injection injuries, or lot number number specifics. The consumer also mentioned that others were told to call in and report and mentioned there may be hundreds with same issue, not sure about lot number for the others (Found groups with issues, well over 2000 in one group, across Covid vaccines, at least several hundred that got Janssen). The groups were having issues post vaccine, severe harm had been done.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inflammatory syndrome, vascular inflammation, multisystem inflammatory syndrome and platelet activation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a consumer  concerned  multiple patients (4 patients:)-2  women, 1 man  over 60 years of age, and 1 patient of  unknown age and sex, who experienced symptoms of  inflammatory syndrome, vascular inflammation, multisystem inflammatory syndrome, platelet activation unspecified time after vaccination . No past medical history or concomitant medications were reported.  On an unspecified date a consumer called in with specific questions about lot number 1805031. The consumer stated that in the local area there were 4 patients who received this specific lot number and experienced symptoms of: inflammatory syndrome, vascular inflammation, multisystem inflammatory syndrome, platelet activation . The outcome of the events is not reported. At the time of the report no other information is available. Information is limited in this case. Multisystem inflammatory syndrome could represent background incidence of such events in the general population. Therefore, the relationship of multisystem inflammatory syndrome, to vaccination is considered unclassifiable due to insufficient information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain
Clinical narrative: SORENESS; PAIN IN ARM FROM SHOULDER TO HAND; CHILLS; FEVER; NAUSEA; DIARRHEA; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: chocolate allergy, seasonal allergies, non alcohol user, non-smoker, and sulfa drug allergy. 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination. On 12-APR-2021, the patient experienced soreness. On 12-APR-2021, the patient experienced pain in arm from shoulder to hand. On 12-APR-2021, the patient experienced chills. On 12-APR-2021, the patient experienced fever. On 12-APR-2021, the patient experienced nausea. On 12-APR-2021, the patient experienced diarrhea. On 12-APR-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm from shoulder to hand on 12-MAY-2021, and chills, fever, nausea, and diarrhea on 15-APR-2021, and the outcome of headaches and soreness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: SORENESS; PAIN IN ARM FROM SHOULDER TO HAND; CHILLS; FEVER; NAUSEA; DIARRHEA; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: chocolate allergy, seasonal allergies, non alcohol user, non-smoker, and sulfa drug allergy. 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included mrna 1273 for prophylactic vaccination. On 12-APR-2021, the patient experienced soreness. On 12-APR-2021, the patient experienced pain in arm from shoulder to hand. On 12-APR-2021, the patient experienced chills. On 12-APR-2021, the patient experienced fever. On 12-APR-2021, the patient experienced nausea. On 12-APR-2021, the patient experienced diarrhea. On 12-APR-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in arm from shoulder to hand on 12-MAY-2021, and chills, fever, nausea, and diarrhea on 15-APR-2021, and the outcome of headaches and soreness was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test, SARS-CoV-2 test positive, Thrombosis
Clinical narrative: STROKE; BLOOD CLOT; COVID-19 TEST POSITIVE; This spontaneous report received from a consumer via social media 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 not reported, batch number: Unknown and expiry: Unknown) dose, 1 total, 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, less than a week later after vaccination the patient was at the emergency room and tested positive for Covid-19. Later the patient experienced a stroke and a blood clot on brain. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, blood clot and covid-19 test positive was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000200514; Sender's Comments: V0- 20211110611- covid-19 vaccine ad26.cov2.s- Stroke, Blood clot. 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: Inappropriate schedule of product administration, Portal vein thrombosis, Splenic vein thrombosis
Clinical narrative: SPLENIC VEIN THROMBOSIS; PORTAL VEIN THROMBOSIS; RECEIVED THE DOSE OF THE PFIZER COVID VACCINE THAT WAS NOT RECONSTITUTED; This spontaneous report received from a health care professional (nurse) concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: type 2 diabetes since 2012, diabetic neuropathy, and hypertension since 2007. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: unknown) dose was not reported, 1 total, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included Pfizer COVID Vaccine (BNT 162) for booster on 25-OCT-2021 administered to left arm deltoid. On an unspecified date, the patient had splenic vein thrombosis and portal vein thrombosis. On 21-SEP-2021, the patient was hospitalized for 2 days and discharge on 23-SEP-2021. On 25-OCT-2021, the patient received the dose of the pfizer covid vaccine that was not reconstituted (Inappropriate schedule of vaccine administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the splenic vein thrombosis, portal vein thrombosis and received the dose of the pfizer covid vaccine that was not reconstituted was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211110785-COVID-19 VACCINE AD26.COV2.S-splenic vein thrombosis, portal vein thrombosis. 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: Cerebrovascular accident, Myocardial infarction
Clinical narrative: HEART ATTACK; STROKE 2 WEEKS AFTER VACCINATION; This spontaneous report received from a consumer via a company representative via social media concerned a 40 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. Patient was healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The reporter stated that "My best friend's fiance had a heart attack and a stroke 2 weeks after getting the Johnson and Johnson vaccine. He was 40 and healthy".. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the heart attack and stroke 2 weeks after vaccination was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211112281-COVID-19 VACCINE AD26.COV2.S-Heart attack, stroke 2 weeks after vaccination. 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: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a 6 decade old female of unknown 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 not reported, batch number: Unknown, Expiry: UNKNOWN) dose, start therapy date were not reported, 1 total 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. The reporter reported that his mother was a healthy woman in her 50s. She got the vaccine in the spring. Reporter was so afraid for her. On 04-NOV-2021, patient had a stroke in the morning and was in the hospital (Number of days hospitalized not reported). Patient was just at doctors for yearly and was healthy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211112386-covid-19 vaccine ad26.cov2.s-stroke. 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: U
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Dyspnoea, Exercise electrocardiogram, General physical health deterioration
Clinical narrative: FEELING LIKE HAD 2 HEART ATTACKS; BOTTOM OF MY HEART IS NOT RECOVERING; SERIOUS HEALTH ISSUES; CONSTANTLY OUT OF BREATH/STRUGGLE TO BREATH; RUN DOWN AND TIRED; NEVER HAVING ENERGY; EARS ARE SCREAMING CONSTANTLY; 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. The patient's concurrent conditions included: genetic high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after having the Johnson & Johnson vaccine the patient experienced serious health issues. The patient reported that, the bottom of heart is not recovering from a tread mill test which was done due to the patient feeling like had 2 heart attacks. The patient had performed with scan to see if there was any blockage to arteries, since patient had genetic high cholesterol, results shows zero build up in main arteries. But patient experienced constantly out of breath with no excursion and struggle to breath. The patient also experienced ears are screaming constantly, run down and tired, and never having energy. Laboratory data (dates unspecified) included: Scan (NR: not provided) Zero build up (blockage), and Treadmill test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bottom of my heart is not recovering, and the outcome of serious health issues, feeling like had 2 heart attacks, constantly out of breath/struggle to breathe, ears are screaming constantly, run down and tired and never having energy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211112604-COVID-19 VACCINE AD26.COV2.S-feeling like had 2 heart attacks. 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: U
Vaccine: COVID19
Symptoms: Malaise, Myocardial infarction, Scan, Tinnitus
Clinical narrative: FEELING LIKE HAD 2 HEART ATTACKS; BOTTOM OF MY HEART IS NOT RECOVERING; SERIOUS HEALTH ISSUES; CONSTANTLY OUT OF BREATH/STRUGGLE TO BREATH; RUN DOWN AND TIRED; NEVER HAVING ENERGY; EARS ARE SCREAMING CONSTANTLY; 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. The patient's concurrent conditions included: genetic high cholesterol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, after having the Johnson & Johnson vaccine the patient experienced serious health issues. The patient reported that, the bottom of heart is not recovering from a tread mill test which was done due to the patient feeling like had 2 heart attacks. The patient had performed with scan to see if there was any blockage to arteries, since patient had genetic high cholesterol, results shows zero build up in main arteries. But patient experienced constantly out of breath with no excursion and struggle to breath. The patient also experienced ears are screaming constantly, run down and tired, and never having energy. Laboratory data (dates unspecified) included: Scan (NR: not provided) Zero build up (blockage), and Treadmill test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bottom of my heart is not recovering, and the outcome of serious health issues, feeling like had 2 heart attacks, constantly out of breath/struggle to breathe, ears are screaming constantly, run down and tired and never having energy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211112604-COVID-19 VACCINE AD26.COV2.S-feeling like had 2 heart attacks. 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: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gait disturbance, Impaired work ability, Malaise
Clinical narrative: INTENSE INCREASED HEART PALPITATIONS; SHORTNESS OF BREATH (SOMETIMES); DIFFICULTY WALKING (HARD TO WALK FROM ROOM TO ROOM IN APARTMENT)/SHUFFLES FEET (ALSO USES A WALKER); REDUCED MOBILITY; INTERFERENCE WITH WORK DAY (TRIES TO WORK AT DESK BUT HAS TO LAY DOWN AND REST) / NOT ABLE TO FUNCTION; RASH ON LOWER BACK; NOT FEELING WELL; TIREDNESS; TINGLING IN THE LEFT CHEEK; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included: heart palpitations, and concurrent conditions included: advanced arthritis in the lower back and in the knee, sinus mass on left cheek cavity, existential tremor, aneurysm (stable), bad night vision, and irregular blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced intense increased heart palpitations, shortness of breath (sometimes), difficulty walking (hard to walk from room to room in apartment) /shuffles feet (also uses a walker), reduced mobility, interference with work day (tries to work at desk but has to lay down and rest) / not able to function, rash on lower back, not feeling well, tiredness, and tingling in the left cheek. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (sometimes), tingling in the left cheek, difficulty walking (hard to walk from room to room in apartment)/shuffles feet (also uses a walker), intense increased heart palpitations, not feeling well, reduced mobility, rash on lower back, tiredness, and interference with work day (tries to work at desk but has to lay down and rest) / not able to function. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Palpitations, Paraesthesia, Rash
Clinical narrative: INTENSE INCREASED HEART PALPITATIONS; SHORTNESS OF BREATH (SOMETIMES); DIFFICULTY WALKING (HARD TO WALK FROM ROOM TO ROOM IN APARTMENT)/SHUFFLES FEET (ALSO USES A WALKER); REDUCED MOBILITY; INTERFERENCE WITH WORK DAY (TRIES TO WORK AT DESK BUT HAS TO LAY DOWN AND REST) / NOT ABLE TO FUNCTION; RASH ON LOWER BACK; NOT FEELING WELL; TIREDNESS; TINGLING IN THE LEFT CHEEK; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included: heart palpitations, and concurrent conditions included: advanced arthritis in the lower back and in the knee, sinus mass on left cheek cavity, existential tremor, aneurysm (stable), bad night vision, and irregular blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced intense increased heart palpitations, shortness of breath (sometimes), difficulty walking (hard to walk from room to room in apartment) /shuffles feet (also uses a walker), reduced mobility, interference with work day (tries to work at desk but has to lay down and rest) / not able to function, rash on lower back, not feeling well, tiredness, and tingling in the left cheek. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath (sometimes), tingling in the left cheek, difficulty walking (hard to walk from room to room in apartment)/shuffles feet (also uses a walker), intense increased heart palpitations, not feeling well, reduced mobility, rash on lower back, tiredness, and interference with work day (tries to work at desk but has to lay down and rest) / not able to function. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED PRODUCT ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced expired product administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired product administered was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: VACCINE WAS ADMINISTERED 2 DAYS AFTER THE VIAL WAS PUNCTURED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 04-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-NOV-2021, the patient experienced vaccine was administered 2 days after the vial was punctured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was administered 2 days after the vial was punctured was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: CONSTANT PAIN IN LEFT ARM; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced constant pain in left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from constant pain in left arm. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood
Clinical narrative: EUPHORIA AND LAUGHING LIKE LITTLE GIRL; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 02-APR-2021 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 euphoria and laughing like little girl. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from euphoria and laughing like little girl. This report was non-serious. This case, from the same reporter is linked to 20211115380.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: DIZZINESS; 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 was not reported, administered on MAY-2021 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 dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness. This report was non-serious.