chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccine positive rechallenge
Clinical narrative: shingles; I got my second shot this morning. It hurts; This non-serious 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.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received 1st dose on an unknown date and had shingles, refer case US2023AMR038408).   On 03-JUL-2023, the patient received the 2nd dose of Shingles vaccine. On 03-JUL-2023, less than a day after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles) and pain (Verbatim: I got my second shot this morning. It hurts). Rechallenge with Shingles vaccine was positive. The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the shingles and pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR038408   Additional Information: GSK receipt date: 03-JUL-2023 The case was received from the patient via interactive digital media. The patient got the second shot this morning (on the day of reporting) and it hurts, but not as much as shingles. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR038408:1st dose case
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Internal pain; Moves from neck; It moves from neck to hips; It moves from shoulder blades; No sores but feels like a knife in my back; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Internal pain), neck pain (Verbatim: Moves from neck), pain in hip (Verbatim: It moves from neck to hips), shoulder blade pain (Verbatim: It moves from shoulder blades) and back pain (Verbatim: No sores but feels like a knife in my back). The outcome of the pain, neck pain, pain in hip, shoulder blade pain and back pain were not resolved.   It was unknown if the reporter considered the pain, neck pain, pain in hip, shoulder blade pain and back pain to be related to Shingles vaccine.     It was unknown if the company considered the pain, neck pain, pain in hip, shoulder blade pain and back pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she got the vax 2 of them over 5 years ago now.  Patient stated he/she older and suffer from internal pain.  Patient stated it moves from neck to hips and shoulder blades.  Patient had no sores but he/she feels like a knife in back. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received both the adjuvant and a full dose of Shingrix; patient received both the adjuvant and a full dose of Shingrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-JUN-2023, the patient received Shingrix. On 20-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received both the adjuvant and a full dose of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient received both the adjuvant and a full dose of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 3-JUL-2023 A nurse practitioner called in to report that a patient received both the adjuvant and a full dose of Shingrix and wished to know if there was any information. The Vaccine Administration Facility was the same as primary reporter. Partial information about vaccine, patient and event collected.  Follow up was declined. Did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received 2nd dose yet; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11 July 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 05-JUL-2023 The nurse reported that a patient received first dose of Shingrix and he had not received a second dose. The reporter did not have the dose lot number / expiration date information.  At the time of reporting, second dose had not been administered.  The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination .
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Engerix-B dose expired on 7/3/2023 and was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B adult) (batch number S73DG, expiry date 03-JUL-2023) for prophylaxis.   On 05-JUL-2023, the patient received the 2nd dose of Engerix B adult. On 05-JUL-2023, an unknown time after receiving Engerix B adult, the patient experienced expired vaccine used (Verbatim: Engerix-B dose expired on 7/3/2023 and was administered to a patient). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 5-Jul-2023 and 6-Jul-2023 The registered nurse only provided gender of the patient. Lot number S73DG did not identify as a valid lot number but was repeated back to the reporter and F73DG did identify as a valid Engerix-B dose, but was not provided by the reporter. No additional adverse event or product quality complaint. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received an expired dose of Engerix-B adult, which led to expired vaccine used.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: extra dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 2-year-old male patient who received HAV (Havrix) (batch number 943Y2, expiry date 05-MAY-2025) for prophylaxis.   Previously administered products included Havrix (dose one was given on 8th July 2022) and Havrix (dose two was given on 9th January 2023).   On 06-JUL-2023, the patient received the 3rd dose of Havrix. On 06-JUL-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: extra dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 Medical Assistant stated that a patient was inadvertently given a third dose of Havrix in error, which let to extra dose administered. The vaccine administration facility was the same as primary reporter. No further details given, and medical assistant did not consent to follow up from safety.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: pharmacy administered Trumenba instead of Bexsero; This non-serious case was reported by a physician via call center representative and described the occurrence of interchange of vaccine products in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 02-JUN-2023, the patient received the 1st dose of Bexsero. On 05-JUL-2023, the patient received TRUMENBA. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: pharmacy administered Trumenba instead of Bexsero). The outcome of the interchange of vaccine products 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 Information: GSK receipt date: 6-Jul-2023 The case was reported by Dentist. The reporter gave permission for follow-up. The patient received first dose of Bexsero and went back to the pharmacy for the second dose, but the pharmacy administered Trumenba instead of Bexsero, which led to interchange of vaccine products.
Age: 18.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: patient was not given Bexsero but a different brand; This non-serious case was reported by a consumer via call center representative and described the occurrence of interchange of vaccine products in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) (batch number ER2621, expiry date DEC-2023) for prophylaxis.   On 02-JUN-2023, the patient received the 1st dose of Bexsero. On 05-JUL-2023, the patient received TRUMENBA. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: patient was not given Bexsero but a different brand). The outcome of the interchange of vaccine products 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 Information: GSK receipt date: 6-Jul-2023 The case was reported by the patient's parent. The patient was administered the vaccine at a local pharmacy. The reporter was told that the patient would be getting a 2nd dose in 30 days. Not all information was available. The reporter did not provide consent to follow-up with health care professional. The reporter did not consent to follow-up. The patient received a dose of Trumenba after Bexsero first dose, which led to interchange of vaccine products.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient has come to get the second dose of Shingrix, however, her first dose was 7 months ago/late dose; This non-serious case was reported by a pharmacist 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 first dose 7 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient has come to get the second dose of Shingrix, however, her first dose was 7 months ago/late dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Jul-2023 The health care professional (pharmacist) called on the day of reporting stating the patient had come to get the second dose of Shingrix. No further information was known. Minimal amount of information was obtained to file adverse event. The adverse event filed after call disconnected. The consent was not asked. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: administration of expired dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA714A, expiry date 30-JUN-2023) for prophylaxis.   On 06-JUL-2023, the patient received Menveo. On 06-JUL-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: administration of expired dose of Menveo). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received a dose of Menveo which was already expired on 30th June 2023, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than Recommended Interval; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 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, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than Recommended Interval). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-JUL-2023 The patient had not gotten his/her second dose within the 6 month window, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: Injury
Clinical narrative: GOT INJURED; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced got injured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got injured was not reported. This report was non-serious. This case, from the same reporter is linked to 20230708559 and 20230639668.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: Side effects of previous vaccinations were painful; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (Side effects of previous vaccinations were painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In August 2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In September 2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2022, received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Side effects of previous vaccinations were painful). At the time of the report, IMMUNISATION REACTION (Side effects of previous vaccinations were painful) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  Treatment Medication use information was not provided by reporter.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Therapeutic response unexpected
Clinical narrative: My bronchial asthma had already disappeared after the second vaccination with Moderna's vaccine; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (My bronchial asthma had already disappeared after the second vaccination with Moderna's vaccine) and NO ADVERSE EVENT (No adverse event) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Bronchial asthma (I have had asthma since I was about 14).    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (My bronchial asthma had already disappeared after the second vaccination with Moderna's vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (My bronchial asthma had already disappeared after the second vaccination with Moderna's vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant medication was not reported.  Patient reported that bronchial asthma had already disappeared after the second vaccination with Moderna's vaccine against the coronavirus. Also mentioned that luckily it did not change after the third vaccination.  Treatment medication was not reported.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacy administer 1 vaccination for lot number 045H22A that expired on 6-12-23; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacy administer 1 vaccination for lot number 045H22A that expired on 6-12-23) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 045H22A) for COVID-19 prophylaxis.     It was unknown whether the patient had received any previous COVID-19 vaccination doses. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Diabetic.    On 06-Jul-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacy administer 1 vaccination for lot number 045H22A that expired on 6-12-23). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacy administer 1 vaccination for lot number 045H22A that expired on 6-12-23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacy administer 1 vaccination for lot number 045H22A that expired on 6-12-23).    No concomitant medication was reported. The expiry date was reported as 12-Jun-2023. No treatment medication was reported.
Sex: F
Vaccine: PNC20
Symptoms: Reaction to excipient
Clinical narrative: Does Prevnar 20 have polysorbate 80?  She's not even sure if that is what she had the reaction to, but she has had chemo and she knows you can develop allergies at any time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "asplenia" (ongoing), notes: 70 year old with asplenia/ she does not have a spleen; "chemotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Trumenba (2018/2019), for immunisation, reaction(s): "no adverse effect"; Shingrix, for immunisation, reaction(s): "adverse event NOS". The following information was reported: REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "Does Prevnar 20 have polysorbate 80?  She's not even sure if that is what she had the reaction to, but she has had chemo and she knows you can develop allergies at any time".  Additional information: The patient was asking if Prevnar 20 has polysorbate because she's not even sure if that is what she had an reaction to. But, she has had chemo and she knows that a person can develop allergies at any time. They're kind of at crossroads with that one too because they're saying Prevnar 20 has Polysorbate 80.  She had the meningitis vaccine back in 2018/2019 with no problems, just from Shingrix.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Pfizer / BioNTech, Dose Number: 4; Moderna, Dose Number: 1, 2, 3, 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 66 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Dec2020 as dose 1, single (Batch/Lot number: unknown), on 03Feb2021 as dose 2, single (Lot number: 032L20A), on 02Nov2021 as dose 3 (booster), single (Lot number: 012F21A) and on 10Sep2022 as dose 5 (booster), single (Lot number: AS7415B) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 09Apr2022, outcome "unknown", described as "Pfizer / BioNTech, Dose Number: 4; Moderna, Dose Number: 1, 2, 3, 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was treated with Paxlovid from 25Jun2023 to 30Jun2023.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive on 13Jun2023; tested positive; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 58 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Feb2021 as dose 1, single (Lot number: EL9261), in left arm, on 01Mar2021 as dose 2, single (Lot number: EN6202), in left arm, on 01Nov2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "hyperlipidimia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 13Jun2023 at 22:00, outcome "recovering", described as "Patient tested positive on 13Jun2023"; COVID-19 (medically significant) with onset 13Jun2023 at 22:00, outcome "recovering", described as "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2023) positive, notes: tested positive; (17Jun2023) Negative, notes: Testing Negative; (18Jun2023) Negative, notes: Testing Negative; (19Jun2023) Negative, notes: Testing Negative; (20Jun2023) Negative, notes: Testing Negative; (21Jun2023) Negative, notes: Testing Negative; (22Jun2023) Negative, notes: Testing Negative; (23Jun2023) Negative, notes: Testing Negative; (23Jun2023) positive, notes: at 22:00 test positive again; (01Jul2023) negative, notes: test negative; (03Jul2023) positive, notes: test positive again; (05Jul2023) negative, notes: test negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.; Sender's Comments: Based on the available information, reported events 'vaccination failure' and 'COVID-19' were likely related to the suspect product due to an established temporal association.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Erythema
Clinical narrative: Bruising and redness covered much of the arm that occurred within days of the injection.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Extra dose administered, No adverse event, Product preparation error
Clinical narrative: Medical assistant administered just the liquid from the menveo without it being mixed with the powder. After consulting with my superiors and doing research of the menveo website, it was decided to give another dosage for full coverage.  The patient was given the MenquadFi 20 mins later to give full coverage. No symptoms to report at this time.
Age: 64.0
Sex: F
Vaccine: COVID19-2, COVID19-2, COVID19-2
Symptoms: COVID-19
Clinical narrative: SECONDARY PROBLEM(S):     COVID-19 -  incidental on admission swab.   no respiratory symptoms, on room air - de-isolation date 7/11/2023
Age: 13.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: There were no adverse events after vaccine given
Age: 81.0
Sex: U
Vaccine: UNK
Symptoms: COVID-19
Clinical narrative: COVID-19 - asymptomatic, on room air - enhanced precautions while in the hospital - will not need isolation upon discharge for home health
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Mood swings, Oligomenorrhoea
Clinical narrative: 30 day long periods, have happened 4 times since the COVID Pfizer vaccine, have never happened before.y periods in general contained a heavier flow, crippling cramps that made me incapacitated to do anything but sleep, and stronger mood swings.
Age: 30.0
Sex: F
Vaccine: COVID19-2, HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Tolerated well, observed for 15 minutes.  Heplisav-B was not recommended, patient received childhood series.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Swelling
Clinical narrative: Awakened with severe nausea and vomiting at 1 am the morning after the injection (approximately 9 hours after injection). Significant local swelling, redness and tenderness also present at injection site. Persistent emesis for hours over the course of the day of 5/18/2023. No other notable reaction.  Resolved without medical intervention.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Awakened with severe nausea and vomiting at 1 am the morning after the injection (approximately 9 hours after injection). Significant local swelling, redness and tenderness also present at injection site. Persistent emesis for hours over the course of the day of 5/18/2023. No other notable reaction.  Resolved without medical intervention.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Developed rash on my back, stomach, arms, and legs the day after receiving the vaccine.  Rash disappeared on the fourth day after receiving the shot.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pt has had a sore arm ever since the injection, it has now been over 2 months.  There is nothing visible on the skin; the pain is all on the interior/muscle.
Age: 4.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna vaccine was thawed on 5/17 and administered on 6/26/23 (10 days past the 30-day stability date). When outreaching Moderna for extended stability data, a lot assessment was conducted and it was determined the lot was active against COVID-19 at this time interval. Patient has not reported any adverse effects to date.
Age: 1.25
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna vaccine was thawed on 5/17 and administered on 6/23/23 (7 days past the 30-day stability date). When outreaching Moderna for extended stability data, a lot assessment was conducted and it was determined the lot was active against COVID-19 at this time interval. Patient has not reported any adverse effects to date.
Age: 1.5
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna vaccine was thawed on 5/17 and administered on 6/23/23 (7 days past the 30-day stability date). When outreaching Moderna for extended stability data, a lot assessment was conducted and it was determined the lot was active against COVID-19 at this time interval. Patient has not reported any adverse effects to date.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling
Clinical narrative: Inflammation at site of injection: Swelling, red, raised, itchy
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested + for covid on 12-12-2022 at CLINIC.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested + for covid at  Facility 3-14-23 HEALTHCARE SERVICE AREA
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site rash, Pruritus, Pyrexia
Clinical narrative: Day 1--2: Fatigue, shivers, fever. Day 3: Localized macular hive like rash below the injection site, extending to lower upper arm (above the elbow). Mild itchiness.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular, Urticaria
Clinical narrative: Day 1--2: Fatigue, shivers, fever. Day 3: Localized macular hive like rash below the injection site, extending to lower upper arm (above the elbow). Mild itchiness.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: TESTED + FOR COVID 7-25-2022
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Eye swelling, Full blood count normal, Hyperhidrosis, Lip swelling, Metabolic function test normal
Clinical narrative: Pt called out 10 minutes after vaccination was given complaining of throat swelling, wheezing, eye's swollen shut, lips swollen, sweating, vomiting, and itching all over. Multiple RNs and Dr. at bedside. IV inserted 50mg Benadryl given, 4mg of Zofran given, IV Decadron given, without improvement, O2 saturation declined to 80%, O2 administered via Non-rebreather at 5Ls. 25mg of Benadryl given. Pt weened off O2 after 20 minutes when O2 saturation was 93-95%. Pt stated she was feeling much better, her throat was just sore. 30 minutes later pt visibly looking so much better, swelling gone, O2 saturation normal, states she feels much better.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Oropharyngeal pain, Oxygen saturation decreased, Pharyngeal swelling, Pruritus, Vomiting
Clinical narrative: Pt called out 10 minutes after vaccination was given complaining of throat swelling, wheezing, eye's swollen shut, lips swollen, sweating, vomiting, and itching all over. Multiple RNs and Dr. at bedside. IV inserted 50mg Benadryl given, 4mg of Zofran given, IV Decadron given, without improvement, O2 saturation declined to 80%, O2 administered via Non-rebreather at 5Ls. 25mg of Benadryl given. Pt weened off O2 after 20 minutes when O2 saturation was 93-95%. Pt stated she was feeling much better, her throat was just sore. 30 minutes later pt visibly looking so much better, swelling gone, O2 saturation normal, states she feels much better.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Wheezing
Clinical narrative: Pt called out 10 minutes after vaccination was given complaining of throat swelling, wheezing, eye's swollen shut, lips swollen, sweating, vomiting, and itching all over. Multiple RNs and Dr. at bedside. IV inserted 50mg Benadryl given, 4mg of Zofran given, IV Decadron given, without improvement, O2 saturation declined to 80%, O2 administered via Non-rebreather at 5Ls. 25mg of Benadryl given. Pt weened off O2 after 20 minutes when O2 saturation was 93-95%. Pt stated she was feeling much better, her throat was just sore. 30 minutes later pt visibly looking so much better, swelling gone, O2 saturation normal, states she feels much better.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: no details available other than date of death
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram, Chest X-ray, Differential white blood cell count, Electrocardiogram, Fibrin D dimer
Clinical narrative: non-stop Tachycardia began at 8:00 pm; left arm near injection site was red, swollen, tender to touch.  Went to ER at around 0100 on 7/8/23 for tachycardia at 137 bpm where I was given medicine to slow my heart rate down. Red, swollen, and soreness for several inches around my injection site and continued for days.  As of today 7/10/23 it is still red and slightly less tender.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Full blood count, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: non-stop Tachycardia began at 8:00 pm; left arm near injection site was red, swollen, tender to touch.  Went to ER at around 0100 on 7/8/23 for tachycardia at 137 bpm where I was given medicine to slow my heart rate down. Red, swollen, and soreness for several inches around my injection site and continued for days.  As of today 7/10/23 it is still red and slightly less tender.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test, Scan with contrast, Tachycardia, Troponin I
Clinical narrative: non-stop Tachycardia began at 8:00 pm; left arm near injection site was red, swollen, tender to touch.  Went to ER at around 0100 on 7/8/23 for tachycardia at 137 bpm where I was given medicine to slow my heart rate down. Red, swollen, and soreness for several inches around my injection site and continued for days.  As of today 7/10/23 it is still red and slightly less tender.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 0.2ML of the 30mcg formula instead of the 10mcg formula.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given 0.2ML of the 30MCG formula instead of 0.2ML of the 10MCG formula.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given 0.2ML of the 30MCG formulation instead of 0.2ML of the 10MCG formula.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was  given 0.2ML of the 30MCG formula instead of 0.2ML of the 10MCG formula.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given 0.2ML of the 30MCG formula instead of 0.2ML of the 10MCG formula.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given 0.2ML of the 30MCG formula instead of 0.2ML of the 10MCG formula.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given 0.2ML of the 30MCG formula instead of 0.2ML of the 10MCG formula.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given 0.2ml of the 30mcg formula instead of 0.2ml of the 10mcg formula.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given 0.2ml of the 30mcg formula instead of 0.2ml of the 10mcg formula.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 0.2ml of the 30mcg formula instead of 0.2ml of the 10mcg formula.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 0.2ml of the 30mg formula instead of 0.2ml of the 10mcg formula.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 0.2ml of the 30mcg formula instead of 0.2ml of the 10mcg formula.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given 0.2ml of the 30mcg formula instead of 0.2ml of the 10mcg formula.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain in extremity, Peripheral swelling, Pharyngeal swelling
Clinical narrative: Arm became pain, red, swollen, warm to touch & within 8 hours, developed a shingles rash on right side of neck & chest, severe ear pain, throat feels swollen
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Arm became pain, red, swollen, warm to touch & within 8 hours, developed a shingles rash on right side of neck & chest, severe ear pain, throat feels swollen
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORUMLA,
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Injection site erythema
Clinical narrative: large erythematous area on 2/3rd of R arm, above elbow. This is where Trumenba was administered.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT WAS GIVEN 0.2ML OF THE 30MCG FORMULA INSTEAD OF 0.2ML OF THE 10MCG FORUMLA,
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VACCINE AFFECTED BRAIN IN A HORRIBLE WAY; This spontaneous report received from a patient concerned a 6 decade old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 54 years old. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine affected brain in a horrible way. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccine affected brain in a horrible way. This report was non-serious.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Eye discharge, Pyrexia
Clinical narrative: presented with dizziness, headache, eye pain. Patient was diagnosed with fever, headache, and acute conjunctivitis.; presented with dizziness, headache, eye pain. Patient was diagnosed with fever, headache, and acute conjunctivitis.; presented with dizziness, headache, eye pain. Patient was diagnosed with fever, headache, and acute conjunctivitis.; presented with dizziness, headache, eye pain. Patient was diagnosed with fever, headache, and acute conjunctivitis.; Information has been received from a medical assistant, referring to a 12 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-MAY-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (lot #, expiration date, strength, administration route and anatomical location was not provided).  Later, on 21-JUN-2023, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W027455, expiration date: 04-JAN-2025, administered intramuscularly for prophylaxis (strength was not provided).  On 22-JUN-2023, the patient was seen by a physician and presented with dizziness, headache, eye pain. Then, the patient was diagnosed with fever, headache, and acute conjunctivitis (onset of the events was June 2023).  At the time of reporting, the outcome of all the events presented was unknown and the causal relationship between dizziness, headache, eye pain, fever and acute conjunctivitis was not provided.
Age: 11.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness, Eye pain, Headache, Pyrexia
Clinical narrative: presented with dizziness, headache, eye pain. Patient was diagnosed with fever, headache, and acute conjunctivitis.; presented with dizziness, headache, eye pain. Patient was diagnosed with fever, headache, and acute conjunctivitis.; presented with dizziness, headache, eye pain. Patient was diagnosed with fever, headache, and acute conjunctivitis.; presented with dizziness, headache, eye pain. Patient was diagnosed with fever, headache, and acute conjunctivitis.; Information has been received from a medical assistant, referring to a 12 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 19-MAY-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered for prophylaxis (lot #, expiration date, strength, administration route and anatomical location was not provided).  Later, on 21-JUN-2023, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #W027455, expiration date: 04-JAN-2025, administered intramuscularly for prophylaxis (strength was not provided).  On 22-JUN-2023, the patient was seen by a physician and presented with dizziness, headache, eye pain. Then, the patient was diagnosed with fever, headache, and acute conjunctivitis (onset of the events was June 2023).  At the time of reporting, the outcome of all the events presented was unknown and the causal relationship between dizziness, headache, eye pain, fever and acute conjunctivitis was not provided.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Skin plaque, Weight
Clinical narrative: Increased plaques in the body; Reaction to Covid 19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SKIN PLAQUE (Increased plaques in the body) and IMMUNISATION REACTION (Reaction to Covid 19 vaccine) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis.    Patient had no known allergies.  Concurrent medical conditions included Psoriasis. Concomitant products included BACLOFEN from 17-May-2023 to an unknown date and SULINDAC from 07-May-2023 to an unknown date for an unknown indication.   On 31-Dec-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2023, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40MG/0.4ML Every 2 week. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN PLAQUE (Increased plaques in the body) and IMMUNISATION REACTION (Reaction to Covid 19 vaccine). At the time of the report, SKIN PLAQUE (Increased plaques in the body) and IMMUNISATION REACTION (Reaction to Covid 19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2023, Weight: weight gain.         The number was reported. In Jun-2023, patient had weight gain. Treatment medication was not reported. Reporter causality for weight gain with Moderna vaccine was given s not provided. Reporter causality for Humira for vaccination adverse reaction and skin plaque was reported as not provided and for weight gain was possible.
Age: 35.0
Sex: F
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional AE; Nurse reported 35-year-old patient received PROQUAD, instead of MMR II in her MMR/varicella series. Patient received both VARIVAX and PROQUAD yesterday. No additional AE/no PQC.; Patient received both VARIVAX and PROQUAD yesterday; This spontaneous report was received from a nurse and refers to a 35 year old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 20-JUN-2023 (also reported as yesterday), the patient was vaccinated with on dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # W024547, expiration date: 31-JAN 2024) upon internal review stablished as therapy type rHA (dose, route of administration, anatomical location not provided) as prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) in her vaccination series (wrong product administered). On the same date, she received varicella virus vaccine live (oka/merck)(VARIVAX) (overdose) (lot #, expiration date, dose, route of administration, anatomical location not provided) as prophylaxis.  No additional adverse events were reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported.; A HCP called and reported an AE where an improperly stored dose of VARIVAX was administered to a patient.; This spontaneous report has been received from a medical assistant referring a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant medications were not provided.  On 22-JUN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection (lot number W039292 was determined to be a valid lot number, expiry date 11-DEC-2024) (strength, dose, frequency, and administration route were not provided) (Product storage error ) concomitantly with a sterile diluent (strength, dose, frequency, administration route, indication, lot number, and expiry date were not provided) both indicated as prophylaxis.  The varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccine was stored at a temperature of 31.8 F (Fahrenheit) for a time frame of 11 hours and 43 minutes. There was no previous temperature excursion.  No additional adverse events were reported.