chrisvoncsefalvay/vaers-outcomes huggingface dataset:
did not prevent shingles as intended; persistent strain of herpes zoster/ severe herpes zoster or shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  In 2016, the patient was inoculated in the medical center with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and she subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated by healthcare provider for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles, she suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not reported.  The events were considered to be related to zoster vaccine live (ZOSTAVAX).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA005082: US-009507513-1910USA005081: US-009507513-1910USA005066: US-009507513-1910USA005083:
No adverse effect reported; received improperly stored PROQUAD; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), with lot# S021617 with expiration date on 09-JAN-2021 for prophylaxis (dose and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion -14°C to -10°C degrees Celsius (-11.7C) for 2  hours 35 minutes.   There was no adverse effect reported.  This call was because of a data logger with no previous temperature excursion.
Had prev rxn to DTP/HIB/OPV 13DEC91 pt recvd DT/HIB 23MAR92; woke w/swollen face, fussiness, not wanting bottle; seen by MD 24MAR92 approx 3PM; edema or swelling of upper & lower eyelids, erythemous rash both cheeks;
Fever on night of vaccines (9/1/2017). Rash and fever 10 days later (9/10/2017). Rash started on inner thigh, belly button, and chin...in 4 hours had spread to legs, face, eyelid...12 hours in was everywhere and she was running a fever of 102 F.
I had vaccination on 06/24/2022. On 06/30/2022 I woke up and had deep stabbing pain in my chest on the left side. I felt weird pain in my left arm. Over the course over the last few months the pain has spread. My heart skips beats pain in toes and knuckles with joint pain. It is terrifying and I don't know why it has progressed. The pain is between my ribs and pain all over. It feels like my nerves are on fire. I have a appointment with neurologist and PCP in October and November 2022.
Adult patient was given the Moderna 6mo-5 year bivalent vaccine.  Patient was given 0.5 mls.  The provider was informed. Pharmacy was contacted who recommended repeat vaccination of appropriate age group vaccine in its full dose.   The patient was informed of the inaccurate vaccine administration and the recommendation to receive an additional vaccine at her earliest convenience.  patient verbalized understanding of this.
received her 1st dose on 04Jan2021 and 2nd dose on 30Jul2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her 1st dose on 04Jan2021 and 2nd dose on 30Jul2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her 1st dose on 04Jan2021 and 2nd dose on 30Jul2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received her 1st dose on 04Jan2021 and 2nd dose on 30Jul2021) had resolved.            Concomitant medication was not provided. Treatment information was not provided.
she now has blood clots and received the first dose in July and second in August, on the 14th; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional via Medical Information Team. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route, on an unspecified date in Jul2021 as dose 1, single for COVID-19 immunisation. On an unspecified date in 2021, the patient has blood clots and received the first dose in july and second in august, on the 14th, she didn't know if it was related or not but she thought she would report it. She wanted to know if any study on things that happened or not to people after the vaccines. The event was medically significant. Outcome of the event was unknown.  The Lot number for BNT162b2 was not provided and will be requested during follow up.
2-shot vaccine and shingles/suspected vaccination failure; Very bad shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 21-Aug-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (reporter's sister) currently have had very bad shingles and both of them had the updated 2 shot vaccine. The reporter stated that but it was still a good idea to get the vaccine, as it apparently did work for most people, just not for everyone. The case was linked with case US2022AMR125478, reported by same reporter for different patient. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR125478:Same reporter
This spontaneous case reported by a consumer, describes the occurrence of dizziness in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 011A21A) for COVID-19 immunization. Concomitant products included levothyroxine for an unknown indication. On Feb 25, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 4, 2021, patient experienced dizziness. On Mar 8, 2021, dizziness resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No treatment information provided.
Cough, shortness of breath, headache, dry mouth, fatigue, body aches, and runny nose, all starting 2/4/21.  No known COVID-19 exposures.  Patient presented to ED on 2/8/21 stating she was using her albuterol inhaler frequently with no relief and felt like she was having difficulty breathing. SpO2 was 99% during ED visit on room air. Patient had a negative rapid COVID-19 test, however chest CT with contrast revealed pulmonary infiltrates consistent with COVID-19 pneumonia. Patient will have PCR testing performed, results pending.   Patient is being discharged to home with azithromycin,  and prednisone.  She has been instructed to continue self-isolation until the PCR test results.
It was the time when Shingrix was very hard to get / couldn't find the vaccine available; This case was reported by a pharmacist via call center representative and described the occurrence of product supply issue in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 7th Jnauary 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter did not have the lot number or expiration date of the vaccine at the time of the call. The reporter stated that, it was the time when Shingrix was very hard to get, the patient called several times to the pharmacy.could not find the vaccine available.The patient went back to the pharmacy today asking to get the 2nd dose. The patient had not received the second dose at the time of the call. Till the time of reporting, the patient did not receive 2nd dose of Shingrix. The reporter did not consented to follow up.
Note:  Initial date is an estimate based on patient scheduled to get 2nd dose on 4/19.  Patient with acute DVT noted.  Note, per patient, he has a history of multiple DVT in the past and was prescribed to be on medication for this, which he stopped years ago.     Patient placed on anticoagulation for acute DVT, seeing specialty to look for possible cause of hypercoagulability.  Patient saw me first for diagnosis of acute DVT, so history prior to this is limited and based on patient's report.
fever v lethargy to ER; pt recv vax dx meningoencephalitis, presumed viral;brain stem/mid brain dysfunction w/cheyenne stokes breathing requiring mechanical ventilator support;probable hepatitis;mild oral-tracheal aspiration;poss sz;
Patient given Pfizer 0.3 mL dose not the 0.2 mL dose that would have been appropriate for an 11 year old.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.  It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional reported that, the patient experienced Shingles after having the SHINGRIX. The healthcare professional declined to provide any additional information including product and patient identifiers.
bigger red spots on [her] arms; mild rash on [her] chest and stomach; This is a spontaneous report from a contactable consumer (patient). A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration in Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Jan2021, the patient experienced bigger red spots on her arms, 2 days after the injection, and she cannot tell if they were there before. She added she now has a mild rash on her chest and stomach (in 2021). She asked if rashes can appear 2 weeks after the receipt of the vaccine, as a side effect. The outcome of the events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
non-arteritic anterior ischemic optic neuropathy; This is a spontaneous report from a contactable physician. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in the left arm on 27Feb2021 11:00 (lot number was not reported) at a single dose for COVID-19 immunisation, vaccinated in a hospital. Medical history included sinus inverted papilloma, hypercholesterolemia, gastrooesophageal reflux disease (GERD), coronary artery disease (CAD), and benign prostatic hyperplasia (BPH). Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]); azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]); colecalciferol (VITAMIN D [COLECALCIFEROL]); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]); metoprolol taken; naproxen; omeprazole (PROTONIX [OMEPRAZOLE]); ranitidine; rosuvastatin calcium (CRESTOR); solifenacin (SOLIFENACIN); all taken for an unspecified indication, start and stop date were not reported.  The patient previously took the first dose of BNT162B2 for COVID-19 Immunisation on 06Feb2021 at 11:00 intramuscularly on the left arm (lot number not reported); and has known allergies with tamsulosin. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. On 01Mar2021, the patient experienced non-arteritic anterior ischemic optic neuropathy. The event resulted in a physician visit, emergency room/urgent care, hospitalization and disability or permanent damage. The patient was hospitalized for four days. The patient was not COVID tested post vaccination. The patient received a steroid as treatment. The patient was recovering from the event.   Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This individual received Pfizer COVID vaccine dose #1 on 1-26-21. About an later he complained of chest pain and EMS called.
42 hours after started notice  noise is heard in the left ear.  Not sure about right ear.  Still the ringing noise on the left ear after  23 days. Checked with in ENT specialist and reported hear loss in the high frequency sound. It is TENNITUS.  22nd day I had a dizziness.
This case was reported by a pharmacist and described a 41 year old male patient who inadvertently received Hepatitis B vaccine recombinant that was stored above the recommended temperature.  Medical history included smoker.  The patient's concurrent conditions, and concurrent medications were not reported.  On 08/12/1992, the patient received the third dose of hepatitis B vaccine.  Approximately 13 years later, on 06/13/2005, a hepatitis B surface antibody titer measured less than 3.0 ml.  On 06/24/2005, the patient received a booster dose of Engerix-B.  The pharmacist reported that prior to the administration the Engerix B "had been stored outside of refrigeration since 06/20/2005".  The recommended storage for Engerix-B is refrigeration between 2 and 8 Celsius.  As of 08/12/2005, no adverse event had occurred.  The reporting pharmacist stated that a follow-up titer would be performed to determine the effectiveness of the Engerix-B booster dose.  In the pharmacist's opinion, the event was possibly related to vaccination with Engerix-B.
pt recv vax & had 3-4hr of severe crying;doing well 2 days later;
no adverse event; patient received expired Moderna Covid-19 monovalent vaccine; patient received a mixed series for his primary vaccine dose, The patient received Pfizer for for his first dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 monovalent vaccine), INTERCHANGE OF VACCINE PRODUCTS (patient received a mixed series for his primary vaccine dose, The patient received Pfizer for for his first dose) and NO ADVERSE EVENT (no adverse event) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 051B22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose) on 24-Jun-2022. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 02-Dec-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 02-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 monovalent vaccine) and INTERCHANGE OF VACCINE PRODUCTS (patient received a mixed series for his primary vaccine dose, The patient received Pfizer for for his first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 monovalent vaccine), INTERCHANGE OF VACCINE PRODUCTS (patient received a mixed series for his primary vaccine dose, The patient received Pfizer for for his first dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 monovalent vaccine) and INTERCHANGE OF VACCINE PRODUCTS (patient received a mixed series for his primary vaccine dose, The patient received Pfizer for for his first dose).    Concomitant product use was not provided by the reporter.  The patient received a mixed series for his primary vaccine dose. More than 35 days had passed in between Moderna Primary Series Covid-19 vaccines.  The patient received expired Moderna Covid-19 monovalent vaccine for his second dose of the Moderna Covid-19 vaccine primary series.  Treatment information was not provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 at 12:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jun2023, 8 months 16 days 11 hrs 30 min after the suspect product(s) administration, outcome "unknown", COVID-19 (medically significant) with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Paxlovid was taken from 29Jun2023 to 03Jul2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Initial misuse report received from a healthcare professional on 06 June 2013. A dose of Tetanus vaccine (manufacturer: unknown) that had expired on 8 February (year not provided) was administered to a patient on 08 May (year not provided). No adverse event was reported. List of documents held by sender: none.
This spontaneous report as received from a registered nurse refers to an unspecified patients of unknown age and gender. On an unknown date 6 doses of ROTATEQ (dose, route of administration, LOT# and expiration dates were not provided) all of which reached the temperature outside the product information, have been administered to unspecified patients. The temperature was supported. No adverse effects were reported. This is one of several reports from the same source (MARRS # 1406USA008283, 1406USA008284, 1406USA008285). Additional information has been requested.
Hepatitis B surface antibody negative; Literature Report.  This literature marketed report has been received from authors of a published literature article, title as stated above, referring to a 52 patients of unknown age and gender.   On an unspecified date, the patients were vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (strength, dose, frequency, route of administration, lot# and expiration date were not reported).  On an unspecified date, revaccination was recommended for the patients due to they were hepatitis-B non-immune (hepatitis B surface antibody negative).  The authors considered the hepatitis B surface antibody negative to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown).  A copy of the published article is attached as further documentation of the patient's experience.
Received injection about 2:30 PM. No adverse reactions that day, woke up around 6:00 AM with significant headache and muscle stiffness.  As I get migraines on occasion, I took a course of Sumatripin and got only slight relief.  That entire day I had extreme fatigue and muscle stiffness, and later that evening I developed a fever of 100.1 (which was controlled by Tylenol).  The injection site was the size and pain as a wasp sting.  The next day continued the fatigue and muscle stiffness, but none of the reactions got worse.  The  following day (today as I submit this) the fatigue and stiffness isn't as pronounced, though the injection site is still large, swollen and painful.
Numbness is vaginal area and buttocks.  She could not feel herself pee, tiredness, achy, fever, headache.