chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body weakness; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st June 2021, the patient received the 1st dose of Shingrix (intramuscular). On 1st June 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On 2nd June 2021, the patient experienced weakness generalized. On an unknown date, the outcome of the pain in arm and weakness generalized were recovered/resolved.   The reporter considered the pain in arm and weakness generalized to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient had received the vaccine in the left deltoid. The patient stated that after getting the shingrix shot, he had arm soreness that lasted about 2 days after the vaccination and the day following his shot, he had body weakness.  All of his symptoms had resolved.  The patient did not consent to follow-up and no health care professional was provided.
Suspected vaccination failure; I got the shot and then a month later I got shingles; it was still painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 month after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I got the shot and then a month later I got shingles) and pain (Verbatim: it was still painful). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUN-2023 This case was reported by a patient via interactive digital media. The reporter stated that did it and still anyone could get it.  The patient received the shot and then a month later got shingles. The reporter mentioned it was not bad, at least they said it was not a bad case. The patient had the shingles which was still painful. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
flu; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event influenza was reported as unknown.  There will be no information available on the batch number for this case.
My tongue felt fat, tingly, and fuzzy. My throat felt tight and my cheeks were red and tingly. That occurred at the pharmacy and I was extremely dizzy when I arrived home. I had to lay down to let it pass. The pharmacy gave me Benadryl and I took an additional Benadryl when I got home and four hours later.
Pt w/ hx of allergy to iodine, glycerin, penicillin (N/V), sulfate/sulfa (trouble breathing), Benadryl, aloe vera.  Pt c/o flushing/sweating.  Pt "felt like I was in a movie", "wobbly", lightheaded, itchy (no rash) within 5 mins of vaccination.  BP 181/69, HR 75, RR 18 -- > 157/68, 79, 18 -- > 158/60, 70, 18.  Pt given water, juice, crackers.  Pt was laid down and rested but was nervous about allergies.  Blood glucose taken: 125.  Provider cleared patient to go home after pt indicated that they felt better.  Pt stable and released from vaccination site.  Recommended that the pt follow up w/ their healthcare provider, f/u instructions provided.
12/20/10- received DTaP at 6 mo PE. 1/18/11- OV for "lump in leg". 1/21/11- recheck lump in leg. 2/7/11 recheck in (R) leg. 2/7/11 - to derm - punch incision.
Patient received 2nd dose of Pfizer vaccine on 6/6/2021. Patient started to develop symptoms on 6/20/2021. Per Mother, patient developed cough, chest pain, mucus production, throat pain. Reports feeling sleepy and tired. Symptoms seem to be worsening in the last 2 days per report from mother over the phone. Mother advised to have patient be seen by a provider. Mother drove patient to Emergency room while on the phone.
experienced a headache; This is a spontaneous report from contactable consumer (reported for her for her brother). A  male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced a headache on an unspecified date. The outcome of the event was unknown. This report was non-serious per the reporter.   No Follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received Covid-19 vaccine at an outside facility on 11/15 and just a few hours after the shot had "asthma attack" per dad with coughing fits and vomiting x3. Dad reports he was getting close to taking to ER but improved with albuterol use and has improved slightly x2 days. Dad called our office to report this to us and request an appointment in our office.
Cold fingers/toes; feeling achy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (Cold fingers/toes) and PAIN (feeling achy) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) Solution for injection in pre-filled pen. On an unknown date, the patient experienced PERIPHERAL COLDNESS (Cold fingers/toes) and PAIN (feeling achy). At the time of the report, PERIPHERAL COLDNESS (Cold fingers/toes) and PAIN (feeling achy) had resolved.            The concomitant medication was not reported by reporter. On unknown dates, the patient experienced Cold fingers/toes and feeling achy.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Clenching of her jaw, headache (started within an hour of injection, lasted less than an hour).
No adverse event; Patient received Moderna monovalent booster instead of Moderna bivalent after 8SEP2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Moderna monovalent booster instead of Moderna bivalent after 8SEP2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Moderna monovalent booster instead of Moderna bivalent after 8SEP2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Moderna monovalent booster instead of Moderna bivalent after 8SEP2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received Moderna monovalent booster instead of Moderna bivalent after 8SEP2022).    No concomitant medications was reported. No treatment medications was reported.
Confirmed Breakthrough  1st - Moderna - 12/23/2020 - No Lot # Provided 2nd - Moderna 1/19/2021 - 012L20A
Patient stated he started to have heart palpitations in his car on the way home from the immunization and was still having  some palpitations the following day. I instructed patient to call his physician.
This spontaneous report was received from a healthcare worker and refers to a 12 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant therapies was provided. On 21-SEP-2015, the patient was vaccinated with improperly stored doses of MMR II (lot # K000738, expiration date 16-JAN-2016, exact dose and route of administration were not reported) and (Oka/Merck) VARIVAX (lot # K002046, expiration date 10-FEB-2016, exact dose and route of administration were not reported. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Decreased mobility of the injected arm; arm and hand pulsating which wakes him up 4-5 times per night (making him grouchy); Loss of strength of the injected arm; making him grouchy; hand pain; shoulder pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in hand in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number Z3H93, expiry date 07-JUL-2024) for prophylaxis.   On 27-APR-2023, the patient received the 1st dose of Shingrix (unknown arm). On 27-APR-2023, immediately after receiving Shingrix, the patient experienced pain in hand (Verbatim: hand pain) and shoulder pain (Verbatim: shoulder pain). On an unknown date, the patient experienced injected limb mobility decreased (Verbatim: Decreased mobility of the injected arm), sleep disturbance (Verbatim: arm and hand pulsating which wakes him up 4-5 times per night (making him grouchy)), weakness of arms (Verbatim: Loss of strength of the injected arm) and bad mood (Verbatim: making him grouchy).  The patient was treated with steroids nos (Steroid (Not Specified)). The outcome of the pain in hand, shoulder pain, injected limb mobility decreased, sleep disturbance, weakness of arms and bad mood were not resolved.   The reporter considered the pain in hand, shoulder pain, injected limb mobility decreased, sleep disturbance, weakness of arms and bad mood to be related to Shingrix.     The company considered the pain in hand, shoulder pain, injected limb mobility decreased, sleep disturbance, weakness of arms and bad mood to be related to Shingrix.   Additional Information: GSK Receipt date: 05-SEP-2023 and 07-SEP-2023 The reporter was the wife of patient.  The patient received the Shingrix dose at a grocery store pharmacy on 27-April-2023 and had immediate pain from the shoulder to his hand.  He came home and he was sore and we thought it would go away but had not gone away. He was in terrible pain. He was picking up steroids or something to calm his pain.  The patient went to see the doctor about a week after the injection and the doctor blew it off as arthritis but it is not arthritis. The reporter indicated that her husband had an appointment today with the doctor and he prescribed steroids and he was going to see the doctor again at the end of next week. They are going to set up a neuro exam' for him.  The reporter mentioned to her that the package insert mentions in the post-marketing area Decreased mobility of the injected arm which may persist for 1 or more weeks. She indicated that her husband had decreased mobility of the injected arm and that his arm had no strength. (Prior to the Shingrix shot he was a very strong 73 year old).  This was also affecting the shoulder and hand. She said he lost 60 to 70 percent of his strength in his arm and hand and it pulsates and keeps him up. He wakes up 4 or 5 times per night making him a grouch'. The reporter consented to follow up. This case was linked with case US2023121051 with same reporter.; Sender's Comments:  US-GSK-US2023121051:Same reporter, different patient
This case was reported by a healthcare professional and described the occurrence of abdominal pain in a female subject aged 20-29 years who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included unspecified allergies. On an unspecified date the subject received 1st dose of ENGERIX B (unknown route, unknown site). At an unspecified time after vaccination with ENGERIX B, the subject experienced abdominal pain, loose stools, loss of appetite, inability to eat much and weight loss. At the time of reporting the outcomes of the events were unspecified. Follow-up information was received on 22 December 2011 via the reporting nurse practitioner. It was noted that the 29 year old subject had presented to have her 2nd hepatitis B vaccine in the series and at that time, reported abdominal pain, "diarrhea" and "anorexia" following the initial dose of vaccine. First dose of ENGERIX B had been given on 18 October 2011. The events were reported to have begun the same day, 18 October 2011. It was reported that no further doses of vaccine would be given. Allergies to latex, eggs, penicillin and clindamycin were reported along with a medical history of gastroesophageal reflux disease. No alcohol or tobacco use was reported. No concurrent medications were received.
Painful LD x 3 days. Pain much more significant in first 3 days. Tender LD x 2 weeks. Pt. reported swollen lymph nodes above (L) clavicle. No other associated symptoms.
Patient received DTap #5, IPV #4, MMR #2 on 31 Mar 06. On 01 Apr 06 developed a inflammed area around injection site on Left thigh. Injection site erythema, 1-5 cm (dia) or mild tenderness within 24 hours.
received the liquid component not powder; received the liquid component not powder; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA799A, expiry date 31st January 2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comment: The medical assistance reported that patient received only the liquid component of the Menveo and not powder. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patients received Menveo vaccines without the powder portion which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Scratchy throat; Tired; Huge purple birth mark with a lump; This spontaneous case was reported by a consumer and describes the occurrence of ORAL MUCOSAL ROUGHENING (Scratchy throat), FATIGUE (Tired) and BIRTH MARK (Huge purple birth mark with a lump) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for an unknown indication.     The patient's past medical history included No adverse event.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 16-Feb-2021, the patient experienced ORAL MUCOSAL ROUGHENING (Scratchy throat), FATIGUE (Tired) and BIRTH MARK (Huge purple birth mark with a lump). At the time of the report, ORAL MUCOSAL ROUGHENING (Scratchy throat), FATIGUE (Tired) and BIRTH MARK (Huge purple birth mark with a lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
5 minutes after receiving vaccine she developed full body erythema, swelling and urticaria. She also started to developed mild stridor, cough and increased work of breathing. She was given Benadryl. IM epinephrine and transferred by squad to the hospital.
shaking with chills diarrhea for 2-3 hours upset stomach (daytime and during night, trying to sleep) headache thrashing legs during sleep
Became a bit dizzy, BP dropped significantly, and he fell while walking into the doctors office (he had no ambulatory issues before this). Legs became weak, couldn?t walk on his own, could barely walk with a walker, legs were beginning to get atrophied, arms began to shake.  He had 5 falls total after receiving both Moderna shots. While in hospital, received IVIG for possible Guillan-Barre Syndrome.
First dose / in February 2020; Injection site redness; Body aches; Fever; This case was reported by a pharmacist and described the occurrence of injection site erythema in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 36 hrs after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site erythema, general body pain, fever and incomplete course of vaccination. On an unknown date, the outcome of the injection site erythema, general body pain and fever were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site erythema, general body pain and fever to be related to Shingrix.  Additional details were reported as follows: On an unknown date in February 2020, the patient received 1st dose of Shingrix at a different facility. About 1.5 days after receiving Shingrix, the patient experienced body aches, fever, and injection site redness. Body aches and fever lasted for about 24 hours. The injection site redness, however, lasted for 5 days. Till the date of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. Information like lot number was not available. The reporter consented to follow up.
Vaccine induced Myelin oligodendrocyte glycoprotein antibody-associated disease; Literature Report:   This literature marketed report has been received from the authors of the published literature article entitled as above regarding a late 30's patient of unknown gender, who was part of a study that evaluate the prevalence and clinical characteristics iatrogenic central nervous system (CNS) inflammatory events of a total of 27 patients in a tertiary neuroimmunology clinic over five years from January 2017 and December 2021. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided. The patient did not have any other autoimmune disease, nor cancer history.  On an unknown date, the patient was vaccinated with tetanus vaccine; measles, mumps, and rubella (manufacturer unknown) and varicella-zoster vaccine (manufacturer unknown) (doses, vaccine schemes, routes, lot numbers and expiration dates were not provided).   After 2. 5 weeks of the last dose of pembrolizumab, the patient experienced vaccine- induced myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) with concomitant brainstem and spinal motor attack. The Naranjo Adverse Drug Reaction Probability Scale result was 7 and was used to score the probability of iatrogenicity. Treatment with plasma exchange (PLEX) and Intravenous Immunoglobulin (IVIg) had full response. The final disease course was reported as monophasic. The outcome was not provided.  The causality assessment between the event and the suspect vaccines was considered to be related.  Upon internal review, the event vaccine- induced myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) was determined to be medically significant.   A copy of the published article is attached as further documentation of the patient's experience.  This is one of several reports derived from the same literature article.; Sender's Comments:  US-009507513-2303USA007194:MSD
Fever 101.5. Body aches. Bones hurt. Feeling of being freezing cold and severe shivering.
No side effects right after the shot other than just feeling tired and a little off. But it seems to have reactivated the rare eczema herpeticum in my system. I had it under control for a year. Following the vaccine - Terrible neck pain - didn't realize it was due to herpeticum - once realized, responded to high doses of L-lysine - diagnosis - Herpetic meningitis, heart beating abnormally, increasingly worsening. Bed rest, taking large doses of L-lysine to try to get it under control and other immune enhancing vitamins - D, C, K, zinc - - meningitis under control, but neck and right rear lobe still low level pain. Increased cold sores on lips and inside nose.
Tiny bumps, rash on thighs (anterior lateral) Left > right which was noticed 1-2 days after vaccines administered.
Pateint received the booster on 12/27/21. At 3am that next morning, he developed a severe headache, nausea, severe fatigue, bruising, shortness of breath, high fever. This was ongoing for 24 hours. On the morning of 1/2/2022, his wife heard him fall. He was found deceased with no pulse. CPR was completed and she was unable to revive him.
very pruritic maculopapular -purple and red rash diffusely throughout body and extremities and neck. Sores in the mouth and blisters forming on palms of hands and soles of feet with some pain, ureteral meatus erythema and anal erythema. pain with swallowing
Soreness in arm day of.   Next day in evening was light headed  Had a syncope episode  Fell backwards onto kitchen floor which caused concussion Severe migraine and vomiting   Went to ER the next morning April 18 2021
left axillary lymph node tenderness; This case was reported by a physician via call center representative and described the occurrence of lymph node tenderness in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 1st July 2019, 3 days after receiving Shingrix, the patient experienced lymph node tenderness. On an unknown date, the outcome of the lymph node tenderness was not recovered/not resolved.   It was unknown if the reporter considered the lymph node tenderness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient who himself was the Physician. The patient experienced tenderness in axillary lymph node after receiving 2nd dose of Shingrix. No other information was available.