chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 21 days 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 reporter stated that, his patient had a case of shingles 3 weeks after the 1st dose of SHINGRIX vaccination. The reporter was unable to provide demographic details at the time of reporting.
Received intradermal influenza vaccine. Immediately experienced localized itching and redness. Over the next few hours took a total of 5x 25mg BENADRYL. Went to urgent care that evening with systemic itching and urticaria. Given steroid injection and oral prednisone.
Reported having a headache and tinnitus the next day. The headache resolved in a day, but the tinnitus continued.
R09.02 HYPOXIA 7/26/2022 HYPOXIA
Information has been received from a medical assistant concerning a 23 year old female patient, who on 21-OCT-2010 was vaccinated with a 0.5 ml dose of PNEUMOVAX 23 (Lot # 665904/0866Z) IM. The medical assistant reported that 18 hours later the vaccination, on 23-OCT-2010, the patient experienced a fever of 102.0. Left arm had some swelling and redness. Patient went to the emergency room on 23-OCT-2010, but no admission was required. At the time of the report the patient was recovering. Follow up information was received and indicated that there was no additional information other than it was already reported. This is one of several reports from the same source. Additional information is not expected.
symptoms started 10 minutes after vaccine given, left sided lower chest pain, with tingling to the left arm and shoulder , pressure to bilateral lower extremities , and left sided neck area. patient was alert and oriented x4 denies worsening in symptoms, vitals taken bp elevated a bit 154/98 , bp improved at 134/90 15 minutes later, patient stable, and alert with rn and provider in room.
got shingles shot, got shingles again/suspected vaccination failure; shingles again on face; This 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.   The patient's past medical history included shingles (the patient got shingles on right shoulder blade).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got the Shingles shot and then recently got the shingles again on his/her face.  The patient thankfully got the medicine (unspecified) to help it and they stayed on the milder side. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Woke up dizzy, intense migraine, vomiting, diarrhea, confusion, muscle weakness, blurred vision. Went to the doctor and was diagnosed with chronic migraine. Twenty three years later still have chronic migraine with episodes of vertigo and anxiety disorder.
Fridge temp went out of range by 4 degrees overnight on Sunday due to storm, DOH was closed 1/17. Vaccine was administered to patient
Legs & arms feel like they are on fire - hurt & has no strength in them - has 4 bumps on arms (mo said they were hives but haven't gone away) symptoms started a couple days after vaccination. No redness temp, rash or swelling.
developed shortness of breath 11/17. Admitted to the Hospital 11/18/21 through 11/22/2021.
Initial report was received from a health care professional on 10 September 2010. A 22-year-old male patient with no reported illness at the time of vaccination and an allergy to cephalosporins, had received on 27 August 2010 a 0.5 ml subcutaneous left deltoid injection of YF VAX, lot number UF795AA and a right deltoid injection of FLUVIRIN (Novartis lot number and route of administration not reported). On 27 August 2010, the patient experienced a swollen gland behind left ear and lymphadenopathy of neck. He was seen by a physician on 04 September 2010. The patient stated the gland had "gone down". No further information was provided at the time of this report. The patient's outcome was reported as not recovered. Documents held by sender: none.
Pain in extremity; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity ) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in extremity ). On 18-Mar-2021, PAIN IN EXTREMITY (Pain in extremity ) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication information was not provided.
witnessed choking; This serious case was reported by a other health professional via sales rep and described the occurrence of choking in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced choking (Verbatim: witnessed choking) (serious criteria GSK medically significant). The outcome of the choking was unknown.   It was unknown if the reporter considered the choking to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.  It was unknown if the company considered the choking to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   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:20-JUL-2023 The reporter was a GlaxoSmithKline representative reporting an adverse event reported by her healthcare professional.  The GlaxoSmithKline representative learned of the event yesterday afternoon.  The healthcare professional reported with the new presentation of the Rotarix vaccine, they had witnessed choking among their youngest patients upon administration (no other information was known). The reporter and healthcare professional both gave consent to be contacted further in this case.  Minimal information was given. The reporter consented to follow up.
Client reported that she went to the nurse because her throat was swelling and she got scared that she couldn't breath.
This case was reported by a consumer via call center representative and described the occurrence of rash in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 18th October 2018, the patient received the 1st dose of SHINGRIX. On 22nd October 2018, 4 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. Approximately 4 days after her injection, she experienced a rash on the right upper chest that resolved after 4 additional days. The patient stated that, the representative she spoke to was knowledgeable, but he was unable to help the patient with her problem, which was a reaction to SHINGRIX, and the patient did not know whether to have it again or have the second shot, or not.
Worrisome: extremely swollen lymph nodes under left arm Bothersome: severe pain throughout and primarily in lateral deltoid, some in posterior and anterior deltoid, headache (brain squeeze, hot kind), chills and overheated (face and head were hot, but wanted a sweater), mild dizziness if move too quickly, achiness (primarily in neck, could be from not being able to sleep well)   Tylenol was taken Waiting to hear back from doctor
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned a 52 year old  male. Initial information was processed along with the additional information received on 25-JAN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and expiry: UNKNOWN) dose was not reported, 1 total administered on 25-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-NOV-2021, patient received a positive covid-19 test result from his physician's office, unsure of what type of test was performed but stated that the physician diagnosed him with covid-19 (confirmed covid-19 infection, and confirmed clinical vaccination failure). The patient had symptoms of shortness of breath, muscle aches, body aches, and fever. On 26-NOV-2021, the patient was given monoclonal antibody therapy and since then the patient had been doing much better. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).  This report was associated with regulatory authority.; Sender's Comments: V0: 20220143954- JANSSEN COVID-19 VACCINE Ad26.COV2.S- CONFIRMED CLINICAL VACCINATION FAILURE. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. 20220143954- CONFIRMED COVID-19 INFECTION- JANSSEN COVID-19 VACCINE Ad26.COV2.S-. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
passing blood clots; The blood looks like merlot wine; Lost 20 pounds; Painful; blood in urine/urinating blood; The vaccine is attacking kidneys; night sweats; colds; nauseated; sore arm; fever; sick; This is a spontaneous report from a contactable consumer.   A male patient (reporter's uncle) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced passing blood clots, the blood looks like merlot wine, lost 20 pounds, painful, blood in urine/urinating blood, the vaccine is attacking kidneys, night sweats, colds, nauseated, sore arm, fever, sick on an unspecified date.  The patient underwent lab tests and procedures which included weight: lost 20 pounds.  The outcome was unknown.  Information about lot/batch number has been requested.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown demographics. No current condition was reported. No historical medication was reported. Approximately on 25-SEP-2014, (as reported that the patient was now in her office) the patient was vaccinated with GARDASIL dose 3 (dose strength unknown). No concomitant medication was reported. Nurse practitioner reports that the patient was administered the 1st and 2nd doses in the GARDASIL series in April 2009 and June 2009 respectively. Nurse practitioner reports that the patient was now (approximately on 25-SEP-2014) in her office to receive the 3rd dose of the GARDASIL series. No adverse effect was reported. No further information was provided. The outcome of inappropriate schedule of vaccine administration was unknown. No PQC involved. Additional information has been requested.
flu three times; Initial information received on 10-Oct-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via social media.  This case involves a patient who experienced flu three times (Influenza), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, past vaccination and family history were not provided. Concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious flu three times (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown at the time of reporting.  There will be no information available on lot number for this case.
Information has been received from a physician concerning a patient who on approximately 24-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck). On an unknown date after vaccination, the patient developed shingles. The physician may be interested in VZV analysis by PCR and wanted to send viral isolates. Follow up information was received from a physician, he reported that the patient had a dose of ZOSTAVAX "one week ago" on his right arm. It was reported that the patient had developed topical vesicles in his right shoulder, arm and right upper chest. Additional information has been requested.
States that the left side of her neck and head began "throbbing" immediately after the vaccine was administered and continued for 2 days. Three days after the vaccine was given she began having severe pain in her left hip to the point that she could not walk on her left leg. She went to an orthopedic doctor at that time. The doctor performed xrays of the left hip and found no abnormalities. He then injected her with a steriod injection and placed her on a Solumedrol dose pack. Patient states that she has no proir history of left hip pain, nor has she injured her left hip in any way. Denies any numbness in the left leg.
Moderna Covid-19 Vaccine EUA After both first and second shot, I got the Moderna arm.  Swelling, itching and red. Started 5 days after first shot and after second shot started next day.  Three days later it still is getting larger.  No other symptoms after first shot.  During the night after the second shot I woke up very cold and chilled.  In morning I had fever of 100.2, headache, nausea and chills.  Tired.  Felt bad all over.  Fever stayed most of day around 99.6.  The following day I was ok, except for the red swollen spot on arm.
No additional AE; Caller reporter improperly stored and administered vaccines for MMR-II, PROQUAD, and VARIVAX to multiple patients since May 2023 (TE occurred 5/9/2023). No symptoms reported. Caller did not have specific AE information available regarding patient inf; This spontaneous report was received from other and refers to an 1-year-old patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot #W026315, expiration date: 18-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). This vaccine underwent temperature excursion before administration in 58.65 degree Farenheit (F) for 25 hours 45 minutes (Product storage error). No additional adverse event was reported.
This spontaneous report as received from a healthcare student refers to a 54 years old female patient with allergic to penicillin and allergic to cephalosporins. The patient had no pertinent medical history. The patient was vaccinated with ZOSTAVAX (lot umber 0562AE, expired date was unknown) (dose and injection site were not reported) subcutaneously on 08-AUG-2012. No other co-suspects were reported. There were no concomitant medications. At some unspecified time point after this vaccination in August 2012, the patient experienced a "red, golf ball sized swollen area at the site of injection". No treatment information was reported. The patient current status was unknown. There was no laboratory diagnostics performed. The patient's family had called the pharmacy for medical attention. Additional information is not expected.
20-24hr p/vax sx of body aches especially @ site of inj, c/o h/a;fever started 5JUN97 in evening while the body aches started on the afternoon of 5JUN97 APAP taken q 4hr helped;it was advised to seek PMD;heart pain also exp;
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021). It was reported that the vaccines was stored in freezer,  took out one to two vials and place in fridge each day as needed.  No treatment was provided to the patient.
Narrative: She related having developed a pruritic rash over her left deltoid, which started the evening after the first vaccination and persisted for 3x weeks. The injection site was additionally also a/w tenderness, which had previously resolved. She was not sure if the affect rea had increased warmth or induration. No hives/urticaria, swelling, or sloughing. No medications have yet been applied or tried.
pt recvd vax & devel a papulovesicular rash @ inj site which was treated w/topical steroid;
covid; almost died; Initial information received on 26-Jan-2021 regarding an unsolicited valid serious media case received from a consumer or non-healthcare professional.  This case involves a female patient (age not reported) who developed Covid (covid-19) and almost died (near death experience), while she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications 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 in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed Covid (covid-19) and almost died (near death experience) (unknown latency) following the administration of INFLUENZA VACCINE. These events were assessed as medically significant.  It was reported that reporter's sister got the flu shot still got covid and almost died. Flu shot did not helped her one bit.   Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: Positive  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for events.  Information on the batch number was requested.; Sender's Comments: This poorly documented media case concerns a female patient (age not reported) who developed covid-19 during the pandemic and reportedly almost died after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset was unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out predisposing etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
I first started developing chills and a mild fever about eleven or twelve hours after taking the vaccine. My entire body felt like burning and a headache came up not long after the fever.  I could barely fall asleep at night due to body ache and excessive sweating. The headache and body pain persisted till the next morning, and as of I am writing this response now, I feel extremely weak and I have no appetite at all.
Chills, Fever/heat intolerance, Dehydration, Headache, Pounding heart/palpitations (shaking body)
8 hours after injection-Fever, chills, nausea, body aches.  4 weeks later-Rheumatoid arthritis flare with swollen joints, painful joints, fatigue, and general malaise.
My son had been complaining of racing heart and became a week after the first dose of Moderna then started vomiting once or twice a week thereafter I tried to get him to go the doctor but he kept saying he was ok. He said he feels like something was wrong but didn?t know what. He received his second dose of moderna 6/13/2021, 5 days later on 6/18/2021 he didn?t feel well laid down around 9 pm was checked on at 9:21 he was unresponsive no heart beat no breathing 911 was called. They resuscitated him after 45 minutes then he was transported to hospital then to medical center. he was in ICU on a  ventilator unresponsive brain swollen , totally unresponsive and organs shutting down. He passed away 9:45 pm June 19
Mild throat closing/restriction, shortness of breath. Took a Benadryl and sometimes went away.
After the 2nd dose of vaccine; got a brain bleed; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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 medical history was not reported. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on an unknown date for Covid-19 immunisation. The patient's concomitant medications were not reported.  The patient reported that after the 2nd dose of the vaccine; she got a brain bleed on an unspecified date. Outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.