chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had both doses in 2018, then Shingles in 2022/ Suspected vaccination failure; Shingles outbreak, currently has shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2018, the patient received the 2nd dose of Shingrix. On 28th May 2018, the patient received the 1st dose of Shingrix. In September 2022, more than 2 years after receiving Shingrix and Shingrix, 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 Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's Comment: The patient was self-reported this case The patient reported that she received both the doses of Shingrix vaccine in 2018. The reporter stated that after received Shingrix vaccine in September 2022 she experienced an outbreak of shingles and also currently had a case of shingles. The reporter did consent to follow up. Additional supportive information: This case was considered as suspected vaccination failure as laboratory confirmation regarding shingles were unknown at the time of reporting.
11OCT95 230PM burning cheeks, 3PM flushing, blotching of face-upper chest; psoriasis lesions, inc red; gen pruritus by 4PM; 6PM nasal congestion-took dimetapp sxs subsided @ 10PM;
This spontaneous report as received from a physician refers to a patient of unknown age who on an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The physician was informed from a nurse, who reported him that on an unknown date, the patient experienced a seizure after receipt GARDASIL. At the time of the report, the patient's outcome was unknown. The relatedness for seizure and GARDASIL was unknown. Upon internal review seizure was considered to be medically significant. Additional information has been requested.
Headache, Myalgia, Fever, NauseaVomiting, Dose 2: fever, migraine, horrible body aches and extreme nausea x 3 days post vaccination. Narrative:  Dose 2: fever, migraine, horrible body aches and extreme nausea x 3 days post vaccination.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid after first dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for covid after first dose). At the time of the report, COVID-19 (Tested positive for covid after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Client received injection at 1:26 and felt dizzy/faint and anxiety at 1:28.  Client also reported muffled hearing.  Client repported this reaction to previous injections.
Redness at injection site; Swelling at injection site, an allergic reaction?; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-DEC-2022 Reporter's Comment: The case was self reported by the patient. The patient received dose of Shingrix and reported that one of the common side effects presented was redness and swelling at injection site. The reporter asked did this side effects count as an allergic reaction.
Recipient was fully vaccinated as of 02-16-2021 with 2 doses of Moderna. He came to the vaccination center on 08/23/2021 and received  1st dose Pfizer. He did not inform staff that he was previously vaccinated.  When contacted after the 08-23-21 visit, the recipient stated he came for the Pfizer because he had 2 antibody tests several months after receiving the second Moderna  and both were negative. So he came for the Pfizer as a booster.  Recipient came in again on 09-13-2021 and received second Pfizer.
This spontaneous report received from a patient concerned a 28 year old male. 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: 1855190, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced little red rash or hives or something inside right thigh under the skin. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little red rash or hives or something inside right thigh under the skin was not reported. This report was non-serious.
(L) arm became red, warm, swollen, tender about 6 hours after vaccine and remained so for 6 days. Pt had some subjective fever and pain.
Information has been received from a registered pharmacist concerning a 43-year-old male with penicillin and tetanus allergies, who on 24-MAY-2006 was vaccinated intramuscularly with one dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 649760/0464R). There was no concomitant medication. On 26-MAY-2006 the patient noticed a bump below the injection site. It formed a knot below the injection site and moved down to the elbow of the left upper arm. On 03-JUN-2006 or 04-JUN-2006, he noticed a slight red spot on his forearm. It became a little more inflamed an swollen on 05-JUN-2006. He went to the emergency room to seek medical attention. It was reported that the patient was not recovered at the time of this report. No product quality complaint was involved. Additional information has been requested.
Narrative:  An 85yo male with PMH of multiple m=Medical problems including Hyperlipidemia, Cognitive Impairment, HTN, DM II, Chronic PTSD, OSA, hyperparathyroidism due to Renal Insufficiency, Peripheral Venous Insufficiency, Full Care by Hospice He received Pfizer Covid-19 vaccine per policy and protocol and without complications. NO ADE was reported System shows the patient passed away on February 25, 2021
This spontaneous report received from a parent concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 26-MAY-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  No concomitant medications were reported. On 26-MAY-2021, the subject experienced vomiting. On 26-MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting and headache was not reported. This report was non-serious.
That night I was cold head to toe, could not warm up, and eventually it went away. I was fatigued for a few days. I do Acupuncture once a month, I went to get acupuncture on 2/10/2021 8 days after my vaccine and I got that cold feeling again. I had the feeling of UTI and some pressure in my lower pelvic region, it was a feeling of pressure. I just let it go because it was getting worse. On 2/12/2021 I went to party and had a gummy with THC in it before I started drinking I noticed I wasn't feeling right, I drank two drinks and ate a ton of food. I started feeling off and I couldn't speak and and I couldn't understand anyone. They put me in chair there were nurses at the party. The nurses said I went gray and my hands were blue. They ended up calling 911 because they were unsure if I was having a seizure or an aneurism. They ended taking me to the ER. They gave me Ativan around 2 am because I hadn't stopped twitching. They sent me home. Then the following Sunday the same thing happened, I was twitching and couldn't talk. This lasted about 3 hours in the morning. I ended up going to my primary.
Developed mild blood in stools for 1-2 days (parent does not remember) after vaccine. Fully resolved 48 hours after vaccine. Child had milk-protein allergic colitis early in life which had also caused blood in stools, but this had fully resolved for over a month prior to vaccination, and no new dietary exposures occurred prior to vaccination.
Patient received past the 12 hours expiration; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received past the 12 hours expiration) in a 65-year-old male patient who received mRNA-1273 (batch no. 025C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ALLOPURINOL, PAROXETINE, SIMVASTATIN and GATIFLOXACIN, LOTEPREDNOL ETABONATE (LOTREL G) for an unknown indication.    On 30-Apr-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received past the 12 hours expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received past the 12 hours expiration) had resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.   For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported
It was reported that a 49 year old female patient received a TD Adult vaccination, intradermal on 26 Jan 2001 at 10:00am. Reportedly on 27 Jan 2001 at 9:00am the patient developed 1/2cm redness, .2cm induration. The patient reportedly recovered from this experience. From follow-up received on 4/3/01, no further information was provided.
pt recv vax 14OCT95 & 16OCT95 was evaluated in a hosp clinical decision unit w/dx of purpura;it is unk whether or not the pt was adm to the hosp as of the date of this report
1545 - varicella vaccine given.  1630 - rash & redness noted.  1640 - retractions & resp distress noted, O2 given, O2 sat 99-100.  1655 - epinephrine given, decreased resp distress.  1700 - Dr. called.  1700 - 911 called.  1725 - transported to hospital, had albuterol in ambulance, received steroids & IV fluids in hospital.  2/29/08 - 1210 returned to center, stable, no resp distress or rash.  4/11/08 Reviewed ER medical records of 2/28/2008. FINAL DX: Anaphylaxis Records reveal patient developed sudden dyspnea, respiratory distress w/retractions & diffuse erythema 30 min after varicella vaccine.  Tx w/epi & nebs by EMS.  ER exam revealed red urticarial hives all over, coarse wheezing & mottled extremities.  Tx w/IV steroids.  Admitted for observation of rebound & d/c back to institution.
Itching (mostly). Took BENADRYL (3 times) helping. Is getting better.
pt recvd vax; pt devel a serum sickness-like hypersensitivity reaction of hands & knees; urticarial rash; malaise; arthritis; petichiae on lower extremities; pt seen by MD; treated w/ NSAIDS;
102.9 degrees F fever. Meds-after taking MOTRIN & TYLENOL reduced fever to 102 degrees F. Staring & jerking with high fever. Fever lasting from Monday evening to Wed. morning. Irritability persisting over a week.
extreme back aches around 8:00 pm;  fever with severe chills, teeth chattering, all over body aches, nausea, heart pounding, dizziness, headache all during the night of shot; early next morning - sweating, soaked, vision issues, dry mouth, headache still, so hot that I couldn't stand anything against my skin;  9:00 Friday morning - 100.3 fever,  all day headache, exhaustion.  Saturday -still headache, exhaustion,  went back to bed and woke up at 1:45 pm soaked again and exhausted.  Headache and exhaustion continued until Monday, 5/11. I took ibuprofen for fever and body and headaches.   Called Dr.'s office Tuesday to report this.  I have never had any kind of a reaction to any shot other than the usual sore arm which is tolerable.  I was too sick to think of going back to the Dr.'s office or the ER with possible coronavirus exposure.
Did not return for 2nd dose likely due to Covid quarantine; Did not return for 2nd dose likely due to Covid quarantine; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received two and a half years prior to the reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem and quarantine. On an unknown date, the outcome of the social problem and quarantine were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The reporter stated that, a patient received first dose of Shingrix two and a half years ago and, likely due to covid quarantine, did not return for dose 2. No further details were provided on call. The reporter was in a hurry to get off phone but consented to follow up. The reporter consented to follow up
Pt feeling light headed, nauseous, urge to empty bowel.  Speaking clear sentences. Provider rec. pt to continue observation for 30 min  Denies, CP, SOB, HA, palpitations
Muscle stiffness; Chills; Fatigue; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscle stiffness), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscle stiffness), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscle stiffness), CHILLS (Chills), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
APRN inadvertently clicked on the PENTACEL tab in EHR rather than the PREVNAR tab.  LPN followed orders then after administering realized that signed consent form had PREVNAR signed for.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2021, the patient received Shingrix. On 30th July 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix and patient experienced sore arm. The patient asked what he/she could take for pain. The patient was wondering if he/she could take ibuprofen or Tylenol after the shot at the day of reporting.
p/giving measles vax, pt lt room standing @ pay area, had been there about 7mins, turned pale, hit wall w/back & slid down the wall; BP 100/60 & pulse 60;
big lump on the collarbone on her left shoulder; hurt; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events hurt, big lump on the collarbone on her left shoulder.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 015M20A) intramuscularly for COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) hurt . On 15 Feb 2021, the patient experienced the event(s) big lump on the collarbone on her left shoulder.  Treatment details included Tylenol and ice.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), hurt was unknown.The outcome of event(s), big lump on the collarbone on her left shoulder was unknown..
Severe nausea; vomiting; loss of consciousness; seizures; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727 and expiration date not provided) via an unspecified route of administration, administered in left arm on 25Mar2021 as a single dose for COVID-19 immunisation. Medical history included Cancer hx, Supraventricular tachycardia (SVT), Sjogrens, Epilepsy, Chronic kidney disease (CKD), Hyperthyroidism, Short gut, Osteoarthritis, malnutrition, Bartter's Syndrome Type 3, Hashimoto's Disease, Allergies to Penicillin, Adhesive, Vicryl sutures and cobalt. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydroxychloroquine; doxycycline; and levothyroxine sodium (SYNTHROID) and more (unspecified). The patient previously took iron dextran, povidone-iodine (BETADINE), metronidazole (FLAGYL), lamotrigine (LAMICTAL) and doxepin and experienced Allergies. The patient also took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6205) in the left arm on 04Mar2021, 01:15 PM for COVID-19 Immunization. The patient did not receive any other vaccine in 4 weeks. On 26Mar2021 19:00, the patient experienced Severe nausea, vomiting, loss of consciousness, seizures. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and Life threatening illness (immediate risk of death from the event). Treatment was given in response to the events which included IV antiemetics, IV hydration, IV Benadryl, Antiepileptics. The patient underwent COVID test post vaccination via nasal swab (rapid antigen test) on 01Apr2021 which was negative and via nasal swab (PCR) on 16Apr2021 which was negative. The outcome of the events was not recovered.; Sender's Comments: Based on the close temporal relationship, the association between the events nausea, vomiting, loss of consciousness, and seizures with BNT162b2 can not be fully 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.
Patient became dizzy 15 minutes after vaccination. Emergency services was called. Patient went into a sleep state for about 15 seconds but with stimulation  was responsive and was able to speak to me immediately.  Patient then became nauseated and approximately 10 minutes from start of event vomited.  After this the patient began to feel better.  Paramedics arrived and evaluated patient.  Blood pressure, pulse, oxygen level, glucose level were all normal.  Patient was convinced to go to Emergency Room with paramedics to be evaluated.
Arm ached at vaccination site for a couple of days.  It is the upper left arm, between elbow and shoulder.  I noticed over the next few months that certain backward motion of the arm caused some discomfort.  I stopped using the arm other than for forward motion.  The upper left arm and shoulder area became painful when use.  After months of discomfort, I went to the doctor who prescribed Naproxen and physical therapy.  The Naproxen upset my stomach, so I am just continuing with physical therapy for now.  The arm and shoulder are still painful and I am working on regaining some mobility in the arm.  It is difficult to get dressed or put on or take off a garment because my left arm will not cooperate in an extended up or backward motion.
I had my shots and boosters and I still had covid 3 times; I had my shots and boosters and I still had covid 3 times; I had my shots and boosters and I still had covid 3 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "I had my shots and boosters and I still had covid 3 times".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
I was administered the flu shot at work. The next day I began  having pain in my shoulder, but it felt different than the regular muscle soreness.  The pain has progressive,y gotten worse since the shot. I have trouble lifting my arm and have very limited motion moving it. Everyday  activities such as putting on a shirt, blowing drying my hair, pulling up my pants, etc are very difficult and cause more pain.  The shot was administered very high in my arm   I scheduled an appointment with an orthopedic doctor. The earliest he could get me in is November 9.