chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got 2 shots, then shingles/Suspected vaccination failure; still got Shingles; 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.   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 and shingles were unknown.   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: 15-SEP-2022 Reporter's comment: This case was reported by a patient's cousin via interactive digital media. The patient got two shots of Shingles vaccine and still got Shingles. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding 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.
vaccine expiration date. it appears that vaccine was given 3 days expiration date; No adverse reaction after vaccination
~24 hours after receiving vaceine, patient experienced muscle spasms all over entire Body. After 1 week, the spasms localized to the right arm. As of 11-3-2021, spasms localized to  right elbow. On 11-3-2021, primary MD notes that patient  has elevated blood pressure not previously observed. Patient's blood pressure elevation continues to be observed as of today
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIARRHOEA (Diarrhea). On 01-Feb-2021, DIARRHOEA (Diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided.Treatment information was not provided. There is no product complaint associated with this case
Case number PHEH2016US023421 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 37 year old patient whose gender was not specified. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 19 Mar 2016. It was reported that the patient received FLUVIRIN multi dose vial (MDV) that had been exposed to 8 to 10 temperature excursion. The patient did not experience any adverse events following vaccination.
pt became nauseated 15 minutes after recieving vaccine  vomited  brought to OBS via wheelchair   upon arrival to OBS  pt vomiting and pale in color  skin warm and dry,  pt positioned self on stretcher laying down.  after laying for a few minutes feeling better  denies further nauseousness. no further vomiting noted.  vs as noted  pt to dangle and standing at side of bed  feeling better  feeling ok to go home. ambulated to exit at 1130 accompanied by wife vs 1105 hr 96 po 98 bp 151/75,  1110 hr 94 po 99 bp 160/111,  1115 hr 95, po 98 bp 148/102  1120 hr 92 po 98 bp 149/100  1125 dangle hr 100 po 100 bp 152/103   1130 standing, hr 86 bp 151/104
A rash from my shoulders to my knees, very itchy.  On June 2, 2021 I received an injection of steroids.   This shot had very little affect on curing my rash.  On June 7, 2021 I began a six day prescription of MethylPREDNISolone 4 mg.  Day one started with 6 tablets, reducing by one tablet each day until conclusion on day six.
Yesterday, 10/11/2023, patient received a vaccine by mistake. Patient was given Pentacel and PedvaxHib, 2 doses of Hib given. Patient was supposed to get Pentacel and Prevnar 13. Occurrence reported yesterday to RN/Practice manager. Occurrence reported today to patient's PCP and provider that saw patient yesterday, and to his nurse, MA who administered the vaccine yesterday. Patient's father was informed of occurrence, he verbalized understanding and accepted an apology. I inquired on patient, asked how she is doing, he verbalized that patient is well, acting her usual, was a little fussy yesterday after vaccines but not fussy today, overall well, eating and sleeping well, no fever. I advised patient's father to call us with any concerns or changes in patient's behavior. He was informed that patient should come in after 4 weeks to have Prevnar 13 administered, an appointment was scheduled.  State notified today of occurrence.
Body rash, moving in location over time.  Occurring for multiple days. Treatment anti-histamines OTC.
The scar seems to be infected.  Started out same size of original scar, but through the years has grown to about 3" x 4".  Keep bandaged to prevent bleeding on shirt. Itches. Reported to several doctors, but none would address the issue.
The following day after vaccination Patient would not wake from naps to eat. I would have to wake her to eat. After eating she would promptly fall back asleep. The entire following week she regressed in motor skills. She was rolling over from belly to back, and she stopped. She was also cooing/talking and this stopped as well. She seemed very withdrawn and unusually tired and not herself. This is a major concern for me since she lost skills that she was doing without any problems prior to vaccination.
Itchy papular rash showed up on face (cheeks and chin) 2 days after receiving first dose. She saw her primary care provider 11 days after onset of rash. Has not treated the rash with anything. Rash was still present at time of evaluation.
This is a spontaneous report from a contactable pharmacist.  A 65-year-old patient of an unspecified race and gender received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced like a huge circular rash around the injection site/ a big rash and blisters at the injection site, in the middle of the rash, it may be boil or inflated balloon, more like a edema, more kind of like blister type. The outcome of the events was unknown.
his hand was also stiff; nose bleed in the left nostril; left fingers numb/numbness/could not feel his fingers in his left hand; left hand hard to open and close; left hand had some pain; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleed in the left nostril), HYPOAESTHESIA (left fingers numb/numbness/could not feel his fingers in his left hand), HYPOKINESIA (left hand hard to open and close), MUSCULOSKELETAL STIFFNESS (his hand was also stiff) and PAIN IN EXTREMITY (left hand had some pain) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced HYPOAESTHESIA (left fingers numb/numbness/could not feel his fingers in his left hand), HYPOKINESIA (left hand hard to open and close) and PAIN IN EXTREMITY (left hand had some pain). On 20-May-2021, the patient experienced EPISTAXIS (nose bleed in the left nostril). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (his hand was also stiff). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Numbness and Pain, at an unspecified dose and frequency. In May 2021, EPISTAXIS (nose bleed in the left nostril) had resolved. On 20-May-2021, HYPOAESTHESIA (left fingers numb/numbness/could not feel his fingers in his left hand), HYPOKINESIA (left hand hard to open and close) and PAIN IN EXTREMITY (left hand had some pain) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (his hand was also stiff) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
24-48hr p/vax fever 103, nausea, stiffening up for 15sec-eye open, febrile then limp;next AM stiffened, still febrile x 2;
1/9/19-5 days after HPV #3 hives to face and chest. Mom reported that this occurred after HPV #2. 01/14/2019 A 16 year old female with "severe ST" - "hurts to swallow." Nausea. "Burning up" today at school. Temp not taken. No antipyretic taken. Sx started five days ago with hives. Mother called to report hives on face and chest and she shows me pictures today. She also told our nurse when she called that patient had fever and flu sx. ALLEGRA 180 mg every day since then and the hives have not returned per patient. Vomited 3 and 4 days ago, once each day, and not since then. The first vomiting was after chicken soup. No diarrhea. Knees and bottom of feet were hurting "so bad" 3 and 4 days ago, but this sx has resolved. Body aches four days ago. No balance issues. ST started severely 3 days ago per patient. No headache. No neck swelling. No cough, except to clear throat patient says. No rhinorrhea. No dysuria. Missed school 3 and 4 days ago, but went to school today. Drinking and eating per MOC. CEPACOL throat lozenge helpful, uses before bed. Ibuprofen 400 mg sometimes daytime and before bed which helped a little. No one at home is sick. Allergy testing 9/2018: "very large positive results" to tree, grass, weed, mold, cat. Borderline to soy and avoidance was recommended. Mom asks if the hives and ST and aches are related to the HPV vaccine given 1/4/19.
Initial misuse report received from healthcare professional on 26 June 2014. A patient (gender and age not reported) had received an expired dose (expiry date: April 2014) of FLUZONE ID. No other information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
He was asleep when parents heard a bump in his room, found disoriented and complaining that his legs were numb, was not able to walk or stand.  Episode lasted about 20 minutes then resolved. He was noted to be febrile at that time, T max 102 over the next 24 hours, fatigue and sleepiness for following day.
No adverse event is known to have occurred. However, we are submitting this report b/c the patient was 45 y/o at time of vaccination, and the FDA approved age limit is 50 y/o or above. The age was missed at time of vaccination and was later brought to our attention by her primary physician. The patient is fine and to our knowledge had no AEs. She asked for the ZOSTAVAX and flu vaccines and received them the same day as her husband.
Worsening pain in arm; specific muscles not working; Can't move arm in a certain direction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Oct2021 (Lot number: FF8839) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Grass allergy" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 15Sep2021. Vaccination history included: Bnt162b2 (DOSE: 2, Batch/Lot No: ER8737, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 31Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (DOSE: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Worsening pain in arm"; MUSCLE DISORDER (non-serious) with onset 11Oct2021, outcome "not recovered", described as "specific muscles not working"; MOVEMENT DISORDER (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Can't move arm in a certain direction". The events "worsening pain in arm", "specific muscles not working" and "can't move arm in a certain direction" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, muscle disorder, movement disorder.  Additional information: Serious- No, events did not resulted in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect - No. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Other vaccine 4 weeks product: Flu, date= 15Sep2021. Reported Event: Worsening pain in arm and specific muscles not working. Can't move arm in a certain direction. Adverse event start date: 11Oct2021, ae resulted in: Doctor or other healthcare professional office/clinic visit, if patient recovered: Not recovered, if treatment ae: Yes, ae treatment: naproxen, tests still in progress. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
body aches, exhaustion,  diarrhea - 3 days neusea - 2 days
I have a very sore very big dark colored lump on my arm since then my fingers in my arm go numb
After administering the first two vaccines in the patient's left arm, I proceeded to give him his last vaccine in his right arm.  In between each vaccination I asked if he was okay and we discussed where he went to school, etc.  Right after injecting the third vaccine, the patient looked as if he just sloped over and was resting his head on the wall.  His mom was giving him a hard time about being tough, I immediately realized the patient was not playing around.  The patient's mom and I got him laying down flat and bent his legs up.  I checked for pulse and signs of breathing.  The patient woke up about 10 to 15 seconds later and was able to tell me his name, his mom's name and where he was.  I then had the technician grab the BP cuff from our immunization kit, and checked it.  It was 135/88.  The patient's mom was very upset and still wanted 911 to be called so we did from the pharmacy.   They arrived and also said he was fine to go home and didn't believe it was an actual reaction from the vaccine but more of a vagal response. The patient's mom signed paper work that he would not be taken to the ER and left.  She was very thankful for how I handled the situation and that I remained calm.
pt recvd vax & 2 wks later exp arthralgias & myalgias which persisted for @ least 2 wks;
diaraherra, sore throat, fever, weakness, headache, stomach cramps, couching, sinus congestion
chest pain; inflammation of the same as a rash all over the body; inflammation of the same as a rash all over the body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), INFLAMMATION (inflammation of the same as a rash all over the body) and RASH (inflammation of the same as a rash all over the body) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain), INFLAMMATION (inflammation of the same as a rash all over the body) and RASH (inflammation of the same as a rash all over the body). At the time of the report, CHEST PAIN (chest pain), INFLAMMATION (inflammation of the same as a rash all over the body) and RASH (inflammation of the same as a rash all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was provided. No concomitant treatment was provided.
amount of blood on his Band-Aid after the injection; This is a spontaneous report from a contactable pharmacist. A male patient unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on 20Dec2020. Relevant history and concomitant drugs were unknown. The patient had a significant (then rephrased to "small") amount of blood on his Band-Aid after the injection on 20Dec2020. Outcome of the event was unknown.    The information on the lot/batch number has been requested.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. This is second report of the total two reports. A female patient received BNT162b2 (BNT162B2), on 29Jul2022 at 16:00 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunisation complete, unknown manufacturer), for COVID-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "I just have slight headaches". Additional information: The patient had received COVID-19 booster shot the previous day at 4 pm. The patient just had slight headaches. The patient did not know if they had to isolate. The patients husband's mother was supposed to come over that night and she was immunocompromised cancer patient. There was nothing in the fact sheet that stated after vaccine if you were just suppose to do not run but then tell you, if you were needing to stay away from people. The patient did not know, that was the question. The patient could not get it on any website or paper. The patient was not worried about herself. She knew it was not allowed for her sake. It was in mRNA so, she did not think it was body responding. The patient responded that she was close to find out and just need to be clearer but that was fine, she would figure it out and hung the phone abruptly. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dose administered IM in patient's left thigh; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number T399L, expiry date 17-FEB-2025) for prophylaxis.   On 28-MAR-2023, the patient received the 1st dose of Rotarix lyophilized formulation (intramuscular, left thigh). On 28-MAR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: Dose administered IM in patient's left thigh). The outcome of the inappropriate route of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Mar-2023 The nurse reported that another staff member inadvertently administered a dose of Rotarix intramuscularly instead of orally to a patient. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. The patient received a dose of Rotarix intramuscularly in left thigh instead of orally, which led to inappropriate route of vaccination.
Vaccinated in 2017; pain of shingles for the last two weeks/ Suspected vaccination failure; Pain of shingles for the last two weeks; Pain of shingles, worst pain I've ever experienced; This case was reported by a consumer via interactive media and described the occurrence of suspected 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was not reported. The patient was vaccinated in 2017 and had been dealing with the pain of shingles for the last two weeks. The reporter stated that, it was the worst pain he/she had ever experienced. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
7 days after vaccine, noticed vaccine site swollen, red, warm to touch, itchy and mild to moderate pain.  10 days after vaccine  noticed vaccine site redness larger, went from 1/2 dollar size to about 4 inches in diameter, increased itching. Pain and site discomfort the same. Read material on what they called covid arm and treating vaccine site with Caladryl or 1% hydrocortisone cream and started taking a antihistamine at night before bed.  The cream helped with itching. Will monitor the next 3 to 4 days to see if this will resolve itself, if not will seek medical advice.
My symptoms began progressively. I had a runny nose and a mild headache on about 06/11/2022 and 06/12/2022. Then I woke up with a raging headache on 06/13/2022 so I took a COVID-19 Test which came back positive. I was on a cruse ship at the time and contacted the medical department and they did a PCR which also came back positive. Other symptoms I experienced was that I lost my sense of taste and smell which still have not come completely back, I felt very fatigued and basically, I felt nasty.
Patient was to receive moderna, instead received afluria. No signs of adverse reaction at this time. Patient also mentioned she had been previously vaccinated for the flu this year already.