chrisvoncsefalvay/vaers-outcomes huggingface dataset:
first vaccine NOV2021, second on JAN2022, got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 2nd dose of Shingrix (intramuscular). In November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 5th April 2022, 3 months after receiving Shingrix and between 4 and 6 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex), ambiguous medication nos (Neurontin (Nos)) and steroids nos (Steroid Pack (Nos)). 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: 28-APR-2022 Reporter's Comment: The case was reported by the patient. The patient received both doses of Shingrix in left arm. The patient described the shingles on the right side of her body from the mid-front, right arm and mid-back.  Her healthcare professional confirmed that, the case of shingles and started her on Valtrex, Neurontin and a steroid pack (no other details given). The shingles had not resolved.  The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting.
presented to the ED with substernal chest pain with right to left side radiation and continuous waxing and waning right sided abdominal pain with back radiation consistent with previous episode of acute cholecystitis; still admitted
discomfort in the injection site; extreme itching; redness in the entire bicep; tingling in the lips and dry mouth.; tingling in the lips and dry mouth.; Pain in arm; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 75-year-old male patient received BNT162b2 (COMIRNATY), in Oct2021 as dose 3 (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: Bnt162b2 (Dose:2, Manufacturer: Pfizer-BioNTech), for Covid-19 Immunization, reaction(s): "no side effects or adverse reactions"; Bnt162b2 (Dose:1, Manufacturer: Pfizer-BioNTech), for Covid-19 Immunization, reaction(s): "no side effects or adverse reactions". The following information was reported: VACCINATION SITE DISCOMFORT (non-serious), outcome "not recovered", described as "discomfort in the injection site"; PRURITUS (non-serious), 72 hrs after the suspect product(s) administration, outcome "recovered", described as "extreme itching"; ERYTHEMA (non-serious), 72 hrs after the suspect product(s) administration, outcome "recovered", described as "redness in the entire bicep"; PARAESTHESIA ORAL (non-serious), DRY MOUTH (non-serious), outcome "unknown" and all described as "tingling in the lips and dry mouth."; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated that, patient received the first 2 doses of Pfizer-BioNTech covid-19 Vaccine and presented no side effects or adverse reactions. On Oct2021, he received the first booster dose, injected into his deltoid, and experienced some adverse reactions. Patient was fine after the Booster until 3 days later. 72 hours after receiving the booster dose, he developed extreme itching and redness in the entire bicep and rock hard. He had no fever but also had tingling in the lips and dry mouth. The redness and itching were resolved after 1 month and he only felt now discomfort in the injection site. Patient wanted to know if, based on this side effects, he should receive the second booster dose. Patient wanted to know if this is considered as a serious adverse reaction or an anaphylactic reaction and if it was contraindicated to receive another dose of the vaccine and explained to patient that non-severe allergic reactions such as itching, injection side redness and injection site pain were reported side effects after vaccination with any dose and also explained that the only scenarios where Pfizer does not recommend to get another dose of the vaccine were when severe allergic reactions occur or when a patient is allergic to an ingredient of the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Rash all over my body appeared within 24h-48; Intense joint pain; Intense fatigue; Felt very weak; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old patient of an unspecified gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 12Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included asthma, known allergies to dust and pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 13Apr2021, the patient experienced a rash all over the body which appeared within 24h-48, intense joint pain, intense fatigue and the patient felt very weak. Therapeutic measures were taken as a result of the events and included treatment with prednisone (MANUFACTURER UNKNOWN). Since the vaccination, the patient had been tested for COVID-19. On an unspecified date in 2021, the patient underwent a nasal swab test and the result was unknown. The clinical outcome of the events rash all over body that appeared within 24h-48, intense joint pain, intense fatigue and felt very weak was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
While intending to administer a influenza vaccination to a patient, I had inadvertently admininstered a Zostavax (that was intended for her mother).  The patient is an 18 year old female with no health problems.  The Zostavax was administer with a 5/8" needle in the left deltoid.(potentially IM).  The patient has yet to have any adverse reaction to the vaccination.  I am simply reporting the vaccine administration error as was recommended on the CDC website.
nausea, vomiting, diarrhea, headache, fever/chills, fatigue
Vision and gait disturbances began 4/9/21, progressively worsened and he began nausea/vomiting 4/11/21, requiring ER visit on 4/12/21 then hospitalization for 5 days.  Comprehensive labs done.  Follow-up advised with Dr.  (has not occurred).  Per Dr. (Neurology), do not get second dose of Covid-19 vaccine as there is a chance the vaccine contributed to development of these symptoms.  Doctor said it could possibly be Guillain-Barre Syndrome. As of 5/11/21, significant vision impairment still exists and patient is unable to work.  Patient is uninsured.
Headache, Myalgia, Arthralgia, fatigue, chills, injection site pain Narrative:
Got the shot and also got shingles/Suspected vaccination failure; Got shingles; 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.   The patient's past medical history included chickenpox (had chickenpox when the patient was kid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and also got shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that years ago he/she was told by a PA (Physician Assistant) that he/she did not need to get the shingles shot because he/she had chickenpox when he/she was kid.  The patient got the shingles shot anyway but he/she also got shingles. 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.
This spontaneous report as received from a registered nurse refers to a currently 20 year old no pregnant female patient with no drug reactions or allergies and no pertinent medical history who on unknown date when was an infant was vaccinated with RECOMBIVAX HB (2.5 mcg/ 0.5 ml) (lot #, expiration date and route were not reported). There was no concomitant medication. Recently she was tested for hepatitis b antibodies and the results showed the patient was non-immune, so the patient was revaccinated with two adult doses of RECOMBIVAX HB (lot #, expiration date and route were not reported). The patient was "non-responder". It was unknown if the patient sought medical attention. The outcome of the adverse events was not recovered. Additional information has been requested.
Painful arm at injection site and surrounding area. Painful with range of motion. Decreased ROM.
Mother reports client with elevated temperature (average 101) following vaccinations,also reports moderate cough. Temperature continued elevated for four days unable to keep down with acetaminophen. Went to emergency room on 4/28/09.  CXray done, diagnosed with pneumonia and put on Zithromax per parent report.
More fatigued than usual still. Soreness on arm for two days, but now is better. Leaking from nose, seems to be slowly going away.   Right side of tongue is swollen.  I bit of congestion in right side of chest.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Patient received vaccine past its 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Mar-2022 at 12:48 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine past its 30 days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose description included: Booster.  No concomitant product use was reported.  Vaccine went into 2 to 8 degree Celsius thaw state on about 24 Dec 2021. The vaccine was administered up until its manufacturing expiry date of 04 Apr 2022. No treatment information was provided.
This is a spontaneous report from a contactable physician communicated to a Merck sales representative, manufacturer control number: 1-9309512235. A female patient of an unspecified age and ethnicity received a dose of PREVNAR on 23Oct2013. The patient's medical history and concomitant medications were not reported. The patient developed a severe rash at the injection site which disseminated to her chest and back and it was reported that the patient was diagnosed with pneumonia. Laboratory data was unknown. Therapeutic measures, if any, taken in response to the events were unknown. The clinical outcome of the events, pneumonia, injection site rash, and rash were all unknown. Follow-up (22Jan2014): Follow-up attempts completed. No further information expected.
pt complained of swelling and pain of the underside of the arm where the vaccine was given and went to urgent care.
The patient called the pharmacy today to report a red spot that appeared around her injection site from PREVNAR (PCV13) which was administered on 08/06/2018 at this pharmacy. She stated the redness appeared yesterday or today (08/13 or 08/14/2018) and just started get slightly tender and itchy. She stated the red-colored area was about the size of the nickle. She later came into the pharmacy to show me, which showed clear redness in almost a perfect circle (above the size of a nickle o r quarter) around her injection site. Also, her entire deltoid area surrounding the round circle of her left arm seemed a little swollen and pinkish compared to her other arm. Her arm was also warmer to touch than her other arm. She reiterated that she had just noticed the red spot yesterday while showing after she had done some mild physical activity (gardening and lawn work). She said she had called her doctor, who had instructed her to consult with the pharmacy for guidance. I told her that she should monitor her symptoms closely and any worsening (ie, systemic effects such as hives, fatigue, nausea, chills, sudden drop in blood pressure, or swelling of her airway/difficulty breathing, fever, etc.) should be immediately brought to the attention of a physician. In the meanwhile, I recommended BENADRYL (DIPHENHYDRAMINE) to help reduce any allergic reaction and itching. I also recommended taking NSAIDs such as IBUPROFEN to help reduce inflammation/pain + TYLENOL (ACETAMINOPHEN) + COLD COMPRESS (ice on/off 10 minutes cycles). I urged her to seek immediate medicalattention if such symptoms occurred and not hesitate to go to the hospital emergency department. I also recommended she take BENADRYL + ingest PLENTY OF WATER to maintain blood vessel volume in the case of anaphylactic reaction. Patient understood recommendations and was thankful for taking the time to assess her situation.
My first shot was delivered at the store and hit a nerve. My second one was delivered correctly at clinic and I felt fine that day and evening. The second day, I took my normal 3.5 mile walk around my hill and I was dramatically breathless, nearly unable to make it around. I figured it was a typical side effect of the vaccine. However, my breathlessness has not gone away and it's been nearly two months since my vaccination. Friends who've I've been walking with for years have commented on my inability to do what I've done for years. I not overweight and only had trouble similar to this in 2017 after a terrible flu. It took me several months to recover from that event, so I'm thinking the same may be true of my body's response to this vaccine.
Severe Headache, Muscle cramping, Joint pain, and body chills for first 24 hours.  Then severe rash over torso, arms, buttocks, thighs, and back consistent with what I experienced during Lyme Disease this past summer.  Raised itchy rash in large red blotches over most of body.  I didn't realize it at the time but the same (but less severe) reaction took place after the first Moderna Vaccine shot as well.  I was prescribed Doxycycline by my local Urgent Care and stayed on it for 14 days following the first dose of Moderna.  I didn't put the two things together immediately because I has gone hunting in the woods and assumed that I was bitten by another tick.  Full body rash is what caused me to go seek attention at the Urgent Care.  The symptoms following the second dose were much more severe and uncomfortable.  The rash subsided in 4-5 days without medication.
Patient has 6 x 4 reddened, circle with some swelling, increased warmth in arm (R) where injection was given.
pt recieved 2 doses of vaccine and then booster in september, he then had an episode where he collapsed in his yard.  not syncopal, just body to weak to hold him up in April.  He learned of another person who had similar episodes and feels it was related to his covid vaccine.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant  medication and drug reactions or allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L018500, expiration date 13-APR-2017 (strength, dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Three days post vax the pt developed a fever up to 102F. No other symptoms. The pt was taken to the ER and it was noted that the pt had red/brown diarrhea like stools. A stool guaiac was positive for the occult blood. The pt was noted to have anemia. A rule out sepsis work-up was done which revealed lumbar puncture (CSF), blood, urine and stool cultures. The pt was discharged home and prescribed Rocephin for 3 days until all cultures returned negative. The pt continued to have guaiac positive stools and increased fatigue and somnolence for approximately two more weeks and slowly improved. As of 06/28/1999 the pts stools were still positive for occult blood. 25 days post vax the pt had a guaiac negative stool and was considered as recovered. No further information is available.
Information has been received from an unspecified reporter referring to a 16 month old patient of unknown gender. The patient's concomitant medication, concurrent conditions and medical history were not reported. On 18-AUG-2016 the patient was vaccinated with PEDVAXHIB (lot #, expiration date, dose and route were not reported) for prophylaxis. The vaccine was administered at a Heath Center during the temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003650.
Little bit of diarrhea; Mild fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (Little bit of diarrhea) and FATIGUE (Mild fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced DIARRHOEA (Little bit of diarrhea) and FATIGUE (Mild fatigue). At the time of the report, DIARRHOEA (Little bit of diarrhea) and FATIGUE (Mild fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported .  No treatment medication reported by the reporter.
Onset red lump approximately  2.5inches in diameter, raised, hard remained on arm from March 26, 2021 - April 13, 2021.  Itchy, painful.  No other side effects encountered outside of mild headache for first 24 hours post injection.
Patient explained itching up until today after receiving vaccine. Arm was red and had a rash.
PT EXP PAIN AND STINGING AT SOI AFTER RECEIVING ENGERIX-B VACCINATION.  TREATMENT:  PT COUNSELING.  DOSE #2 22Jan90 PT EXP SIMILAR PAIN AT SOI.
Breakthrough case admission after two vaccines  Moderna 3/18/21 Lot# 002B21A;  Moderna 4/22/21 Lot # 002c21a
This spontaneous report as received from a nurse refers to a patients of unknown age. On an unknown date the unknown number of patients were vaccinated with LIQUID PEDVAXHIB and GARDASIL which was improperly stored. The patients did not experience any adverse effect. Additional information has been requested.
pt recvd DTP/HIB/OPV on 4SEP91 & devel extreme pallor, t100.4, shrill, high pitched crying intermittently for 48-96 hrs following vax; pt recovered;
Information has been received from a registered nurse concerning her daughter a 9 year old female with no medical history or allergies who on 24-MAR-1998 was vaccinated with a first dose of Varivax (lot # 620642/1340D). Concomitant therapy included a third dose of poliovirus vaccine oral # 0769K/448498), a first dose of MMR II (lot # 622264/0596E) and a fourth dose of TriHIBit (lot # 0875900). On 15-MAY-2006 the patient developed varicella. She broke out in over 400 chickenpox. Medical attention was not sought. The patient recovered on 25-MAY-2006. It was reported that the patient nor her siblings ever experienced an adverse event following prior vaccination. The patient's vaccination history included the following: a first, second, and third dose of TriHIBit on 25-FEB-1997 (lot # 429-968), 29-APR-1997 (lot #438-621) and 08-JUL-1997 (lot # 438-621); a first dose of DTaP on 03-APR-2001 (lot # U0317AB); a first and second dose of hepatitis A virus vaccine in activated on 16-FEB-1999 (lot # 627922/1444H) and 21-SEP-1999 (lot # 632776/1148J); a first, second and third dose of hepatitis B virus vaccine on 24-DEC-1996, 25-FEB-1997 (lot # 620761/1308D) and 08-JUL-1997 (lot # 622477/0071E); a first dose of poliovirus vaccine inactivated (unspecified) on 03-APR02991 (lot# T0485-2); a second dose of MMR II (lot # 632236/0937J) on 03-APR-2001; a first and second dose of poliovirus vaccine (lot # 0747K/438118) on 25-FEB-1997 and 29-APR-1997; a first dose of Trivalent Flu (VFC) (lot # U1268AA) on 10-NOV-2003. Additional information is not expected.