chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix given to a 1-year-old; Kinrix given instead of Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 20-DEC-2022, the patient received Kinrix. On 20-DEC-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 1-year-old) and wrong vaccine administered (Verbatim: Kinrix given instead of Infanrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: 16-MAR-2023 The licensed vocational nurse (LVN) reported administration of Kinrix vaccine to a 1 year 3 month old patient instead of Infanrix.  No adverse reaction noted with patient. The reporter consented to follow up. The patient received Kinrix vaccine instead of Infanrix at inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered.
2 inch diameter, dark red, raised 1/2 inch above skin surface, per Mom.
declined fast mentally and physically and died in July; declined fast mentally and physically and died in July; he was a downward slope cognitively; weight loss; This is a spontaneous report from a contactable consumer.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) 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. Per reporter, "mother's boyfriend was better than her cognitively and would get them to events and meals etc. They were both vaccinated the same days with Pfizer. From about that time, he was a downward slope cognitively like mini strokes often and declined fast mentally and physically and died in Jul2021. Very, very odd. I hope things like that get studied as well. A few weeks ago, I was pondering the unusual occurrences in my head and then dawned on me to perhaps report. Maybe nothing, but could be studied in Real World Data. Not sure the medical diagnosis since my mother's boyfriend was not our family, but talking to him there was an obvious and rapid change. He used to be the first to the musical events at their facility as he loved to sing and dance and would get my shy mother up there with him harmonizing and dancing with him. The facility would often make sure (Name) would participate because he added to the entertainment with his singing and dancing. He just declined so fast. First, I noticed the weight loss, but when we could finally get inside the facility and actually have real visits he was so "out there" the few months before he died". The patient died on Jul2021. It was unknown if autopsy was performed.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: he was a downward slope cognitively; weight loss; declined fast mentally and physically and died in July; declined fast mentally and physically and died in July
No side effects after vaccine.  I had my hair done on 4/1/21 (it was bleached which I have had many times before in my life).  It tingled and burned like crazy nearly as soon as it was applied.  The tingling and burning started to spread throughout my body like my nerves were all reacting.  I begged the stylist to get the bleach off so she rinsed it immediately.  I've NEVER had that reaction before.  One of the stylists said a couple of other patients reported similar reactions and noted it was after that had received their Covid vaccinations.  I thought it was important for me to report it just in case there is any link.
Began with hives and facial swelling.  After the 2nd vaccine, hives covered entire body, face, eyes, lips, tongue and throat swelling, I also developed anaphylaxis.
ARM TURNED RED AT THE INJECTION SITE. REDNESS GOT BIGGER AS THE DAY WENT ON.  PATIENT WENT TO ER. DOCTOR TOLD HER IT WAS CELLULITIS. PATIENT WAS GIVEN AN ANTIBIOTIC. GENERIC BACTRIM DS.
My menstrual cycle started 7 days early. My cycle is always exactly 28/29 days apart with a heavy flow. Very regular FOR YEARS. Can set a calendar by it.  I was shocked when it started 7 days early! There would be no other reason except a side affect from the vaccine.  I have read this happening to others, but being looked at as an anecdote, however with younger people getting vaccinated now, I am looking forward to learning of this is more common among women in their reproductive years.
Sudden Death; The first and second dose of vaccine was administered on 28Mar2021 12:00 PM.; The first and second dose of vaccine was administered on 28Mar2021 12:00 PM.; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EN6199) and second dose (lot: ER8730); both via an unspecified route of administration into the right arm on 28Mar2021 12:00 for COVID-19 immunization. Medical history included coronary artery disease (CAD), hypertension, parkinson's disease, abdominal aortic aneurysm, cerebral aneurysm and arthritis. Concomitant medications included paracetamol (TYLENOL) taken for arthritis and a pill for his hypertension. It was reported that the first and second dose of vaccine was administered on 28Mar2021 12:00 PM. The patient's sudden death on 30Mar2021 15:30 was also reported. An autopsy was not performed. The patient was not diagnosed with COVID-19 prior to vaccination.  Further information has been requested.; Reported Cause(s) of Death: Sudden Death
My wife is allergic to pnuemovax; This spontaneous report was received from a consumer and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot # and expiration date were unknown) )for prophylaxis. On an unknown date, the patient experienced allergy to vaccine. The outcome of allergy to vaccine was unknown. The reporter considered allergy to vaccine to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).
Pt exp long-term myalgia & fatigue following vax w/Hep B;
Fatigue, headache for 48 hours starting approximately 16 hours post-injection.
January 4.  Noticed neck swelling and pulsating neck while brushing teeth.  No fever noted.  Neck swelling noted with bounding pulse in jugular region x 9 days.  Seen by physician Jan 5.  Neck ultrasound performed Jan 11.  Awaiting results.
Pt reported being diagnosed with shingles 9 days after getting first shingrix vaccine.
30 seconds after receiving COVID19 Pfizer vaccine # 1, felt dizzy, felt HR and BP increase, and pressure in throat.  RN at  vaccine clinic confirmed HR to be tachycardic (rate unknown) and BP (170/98) to be elevated.  50 mg IM Benadryl administered and brought via wheelchair to ER which is connected to.  ETA 2 -3 minutes.
This case reported by a healthcare professional and described the occurrence of sore arm in a 40-year-old female subject who was vaccinated with FLUARIX. On 16 October 2008 the subject received a dose of FLUARIX (unknown). On 16 October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced sore arm. The event resolved. Later, on 28 October 2008, the subject went in to receive another vaccine and inadvertently received a 2nd dose of FLUARIX. This was considered to be a maladministration (asymptomatic/extra dose given). No adverse events were reported. Follow-up information was received on 01 December 2008, via healthcare professional who reported the subject's event was due to erroneous administration. The subject was given a second dose of FLUARIX (intramuscular) 12 days after a single seasonal dose of received. The subject had a sore arm after the first dose on 16 October 2008 and fatigue 24 hours after the second dose was given on 28 September 2008.
I20.9 ANGINA, UNSPECIFIED 6/17/2021 ABDOMINAL BLOATING T78.40XD ALLERGIC REACTION, SUBSEQ 4/30/2021 ABDOMINAL BLOATING I20.9 ANGINA, UNSPECIFIED 6/17/2021 SHORTNESS OF BREATH T78.40XD ALLERGIC REACTION, SUBSEQ 4/30/2021 SHORTNESS OF BREATH
sever headache. Fevr. Shivering. Dizziness. Body ach. Muscle pain. Joints pain.swelling in the shot area..extreme fatigue.
pt recvd vax;swelling & pain since inject;redness began 27mar95 10 days p/ shot;area outer mid upper lt arm appears very warm to touch w/ mottled redness;MD prescribed Keflex & Atarax 28mar95;
Patient is a 33 year old female who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: other - c/o sharp stabbing and pressure chest pain, palpitations, nausea. Pfizer-BioNTech COVID-19 vaccine #1 in series administered.  o Action(s) taken: Other - vital signs, monitoring, MD consult o Allergy to COVID-19 vaccine documented in Allergies activity: yes o Patient advised to discuss second dose considerations with a clinician 1249:  Pt was observed sitting on chair past her 30 minute observation period which ended at 1248.  When asked if she felt well, pt reported sharp chest pain and palpitations.  Pt reported feeling symptoms for the last 5 minutes.  Pt had reported feeling anxious about receiving vaccine.  Stated it was mandated by her employer and that was the only reason she received it.  Pt was reassured and instructed on deep breathing and relaxation, however, after a couple minutes she continued to c/o chest pain and palpitations.   1255:  Pt taken to HR.  Vitals taken.  BP 121/74, HR 62 SpO2 100% RA.  Pt continues to c/o stabbing CP and now pressure, palpitations and nausea.  Pt did report hx of panic attacks during her pregnancy.  1300:  Continued reassuring patient.  No c/o pruritis, no rash noted, no angioedema, clear breath sounds bilaterally.  No c/o SOB, pt able to speak in full sentences without pausing, skin pink and warm.   1304:  I have attempted to reach Dr. and no answer.  I called reception on 6th floor and they also attempted to reach Dr. No answer.    1305:  While I was on the phone pt stated she wanted to leave. Pt declined to wait for provider, declined further monitoring.  Stated she just needed to go home and lay down. .  Pt was instructed to keep paperwork (EUA and What to Expect After Your Covid 19 Vaccination) in a safe place and to refer to it if she developed any sxs of severe allergic reaction such as swelling of the tongue, throat, face, difficulty breathing, SOB, generalized rash, abdominal pain, vomiting, dizziness and / or palpitations. In which case she should seek immediate medical attention.  Pt verbalized understanding. Left ambulatory in no distress.     - RN
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 27-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # R020652, expiry date 18-JUL-2020 (strength, exact dose, route and site of administration were not reported) for prophylaxis. The suspected vaccine was reconstituted with sterile diluent. The suspected vaccine was stored in temperature from -9 degrees Celsius (C) to 8 C (-9.1 C) for 1 hour and 13 minutes. There was no previous temperature excursion. Digital data logger was not involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1903USA000242:
pt rec vax and devel atrophy @ inject site measuring 8mm in diameter & 4mm deep
I just realized  a week later after my 2nd vaccine shot, ringing in my ears became louder especially at night even after having few massages.
sore arm; inappropriate schedule of vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm and drug dose administration interval too long. On an unknown date, the outcome of the pain in arm and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Consumer states that her mother received dose 2 of Shingrix one year after dose 1, which led to which led to lengthening of the vaccination schedule.  She stated her mother also had a sore arm. The reporter did not give consent to follow up. Consumer did not have any more information for her mother's adverse event. This was 1 of 5 cases reported by the same reporter.
Pfizer monovalent covid vaccine was given instead of the bivalent Pfizer covid vaccine.
No additional AE; HBP called to report a TE with PROQUAD from 8/19/2022.  Administered to this patient on 1/9/2023. Also administered to 7 other patients:  8 AE cross-reference cases: 02439769, 02439770, 02439771, 02439773, 02439801, 02439807, 02439777, 02439808. No a; This spontaneous report was received from an tther and refers to a 6-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-JAN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHa) (PROQUAD) injection, 0.5 milliliter, lot # U039261 and expirasion date 09-JUN-2024, administered for prophylaxis (strength and route of administration were not provided). This vaccine underwent temperature excursion on 19-AUG-2022 (Product storage error). No additional adverse event was reported.
Patient's (L) thigh became swollen and developed limp. No redness or warmth to thigh.
Started w/itchy rash around waist area - 6 mo. Some relief w/steroid but severe reaction to them. Hospitalized 2-2008 lessened some then returned spreading other locations (areas back, arms, waist, buttock) stinging & very itchy. Hosp several times due to steroids.
13 month old child given KINRIX. No adverse reaction noted. HD RN notified. Education to clinical staff on age appropriate vaccine administration.
He got his vaccine, he had pain in the arm and redness.  He started noticing weakness in his legs about 2 weeks after the vaccine, did not think it was related to the vaccine, though it was neuropathy or fibromyalgia.  He legs gave out on him and they went to the ER at Hospital.  They ran a lot of tests, they were having problems with getting him to get tests done as he had a UTI and started to get confused and upset.  They claimed that moving a lot and could not tell if it was Parkinson's or GBS.  He was admitted to the hospital on 12/2/21 they ran tests, MRI's from his back, he had antibiotic treatment for the GBS.  He was discharged on 1/7/22.  He went PT in the same facility and was instructed to continue therapy and they just sent him home.  He has FU with his doctors since going home, he was taking his medicines.  He was bed bound and still is.  He is not even able to turn in bed.  He had a huge bed sore on his buttocks and was released in a very bad condition.  He was quadriplegic, but now has a little strength in his arms more than before.  He is having problems with the strength of his arms, things fall out of his hands.  He is not able to walk.  He is wheelchair bound, he cannot sit up long in his chair as his legs, back and knees hurt and then he has to be put back to bed.  He is not able to do anything for himself, he is not able to bath, has to be helped with everything.  He is able to feed himself at this point, but he was not able to for several months after he was discharged from the hospital.     They moved from area to area in August and are in the process of getting things started back with therapy in the new location.  He had no problems walking prior to the vaccine but he did have a power chair due to the long hallways that he was using.  He was walking with a cane at home prior to the vaccine, and he would have to have the electric chair on long walks due to his neuropathy.  The wife made an appointment for him to see a neurologist but it is not until 3/30/23.
Swollen right armpit, painful. Abdominal pain and bloating, loose stools, brief nausea, fatigue. Abdominal pain started 10/16 around 8pm, got much worse over night, communicated with my doctor on Thursday 10/27, that evening I thought about going to the ER the pain was so bad in my abdomen. Woke up to relief almost on 10/28, saw a Dr. in person who examined me and did blood work. All labs came back normal so no imaging was ordered. Fasted for 2 days and pain was relieved. Have not tried eating food yet. Hopefully it will be ok.
Uncontrollable screaming, sz, development delay,brain damage.Low grade fever approx 100-101.
dizzy still after 23 hours from second dose.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy still after 23 hours from second dose.) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizzy still after 23 hours from second dose.). At the time of the report, DIZZINESS (dizzy still after 23 hours from second dose.) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.
Chills; tiredness; headache; feeling unwell; swelling & pain in right wrist; swelling & pain in right wrist; This is a spontaneous report from a contactable consumer(patient). A 78-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 06Mar2021 at 10:15 AM (age at vaccination: 78-years-old), as dose 2, single for COVID-19 immunization. The patient's medical history included arthritis. Concomitant medications included atorvastatin. The patient was allergic to morphine, codeine and darvacet. The patient did not receive any vaccine within four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 08Mar2021, at 7:00 PM, the patient experienced chills, tiredness, headache, feeling unwell, swelling & pain in right wrist. The patient did not receive any treatment for the events. Outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Was extremely sick after the second shot with flu like symptoms.  On the second day, my blood pressure was 190 over 110 and still sick with flu like symptoms.  Got the blood pressure to come down by doubling up on high blood pressure meds.  Remained sick for 13 days.  During this time, was working full time (Office duties) and off hours working extreme hours to physical exhaustion on family farm.  On the 13th day, suffered severe seizures that broke my collarbone and shoulder to the point my shoulder needs to be replaced.  The broken bones were not from the fall when I passed out, as my brother caught me and took me to the ground.  No medical history of seizures with me or my family.  Right before the seizure I could only describe myself as feeling off, like I was in a slight fog and not clear of thought or sight.  My brother told me I had about 10 mini seizures while standing and holding on the tailgate of the truck and then one big one that knocked me out for about 15 minutes dislocating and breaking my should and collarbone.
Case number PHEH2011US02821, is an initial spontaneous report received from a nurse on 26 Aug 2011: This report refers to a child female patient. She was administered only the MenCWY liquid component of MENVEO (batch number M10047) without being reconstituted with the MenA conjugate component, intramuscularly, on an unspecified date. No adverse event occurred following this administration.
Pt was given Tdap (unknown manufacturer however above field was required. Pt will call  hospital for specific manufacturer.) the day after delivering her child at Hospital. She woke the next morning with complaint of inability to use L arm. States she couldn't move her L arm and had severe shooting pain into L arm for ADLs. States this severity lasted about 2 months then use of arm slightly improved. Now complains of diffuse pain, weakness and fatigue throughout B hips and lower extremities. Continues with sharp pain and weakness in L shoulder. Complains about constant aching in wrists and arm as well as generalized fatigue.  After consultation with primary care, orthopedics, and rheumatologist pt was referred to Physical Therapy to address shoulder pain and weakness.
Information has been received from a physician referring to a 9 month old male patient. The patient had no concomitant medication, pertinent medical history or drug reactions/allergies. On 14-JUL-2016, the patient was inadvertently administered a dose of PNEUMOVAX 23 (lot# L040178 with expiration date 18-AUG-2017; dose and route were not reported) (wrong vaccine administered). 4 hours after the injection, the patient spiked a fever of 102.2 Fahrenheit (F) and was fussy. The patient came to the physician's office seeking medical attention and treatment was given for the events. No lab diagnostic studies were performed. At the time of reporting, the patient was recovering from the events. The causality was not reported. Additional information has been requested.
Pt given vaccine and 2 minutes later she started to feel light headed and foggy. The reaction nurse laid her down and elevated her feet. No c/o nausea. Guardian present and watching. Pt eating w/o issues.
ears started ringing after 30 min of injection of J&J covid 19 vaccine.  At this time unable to fall asleep as I get cold sweats & clammy  at night.
My spine ceased and I couldn?t walk. Extreme pain in my hip area.  I gained 10 lbs in less than a week in fluid. My belly was extremely distended. Arthritic feeling in joints
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 13-MAY-2009, the patient was inoculated with ZOSTAVAX at a hospital as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 17-MAR-2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.