chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It started with migraines and overall feeling of being unwell on 10/17/2020. On 10/20/2020 I broke out in a rash. It started on my arms then it travel throughout my body. The itch was uncontrollable. I spoke with my doctor's office on 10/21/2020 (provided them photos) and they asked I go to urgent care immediately.   I was told to take Claritin asap and was prescribed steroids.
This case was reported by a lawyer and described the occurrence of neurological injury in a male subject who was vaccinated with hepatitis B vaccine (Engerix B) and or unidentified hepatitis B vaccine for prophylaxis. On an unspecified date the subject received unspecified dose of hepatitis B vaccine. According to the legal complaint, at an unspecified time after vaccination with hepatitis B vaccine, the subject experienced serious and permanent neurological injuries which was attributed to toxic mercury exposure. The following information was received via medical records, the subject was vaccianted with Hep B on 8/23/94 and 1/27/95. The subject was vaccianted with Dtap on 3/24/94 and 5/25/94, the subject was also vaccianted with oral polio, Hib adn MMR for prophylaxis. A pediatric master problem list indicated the following hypotonia/poor condition 1/24/97, developmental delay 1/23/98, and pervasive developmental disorder 5/22/98. No delays were noted during the first year, and at 12 months was able to say mama. The subject did not walk until 18 years of age. AT two years old she had a few words, which were lost by age three years. At age tow she also began to scream for 5 to 10 minutes per episode for no known reason. According to progress notes dated 1/23/98, the subject experienced problems with toilet training, was not speaking, and made fleeting eye contact. Neurological examination revealed hypotonia. Impression included developmental delay with loss of speech. The subject was referred for evaluation of possible probable Rett's syndrome with deteriorating milestones, loss of language, and hypotonia floppiness. In April 1998, the subject was hospitalized for diagnosis of Rett syndrome due to excellent hand use and ability to follow simple commands. She was assessed to have pervasive developmental disorder. She exhibited severe tantrums, initially treated with Prozac and later changed to clonidine. On 5/13/98, testing revealed cognitive skills commensurate with a 12 month level as measured by the Battelle Developmental inventory. Expressive and receptive speech and language skills, and fine motor and socialization skills, were below expected for age. At that time it was noted that the subject was exhibiting stereotypical behaviors consistent with autism. On 9/2/1998, the subject was treated in the ER for an accidental overdose of Clonidine, at that time she was noted to have a mental age of approx 22 months. By approx Feb 2000, she had begun to repeat words and was using some sign language, and was described as having made continued progress in a special education program which included speech and language therapy. By Jan 2001, the subject had been diagnosed with autism, and she failed a vision test at school. On 4/30/04, the subjects mother reported an increase in combative behavior and property destruction.
In order of onset: Pain at the injection site, fatigue, general musculoskeletal soreness, chills, abdominal discomfort. Treated with Ibuprofen, which eased some of the symptoms
At about MN, dizzy, unable to stand, vomiting; Ambulance transported pt to Hosp; treated w/IV ATB x 5 days, discharged on po ATB; no fever or cold sx; myalgia;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "Known allergies: Adhesive" (unspecified if ongoing); "Known allergies: wakame (seaweed)" (unspecified if ongoing). Concomitant medication(s) included: ZIOPTAN, start date: 01Jan2020, stop date: 10Oct2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received other medication (ZIOPTAN) in 2 weeks of vaccination. Anti-viral details included COVID 19 Treatment, (Paxlovid from 03Oct2022 to 08Oct2022).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever (101.2) , chills, body aches, sore throat/achey ears, headache, nausea.   I?ve had the sore arm since yesterday (no big deal re: that), but today I am too sick to function and can just lay here.  Was told to expect some sickness after second shot but scared since first shot and how bad the second will be if it is worse than this.
received her COVID-19 Vaccine #2 on 1/27/2021 at approximately 2:45pm.  At 2:53pm she complained of headache and dizziness.  She denied SOB or difficulty breathing.  Her blood pressures were  150/84 at 2:53pm, 130/78 at 2:57pm, 146/92 at 3:05pm and 154/96 at 3:15pm.  AT 3:15pm patient continued to c/o HA and dizziness.  She also said, "It's hard to move my lips."  I noted some  facial twitching to the right side of her face as well as some right sided facial drooping.  She was taken to the ER at 3:20pm via wheelchair for evaluation.   I was able to talk to patient at 4:25pm on 1/27/2021 as she was leaving the ER.  She said that she had a CT Scan done that was normal and that the ER doctor had diagnosed her with Bell's Palsy.   I spoke to on 1/29/2021.  She said that on 1/28/2021 she had chills, body aches, nausea and a headache.  She also complained of pain to her left arm where she received the vaccine.  She told me "I feel 90 times better than yesterday."  She reported that her face was back to normal and that the ER physician had instructed her to f/u with her PCP in 5-7 days.
Information has been received from a health professional concerning a 21 year old female with no known allergies and on and off chest pain beginning in 2002 (attributed to stress), and a history of sinusitis, who on 5/20/04, was vaccinated in the left arm with a 0.5mL first dose of MMR (lot # 646343/0960N). On 5/20/04, the patient was given a 0.1 dose of PPD in the left forearm. On 1/5/05, the patient presented with a history of consistent tiredness and tingling up to 2 hours/day (left greater than right thigh). No weakness seemed to resolve. In June 2004, the patient experienced extreme fatigue. At the time of this report, the patient had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information received from a physician indicated that in the beginning of July 2004, the patient developed oral blisters. She also was noted to be ill with fatigue, rashes, head/neck pain, a tingling sensation, and weakness (noted to have recovered). She had escaped a specific diagnosis, despite numerous tests. Medical records indicated that the patient presented to the physician on 2/9/05 with multiple neurological symptoms. It was noted that beginning roughly in July 2004, the patient began to experience a series of problems, the first tingling in her lower extremities, but then went on to have symptoms of a feeling of diffuse weakness at times, a burning sensation across the right side of the head, as though she had trouble with her throat closing spontaneously, achy joints, and mostly extreme fatigue. The latter became particularly evident in the fall of 2004, when she had an axillary rash bilaterally, with itching. It was mostly a vesicular rash that had a somewhat linear vertical orientation. She had no had a rash elsewhere. Whereas her lower extremities tingling symptoms were very prominent in July 2004, lasting less that 30 minutes on a given occasion, they became much more of a persistent problem in December, and have bothered her since. In the meantime, she underwent an MRI scan of the brain which was performed on 12/28/04, without contrast. The study was normal. She also had an MRI of the thoracic spine on the same date, which was normal. During this time, she had not had any fever, though she had blood tests done, including a chemistry profile that was unremarkable, except for a fasting glucose of 61, but the subsequent glucose was 85 with normal insulin. In addition, a CBC diff was normal, and a mono screen on 1/5/05 was negative. On 2/9/05, the patient's albumin was high at 5.1g/dL. It was noted that the child had no childhood immunizations - were waived by parents. It was noted that the reaction was possible related to vaccination with MMR. The reporter indicated that the events were considered to be disabling. The reporter expressed a concern with the lot. The records of testing prior to the release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.
Slight stomach pain began 7 hours after injection. As the night progressed, I felt the pain getting stronger. After eating dinner, I was expecting the pain to subside, but that did not happen. As the pain became more intense, I decided to lay down for the night. I was awaken in the middle of the night with several bouts with sharp abdominal pains. I took (2) Tylenol for the pain in the middle of the night. The next morning, the pain was still there, and more intense. The day after I continued to experience constant sharp abdominal pains. Again, I took another (2) Tylenol for the pain. As the day progressed I continued to experience sharp abdominal pains. I thought it might have been trapped wind, so I took Miralax. Unfortunately that did not help. Again, I went to bed the second evening with concerns this may be a reaction to the virus. On the third day, I started to feel slightly better. I the sharp abdominal pains were subsiding from a level 10 down to a level 8. As the day progressed, down to a level 6. However, I began to feel a headache in the front right lobe. So, I took (2) Tylenol and went to bed. On day four, I woke without any abdominal pains, however I still had a headache and it was non-stop. This continued through day four and through the evening. On day five I still had a headache, but  was feeling slightly better. By end of day five the headache stared to subside. On day six, I was feeling back to normal.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a adult female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (started in October 2017). Previously administered products included SHINGRIX with an associated reaction of chills (1st dose received on 27th March 2018 refer case US2018GSK182175). On 26th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced shoulder pain, headache, fever, erythema, injection site rash, sore throat, esophageal acid reflux, shingles, tingling, blisters and eye pruritus. On 26th September 2018, the patient experienced shivering. On 28th September 2018, the patient experienced pruritus. On an unknown date, the patient experienced blotchy and back pain. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the shivering, shoulder pain, headache, fever, erythema, injection site rash, blotchy, pruritus, sore throat, esophageal acid reflux, shingles, tingling, blisters, eye pruritus and back pain were unknown. It was unknown if the reporter considered the shivering, shoulder pain, headache, fever, erythema, injection site rash, blotchy, pruritus, sore throat, esophageal acid reflux, shingles, tingling, blisters, eye pruritus and back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose on right arm at 10:30 hours. The patient reported she received the second dose, she said she shivered all night long. On a scale from 1 to 10, she said the side effects were a 6 or 7 when they occurred. With the second dose, she said the side effects that were more intense, like a 9 or a 10. In September 2018, less than a week after vaccination, the patient had shoulder pain, excruciating headache, redness and fever. The patient said there were blotches around the injection site on her right arm. On 26th September 2018 at morning the middle of her back was red and itchy. The patient thought the blotches looked like they might be the start of a breakout. Her sore throat might not be from the vaccine, there was a probability it might be acid reflux but she was not sure. During the conversation, she said it might feel like shingles because her face and chest feel tingly. Additional comments from call discussion. The caller stated pain, shivering and chills with first dose. With second dose she had extreme headache and the site of injection on her right shoulder looked like a shingles outbreak is occurring. Little red blisters were also on her cheek. She had tingling under her skin on her face, chest and back. She had itching of her inner eye, and upper back with pain in her lower back. She had been referred to see a physician, although she was visiting. This case has been linked with case US2018GSK182175 reported by the same reporter for the same patient.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 06-SEP-2017 the patient was vaccinated with GARDASIL 9 lot # N003703 for prophylaxis.    Concomitant therapies included sterile diluent (STERILE DILUENT). On 06-SEP-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown.; Sender's Comments: US-009507513-1709USA003214:
Throbbing pain in upper left arm that worsened over time. The pain began night of injection and progressed to patient not being able to raise left arm over a period of 2 weeks. Patient went to primary care physician office for injection for bursitis at site and was ordered physical therapy. Patient has already received two weeks of physical therapy. Patient is able to raise arm now but is still experiencing pain.
09/24/22 presents to ED for "weakness". PMHx of "metastatic pancreatic cancer undergoing chemotherapy"
tingling, swelling, redness w/feeling like pinpricks in rt cheek radiating from rt side of nose to ear lower eyelid to mandible;progressed to numbness, severe redness, blisters & severe swelling, inflamed rt eye;herpes zoster;numbness & pai
This report describes the occurrence of an allergic reaction in a 53-year-old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophalyxis. The pt's medical history included unspecified liver dysfunction. Concurrent conditions and medications were not reported. On 12/02/2002, the pt received her 1st injection of Engerix-B (lot ENG5305B6). On that date, she also received a tuberculin Mantoux test. On 12/07/2002, 5 days post-immunization, she experienced 5 episodes of being awakened in the night with "extreme" itching on the palms of her hands that then spread to her pubic area, head, arms and thighs. There was no rash. She also noted a thickening of the anterior portion of her tongue and swelling of her lips that affected her ability to speak. She also experienced tightening of her neck, heaviness of her mid upper chest, "severe" discomfort, "copious" amounts of frothy sputum and hoarseness. She was seen by her physician, who made a diagnosis of allergic reaction. She was treated with unspecified medications. The allergic reaction persisted as of 12/18/2002. The Engerix-B immunization series was discontinued. The allergic reaction in this report is considered GSK medically serious.
Severe headache lasted three hours; pain in left arm where shot was given; body tiredness 12-hours. 36-hours later: chills, shaking, temperature 101-degrees - lasted 2.5 hours.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 02-JUL-2016, he was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
pt recvd 12APR95 reported to ER same day c/o vomiting, shaking, tachycardia to 190;fever 102.9R, pallor;parents ? passed out
Possible reaction to Adacel, Tdap, vaccine given on 12/19/2005. Approximately 18-20 hours after receiving vaccine had sudden onset dizziness, chest and throat tightness and pain. She had swelling at injection site but no erythema or itching. No rash was present. She had wheezing which resolved after 2 nebulizer treatments of Albuterol (1 with Pulmicort), Prednisone and Zyrtec. No prior history of wheezing. All symptoms resolved by 48 hours after injection.
1/22 pain in arm very painful full to lift 1/23 arm loss painful. Can raise with little pain 1/24 3 pm - upset stomach, chills, headache, fever. Very bad night. 1/25 8 am - feeling better. 3 pm - feeling good, no symptoms 1/ 25 3 PM- husband has temperature of 101 and headache. 8 pm temperature of 100 1/ 26 - temperature of 99. Goes for covid test which is negative. 3 pm - husband is fine. 1/27 - 3 pm husband has first covid vaccine shot. No problems and continued problems thru today
Vaccine was given by employee who no longer works with us. She was given 0.3 pfizer 12 and up vaccine
12-24 after administrator, muscle soreness, body aches, fever, HA, chills, N/V x1, last day, severe back/shoulder pain (R) side, dizziness, fatigue blistered at site, red & warm.
Headache, nausea, chills, flu-like symptoms, warm, body/muscle ache, sinus
Was in bed and could not get out; Dizzy if stood up; Flu; Fever; Chills; Nausea; This case was reported by a consumer and described the occurrence of bedridden in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose in April 2019, refer case US2019AMR180629).   In September 2019, the patient received the 2nd dose of Shingrix. On an unknown date, 7 hrs after receiving Shingrix, the patient experienced bedridden, fever, chills, nausea, dizziness and influenza. On an unknown date, the outcome of the bedridden, fever, chills, nausea, dizziness and influenza were unknown.   It was unknown if the reporter considered the bedridden, fever, chills, nausea, dizziness and influenza to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix received Shingrix last week and excepted the same and was in bed and could not get out. The patient had a fever with chills and nausea for 24 hours.  The patient was dizzy if stood up. The patient never had the flu as bad as this. This was the worse vaccination the patient had ever received.
felt that when she received the first shot of Moderna vaccine the Pharmacist did not inject her; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DISPENSING ISSUE (felt that when she received the first shot of Moderna vaccine the Pharmacist did not inject her) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No reported medical history).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DISPENSING ISSUE (felt that when she received the first shot of Moderna vaccine the Pharmacist did not inject her). At the time of the report, PRODUCT DISPENSING ISSUE (felt that when she received the first shot of Moderna vaccine the Pharmacist did not inject her) had resolved.
The patient received only the diluent of ACTHIB, no AE; Initial information was received on 26-Apr-2021 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 2 months old female patient who received only the diluent of HIB (PRP/T) VACCINE [ACT-HIB] 0.5 ml (lot UJ405AAA, expiry date: 08-Oct-2021) via intramuscular route in the right thigh for prophylactic vaccination on 12-Apr-2021 (Product preparation issue)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX), ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate reconstitution technique (latency same day)  At the time of report, no adverse event was reported.  One of the nurse gave only gave the diluent of ACTHIB and asked if they could give the HIB with another diluent.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a nurse refers to a 6 months 19 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Patient was checked by the doctor and advised mom that he would have a larger immune response and any severe reaction would have happened within 15-20 minutes after administration. No adverse reaction noted.
Itchy on skin on left shoulder (4-5 inches diameter), treated with topical hydrocortisone, still persists today and appears to be spreading