chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 100. 8; 8Hives on arm; Itching; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 22Jun2021 at 12:30 as a single dose for COVID-19 immunisation. The patient medical history included lupus. The patient received unspecified other medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in 2021 as a single dose for COVID-19 immunisation and also received tetanus and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Jun2021 at 00:00, the patient experienced fever of 100. 8, hives on arm and itching. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. On 23Jun2021 at 00:00, the patient underwent body temperature and the result was 100. 8(unit unspecified). The clinical outcome of the events fever of 100. 8, hives on arm and Itching was resolving at the time of this report.   Information about lot/batch number has been requested.
Arm became red, warm, swollen at site.  Client states that it was very sore (9 out of 10) and she could not lift her arm. Client states that the intense pain lasted for a couple of days.  1 1/2 weeks later client states that the arm is still sore but is better but hurts with constant pressure being applied.  Client states that she saw her doctor about a week after she received the shot.  She states that she was told that 1 in 500 shots given can hit a nerve and if it lasts for awhile longer she may need physical therapy.
Bad reaction; This case was reported by a nurse via call center representative and described the occurrence of adverse drug reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that almost every patient who has received shingrix in her clinic has complained of a bad reaction. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by the same reporter.
No known adverse events. Age criteria of vaccine (18+) inappropriate for patient (age 14)
had 2 flu shots and the flu both times\suspected vaccination failure; had 2 flu shots and the flu both times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient had flu shot and the had flu, he or she was staying away from this shot. This case was considered as suspected vaccination failure as time to onset, laboratory confirmation test were unknown at the time of reporting. This case was linked with case US2020AMR236388, reported by the same reporter for the same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR236388:same reporter
Information has been received from an occupational health registered nurse via the mother of a 3 year old male who in November 2000, when the patient was 11 months old, was vaccinated with MMR (second generation). In approximately June 2001, when the patient was approximately 18 months old, the mother reported she feels he now displays pre-autistic tendencies. The mother felt that pre-autistic tendencies was related to therapy with MMR (second generation). Unspecified medical attention was sought. Follow up information was received from the physician who reported that on 12/11/00, the patient was vaccinated with MMR (second generation) (lot # 636400/1276K). This was the only vaccination the child received on that date. The child was well at the time of the visit, and did not have any history of any allergies. In approximately 5/01, at 17-18 months of age, it was noted that the child was not as vocal has he should be at this age, and the child's behavior was noted to be uncooperative. At 2 years of age he was referred for hearing tests and the results were reported as normal. Also, at 2 years of age, the child was referred to the intermediate unit for speech therapy and intervention, it was reported that the child continued to be uncooperative during appointments. His speech had improved, with speech therapy he could now say short sentences. At the age of 2 years 7 months, another specialist saw the child and diagnosed the patient with Pervasive Developmental Delay. The physician reported that the child is currently 3 and one-half years old, speaks in small sentences, and continues to have uncooperative behavior. The physician reported that the patient has a sibling who is 18 months of age and has not been immunized with MMR (second generation). Upon internal review, pre-autistic tendencies and pervasive developmental delay were considered to be an other important medical event (OMIC). Additional information has been requested. A 15-day follow up report received 10/24/2003 adds: Follow up info was received from the physician who reported that the parent of the pt "wanted to cancel the report of their child's condition, as he is progressing to improve". Upon internal review, pre-autistic tendencies and pervasive developmental delay were considered to be an other important medical events. Additional info has been requested.
No adverse event; Medical assistant is reporting that a  4 year old female patient received a partial dose (5%) of MMR II on 5/17/2022. No additional AE reported. No PQC reported.; This spontaneous report was received from a medical assistant concerning a 4-year-old female patient.   The patient's medical history, concurrent conditions, concomitant medication, and previous drugs reactions or allergies were not reported.   On 17-MAY-2022, the patient was vaccinated with a partial dose (reported as 5%) (inappropriate dose of vaccine administered) of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (recombinant human albumin (rHA)) (M-M-R II) lot number U013035 and expiration date: 23-APR-2023 (strength, dose, route of administration and anatomical location were not reported) administered for prophylaxis. No adverse events were reported.
approx 1 hrs p/vax pt noted to have chills & fever  (102.4 ax); then progressed to become pale w/mottled extremities, & had transient intervals of limpness & unresponsive to voice w/eyes rolling backwards, lethargy;
Fever; Infection; This case was reported by a consumer via call center representative and described the occurrence of fever in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2023, the patient received the 2nd dose of Shingrix (intramuscular). In February 2023, unknown after receiving Shingrix, the patient experienced infection. On 26th February 2023, the patient experienced fever. On an unknown date, the outcome of the fever and infection were unknown.   It was unknown if the reporter considered the fever and infection to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's Comment: The reporter was the patient. She received Shingrix shot in right deltoid on Saturday.  She did not had the lot number of the Shingrix which was administered.  On Sunday night, she began experiencing a fever. The patient had a lot of fever last night. She was wondering if Shingirx could had caused the fever (or alternatively if she might had caught an infection because she felt the onset of the fever was later than she would had expected, and she considered the onset two days later).  She did not want to share her physician contact information. The reporter did not consent to follow-up.
patient received incorrect dose.  Not sure exactly how much but it was less than the required 0.3ml.
Information received on 08JAN2016 from a pharmaceutical company and consumer. A 38 year old male experienced Multiple Sclerosis following the administration of BioThrax (anthrax vaccine adsorbed) and other vaccines. On 05JAN2016, the consumer contacted a pharmaceutical company to report that he was John Cunningham virus (JCV) positive. At that time, he was on therapy with Aubagio (teriflunomide) and Tysabri (natalizumab) for multiple sclerosis. The natalizumab was stopped for the JCV. During contact with the consumer, he revealed to the pharmaceutical company that he felt that there was a link between the multiple sclerosis and anthrax immunization that he received. The pharmaceutical company forwarded the report to the vaccine manufacturer. On 08JAN2016, contact was made with the consumer by the vaccine manufacturer. The consumer reported that he had received the vaccine in two intervals for a total of 5 doses. He recalled that in 1999 his dosage of anthrax vaccine was halted due to the agency "putting the vaccine on hold for side effects". Immunization was resumed in approximately 2000-2001. The consumer also recalled that he was immunized for smallpox, Japanese encephalitis, and other vaccines on or around that time.  In 2010, he was diagnosed with multiple sclerosis. The consumer stated that he felt the multiple sclerosis was related to anthrax vaccine because he had no prior hereditary issues or autoimmune disorders, and he was told that his multiple sclerosis could be due to "environmental triggers" which he attributed to the anthrax vaccine. The consumer denied concurrent medication and medical history at the time of event. Reporter's Comments: Report forwarded from Sanofi, which contains information regarding an Anthrax vaccine. Sender's Comments: This is a consumer report from an individual who received multiple vaccines including BioThrax, smallpox and Japanese encephalitis vaccine and reports his subsequent diagnosis of multiple sclerosis. While the consumer believes the diagnosis of multiple sclerosis is related to BioThrax vaccination, multiple vaccines were administered on or about the same time.  In the absence of adequate medical assessment of the reported events a causality association is deemed not assessable.
"Pt w/ hx of PTSD, Panic Disorder, Obesity, Migraines, HTN, Depression.  Pt is s/p bilateral salpingectomy on 12/3/20.  Pt has no known allergies. 5mins post vaccination, pt c/o hives.  Vitals: BP 98/67, HR 72, RR 20.  Pt given Benadryl PO @14:45.  Pt improved, pt stable and released from the vaccination site."
Five hours after shot starting getting extremely cold, major chills could not get warm.  No fever.  Went to bed with lots of blankets to stop shaking.  Eventually stopped in early am.
Pt's mom called about 2 hours after vaccine administered to report intense pain in the entire arm and ability to close hand. Mom was advised to instruct patient to begin Ibuprofen at a 600mg dose around the clock to help improve inflammation and to contact RPh if symptoms worsened. I followed up with Mom the morning of 11/25. Mom reported that symptoms are improving and pain is less intense today and patient can close their hand. Pt is still in discomfort mainly due to sore arm as of 11/25.
Injection site reaction-erythema, warmth, induration, pain. GI upset-nausea, loose stools.
Patient presented approximately 4 weeks following smallpox vaccination (3-19)with fatigue, fever of 103.2F, pharyngitis, lymphadenopathy, myalgia, wax and waning periorbital edema, with elevated transaminases and leukopenia.  Suspected EBV infection and patient required hospitalization (admit date 4-17).  In discussion with physician on 4-25 he does not know feel like it is an EBV infection and still unclear on diagnosis.
soreness/some soreness on his arm; I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shots. Past adverse reactions to the above products included Pain in arm with flu shots. Concurrent medical conditions included Penicillin allergy.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him). At the time of the report, PAIN IN EXTREMITY (soreness/some soreness on his arm) and VACCINATION SITE ERYTHEMA (I had a red circle by where the injection was/red circle about a quarter inch from where the injection was given to him) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. The patient says that something unusual did occur after receiving the 1st dose of the Moderna vaccine. There was a red circle about a quarter inch from where the injection was given to him. No treatment medications was reported.   This case was linked to MOD-2022-645575, MOD-2022-645576 (Patient Link).
Lymph node swelling in clavicle area requiring biopsy (benign). Arm pain from shot right deltoid.
Patient is a 33 year old female is here today with a possible allergic reaction to the flu vax, just received less than 10" ago. She has received flu vaccines in the past without reaction, no history of allergy, including foods. No upper respiratory infection symptoms, felt well today. Received the vaccine in the L deltoid, hurt a bit more than previous. Felt flushed, with rapid heartbeat, mild SOB, no throat tightness, no reaction at the vaccine site, felt anxious, is with her young daughter. No chest pain, no palpitations, no nausea, no vomiting, no neuro symptoms, but is understandingly anxious. No wheezing. O-BP 104/68 | Pulse 75 | Temp (Src) 98 °F (36.7 °C) (Oral) | Resp 16 | SpO2 97% | LMP 11/26/2017 well nourished well developed female in no acute distress but slightly anxious. Lungs-clear. CV-regular rate normal S1S2 without murmur. Eyes-extra ocular motions intact, pupils equal and reactive to light and accommodation. Neck-supple without adenopathy. Throat-airway open and clear, no lip or oral swelling. Skin-flushed at her face, no urticaria, injection site is clear without erythema or swelling,  No dermatographism. Patient is given benadryl 25mg po and prednisone 40mg po and then observed, with no further reaction. A-possible reaction to the flu vaccine, consider also anxiety reaction as well. Discussed at some length. P-reassurance, information given, repeat benadryl at bedtime, if any further symptoms continue benadryl and start prednisone, return to clinic if no improvement.
Just given a Moderna when not quite 18... realized and gave Pfizer dosage for 2nd vaccine
On March 30, 2014 I was given a Tdap shot for a leash burn on the back of my legs. My VIS said I should get the booster Td only Tdap once in a lifetime but NP said that recommendations had changed so I received the shot. On June 13th, I had pain behind my right eye, paresthesias in my face which continued followed a few days later by pain in my toe and tingling/numbness extending up my leg, spine and back of head rendering me with blurred vision, difficulty turning my eye, weakness in both legs and arms, burning pain in legs & spine, slurred speech, & difficulty chewing. This lasted for at least 6 months or more. I was left with muscle twitching and sensory issues in my calves then experienced a relapse of the same symptoms as the original attack in February 2015. This time it resulted in further disabilities with autonomic problems with racing heart, chest pains, digestive problems, leg and arm numbness, back stiffness and pain and possibility of permanent disability given difficulty in standing and walking.
Swelling under left arm in armpit area and side of chest. Slight discomfort and pain.
Extreme pain in back of head/neck/shoulders, blood glucose spiked, nausea, vomiting, whole arm hot to touch, chills, excessive sweating, body aches, meningeal inflammation, swelling in hands/feet, a lot of head pressure that only felt better if I laid down. Started 4 hours after 2nd vaccine and worsened over a 6 day period. Resulted in visit to urgent care then ER and admittance to hospital for intervention.
Dermatographia-like symptoms and skin inflammation. Stimulating the skin through scratching with my fingernails or applying pressure to the skin (for example, affecting the hands through carrying a heavy bag by holding straps, using dumbbells and grabbing a bar for pullups) causes inflammation, itchy red bumps, or itchy red lines. This can happen at any time of the day and I am still experiencing these issues. The problem is usually started by some part of my skin being itchy, and I scratch it in response. I scratch pretty lightly and keep my fingernails trimmed.
Urticaria, pruritus, and erythema surrounding the injection site 2 days after vaccine administration. Body aches, rigors, chills within 24 hours since administration that improved and resolved 72-96 hours after administration.
Child received Gardasil injection in right deltoid, complaining only of local pain at site. Approximately 8 minutes later, while walking around, she fainted and fell backwards, hitting head on the ground. Syncope lasted approx 30 seconds, after which she c/o headache. Headache persisted until following morning, though she is still sore at point of impact. She has never had vaccination related syncope. Retrospectively, near identical event occurred when older sister received Gardasil vaccine 2 years prior. Reporting mom is a physician.
Patient was given the incorrect Pfizer vaccine for dose 2. Patient was given Bivalent instead of the monovalent for dose 2. Patient received these on 11/4/22. The patients parents have been notified of the error at a follow up visit by the Provider in the office. Patient reported no concerns.
child another dose that day with no reported adverse event; twisted the needle onto the syringe and when administering the injection about half the vaccine came out around the luer lock no reported adverse event; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Agency (Reference number- 00883700) and transmitted to Sanofi on 03-Dec-2021.  This case involves an 11-years-old male patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV], child another dose that day (extra dose administered) and twisted the needle onto the syringe and when administering the injection about half the vaccine came out around the luer lock (needle issue).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included COVID-19 VACCINE (PFIZER BIONTECH) for Immunisation.  On 30-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7411JA, expiry date: 30-Jun-2022) via intramuscular route in the left arm for prophylactic vaccination.  It was an actual medication error due to extra dose administered and needle issue. (latency: same day).  At time of reporting, no adverse event reported.  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 the 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.
Began around December 5, 2021, with a pain in my chest.  Over the next few days, it moved up to my throat and eventually my head with a full-fledged head cold. I began to have a productive cough. I felt very tired.  I stayed home from work on December 9, 2021, and then returned to work on December 10.  By the end of the day on the 10th, I felt so bad I went straight to a medical facility.
FEVER; HEADACHE; CHILLS; FATIGUE; NASAL CONGESTION; DRY COUGH; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070, expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 14:00 to Right Arm for prophylactic vaccination. Concomitant medications included ethinylestradiol/levonorgestrel for birth control, and insulin lispro. On 08-MAR-2021 06:00, the subject experienced nasal congestion. On 08-MAR-2021 06:00, the subject experienced dry cough. On 08-MAR-2021 07:00, the subject experienced chills. On 08-MAR-2021 08:00, the subject experienced fever. On 08-MAR-2021 08:00, the subject experienced headache. On 08-MAR-2021 18:00, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from fatigue, chills, fever, headache, nasal congestion, and dry cough on 09-MAR-2021 08:00. This report was non-serious.
complained of lightheadedness. Pt was clammy to touch.  Pt had rx at 12:30 Pt was given water and placed in Trendelenburg position. Vitals:  BP 108/68, O2 99%, HR 57  Vitals at 12:50 BP 100/60, O2 97%,  HR 82  Pt recovered, vitals signs stable. Pt left and stated her friend will be driving pt home. Pt was discharged at 12:52.