chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; This spontaneous report received from a patient via social media  a concerned a female of unspecified age. The patient's weight, height and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced side affect and head ache. On 2021, Laboratory data included: Blood test (NR: not provided) normal and MRI (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head ache and side affect was not reported. This report was non-serious.
had shots break out on head, suspected vaccination failure; didn´t stop them break out on upper left side of head; pain; pos herpetic neuralgia; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received on an unknown date, 10 years ago).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had shots break out on head, suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: didn´t stop them break out on upper left side of head), pain (Verbatim: pain) and post herpetic neuralgia (Verbatim: pos herpetic neuralgia). The outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not reported and the outcome of the pain was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-APR-2023 This case was reported via interactive digital media. The patient reported as it has been 6 weeks and still have the pain.  Diagnosis post herpetic neuralgia. The patient had shot for shingles 10 years prior to the reporting and then had 2 shots 2 years prior to the reporting. The patient said did not stop them when they wanted to break out on the upper left side of his or her head. Most painful thing.  The patient said had ever gone though.  The patient would not wish them on his or her worst enemy. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available.
Patient experienced pain throughout arm post vaccination. Within 24 hours patient developed discoloration in the 4th  finger, trouble with mobility of 4th finger. Seen in Urgent care and diagnosed with Achenbach syndrome. Venous doppler ordered. Visited ER on 9/14 after evaluation in Urgent Care. On 9/15 saw PCP. Has some discomfort at injection site improvement in condition noted.
- Warm & redness at injection site x 1 day post injection. - Soreness at injection site x 3 days post injection.
I have been menopausal for 2.5 years, and two weeks and six weeks after the booster I started bleeding again.  I have had two menstrual cycles that have lasted 10-12 days each, which is long for even before I was menopausal. All the usual issues with menstruation that I used to have accompanied these menstrual cycles: moodiness, ocular migraine, exhaustion, sleep disturbance, nausea, cravings, etc.
My wife was six weeks pregnant when she took the second shot of Pfizer COVID vaccine, estimated date of birth is oct 4 2021. Within 10 minutes of the vaccine she became ill dizziness nausea throwing up vertigo and it persisted for about a week heavily. The nurses were unequipped to handle possible side effects from the vaccine putting her in a corner and having her vomit in a box. They ignored her when suffering from obvious effect from the vaccine.  One nurse on our way out even told her to put on her mask as I dragged her out of terrible situation.She was unable to work drive or function somewhat normally for 4-5 days then it began to diminish. She is still having instances of vertigo and dizziness however much less.
Starting immediately after receiving the vaccine, I felt a little funny afterwards but waited the 15 min and then left. I was fine all day until I got into bed and all of a sudden it was like a bomb went off. I could not breath and I was gasping for breath. I managed to call my daughter, who could hear me gasping for breath, she dialed 911 and came right over. My daughter and her husband arrived at the same time as the paramedics. The paramedics ran tests and they said it was likely a reaction to the vaccine, but my vitals seemed to be normal. That gasping episode lasted for about 20 min and then resolved. During the EKG test, they had me stand up and I felt extremely faint. It indicated my blood pressure was dropping while standing and I was told to sit down. They asked me to go to the ER but I declined to go due to the hospitals being overwhelmed with COVID patients and me starting to feel better. So, I went home with my daughter and, when I lied down I got the same symptoms, so I had to sleep sitting up. 2 days later, I went home but I still had to sleep propped up so I could get relief and breath normally. So, for about 1-2 weeks later I still didn't feel right, but what bothered me is as I was going about my day, I was not breathing right. My breathing was so faint that if I was not putting effort to breath then I would've stopped breathing, which I've never experienced before. At the point where I was gasping for air doing normal activities, I decided it was time to call the doctor. They asked me a lot of questions about asthma (which I've never had and doesn't run in the family). He prescribed me albuterol and was told to use it for 7-10 days. I have been fine since the albuterol. I have not taken the booster since then due to my reaction to the second dose.
This is a spontaneous report from a contactable nurse through a Pfizer sales representative who reported similar events for two different patients. This is the 1st of 2 reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13 (lot M35761) at 0.5 ml single, on 11Feb2016 at 12:00. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced a severe reaction with redness, fever and cellulitis, all on an unspecified date in Feb2016, with outcome of unknown. The reporter added that subsequently they just quitted administering any vaccine from that lot.
Intense pain around base of tailbone.   Mild fever, fatigue,  hand/wrist pain, sensitivity to cold. Intense bloating.
I received the vaccine on January 15, 2021 at 4:37 in the evening. Everything was good until about an hour after I got home, and I developed a headache and was very tired. Went to bed at my normal time which is 9o?clock, and slept all night. When I woke up the next morning which is January 15, 2021 my left arm was very sore and my headache was gone. Went to work at normal time, 7:00 am and began feeling very fatigued with muscle soreness and joint pain. Left work and came home and slept for two hours. Still experiencing aches and pains and fatigue. I do feel it necessary to report I have had a positive covid-19 result in April of 2020.
This spontaneous report as received from a pharmacy intern refers to a 66 years old female patient with allergy to erythromycin, macrolides and morphine and without pertinent medical history. The patient was inadvertently received her second dose of 0.5 ml PNEUMOVAX 23 (lot number not provided) intramuscularly on 05-SEP-2012 after receiving first dose in January 2012. No other co-suspects were reported. There were no concomitant medications. Patient did not experience any adverse effects after the first dose in January but after the second dose, she experienced swelling around the injection site which went away in a couple of days but on approximately 26-SEP-2012 about 3 weeks after second injection in September 2012, patient came down with rash all over her body and swelling of lymph nodes and high fever. Patient went to see internist and dermatologist (name of physicians unspecified) but they could not find anything wrong with the patient. Patient received some kind of treatment (unspecified) and all the symptoms were resolved at the reporting time. No laboratory diagnostics studies were performed. Additional information has been requested.
Suspected vaccination failure; Had my 2nd shingle fix shot / but the shingle have come back; This case was reported by a consumer via interactive digital media (Shingrix Chatbot) and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and the 1st dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient had 2nd shingle fix shot before COVID 19 shot. The patient was due to take 2nd COVID 19 shot but the shingle had come back after the patient took the 1st covid-19. The patient asked for further guidance. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. It was unknown if the reporter considered shingles to be related to the covid-19 vaccine.
FLU LIKE SYMPTOMS; INSOMNIA; PAINS IN LEGS; HEADACHE; This spontaneous report received from a consumer concerned an 86 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms, insomnia, pains in legs, and headache. Laboratory data (dates unspecified) included: CAT scan (NR: not provided) not reported, and Doppler scan (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu like symptoms, headache, pains in legs and insomnia was not reported. This report was non-serious.
Patient reports her muscle was very sore.  So sore she couldn't use her arm for two days.  She says it is improving every day.
fever; chills; fatigue; This is a spontaneous report from a contactable male nurse reported for a patient. A patient of an unknown age and gender received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Batch/Lot Number: unknown), via an unknown rout of administration on an unknown date as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. On an unknown date, after the second dose, the patient experienced fever, chills and fatigue. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Does 1 = Very sore arm for two (2) days after shot given the night before.
Bad pain during injection.  Sore arm near injection site lasted one day, chills for a few hours same day and fatigue.  Headache for 2 days.  Several days later developed cold sores on both sides of mouth. They have not gone away completely.  This is the longest I have ever had a cold sore.  Normal is 1 week, 2 at the most.  This is persistent.
Right thigh developed 3 1/2cm bruised area 8x8cm red, warm area around injection site by 03/27 and 03/28. Put on Omnicef.
Information has been received from a Registered Nurse concerning her 22 year old daughter who on 27-OCT-2006 was vaccinated with first dose of GARDASIL (Lot# 653937/0637F) intramuscularly right deltoid. Concomitant therapy included influenza virus vaccine (unspecified). On 02-MAR-2007 "she developed restless leg syndrome". The restless leg syndrome resolved but recurred in May 2007 and it was no know if she had recovered. The patient sought unspecified medical attention. Follow up information has been received from a Registered Nurse concerning a 21 years old female patient with colitis ulcerative and scoliosis. Illness at time of vaccination included a slight cold. The patient was taking NYQUIL which she had used before. Other concomitant medications included hormonal contraceptives (unspecified). On 02-MAR-2007 patient experienced tingling, itching, restless feeling where legs and arms had to keep moving and it was reported that it lasted all night until 03-MAR-2007 (am). She went to the emergency Room and was diagnosed with possible restless leg syndrome. On approximately 09-MAR-2007 the patient was seen by Neurologist and ruled out a stroke. On approximately 07-MAR-2007 she recovered. In approximately May 2007, the patient experienced a reoccurrence of the events. Blood test and neurologic exam were performed at Emergency Room (results were not showed). The registered nurse considered possible restless leg syndrome to be an other important medical event and also disabling as it reoccurred 2 to 3 months later. Additional information is not expected.   3/4/09 Received Neuro medical records of 3/2-3/19/2007. FINAL DX: probable post-viral syndrome Records reveal patient experienced pruritis & tingling of extremities x 2 days when hospitalizeed 3/2-3/4/2007.  Had similar symptoms briefly & intermittently x 2 mo.  Had URI approx 2 wks prior to hosp admit.  When seen as outpatient 3/19/07, resolved intermittent pins/needles of legs 3-4 days s/p hospital d/c.  3/4/09 Received ER medical records of 3/2/2007. FINAL DX: extremity paresthesias Records reveal patient experienced bilateral numb sensation x 2 days worse in legs & had similar s/s several weeks ago that resolved in less than a day.  Neuro consult done in ER.
She has not taken the second vaccine; last episode of hot flashes "about a month ago"; She gets cold; she gets hot; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (She gets cold), FEELING HOT (she gets hot), HYPERHIDROSIS (Sweating), PRODUCT DOSE OMISSION ISSUE (She has not taken the second vaccine) and HOT FLUSH (last episode of hot flashes "about a month ago") in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Tremor. Concomitant products included TRAMADOL, PRIMIDONE, PROPRANOLOL, LOSARTAN, TRIAMTERENE and PREDNISONE for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced NASOPHARYNGITIS (She gets cold), FEELING HOT (she gets hot) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She has not taken the second vaccine) and HOT FLUSH (last episode of hot flashes "about a month ago"). At the time of the report, NASOPHARYNGITIS (She gets cold), FEELING HOT (she gets hot), HYPERHIDROSIS (Sweating) and PRODUCT DOSE OMISSION ISSUE (She has not taken the second vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that she was allergic to lot of medications. Treatment for the events were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Additional events added
pain in the arm where the shot was administered/the arm was very sore; feeling very badly; This non-serious case was reported by a physician via sales rep and described the occurrence of feeling bad in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling bad (Verbatim: feeling very badly) and pain in arm (Verbatim: pain in the arm where the shot was administered/the arm was very sore).  The outcome of the feeling bad was resolved (duration 2 days) and the outcome of the pain in arm was not reported.   It was unknown if the reporter considered the feeling bad and pain in arm to be related to Shingrix.     It was unknown if the company considered the feeling bad and pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-AUG-2023 The patient reported that after receiving Shingrix shot he started feeling very badly for at least 2 days after the shot. He reported pain in the arm where the shot was administered and said the arm was very sore. He reported his reaction to dose 1 of Shingrix was worse than his reaction to the COVID shot. He did understand he needed the second shot and he planned to take it in December 2023.
A 56 year old female: within 5 minutes of receiving Pfizer vaccine lot # 6200 Patient had red raised area on right arm and it was itching, Patient had no other complaints of shortness of breathe or difficulty breathing,  Dr and  RN assessed patient and she was given 50mg of benadryl.  Initial vital signs HR 74, RR 24, bP 155/50, SpO2 98%.  RN observed patient for 30 minutes and the welt appeared less than before and the patient stated that it wasn't bothering her as much.  Exiting vital signs, HR 70, RR 16, BP 140/42, SpO2 97%.  Patient driven home by friend/significant other.
got sick both times; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 07-Dec-2020.  This case involved unknown demographic patient who got sick both times (illness) while received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Vaccine (produced by unknown manufacturer) [lot number, expiry date and other dosing details were not reported] for prophylactic vaccination.  On an unknown date, unspecified time after receiving the vaccine, it was reported that patient had a flu shot twice, got sick both times (illness). Had not had one since  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  The reporter assessed the causal relationship with suspect vaccine as related.
A company representative reported that several patients developed "excessive" redness at the injection site between 7/24/00 and 7/26/00. The reporter was unable to specify the number of patients who experienced this event.
States the left injection site developed redness and swelling approx. size of a 50 cent piece. There is also a quarter sized whelp on the back of his left arm close to the axilla. There was a third red, raised whelp on his left side that is approx. 6 inches long and 1.5 inches wide. Has itching with these areas. Has taken Benadryl which helped with the itching, but whelps remained at the time. Provider had recommended to continue Benadryl q6h and apply cool compresses and follow up in office if no improvement by 8/12/2020.
temp 104.6R @ 830PM which was highest temp recorded;area of inj red & sore;temp @ 8AM on 12DEC was 101.1;cried 2 hrs ever of 11DEC95
Low grade temperature times 2 of lethargy, pallor and vomiting 10/28/03. Seizures and hyponatremia secondary to SIADH 10/28/03. The discharge summary and medical records received on 12/16/03 states traumatic brain injury w/ neurological depression, retinal hemorrhage, intracerebral hemorrhage, SIADH, and hyponatremia.
grandma accompanied child today & stated child devel fever, rash & irritability p/vax AUG97;taken to ER;had ear infect along w/side effects of vax;inc rash & sores in mouth;seen by MD;
About 4.5 hours later swelling occurred under the left ear and swallowing was impaired. Effects have resolved itself this morning and patient wanted to just let pharmacy know.
2/21/04-rash started. Resolved with Benadryl post 8-10 hrs. 2/22/04 fever x 1 day.
no adverse effects reported; patient inadvertently received first dose of MMA II that was past its expiry; This spontaneous report was received from a nurse and refers to a 3-year and 4-month-old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.  On 26-SEP-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHA) (M-M-R II), lot # N025898, expiration date 19-SEP-2019, (dose, route of administration and anatomical location were not reported) for prophylaxis. Concomitant therapies included sterile diluent, hepatitis A vaccine and inactivated and diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (DAPTACEL). No adverse effects were reported.
weakness in the legs; back problems; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (weakness in the legs), MUSCULOSKELETAL DISCOMFORT (back problems) and HEADACHE (headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Thyroid disorder NOS, Hypertension and Pain.    On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced MUSCULAR WEAKNESS (weakness in the legs), MUSCULOSKELETAL DISCOMFORT (back problems) and HEADACHE (headache). At the time of the report, MUSCULAR WEAKNESS (weakness in the legs), MUSCULOSKELETAL DISCOMFORT (back problems) and HEADACHE (headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant Product was included Blood pressure, diabetes, thyroid and pain medications. No treatment information was included.
Difficulty breathing Swollen eyes Itchy Throat symptoms escalated at time passed 1:1000 epi 0.5 cc given IM right DT follows with Benadryl 50 mg (1 cc) IM right UG and Prednisone 40 mg PO. Patient was given PO Claritin & Bendryl at discharge. 11/24/09 Medical records received for date 11/18/09. DX: allergic reaction. Pt. presented w/ c/o itchy throat, swollen teary eyes, unable to breath. Pt states received H1N1 vax approx 45min prior. Assessment: pt distressed, red throat, swelling of eyes. Pt tx with epi, benadryl IM. Pt escorted back to room when stable. Pt seen following day and pt states felt better.