chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She received the influenza vaccination at the hospital on her way into her shift at work sometime after 6:30am in her left deltoid.  She deveolped symptoms and admitted herself to the ER @ 8:17am.  She said about an hour after the injection she started to have some itching at the site.  She had some erythema streaking down the arm and up the arm towards the neck.  She developed feelings like having a lump in her throat and as a result, she was seen here in the ER.  She was given some Benadryl, steroids, Pepcid, and SQ epi.  Symptoms improved after her second SQ epi.  She was admitted to the hospital overnight with a diagnosis of "allergic reaction" for observation of her symptoms. She continued to receive steroids, Benadryl and Pepcid and has had resolution of her symptoms.  She was recommended to see an allergy and immunology specialist as an outpatient as she has multiple allergies and the fact that she has had prior flu shots each year since 2003 without problems.  She was discharge 10/25 @ 3pm on her same home meds.  She was then seen in the ER again on 10/26 from 11:58am thru 4:03pm for difficulty breathing.  The ER physician diagnosed her with angioedema recurrence related to allergy reaction from 10/24.  She received steroids, Benadryl, Pepcid, and breathing treatments.  She was discharged from the ER with scripts for Pepcid, Benadryl, and prednisone 20mg X 5days in addition to her previous home meds.
injection site soreness; Hurt to move arm; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be between 51 or 52 years. The age group was not reported but was selected as per the vaccine indication. The patient experienced injection site soreness and hurt to move her arm for a week. The patient consented to follow up. This case has been linked with cases US2019153955, US2019153962, US2019153964, US2019153966, reported by the same reporter.
The patient said she vomited once today (4/25/2021)  and has been having excessive thirst and urination.  She has chills and dizziness.  Patient received her 1st Pfizer COVID-19 vaccine dose on 4/15/21@ 1530. @ 2100 the same day she had swelling between lips and nose and she started feeling chilly. On 4/16/21 her symptoms went away.   Last February she said her glucose was 211 mg/dL when she went to the ED. She said she was not diagnosed with diabetes, but she does check her blood sugar daily.  The patient has excessive thirst and finds her self drinking a lot of water. The patient was wondering if vomiting a side effect of the Pfizer COVID-19 vaccine?  glucose = 172 mg/dL @ 2200 Saturday night 4/24/21 glucose = 77 mg/dL @ 2330 Saturday night 4/24/21 glucose = 90 mg/dL @ 0115 4/25/21  Follow Up with Patient Around 0700  o 4/25/2021 the patient reported her thirst has come down some.  Has still been drinking plenty of water but has not had any further vomiting.  States she has had an issue with GI sxs since February.
Got 100.6 degree F fever after vaccination.  No treatment given, resolved on its own.
Received first dose of COVID-19 vaccine on 1/10/21.  On 1/11 patient developed fever, cough, diarrhea, and rhinorrhea.   tested positive for COVID-19.
This is a spontaneous report from a Pfizer sponsored program. This contactable consumer (patient) reported for herself that the female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single, dose 2 via an unspecified route of administration on 04Jun2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included hypertension (For 3.5 years, was training to be a dietary aide, but her blood pressure was too high). The patient's concomitant medications were not reported.  The patient experienced stroke (hospitalization, medically significant) on May2021 with outcome of unknown, having a hard time with memory on 2021 with outcome of unknown, having a hard time processing information/is so messed up right now, doesn't know what's going on 2021 with outcome of unknown, states she can't read her own handwriting on 2021 with outcome of unknown. Therapeutic measures were taken as a result of stroke. The clinical course was reported as follows: Got her first and second dose of Pfizer COVID-19 Vaccine. Caller mentioned she had a stroke. Caller states she can't remember. Had stroke back in May2021, can't remember anything. Had second dose 04Jun2021. Having a hard time processing information. Still treating for the stroke now. Will have to ask the hospital when she had the stroke. Knows the date of her second dose as 04Jun2021, because the funeral for her nephew was that day. Doesn't know if she had her stroke before or after the COVID-19 Vaccines. Has a hard time remembering. Declines report stating she doesn't have any pertinent information and what she would provide wouldn't be correct. She will follow up with her hospital and get back up with Pfizer to provide it. For 3.5 years, was training to be a dietary aide, but her blood pressure was too high. Called withheld for information about the Pfizer BioNTech COVID-19 Vaccine, because she wants to know has enough time passed for her to get the booster dose. States she will ask her doctor. Having a hard time with memory. Has missed appointments and everything. She is so messed up right now, doesn't know what's going on. States she can't read her own handwriting.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a registered pharmacist concerning a newborn female who on 27-JUN-2010 was vaccinated with 0.5mL of RECOMBIVAX HB IM (Lot # 666188/1491Y). On approximately 27-JUN-2010 the patient experienced apnea and full arrest. On an unknown date, the patient recovered from apnea and full arrest. The patient was in the hospital and sought medical attention. The pharmacist wanted to know with the lot check it will be tested if there was overfill or contaminates. Apnea and full arrest were considered to be immediately life-threatening. This is one of 4 reports from the same reporter. It was noted that three of the four patients had seizures and one of the four had full arrest. It was unknown what patient had which of the reactions. A lot check has been initiated. Additional information has been requested.
Headache, chills, and muscle aches. All adverse events went away with an appropriate dose of Tylenol/ Ibuprofen.
Since receiving the flu shot on November 7th, 2003, I have had consistent pain in my right arm.  The pain has subsided a little bit but I would have assumed that it would have gone away completely after a months time.  The pain mainly occurs when I move my arm and is limited to the upper part of my arm.
Information has been received from a medical assistant concerning a patient who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck).  Subsequently the patient developed a "herpes like rash".  It was unspecified if medical attention was sought. The patient's outcome was not reported.  There was no product quality complaint involved.  No further information was provided.  No further information is available.
3:30pm inj. given then within seconds pt c/o inj. site itching and by 3;31 pm there was a hive. Dr looked at it ordered 25 mg of antihistamine and by 3:54 pm pt's leg was looking better red but no hive. Follow up on 7/25 and pt's leg all normal per mother.
the skin was right off, right down to the bloody arm/ The skin is like ripped off/ there is no skin/You can see where the skin came off; A red raw perfect circle/ There was a round circle, a light pink place around that. at the injection site.; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WOUND (the skin was right off, right down to the bloody arm/ The skin is like ripped off/ there is no skin/You can see where the skin came off), VACCINATION SITE ERYTHEMA (A red raw perfect circle/ There was a round circle, a light pink place around that. at the injection site.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson (Batch Number:1805022) on 15-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced SKIN WOUND (the skin was right off, right down to the bloody arm/ The skin is like ripped off/ there is no skin/You can see where the skin came off). an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (A red raw perfect circle/ There was a round circle, a light pink place around that. at the injection site.). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN [BACITRACIN ZINC;NEOMYCIN SULFATE;POLYMYXIN B SULFATE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. On 27-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, SKIN WOUND (the skin was right off, right down to the bloody arm/ The skin is like ripped off/ there is no skin/You can see where the skin came off) outcome was unknown and VACCINATION SITE ERYTHEMA (A red raw perfect circle/ There was a round circle, a light pink place around that. at the injection site.) had not resolved.            It was reported that patient felt burning sensation when she applied cortisone on the wound.  No concomitant medications were reported.  Three to four days after the booster dose, patient saw a red raw perfect circle at the injection site which was not big.
Fever up to 105.4 (charted in ER), listless with 36 hours after giving vaccine.  Given tylenol 220 mg per rectum.  Then had generalized tonic-clonic seizure which lasted 7-8 minutes.  Good color and oxygen saturation.  Gaze deviation to left during seizure but no focality.  IV established but no medicine given.  REceived 280 ml saline bolus.  CBC, BCx, UA cath, UCx, lumbar puncture with cell count, gram stain and Cx done.  All studies within normal limits.  No antibiotics or other medications given.  Observed for several hours and had great improvement in appearance, tracking mom well, interactive.  Defervesced and no further fevers.  Per mom no viral symptoms associated and all fevers gone within 8 hours.
Patient admitted as inpatient on 12/3 due to crescendo angina in the setting of worsening blood loss anemia. Patient was tested for COVID-19 and was positive on 11/23.
Information has been received from a RN concerning a pt who was vaccinated SC with a 0.5mL dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 641088/1347L). Subsequently the pt experienced autism. Unspecified medical attention was sought. The outcome was reported as not recovered. There was no product quality complaint. No further information is available. Follow up information received from a RN indicated that she had absolutely no additional information, and did not expect to obtain any additional information. Upon internal review, autism was considered to be an other important medical event (OMIC). No additional information is expected.
Breast cancer came back and is in the bone marrow, I was diagnosed with this in July of 2021. By January 24th 2023, my gallbladder had an infection which also ended up being a tumor. I started having gallbladder issues in 2022, I do not remember if they were spiked every time I took a vaccine or not. I also got diagnosed with emphysema.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a four-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  Neither medical history nor concomitant medications were provided.  The patient received FluMist on 12-Mar-2008.  The FluMist had expired on 10-Mar-2008.  The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccines expired on 10-Mar-2008.  The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients.  No adverse events were reported.  The event has resolved.  It was not reported whether or not FluMist was re-administered.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  This case is linked to following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006659; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:01 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 19.53. Concomitant products were not provided. On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210 condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine date was 29-Apr-2021. On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 PM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
He received flu vaccine on 10/5/16. ~2 days after the flu vaccine, he started to feel tired and vaguely weak. He had trouble completing a bicycle ride and experienced cramps in his thighs during the ride on 10/8. He continued to feel unusually tired during the following week. On 10/17, he started noticing numbness and paresthesias in his right foot. The numbness and paresthesias progressed and continued to progress until 10/24. Symptoms have been stable since 10/24. He has numbness and paresthesias in both hands, subtle paresthesias in left arm, and numbness in lower half of body from upper abdomen level and extending distally through both lower extremities. He also feels slight weakness in his hands. He has trouble typing because of the numbness in his hands and fingers. He has to be careful walking because of the numbness in his feet. He was treated with intravenous immunoglobulin (IVIG) 2 grams/kg administered over 3 days from 10/19-10/21/2016.
mini-stroke; passing out; erectile dysfunction; dry mouth; urinary problems; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Apr2021 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Apr2021, outcome "recovering", described as "mini-stroke"; LOSS OF CONSCIOUSNESS (medically significant) with onset Apr2021, outcome "recovering", described as "passing out"; ERECTILE DYSFUNCTION (medically significant) with onset Apr2021, outcome "recovering", described as "erectile dysfunction"; DRY MOUTH (non-serious) with onset Apr2021, outcome "recovering", described as "dry mouth"; URINARY INCONTINENCE (non-serious) with onset Apr2021, outcome "recovering", described as "urinary problems". The events "mini-stroke", "passing out", "erectile dysfunction", "dry mouth" and "urinary problems" were evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of cerebrovascular accident, loss of consciousness, erectile dysfunction, dry mouth, urinary incontinence. The lot number for bnt162b2 was not provided and will be requested during follow up.
next morning around 7am Severe left arm pain, mild head ache for 30min,alot body aches and joint pain thought the day especially knees, legs and ankles , chills for a few minutes, light dizziness with head ache, back pain.
Moderna COVID-19 Vaccine EUA In arm where vaccine was given: pain, redness, swelling, heat Prescribed cephalexin for suspected cellulitis by my PCP.  Currently on day two of a seven day course of treatment.
Heavy heartburn, Acidic stomach; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Heavy heartburn, Acidic stomach) in a female patient of an unknown age 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (Heavy heartburn, Acidic stomach). At the time of the report, DYSPEPSIA (Heavy heartburn, Acidic stomach) outcome was unknown.            Concomitant medication information not provided.  Treatment information was not given.  Action taken with mRNA-1273 in response to the events were not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received on 09 Jul 2021. contains no new information.
Left thigh red, warm, slight tender, 10 x 15cm normal gait, afebrile
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; no adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.            This case contains information for the 29th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter. There were 13, 11, and 6 different doses were given. The 30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date. The batch lot no 022D21A expired on 20 Apr 2022, the Lot number 033F21A expired on 08 Apr 2022 and the Lot  number 037C21A expired on 02 Jan 2022.   Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:master case
flu; Initial information received on 31-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient of unknown demographics who experienced flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (with an route, strength) produced by unknown manufacturer lot number not reported in unknown administration site.  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE..  It was reported"Never had the flu until I got a flu shot. Not about to do that again. It is unknown if the patient experienced any additional symptoms/events."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.