chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via other and described the occurrence of pain in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain, erythema, swelling, fatigue, fever, myalgia and headache. On an unknown date, the outcome of the pain, erythema, swelling, fatigue, fever, myalgia and headache were recovered/resolved. The reporter considered the pain, erythema, swelling, fatigue, fever, myalgia and headache to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter did not specify when they received the dose. It was unknown if the events caused the patient to be admitted to the hospital overnight or prolong an existing hospitalization. It was unknown if the reporting health care professional consider the events to be life threatening. It was unknown if the reporting health care professional consider the events to result in persistent or significant disability or incapacity. The patient did not die. It was unknown if the events require surgical or medical intervention to prevent one of the outcomes described in preceding questions. The events did not result in a congenital anomaly or birth defect. This case is 1 of 4 cases reported by the same reporter.
1015-felt dizzy; tingling starting in hands and feet.  EE ate a granola bar and drank some water and related she was feeling much better
The patient felt sick for a few minutes post vax. The next day the patient had swelling that lasted a few days, the size of a baseball. The patient's arm is now bruised, but clearing.
Patient received vaccine at 11:15 AM and called pharmacy at around 5 PM complaining of diarrhea and shortness of breath. Patient was advised to call physician or go to emergency room.
low fever; chills; severe body/muscle aches; severe body/muscle aches; This is a spontaneous report from a contactable healthcare professional. A 32-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history included the patient does not get vaccines such as for influenza regularly. Concomitant medications were not reported. The patient previously received dose 1 of BNT162B2 on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date 12 hours after receiving dose 2 of BNT162B2 the patient experienced low fever, chills, and severe body/muscle aches. The muscle aches were severe for approximately 3 days and then subsided to mild aches for the next few days. The outcomes of low fever, chills, and body/muscle aches were unknown.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained.
Hives, pharyngitis, leg edema, inc WBC - occurred 2 days post vax.
Within 1 day of receiving her 'booster' (3rd dose) of Moderna vaccine, patient developed extensive diffuse 2+ edema and inflammation of entire left upper arm extending from left shoulder to left elbow within 1 day of vaccination. As edema resolved over 5-7 days patient presented to our clinic with desquamation of the overlying skin (post inflammatory desquamation). No other rash on the body, otherwise feeling well. Desquamation resolved with topical steroids within 2 weeks. At 3 week follow up area was healed with mild hypopigmentation and no residual inflammation or edema. Patient has no history of immunosuppression or underlying autoimmune disease, wanted to get booster simply because she was afraid and felt getting it would be a good preventative practice.
1st dose 3 years ago, never completed the series; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (was vaccinated with the first dose of Shingrix about 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-JAN-2023 Reporter's comment: The consumer had called up today at the time of reporting and had stated that, he was vaccinated with the first dose of Shingrix about 3 years ago but never had completed the series. The consumer had stated that, he had plans on getting the second dose as soon as possible. The reporter had consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which had led to incomplete course of vaccination. The details provided corresponded to the 1st dose of Shingrix as the 2nd dose was not administered yet.; Sender's Comments:  US-GSK-US2023007570:Same reporter
pt recv vax 3FEB98 & presents in office 0740 w/lt deltoid w/approx 3.5' redness, warmth, central bruising, mild tenderness;
On 9/21/01, the infant received his 1st 10mcg dose of Engerix-B (lot ENG5144A2). On 9/27/01, 6 days post vax, the infant developed fever. He was seen by the physician and hospitalized on 9/28/01. The infant receive IV ampicillin and cefotaxime for 2 days. The fever resolved on 9/30/01 and the infant was discharged from the hospital. Discharge DX was neonatal fever. Discharge medication included cefprozil (Cefzil). The infant was seen by the physician for follow-up on 10/01/01. On 10/24/01, the infant received injections of DTAP vaccine adsorbed (see report 20010288362), 7-valent pneumococcal conjugate vaccine (Prevnar) and Hib. The infant experienced emesis on 10/30/01. On 11/27/01, when the infant was 2 months old, he received his 2nd 10mcg dose of Engerix-B (lot ENG5156A2) and an injection of IPOL. Two days later, on 11/29/01, the infant again experienced emesis. He was seen in the physician's office and blood was drawn for unspecified lab analysis. The infant continued to experience intermittent emesis, with episodes occurring on 12/15/01 and 1/3/02. As of 1/7/02, the infant was being evaluated for possible malrotation or volvulus of the stomach. The most recent info was received on 1/11/02. The fever resolved on 9/30/01. The vaccine provider considered the fever to be moderate in intensity and possibly related to either Engerix-B administration or to a possible viral illness. The intermittent emesis was ongoing. The vaccine provider considered it to be moderate in intensity and possibly related to either Engerix-B administration, malrotation or volvulus of the stomach.
circumoral rash around her mouth; swollen lip; circumoral swelling around her mouth; Sore arm; This is a spontaneous report from a contactable Nurse (the patient's mother).  An 18-year-old female patient  (the reporter's daughter) received the second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine),  via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: EW0170) as a single dose for COVID-19 immunization.  Medical history included , Klippel-feil syndrome from 11May2003 and ongoing The patient was probably 7 or 8 years of age when this was diagnosed , oculoauriculovertebral dysplasia from 11May2003 and ongoing The patient was probably 7 or 8 years of age when this was diagnosed, ongoing asthma,  spinal fusion surgery from 2016 to an unknown date, craniofacial deformity from an unknown date and unknown if ongoing, abnormal organ growth from an unknown date and unknown if ongoing.  The patient's historical vaccinations included the first dose of  bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine (Lot number ER8727 expiration date unknown) on 09Apr2021 for COVID-19 immunization. There were no concomitant medications. The patient experienced circumoral rash around her mouth on 30Apr2021 with outcome of recovered on 30Apr2021,  swollen lip on 30Apr2021 with outcome of recovered on 30Apr2021, circumoral swelling around her mouth on 30Apr2021 with outcome of recovered on 30Apr2021, and  sore arm on an unspecified date in Apr2021 with outcome of recovered in Apr2021.  The events were considered medically significant.; Sender's Comments: As there is limited information in the case provided, the causal association between the events circumoral rash around her mouth, swollen lip, circumoral swelling around her mouth and sore arm and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Developed injection site reaction. Was seen in ER and then went to a different hospital where he was treated for a cellulitis. On day 7 after vaccination still with significant swelling of arm with tenderness. Able to move extremity well and no signs of systemic infection.
The same night after receiving the vaccine part of his left hand went numb. That lasted for about a week. In October he was diagnosed with pneumonia and valley fever. He was sick for a month and went to the ER 4 times. He had IV antibiotics and IV fungal when he was hospitalized for 3 days in November. He was prescribed an antibiotic and fluconazole for the valley fever. Last week he caught covid and had a sore throat and congestion.
55 year old female with PMH of rheumatoid arthritis and asthma presents with cc of intermittent persistent fevers since first dose of COVID19 Moderna vaccine on 5/4/2021, reports she was instructed by Rheumatology/PCP to d/c methotrexate on day of first COVID19 vaccine dose. Pt reports associated symptoms of headache, chills, myalgias as well as mild joint pains in shoulders and fingers. Pt denies sore throat, cough, CP, SOB, emesis, nausea, diarrhea, loss of smell/taste, abdominal pain, worsening joint pain, dysuria, hematuria, urinary frequency/urgency/hesitancy, back pain, neck pain. No known sick contacts, no recent travel history per pt. On 5/4/2021, ESR was 14. CRP was < 0.3.
Vertigo - Continued for 5 days. BPPV on right side. Did PT - Epiley movement position. Resolved.
Approximately 24 hours post injection, patient noted tenderness and hyperemic warmth at site. Local treatment was recommended along with Motrin or Advil.
Severe muscle aches, headache, 100.3 temp, chills, tirid
11:00pm Pain started running through left arm (vaccination received in left arm), sharp, shooting pain radiating into the thumb in particular.  Awoke from sleep approx. 1:00 am, severe lower back pain, arm pain continues, restless and unable to sleep. 9:00 am, upon getting out of bed, both upper arms are sore, front of both legs very sore, sharp pain in lower back, able to walk but very painful. 11:00 am leg pain and right arm pain decreased considerably. Back back pain moves lower into the buttock region, feels like a burning sensation that begins to shoot down both legs. No relief either lying or standing. 2:00pm No longer sore in extremities with the exception of injection site. Lower back pain continues and shoots down mostly the left leg, causing pain all the way down to the ankle. 9:00pm All pain disappears abruptly. Full recovery.  **Times are approximate**
Pain injection site next day Left Arm. Pain intensified upper arm difficult to sleep. Pain intensified and tingling developed down arm. Dr visit said I had neuropathy. Predinsone given 2 weeks. Pain less still painful at night x4 Advil per night. MRI shoulder done no structure abnormalities(per office normal wear in shoulder). PT ordered for x3 weeks and need to Follow up after with PCP (first week in January). Have had x2 therapies so far so far.
I developed severe R-sided, recurrent headaches that awoke me from sleep lasting 5-10 minutes.  Presented to PCP and was sent to the ED for full workup including CTA and LP.  Workup negative, followed up with neurologist.  Working diagnosis was neuralgia.  Severe symptoms lasted about 5 days, then gradually improved over the subsequent 2 weeks.
Information has been received from a registered nurse reporting on an unknown number of patients of unknown ages and genders. There was no information about the patients' concurrent conditions, medical history or concomitant medication. On unspecified dates in September 2017 (reported as on "07-SEP-2017 or after"), the patients received improperly stored doses of VARIVAX for prophylaxis lot # N017698 expiry date 09-JUN-2019 or lot # N001530 expiry date 13-JAN-2019 (anatomical location, dose and route of administration were not reported), that were reconstituted with properly stored sterile diluent (MRK). It was reported that on an unspecified date, the vaccines were exposed to a temperature between - 9 Celsius degrees and 8 Celsius degrees for 11 hours. The vaccine underwent a previous temperature excursion between - 9 Celsius degrees and 8 Celsius degrees for 2 hours. The call was placed because of a Digital Data logger report. No adverse effects were reported. This is one of two reports from the same reporter. Sender's Comments: US-009507513-1709USA011270.
pt recvd vax & 1 day p/vax exp erythema & muscle tenderness; pt was seen by a MD; sx  have not resolved;
pink rash with "small bumps" appeared 3-4 days after shingrix: appx. 8" long and 4"wide; mild itching; did not resolve for appx. 3m's when it gradually faded.  Rash was upper chest extending both sides of mid line.  No other signs or symptoms.
Pt received 1st COVID vaccine on 2/23/21. Returned to clinic on 3/17/21 for 2nd dsoe. Reports "being itchy without any rash on various parts of the body" about a week after injection. Also reported no appetite and a dry mouth along with being weak and tired. Denied any dyspnea, rash, or other s/s allergic reaction or anaphylaxis. States s/s resolved after 1-1.5 weeks. Did not seek medical care. States "she thinks it may have been pre- or post- menstrual issues and/or supplements". Also states she had had rash in December 2020 of unknown cause. Reports she used "allergy cream then and was sick to her stomach" and was resolved before first dose.
This is one case out of a cumulative total of 243 cases solicited from the EDSS database during the surveillance period from 01 January 2010 to 16 December 2014. These 243 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial solicited report received on 17 December 2014 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 6 month old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL, lot number C4669AA received on 10 June 2014, lot number C4538AA received on 12 August 2014, and lot number C4724AA received on 09 October 2014 (routes and sites of administration not reported). On 17 October 2014, the subject developed a cough and catarrhal illness. Paroxysmal cough was noted on 19 October 2014 without a whoop. The subject also experienced sleep disturbance and apnea. Laboratory testing included positive PCR on 20 October 2014. Chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 20 October 2014 for 5 days. The subject was not hospitalized. At the time of final contact on 11 November 2014 the subject's cough was still persisting. The duration of the cough was reported at that time as 25 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
shortly after patient received afluria vaccine at pharmacy, patient fainted in pharmacy area and hit head on concrete floor of building. immediately went to patient and she came to within 5-7 seconds. she began to cry and said her head/neck hurt. she was alert and oriented x 3. technician called 911. checked blood pressure. it was 98/77. EMS arrived about 10-15 mins later.  patient remained on floor. We propped up her head on her sisters sweatshirt and got a blanket from the store to cover her  due to her being cold. EMS didn't think she had a concussion but wanted to take her to the hospital. her mother didn't want her to go via the ambulance. mother stated she would take her to the hospital. the EMS personnel helped her up into a chair. A scooter that is used for shoppers was brought to the pharmacy. patient was helped into the scooter and was followed out by the EMS personnel and her mother and twin sister.
Patient had Bell's Palsy on 4/18/2021. She had Moderna #1 on 4/6/2021. History of Bell's Palsy November 2020.
Within 10min of administration, patient began to complain of a tingling, "crawling" feeling in her right arm where she received the shot.  I had her try to move her arm a bit to distribute the dose.  Then the tingling/crawling feeling spread to her right scapula, then the entire right arm and right face.  Her blood pressure was elevated 156/87.  She admittedly has not taken her HTN meds in a year.  Patient was sitting in an office chair and began to feel dizzy, lightheaded and onset of a headache.  When she said that her vision was starting to get black, I layed her to the floor and called EMS.  Then her right leg also started to feel tingling.  Patient was sent to the ED via ambulance and admitted to the hospital for code stroke.
This initial spontaneous report was received from a pharmacist concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were unknown by reporter. On an unspecified date the patient was administered a dose of PNEUMOVAX 23 (Lot #, dose and route were unknown) as prophylaxis. It was reported that on an unknown date, the patient developed an unspecified "reaction" to the injection. It was unknown if the patient received treatment for the event or if there were diagnostic laboratory tests performed. It was also unknown if she sought medical attention. At the time of the report, the patient was recovering from the event. The causal relationship between PNEUMOVAX 23 and the event was related.
The patient is a 69 y.o. male with a past medical history notable for atrial fibrillation, CHF, COPD, history of GI bleed, coronary artery disease. The patient presents for evaluation of worsening issues with nose bleeds and shortness of breath. Patient is found in the ER to have a significant nose bleed which required packing. Patient was also found to be in atrial fibrillation. Patient was previously at skilled care facility undergoing care and it is unclear patient had been using illicit substances. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/3/2022 LEUKOCYTOSIS D68.9 COAGULOPATHY, UNSPECIFIED TYPE 4/3/2022 ANEMIA
Fasting Blood sugar increased from 100 to 150 and stayed elevated for 2 weeks. Felt weak and lost balance.
Fever, headache, sore throat 04-02-16 rash late on 4/3/16.
Information has been received from a medical assistant concerning a 24 month old female with no known allergies who on 04-JUN-2004 was vaccinated with a first dose of VARIVAX (Oka/Merck) (Lot # 647521/1108N). The medical assistant reported that on 05-MAY-2008 the patient presented to the office with break through chicken pox. The patient had blisters, red, itchy spots on her legs, arms and back. There was no treatment. The patient's chicken pox persisted. Follow up information was from the physician who reported that the patient was vaccinated intramuscularly with a first dose of VARIVAX (Oka/Merck) (Lot # 647521/1108N). There were no concomitant medications (noted as observation). On 05-MAY-2008 presented with vesicle of different stages consistent with acute chickenpox infection. Subsequently, the patient recovered. The physician thought that it would be a vaccine failure. Additional information is not expected.
Patient received first dose of Pfizer COVID-19 vaccine. Patient started to feel nauseous and dizzy. EMT was called and stated patient was anxious but checked out cleared and patient refused services.
leg swelled, mostly the proximal anterior thigh w/in 12hr of inj;
malaise, nausea, vomiting, headache, chills, momentary loss of consciousness
arm was sore; full day of full-body pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 17Apr2021 (Lot number: EP7533) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Glucose tolerance impaired" (unspecified if ongoing); "Known allergies: shellfish" (unspecified if ongoing); "covid" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; DAYSEE; PROZAC; HYDROXYZINE. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "arm was sore"; PAIN (non-serious), outcome "recovered", described as "full day of full-body pain". Therapeutic measures were not taken as a result of pain in extremity, pain.  Additional information: Patient reported after the first dose, that she didn't feel pain until 12 hours after. Then she had a full day of full-body pain. Patient told her arm was sore for a full week after. After the second dose, her arm was sore immediately and she had a low grade fever the day after the shot. The pain in the arm passed on day two after the dose. Patient had covid prior vaccination and was not covid tested post vaccination. Patient did not had any vaccine in four weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker refers to multiple unknown patients of unknown gender and age. Information regarding patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. Healthcare worker reported that before she became aware of the excursion, it is possible but unknown that on multiple unknown dates, the patients received improperly stored ROTATEQ (lot # L038536, expiry date: 19-AUG-2017; lot # L048854, expiry date: 31-AUG-2017; lot # M004542, expiry date: 18-OCT-2017 and lot # M004890, expiry date: 10-NOV-2017). She mentioned that it could not be ruled out that vaccine was or was not administered prior to her awareness. The vaccine was exposed to minimum 8.4C or maximum 14.5C for 368 hours. A data logger was used to document the temperatures. There were no prior excursions. No adverse effects were reported. Reporter also mentioned that after she was aware, no vaccines were administered to the patients that were improperly stored. This is one of the several reports received from the same reporter. Additional information has been requested.