chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse and refers to a patient of unknown age and gender (colleague of the nurse). On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route of administration not reported) and developed cellulitis post vaccination (date unspecified). The outcome of the event was unknown The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Information has been received from a 27 year old pregnant female (LMP date 7/2/01) with no past medical history and no allergies who, four weeks after her last menstrual period, on 8/1/01 was vaccinated with a dose of mumps virus vaccine live. There was no concomitant medication. The pt sought unspecified medical attention. Follow up info was received from a physician's office. The reporter indicated that the pt had no previous pregnancies and that medication taken by the pt during the current pregnancy included unspecified vitamins. The pt had an ultrasound performed during the pregnancy, but no results were reported. It was reported that the pt did not have any infections or illnesses during the pregnancy, nor did she take any prescription drugs during the pregnancy. It was reported that the pt delivered a normal live born male infant on 4/17/02, weighing 8 pounds 5 ounces. It was noted that the infant had a congenital anomaly of pyloric stenosis but that there were no other complications. Additional info has been requested.  A 15-day follow up report received 7/29/2003 adds: Additional info is not expected.
Extremely cold; Did not feel good for three days; No appetite; Losing weight; Still not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Extremely cold), MALAISE (Did not feel good for three days), DECREASED APPETITE (No appetite), WEIGHT DECREASED (Losing weight) and MALAISE (Still not feeling well) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M200A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Extremely cold), MALAISE (Did not feel good for three days), DECREASED APPETITE (No appetite), WEIGHT DECREASED (Losing weight) and MALAISE (Still not feeling well). At the time of the report, FEELING COLD (Extremely cold), MALAISE (Did not feel good for three days), DECREASED APPETITE (No appetite), WEIGHT DECREASED (Losing weight) and MALAISE (Still not feeling well) outcome was unknown.            Concomitant product used was not provided by the reporter. The patient has a call into her physician.
My arm has progressively hurt and now itches/is red in the area the shot was given. It's been over a week. Not life threatening but I was advised to fill this form out. Thank you!
migraine headaches after receiving the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 19Jan2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: MIGRAINE (non-serious) with onset 19Jan2021, outcome "not recovered", described as "migraine headaches after receiving the vaccine". The event "migraine headaches after receiving the vaccine" required physician office visit. Therapeutic measures were taken as a result of migraine.  Additional information: It was reported that the patient had ongoing migraine headaches after receiving the vaccine. Stated that 3 hours after the second dose of Pfizer Covid Vaccine on 19Jan2021, she started having migraines. Migraines ran all day. She could sleep but when she woke, she had them. She was seeing a neurologist. She worked at Hospital, that's why she was able to get it so soon; although she was not clinical. The migraines were exacerbated by loud noise and high-pitched sounds; like if the fire alarm went off at work she had to leave. They had tried a multitude of things but she had no relief. She saw the neurologist and told them she had run out of options, asked what they could do and the neurologist told her they could try surgery. She had tried 13 medicines. It was not easy to work, but she had to work. She did have the booster dose of Pfizer Covid Vaccine she thought in the fall and her symptoms did not change after the booster; but she was still (at the time of this report) suffering. Onset latency of event Migraine headache was 3 hours after vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
4/28/2019: 7pm - pain at injection site, very cold, shivering,  muscle soreness throughout the entire body, like flu.
Pt was to receive PPD intradermally and by mistake was given Pneumovax. Same day post vax, the pt started having some diarrhea followed by brief vomiting and then simply felt unwell on a diffuse nature, culminating in rather severe discomfort and pain across the trapezii on both sides of the shoulders. The following day she was seen by a physician. The injection site was red and swollen and she was clearly unwell. She was transferred to ER where she received some IV fluids and Solu-Medrol IV. Pt was dx with adverse reaction to intradermal injection of pneumonia vaccine, resembling serum sickness.
Terrible vertigo; This case was reported by a consumer via interactive digital media and described the occurrence of vertigo in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th May 2022 12:00, the patient received Shingles vaccine. On 7th May 2022, 2 days after receiving Shingles vaccine, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown.   It was unknown if the reporter considered the vertigo to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 7-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine on Thursday at noon and he/she woke up this morning (day of reporting) with terrible vertigo. Additional supportive information: The follow-up would not possible, as no contact, details were available.
The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.; The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1417B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.), PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (The batch was administered to patient after 12-Jan-2023, last dose given was 13-Apr-2023.) and PRODUCT STORAGE ERROR (The vial which was delivered on 12-Dec-2022 was in refrigerator since then and administered to patient after 12-jan-2023 till 13-Apr-2023).    Dosage text for suspect product was reported as unknown.  Concomitant drugs were not reported.  It was reported that the Moderna Covid-19 vaccine monovalent 6months-5 years which was delivered on 12-Dec-2022 was administered to patients after 12-Jan-2023 with last dose given on 13-Apr-2023.  Treatment medications were not provided.  This case was reported for patient 6 of 6.   This case was linked to US-MODERNATX, INC.-MOD-2023-721723 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721723:
patient received DTaP-IPV (Quadracel) as a first dose of DTaP and first dose of IPV even though it is licensed to be used as fifth dose of DTaP and either fourth or fifth dose of IPV.  Nurse noticed this while reviewing the vaccine record as the patient came in for subsequent vaccination about 6 months after vaccine was given.
Within 5 minutes after vaccines, pt fainted briefly, had vision abnormalities for 20 minutes. When she arrived some 1hr after vaccinations, she vomited x 5 (also had hit head with syncope)
Patient was vaccinated at Pharmacy with 2nd dose Moderna 03/28/2021, patient called dialysis clinic that she was coughing up blood and she is going to Hospital in the afternoon. Pt's daughter called the clinic informed staff that pt passed away 4/3/2021 due to internal bleeding.
Patient was still in clinic to get a lab draw after the vaccinations. Patients reaction was noted approximately 5 minutes after the vaccination. The patients mother voiced concern about the a possible reaction and the lab tech went and got the nurse. The patient was taken back to a room for further observation. Patient's left thigh had some moderate swelling and erythema. Patient was given Benadryl and examined for 15 minutes.  Patient was examined by a provider and no further reactions observed and patient was released.
pt recvd 1st dose of Hep B vax 21FEB89.On 06MAR89 devel swelling & itching of eyes & hands.Pt recvd 2nd dose 20MAR89 & later devel itching of eyes & hands Tx w/ Dex & devel hypertension & dizziness on 23MAR89.
This is a spontaneous report from a contactable nurse. A 18-year-old female patient received the first dose of TRUMENBA, NDC number: 00005010010, Expiry Date: 30Apr2017, lot M37315, on 23Jun2016 14:15 at 0.5mL intramuscular into left deltoid. Medical history included ongoing hypothyroidism  and weight loss. Concomitant medication included SYNTHROID, ongoing. The patient experienced did not feel well, awoke during the night shaking , migraine-like headache, neck pain radiating down arm, emesis, nauseous, fever greater then 102 degrees Fahrenheit, swelling at the site of injection all on an unspecified date with outcome of unknown. Follow-up (22Aug2016): This is a follow-up spontaneous report from a contactable Nurse and another Nurse. This both Nurse reported in response to HCP letter sent that included: Did the patient provide information to you regarding the reported adverse events with the use of product: Yes, (Mother). If yes above, do you consider the Pfizer product had a causal effect to the adverse event: Yes. Are you willing to be contacted again by Pfizer on the reported adverse events: Yes. Suspect vaccine: Suspect Vaccine name and/or generic name: TRUMENBA. Batch/Lot# and expiration date: M37315. Prescribed dose, units, and frequency: 0.5 ml. Route of administration: IM. Start Date: 23Jun2016. Stop Date: 23Jun2016. Time vaccination was given (hour; minute-24 hour clock): 1:49 PM. Anatomical location of the administration of the vaccine: Left Deltoid. Did any of the AEs require an emergency room or physician visit: No. If the patient was hospitalized, how many days was the hospital stay: -. What was the final action taken with the products: Dose not changed. Adverse Event: Was the patient admitted to hospital: No; Event Onset Date: 23Jun2016, Causal Relationship: Is there a reasonable possibility that the event is related that the event is related to suspect products: Yes. Suspect product name: TRUMENBA. Batch and/or Lot number and Expiration date: M37315, Exp: 30Apr2017. Please circle the Outcome of the Event for each event: Outcome of the Event: Recovered. Adverse event following prior vaccination: In patient: Adverse event: None. As applicable, list all vaccines given on same date along with suspect vaccine: Vaccine name: None. As applicable, list any other vaccination within four weeks prior to date of vaccination: Vaccine name: None. Dechallenge/Rechallenge? Did reactions recur on re-administration: If yes, please specify: N/A. Were specified tests and/or treatment required: No. Is patient deceased: No. Vaccinated at: Private Physician's office/Hospital. Vaccine purchased with: Private funds. Illness at time of vaccination: Weight loss. Patient Medical History: Illness Hypothyroidism; Onset Date: 09Jun. Illness: Hashimoto Thyroiditis; Onset Date: 09Jun. Follow-up attempts completed. No further information expected.
administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired moderna vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported  No Treatment medications were reported
Swelling of left upper lips on Day 2 which resolved on its own but came back same evening to become worse on Day 3 with swollen eyes, cheeks, nose and lips on the left side. Pediatrician was seen and zyrtec was given
Atrial fibrillation (aFib), rapid heart rate, swollen lymph nodes in arm pits (More pronounced in right arm pit), fever, fatigue, and aches.
Information has been received from a health professional concerning a 6 year old female who on 09/13/2000 was vaccinated with a 0.5 ml subcutaneous first dose of varicella virus vaccine live (Oka/Merck) (Lot #634496/0535K). There was no concomitant medication. On 11/29/05, the patient developed a vesicular rash of 15 lesions on her trunk and legs after exposure to other children with chicken pox. It was reported that the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that the patient had multiple vascular lesions on her trunk and buttock. Approximately 15 lesions were noted on 12/01/2005. Additional information has been requested.
Patients received undiluted 0.3ml of the Pfizer-BioNTech COVID-19  Vaccine, Bivalent, for use in individuals 5 through 11 years of age vials (vials with an orange  cap and a label with an orange border) instead of the Pfizer-BioNTech COVID-19 Vaccine,  Bivalent for use in individuals 12 years of age and older (vials with a gray cap and a label with a  gray border).
Temporary loss of vision, sweating, faint feeling (aforementioned symptoms lasted less than 15 mins). Also experience nausea, headache for over 1 hr.
Approximately five years post vax the pt developed shingles on the right thoracic area under the front arm and back.
Injection site warm, very tender to touch. Red line approx 3" from top of biceps to axilla. Followed up with visit to doctor and treated with Ibuprofen and heating pad.
Injection site necrosis - Injection site atrophy. Initial report was received on 19 November 2008 from a health care professional in the USA. A 45 year old female patient received a left deltoid intramuscular injection of FLUZONE No Preservative 2008-2009 (lot number U2797BA) on 22 October 2008. On 18 November 2008 the patient noticed that she had a red, dime sized indentation on the left deltoid where she had the injection. The area was not inflamed or painful. The nurse stated that the area looked like tissue necrosis. The patient is scheduled to visit with her doctor on 19 November 2008. The patient was not recovered at the time of the report. List of Documents held by Sender: None.
High fever first 48 hours / migraine. Then developed shingles blisters on my chest. A patch of about 8. Today noticed two shingles blisters under my lip.
Per phone call - sx appeared 7d after injection - mom describes.  Rash that looked like large whelps resembling "ring-worm" - faded away after 5-7d with meds - rash was on back arms - hips.
Patient received Pfizer COVID vaccine on 7/16/21 and 8/6/21. On 1/11/22, patient admitted to our inpatient facility for acute hypoxemic respiratory failure and sepsis due to COVID-19. As of today (1/13/22), patient is still admitted in our med/surg unit.
A 76-year-old male patient received, on 02DEC2014, intramuscular PREVNAR13, lot J49845, expiration date: 01MAR2015 0.5 ml single dose. Relevant medical history included diabetes, hypertension, and tobacco user. No allergies were reported. Concomitant medication included oral AMLODIPINE (tablet)  5 mg daily, oral CIALIS (table) 20 mg, as needed, oral LIPITOR (tablet) 20 mg, once daily, oral ASPIRIN (tablet) 81 mg, daily and oral METFORMIN (tablet) 500 mg once daily (2 pills by mouth for 3 months (90 day). The patient previously received a flu shot two months ago. On 02DEC2014, 4 hours after the vaccination, the patient experienced a temperature of 103 F degrees. Patient remained febrile for 3 days and he was treated with ibuprofen. Fever went high up to 103.4F. On 04DEC2014 temperature went to 101F and he went to play tennis that day. The patient recovered from fever on an unspecified date. Nurse mentioned that in addition to fever he experienced severe cough, mucous and aches and pain. Clinical outcome of the events, productive cough and pain, was unknown. Causal relationship between the event, fever and PREVNAR13 was unknown. Follow-up (20JAN2015): New information reported from the contactable nurse includes: medical history, suspect drug and concomitant medications details, patient's clinical course and reporter's assessment. Follow-up attempts completed. No further information expected.
Sudden increase in girth of thigh to 2cm> than other leg within 6 hrs of injection.  Mild tenderness, no fluctuation no palpable mass.
Employee called in to center to report hives/rash on left side of neck. Area is itchy and hot. No SOB or CP. BENADRYL taken at home. Advised to monitor area. If symptoms worsen or new symptoms occur seek medical attention.
Patient had injection on 8/20/08. Patient called on 10/7/08 stating her arm still hurt with certain movements. Felt that her arm was "restricted". Stated ibuprofen was helping. Patient called 12/23/08 and says her arm much improved but not 100% yet.
This is a spontaneous report from a contactable consumer (patient's father) via Medical Information team. A 16-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the right arm on 02Apr2021 at 10:15 (batch/lot number and expiration date were unknown) as a single dose for COVID-19 immunization. The vaccination facility type was reported as a "drive thru COVID-19 vaccine clinic." The patient's parents thought it was best for the patient to take the Pfizer COVID-19 vaccine, since she was eligible to get it so she would be protected. Relevant medical history included acne on the face from an unknown date and unknown if ongoing. Concomitant medication included isotretinoin taken for acne on the face, which she took for almost 3 months from an unspecified start date to 19Apr2021. The patient had no history of previous immunization with the Pfizer vaccine, since this was her first dose. There were no additional vaccines administered on the same date of the Pfizer suspect vaccine. The patient had no prior vaccinations (within 4 weeks) and had no adverse events (AEs) following prior vaccinations. The patient had no family medical history relevant to the AEs. On 17Apr2021 at about 16:15 in the afternoon, the patient experienced seizure. It was further reported that the patient had a side effect after receiving the Pfizer COVID-19 vaccine; the patient had a seizure 15 days after receiving the vaccine. The reporter was asking if seizure had been reported with the vaccine. The reporter had no idea for sure if it was the vaccine, but he wanted to let Pfizer know. The reporter was hoping the patient would be okay and it won't happen again. The patient would see her physician at the time of the report on 21Apr2021 in a few hours. They would listen to the doctor at the appointment, and they had an appointment with the neurologist to see if she should get the second dose on Friday. They didn't know yet. The reporter didn't have the vaccination card with him. The patient had no conditions other than this event. The patient went to the emergency room for the event on an unspecified from which she had blood tests, urine tests, and a computerized axial tomography (CAT) scan of her brain and they said they couldn't find anything wrong at that time. They needed to follow up with the hospital in the area to see a neurologist, which they would be doing the following day. They told them to follow up with the neurology department at their Hospital and told them until they find out more information; the patient could do what she needed to do, but she couldn't drive a car. The reporter asked if Pfizer has had any reports of this and wondered if there had been other reports of seizures. The outcome of the event was unknown.  Information on the batch/lot number has been requested.
Extremely rapid heartbeat for 3 days, with shortness of breath, dizziness, fatigue, Outbreak of what appeared to be shingles under the left armpit.  Unable to drive or work for 3 days.
Mom called office 7/25/06 stated he had a temp 101.5 and vomited 3 times after immunization on 7/21/06. was fine on 7/25/06.
Pain, redness, swelling, fever(101), headache, tiredness, chills, body aches, sore joints, 3" hard mass at injection site, sugar spiked to 286 (norm has been 160)
Pt states approximately 5-6 hrs after receiving vaccine experienced pain, swelling and redness to both arms, more pronounced on the left. Also c/o sore throat, earache and congestion. Went to ER on evening of 01/7/10, given Ibuprofen and meds for congestion.