chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe body hives with refractory itching  all over face, neck back- none responsive to anti-histamines at home; Treated at Emergency Department with IM Benadryl
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included headache (had headaches). Concurrent medical conditions included chronic pain.   On 13th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The reporter stated that, after vaccination, had headach that lasted for approximately 1 day. The reporter did not consent to follow up.
Vial was stored in refrigerator on 26-May-2022 and administered on 28-Jun-2022; Vaccine administered 2 days after beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 28-Jun-2022) in a 54-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 0559A22) for COVID-19 prophylaxis.     Concurrent medical conditions included Headache. Concomitant products included IBUPROFEN and RIZATRIPTAN for Headache.    On 28-Jun-2022 at 4:30 PM, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 28-Jun-2022 at 4:30 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 28-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 2 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 26-May-2022 and administered on 28-Jun-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   The patient had never been diagnosed with/ tested positive for COVID 19. Acute illness at the time of vaccination and up to one month before was reported as none.  The patients had reported no side effects.  Number of doses or vails were reported as 7.  The vial was initially stored in the refrigerator on 26-May-2022. The vial did not undergo any temperature excursion.  Treatment details were not reported by the reporter.
two days fever on 5/11 & 5/12 after had the 1st dose on 5/10. The arm pain last for about 2 days. Later, Covid arm happened on 5/19, with rash, swollen & pain around the injection area. The lower arm & hand which had the injection felt soar & numb starting from 5/23 & getting better today, on 5/24. As of today, still can see the redness from the rash although it has been getting much better.
No additional AE reported; First dose of GARDASIL was administered whenever patient was 4 years old on Oct 3, 2014. Second dose of GARDASIL was administered whenever patient was 5 years old on Nov 18, 2015.; received the GARDASIL series at ages 4 and 5 years old; This spontaneous report was received from a medical assistant and refers to a 13 years old male patient.  The patient's current condition, medical history and concomitant medications were not provided.  On 03-OCT-2014, the patient was vaccinated with first dose ofquadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (expiration date, lot number, formulation, anatomical location, route of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). On 18-NOV-2015, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) dose 2 (expiration date, lot number, anatomical location, route of administration were not reported) for prophylaxis (Inappropriate schedule of product administration). No additional adverse event was reported. The patient was planing to received quadrivalent human papillomavirus (types 6,11,16,18, 31, 45, 52, 58) recomb. vaccine (GARDASIL-9). However, in system there was an information that the patient was already received quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) series at ages 4 and 5. The reporter stated she was not sure if her system was accurate because she did not known how insurance would payed for reported vaccines with the patient at that young age
Patient experienced local site reaction. After administering vaccine, the area immediately began to swell and cause hard bump/knot at the site of injection. I massaged the area and the reaction became less severe (swelling went down and knot soften).
Pt states: Arm became blood-red. Neck became itchy. Resolved over next few days.
This spontaneous report as received from a physician via a company representative refers to a 30 year old female patient who was asthmatic. The patient was not pregnant. On 25-JAN-2014, the patient was vaccinated with PNEUMOVAX 23 (lot # not provided) dose and route as directed recommended due to history of asthma. Concomitant therapies included TDAP vaccine administered on the same day. In 2014, the patient developed a localized reaction on the right side of her arm that included swelling and redness of the size of a golf ball. At the time of the report, the outcome of the events was unknown. Additional information has been requested.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4467502-00 (AbbVie).  A 60-year-old female patient received BNT162b2 (BNT162B2), on 02Apr2020 as dose 1, single (Batch/Lot number: unknown) and on 01May2020 as dose 2, single (Batch/Lot number: unknown) at the age of 58 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for product used for unknown indication. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The action taken for adalimumab was unknown.  Clinical course: The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was no reasonable possibility. Causality as per reporter (Drug/Vaccine): Not related for COVID-19. The reporter's causality for the event(s) of COVID with Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran) as per reporter: Probable. The reporter's assessment of the causal relationship of "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "covid-19" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Comirnaty yesterday (booster); Fatigued; has a back ache; A slight fever 99.5 - 100.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date 22Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose unknown, MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Dec2021, outcome "unknown", described as "Comirnaty yesterday (booster)"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "Fatigued"; BACK PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "has a back ache"; PYREXIA (non-serious) with onset Dec2021, outcome "unknown", described as "A slight fever 99.5 - 100.5". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The reporter reported that, "My son, 17 years old received Comirnaty yesterday (booster). He told me today he is fatigued, has a back ache, and has a slight fever 99.5 - 100.5".  The lot number for bnt162b2 was not provided and will be requested during follow up.
No adverse effect; the patient was administred a dose of improperly stored VARIVAX; This spontaneous report has been received from a nurse, concerning one patient of unknown age, gender and ethnicity.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 09-MAY-2019 (also reported as "today"), the patient was vaccinated with a improperly stored of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # R034396 and expiration date 27-NOV-2020) (dose and anatomical location not reported) (product storage error) as prophylaxis. The vaccine varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent (Lot # S008564 and expiration date 05-AUG-2021). No adverse effects reported.   Additionally, temperature for vaccine was -9C to 8C (7.5C); time frame: 4 hours 55 minutes; with no previous temperature of excursion. The error was identified via a data logger.
Nausea, stomach pains, diarrhea, fever, chills, body aches, malaise.
7 days post vaccine I had severe nausea and extreme fatigue followed by migraines. The nausea came on suddenly and the fatigue / migraines followed about an hour later. I had constipation with some loose stools on days 10&11. These symptoms lasted for almost 5 full days. I hit my peak ovulation day on day 9 or 10 after receiving the shot, so the symptoms may or may not be related. I have NEVER had symptoms of ovulation other than occasional breast sensitivity. I have not been exposed to anyone with COVID, work from home, etc. and took 2 COVID tests to be sure that wasn?t it, and they both came back negative. No other symptoms (ie no runny nose, cough, fever, etc.)
This spontaneous report as received from a registered nurse refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 23-JAN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) (dose, frequency and route unspecified) (lot number: K011314 with expiry date of 14-FEB-2016). Concomitant medications were not reported. The reporter stated that, between 07-JAN-2015 through 19-FEB-2025, the varicella virus vaccine  (Merck) was exposed to 34.4 Fahrenheit temperature which was outside the recommended condition. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with varicella virus vaccine live (Merck) was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
More than 35 days between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 090A21A, 0J8(H or N)20X and 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Cholesterol.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose). On 18-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between first and second dose) had resolved.            Patient had cholesterol blood pressure issues that were managed by medication.  Patient was not immunocompromised. Treatment information was not provided.
Raised red skin about 5 cm at injection site with no pain or itching, patient claims dermatitis.
Some time between the 2nd dose of Moderna and March 18, 2021, developed a severe rash/hives all over body
Sunday, 8/22: Flu-like symptoms. Fatigue, chills, body aches. Arm very sore at injection site. 8/23: Felt better. Arm still sore. 8/24: Same as 8-23, except a bit more fatigued. 8/25: Woke up feeling fatigued and slightly unwell. Felt waves of "unwellness" throughout the day - warm, then chills, slight scratchy throat. At 4:40pm, I smoked prescribed medical cannabis, then about 10 minutes later, felt what could be described as a classic panic attack. Increased heart rate, chest felt heavy and breathing was shaky, chills, 99.1 degree temperature, numbness and tingling throughout my body, especially on my left arm and chest area. Random stabbing pain beneath my left breast. After drinking a lot of water and eating some food, resting, and focusing on staying calm, the "panicky" feeling subsided. Still feeling fatigue and generally unwell.
This spontaneous report as received from a certified medical assistant refers to a 17 year old female patient. There was no pertinent medical history and no drug reactions or allergies. On 02-OCT-2013, the patient was vaccinated with GARDASIL lot # J003727 expiry date 07-NOV-2015, first dose, (dose and route not reported) to prevent human papillomavirus (HPV). Concomitant therapies included ethinyl estradiol, SPRINTEC. On 02-OCT-2013, 6 hrs after onset of  therapy, the patient experienced dizziness and shortness of breath. The patient did not report these symptoms to anyone prior to her appointment in the office on 03-DEC-2013 when she came in to receive her second dose of GARDASIL. No treatment given for the events. No lab diagnostics performed. The outcome of shortness of breath and dizziness was reported as recovered on 02-OCT-2013. Additional information has been requested.
Patient arrived to drop-in immunization clinic with mother. Patient was due for TDaP booster per his historical record. Immunization reviewed with mother, mother gave verbal consent. Immunization screening questions were reviewed, and no contraindications noted. 5 rights reviewed. TDaP vaccine administered per protocol in patient's right deltoid. Approximately 15 seconds after administration, patient postured backward rigidly while seated in his chair. He then slumped over to his right side, and was caught by me. Patient did not fall out of his chair, did not hit the floor, and did not hit his head. Patient was placed seated back in his chair and was A&O x4, but stated he felt "funny and dizzy," and stated he had positive LOC. Skin pale, cool, and clammy. VS taken immediately, all WNL except for BP which was low. Patient was placed onto exam table to lay down and VS were reassessed q5 minutes. Pt was given juice and crackers, and given O2 at 8LPM via face mask. BP did not normalize despite supine positioning, O2, and juice. Pt stated he felt "a little better" after juice and crackers, but still felt dizzy, and that his "head felt funny." Charge nurse was unavailable, but resource RN notified. Pt still A&O x4 but very slow to respond, and skin signs had not improved. Paramedics called, and patient was transported to medical center with mother's consent. All communication assisted with public health staff. Public health RN supervisor notified.
Pt was seated in the waiting area (the shot was administered in our "shot room" and the pt was beginning his 15 minute observation period in the waiting area.)  He slumped to the right.  He was breathing but unresponsive.   We guided him to the floor.  His face was becoming red in color, and he was still unresponsive.  After hearing two wheezing breaths I administered one dose of (Teva branded) epinephrine.  Emergency Med Tech arrived about 90 seconds after the dose was administered and took over from there.  Pt became fully alert shortly after the EMT arrived.  Pt was transported  via stretcher from the store.
Vial used open over 12 hours but under 24 hours. Reported to Pfizer, per rep ok as long as under 24 hours.
ER informed me 12-1-12 that child brought to ER after being found unresponsive in parent's bed.
Systemic: Fainting / Unresponsive-Mild, Additional Details: pt fainted (slumped over in chair) aprox 1 min after receiving the vaccine. she recovered within 60 seconds
My daughter has always been healthy with the exception of ear infections when she was younger.  She played soccer, did cheerleading and currently dances twice a week.  My daughter received her first dose of the Gardasil HPV vaccine on 7/22/14 and a second dose on 7/22/14.  On 12/6/14 she woke up with a rash on her thighs, stomach, arms and back.  We took her to the doctors and they diagnosed her with Pityriasis Rosea.  On the evening 12/7/14 she started experiencing muscle pain and could barely walk on her legs.  We took her back to the doctors on 12/8/14 and was told that she did not have Pityriasis Rosea and that what she most likely had was a virus.   Her symptoms, rash and muscle pain, continued to worsen and we took her back to the doctors on 12/10/14.  We were told that she appeared to have a viral infection and it needed to run its course.  On 1/13/15 we took her back to the doctors as she was still having her rash, was tired all the time and was still having muscle pain her legs, arms and wrists.  Weight loss also became a concern.  On 12/8/14 weight was 110 pounds on 1/13/15 she was down to 99 pounds 8 ounces.  Blood was drawn results were negative for mono, a weak positive for autoimmune, SED RATE showed inflammation and positive for anemia.  On 1/16/15 saw a dermatologist for a skin biopsy which came back as vasculitis. On 1/28/15 we saw a Rheumatoid Arthritis specialist who diagnosed her with undefined Juvenile Idiopathic Arthritis and prescribed her 125 mg Naproxen 2 times a day.  As Naproxen was not working on 2/6/15 Prednisone was prescribed at 3 tablets of 10 mg of prednisone a day for 1 week, than 2 tablets for a week and then 1 tablet for a week. Follow up with RA specialist on 2/27/15.  Continues to have rash and joint pain in her legs and arms.  Was left on taking 10 mg of Prednisone daily and went for x-rays on wrist.  Wrists x-rays came back good.  On 4/1/15 follow up with RA specialist.  Range of motion better in legs and arms.  Still pain and limited range in both wrists.   Steroid injection into joint of left wrist and Prednisone was reduced to 7.5 mg daily.  As I am writing this on 4/19/15 she still is experiencing a rash on her legs, arms, stomach and back.  The rash comes and goes.  She is still having pain in her wrists more in the right as she had the steroid injection in the left.  She is unable to put pressure or support her weight on her hands.  There is once again a loss of range of motion in her right arm.  She cannot straighten her arm as it hurts too much.
Sore arm for greater than 2 1/2 wks, firm on palpation-arm appears swollen/larger on right than left on inspection in deltoid area.
No adverse effects reported; patients received unspecified doses of PEDVAXHIB, MMR II, VAQTA that were improperly stored; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R021083 , expiration date 13-JUN-2021 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 10.9 degrees Celsius for 1 hour and 14 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003340: US-009507513-1904USA003832:
started having sx 1/1/22, tested negative 1/3/22, tested positive for covid 1/5/22 is fully vaccinated with Moderna plus booster dose listed above cough, congestion, headache, fatigue states went to physician office 1/5/22 for monoclonal antibody infusion
wednesday i developed bilateral breast swelling overnight at 0200. chills, headache, fever to 104.1F at 5pm. antibiotics started to rule out mastitis by OB. decreased milk production (breast feeding mother for 8 months, no history of mastitis). i did go to patient first on thursday where my rapid covid was negative,  flu was negative, WBCs were not elevated (9). covid PCR pending.
COVID-19 Pfizer LOT # FT9142 kept in fridge BUD. Received 7/26/22 and administered 10/17/22.
Fever of 101, chills, body aches, feet and legs hurting very badly, arm sore, itching all over
Vaccination given at 9:20 a.m. Patient showed signs of excessive tiredness at 7:45 p.m. Vomiting occured beginning at 4:00 a.m.
Patient reported swelling and redness at the injection site on second day after receiving the vaccine . She claimed that the second series side effects are way more intense than the first series she received couple months before. Pharmacist on duty consulted that these are known side effects, however the severity of the side effects i(redness and swelling of the injection site) was about the tennis ball size, thus pharmacist recommended her on taking OTC Tylenol for pain and OTC Benadryl for redness and swelling. Pharmacist followed up after 3 days of recommendation and she reported that symptoms were lessened after couple days of taking those OTC drugs.
Headache; High Fever; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 24Aug2022 as dose number unknown, single (Lot number: FM0698) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 25Aug2022, outcome "unknown"; PYREXIA (non-serious) with onset 25Aug2022, outcome "unknown", described as "High Fever"; HEADACHE (non-serious), outcome "unknown". Therapeutic measures were taken as a result of pyrexia, chills, headache.  Additional Information: It was reported that, Transferring agent stated, I have a caller on the other. She was a consumer. The caller got the Pfizer COVID 19 vaccine yesterday and today she experience high fever and chills. She was asking if she can take Tylenol and I tried to give her the number of our Pfizer Medical Information department but she refused. You can transfer her later with the Pfizer Medical Information Department for her question. When paraphrased the concern, consumer stated, Yes, I am also having headache. Is report related to a study or programme was Yes. Product Name as Reported by the Primary Source: Tylenol.      No follow-up attempts are possible. No further information is expected.