chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist via other company (Pfizer) on 02 September 2016. Manufacturer Report Number: 2016407947. This case involves a patient (age and gender was not reported) who was vaccinated with a dose of FLU VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had seizure. The patient's laboratory data and corrective treatment was not reported. The outcome of the event was not reported. Upon medical review, the case was considered as serious due to important medical event: seizure. List of documents held by sender: none. Sender's Comments: Patient had seizure following flu vaccine manufacturer unknown. Time to onset is unknown, detail medical history during or before vaccination, past vaccination history and its tolerance, any CNS disorder, traumatic history etc. are needed to further assess the case. Based on available information the role of vaccine cannot be assessed.
Approx. 12 hours, after MMR, child couldn't swallow; had a rash (pink, flush on skin) on lower park of knees only. Temperature 102F (rectal), sore throat, and wouldn't drink. Resolved 2 hours, after it appeared on it's own.
Wrong dose of Pfizer was given to patient, patient was given an adult dose instead of a pediatric dose.
Information has been received from a nurse practitioner concerning a 17 year old female with no medical history or drug allergies, who on 05-SEP-2008, was vaccinated IM with the first 0.5 ml dose of GARDASIL (lot#:660612/0229X).Concomitant therapy included drospirenone (+) ethinyl estradiol (YAZ). It was reported that the patient experienced fever, nausea and vomiting within a couple of hours of getting home from her appointment. She had no localized reactions. Her symptoms lasted for 48 hours. The patient recovered from fever, nausea and vomiting. Additional information has been requested.
Cellulitis at the injection site.  Erythematous indurated plaque with mild swelling and soreness, hot to the touch.
Left upper arm swelling and tenderness at injection site that was expected initially, but took a few weeks to resolve. Large swelling and sharp pain in shoulder for 3 weeks after injection.
Arm soreness; Severe aches on her legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and PAIN IN EXTREMITY (Severe aches on her legs) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and PAIN IN EXTREMITY (Severe aches on her legs). On 11-Mar-2021, PAIN IN EXTREMITY (Arm soreness) and PAIN IN EXTREMITY (Severe aches on her legs) had resolved. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No concomitant medications were provided.  No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-059796 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-059796:Dose 1
Patient developed a severe migraine, patient has had the migraine every day since the injection of the vaccine. Also patient has had trouble sleeping since the injection of the vaccine.
Developed fever of 102.5, with chills and muscle aches. Lasted about 36 hours
fever, chills, vomiting, anorexia, painful stiff neck, unable to tilt head up towards ceiling or down towards floor, could not put chin to chest, was able to turn head lt to rt but slowly & w/discomfort;
Information has been received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. From November 2016 to 23-FEB-2017, improperly stored doses of PROQUAD (dose, strength, frequency and route were unknown, lot # M037652 with expiration date 28-FEB-2018, lot# M038862 with expiration date 13-MAR-2018) were each administered to the unspecified patients for immunization. The PROQUAD was exposed -4.3 Celsius for a time frame of 1 hour 18 minutes. The previous temperature excursions of the PROQUAD with lot# M037652 are from -15 Celsius to -10 Celsius in 3 hours 59 minutes and from -10 Celsius to 8 Celsius in 1 hour 10 minutes. The previous temperature excursions of the PROQUAD with lot# M038862 are a range between -10 Celsius and -8 Celsius in 10 hours 40 minutes and a range between -15 Celsius and -10 Celsius  in 3 hour 59 minutes. A data logger was in use. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA011099.
Patient experienced "throat and lip tingling" immediately post vaccination, but did not inform medical staff until 30-40 min post injection. The tingling progressed to "tightness." around 45 min post vaccination.  The OP was visualized and  mildly erythematous initially. Loratidine 10mg PO x1 administered at this time.  The OP erythema progressed with no resolution of reported "tightness",  therefore Diphenhydramine 0.5ml IM administered. Sxs began to  improve over 30 min. EMS was notified to further evaluate patient. Patient declines transport to ED.  AFVSS throughout medical response. Patient was monitored an additional 15 min after EMS completed eval and was dc'ed home with strict ED precautions.
Admit for COVID infection with poss superimposed bacterial pna. Fully vaccinated. Rocephin, zithromax, steroids, remdesivir, zinc, HFNC, intermittent Bipap, singulair. Unfortunately patients never really improved during her long and complicated course.  She was made DNR and decision made to withdraw care by palliative care, icu team in discussion with family. She was extubated on 9/6 and pronounced dead.
On 2/2/04, during the evening, she began to itch all over. The next day, it recurred. Took something she thinks was Promethazine. No itching today. Denies rash but did say after scratching "it welted up".
arm redness, warmth, swelling, pain, itching. nausea, diarrhea, chest pain, headache
Initial report received from non-health care professional on 10 January 2014. Reporter was also the patient in this case. It was reported that the 66 years old female patient received FLUZONE HD on 09 January 2014 by intramuscular route in deltoid left. Several hours later felt she was "sweating more than usual", had decreased urine output, and experienced muscle soreness at injection site. Stated continued to feel "as if sweating more than usual today, 10 January 2014. The subject's medical history was not reported. The lab details were not reported. The event sweating more than usual outcome is unknown at the time of reporting. No more information available. Documents held by the sender: none.
Fever,  chills lasting 24hrs (less severe than Moderna dose 1 & 2 )   Rash as injection site appearing 24hrs after injection and last >72hrs
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 08-NOV-2012, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX) did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 19-APR-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. She was prescribed lidocaine, topical film, and acetaminophen/hydrocodone bitartrate for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Patient received MMR and Varivax vaccines. Patient was seated and asked for proof of vaccination. Pharmacist stepped away to grab and heard a thump. Ran out, patient was on the floor. Patient lost consciousness briefly (10 seconds) about 2 minutes after receiving vaccine and immediately after standing. Patient regained consciousness upon pharmacist speaking to her. Patient said she was warm, remained on floor and given water until EMS arrived. All vitals clear, EMS approved her to leave without being seen.
LUMP ON RIGHT TESTICLE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported No concomitant medications were reported. On an unspecified date, the subject experienced lump on right testicle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lump on right testicle. This report was non-serious.
Bivalent booster given erroneously as Primary series. Patient's and his caregiver notified. Primary care Provider notified.
Since getting the vaccine I have had a rash and itching that I have been seen twice for and none of the prescribed medications have cured it.  Additionally my mental cycle is sometimes twice monthly and the clotting is large and abnormal for my usual period. I experience heavy bleeding that last for several days.
Mother called today & reported child has seizure last night. Was not sure if it was side effect of vaccine. Child was seen by Dr at Hosp ER. Sent home and monitored. No other problems mother stated but child had a seizure in Dec. but no other time.
Redness and swelling at (L) thigh where IZ administered- 7cm x 7cm in size No fever, walking is normal, active, no acute distress BENADRYL susp-1 tsp given at office - con't Q4hrs- F/U w/OV in 24 hrs.
Pt was seen on 12/5/00 for 1 month well check-up and given 1st Hep-B shot. Within hours, post vax, mother noted irritability and "paleness". Pt vomited on/off for 2 days and returned to our office on 12/8/00. The pt was found to have supraventricular tachycardia and shock. Transported to ICU where she was intubated and converted.
(R) deltoid - red, hard, warm area and painful noted where Influenza vaccine given.
Sedation, Myalgia, Arthralgia, Back pain, congestion, shortness of breath Narrative: Received 2nd dose on 1/26/21 and 6 hours later developed bilateral hip arthralgia. Throughout the night noted arthralgias, back pain and muscle pains that interfered with sleep. Noted congestion, chest tightness and inability to take a deep breath starting 1/28/21, requiring use of inhalers. Noted fatigue for several days - at least through 2/1/21. Missed work x 2 days. No known prior covid infection.
Mom noticed left deltoid became red, swollen. No fever. Swelling has since decreased.
High fever- temporal temperature of 104.4 -105.1 F for 2 days then  mild fever 99-103 F there after for another 2 days. fever would temporarily improve but not resolve with Tylenol or Ibuprofen until 3 days after fever started Severe headache.  Severe body aches & difficulty walking/moving. for 2 days Nausea and vomiting for 2 days profuse sweating for 4 days Fatigue, dizziness , & Malaise for more 10 days weight loss- 5 lb weight loss in 1 week
Severe chest pain requiring a visit to the ER.  Patient was admitted into the hospitaland evaluated by the Er Physician and moved to Cardiology.  He was diagnosed with Myocarditis.  He was released midday on Monday.  On Monday night, we returned to the ER with even worse chest pains (self rated at 10/10).  He was re-diagnosed with both Myocarditis and Pericarditis.
Period is delayed. Cycle is longer by 4-5 days. Menstrual  phase is longer by 3-4 days.
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 12-MAR-2021, the patient was vaccinated with one hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number T007035, which has been verified to be valid, the expiration date was reported and validated as 01-MAY-2022), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
positive COVID test after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (positive COVID test after vaccination) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive COVID test after vaccination). The patient was treated with VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; MULTIVITAMIN [VITAMINS NOS] at an unspecified dose and frequency; MELATONIN at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 TEST POSITIVE (positive COVID test after vaccination) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-116363 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116363:
Grapefruit size redness to left arm, warm to touch. Benadryl 2 tsp q 6-8hrs prn/ warm compress.
Patient indicated that he wished to receive the vaccine and denied having received a previous Covid vaccine. Staff utilized the state Regulatory Authority system to identify patients who may have already received a Covid vaccine; this patient may have been added to list after checks were completed. The patient received the Janssen Covid vaccine; Regulatory Authority was entered into the Regulatory Authority management system and at that time it was found that the patient had received Covid vaccine, Pfizer, at another location on 3/25/21. The nursing director was notified on 8/13/21 and was advised to monitor patient for vaccine reactions.
Patient passed out after an hour of getting the shot. Patient had a lump and redness around the injection site. She called her dr and he advised her to please heat over it. It resolved the lump, but redness and itching down the left arm continues. The arm is also warm and has a burning sensation. We advise the patient to see her Dr.
Patient complains of prolonged pain at the injection site with a decrease in abduction of the affected arm (unable to reach behind head). Pain on palpation on the lateral aspect of the triceps.
Pt returned to pharmacy complaining of her throat closing and difficulty swallowing.  Administered 1 Epipen.
Pt was very anxious before shot given. Mother had to physically hold pt down for her to receive the shot. Afterwards, pt reported headache, dizziness, and sore throat immediately after the shot. Pt was hyperventilating so I encouraged deep breathing and hydration. HEENT and Pulm exam were normal, as were the vitals. Pt eventually recovered without any other intervention. Pt waited for full 30 minutes after dose.
Infant had some sinus congestion at the time of her vaccinations. Two days later she developed fever and cough. She was diagnosed with pneumonia 2-6-09. She responded well to Azithromycin treatment.
Headache, fever, sweats, nausea and severe chest pain with vomiting X 48 hours. Contacted employee health 2 to 2 1/2 hours after receiving injection. Still have some nausea and vomiting bile. Had TD/Aventis Pasteur on 11/24/01.
reoccurance of my pre-existing Chron's Disease; reoccurrence of my pre-existing Chron's Disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pre-existing crohn's disease " (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "feeling run down", "comparable to getting the flu", "malaise", "fever"; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "feeling run down", "comparable to getting the flu", "malaise", "fever".  The following information was reported: CROHN'S DISEASE (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "reoccurrence of my pre-existing Chron's Disease". Therapeutic measures were taken as a result of crohn's disease, disease recurrence.  Clinical information: With the first booster, there was a reoccurrence of patient's pre-existing crohn's disease characterized by Chronic pain in the ileocecal intestinal area. It was painful enough to require the patient's taking prednisolone (starting at 20mg) for about 6 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
A nurse reported that a 35-year-old male did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series. The pt's medical history, concurrent conditions and concurrent medications were unknown. The pt received injections of Engerix-B on 03/27/2002 (lot ENG5257A4), 05/20/2002 (lot ENG5257A4) and 11/05/2002 (lot ENG5291A4). 85 days after his 3rd injection of Engerix-B, on 01/29/2003, an unspecified titer was "less than 2". Comment: the reporter indicated that 4 additional subjects did not achieve protective antibody titers following immunization with Engerix-B. Please see reports A0398883A, A0400569A, A0400570A, and A0400571A.
Client woke up the next morning  feeling soar all over, freezing cold with dry hives.  Denies any hives, swelling or palpitations.  Client states she felt like she had a terrible cold.  Client did go to emergency department 08/31/19  due to the chills and fever of 100 plus (cannot remember her temperature but stated it was over 100 F)where they did blood work, IV fluids and gave her Benadryl, Toradol, Tylenol .    Client said she was treated for dehydration and blood work did not show anything abnormal with liver.
This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site pruritus in a 62-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 16 November 2010 the subject received a dose of BOOSTRIX at 0.5 ml (prefilled syringe) in an unknown deltoid. On 18 November 2010, 2 days after vaccination with BOOSTRIX, the subject experienced injection site pruritus and injection site rash. At the time of reporting the outcome of the events was unspecified.
On May 22nd I had an incident where I got very dizzy, hot, flushed faced, and I felt very miserable. I had several dizzier spells like that afterwards. On July 31st I had one where I totally blacked out. When I came out of it, I was fine. I had gone to the doctor, and they ran test. They couldn't find anything. They tried switching my medications but that made things worse, so I went back to taking my normal medications. I started taking 1 baby aspirin about every other day. I still have dizziness, flush feelings, and hot. I am tired all the time. My energy is coming back slowly. Some days I feel like my balance is off. I also ended up catching COVID-19 on September 7,2021. On September 11th I got the Monoclonal Antibody infusion.
DID NOT TAKE THE FOURTH DOSE AND TRAVELLED TO AN ENDEMIC AREA; This spontaneous case report was received from a consumer (PVX2019-497) on 25-Feb-2019. The report described a 51-year-old female consumer who "did not take the fourth dose and traveled to an endemic area". The consumer was receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  It was reported that the consumer took the third dose of Vivotif on 12-Feb-2019 and did not take the fourth dose, instead she traveled to an endemic area from 14-Feb-2019 to 23-Feb-2019.  The action taken with Vivotif with respect to the event "did not take the fourth dose and traveled to an endemic area" was not applicable.  The clinical outcome of the event "did not take the fourth dose and traveled to an endemic area" was unknown.  Company's Comment: The causality of the event "did not take the fourth dose and traveled to an endemic area" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the fourth dose and traveled to an endemic area" was considered as not applicable.