chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Physician). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (Pfizer-BioNTech COVID-19), on 14Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1 , single (Batch/Lot number: unknown) and as dose 2 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient receive Paxlovid to treat drug ineffective, covid-19, treatment start date: 12May2022, treatment stop date: 16May2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The contribution of the suspect drug to the onset of event drug ineffective cannot be ruled out since drug efficacy varies from one patient to another and affected by different factors.
Swelling, warmth and erythema in the left thigh that resolved the next day.  "Wavy" rash on both legs on 4/30/2010 that resolved within a few hours.  Varicella lesions on the face that began on 5/5/10.
In my left eye, I saw an arc of light and started to have significant floaters.  My right eye did not have floaters.   On Dec. 1, 2021, when I had the booster shot, that evening, I saw an arc of light in my right eye and also now have significant floaters.
tested positive  for COVID-19; tested positive  for COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 45-year-old female patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL9264), on 17Feb2021 as dose 2, single (Lot number: EL9266) and on 21Sep2021 as dose 3 (booster), single (Lot number: 301458A) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (ongoing); "Seasonal allergy" (ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; PANTOPRAZOLE [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; XYZAL taken for hypersensitivity; FLONASE ALLERGY RELIEF taken for hypersensitivity; PROVENTIL [SALBUTAMOL] taken for asthma. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "tested positive  for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Positive; (19May2022) Negative; (24May2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Chest tightness, harder to breathe, fatigue, some chest muscle soreness and dry mouth & throat.
a portion of the vaccine leaked out of the syringe with no reported adverse event; Initial information received on 09-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 1 months old female patient who had a portion of the vaccine leaked out of the syringe with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation; and HEPATITIS B VACCINE (VACCINE, HEPATITIS B) for Immunisation.  On 08-Aug-2022, the patient received less than 0.5ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE as portion of the vaccine leaked out of the syringe with no reported adverse event (incorrect dose administered, Latency: same day) (strength, formulation, lot number and expiry date was unknown) via intramuscular route in the left thigh for immunization. This situation was reported as a medication error due to less than the recommended dose of PENTACEL being administered to a patient due to employee not attaching the needle correctly and a portion of the vaccine leaked out of the syringe. Reporter would like to know should her daughter be revaccinated and are there any black box warnings.  Action taken: not applicable.  Outcome: Unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
perfused runny nose; Severe sneezing; This is a spontaneous report from a contactable consumer (patient). This male patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 18Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number unknown) on 26Feb2021 for COVID-19 immunisation and experienced severe sneezing, runny nose and cough. The patient reported that after the first shot for four days he had severe sneezing and a runny nose that really went away, the second shot he "really" noticed that he had a shot or anything and now (as of 05Apr2021) with the second one about two weeks he had severe sneezing again and got a runny nose, nothing seemed to stop. He inquired if these were side effects. He reported that with the first shot for four days severe sneezing night and day, and a runny nose for a few days and the second shot he did not have any problems until 2 weeks after and now (as of 05Apr2021) he had developed sneezing again and had it for 5 days stating "it does not seem to be holding," and he had a perfused runny nose again. The clinical outcomes of severe sneezing and "perfused" runny nose were not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
On the fourth of May, evening after the second shot, I started to get body aches and a sharp pain in the injection site. So I took some Aleve and went to bed early at 9:00pm. At 3:00am I woke up with vomiting, diarrhea, a fever of 102.2, chills and worse body aches. I threw up everything I tried to drink, even water and Vitamin Water. Trying to eat anything produced the same result. I live alone, so I thought I was prepared for getting sick, but it just kept going on for days. I called an ambulance Friday morning when vomiting and nausea still had not passed. I wasn't having diarrhea anymore, but I wasn't keeping anything down, so that's probably why. My urine was brown and sticky, I had dropped weight and was missing multiple days of work. I was given Zofran IV and fluid IV in the ambulance, first bag of three. The ER gave me two bags of fluid before I could produce a urine sample, which was very dark orange. Then "one more for the road" as they said. They did a CT scan of my abdomen with and without contrast. They prescribed Zofran. The next day I went back to the ER with more nausea and vomiting, severe stomach and abdominal pain, and still dark orange urine. I was taking the Zofran as prescribed, and the also prescribed Prilosec.
Within hours of  second dose(3/10/2021) in the right arm on 3/11/2021 I started feeling pain on the underside of my left arm. As the days have gone on it?s gotten a little worse. Left under arm pain, armpit area, left chest (pectoral) pain. Just lingering pain. Very sensitive to the touch. I also developed a rash on the left side of my spine between the shoulder blades. It  showed up this past weekend or the end of last week. It?s more of a painful rash than itchy. It?s very uncomfortable to lean against or lay on.  This is all 13 days after the second shot. I have just been taking ibuprofen for the pain.  Going to see my doctor today.
Dizziness persisting for over a week. Skin splotches on arms and legs.
Pediatric office states that 3 scheduled vaccines were prepared for a patient, but the parent refused with no reported adverse event; Initial information was received on 14-Nov-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case is linked to cases 2022SA471962 and 2022SA473333.  This case involves Child with unknown gender patient and reporter reported that office states that 3 scheduled vaccines were prepared for a patient, but the parent refused with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the vaccine Meningococcal A-C-Y-W135 (T CONJ) (with unknown strength, dose, lot number and expiration date) for Prophylactic vaccination was scheduled and prepared for a patient, but the parent refused with no reported adverse event (product dose omission issue) (unknown latency).  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Pt reported a generalized rash that began at injection site, spread to her elbow and up to her shoulder. She went to her physician who confirmed a reaction. Pt experienced these symptoms for several days. She was treated with Augmentin 875 two times per day for 7 days.
21APR TC 415Pm from mom states pt has been crying since 10:30 this AM p/vax;22APR97 mom reports MD felt the crying d/t pertussis & that pt should not recv any more pertussis;
At 230 pm I received the shot by 600pm on 9/28/2018 my arm became locked into the position that it was in, as the night progress the pain in my arm began to worsen, I awoke at 430am Saturday 9/289/2018 to get pain meds and warm cloth for some pain relief. I was unable to move my arm at all. I woke up at 900am became dizzy and passed out hitting my face and chin on the floor the ambulance was called and I was taken to the hospital. I was given oxycodone and test I was sent home with prescriptions for steroids and lidocaine patches,. as of 10/02/2018 Iam still unable to move my shoulder without excruciating pain.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   date of refrigeration is given as 6-Aug-2021. no concomitant and treatment medications are provided by the reporter.
Information has been received from a certified medical assistant referring to an approximately 44 year old female patient. The patient concurrent condition included high cholesterol, high blood pressure and allergic to LEVAQUIN, CECLOR and penicillin. The patient's medical history included back issues. On 06-OCT-2015, the patient's titers for hepatitis B were drawn and they were non-reactive. On the same date, the patient was vaccinated with her first dose of RECOMBIVAX HB (lot#, dose, and route not reported) and subsequently on 06-NOV-2015 and 16-MAR-2016 (inappropriate schedule of vaccine administration) with the second and third dose of RECOMBIVAX HB (lot#, dose and route not reported) respectively for vaccination. Concomitant therapies include WELLBUTRIN, EFFEXOR, EPIPEN. On 03-MAY-2016, the patient's titers for hepatitis B were drawn again and the results were still non-reactive. At the time of reporting, the outcome of non-reactive hepatitis B titers was unknown. Additional information has been requested.
After first and second night had 101 F fever. Rash started on back as mild faliculitis, now has spread to cover a large portion of his back and to his legs and arms. The rash appeared the 3rd day after the vaccine. Rash is very itchy and burns/stings. PCP gave prednisone - may have helped a little but has now quit responding. Will begin tapering.
No adverse reaction.  Adacel given to 10year 9.5 month old female.  Given in Vaccine clinic, pt was not seen by physician that day.
Patient given PNEUMOVAX while undergoing evaluation and follow up for non-cardiac chest pain. Left upper extremity pain, paresthesia, and weakness, and feet numbness. Subsequently developed weakness in all extremities. Currently being treated for suspected Guillain Barre syndrome.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 30-SEP-2015 the patient received a dose of improperly exposed VAQTA (lot # L023232, expiration date 25-FEB-2017, dose and route were not reported). Concomitant drug was not reported. The vaccine had been improperly exposed to 47.5F for 2 hours and 28.9F for 11 hours on an unspecified date prior to 30-SEP-2015. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
On  Dec 1st, the patient experienced soreness at the injection site.  On Dec 2nd, the pain ran down her arm and caused fingers to tingle.  On Dec 2/3 she experiences body aches, fever and chills.  On dec 6 at about 1am, she experienced a rash on her arm.
Patient called 1-14-2010 and stated that he developed a rash after the H1N1 vaccination.  He was given the shot in the left deltoid, but the rash appeared on the right deltoid.  He had no problems breathing.  He was instructed to take some Benadryl and use some calamine lotion.  On 1-16-2010 a follow-up call was made to patient.  He stated the rash was almost gone and that he felt fine.
This spontaneous prospective pregnancy report was received from a Registered Nurse via company representative regarding a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous (Dose strength and lot number was unknown). No concomitant medication was reported. It was reported that the patient was pregnant (exposure during pregnancy). The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient experienced redness and swelling at injection site. No product quality complaint (PQC) was involved. Patient did not seek any medical attention. It was reported that the therapy was not reintroduced. The pregnancy outcome was unknown. The outcome of redness and swelling at injection site was reported as recovering. Causality between Redness and Swelling at injection site and ZOSTAVAX was unknown. Additional information is not expected because we cannot contact physician.
Nausea and dizzy right away. Stayed at the pharmacy for 20 mins. Within and hour of receiving the vaccine I was wheezing,  SOB, hives on my hands and heart rate was going from 159 to 55. I had to lay down due to extreme nausea and the above symptoms. Hives went away in an hour. Other symptoms reduced by the next day. I'm still wheezing and SOB at times. Seeked triage and urgent care at my DR office following days. 1 week later,  prescribed steroid inhaler. Still feel very sick with nausea and dizziness. Swollen lymph nodes around my body.
Patient reported a rash that started on the opposite arm from the vaccination (right arm) 2 days after receiving the vaccine. The rash then showed up on the arm where she received the vaccine 3 days after receiving the vaccine. It was slightly itchy, but not warm to the touch, and not painful. It didn't interrupt her sleep. It was in the elbow area of her arm.
AFTER RECEIVING PFIZER COVID 19  VACCINE, PATIENT SAT DOWN. HE THREW UP. HE SAID HE BLACKED OUT FOR A BRIEF MOMENT. HE WAS ALWAYS SEATED. THE LADY WITH HIM VERIFIED WHAT HE SAID. HE THEN SAID HE FELT DIZZY. HE DRANK WATER AND SOME SODA HE BROUGHT WITH HIM. WE CALLED 911, EMS CHECKED HIM OUT. HE REFUSED TO GO WITH EMS/AMBULANCE AND SAID HE WAS FINE. HE SAT FOR A WHILE , HIS OTHER MEMBERS OF HIS FAMILY CAME AND HE WALKED OUT OF THE STORE WITH THEM UNAIDED.
pt devel redness & swelling around neck & puffiness around eyes;no SOB;improved w/oral DPH;
I can't lift my left arm without excruciating pain from neck down to fingers; I can't lift my left arm without excruciating pain from neck down to fingers; could not feel left arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced could not feel left arm and I can't lift my left arm without excruciating pain from neck down to fingers.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 on 25 Jan 2021 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Patient received the vaccine on 25 Jan 2021, in left arm. Four hours after dose, she stated, I could not feel left arm all the way up to her neck'. It was twelve-thirty-one pm (post-meridiam) and patient stated, I can't lift my arm without excruciating pain from neck down to fingers'. No further information was reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event could not feel left arm was unknown. The outcome of the event I can't lift my left arm without excruciating pain from neck down to fingers was not resolved.  The reporter did not provide an assessment for the events, could not feel left arm and I can't lift my left arm without excruciating pain from neck down to fingers.
Patient states that soreness began a few days after vaccination. She states that soreness persists three weeks after vaccination. Patient states that she has difficulty sleeping due to soreness.
patient who got the Pfizer vaccine 22DEC2020 got the Moderna vaccine today 13JAN2021; A spontaneous report was received from a professional concerning a 48-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who got the Pfizer vaccine 22 Dec 2020 got the Moderna vaccine today 13 Jan 2021.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 22 Dec 2020, the patient received the Pfizer COVID-19 vaccine for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient received mRNA-1273 (Lot number 029L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced receiving the Moderna vaccine after receiving the Pfizer vaccine.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event patient who got the Pfizer vaccine 22 Dec 2020 got the Moderna vaccine today 13 Jan 2021 was not reported.; Reporter's Comments: This case concerns a 48-year-old female patient who received their first of two planned doses of Pfizer COVID-19 vaccine and second of two planned doses of mRNA-1273 (Lot number 029L20A), reporting Wrong product administered.
It appears that each time I received the COVID vaccine my rate of blood dropped to near normal.; It appears that each time I received the COVID vaccine my rate of blood dropped to near normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "polycythemia vera" (unspecified if ongoing), notes: I have polycythemia vera which causes me to generate large quantities of, red blood cells. The patient's concomitant medications were not reported. The following information was reported: FULL BLOOD COUNT NORMAL (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown" and all described as "It appears that each time I received the COVID vaccine my rate of blood dropped to near normal.". The patient underwent the following laboratory tests and procedures: blood test: near normal, notes: my rate of blood dropped to near normal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 12-NOV-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot#, dose and route were not reported). Then the second dose of the series was GARDASIL administered on 13-JAN-2016 (lot#, dose and route were not reported) and the last dose of the series was GARDASIL 9 administered on 23-JUL-2016 (lot#, dose and route were not reported) (interchange of vaccine products). No adverse effect was reported. Additional information has been requested.
Developed diarrhea which lasted  nearly 3 months and resulted in over 12 lbs. weight loss. All infectious testing was negative. Symptoms resolved after weeks of treatment with Imodium and Pepto-Bismol.