chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jul2022) Negative, notes: Negative antigen on 28Jul; (unspecified date) Positive, notes: indication: Covid-19 treatment; (29Jul2022) Positive, notes: Then tested on 29Jul which was positive and return of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. It was unknown if patient had received any other medication in two weeks. Patient had received paxlovid from 13Jul2022 as a COVID 19 Treatment. After 2 days post Paxlovid, symptoms back and worse. Started 2nd pack of Paxlovid which finished on 25Jul2022. Negative antigen on 28Jul. Then tested on 29Jul which was positive and return of symptoms. 2nd rebound. This was causing Covid to last now over 20 days of loss of work and health.  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 available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of LOE.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 10-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-NOV-2015, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported). Later on the same day, the patient experienced injection site itching. The reporter noted that no rash had developed. The patient sought medical attention (spoke to the reporting pharmacist). The outcome of injection site itching was reported as not recovered. The relatedness between the adverse event and the suspect vaccine was not reported. Additional information has been requested.
Patient got shot on 1/7/20. On 1/10/20, they came in pharmacy, saying that on 1/8, their arm swelled up, got red and itchy. Since evening of 1/9, it has gone down, much better by 1/10. No systemic reactions. Told patient to let Dr know if it doesn't continue to get better.
Slight soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Slight soreness) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Slight soreness). At the time of the report, PAIN (Slight soreness) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Case number PHEH2014US002786, is an initial spontaneous  report received from a nurse on 04 FEB 2015. This report refers to an 11 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with TDAP (unknown manufacturer, batch number: not reported) on 04 FEB 2015. She was also inadvertently vaccinated with only Men A lyophilized component of MENVEO (batch number: M14042) reconstituted with normal saline instead of Men CWY liquid component intramuscularly on 04 FEB 2015. No adverse events reported after the maladministration (inappropriate preparation of medications.
Patient received the immunizations and was feeling strange when she approached the front of the store to leave she felt like she was going to fall. She was placed into a wheel chair and taken to the pharmacy where she was counseled by the Pharmacist on duty.
Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Lymph Node Swelling-Mild
Swelling, redness, tenderness (5cm). Only reacted to Varicella injection site.
HIVES AT INJECTION SITE.  HIVES SPREAD TO CHEST, NECK, AND FACE WITHIN 5 MINUTES.  PT C/O TINGLING IN HANDS AND FEET.
A non-serious spontaneous report of Flu-like symptoms has been received from a consumer/mother concerning her 43-month-old daughter, subsequent to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's past medical history and concomitant medications were not reported. About two months ago in approximately September 2009, the patient received FLUMIST. The same night after the vaccine was administered, the patient experienced a fever and other mild flu-like symptoms. The event resolved within 24 hours of onset. Required follow up attempts have been performed, requested information unable to be obtained.  23-Feb-2010.
BODY CHILL, BODY ACHE, SHORTNESS OF BREATH, AND FEVER FOR 5 DAYS.
On 1-24-14 mom called and then came to clinic. The PROQUAD was given left leg. The area where given was red, hard and swollen the size of a 50 cent piece.
84 Years  old male who received the Moderna vaccine 1 day ago. It is his 4th dose of the Moderna Vaccine per the patient and wife. Pt is experiencing body pain and fever.
This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in a patient who received BEXSERO (batch number 16D501, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced adverse reaction, injection site pain, injection site erythema, fever and injection site swelling. On an unknown date, the outcome of the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling were unknown. It was unknown if the reporter considered the adverse reaction, injection site pain, injection site erythema, fever and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site pain, redness, swelling, and fever were beyond typical reactions the reporter had seen in the past and with other products. The reporter stated that, they noticed that it stems from Lot 16D501 from the Vaccines for Children (VFC) program. At the time of this report the reporter was choosing to not use BEXSERO until they receive further information from VFC program and manufacturer medical team. The reporter agreed to be followed up. This is 1 of the 8 cases (8 out of 20 patients reported adverse reactions) reported by same reporter for same event.
Rash, Fever - Information has been received from a registered nurse concerning a 2 year old female patient who on 01 Apr 1999 was vaccinated with one dose of varicella virus vaccine live.  These were no concomitant medications or known allergies.  On 24 May 2000 the patient broke out with 30-50 pruritic lesions and experienced a fever of 101 degrees fahrenhelt.  unspecified medical attention was sought.
Suspected vaccination failure; I had the shot and still got Shingles.; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient stated that, it was horrible. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
infant (4 weeks old) had vomiting and diarrhea after breastfeeding after vaccine; infant (4 weeks old) had vomiting and diarrhea after breastfeeding after vaccine; infant (4 weeks old) had vomiting and diarrhea after breastfeeding after vaccine; This is a spontaneous report from a non-contactable consumer (patient's mother). This consumer reported information for both mother and baby. This is a baby report. A 4-weeks-old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and lot number was not reported), via transmammary on an unspecified date as dose unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient was infant (4 weeks old) had vomiting and diarrhea after breastfeeding after vaccine on an unspecified date. The patient mother (age: 35-year-old) was breastfeeding. The outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021831986 Maternal case
I had scratchy throat, that caused me to constantly clear my throat. On Sunday I was extremely fatigued, slept through most of the game. On Monday I woke up and felt like I had an elephant sitting on my head. I decided to take home COVID-19 that came back positive, I waited a bit and took another test another test and it was also positive. I waited to call the telehealth doctor; he called in a prescription for Ibuprofen 800mg. It took me two weeks to recover. I am back to myself now.
Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe, Systemic: Unable to Sleep-Severe, Systemic: Visual Changes/Disturbances-Medium
She stated that he had the virus and got over it.; This is a spontaneous report from a non-contactable consumer via a medical information team. A male patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. She was calling on behalf of her boyfriend. On an unspecified date, she stated that he had the virus and got over it. He got his first dose of the Pfizer vaccine. Can he get tested again for COVID-19 infection? Referred back to her boyfriend's HCP for recommendations on getting tested for COVID-19. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient came to pharmacy to receive COVID19 (Pfizer-BioNTech Bivalent). A vial of regular COVID19 (Pfizer-BioNTech) was used when technician drew up the vaccine. The pharmacist did not realize the new vial used was not the bivalent formulation. This was mistakenly injected in place of the bivalent formulation. Patient and guardian contacted and aware per CDC guidance patient to return after 2 months for COVID19 (Pfizer-BioNTech Bivalent).
Case number PHEH2014US024338, is an initial spontaneous report from a nurse received on 02 Dec 2014 and with follow-up from a nurse received on 19 Jan 2015. This report refers to a 71-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN, (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 17 Nov 2014. THe nurse reported that FLUVIRIN prefilled syringe stored at 49 F for 1 hour and 15 minutes was administered to the patient. No adverse event reported following this medication error (incorrect storage of drug). Follow-up from a nurse received on 19 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
On 12/17/08 patient presented as a new patient and I found she was under immunized needing one polio and two tetanus boosters. I elected to give her KINRIX followed in 6 months by ADACEL. I did no know then KINRIX was limited to <7.
Approximately 6 minutes after receiving the Tdap vaccine in left arm, patient had difficulty breathing and felt dizzy, nauseous, and light headed. I layed her down on the floor and wiped her face and neck down with a damp cloth. After a few minutes, she was helped into a wheel chair and taken to a room where she layed down. The Dr and nurse took her blood pressure twice and told me she was fine. Around her lips were still blue and the Dr told her she needed to lay down for a few more minutes. She had pain and soreness from her neck down her left arm and to her pointer finger. She was very sick of her stomach. I gave her a piece of ice and she felt better. We left about 10 minutes later, and she developed a headache, more nausea, chills and cried from the constant pain in her neck and arm. I gave her Advil. The next day she still had the pain in her neck and arm, and also diarrhea, headache, fatigue, chills, and loss of appetite. This lasted for 2 days.
Three days of high fever (102, 103 and 103.9) with severe body aches, headaches and chills lasted 30 minutes, relieved after taking naproxen.
A report was received from a healthcare professional on 10/23/2003 concerning an 8 month old female vaccinee who inadvertently received Fluvirin on 10/07/2003.On 10/07/2003 the vaccinee who was less than 4 years of age inadvertently received Fluvirin. No adverse event had occurred at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
No adverse effects reported; the patient was administered the first dose of GARDASIL 9 on 20-SEP-2018 and then the second dose of GARDASIL 9 on 26-DEC-2019; This spontaneous report was received from a pharmacist referring to a 23-year-old female patient. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not provided.  On 26-DEC-2019, the patient was vaccinated with  first dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), then on 26-DEC-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (concentration, route and anatomical location, lot number and expiration date were not reported) as prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Information has been received from a physician concerning a 17 year old female who on 01-DEC-2006 was vaccinated with the first dose of Gardasil. IM. Concomitant medication was not reported. In February 2007, the patient went to the physician's office for the second dose of Gardasil but the patient had a fever and was sick, so the second dose was not given. On 20-MAR-2007, the patient received the second dose of Gardasil. Subsequently on an unspecified date, the patient recovered from the events. The causality of the events was not reported. Additional information has been requested.
swollen gland under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen gland under arm".  Additional information: Her husband's experience with the Covid 19 vaccine, she mentioned that two other guys her husband went with on the same day to get their Covid 19 vaccines, had the same problem with a swollen gland under their arm. She had no further information regarding the guys that received their Covid 19 vaccine with her husband.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
short of breath for years that got worst with Regen-Cov a few days after taking this; received the 1st dose of the Pfizer COVID 19 Vaccine on 03Aug2021 and tested positive for COVID-19 on 09Aug2021.; This is a spontaneous report from a contactable consumer (patient himself) via from a Pfizer sponsored program. A 64-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: FC3183), via an unspecified route of administration, administered in left arm on 03Aug2021 (age at vaccination: 64 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included ongoing dyspnoea, pleurisy in early to middle 70s , pneumonia aspiration. The patient's concomitant medications were not reported. On 09Aug2021, the patient experienced received the 1st dose of the pfizer covid 19 vaccine on 03aug2021 and tested positive for covid-19 on 09aug2021, short of breath for years that got worst with regen-cov a few days after taking vaccine. On 09Aug2021, the patient underwent lab tests and procedures which included sars-cov-2 test which was positive and on 21Sep2021 sars-cov-2 test was negative. The patient received Regeneron for treatment of his COVID-19. He was suppose to receive his second dose of the vaccine on 24Sep2021 (tomorrow). The patient was prescribed two other medications of an antibiotic and steroid. The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTBLE lot FC3183 was investigated. The investigation included reviewing, manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of covid-19 was recovered 21Sep2021 and dyspnoea was not recovered.  Follow-up attempts are completed. No further information is expected.
chest tightness, watery eyes, congestion, cough, malaise w/in hr of vax 3PM f/u cont coughing since vax recv;will see own MD for addtl f/u;
Initial information received on 12-Feb-2019 regarding an unsolicited valid serious case received from an other health professional (medical assistant) via other company (Pfizer) under reference number: 2018203708. This case involves a female patient of unknown age who passed out after she received vaccines MENACTRA and TRUMENBA. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 04-May-2018, the patient received a dose of suspects MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848AA and TRUMENBA lot S56026 via unknown route (both vaccines in the left arm). On 04-May-2018, the patient passed out (loss of consciousness) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and TRUMENBA. This event was assessed as medically significant (IME). The patient was taken via ambulance to the emergency room. Other relevant tests included: urinalysis, urinalysis for pregnancy, Basic metabolic panel (BMP) and Complete blood count (CBC), with results that showed "glucose of 124, platelets 101 and neutrophils 8.9". Final diagnosis was loss of consciousness. It was not reported if the patient received a corrective treatment. The patient outcome was not reported. (reported that patient was observed in the emergency room and was discharged). List of documents held by sender: none.; Sender's Comments: Sanofi Company Comment on 18-Feb-2019: A female patient of unknown age presented loss of consciousness same day after vaccination with MENACTRA and TRUMENBA. Time to onset is compatible with the role of vaccine. Basic metabolic panel (BMP) and Complete blood count (CBC) along with other laboratory testes were performed without any significant finding. Further information including patient's medical history, concomitant medications, previous vaccination and tolerance, lab test excluding other etiology would be needed to fully assess this case. Moreover, concomitant administration of two vaccines preceded the event. Based on available information the role of individual vaccine cannot be assessed.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 25-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) with lot number: L007230, expiry date: 03-SEP-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.