chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dose #5: Moderna/ Dose #6: Pfizer; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 14:00 as dose 1, single (Lot number: HG4628) at the age of 72 years, in left arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Moderna, start date: 07Aug2023, stop date: 07Aug2023, for Covid-19 Immunization, notes: DOSE 5, SINGLE, Vaccine administration date- 07Aug2023,, Vaccine administration time- 03:00 PM,, Vaccine lot number- AS7647B,, Vaccine location- Left arm; Covid-19 vaccine, start date: 07Aug2023, stop date: 07Aug2023, for Covid-19 Immunization, notes: DOSE 4, SINGLE; Manufacturer unknown; Covid-19 vaccine for Covid-19 Immunization, notes: DOSE 3, SINGLE; Manufacturer unknown; Covid-19 vaccine for Covid-19 Immunization, notes: DOSE 2, SINGLE; Manufacturer unknown; Covid-19 vaccine for Covid-19 Immunization, notes: DOSE 1, SINGLE; Manufacturer unknown. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose #5: Moderna/ Dose #6: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received any other medication in 2week. Patient received treatment for COVID 19 with Paxlovid. Treatment start date was 21Oct2023 and Treatment stop date was 25Oct2023.  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 concerning two male patients who on 17-JUN-2009 were subcutaneously vaccinated with PNEUMOVAX 23. Subsequently the patients developed cellulitis in the injection arm. The patients were seen on 20-JUN-2009 and the diagnosis was confirmed. The patients were not recovered at the time of reporting. Follow-up information was received from the pharmacist. The pharmacist provided the lot number 662840/1577X but clearly stated that after talking to her supervisor, the name of the patient would not be provided. This is one of several reports from the same source. No further information was available.
Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Unknown if patient experienced adverse effects 2-13 or 2-14, patient called facility 2-15 reporting body aches and chest pressure and was told by facility to seek medical attention, she passed later that day
female with no significant past medical history who presented with chest pain, fatigue, nausea, vomiting, dyspnea.  Grandmother tested positive for COVID 1 week ago, patient is vaccinated.  Went to UC for COVID test, which was negative.  Found incidentally on labs to have profound thrombocytopenia, so patient was transferred to ED.  Had 4-6 schistocytes on CBC, given 1u RBCs and 2u FFP.  Given methylprednisolone, consulted and transferred to UMMC MICU
Had IPV, flu and PCV 7, 4 days prior to being S/B MD, developed rash on 10/14 on feet and hives on face as well as small bumps on chin. Hives noted by doctor on primarily face and neck, trunk rash sporadic, several hives on right arm were noted. Treated with Benadryl 3/4-1 tsp every six hours prn. Call if any respiratory sxs or edema. Do not give second flu.
I became pregnant following my second covid vaccine shot and suffered a miscarriage and lost the pregnancy at 6 weeks in June
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # N000326 with expiration date on 14-OCT-2019. Administered doses of vaccines underwent following temperature excursions: twice an excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit, which each lasted for 12 hours and ten excursions from 32 degrees Fahrenheit to 35 degrees Fahrenheit, which each lasted for 12 hours (total timeframe of excursions was 144 hours). A digital data logger was involved in recording the excursions. No adverse effects were reported. Product quality complaint was not involved. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1708USA011556: US-009507513-1708USA008052.
Pt received HPV #1 3/17/12 and AVA#4 on 4/3/12. LMP (light) was sometime between 25 Feb12. The pt has a history of irregular menses. She uses condoms for birth control (not consistently). On the pt demonstrated how to perform a home pregnancy test for a friend which was positive. The pt repeated the home pregnancy test 4 more times which were all positive. The pt was given TAD orders off the ship on 4/13/12. The pt contacted the center on 4/19/12 and desired pregnancy follow-up.
This is a spontaneous report from a contactable nurse. A 12-week-old male patient of an unspecified ethnicity received PREVNAR 13 (NDC number 0005197102, Lot# S15257, Expiry date: 01Sep2018), intramuscular on 11Dec2017 at 0.5 ml, single for child immunization schedules. Medical history were none. Concomitant medication included VITAMIN D Drops as supplement. The patient experienced brief resolved unexplained events in an infant, basically stopped breathing on 12Dec2017. He was given the vaccine on 11Dec2017 and then the following day, the patient went to the ER for basically stopped breathing. It just happened that one time. No treatment received. He had not received any additional doses of pneumococcal 13-val conj vac (dipht crm197 protein). The outcome was recovered.
back pain; muscle tightness in his shoulder; pain in his leg; pain in his arm; he can't move his neck; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), MUSCLE TIGHTNESS (muscle tightness in his shoulder), PAIN IN EXTREMITY (pain in his leg), PAIN IN EXTREMITY (pain in his arm) and MOVEMENT DISORDER (he can't move his neck) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced BACK PAIN (back pain), MUSCLE TIGHTNESS (muscle tightness in his shoulder), PAIN IN EXTREMITY (pain in his leg), PAIN IN EXTREMITY (pain in his arm) and MOVEMENT DISORDER (he can't move his neck). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, BACK PAIN (back pain), MUSCLE TIGHTNESS (muscle tightness in his shoulder), PAIN IN EXTREMITY (pain in his leg), PAIN IN EXTREMITY (pain in his arm) and MOVEMENT DISORDER (he can't move his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Left arm red/ swollen and warm to touch. No Primary Care Provider,  child had fever. Mom gave Ibuprofen/Tylenol and cool shower. Fever gone arm still swollen.
SLEEP RELATED HYPOVENTILATION OR HYPOXEMIA CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 11/8/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Rebound of symptoms after completing Paxlovid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound of symptoms after completing Paxlovid) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L2A, 034F21a, 006B21A and 010A21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Lupus syndrome, Rheumatoid arthritis, Blood pressure high and Seasonal allergy. Concomitant products included HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), NIFEDIPINE, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and LISINOPRIL for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021 at 11:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022 at 11:00 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 10-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Rebound of symptoms after completing Paxlovid). At the time of the report, COVID-19 (Rebound of symptoms after completing Paxlovid) had not resolved.            No concomitant medications was reported.  Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Patient was previously received a COVID-19 Vaccine.  No treatment medications were provided. Company comment: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious of COVID-19. The event occurred 19 days after administration of fourth dose of mRNA-1273. The initial two doses of mRNA-1273 were administered 13 months prior, the interval between the two doses is 27 days, the third dose of mRNA-1273 was administered 5 months prior. Details of clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 66-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 19 days after administration of fourth dose of mRNA-1273. The initial two doses of mRNA-1273 were administered 13 months prior, the interval between the two doses is 27 days, the third dose of mRNA-1273 was administered 5 months prior. Details of clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
when I got up Saturday morning (24 hours after I received my vaccine)  my head was spinning and I couldn't walk straight and almost fell. I ate and felt better but was still dizzy. I was queasy nauseous and I went back to sleep. when I woke up I felt better. On Sunday I felt better but still have dizzy spells. the nausea also comes and goes.
Hives began on 2/4/21 on bilateral thighs, progressed around legs and then on bilateral upper arms and right heel
8 days after the 2nd dose, I started to experience heart PVCs on a frequent basis (approximately 4 per minute)
A nurse reported that a 27 year old female did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The subject had no relevant medical history or concurrent conditions. There were no concurrent medications. The subject was administered her first series of Engerix B injections on 12/7/01, 1/13/02 and on 6/3/02. A titer, measured one to two months after completion of the series, was negative. The subject then received three additional injections. The dates were unspecified for the first and second injections; the third injection was administered on 1/22/03. A second titer, measured on an unspecified date, was negative.
fever & rash for 4 days onset 7 days post vax;ataxic gait 10 days post vax;
Pt complaining of feeling fever, weak with swollen lymph nodes. Exam revealed left occipital and submandibular node was tender. Patient was afebrile. Only treatment was Tylenol. Signs and Symptoms resolved by 02/04/2005.
local react w/redness, swelling & warmth rt leg; crying x 6 hrs;
At 1pm, pfizer vaccine was ready for diluent to be added post coming to room temperature. MA had diluent and step by step sheet infront of her. She mistakenly grabbed wrong syringe which was a 1ml syringe and proceeded to draw up 0.18 ml of diluent to mix with pfizer. (She should have used a 3ml syringe and drawn up 1.8 of diluent to be mixed with pfizer.)  She mixed the 0.18 of diluent with the pfizer and then drew up 0.3ml dose to deliver to pt. She gave to pt and pt sat in waiting area until time was up and then left the building. Lead RN was informed when another MA had gone to draw up a dose of pfizer and observed that there was an incorrect amount in vial to draw from since only one dose had been drawn from vial. Lead dug through garbage for diluent and was able to pull out 1.8ml of diluent from vial. This confirmed that only 0.18ml had been pulled to dilute vial. Confirmed with MA that she had grabbed wrong syringe and drew up wrong amo of diluent. Rest of vial was wasted as unusable. Pt was contacted and informed of error and discussed with pt potential for local and systemic adverse events. Pt instructed that if she encounters any difficulty breathing, heart concerns/CP/SOB, swelling etc that she is to report to the ER and let them know she received larger than intended dose of Pfizer.  Pt at time of call (45 minutes post vaccine) is asymptomatic, denies the above reactions. Verbalizes the importance to monitor for symptoms and report as needed. Lead RN informed provider as well. Lead RN to contact pt next day to see how she is feeling. pt encourage to also reach out if any significant symptoms occur.
Boostrix administered after temp excur; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number N254C, expiry date 23rd November 2023) for prophylaxis.   On 2nd March 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The reporter reported that Boostrix underwent above temperature excursion with high 67 Fahrenheit for 14 days and was administered to a patient, which let to Incorrect storage of drug. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. This is 1 of the 6 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022040251:Same reporter US-GLAXOSMITHKLINE-US2022040252:Same reporter US-GLAXOSMITHKLINE-US2022040254:Same reporter US-GLAXOSMITHKLINE-US2022040246:Same reporter US-GLAXOSMITHKLINE-US2022040248:Same reporter
PT reports she noticed itching and a rash  to left upper arm at injection site upon waking up on the 7th day after first Moderna dose.  Report the rash looked like pictures of "COVID arm" and was circular, raised, non-painful, and was darker at the border.  Similar to a ring/bullseye.   Further reports she noticed a similar rash and itching to right anterior thigh which developed ~ 2 days after the arm rash developed.  PT reports that ~2 days after that another itchy and similar rash developed on her right cheek of her face.  Reports the itching and rash went away after ~7-10 days from the time it first appeared.  Reports she applied OTC topical ointment and OTC topical Camphopheniq ointment.  Reports she also took OTC Aleve for comfort during period of rash.
pt recvd vax 11SEP95 & 20NOV95 pt had a neg titer;no further details were provided;
This spontaneous report was received from a nurse, who referred to multiple patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot# N000172 with expiration date: 10-JUN-2018, lot# M040267 with expiration date: 14-MAY-2018, lot# M040270 with expiration date: 29-APR-2018, lot# M038744 with expiration date: 26-APR-2018; route of administration defaulted to oral; dose and frequency were not reported) for prophylaxis. The vaccine underwent the temperature excursion of more than 47 Fahrenheit degrees (F) but less than 77 F for 4 hours, which was detected by a data logger. No previous temperature excursions were reported. No adverse effects were reported.  No product quality complaint (PQC) was involved. This is one of four reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA015585: US-009507513-1706USA002227: US-009507513-1706USA002229:
Subsequent to receiving vax, the pt experienced and unevaluable reaction. It is unknown if the pt was taking concomitant therapy and medical history was not provided. The caller refused to provide any additional information and therefore, additional information is unattainable.
This report was received from the investigator on 07 June 2010. A 31 year-old male subject with a history of elevated cholesterol received ACAM2000 (lot number not reported) on 18 February 2010. Fourteen days after vaccination, the subject was diagnosed with unspecified disease of the pericardium. On day 15, the subject was diagnosed with non-specific myocarditis and on day 18, the subject was diagnosed with acute pericarditis. On day 12 (02 March 2010), the subject had an abnormal electrocardiogram. On day 14 (04 March 2010), the subject had a Troponin I of 0.95 (abnormal). On day 15 (05 March 2010), the subject had a normal echocardiogram and an abnormal MRI of the heart. The outcome was not reported. Additional information will be requested from the investigator. There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Generalized flushing occurred approximately 3 hours after vaccine administration per RN in report called to myself.
This case was reported by a consumer and described the occurrence of injection site movement impairment in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of FLUARIX (details unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site movement impairment and injection site discoloration. At the time of reporting the outcome of the events was unspecified. No further information was provided. This case was also reported as a pharmaceutical product complaint. The consumer reported a personal adverse event following FLUARIX vaccination (see case ID A0863089A). The consumer also reported that 3 other subjects at the same hospital where they received the vaccination experienced the same events. This is case 1 of 3, see case IDs A0863114A and A0863115A for the other reports. Follow-up received 18 June 2010: QA analysis revealed the complaint to be unsubstantiated.
Soreness of the arm; Inappropriate route of vaccine administration(Implant); Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY, INCORRECT ROUTE OF PRODUCT ADMINISTRATION, CHILLS, and PYREXIA in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY, INCORRECT ROUTE OF PRODUCT ADMINISTRATION, CHILLS, and PYREXIA. At the time of the report, PAIN IN EXTREMITY, INCORRECT ROUTE OF PRODUCT ADMINISTRATION, CHILLS, and PYREXIA outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided. Sender's Comments: This report refers to a case of Product administration error  for mRNA-1273, lot # unknown with associated AEs (Soreness of the arm, Chills, Fever). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I got Pneumococcal & Tetanus at around 5: PM on Thursday , June 15, and at around 11:00 PM of the same day, I got a severe vaccine reaction ended up to emergency. I had lot of headache, stomach, vomiting, diarrhea, dizziness, fatigue, weakness, loss of memory and shot breathing. I lost 10 pounds in two days
FATIGUE Narrative: Patient reported fatigue after 2nd COVID vaccine dose to clinical pharmacist on 3/23/2021 during a DM follow-up appt. Second dose was given on 3/06/2021. No further details noted in chart.
Hives/rash starting in arm pit and abdominal areas day after shot. Spread to entire body within week after shot.
Patient stated she suffered a stroke about 1 week after getting the vaccine. The patient went to the hospital and was successfully treated. The patient is now on plavix and pravastatin for further prevention.
Had been having constipation (2-3 days) and diaheera(1-2) in repeated fashion.
Patient was given Pneumovax 3:30 PM 8/26 in office. Patient was taken to ER with temperature 101, chills, tremors, red and white areas on legs. Patient was admitted. Discharge Summary states Strep/ bacterial infection, urinary tract infection, pneumonia, dehydration, nausea and vomiting. msv
expired ACTHIB being administered to a patient with no reported adverse event; Initial information received on 23-May-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 39 years old male patient to whom expired acthib being administered to a patient with no reported adverse event while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine polysacch 23V (Pneumovax) for Immunisation.  On 23-May-2022, the patient received suspect HIB (PRP/T) vaccine at a dose of 0.5 ml total (lot UJ661AA , expiry date: 06-May-2022, form, strength: not reported) via intramuscular route in the left deltoid for immunisation.  On 23-May-2022, expired acthib being administered to a patient with no reported adverse event (expired product administered, latency: same day) following the administration of HIB (PRP/T) vaccine.  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 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.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Exhaustion / Lethargy-Medium, Additional Details: After patient's vaccine she developed a large red spot around her injection site. It is warm to the touch and hurts. It slowly got larger for a week and is still present after 12 days post-vaccine. It has now stopped spreading and patient is monitoring for any worsening side effects. She was told to seek medical attention if the rash gets any worse.