chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fever of 100.5-98.8; Nausea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm), CHILLS (Chills), PYREXIA (Fever of 100.5-98.8) and NAUSEA (Nausea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer. Concomitant products included RIVAROXABAN (XARELTO) and IRON for an unknown indication.   On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore arm), PYREXIA (Fever of 100.5-98.8) and NAUSEA (Nausea). On an unknown date, the patient experienced CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (Sore arm), CHILLS (Chills), PYREXIA (Fever of 100.5-98.8) and NAUSEA (Nausea) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-089192 (Patient Link).
diarrhea; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 25Jan2021 09:15 (Lot number: EL9261) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, administration date: 04Jan2021, for Covid-19 immunisation, reaction(s): "Joint pain", "GI Symptoms", "Headache", "Muscle ache", "Temperature of 102.9", "chills", "Nausea", "Dry cough", "Fatigue". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  No follow-up attempts are possible. No further information is expected.  Additional information; The patient provide information to you regarding the reported adverse event(s) with the use of the product Yes, I am the patient If  yes above, do you consider the Pfizer product had a causal effect to the adverse event Yes  Pfizer-BioNTech Covid-19 Vaccine Anaphylactic Reaction Data Capture Aid. AER/Manufacturer Report  (Reference number withheld)  AER/Manufacturer Report (Reference number withheld). Reported event term prompting special follow-up activities: Dry cough Reported  Details, Dry cough after onsets symptoms from vaccine it lasted 24 degree Cardiovascular: Yes  Vomiting: Yes 1st Injection lasted start 24-48 degree finish, 2nd injection lasted start 12 -96 degree finish.  The patient was taking any medications prior to the event being reported: Yes (Ocella OCP).The patient did not receive any recent vaccines for any other conditions prior to the event being reported, The patient did not receive any recent vaccines for SARs-CoV2 other than Pfizer-BioNtech Covid-19 Vaccine prior to the event being reported, The patient  has not been received any other vaccines around the time of Pfizer-BioNtech Covid-19 Vaccine Vaccination.
After getting the first shot, she fell/she fell and was in the hospital and two nursing homes; was scared to death to get the second vaccine; This is a spontaneous report from a contactable consumer (Patient). A 85-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0150), via an unspecified route of administration on 12May2021 (at the age of 85-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation, CHF. The patient's concomitant medications were not reported. On 12May2021, the patient after getting the first shot, fell/she fell and was in the hospital and two nursing homes. On an unspecified date, first dose 12May2021, 98 days after first dose. After getting the first shot, she fell, and was in the nursing home. She thought they would give her second dose there, but they did not,  said she was scared to death to get the second vaccine. Caller stated she should have had her second vaccine on 02Jun2021. Caller asked about booster dose and if she would need that, if it is recommended for her to now get the second vaccine. Patient was hospitalized for event. The clinical outcome of event was unknown.
Information has been received from a mother concerning her 26 year old daughter with no pertinent medical history and no drug reaction allergies who in last May or June 2007 was vaccinated with the first dose of GARDASIL (Lot # not provided), in August 2007 was vaccinated with the second dose of GARDASIL (Lot # Not provided) and in November 2007 with the third dose of GARDASIL (Lot # not provided). Concomitant therapy included hormonal contraceptives (unspecified). The mother reported that in December 2007, the patient developed warts on her foot and she started to experience difficulty in breathing and tightening of the chest this year and on 13-JUN-2008, she was hospitalized for 4 days. The mother noted that the patient was placed on warfarin sodium (manufacturer not provided) that she needs to take for 6 months. Patient still has clots on her lungs. On an unspecified date, a full coagulation panel was performed (results not provided). Additional information has been requested.  07/23/2008 MR received for DOS 6/5-7/2008 with D/C DX:  Acute Bilateral Pulmonary Emboli.  Oral Contraceptives.  Possible Family hx of thrombophilia.  Pleuritic pain 2' to acute PE. Pt presented with increasing SOB x 1 week, inability to run usual distance 2' to SOB, recent onset of R-sided back and posterior thorax pain and R axilla pain. Recent calf pain. PE (+) for mild crackles R lung base, anxiety and tearfulness r/t dx. Significant pleuritic pain. Started on Heparin then Coumadin and switched to Arixtra for outpt use. D/C BCPs. Seen in ER on 6/14/08 with DX: Hematoma in SubQ tissue (at Arixtra injection site).
unable to see out of her left eye (pt is blind in the right eye due to macular degeneration)
Severe erythema in the left arm (injection arm), complicated with blisters and heat.
Patient describes swelling (hemotoma) at the site of injection 8 days after recieving the Prevnar 20 shot.
This spontaneous report was received from a Registered nurse regarding a 14 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
REDNESS DESCENDING DOWN ARM TOWARD ELBOW, SWELLING, HARDNESS, AND PAIN. BEGAN THE EVENING OF 10/15/18.
Feeling hot/chills about 10 hours after administration Fatigue and headache for 3 days , gradually improving
Summary narrative including initial information received from healthcare professional on 14 June 2012 and follow-up information received on 17 September 2012. A 4-month-old male patient with no reported medical history and concomitant medications received intramuscular DAPTACEL (batch number: unk) in the right thigh on an unspecified date (1 month ago). On an unspecified date, the patient developed injection site redness. The treatment medications were not reported. The lab investigations were none. The event of injection site redness resolved in 2 days. Documents held by sender: none.
rash on different parts of her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on different parts of her body) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer, Blood pressure abnormal, Blood cholesterol abnormal and Thyroid disorder. Concomitant products included TAMOXIFEN for Breast cancer.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH (rash on different parts of her body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Rash, at a dose of UNK dosage form, qd and TRIAMCINOLONE for Rash, at a dose of UNK dosage form, qd. At the time of the report, RASH (rash on different parts of her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included that on 11Mar2021 she started taking a 9 days treatment with steroids
Pain, red, swollen, "rash" keeps growing.  Doctor at URGENT CARE  prescribed cephalexin 500 mg capsule. (2 caps for 7 days).  Monday night it hurt, I took Tylenol and iced it.  Tuesday and Wednesday same thing and  it was pink. Thursday it was spreading down my arm and it was hot to the touch and red. Went to urgent care.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient with no medical history or drug allergies. On 10-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot#J001009, expire date: 24-APR-2014), subcutaneous injection, subcutaneous, 0.65 ml. Concomitant therapies included potassium chloride USP, tizanidine hydrochloride, furosemide, doxepin hydrochloride, folic acid, VIVELLE-DOT, SYNTHROID and acetaminophen, hydrocodone bitartrate and omeprazole. On 12-JUN-2013, the patient experienced swelling and redness that was 2x3 inches at the injection site and the area was very painful, mainly painful to the touch and "the pain has worsened in the last day". The patient had sought medical attention via phone call. No lab test was performed. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
welt formed on upper lip @ 2:37 PM; Took 2 Benadryl at 2:45 PM; Nose and cheeks became red and stiff shortly after, before 3pm; By 3:15 welt and other areas on face diminished.
MAJOR SWELLING, WARM TO TOUCH--  NO TREATMENT, RESOLVED WITHIN 48 HOURS.
no adverse reaction reported by patient, but was indicated to receive  one Covid19 vaccine NOT other, as her first dose lot# EN6201 expired 06-30-2021 given 2-18-2021.
07/10/22 - hives, stomach ache 07/11/2022 - fever, rashes, stomach ache, fatigue 07/12/2022  - low-grade fever, stomach ache, rashes 07/13/2022 - stomach ache, rashes  07/14/2022 - fever, fatigue, rashes Medications:  Children's Tylenol, Benadryl or Zyrtec, Pepto-bismol
Pfizer covid vaccine was held in freezer past beyond use date, and administered. expired 6/15, given 6/19
not received 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-OCT-2023 A pharmacist reported that a female patient received the 1st dose of Shingrix several years ago and was late for the 2nd dose. The reporter consented to follow up. The Healthcare professional did not have exact vaccination details of initial dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The Healthcare professional consented to follow up via email.
Patient received zostavax on 7/9/08. Patient developed a itchy area left side of abdomen 2 days after injection.  Then a vesicle red rash appeared 2 days later.  The rash is painful when scratched.  Patient came into clinic 7/22/08 and a diagnosis of shingles was made.
Pt was given a DTaP instead of Tdap. Spoke w/ Health Dep't and was told this would be OK.
A report has been received from a Physician concerning a 66 year old, male subject, who had been receiving FLUMIST (INTRANASAL). The patient's medical history included CHEMOTHERAPY. The patient's concurrent disease(s) included CANCER, DIABETIC and HYPERTENSION. FLUMIST (INTRANASAL) started on 08-Jan-2014. The patient experienced no AE, only inadvertent administration of vaccine. FLUMIST was discontinued on 08-Jan-2014. The outcome of the event of NO AE, ONLY INADVERTENT ADMINISTRATION is unknown. The report was considered to be non-serious.
A rash the size of my open hand at site for about 7 days, body aches (both my husband and I were out of it for 4-5 days). We are retired, never had a reaction from any shots like this. My husband and I both had reactions. Got over them in several days. Our concern is we are suppose to take 2nd shot 10/17 or later or it does not help. My hx I had chicken pox as child, shingles in my 30's. I am the one that got a larger rash where the injection was given. Do we get the 2nd shot?
Patient with near synacopal episode cool/clammy/pale/weak with loss of consciousness with vaccine admin - eval by MD. EKG 02 Sat food given - upset during vacc  poor po intake this AM before Rx.
Dizziness and nausea; rest and sips of juice; calming breathing exercise to prevent hyperventilation (pt had tingling fingers).  All sxs improved.  Pt's mother did not want to call 911.  EpiPen was available but was not needed
Shortly after receiving the flu vaccine, the client complained of dizziness and weakness. She was advised to sit with her feet up and given an orange. Symptoms not resolve and client then stated she had facial numbness and ringing in ears. Pulse was 84, capillary refill less than 3 seconds. Client became cold and pale, and complained of numbness in throat so EMS was called. While waiting for EMS to arrive, client stated she was having difficulty breathing and had rapid shallow respirations which seemed to resolve when EMS arrived. EMS reported good pulse and BP at site. Client was transported to ED.
Injection site began to itch/swell within 2 hours of shot. By end of day, the swelling increased, was hot to the touch, red and the injection location turned to a hard bump about the size of a quarter and it hurt to touch it. Looks like a bee sting at the injection site. Over the next several days, the swelling expanded to a few inchess and continued to itch. I had a scheduled doctor appointment the following day for an annual physical and the doctor said it appears to be an allergic reaction and to take Benadryl. On Sunday, four days after the shot, I saw another physician who is treating me, following unconfirmed COVID in 2020 (testing was not available at the time), which was attributed to reactivating EBV.
Systemic: Fainting / Unresponsive-Medium, Additional Details: AFTER giving the vaccine, his mother told me he has vasovagel syndrome and she was expecting him to faint afterwards.
Patient suffered a stroke 4 days after he got the Pfizer Bivalent vaccine. Started on 10/23/22 with dizziness, felt like it may be vertigo, had had cataract surgery a week earlier. He had spoke with the ophthalmologist who did the surgery and a physical therapist to rule out vertigo. Next day went to ER, they did not do an MRI so couldn't tell if it was a stroke. He then went to Hospital and did MRI 2 days later. They also missed reading it as a stroke. Results were then sent to neuro-ophthalmologist and confirmed as stroke on 10/26/22 in cranial nerve 4 and 6.
The Patient was known to be pregnant prior to having the vaccines; inadvertently administered properly stored VARIVAX  (lot R029519 & expiration date 10/14/2020 and properly stored M-M-R Il; This spontaneous prospective pregnancy report was received from a nurse regarding a 40-year-old female patient. The patient's medical history and concomitant medications was unknown. The patient's concurrent condition included diabetes. The patient did not have any drug allergy or drug reaction. The patient was pregnant and last menstrual period was approximately on August 2019.   On 06-SEP-2019, the patient was inadvertently vaccinated with properly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R029519, Expiration date:14-OCT-2020), rubella (wistar ra 27-3) virus vaccine, live, recombinant human albumin (rHa) (M-M-R II) lot No. R010713 has been verified to be a valid lot number, expiration date reported as 12-APR-2020, but upon internal validation established as 11-APR-2020 (strength, dose number, dose, anatomical location were not reported) subcutaneously for prophylaxis use (reported as immigration purposes) (contraindicated product administered). Both vaccines were reconstituted with properly stored sterile diluent. Other suspect therapy included insulin. The patient was known to pregnant prior to administration of the vaccines (exposure during pregnancy). The gestation period at exposure was at 5 weeks. On an unknown date in September 2019, a Quanti feron- Tuberculosis (TB) gold test was performed and the result was unknown. The patient did not seek medical attention and no treatment was given for adverse events. The Estimated Date of Delivery (EDD) was unknown. The pregnancy outcome was pending. The fetal outcome was unknown. No product quality complaints (PQC) were involved.
Information has been received from a nurse concerning a 10 year old female who on 31-MAR-1998 was vaccinated with one dose of COMVAX (MSD) (lot # 623436/1176E). There was no concomitant medication. On 04-AUG-1998 the patient was vaccinated with COMVAX. Concomitant vaccinations included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, and poliovirus vaccine inactivated (unspecified). Subsequently, the patient was tested for Hepatitis B and Hepatitis C titers. The results came back as non-reactive. No other details were provided. Patient outcome was not reported. Additional information has been requested.
Soreness in left arm, chills, tongue and lips numb and z right side of face paralyzed.