chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (his hand was hurting/ arm pain), ORAL HERPES (woke up with fever blisters on his mouth today), ERYTHEMA (His arm is still sore and red) and HEADACHE (headache. Headache felt like his brain was exploding) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037AA21B) for COVID-19 vaccination.  No medical history was provided by reporter. Concomitant products included CARBAMAZEPINE, LEVETIRACETAM (KEPPRA), PRAVASTATIN, FISH OIL and VITAMIN B [VITAMIN B NOS] for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (his hand was hurting/ arm pain) and ERYTHEMA (His arm is still sore and red). On 21-Mar-2021, the patient experienced HEADACHE (headache. Headache felt like his brain was exploding). On 22-Mar-2021, the patient experienced ORAL HERPES (woke up with fever blisters on his mouth today). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (his hand was hurting/ arm pain), ORAL HERPES (woke up with fever blisters on his mouth today), ERYTHEMA (His arm is still sore and red) and HEADACHE (headache. Headache felt like his brain was exploding) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I received my shot Friday morning, no problem, easy peasy....however, around 1:00 in the morning suddenly my arm hurt.  A bump appeared about the size of a mosquito bite.  On a scale of 1 to 10...a mild 1.  Arose Saturday morning and my shot site was a little more sore, still a 1, a medium 1.  Took a nap late Saturday afternoon and awoke at 6:30, poof, no pain no bump....just gone.  Put all of this up on social media and my peeps responded with a variety of reactions to Moderna and it was all mild, but a little different for everyone. No reaction on Pfizer vaccine.  Several of my peeps had received Pfizer and ......nothing.
COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0428B21A, 012M20A and 02BL20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Vibramycin and Arithromycin. Past adverse reactions to the above products included Allergy with Arithromycin and Vibramycin. Concurrent medical conditions included Diabetes and Cancer.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 infection) outcome was unknown.            No concomitant medication was provided by the reporter.  It was reported that on 31-May-2022 patient started  with nose stopping up and stuffy. Then patient had ulcers in mouth. Had trouble sleeping at night.The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment. The device date was reported as 04-Jun-2022.  Company Comment: This is a spontaneous case concerning  a  67-year-old, female patient with concurrent medical conditions of Diabetes and Cancer, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on an unknown day after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on August28, 2021. Patient was treated with nirmatrelvir and ritonavir from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. It was reported that on May 31, 2022,started  with nose stopping up and stuffy. The event was reported as resolving. The concurrent medical conditions of Diabetes and Cancer remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: This is a spontaneous case concerning  a  67-year-old, female patient with concurrent medical conditions of Diabetes and Cancer, who experienced the unexpected non-serious AESI event of Covid-19. The event occurred on an unknown day after the third dose of mRNA-1273 COVID 19 Vaccine which was administered on August28, 2021. Patient was treated with nirmatrelvir and ritonavir from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. It was reported that on May 31, 2022,started  with nose stopping up and stuffy. The event was reported as resolving. The concurrent medical conditions of Diabetes and Cancer remains a confounder. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
1002am- pt c/o dizziness and nausea.  pt starts to vomit and states that she cannot feel her feet and they feel heavy- she cannot lift her legs.  Two RN's with pt.  Called for doctor to assist. pt is alert to person, place and time 1005am-  BP- unable to obtain with BP machine.  called for manual cuff HR- 148 SA)2- 100% assisted pt to lay down on the floor on her left side.  pt continues to vomit. 1008am- V.O.Dr - give 1mg of epi IM now 1010am given R deltoid epi 1mg IM. by this nurse. HR 115 SAO2- 100% BP- still unalbe to obtain with BP machine. per Doctor pt with wheezing. pt continues to vomit V.O. Doctor give albuterol neb 2.5mg/3ml now unalbe to give abluterol neb as there was no plug outlet near pt. 1011am Ambulance called for transport to the ER 1014am pt states that she is feeling better.  no longer vomitting.  now denies dizziness.  pt states that she can feel her feet and can now llift her llegs.  pt has now moved from laying on her left side to her back.  per dr pts lungs are now clear with good air exhchange- no longer wheezing.  pt does have some lip swelling. pt remains alert to person, place and time V.O. DR Benadryl 25mg IM now 1015am given 25mg of Benadrul IM R deltoid. by this nurse. 1020am BP-168/104 with manual cuff HR- 75 SAO2 100% pt continues to state that she is feeling better.  no longer vomitting.   denies dizziness.  per dr  pts lungs continue to remain clear with good air exhchange. contacted pts daughter in law per pts request to inform her that the pt was being transported to the ER.  pt continues with some lip swelling.  pt is alert to person, place and time 1025am HR-72 SAO2-100% BP-168/104 with manual cuff HR- 75 pt continues to state that she is feeling better.  pt continues to deny dizziness and is no longer vomitting. Ambulance arrives and transports pt to the ER.
Fever of 102.5 for approximately 30 hours. Aches, pains, headaches, fatigue, loss of appetite and energy for 3 days. Missed 3 days of school.
A nurse reported that a 76 year old female received an injection of Tetanus Diphtheria Toxoids Adsorbed, Purogenated on 07/06/00, and subsequently developed an injection site reaction characterized by redness, soreness, and warmth. This is 1 of 2 patients from this facility who developed an injection site reaction following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Purogenated lot #471-637.
12pm Post vaccination reports tingling to lips w/slight swelling, and itchiness to neck, no rash noted; medical monitoring x 30 min, po hydration offered / consumed; BP150/98 P91 denies any additional complaints 12:30pm Reports symptoms resolve, BP 130/90 P88; released from facility w/selft
administered Adacel that were exposed to temperature excursions and not acceptable for use; Initial information received on 06-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA157616.  This case involves a 52 years old male patient who was administered with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot C5585AA, Exp date: 06-MAR-2020) that were exposed to temperature excursions and not acceptable for use.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is a actual medication error due to Incorrect product storage.  It was reported that 5 patients were administered Adacel that were exposed to temperature excursions and not acceptable for use.  It was not reported if the patient experienced any adverse event following vaccination.  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 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.  List of documents held by sender: none.
Patient received booster of Moderna (025ml) on 10/25/21. According to moderna website specific lot number has an exp of of 10/24/21. LOT 026C21A. I reached out to manufacturer for guidance if patient should receive an additional booster dose -still waiting on contact from manufacturer.
Patient got flu shot on 9-21-17. Patient called 10-11-17 with symptoms of painful arm that started the previous evening. Patient said it hurt to lift her arm above her head but was not red or warm to touch. Patient wanted to know if that was normal after receiving flu shot.
Information has been received on 23-MAR-2018 from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain condition of herpes zoster. On or about May 2016, the patient was treated at a prompt care and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I had a miscarriage at 4 months; Bell's palsy; This is a Spontaneous report received from a contactable other HCP (patient).  A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 intramuscular on 28Apr2021 (Batch/Lot number was not reported) age at vaccination of 27-years-old, as single dose, for covid-19 immunisation.  Medical history was none. No known allergies. The patient was not pregnant and was not pregnant at the time of vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unspecified date in 2021 (Batch/Lot number was not reported), age at vaccination of 27-years-old, as single dose, for covid-19 immunisation. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced miscarriage at 4 months on 26Jul2021 and bell's palsy on 26Jul2021; the events were serious as congenital anomaly. The events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included D&C (as reported), antiviral medicine and steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events were recovered with sequelae on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Miscarriage, Bell's palsy and suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Left arm large reddened area - advised to apply cool compresses and may take Tylenol for discomfort
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 29-MAY-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R024906 with expiration date 30-AUG-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Fast heart rate; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported she experienced a fast heart rate on an unknown date with the first dose of BNT162B2 and inquired if there was any information about that. The patient inquired how many people had reported this side effect and if anyone had died from it, further stating she was concerned about taking the second vaccine dose. The patient also inquired how protected she was from the first dose if she didn't take the second dose. The clinical outcome of fast heart rate was unknown.   No follow-up attempts are possible; information about the lot number cannot be obtained.
The patient claims to have received the J and J vaccine on 3/30.  He also claims it was his "second shot". He says he has felt ill since this shot, had an admission to the hospital and discharge for CHF.  On 4/15, admitted again with Bilateral pulmonary emboli. He says the only thing he has done differently is vaccine.
Screamed for 4 hours after receiving vaccine. Continued to cry during the night.  Temperature was 100.5 on 01/31/2002.
Involuntary muscle contractions of face, neck, shoulders, and limbs.  Started with small ticks and got progressively worse.  Came in waves for approximately 60 seconds with intense muscle contractions, body shaking, patient could not speak and it was difficult to breath during intense contraction periods.  When the intense wave would release, patient could speak and breath, but continued with less intense contractions.  Patient took 2mg oral Lorazepam and 20mg of dicyclomine.  Patient became functional within 20 minutes from taking medication and was able to walk out of the clinic with assistance to balance.  Patient continued to take 1mg Lorazepam at home as needed.
Systemic itchy rash - bumps. Gradual onset approximately 2 weeks after vaccine; continues to progress.
This spontaneous report was received from a registered nurse concerning on herself, a 78 year old female patient with high blood pressure, gastrooesophageal reflux disease (GERD), asthma, irritable bowel syndrome (IBS), diverticulosis, penicillin allergy and Guillain-Barre syndrome (diagnosed on an unspecified date, in about 1989 or 1990, after received an unspecified flu vaccine). The patient's medical history included leg weakness and a racing heart (in about 1989 or 1990, after received an unspecified flu vaccine, she recovered a few months later), stomach sickness, chills, fever and rubella rash all over her body (MARRS# 1511USA001618) and a burning sensation up the spine in about 2001 after taking the second dose of ciprofloxacin (manufacturer unknown). On an unspecified date, reported as "in the early 1990's", the patient was vaccinated with an unspecified dose of MERUVAX II, intramuscular injection (anatomical location, lot number and expiration date were not provided). On an unspecified date, in approximately October 2014, reported as "about 1 year ago", the patient was vaccinated with PNEUMOVAX 23, intramuscular injection, (anatomical location, lot number and expiration date were not provided). Concomitant therapies included PRILOSEC, ZANTAC, aspirin, XOPENEX, ALVESCO, atenolol and lisinopril. On an unspecified date, in approximately October 2014, later that the same day that she received the unspecified dose of PNEUMOVAX 23, the patient began to feel achy all over her whole body and tired. She did not seek any medical attention for the tired and achy feeling. She recovered, on an unspecified date, in 2014, 2 days later for the adverse events. On an unspecified date, in June 2015, the patient developed an unspecified viral infection. She also developed fever (temperature unspecified), cough and chills. On an unspecified date, in June 2015, the patient sought medical attention at an unspecified emergency room in an unspecified city and she received 1 dose of erythromycin. On an unspecified date, in 2015, 48 hours after visiting the emergency room, the patient recovered from the viral infection, cough, pyrexia and chills. The reporter did not assess the relatedness of pain, fatigue, viral infection, fever, cough, chills and pyrexia with MERUVAX II and PNEUMOVAX 23. This is one of several cases from the same reporter. Additional information has been requested.
Swollen and inflammed area of vaccination about 3-4 inches in diameter, hot to the touch and soreness
Initial report received from a physician on 23 February 2011. A 5 year-old male patient (date of birth not reported) who had no reported medical history had received in May 2010 a 4th dose of IPOL, 5th dose of DTaP (manufacturer unknown) and a dose of PREVNAR (Wyeth) vaccine. The lot numbers were not reported for any of the vaccines. Several hours post vaccination, the patient experienced coughing, wheezing, urticaria and angioedema requiring a emergency room and/or doctor visit. He subsequently had a skin test (date not reported) that was positive for DAPTACEL and FLUZONE. Treatments received and other diagnostic/laboratory test performed were not reported. Outcome was not reported. Documents held by sender: None.
15 minutes after temp excursion started 2 doses were given to twin boys from opened vial of IPOL/ No reported side effects; Initial information received on 10-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA103574 same reporter.  This case involves a four years old male patient who received vaccine IPV (VERO) [IPOL] lot PIA461M, expiry date: 03-May-2020 via unknown route in the right deltoid On 09-Apr-2019.  It was reported that, excursion for 60 minutes with max temperature 9.11 Celsius. Products: ActHIB, Daptacel, IPV (excursions-open - 2 unopened), Pentacel, Tubersol, Adacel, Menactra.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to Incorrect product storage.  It was reported that, excursion yesterday afternoon around at 14:15 for 60 minutes with max temperature 9.11 Celsius. Products: ActHIB, Daptacel, IPV (excursions-open - 2 unopened), Pentacel, Tubersol, Adacel, Menactra. Caller reports that 2 patient got IPOL vaccination form open IPOL at 14:30  No reported side effects.   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 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.  Documents held by sender: none.
Pain upon administration, arm muscle sore and rigid. Pain continued and moved across top of left shoulder and left back. Client interviewed on 2/24/04 and states cannot move left arm about shoulder without "terrible shooting pain" and chronic pain.
Received 2 doses of H1N1 vaccine. Denies any adverse effects after either dose. Reports allergy to preservative so was vaccinated with preservative free pediatric dose x 2 on 11/14/09 but then came back and was vaccinated again on 12/17/09.