chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt odd 30 mins. no tired out, nodded off. Later 1hr at home felt tingly that pm heart felt pounding in chest, insomnia x 2 days. 3rd day heart is decreased pounding sensation. Felt like had a fever with the sweating. Today temp Nml upon arrival and then 99.2 while talking-retook as she complained felt hot. Also today but better then 2 days ago. Does not believe she is ill believes this was result of vaccinations.
Chills, muscle aches, injection site pain/irritation, fatigue, no appetite  Took Tylenol starting the evening of the day after the vaccine (1/29) and everyday until 2/1 (Friday, Saturday and Sunday)
One week and 1 day after vaccine,  area on right arm is red, raised and itching.
8 days later the patient developed shingles on the same side of her body that she received the vaccine in; Fever; Swollen glands; felt sick; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ILLNESS (felt sick), HERPES ZOSTER (8 days later the patient developed shingles on the same side of her body that she received the vaccine in), PYREXIA (Fever) and LYMPHADENOPATHY (Swollen glands) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]) and GANCICLOVIR for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ILLNESS (felt sick), PYREXIA (Fever) and LYMPHADENOPATHY (Swollen glands). On an unknown date, the patient experienced HERPES ZOSTER (8 days later the patient developed shingles on the same side of her body that she received the vaccine in). At the time of the report, ILLNESS (felt sick), HERPES ZOSTER (8 days later the patient developed shingles on the same side of her body that she received the vaccine in), PYREXIA (Fever) and LYMPHADENOPATHY (Swollen glands) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not reported.
104 fever after advil,rash on upper chest like sunburn, chills, body aches, felt like joints were on fire.
got a brain tumor and got surgery; got a brain tumor; blood clots in her lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, 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: BRAIN TUMOUR OPERATION (medically significant), outcome "unknown", described as "got a brain tumor and got surgery"; BRAIN NEOPLASM (medically significant), outcome "unknown", described as "got a brain tumor"; THROMBOSIS (medically significant), outcome "unknown", described as "blood clots in her lungs".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Moderna on 1/10/21, 5/17/2021, 6/14/21, and 5/19/2022. Presented to ED w/worsening SOB with cough x2days. CXR revealed emphysema. Admitted with acute on chronic respiratory failure w/hypoxia 2/2 COPD exacerbation, ESBL UTI elevated troponin and AKI. Cont'd to decline w/increased physical debilitation, and worsening respiratory symptoms on 10L NC. CXR showed bilateral infiltrates and suspected aspiration. Cont'd to deteriorate, code status changed to  no cpr/chest compressions. Pt expired 11/16/2022. Tx'd w/meropenem, vancomycin, methylprednisonlone, and ceftriaxone. on 11/16/2022. Pt treated with meropenem, vancomycin, methylprednisonlone, and ceftriaxone.
I got my booster was fine went back to work. After a week experienced pain in my left arm at the injection side, to shoulder and to my elbow. I used Epsom salt with warm water for the pain. I went to the doctor was prescribed a patch didn't help. She referred me to start therapy on last week and have upcoming Ultrasound. On a scale of 1-10 my pain it is a max of 10.
Approx. 1 hour after the vaccine I felt really sleepy.  Slept from 11:00 a.m. to 7:30 P.PM.  Felt good and well-rested.  The next morning, I got up and had breakfast at 9am.   Around 11:30 A.M. I felt really nauseated, started throwing up and had diarrhea really bad.   Started throwing up something really bitter, I was really sick.  I got much better around 11:15 P.M.  The next day I was knocked down with a bad sinus infection.  2nd Pfizer Vaccine April 14th.  Had a slight chill.  Chill went away approx.  6 hours.  Did not get sick.
Vaccine received at approx. 1130. Onset of signs & symptoms approx. 6 hours later, at 1730: nausea; diarrhea; muscle pain (general body ache); joint pain; mild to moderate edema in distal limbs; vertigo/dizziness. Nausea and diarrhea cleared up after about 36 hours, with muscle/joint pain and vertigo lasting almost 48 hours. Treated with OTC Tylenol, fluids, and rest.
Headache, Fever, COLD SWEATS, CHILLS, SHOULDER/NECK PAIN Narrative:
50 year old received a dose of Bexsero; This case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 50-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concurrent medical conditions included asplenia.   On 17th September 2021, the patient received the 1st dose of Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. On 17th September 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were reported as follows: The patient who received a dose of Bexsero at the advice of her cancer doctor at the health department which led to inappropriate age at vaccine administration.  The patient also received 2 other vaccines that day but was unable to provide further details. The reporter was unable to provide further details on the vaccine administered (which arm, dose given, lot and expiration). The reporter consented to follow up. The reporter gave consent to contact her health care professional.
Refrigeration excursions identified/vaccines have undergone several temperature excursions; No adverse event; vaccines undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Sep-2022 at 6:22 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 20-Sep-2022 at 6:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/vaccines have undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (vaccines undergone several temperature excursions and have been administered to patient).    No concomitant medication was provided.  The patient had ever been diagnosed with/ tested positive for COVID-19 was unknown.  On an unknown date, patient had received dose 1, dose 2, dose 3 of Moderna vaccines. Route was Intramuscular and site was deltoid for all three doses. Patient had received on deltoid body site for dose 4.   Date vial was moved from freezer to refrigerator on 7-Sep-2022. The 2 unbroken cartons 20 vials.  It was reported that refrigeration excursions identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department and made aware of the situation. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. It was reported that no adverse reactions were reported to their knowledge for any patients.  Treatment medication was not provided by the reporter
I developed severe body aches, chills, fevers, right arm pain approximately 8 hours after my vaccination. This was my first dose so I did not expect such severe symptoms. I was completely unable to function the day after my vaccination. I was severely weak, dizzy, fever was 100.7, severe chills and shaking. I had COVID 10/13/21 with some cardiac complications at the time which resolved entirely in November. I was hesitant to boost my immune system after having this, but decided to get it fearing some long-covid syndrome should I get infected again. I want to document what I have also seen in the news as of this week stating I had covid and was vaccinated and had a very strong immune reaction to the 1st dose. It would help people to be more prepared for this as I was sick in bed all day and had to cancel and have other people cover my responsibilities. My arm continues to be sore, but the rest mostly resolved by Sunday evening.
A nurse reported the occurrence of a burning sensation in an adult male of unspec'd age who was vax'd w/Hep A vax inactivated for prophylaxis. The subject's relevant medical history, concurrent conditions, and concurrent medications were not reported. In Dec. 02, the subject received an injection of Havrix. It was not known if he had received previous injections of Havrix. 18 hrs later, he started to experience burning sensation in the thigh, back, and shoulders. As of 12/23/02, the burning sensation persisted.
The patient Requested the Bivalent Form of the Vaccine and Received the Booster instead
Resolution of Symptoms:  Covid-19 Vaccine Yes/No:   Y     Date of last dose: 1/11/21  Notes: No initial incident created. Patient tested positive on 8/13/21.  After her isolation period was cleared for 8/23/21.  Advised to update mgmt.  8/16/21: Informed that patient tested positive for COVID-19, specimen collected 8/13 (TYPE OF TEST); Patient works as a Pharmacist. Patient was vaccinated on  12/21/20 1/11/21 (Pfizer).  Last day of work was 8/13. Patient reported that she had a headache on Saturday.  Patient did not have any other symptoms to report at this time.   This patient reports that she has not attended any large gatherings and has mainly interacted with close relatives- parents and sibling who do not report any symptoms.  Significant other, who is a household contact, became symptomatic on Friday- sore throat, cough and is going to be tested today.  He does not work in healthcare. At work, Patient does wear a mask and eye protection for all patient encounters.  Patient does not recall being in contact with any COVID+ patients but did work with the recently positive pharmacy student in the department.   Patient reports eating alone.
My arms swelled up to double its size and was very hot and painful. I couldn't lift my arm for two days. The day after the vaccination I developed flu like symptoms and was sick for two days. Today, four days after the vaccination, my arm is still a bit swolen and sore. I had the same vaccination 5 years ago when I was 60 and did not suffer like this.
Client states that 7-10 days after receiving vaccine, her left hand started swelling and turned gray, followed by swelling in right hand and then individual fingers. Client also stated that she had a stiff neck. Client was seen by MD around 1/30/21 and reports that several labs were drawn and that her "clotting level was off". She also had an ultrasound that revealed a nodule in her thyroid. She had xrays of her hands - results pending. Client's MD told her that she should be vaccinated with the 2nd COVID vaccine today.
Breakthrough case admission after 5 vaccines Moderna 3/17/21 lot# 002B21A;  Moderna 4/14/21 lot# 037B21A;  Moderna 11/22/21 lot# 004F21A;  Moderna 6/25/22 lot# 060A22A;  Moderna 10/12/22 lot# 062F22A
Reporting vaccine mix-up; Not an ADR   Pt was given the Pfizer vaccine as his 2nd dose of a COVID vaccine, however, after administration it was realized he received Moderna for his 1st dose. Pt was not concerned as he had read an article that it may be beneficial to receive 2 different types of COVID vaccines. He felt fine after additional observation/length of stay and went home.
Pt received vaccine at 1159. 1224 pt c/o "tingling" lips and tongue only. No redness, swelling, hives, sob. Benadryl 50mg/20ml given PO. 1236 Pt reports reduction of symtoms and wants to leave. Pt released to home being driven by another person.
Pt recvd vax & MD reported that Enalapril stopped working following flu vax;
Seen 6/3/14 with cellulitis weepy, red swollen (R) arm put on BACTRIM (allergy to amox) came in 6/4/14 with massive cellulitis - sent to ER (red, hot, swollen elbow to deltoid). (L) arm today 3 x 3 cm erythema, sl firm.
He felt irritated and inflamed the same day and rested for most of the next day. Seeing his arm on the 6th I saw about 2 inch red zones around the injection sites. He had a shingrix in the right shoulder with no problems and flu & pneumonia in the left arm. No unusual pains, just uncommonly inflamed left arm where he got the flu & pneumonia. A nurse the other day said it felt hot and was raised he said.
Pruritic rash arms, abdomen and legs Lt hand erythematous and edematous. Tx: Methylprednisolone 4mg oral table therapy pack.
Narrative:  Patient began experiencing itching and hives after vaccine. Treated with diphenhydramine in clinic and symptoms improved.
very nauseated after injection. Close to vomiting.  BP 149/74, HR 95.  Given water to sip on and monitoring.  Repeat BP 151/72, HR93.  Nausea resolved after 20 minutes
MMR # of previous doses: 3; indicate at which point in the process the medication error occured: dispensing; No additional AE details provided.; Varivax # of previous doses: 2/ MMR # of previous doses: 3; MOA calling to report expired MMR II had been administered to a patient. Product and sterile diluent used to reconstitute product had not experienced any temperature excursions.; This spontaneous report was received from the Medical Office Assistant (MOA) and refers to a 24-year-old male patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included hepatitis b vaccine rhbsag (yeast) (ENGERIX B) and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP).   On an unknown date, the patient was vaccinated with the 3 dose of the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (extra dose administered) (dose, route of administration, anatomical location, strength, expiry date and lot number were not provided). On an unknown date, the dispensing medication error occurred and the expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA type: recombinant human albumin) was dispensed. On 14-JUN-2022, it was administered to the patient, already as a 4th dose of this product (3 previous doses reported) (extra dose administered), subcutaneous injection, lot #T018669, expiry date: 29-MAY-2022, for prophylaxis (strength and dose not provided), with the sterile diluent, used to reconstitute the product (lot number: U005973, expiry date reported as 08-APR-2023, but validated as 09-APR-2023). On the same day, additionally the varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection was given to the patient, as a third dose already (two previous doses reported) (extra dose administered), lot #U010400, expiration date: 01-APR-2023, for prophylaxis (strength and dose was not provided). On 14-JUN-2022, the 4th dose of hepatitis b vaccine rhbsag (yeast) (ENGERIX B) (3 previous doses) and 2nd dose of diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (1 previous dose) were also administered. No additional adverse event details were provided.
After one month, I used my left arm to carry grocery's home 4 blocks. My arm got sore again that night and felt the same soreness as it did after getting the first two shots. The next day it was not sore anymore. I've experienced soreness with my body the same way ever since the first month after getting the shots. It's all over my body and I get sore after walking and it feels sore like it should feel sore maybe the next day but.it feels sore that day, it is not normal to get sore this way from such little.excercise for me. My joints hurt as well for 3 months but that has gone away. When I feel sore the day of walking, by tomorrow the soreness will go away but it hurts in every muscle in my body. It's not normal to feel this way, I walk a half mile then I'm sore.all day as I walk around and I have to take frequent rests to stop the sore feeling of pain.
Found down by family 12/16 with altered mental status. Ultimately discovered to have left MCA stroke complicated by focal status epilepticus and DKA.
None known at this time. Patient received an undiluted dose of Pfizer totaling .3
Received Tdap left arm 5/8. MMR right arm 5/8. 5/9 edema, tenderness left arm and upper back, muscle cramps, fever (102) all relieved with ibuprofen.
VACCINE EXPOSURE DURING PREGNANCY; This prospective pregnancy case was reported by a healthcare professional and described the occurrence of vaccine exposure during pregnancy in a 21-year-old female subject who was vaccinated with tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed (Boostrix, GlaxoSmithKline) for prophylaxis during pregnancy.   The subject's past medical history included no previous pregnancies.  Prior to becoming pregnant she had not been using contraception.  On 31 August 2011 at 08:40 the subject received a booster dose of Boostrix (.5 unknown units, intramuscular, right deltoid), and experienced vaccine exposure during the third trimester of her pregnancy.  The conception was reported to be normal.  The subject was approximately 32 weeks gestation at the time of vaccination.  Date of last menstrual period was 19 January 2011 and estimated delivery date was 26 October 2011.  Prenatal testing including ultrasounds performed on 11 March 2011 and 03 June 2011 had revealed no evidence of a defect.   Upon internal review done on 16th September 2019, the pregnancy outcome was updated to lost to follow-up.      Lab Comments: Lab Tests: Ultrasounds on 11 March 2011 and 03 June 2011 revealed no evidence of a defect.
I have bruises all down my left arm from my shoulder and armpit. The bruises are 3 fingers across in size. My arm is very tender and sensitive to touch. I can't even apply lotion. The bruises are getting bigger.
Information has been received from a physician concerning a 69 year old female who at 9:26 am on 22-OCT-2008 with a first dose of PNEUMOVAX (lot # 656233/0200U) in the left deltoid. Concomitant therapy included FLUZONE (lot # U2747AA) in the right deltoid which was vaccinated at 9:05 am on 14-OCT-2008. On the morning of 22-OCT-2008, after getting the vaccine, the patient developed swelling, pain, and redness at the injection site and also underarm redness. The swelling and soreness lasted one week. The medical attention was sought. The body temperature was normal (reported as "no temp"). The patient refused treatment. On 30-OCT-2008, the patient recovered. No further information is available.
They both have developed a strange dermatitis that has lasted for months/ her son's are on the crook of his elbow; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 (Lot number: EW0173) at the age of 16 years as dose 2, single and administered in arm left, administration date 28Apr2021 (Lot number: EW0170) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ringworm" (unspecified if ongoing), notes: He actually has had ringworm prior because he is a wrestler and he thought that it was also ringworm.; "Seasonal spring allergies" (unspecified if ongoing), notes: diagnosed when he was 3 years old. There were no concomitant medications. The following information was reported: DERMATITIS (non-serious) with onset Dec2021, outcome "not recovered", described as "They both have developed a strange dermatitis that has lasted for months/ her son's are on the crook of his elbow". The event "they both have developed a strange dermatitis that has lasted for months/ her son's are on the crook of his elbow" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dermatitis.  Additional information: The patient's wife first stated she was calling about both the pediatric and adult dose of the Pfizer COVID vaccine and later stated that both her husband and son, who was 16 at the time, both would have received the adult dose, she assumed. They are at a point where they are thinking her husband and son are having reactions to it. Maybe a month or two later, her husband started having a strange dermatitis on his hands, which has now been treated by several different doctors and continued to get worse. Son has a similar issue with it on his arm. Maybe it could be in relation to their vaccines. Neither had very much of a reaction with either dose. This report is to capture information for her son. It is unknown patient received any other vaccines within four weeks prior to the first administration date of the suspect vaccine. Patient's Medical History including any illness at time of vaccination is Unknown Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity Illness.  No follow-up attempts are possible. No further information is expected.
Patient reported that 4-5 hours after vaccination she had a swollen arm in the area of the vaccine and redness and pain, she also reported a fever.