chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient stated that he felt itching and numbness all over a few minutes after receiving the Moderna vaccination.  He was offered dihpenhydramine but refused because he stated that he had to leave to go to work.   He said that he was stopping by his house before work so he would take diphenhydramine if he needed to at home.  I told the patient he should wait at the pharmacy longer for observation but he still left because he had to go work.  He said that he felt okay before leaving the pharmacy.
Tightness in my chest, wheezing and coughing. Soar throat and itchy feeling. Head and body aches, chills and sweats. Extreme Nausea. This lasted for 12 hours.
Swollen, red, painful, itchy, about 2-3 inches in diameter.
Headache FATIGUE, CHILLS, PAIN/SWELLING INJ SITE Narrative:
WARM AT SITE; WOKE HER UP; HURTS TO RAISE LEFT ARM; ACHY AT SITE; SPACY; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, not treated, codeine allergy, alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use. patient consumes 1-2 glasses of wine per week.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccinatio on left arm.. Concomitant medications included ascorbic acid, and . On 08-MAR-2021, the subject experienced spacy. On 23-MAR-2021, the subject experienced achy at site. On 25-MAR-2021, the subject experienced hurts to raise left arm. On 26-MAR-2021, the subject experienced woke her up. On an unspecified date, the subject experienced warm at site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacy on 08-MAR-2021, had not recovered from achy at site, and warm at site, and the outcome of woke her up and hurts to raise left arm was not reported. This report was non-serious.
APPROX 7 DAYS FOLLOWING SVP ADMINISTRATION HAD ONSET OF PRURITIC RASH LEFT ANTECUBITAL, SPREAD NOW TO BILATERAL ARMS, ABDOMEN, FACE; HAD FEVER AND CHILLS AND DRY MOUTH IN THE WEEK BEFORE NEW LESIONS APPEARED. NO TX UNTIL YESTERDAY, GIVEN ALLEGRA AND NSAID.
Crimson spot @ site and 2x3" erythemtous macular reaction.
Within 48 hrs of KINRIX admin in patient's right thigh, a serpiginous area of redness developed approx 1 in from the injection site, ie, the injection site was not within this area. The redness gradually resolved over the next 3 days, with no sequelae.
01/22/2020-rash-Urgent Care clinic-oral steroids 01/23/2020-puffy eyes-ER-Epi, Steroid, Benadryl. Admitted for observation. Discharged from hospital 01/24/2020
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 4:27 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:27 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 47.55 for dose administered on 15-Apr-2021.  No concomitant medications were reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 06-Apr-2021 and beyond use date for the vial was reported as 09-May-2021. Product moved to clinic on 15-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Pt was given wrong covid vaccine. Pt was given covid 5-11 yr vaccine when pt was 4.
very bad reaction; very bad headache; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (very bad reaction) and HEADACHE (very bad headache) in an elderly female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Sep-2022, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (very bad reaction) and HEADACHE (very bad headache). At the time of the report, IMMUNISATION REACTION (very bad reaction) outcome was unknown and HEADACHE (very bad headache) had not resolved.            No concomitant medication was reported.  It was reported that the patient got omicron. On an unknown date in Sep-2022, the patient had a very bad reaction and had a very bad headache that won't go away with the migraine medicine (unspecified).   This case was linked to MOD-2022-643411 (Patient Link).
Diffuse arthralgias after TdAP onset 2/20/08.  (Vaccination was 2/19/08).
Immediate swelling at injection site, pt reports swelling has gone away by 9/21/10.
Chils, Muscle aches, body aches...Fatigue...Fever...Sweats...Headache
Patient's parent lied about date of birth to qualify for vaccination. Wrong dose was given for patient's actual age. Date of birth submitted was 12/07/2008, correct DOB is 12/07/2009. No adverse events occurred.
At the time of the vaccination, I felt some stabbing sensation in some parts of my body. Because it was dark and I was inside of a car, I turned on the lights. I did not notice any rash or redness.  That day at night I had a little redness on one part of my back. In the following days, I have itched in different places on my body, but I have not developed any hives or rash, but the inexact itching sensation continues.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 22-APR-2015, a pharmacist at a pharmacy administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Pain and local mild induration within 12 hours of injection. Worsening induration/redness/warmth AND swelling of entire left upper thigh and left knee by 24 hours (office visit at that time).
13 year old sustained grand mal seizure about 24 hours, post vax of Hep-B #1. Had no illnesses prior to shot. Emesis all day on 3/17/01 until 17:00, then seemed fine.
Fever (101) and exhaustion for 24 hours after the shot. Also, sore arm at injection site and enlarged lymph node under the left arm, in the armpit. The lymph node was the size of a golf ball and very uncomfortable from Saturday, 12/10 - Wednesday, 12/15 .  Doctor recommended ibuprofen and ice until swelling finally went down five days after the shot.
Patient presented on Thursday, September 23, 2021 to ask the pharmacist about a "reaction" he had 2 weeks after getting the Janssen vaccine. This vaccine was given on 5-5-21. The patient had a round, raised area about 3 inches in diameter on either side of his neck going down into the shoulder area. Each area looked like it was puffy and fluid filled; it wasn't hard.
pt initially developed hives the day after the vaccine, but on 3/22 he developed left groin pain. exam suggestive of epididymitis with no other known precipitating event other than recent vaccine
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Feb2021 (Lot number: EL3242) at the age of 75 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, date: 28Jan2021, Lot: EL3302), administration date: 28Jan2021, when the patient was 75 years old, for COVID-19 Immunization, reaction(s): "sore arm". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm".  Additional information: Consumer (name-withheld) calling, unknown telephone number. Called because she has question about the Covid vaccine and she has experienced adverse events. She has a question about long term side effects, she had the first and second dose of the Covid Vaccine. First dose on 28Jan2021, second dose on 25Feb2021, and she also had booster on 01Nov2021. No additional Vaccines Administered on Same Date of the Pfizer Suspect. No prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines.  No follow-up attempts are possible. No further information is expected.
Per mother of child: See attachment telephone conversation 6/25/09 3:30 PM.
Had flu shot "last week" (not sure) and complained of sore throat and rash 3-4 days after shot, mostly behind knees and on elbows. Referred to PP and given resources.
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 17-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
I had a slight fever the night of the vaccine. The next day I had back pain. Three days after, I was in the ER for four hours with back muscle spasms. I did have covid in April. I had a ultrasound done a week or two ago because I had developed lumps in my shins. They thought it could be blood clots, but it was not. My Doctor advised me to not get the second dose.
10 Days after the vaccine, I developed a petechial spearing rash on my thighs. The rash rapidly spread to my entire lower extremities and became much more severe in nature. I developed foot and ankle swelling and joint pain in my ankles. The rash spread to my hands and the posterior aspect of my upper arms on the night of 12/29/2020. I was prescribed topical triamcinolone cream to apply to the rash.
Fever, SkinRash, Rash, UrticariaPruritus, first shot 3/12/2021 12 hour later developed fever, chills, headache and rash developed 1/12 to 2 days after injection. The rash lasted a full 24 hours and was present from injection site down to right elbow and was warm to touch and was hard Narrative:
3rd dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number PM35L, expiry date 4th February 2023) for prophylaxis.   On 19th October 2021, the patient received the 3rd dose of Shingrix. On 19th October 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received a 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
I came home after having the shot, and I was doing my normal at home, and around 5 in the afternoon, I got up and I had aches and pain all over.  Then I had a heaviness in my head. Then the chills started. I took two tylenol around 8pm. Then throughout the night, I had really bad chills. My husband gave me more tylenol and it helped. I woke up and I had more chills, and then I checked my temp and it was 101.6. I took more tylenol. I also have this intense tiredness. All my symptoms are like when I had covid in May.  My injection site is the width of a flat orange.
Breakthrough COVID first vaccine 1/6/21.  Sent due to positive COVID and shortness of breath/dyspnea on exertion. Patient has had progressive shortness of breath for approximately 3-4 weeks.  It appears that her shortness of breath per minute her from going to the dining hall at night.  According to the daughter, patient's shortness of breath has gotten progressively fever worse over the past 2 days.  Patient was checked for COVID today and she reportedly was positive.  Due to her positivity and shortness of breath she was sent to the ED for further evaluation.  Once in the ED, patient was found to have a saturation of 90-92% at rest.  Patient denied fever, chills, cough.
12/4/02 Patient reports Pneumovax and flu shot given in left deltoid 12/2/02. He then had fever of 102, left shoulder pain, erythema, swelling and nausea.
Varicella vaccine was being administered to pt's child when child struggled, and pt was accidentally scratched by clean needle. A clean needle was replaced on the syringe and child was given injection. On 8/22/01 pt complained of runny nose, cough and cold symptoms due to scratch.
received a vaccine that was expired by 2 days/No AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves an 18 months old female patient who received expired dose of vaccine that was expired by 2 days, while she received vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history included very little in body weight as it is. Past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an expired dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] that was expired by 2 days lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to Expired vaccine used.  At the time of report no adverse event was reported.  Information on the batch number was requested.  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.
About 5.5 hours after injection I had a sudden onset of symptoms starting with cramps and nausea. I nearly fainted at work while seated at my desk. Symptoms were dizziness, faint, blurred vision, nausea, stomach cramps, chills, clamminess, and fever.  The symptoms improved slightly with Tylenol for about 4-5 hours and then became severe again.  Throughout the night I had chills/shaking and sweats and body aches.  The next day I had a low fever that was better with Tylenol and severe muscle pain in my lower back and around my spine. The third day (today) I had severe neck and shoulder pain.
Arm pain; Injection site pain; Arthralgias; Headache; All of that plus fever; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm pain), INJECTION SITE PAIN (Injection site pain), ARTHRALGIA (Arthralgias), HEADACHE (Headache) and PYREXIA (All of that plus fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain), INJECTION SITE PAIN (Injection site pain), ARTHRALGIA (Arthralgias), HEADACHE (Headache) and PYREXIA (All of that plus fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), INJECTION SITE PAIN (Injection site pain), ARTHRALGIA (Arthralgias), HEADACHE (Headache) and PYREXIA (All of that plus fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.   This case was linked to MOD-2021-314678, MOD-2021-314741 (Patient Link).
Pediatric vaccine was diluted with 0.13 ml instead of 1.3 ml so the patient got a more concentrated dosage than recommended.  Patient presented pain at injection site that extended to the armpit
Had a fall; The lower part of her body was without feeling; There was a lot of damage to the nerves; A spontaneous report was received from a consumer for a 75-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was hospitalized as she had a fall and the lower part of her body was without feeling, and there was a lot damage to the nerves.  The patient's medical history included a back surgery. No concomitant product use was reported.  On 15 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 042L20A) intramuscularly for prophylaxis of COVID-19 infection.   02 Feb 2021, approximately 17 days after receiving the vaccine, she had been hospitalized as had a fall and the lower part of her body was without feeling. She had previous back surgery, so there was a lot damage to the nerves and she was still presently in rehab. She could not receive her second dose because of hospitalization.  The treatment medication was not reported.  Action taken with mRNA-1273 with respect to the events was not reported.  The outcome of the event(s) for which she had a fall and the lower part of her body was without feeling, and there was a lot damage to the nerves were unknown.; Reporter's Comments: 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 received an injection Sanofi Pasteur Fluzone high dose, lot UJ27 488 in my left upper biceps. Two days later I awoke to a 10 + cm area of blanching erythema and induration that was painful and tender. I also had severe malaise and fatigue, and a low grade fever of 100 F. I was bedbound for 3 days. The injection site is now tender but all other sx have resolved.
Extreme pain in head; This case was reported by a consumer via call center representative and described the occurrence of temporal headache in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th January 2020, the patient received Shingles vaccine. In January 2020, less than 2 weeks after receiving Shingles vaccine, the patient experienced temporal headache. On an unknown date, the outcome of the temporal headache was unknown.   It was unknown if the reporter considered the temporal headache to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received new Shingles vaccine 8 days prior to reporting date. The patient had extreme pain in left temple of head. The patient was wondering if these could be reaction.
Started running a fever 6 hrs after injection and 54 hrs later it?s getting higher not lower.  Was running 99.5 on Tuesday and hit 101 at 3:00 today, Thursday.