chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore/swollen arm; sore/swollen arm; bad headache; so red arm; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th June 2021, the patient received the 2nd dose of Shingles vaccine. On 11th June 2021, less than a day after receiving Shingles vaccine, the patient experienced swelling arm, pain in arm, headache and erythema of extremities. On an unknown date, the outcome of the swelling arm, headache and erythema of extremities were not recovered/not resolved and the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the swelling arm, pain in arm, headache and erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received 2nd dose of shingles vaccine and experienced arm was very sore and bad headache and so red and swollen arm.  The reporter inquired could he/she take Advil, if so, how often also could ice or heat compress. The follow up would not possible as no contact details were available.
Patient received 1st dose of Moderna vaccine on 01/30/2021.  Patient received second dose on 2/27/2021 and within an hour noticed slurred speech and drooped face.  Patient went to ER and was transferred to another Hospital on 2/27/21 due to stroke.  Now patient believes stoke may have started 2/26/21, as she was somewhat confused  that day, but didn't realize stroke until after vaccine.
My adverse event started on 11/27/2022. I've noticed while brushing my hair I was losing hair. It was a little less than a dime. It was a patch on my head. It look like a tennis ball court. I also read online about Alopecia. I don't have a history of a Alopecia. It could be that my immune response but not quiet sure. On 01/24/2023 I went to my doctor's office. She prescribed me a topical steroid clobetasol propionate (2 times a day) and ROGAINE (1 time per day). She did thyroid and CBC test which were normal. As of now it's getting worse. Am not sure if the medication is working or not. I will probably going to do a follow up with her. I got an extra patch on back of my head. Am loosing a lot of hair out of know where.
Rash on the injection site; Injection hurt a lot / hurt like a regular flu shot; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash on the injection site) and VACCINATION SITE PAIN (Injection hurt a lot / hurt like a regular flu shot) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included DIAZEPAM for Anxiety, CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection hurt a lot / hurt like a regular flu shot). On 26-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash on the injection site). On 20-Mar-2021, VACCINATION SITE PAIN (Injection hurt a lot / hurt like a regular flu shot) had resolved. At the time of the report, VACCINATION SITE RASH (Rash on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.; Sender's Comments: Based on the current available information which includes a temporal association between the use of mRNA-1273 and the start date of the reported events, a causal relationship with the event cannot be excluded. The reported events are consistent with the known safety profile of the vaccine.
Pain in upper left back, growing to severe (8/10) over 2-3 days accompanied by 90% loss of strength in deltoid muscle.
Initial report received from healthcare professional on 01 Dec 2009: The reporter stated that a 9 month old child received FLUVIRIN 0.5 ml IM on 01 Dec 2009. No adverse event was reported.
This case was reported by a physician to a sales representative and described the occurrence of fever in a 4 month old subject of unspecified gender who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined for prophylaxis. On an unspecified date on or before 06/21/2005 the subject received a dose of Pediarix. At an unspecified time after vaccination with Pediarix, on or before 06/21/2005, the subject experienced a fever of 104 degrees Fahrenheit. The outcome of the fever was not reported.
No other issues or concerns noted; only half the dose being given; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 03-MAY-2022, the patient was vaccinated with half of the dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) subcutaneous injection, lot #W004030 (lot number W004030 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)), expiration date: 02-AUG-2023 (anatomical location and route of administration were not provided) for prophylaxis (Underdose). The reported inquired if the patient needed to be readministered with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD). No other issues or concerns were noted (No adverse event).
58 y/o female, s/p 1st vaccine. C/o hotness to throat and intermittent right hand numbness.  Speech clear, drinking water, a/o x4; medic 71 on scene, care assumed. Pt signed out AMA. Symptoms resolved.
Patient had received vaccine 5 minutes prior and gone to the bathroom. She came back to sit in the waiting room and then passed out in the chair. She reported that she had been nauseous prior to sitting down. She came back too quickly and stated that she was just thirsty and her chest was tight. 911 was called and they asked us to give her 4 chewable baby aspirin as a precaution. Before EMS arrived she was sitting up and talking with her husband.
Had both vaccines and still got shingles / Suspected Vaccination Failure; Had both vaccines and still got shingles; Pain was intense; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient stated that, vaccine does not mean you wont get shingles anymore. He or she had both vaccines and still got shingles on the right side of nose and the pain was intense. This case was considered as suspected vaccination failure as details regarding the laboratory test confiding shingles and time to onset for shingles were unknown at the time of reporting.
She stated about 9:00pm on 1/29/21, the same day she received the vaccine, she started to have pain and redness on her right side above her hip. The next morning she had a blister present surrounded by redness. She was seen in the Emergency Department and discharged with no treatments or medications given. She noticed a red blotchy rash on her right forearm the next day, 1/30/21. She went to the Emergency Department again. No treatment given. She was seen by her Primary Care Provider on 2/4/21 and was told not to get the 2nd COVID vaccine due to a reaction to the 1st vaccine.
3"X1" DARK RED PATCH, VERY HOT AND SORE, HEADACHE, ITCHY, ARMPIT SORE TO TOUCH, ON 6TH DAY BRUISE DEVELOPED, SEVERE LOWER BACK ACHE, 3RD WEEK DEVELOPED ITCHY SPOTS ON LEFT BACK, 5TH WEEK DEVELOPED RASH ON LEFT BACK AND AROUND LEFT KNEE.
covid vaccine which killed many people and probably my dear wife; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  An elderly female patient received BNT162b2 (BNT162B2 NOS), 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: DEATH (death, medically significant), outcome "fatal", described as "covid vaccine which killed many people and probably my dear wife". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: "Continued hatred abd dusdain die the faulty Pfizer so called covid vaccine which killed many people and probably my dear wife". Reporter consider event caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: covid vaccine which killed many people and probably my dear wife
This case was reported by a consumer via call center representative and described the occurrence of skin red in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced skin red and influenza-like symptoms. On an unknown date, the outcome of the skin red and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the skin red and influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: This case was previously reported to doctor. The reporter was the patient's husband. The patient received SHINGRIX on the left arm. In 2018, the patient had a red patch and flu like symptoms but all resolved within a week.
This case was reported by a healthcare professional (also the consumer) and described the occurrence of fever in a female subject of unspecified age who was vaccinated with Flu vaccine (manufacturer unspecified). Approximately ten years ago, the subject received a dose of Flu vaccine (unknown). An unspecified amount of time following vaccination with flu vaccine, the subject developed fever and chills. The subject additionally missed work for a period of three days. At the time of reporting the events were resolved. In the reporter's opinion, the events of fever and chills were probably related to treatment with flu vaccine. A year later, the subject received the flu vaccine again and had a similar reaction. For details concerning this case, see suffix case A0751658A.
Patient states they had cold chills, night sweats, and breathing difficulties. Stated the symptoms lasted 8-12hrs, but were worrisome. The patient states they are no longer having any symptoms, and did not seek medical treatment for the symptoms.
Preemie baby died in the NICU; Maternal Exposure During Pregnancy; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported information for both mother and fetus/baby. This is a baby report. A 36-year-old female pregnant patient received BNT162B2, first dose via an unspecified route of administration, administered in right arm on 12Apr2021 05:00 PM (Batch/Lot Number: EW0153) as dose 1, single; second dose via an unspecified route of administration, administered in left arm on 03May2021 (Batch/Lot Number: ER8735) as dose 2, single for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. Until Monday the 17, She has emergency cesarean to deliver at 24 weeks, 4 weeks later the preemie baby died in the NICU. The preemie baby died in the NICU in 2021. The event was serious per death, life threatening, hospitalization. The patient died in 2021. It was not reported if an autopsy was performed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100986436 mother case;US-PFIZER INC-202100987372 mother case; Reported Cause(s) of Death: Maternal exposure during pregnancy; 4 weeks later our preemie baby died in the NICU
No negative side effects to report.  Only reporting that dose was administered to a child under the approved age limit.
Vaccine site was inflamed, warm and there was a small nodule below the skin within an hour after recieving the vaccine. No intervention was taken by the patient. 7/9/18 patient came back the the clinic and still had some tenderness but it was reduced.
The resident received the Moderna Booster (0.25ml) vaccine on 11/23/21 in his right deltoid. A full set of vitals was obtained prior to administration and all were unremarkable (T=97.4, RR=16, BP=153/89, P= 80, O2 sat=96%). On 11/24/21 at 2:05pm, the resident was noted to be lethargic with decreased responsiveness and having an altered mental status. The nurse noted that the resident felt warm to the touch and that his vitals were not within normal limits (Axillary Temp=102.5, RR=50-56 requiring accessory muscles, P=100, BP=189/99 and O2 Sat=95%). His nurse stated that he would not verbally respond to questions but maintained eye contact throughout the assessment. The nurse noted that the residents injection site was swollen, red, warm to the touch and hard. No s/s of pain when area palpatated. The on-call provider elected to send the resident out to the hospital at 2:44pm. A comprehensive workup was performed at the hospital and no source of infection was noted. The resident returned to the facility on 11/30/21 at 12:38pm with normal mentation and vitals. No changes to the residents medication profile were made upon readmission.
swelling on my neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling on my neck) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Non-Hodgkin's lymphoma.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced SWELLING (swelling on my neck). At the time of the report, SWELLING (swelling on my neck) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0177, expiration date: Aug 2021), at the age of 72,  via an unspecified route of administration, in right arm, on Jun 15, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Patient previously took flu shot for immunization and experienced a problem with the needle. She has to put on an ice pack. On Jun 15, 2021, patient had injection site pain. On Jun 2021, tiredness, headache, muscle pain, chills, joint pain, dizziness and weakness. She doesn't know if she will get the second dose of the COVID-19 vaccine. She felt bad, sleepy, joint and muscle pain (got worse and worse). This resulted in a drive to the hospital. The outcome of injection site pain: recovering; for the rest of the events: unknown. Follow-up attempts completed. No further information expected.
patient reported today that she had a full body rash that was unresolved with benadryl and topical antihistamine/steroid.
pt recv vax 20AUG96 & 23APR97 pt devel chickenpox w/6 lesions;pt recovered;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 30-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K010574, expiration date 08-APR-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected as there was no consent for follow up.
Beginning on the day after thee 2nd shot:severe stomach pain, fever, fatigue, bloody loose stool, fever went away after several days but digestive problems persisted.  Elevated heart rate gradually beginning to be noticeable and bothersome with a feeling of being "winded".  This also was totally out of character for my daughter who is a runner.   She has never had any symptoms like this before.
pt came in on 20OCt97 w/rt side of face numb & was given B12 inj;pt returned 30OCT97 Bell's Palsy cleared;
Severe Menstrual cramps, to the point of debilitation. Sudden, Heavy pressure in my Right Ovary and sharp, stabbing pains. Shallow breathing due to pain. Fullness and discomfort continued for a week after my menstrual cycle ended. There was sensitivity to tight pants, where my ovary would feel full and sharp stabbing pains would ensue.
Systemic: Abdominal Pain-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Medium, Systemic: Vomiting-Severe
Approximately 5 minutes after vaccination Pt stated that her throat felt "weird" and requested a drink of water, I immediately called 911 and explained to her that she could not have anything to drink. She was awake and oriented. She had some labored breathing while speaking but did not complain of shortness of breath. The Paramedics arrived around 3:55pm, administered Benadryl IM, at this point she started having hives. She was taken to the ER. At ER she was seen and as per RN she is stable, vital are normal, alert, awake and oriented.
Pt reports after 1st dose very small cough. He reports after the second dose he developed a cough that would not go away that was try
12FEB96 c/o prolonged pain rt arm since flu shot 30OCT95;able to use arm-exam by MD told to exercise-has been using weight;had ?sz 23NOV;was working in yard woke up on the ground;taken to ER-told may have sz d/t exhaustion on no med;
itching; rash around injection site; injection site was red; swollen injection site; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching), VACCINATION SITE RASH (rash around injection site), VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE SWELLING (swollen injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical history was reported.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT HFA) and FORMOTEROL FUMARATE, GLYCOPYRRONIUM BROMIDE (BEVESPI AEROSPHERE) for an unknown indication.    On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE SWELLING (swollen injection site). On 04-Jun-2021, the patient experienced PRURITUS (itching) and VACCINATION SITE RASH (rash around injection site). At the time of the report, PRURITUS (itching) and VACCINATION SITE RASH (rash around injection site) had not resolved and VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE SWELLING (swollen injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
STAFF MEMBER VOMITED.  STAFF NURSE CHECKED ON HER AND SHE EXPRESSED THAT SHE WAS FINE.  THIS REPORTER CHECKED ON STAFF MEMBER AND SHE EXPRESSED THAT SHE WAS FINE, AND JUST HAD A "BREAK-OUT" ON HER FACE.  ENCOURAGED STAFF MEMBER TO GO TO THE HEALTH CENTER FOR FOLLOW UP AND SHE EXPRESSED SHE WOULD IF SHE DIDN'T IMPROVE.
I started with what I thought was a nasal drip. I had congestion and took some  medicine for allergy. It hit me to get tested. On that Saturday I felt achy and fatigue. I got tested. After, being on quarantine I lost taste, and during healing I felt itching on my tongue from the front to the back. These little knots developed on my tongue. I had made a mistake and bit my tongue on day and it felt as if I lanced a boil  on my tongue. I went to an ENT doctor who gave me mouth wash that helped the back of my tongue, but not the tip of it where the bumps are. I did have blisters on the roof of my mouth that popped and made little hole in the top of my mouth. It hurt for days but it went away. I am still using the mouthwash from the ENT doctor. It helps for a minute but the bumps on the tip of my tongue have not went away.  My smell has definitely changed and things smell different and everything smells like a chemical factory. I could not smell a dead deer in my yard.
Mild adverse effects.   Still experiencing.  Low grade fever (102.4), headache, weakness, aching/tingling joints, lightheadedness, very sleepy
3RD DOSE PFIZER COVID VACCINE GIVEN 9/8/21, LOT # NOT AVAILABLE 4TH DOSE CORMIRNATY COVID VACCINE GIVEN 5/25/22, #FK9894 9/3/22 pt had a positive COVID test; 9/6/22 to hospital with fever, cough, SOB, weaker past 3 days; O2 supplementation; worsening confusion and seizure like activity while infusing Remdesivir, dc'd medication; continued with Dexamethasone; worsening respiratory failure; ABX; increased agitation and confusion; on high flow NC O2; transitioned to comfort care and pt passed away in the hospital
improperly stored VARIVAX administration; No adverse experience; This spontaneous report was received from a registered nurse referring to a patient (age and gender unspecified). The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 19-OCT-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# T012551, expiration date 10-APR-2022, exact doses and route of administration were not reported) for prophylaxis. The vaccine underwent a temperature excursion between 6 degrees Fahrenheit (F) to 14F with an average of 11.8F for 31 hours. The data logger was involved. No previous temperature excursion was reported.  On 04-NOV-2020, an inbound call was performed and the reporter stated that the vaccines were all still viable and that she was unsure of the number of minutes that the vaccines underwent the temperature excursion. The reporter reported that there were no adverse experiences as a result of the temperature excursion.  This is one of three cases from the same reporter (same reporter link # 2010USA011004 and 2010USA010839).; Sender's Comments:  US-009507513-2010USA011004: US-009507513-2010USA010839:
Cellulitis vs vaccine reaction Right upper arm s/p shingrix vaccine - Received Shingrix vaccine in right deltoid on 08/24/2018. Noted minor pain at injection site for a couple of days after injection. Noted increased pain and redness around 08/27/2018. On 08/29/2018, redness seemed to be worsening. Patient was evaluated on 08/30/2018, given increasing redness, pain and warmth cephalexin x 7 days was prescribed for possible cellulitis. Reports symptoms seemed to peak on 09/03/2018. Then redness and swelling resolved. UrticariaPruritus & swelling, redness CEPHALEXIN