chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the time pregnant, I was 31 weeks. EDD: 07-03-2021.  I experienced the day after I had a left sore arm, limited mobility. Day 2: no issues, arm did not hurt. On 04-30-2021, I started throwing up, diarrhea also started on Saturday morning on 05-01-2021. I also had cramping and had food poising stomach type pain.   I went to the ER, because my diarrhea was bad, and also had a fever of 104.F.  They did a UA and lab work as well.
I got hives all over me and took Benadryl a couple of times and they didn't go away. I went to a doctor and was told I had Shingles and was given an antiviral. Then I felt worse  and had an anaphylactic shock  reaction, my tongue and lips got numb to the antiviral and was taken to the hospital for observation. When I returned home and saw my main doctor and was informed I didn't have Shingles. The hives are slowly going away.
cervical and supraclavicular lymphadenopathy , confusion, rigors or seizure like shaking
Per pharmacist, patient is pregnant and came in for her second Pfizer dose. About 30 minutes after receiving the shot, the patient experienced a reaction. She was throwing up and her lips were swollen. She went to the emergency room and was given Zofran, Epi-Pen, and Benadryl. Patient reported feeling better after the pharmacist followed up with her.
15 hours after receiving J&J vaccine, I had heart fluttering, chills, and headache.
Patients mother contacted this office reporting allergic reaction, hives, itching, lip swelling. Patient sent to Emergency room. Treated with IV BENADRYL, SOLOMEDROL, PEPCID, EPI PEN. At hospital, patient had facial swelling, hives, itching, resp. increase rate, sent home with Rx for PO Prednisone, and EPI PEN.
caused a rib head to come out of socket; The vaccine caused a flair up of the arthritis in her shoulder; She still has pain in the shoulder now because it has pinched a nerve; She still has pain in the shoulder now because it has pinched a nerve; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in her arm on an unspecified date at a single dose for COVID-19 immunization. Medical history included arthritis in her shoulders bilaterally. Concomitant medications were not reported. The vaccine caused a flair up of the arthritis in her shoulder and caused a rib head to come out of socket. She still had pain in the shoulder now because it had pinched a nerve. Can she get the second dose in another site besides her deltoid? The outcome of events was unknown.  Information about batch/lot number has been requested.
DIFFICULTY BREATHING; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic obstructive pulmonary disease (COPD).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration unknown, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after receiving the vaccination, the patient developed difficulty breathing. She was hospitalized within 24 hours of the onset of the event. She was admitted and stayed a few hours and received some medical treatment before being released later that day. Symptoms have resolved and the patient was currently in a great shape. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from difficulty breathing. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: -COVID-19 VACCINE AD26.COV2.S-Difficulty breathing. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
This case was reported by a physician via sales rep and described the occurrence of seizure in a 4-year-old patient who received KINRIX. Co-suspect products included MMR vaccine and Varicella vaccine. On an unknown date, the patient received KINRIX, MMR vaccine and Varicella vaccine. On an unknown date, less than a day after receiving KINRIX, MMR vaccine and Varicella vaccine, the patient experienced seizure (serious criteria GSK medically significant and other: as per reporter). On an unknown date, the outcome of the seizure was recovered/resolved. It was unknown if the reporter considered the seizure to be related to KINRIX, MMR vaccine and Varicella vaccine. Additional details were provided as follows: The patient had no previous history of seizure activity. The patient began to experience seizure activity within 24 hours after receiving KINRIX, Varicella, and MMR vaccine. The patient was taken to the emergency room, where they were treated and symptoms had resolved. The physician did not think that the vaccines caused the seizure. Further product details and patient identifiers were unknown. No further information was reported regarding the event.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml; unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756541A, A0756543A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report in Safety received stated AFLUA3508A. With a possibility of coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 79 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 230A21A, and batch number: 230A21A expiry: 21-SEP-2021) dose was not reported, administered on 27-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210952911.
Deep pain & numbness to (L) buttock & down front & back of thigh, appeared after injection given & not improved. No other explanation for symptoms. Pt was restless at time of visit - difficult to administer to pt.
Chest tightness started 14 hours after injection. Continued to hurt 24 hours later, low grade fever, severe nausea, headache, sore arm, fatigue
1/12 vaccination 6:30 I felt nauseous. Vertigo. Started to get chills and HA. Progressively got worse. 103 temp middle of night. Asthma was bothering me. Took my nebulizer, tylenol and motril. Called employee health; COVID test/negative, Symptoms lasted 2 days.  PCP ONLINE; prescribed prednisone *Irritated my asthma for 2 weeks which was very unusual for me. Couldn't work because I couldn't breath with the 2 masks required. I would start to wheeze really bad just walking up flight of stairs.
Left deltoid area got swollen, red, warm to touch. Swelling approx. 4" x 2" area.
sore arm, slight fever, extreme fatigue. lasted most of the day and they are gone now.
malaise; knot forming near the elbow, below the injection site; Limited ability to place her arm above her head / decreased mobility; swelling at injection site; arm is still painful; pain at injection site; Fatigue; This case was reported by a consumer and described the occurrence of injected limb mobility decreased in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date 15th April 2022) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix. On 13th October 2020, less than a day after receiving Shingrix, the patient experienced injection site swelling, pain in arm, injection site pain and fatigue. On 14th October 2020, the patient experienced injected limb mobility decreased, malaise and mass. On an unknown date, the outcome of the injected limb mobility decreased, mass and pain in arm were not recovered/not resolved and the outcome of the injection site swelling, malaise, injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased, injection site swelling, malaise, mass, pain in arm, injection site pain and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and the patient reported pain at injection site, swelling at injection site, fatigue, and malaise. The patient reported that the next day, she experienced a knot forming near the elbow, below the injection site.   The patient reported that the arm was still painful and she had limited ability to place her arm above her head without the pain increasing. The soreness and the decreased mobility of the injected arm was still present, but all other events had resolved. The reporter did not consent to follow-up.
within 30 seconds of the injection I felt my breathe slow up , got dizzy and heartbeat was beating irregular. The doctor can over , took my blood pressure, pulse rate and stayed with me and told me to concentrate on my breathing. He said my heart was beating with an extra beat but believed that was maybe the way my body reacted to stress. Symptoms got less in 5 mins,although I felt weird, it took everything I had to drive home, was on the verge of going in panic attack, had high anxiety and felt choppy like, like shakey nerves. I am still having these symptom today, so it's4 full days now.
A report has been received from a Health Professional concerning a Child, patient of unknown gender, who had received Nasal FLUMIST Quadrivalent (Intranasal), was started on an unknown date. FLUMIST administered to patient outside the approved age indication. Child came into doctor's office today to receive the second dose of FLUMIST. The doctor covering realized that the child had just turned 2 years old on January 14th 2016. This meant that the first dose was administered back in Dec 2015 when the child was not 2 years old yet. The outcome of inadvertent administration to child less than 2 years of age was unknown. The report was considered to be non-serious. The reporter and the company physician both considered inadvertent administration to child less that 2 years of age to be unrelated to FLUMIST Quadrivalent.
Red itchy welts all over my body; began 2/7/21 at approximately 10am; self-medicating so far with Benadryl every 4-6 hours since approximately 10pm on 2/7/21.
This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored VAQTA (dose volume, lot number, expiry date were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
He woke up the morning after getting the shot with a fever, flu like symptoms, and a few hives on his body. As the day went on, the hives got worse. On Thursday, 11/16, I called the dr. and took him back in because the hives were getting worse and really starting to itch. I gave him a dose of Benadryl before calling the doctor. Dr. did a strep test and sent us for a chest X-ray but didn't think the hives were a reaction to the flu shot. She called in 3 days of Prednisone 20mg Tab and he started taking those + Benadryl for the rest of the day. By 11:30 that night, the hives and itching were unbearable and my husband took him to the ER and he was given an IV with more Benadryl, more steroids, and Pepcid. On Friday 11/15, he was still miserable so we did a telemedicine visit with another doctor who prescribed another 2 days of steroids and said it would just need to run its course. We started adding another allergy medicine - xyzal - the the Benadryl and Pepcid and that seemed to help with some of the itching. On Sunday, 11/17, we did a on-call dermatologist appointment because the itching was still not getting any better and was prescribed Triamcinolon 0.1% Cream. We are now almost a week after the flu vaccine and the hives are still all over his body - neck, legs, back, arm pits, face, etc.  He is getting some relief from the Triamcinolon 0.1% Cream and we are still giving him Benadryl, Pepcid, and xyzal as directed.
After 5 hrs pt had high fever, cough, dry mouth. After 8 hrs her heart was flittering. Then she went to trauma center. They gave her 50mg of BENADRYL.
Have had spells of tiredness, headaches and sometimes nausea since the vaccine. Also, noticed my urine was staining the toilet bowl. After a few weeks I  started having a strange feeling after urinating. I was a feeling of "letting down" or needing to urinate some more, but I couldn't go anymore.  This feeling went on for several weeks and then I also started to have some discomfort in my abdomen and back. I didn't worry about it for a while. Thought it would go away. As it started getting worse I wondered if it was my kidneys, so I called my nephrologist. I did not personally see or talk to him, just his assistant. They sent orders for 3 urine tests.
Developed extreme pain, redness of right arm following Pneumovax. Called doctor at home that evening. Follow-up call was placed to pt on 12/2/03.
Fever, complaining of leg pain X 2 days, large red and tender area 7.5cm X 11cm. Dx'd with local reaction at Prevnar site.
feeling sick and ache; runny nose; feeling sick and ache; little headache; Fever; tired; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feeling sick and ache), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), PAIN (feeling sick and ache) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-1900, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 12-Mar-2021, the patient experienced FATIGUE (tired). On 13-Mar-2021, the patient experienced HEADACHE (little headache) and PYREXIA (Fever). On 14-Mar-2021, the patient experienced ILLNESS (feeling sick and ache). On 15-Mar-2021, the patient experienced RHINORRHOEA (runny nose). On an unknown date, the patient experienced PAIN (feeling sick and ache). At the time of the report, ILLNESS (feeling sick and ache), RHINORRHOEA (runny nose), OROPHARYNGEAL PAIN (sore throat), PAIN (feeling sick and ache), FATIGUE (tired), HEADACHE (little headache) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.  No concomitant medication was provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Outcome of events updated to Recovered/Resolved.
Day 1-headache-no treatment Day 2-fever, headache, nausea, body aches, chills-no treatment Day 7-rash, left arm, topical ointment on continued through today Day 7-carbonated drinks taste flat continued through today
Initially began with pain in the upper left arm and at site of injection. After three hours, urticaria rash spread to ears, legs, stomach, back, both hands, both feet, both arms, neck, and face. Sought medical attention on 11/8/2018 from work place clinic, on 11/9/2018 from medical facility, and on 11/11/2018 reported to the emergency room. I was prescribed Benadryl, Allegra, and Zyrtec-D on 11/8/2018 and 11/9/2018. On 11/11/2018, the ER clinical staff prescribed me Prednisone and Ranitidine. After taking two doses of Prednisone and Ranitidine, the urticaria symptoms were reduced.
Acute Appendicitis that led to an appendectomy.  Symptoms: severe abdominal and back pain, nausea and vomiting, diarrhea (8-2-21, starting at about 7:00 PM)
Delivery of vaccine was inappropriate. Vaccine given too high. Pt complaining of continuous bleeding after administration, even >12 hours later, and continuous increasing arm pain. She is a nurse and says the vaccine was administered too high.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 11:27 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 11:27 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 51.57.  Concomitant products were not provided.  For Lot no 041L20A on 11-Jan -021, excursion time was at 2 PM with temperature 35 a nd on the same day vial was moved to clinic.  On 12-Jan-2021, excursion time was 8 AM and 9 AM temperature was 34, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021, vial was moved to clinic on 12-Jan-2021. 3 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Received 4th Anthrax shot and blood pressure was 158/102, 45 minutes after shot. On 4/17 or 4/18, left work 4 hours early due to extreme fatigue. BP did drop to normal, 20 minutes later. Also, had localized redness and swelling, 4" in diameter. All symptoms were concurrent with previous Anthrax shots.
29 hours after vaccines given pt developed fever and severe headache requiring visit to ER. Symptoms lasted 24 hours.
Went to emergency room.  Diagnosed with cellulitis.  Symptoms were large red/pink rash on arm between injection site and elbow, warm, swollen, and painful.  Prescribed Keflex (cephalexin) 500mg, 4 times a day, for 10 days.  Symptoms improved after 48 hours of taking oral antibiotics.
pt recvd vax; exp sore arm, tender to touch & red welt size of baseball;
Fever 103.2 degF 4 days after vaccine. Felt unwell, achy joints reddened eyes, sore throat; bad headache (x 1 week). Sore throat started Tuesday. Get dramatically better on Thursdau; Antibiotics - amoxicillin 500mg tid started on Sunday (6-11-08); Well by Friday; No cultures done, PMD not seen
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 05-JUL-2017 the patient was vaccinated with GARDASIL 9 lot # M033583 dose 4 for prophylaxis. On 05-JUL-2017, 1 day after onset of therapy the patient experienced extra dose administered. On an unknown date the patient experienced inappropriate schedule of drug administration and no adverse event. The outcome of extra dose administered, no adverse event and inappropriate schedule of drug administration is unknown. The reporter considered extra dose administered, no adverse event and inappropriate schedule of drug administration to be not related to GARDASIL 9.
Myalgia & Rash Narrative: Left arm swelling at injection site, size of tennis ball, red, warm, and itchy
Description of Event Pt received vaccination at 1205. Experienced dizziness with syncopal episode at 1224.  Interventions:Patient given water, instructed to lie recumbent, vital signs taken, observed for 30 mins.  Medications administered: none   Response to interventions and/or medications given: Patient status improved.    Disposition:Home Treatment Pt accompanied by mother.
Patient received Pfizer Pedi dose (0.2 ml) instead of recommended standard dose (0.3 ml).
R leg with edema, induration, heat. Fever 101 deg F x 3 d. Given Rocephin IM in ER. Given po Zithromax.