chrisvoncsefalvay/vaers-outcomes huggingface dataset:
*PROGRESSION* NEAR IMM, MUSCLE TENSION - THROAT TIGHT, - HEADACHE, DIZZY NAUSEA & VOMITING, MUSCLE PAIN, HEART RACING FOR PROLONGED TIME SHD HAVE GONE TO ER BUT IM POOR. PROGRESSED FROM APPROXIMATELY 12 PM TO 2:30 AM (14 HRS) SEE ATTACHED  IT GREW INCREASINGLY WORSE & I WAS CLOSE TO BEING TAKEN TO ER. I FINALLY FEEL ASLEEP APPROXIMATELY 12 MIDNIGHT (SHOT WAS 11AM). I WOKE @ 2:30 AM & IT WAS PASSED. NO RESIDUAL - JUST GONE. (NOTHING BEYOND EXHAUSTION FROM < 14 HRS ILL). EVENT WAS VERY FRIGHTENING - THIS WAS MY FIRST SHOT. I HAD FLU SEVERE LAST YR - AGAIN, WERE IT NOT FOR $ I WOULD HAVE SOUGHT MED HELP). SO, BECAUSE OF LAST YR I THOUGHT SHOT WD BE PRUDENT! NEVER AGAIN.
Chills, body aches, headache that lasted about 36 hours- all set in about 8 hours after vaccination.  This is my first pregnancy and I?m due at the end of October. No affect on the pregnancy that we know of so far.
After vaccination my arm started getting sore and swollen and it's now eight weeks later and it's still sore and swollen and hard.  I went to the ER on the 31st and got an ultrasound and said there was not a blood clot. I have an appointment with the orthopedic doctor to see what's going on with my arm.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 66-year-old male patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 8th March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 8th March 2018, 10 hrs after receiving SHINGRIX, the patient experienced chills. On 9th March 2018, the patient experienced malaise and myalgia. In March 2018, the patient experienced fever. On 9th March 2018, the outcome of the chills was recovered/resolved. On 12th March 2018, the outcome of the malaise and myalgia were recovered/resolved. On an unknown date, the outcome of the fever was unknown. The reporter considered the chills, malaise, myalgia and fever to be related to SHINGRIX. Additional information was received as follows: The health care professional who himself a patient reported that about ten hours after administration of dose of SHINGRIX, he experienced chills overnight for four to five hours. The patient also experienced myalgia and malaise, which he noticed in the next morning and it, lasted for about 3 days. After conversation with call center representative, caller mentioned that the patient also experienced a fever after receiving SHINGRIX. No additional information was obtained. The reporter was certain this was due to the vaccine.
Swollen lips, eyes, tongue, throat, temp of 102.1 at 7:45 PM. Took PROAIR HFA at 2:30 thinking I was having issue breathing - but progressed to numb tongue - took BENADRYL every 4-6 hrs for 2 days.
Per emergency room notes at 0530hrs on 14 Aug 2012: +fussy and fever Tmax 100.9 axillary; eczematous rash upper and lower extremities and abdomen.
Patient recieved the smallpox vaccination on July 18, 2013, with no restrictions. Then on 29 July she developed a widespread macular, papular rash to her chest, abdomen, lower extremities and upper arms. The rash originated in her left lower leg.  The rash was accompanied with itense itching along with body aches.  Patient described pain as a burning sensation.  She did have a hx of chickenpox as a child.  Initial treatment consisted of Benadryl, calamine lotion and oral acyclovir, as recommended by the CDC.  On 31 July the rash hand intensified, so I had the patient seen by a physician upon pulling into port.  The clinic physician agreed with the current treatment plan and consulted with a dermatologist. Who called the reaction a benign hypersensitivity to vaccinia and prescribed topical triamcinolone and oral Atarax/Claritin.  Upon futher questioning of the patient, we found out that she had a history as a child of hypersensitivity to detergents and other skin conditions.
7 days after injection, itchy red hives on stomach and legs and left arm and around rib cage. Took antihistamines and has not gotten better yet. (Have had for 2 days now)
Dizziness, Headache, Myalgia, Arthralgia, Fever, Rash, Diarrhea, NauseaVomiting, , Chills, Fatigue, Injection site pain, Injection site swelling, congestion Narrative:
On 6/1/09, pt. called & left a message that following having received VARIVAX, she developed a rash on her arm. The message was misplaced, but an RN tried to call pt. on 6/5. Dr. also called, but neither were able to reach her. (She was already on her trip). On 6/22, pt. called to say that she received steroid medication from her PMD before departing on trip. She reports that the rash has cleared up.
SHE GOT FIRST DOSE OF THE PFIZER VACCINE AND GOT JOHNSON AND JOHNSON VACCINE 4 MONTHS AGO; This spontaneous report received from a patient and concerned a 67 year old female. The patient's weight was 101.15 kilograms, and height was 166 centimeters. The patient's past medical history included: pace maker for heart, and concurrent conditions included: stage 4 kidney failure, controlled high blood pressure, and depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was reported and has been requested. Concomitant medications included rivaroxaban for blood thinner, and bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced she got first dose of the pfizer vaccine and got johnson and johnson vaccine 4 months ago. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of she got first dose of the pfizer vaccine and got johnson and johnson vaccine 4 months ago was not reported. This report was non-serious.
Five minutes after the shot I felt lightheaded and funny. Then my heart started to beat hard.  It didn't last too long and by the time I told the nurse she checked my pulse and said it was strong but normal. They watched me for 30 min. I felt better, but ever since then I have had flutterings of the heart.  I called my doctor who said it was nerves and to take the second shot. About ten days later I went to Urgent care who did a electrocardiogram and said it was normal, they didn't catch the flutterings.  They told me it was nerves and to take the second shot. 14 days after the shot I took Claritin D which seemed to calm the heart.  I am taking it every day now, until I'm sure the flutterings are gone.  I'm pretty sure I had an allergic reaction and I will not be taking the second shot unless you can assure me I should. I called my doctor again and was told they weren't seeing sick people, go to a heart specialist, although they didn't recommend one.
Information has been received from a medical assistant referring to a 5 month old female patient. No relevant medical history or concurrent conditions were reported. On 06-JUL-2015, the patient was inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322.  Additional information has been requested.
7 hours after vaccination patient experienced onset of headache, diffuse myalgia, chills, fever, anorexia, and fatigue.  Maximum temperature was 103.0 degrees F.  Reaction resolved after 30 hours.
Patient received pneumonia vaccination on 9/29/2010 and presented to her PCP w/a 4 X 4 inch hot, red swollen area around the injection sight. Patient was given a steroids shot at PCP office and told she take ibuprofen and elevate arm.
This spontaneous report as received from a healthcare worker refers to an 8 year old patient of unknown gender. The patient's concurrent conditions and medical history were not reported. On 21-AUG-2015, the patient was vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number L005297 and expiration date 23-SEP-2016; dose and route of administration were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A physician reported that a 4 month old infant received a dose of Prevnar and presented with a fever. A lumbar puncture was done which war purulent. The culture grew out pneumococcus. Dx: Pneumococcal Meningitis. This event was considered "Medical Important". No further information was available as of the date of this report.
HOT WAVES; NIGHT CHILLS FOR SEVERAL HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number No concomitant medications were reported.  On an unspecified date, the subject experienced hot waves, and night chills for several hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the night chills for several hours and hot waves was not reported. This report was non-serious.
Getting hives as of Jan 3, 2022 in the morning. They're persistent and get worse when I touch any surfaces.
3/30/21- Chills, inability to sleep, nausea 3/31/21 - Chills, Headache, severe Muscle/body aches, runny nose, fatigue 4/1/21- chills, headache, muscle/body aches
Suspected vaccination failure/shingles hurts more; Shingles hurts more; Shot hurts; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure/shingles hurts more) (serious criteria GSK medically significant), shingles (Verbatim: Shingles hurts more) and pain (Verbatim: Shot hurts). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 04-MAR-2023 This case was reported the patient via interactive digital media. The patient reported that the vaccine shot hurts and shingles hurts more, much more. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Concomitant products included GABAPENTIN for an unknown indication.   On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant). At the time of the report, SEIZURE (Seizure) had not resolved.            Since past Tuesday, patient suffered a seizure, and has been in the hospital ever since then. So far, the doctors have not been able to figure out what the problem was. No Treatment information was provided.  Company comment: This spontaneous case concerns a 25-year-old female patient with no medical history and co-administration of Influenza vaccine, who experienced the unexpected serious (hospitalization and medically significant) event of Seizure after mRNA- 1273 vaccine. The event occurred approximately 6 days after the booster dose of mRNA- 1273 vaccine and led to hospitalization. Very limited information is available regarding course of hospitalization, diagnostic work-up and treatment received. Co-administration of Influenza Vaccine remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 25-year-old female patient with no medical history and co-administration of Influenza vaccine, who experienced the unexpected serious (hospitalization and medically significant) event of Seizure after mRNA- 1273 vaccine. The event occurred approximately 6 days after the booster dose of mRNA- 1273 vaccine and led to hospitalization. Very limited information is available regarding course of hospitalization, diagnostic work-up and treatment received. Co-administration of Influenza Vaccine remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Developed rash on opposite arm of injection within several hours. Parent took child to PMD. Dx hives had cortisone inj & prednisone rx.
On Saturday the 30th well I started off I didn't feel good. I noticed that I had a temperature of around 99.6 and I normally don't get a fever. As it got later I aching, a bad cough and diarrhea. During the night I temperature of around 101. The next morning I called my son and he came over and he called an urgent care who advised him that is was probably a reaction to the vaccine and to give me Tylenol. I got better and my temperature went down yesterday (Monday). I still didn't feel good on Monday and slept all day.  I still feel a little washed out today.
Shoulder became sore at vaccination site about 3 hours after receiving it. Fever began about 5 hours after and was treated with ibuprofen, rose 2.5 degrees before 200 mg of ibuprofen was taken. Chills, body aches, muscle tremors and stomach cramps began about 7 hours after the injection. All of those symptoms continued for 16 hours and were treated with 200 mg of ibuprofen as needed. Vomiting occurred 14 hours after the injection, just once. Fever returned with headache, stabbing abdominal pains and mid back pain 30 hours after the injection. Ibuprofen was taken and fever lasted for 3 hours before disappearing indefinitely. Headache continued for another 12 hours. Fatigue, body aches and stomach cramps continued for another 36 hours. All symptoms were treated with rest and fluids.
Heart & BP Event: Angiogram - to rule out heart attack - heart looks good and no blockages; Echocardiogram - showed small area in left ventricle thinning/bulging; MRI of heart - findings were consistent of acute myocarditis. I am on 2 additional BP medications and 1 heart medication. I was in the hospital for 5 days.
Client stated on phone that woke up night of 11/1/16 with extreme pain, warm at injection site, relieved by Ibuprofen. Felt better while active next day but pain returned night of 11-2-16. On 11-3-16 she noted injection site(s) were red and hot and hardened, area = to "the palm of my hand". Resolved in 2 days after with no lasting effects. Had both vaccinations in (L) deltoid due to HX shoulder surgery.
Patient had erythematous blanching patches erupt on chest, abdomen, back, arms a few minutes after vaccines. No wheezing, no emesis, no diarrhea, no lip swelling. No evidence of anaphylaxis. Was given 12.5mg diphenhydramine and monitored in clinic. Patient improved, thus discharged home. Next day, has a phone visit with physician to follow up, patient continued to do well, did have one fever, the next day, thus given Tylenol, resoled with Tylenol. Called mother again 4/25/21, patient continues to do well without symptoms.
I developed mild tingling and swelling of my lips and tongue and a slight tightness in my throat.  No trouble breathing.  My stomach feel upset.  Now I am having tingling in my left hand.  I took more Zyrtec and Benadryl and made an appointment with a doctor.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 37-year-old male.  Neither medical history nor concomitant medications were reported.  On 26-Jan-2009, the patient received expired FLUMIST vaccine.  The vaccine had an expiration date of 11-Jan-2009.  As of 18-Mar-2009, there were no adverse events reported through the medical clinic associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak fo the flu season resulting in some medication errors that occurred shortly after the product expired.  Additional information was received on 12-May-2009: product complaint investigation results.
Pt recvd 1st & 2nd dose of Hep b vax 15AUG90 & 17SEP90, respectively; lab eval revealed SGPT 112 & SGOT 50; subsequently, pt recovered; no further details were provided;
Arm soreness; Fatigue; Racing  pulse; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain in arm, fatigue and pulse rapid. On an unknown date, the outcome of the pain in arm, fatigue and pulse rapid were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fatigue and pulse rapid to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine approximately 4 or 5 months ago (reporter was not sure of exact date) and experienced arm soreness, fatigue, and racing pulse. The patient reported all symptoms resolved after approximately 2 to 3 hours. The reporter did not want to provide more information. The reporter did not consent to follow up.
This is a spontaneous report from a contactable physician. This report was received via a Pfizer sales representative. This Physician reported similar events for 3 patients. This is 1st of 3 reports. A patient of unspecified age and gender received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician reported 3 kids (including the patient) last 2 years; patient reported flu-like symptoms with high fevers after the use of meningococcal group b rlp2086. No other vaccine given at the time. Some went to the ER and were diagnosed with having vaccine reaction. The outcome of the events, flu-like symptoms and high fevers, was unknown. No follow-up attempts are possible; information about batch number cannot be obtained. Sender's Comments: Linked Report(s): US-PFIZER INC-2018325374 Same reporter and suspect drug, similar events in different patients; US-PFIZER INC-2018325373 Same reporter and suspect drug, similar events in different patients
Thrombocytopenia (ITP) Pt had BLLE petechial rash, with BLLE and BLUE bruising as well as bloody blisters in the oral mucosa   IVIG + Prednisone
Tingling sensation of mouth, tongue, and lips.  Hives appeared across  upper chest, arms, and cheeks.   After taking 50mg Benadryl (diphenhydramine), the mouth sensation subsided quickly. Approximately 24-36 hours later, I experienced mild localized pain and lump in left arm at injection site. Large rash with fluid filled blisters on left upper arm. Redness, warmth, swelling of upper arm.  Burning/itching sensation (bad enough to wake me up at night). I experienced this reaction with all three COVID vaccines (3/26/21, 4/16/21, 4/10/22). with the first two doses, the mouth/tongue reaction occurred within 30 minutes and subsided with Benadryl. With the third dose, I took Benadryl proactively and did not experience the mouth sensation, just the painful rash. The rash lasts approximately 7-10 days and does not improve much with Benadryl every 6 hours and application of hydrocortisone cream. I also experience sever diarrhea approx 3-4 days after each shot when the rash is at its worst.
Had itching, redness, and pain at injection site within ~ 15 min. progressed to "dry throat that felt swollen" within 2 hrs.
13AUG98 p/vax pt slep 10hr, lack of appetite, pounding h/a, cold legs, skin flushed, listless, feels sick, diarrhea;
Vaccines were given on 3/9/01. On 3/10/01 the mom noticed increased erythema. The child complained of severe pain in the left arm. The child had a temp of 101-103. On 3/12/01 the erythema covered an area of 10 x 20cm that was indurated and warm.
5 days after vaccination I was eating dinner and I felt very "strange" and I could not remember the name of the foods I was eating at that moment. After 10-15 minutes, I could remember the names of the food. I thought I was having a stroke.
Patient received Vaccine Booster (Dose 3) which had hindsight was expired past 10 weeks in refrigerator temperatures. (8 days past)
Information has been received from a nurse concerning a 11 year old female who was vaccinated intramuscularly with a dose of Gardasil. There was no concomitant medication. Subsequently the patient experienced pain and numbness immediately after vaccination. Subsequently, the patient recovered from pain and numbness. Additional information has been requested.
Tinnitus medium to high pitch buzzing in both ears. Started approximately 10 days after first shot. Still present.
Diarrhea 4 to 5 times per day starting 5 hours post injection, and hasn't stopped yet. Fever 11 days post injection. Child is easily tired and complaining of pain in legs.
About 30 min after being vaccinated with second dose Pfizer, patient reported feeling dizzy with tingling sensation in fingers. Ice pack applied to back of neck, BP taken x2 (high with no known history of HTN)- patient refused a third reading,  and juice/water was refused by patient as well. He stated his current symptoms were similar to what happens prior to anaphylaxis with shellfish. Transported to
A report has been received from a Health Professional concerning a 26 year old. Female subject, who had been receiving FLUMIST 2 doses. FLUMIST started on 17-SEP-2013. It was reported that the patient was administered two full doses of FLUMIST, one in each nostril on 17-SEP-2013. The outcome of the event of TWO FULL DOSES OF FLUMIST, ONE IN EACH NOSTRIL is unknown. The report was considered to be non-serious.
Pt received Gardasil #1 10/29/13. On the evenings/nights of 10/29 and 10/30 he reported to his doctor feeling as if the room were "spinning", "dizzy" woke at night to use bathroom and walked or fell into his door. Felt off balance-during days and subsequent to this felt fine. Question if he can safely continue vaccine series. Also received flu vaccine same day.
Received vaccine at doctors office on 2/8/10 about 9:30 am at 4:00am the next morning I woke up and my head had what looked like hives all over it. It itched very bad. That lasted about 24 hours. My arm was very swollen & hot. That soreness lasted about 48 hours. Called my doctor and went into office.
4cm x 2cm area of redness and swelling around area of injection with warmth. Instructed to apply warm compress and observe. To return to office if worsening of Sx. The follow up received on 10/16/03 states left thigh (Prevnar site) problem area.