chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It was a fully body rash the developed over the course of 24 hours.  The night before I noticed a bit of itching an a bump that seemed like a bug bite. The following morning I had many such bumps in clusters on my neck and arm (and a few more bumps on my legs). At the time I thought I had bed bugs. By about 6 PM, I had more bumps and many of them had spread and turned into welts. There were bumps and rashes on all limbs, my neck and redness on my chest and back, The itchiness was severe. While not extremely painful, it was extremely uncomfortable and seemed like it would be hard to sleep or do anything.  Around 9 PM I took Allegra to try and alleviate symptoms. I also used hydrocortison cream and calamine lotion all over my body to reduce symptoms of itching.  By around 11 PM, I the rash was spreading into my face in the form of some bumps and redness. I visited the ER after consultation with a nurse over the phone, who said that anaphylactic shock could be a possibility and that it would be best to go in.  At the ER, I was treated with 50 mg diphenhydrAMINE , 20 mg famotidine , 10 mg dexAMETHasone. I was given a prescription for dexAMETHasone and instructed to take a refill in 3 days if I still had symptoms. I was discharged a couple hours later.  I did not need to refill the dexAMETHasone  as the sympoms subsided and was almost unnoticeable by day 3 (and completely gone by day 4).
Light Dizziness .BP 130/62,P61,Pulse Ox 96, R20.Took BP meds this AM.  PO fluid offered accepted. 13:35  States he feels good will drive home. Instructed to notify his PCP or EMS if symptom returns /severe. Verbalise understanding.
Patient developed hives between his (R) thumb and index finger. Took 50mg of Benadryl and Sx resolved.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 36-year-old female. Neither medical history nor concomitant medications were reported. On 09-Feb-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events 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 of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
vaccine given at 9:30.   At 9:45 Patient experienced severe nausea and dizziness.   Blood pressure 90/60 pulse 74 O2sat 98 room air.   She started vomiting.   As per doctor; transfer to ER.  Patient transfer to ER via EMS at 10;17a
Severe sciatic nerve pain in right leg within 24 hours of vaccine. Doctor had no answer other than physical therapy, which was ineffective. Symptoms continued for 18 months, then went away within a few days.
Saline diluent used a second time for a second pfizer vial . No adverse events reported
Had pneumo shot same time, same arm.  Now very red, very tender and swollen. Swelling started approx. 2 hours post shots.  General fatigue sore muscles, weak in both arms 4 hours post.  Pain so severe, that she became nauseuous 14 hours post.  Two days in bed, third day a little improvement in general fatigue.  Still swollen, very tender and red in left arm at site of shots.
Incredibly arm soreness. Difficult to lift and move. Hurts to the touch. Headache, nausea, chills, low grade fever 99.9
Father called clinic later in the evening stating patient's left arm was warm to touch, firm, tender.
Severe itching at site and formation of multiple small bumps surrounding injection site injection given and still having problems w/bumps, itching, scabbed lesions on Oct.
liver enzymes to be elevated; This is a spontaneous report from a contactable consumer.   A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration on 05Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. 09Apr2021, the blood work they conducted showed his liver enzyme to be elevated. The patient underwent lab tests and procedures which included liver enzymes to be elevated on 09Apr2021. At the time of reporting, the outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report has been received from a Medical Assistant refers to a unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX injection, lot # M024680, expiration date 18-MAY-2018, lot # M028546, expiration date 07-JUN-2018 and lot# M028552, expiration date 07-JUN-2018 (dose, site and route of administration were not reported). No adverse effects were reported. The vaccines experienced a temperature excursion of between -10 and 8 Celsius degrees (C) for 2 hours and 21 minutes, which was detected by a digital data logger. There was previous temperature excursion: for vaccine with lot # M024680 between -10 and 8 Celsius degrees (C) for 21 hours and 7 minutes; for all other lots # between -10 and 8 Celsius degrees (C) for 18 hours. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013571:
Rash to all four extremities and face, patient c/o itching. Patient stated she took Claritin and that she does not think it has spread to anywhere else on her body.
Myalgia, Fever, 106 FEVER, CHILLS, BODY ACHES Narrative:  Other Relevant History:
At 10: 30 child received vaccine, a couple of minutes later he collapsed onto the ground, waking up moments later.  RN assessed child, all systems were within normal limits, vital signs stable. Paramedics called, and upon evaluation of child deemed him stable, and informed family to follow up with child's pediatrician.  Mom states post-vaccination that syncopal episodes post-vaccination "run in family" and that child felt dizzy before vaccination (has fear of needles).  None of the above information was indicated by the family on pre-vaccination screening.
10 minutes after receiving MMR vaccine subcutaneously, developed a 1.5 cm wheal that itched and hurt at the site of this vaccine administration. Treated with ice, benadryl 12.5mg PO and observed. 22 minutes after vaccine, began to develop facial redness, ear swelling and urticaria on the hands and feet. Never hypotension, wheeze, respiratory distress or oropharyngeal swelling.Treated with epinepherine IM 0.15 mg. 30 minutes after epinepherine administered, child had no urticaria and only 2 cm wheal at the injection site. Treated with benadryl 12.5 mg Q4hr while awake for next 48 hours with complete resolution of all urticaria by 4 hours after injection. NO recurrence in past 24 hours since vaccine
Hoarseness; a slight soar throat; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right upper arm on 25Feb2021 at 13:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic asthma under control with medication. The patient was not aware of any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ADVAIR and SPIRIVA inhalers for asthma, from an unknown date.  On 25Feb2021 at 14:45, the patient experienced hoarseness and a slight sore throat, much better on reported day (01Mar2021) and hoarseness was not as bad as the first day. It was reported that the patient wanted to know if she would have the same problem when she receives the 2nd dose which was set for 18Mar2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events hoarseness and a slight sore throat was resolving at the time of the report.   No follow-up attempts are needed. No further information is expected.
Sx vomiting, fever, irritability, decreased sleep. Tx: 5cc fluids (po) over 5 min - TYLENOL.
Severe inflammatory response resulting in hamstring tear from attempt to jog (3 steps), rotator cuff injury from light weightlifting. Dr. prescribed prednisone for 5 days to relieve inflammation. Inflammatory response to exercise slowly decreased over the next 3 months, although I still have not recovered full strength.
Fever ranging from 101.9-103.0, spots on belly, thighs and face for 5 days after shot. Lasting until 9 days later. Extreme crying, discomfort, sleep disturbance and possible throat discomfort.
their arm was sore for a couple of days and no other symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "their arm was sore for a couple of days and no other symptoms". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional information: A person not known to the reporter mentioned they had gotten their latest Pfizer COVID-19 vaccine in casual conversation. They reported their arm was sore for a couple of days and had no other symptoms. The exact date of the vaccination and number of prior vaccines doses this person received was unknown. No other information was reported or collected.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Started with hives 2 hours after shot..then 1 hour later..tongue swelled, lips swelled, stomach started hurting,difficulty breathing
Patient was behind in baby vaccination do to always having chronic ear infections so she received her 12 mos shots when she was 17mos old at the time the P.A. had said that because she had no fever with double ear infection that she had to have her 12mos shots I had just given my daughter motrin about one hour before her appointment and I stated that I felt that the P.A. should wait for the vaccinations in till she felt better the P.A. denied my requested and told me she has fallen way behind. when I took my child home is was no longer then 40 minutes when she had a major seizure I jump in to my car and rush her back to the doctor's office the P.A had left the office so the doctor order antibiotic shot's in both of her legs to fight the bacteria that was in her little body from then on I notice that she was falling behind in her childhood skills finally when my daughter kept on having unusual tantrums holding her ears and screaming uncontrollably don't touch me for 45 minutes in fists finally by the time she was 3yrs olds I demand that my daughter be tested for Autism Dr. sent her to a pediatric Neruoloist and she was diagnose with moderate Autism. I believe that the MMR with the other mixture of shots that day Caused my daughters Autism.
This retrospective pregnancy case was reported by a physician and described the occurrence of neonatal jaundice a male neonate subject who was exposed to BOOSTRIX (GlaxoSmithKline) taken by the mother during pregnancy. On 26 August 2011 at 14:31 the mother of the subject received a dose of BOOSTRIX (.5 ml, intramuscular, left deltoid) when she was approximately 38 weeks pregnant. The baby (one fetus was reported) experienced maternal vaccine exposure. The mother's estimated delivery date was 05 September 2011. Date of last menstrual period was not provided. Conception was normal. The male neonate was on delivered on 09 September 2011, at 41 weeks gestation via normal vaginal delivery. The neonate weighed 8 pounds and 13 ounces, was 20 inches long and had an head circumference of 14 cm. No defects were noted at birth, however, the baby experienced neonatal jaundice and delayed return to birth weight at an unspecified time following delivery. Outcome of the events was not reported. Linked mother case suffix is A0943039A.
This spontaneous report as received from a registered nurse refers to approximately 21 years old female patient. On an unknown dates, the patient received the first dose and a second dose of GARDASIL (lot number, expiry date route and dose were not reported). After receiving the second dose of vaccination, on an unknown date in 2008, the patient was diagnosed with Hodgkin's lymphoma. The patient had sought medical attention (office visit). The patient was treated with chemotherapy and radiation. On an unknown date in 2008, the event Hodgkin's lymphoma had resolved and the patient was in remission from approximately the past five years. The patient had not received dose 3 of GARDASIL yet. Upon internal review, the event Hodgkins lymphoma was considered as medically significant. Additional information has been requested.
Hyperpigmentation of lower extrememities. Dark discoloration of skin from the pelvis down to ankle
The adverse event was administering MMR too soon at 15 months old. Treatment is not necessary as this is still considered "valid dose" according to CDC guidelines.
Narrative: She developed nausea about 45 minutes after the initial vaccination,  which lasted for about 1-1.5 hours prior to spontaneously resolving. It was not associated with vomiting, abdominal cramping or diarrhea. After resolution, she was able to tolerate oral (both food/liquid) intake.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of 13 months old child patient and unknown gender. On 01-AUG-2014 the patient was vaccinated with a dose of an improperly stored M-M-R II (lot H020255, expiration date not reported)(dose, route, were not reported). No adverse effect was reported. The outcome of events reproted was unknown. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Paresthesias distal to injection site (ulnar nerve distribution): onset 6 hours after administration, fading alongside inflammation around injection site 18 hours after vaccination. Fever, headache, lightheadedness, nausea: onset 11 hours after administration, with nausea persisting until 30 hours post-vaccination. Neck pain, mild bilateral cervical adenopathy: onset 11 hours after administration, with right-sided neck pain persisting beyond all other symptoms (hour 128+ post-vaccination).
Individual received 1st dose of Covid 19 vaccine manufactured by Pfizer, their age of 14 years does not meet standard listed in the EUA.
On day10, 01/22/2021 about 3pm I went to touch my arm and it felt sore. When I got home from work, I noticed what looked like 3 round/oval shaped redness and swelling spots that were warm to touch on my arm, I applied Benadryl cream and that helped decrease. The next day the three spots had became one and was the size of a tennis ball; it was red, a little swollen and warm to touch. The following day (today 01/24/2021) the the redness and swelling had grown about 6 inches wide and 5 inches in height; I took Benadryl 25 mg po and within 30 minutes then swelling and redness had began to decrease, warm to touch was still there and it began to get a little itchy but very manageable, I applied benadryl cream and that seemed to help a little, but when cream wore off it began to get a little itchy, but still very manageable; I did not reapply the cream.  No pain or discomfort at the area of concern on any days above.
For 3 1/2 days after the shot I experienced nausea, diarrhea, migraine headache, fever and total exhaustion and during the following 10 days I had a constant headache and sore theoat.
Redness, Body Aches, Nausea, tired, arm pain around injection site.  Next day: arm war to the touch, redness, unable to raise arm, arm pain. Took Tylenol 500 mg (2times), Swollen under armpit, PCP said it was a bacterial infection.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The nurse reported that multiple unspecified patients were vaccinated with improperly stored RECOMBIVAX HB (dose, route, lot number and expiration date were not reported) on multiple unspecified dates. The nurse did not have temperature excursion information as RECOMBIVAX HB was being stored in the pockets of the administering nurses uniform. No adverse effects had been reported in any patients. No other information was available. Additional information is not expected since the reporter did not consent for further contact.
This case was reported by a physician via sales rep and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced feeling unwell, fever, general body pain, weakness, fatigue, malaise and influenza. On an unknown date, the outcome of the feeling unwell, fever, general body pain, weakness, fatigue, malaise and influenza were unknown. It was unknown if the reporter considered the feeling unwell, fever, general body pain, weakness, fatigue, malaise and influenza to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported feeling very sick after receiving SHINGRIX. The symptoms included, fever, body aches, extreme fatigue, weakness, and malaise. According to the doctor this patient felt sick for about 7 days, and reported feeling as though she had the flu.
Last year in November I did have COVID. Each time I got the vaccine I would have a headache, a low grade fever, and chills. I would take Tylenol, and it would relieve those symptoms. I was tired as well. Last Monday night I started bleeding from my rectum. A few weeks before that I had loose stools and diarrhea. I had chronic bathroom issues. I started seeing the blood last night. My stools were totally black and loose. I went to bed. Then it did it again and it was getting worse. I went to a hospital. The doctor told me I was bleeding in my sigmoid colon. They placed a temporary clip where the bleeding was coming from. They told me if the bleeding started happening again to go back to the hospital so that they can stop it. I left the hospital on Wednesday. I will see my GI doctor tomorrow. They don't know why it happed and if it will happen again. I do still have loose stool but there is no blood. The whole time I was at hospital I was bleeding. I was prescribed Pepcid, but I have stopped taking it. The doctor also took me off of Spironolactone. I was released from the hospital on 12/3/2021.
Has patient who had 1st dose of covid vaccine. Has tested positive for covid virus; Has patient who had 1st dose of covid vaccine. Has tested positive for covid virus; This is a spontaneous report from a contactable consumer via a Pfizer-Sponsored Program. A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. On an unspecified date, the patient had tested positive for covid virus. The patient was supposed to get second dose end of this week. The patient enquired about what we recommend as far as quarantine and 2nd dose appointment. Lab data included SARS-CoV-2 test positive on an unspecified date. The outcome was unknown. Information on the lot/batch number has been requested.
DIZZINESS; EYE PAIN; MEMORY FAILURE; CHILLS; HEADACHE; 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. The patient's pre-existing medical conditions included the patient never had health problems. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced dizziness, eye pain, memory failure, chills, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness, eye pain, chills, memory failure and headache was not reported. This report was non-serious.
pain in the arm; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported that female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiry date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. Patient received Pfizer Covid-19 vaccine 2nd dose and experienced pain in the arm on an unspecified date. Wanted to know if she can take Ibuprofen after the shot. The outcome of the event was unknown.  Information about the Lot/batch number has been requested.
patient had stinging pain to bilateral abdomen injection site, the left site hurts more; bilateral injection site swelling; patient had stinging pain and swelling bilateral abdomen injection site; Initial information regarding an unsolicited valid non-serious case was received on 14-Oct-2020 from a nurse (on behalf of consumer) (Reference number- 00315838) and transmitted to Sanofi on 14-OCT-2020.  This case involves a 62 year-old male patient who experienced stinging bilateral abdomen pain (left site hurts more) and bilateral abdomen swelling at injection site (vaccination site inflammation), (vaccination site pain), (vaccination site swelling), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious stinging bilateral abdomen pain (left site hurts more) and bilateral abdomen  swelling at injection site (vaccination site inflammation), (vaccination site pain), (vaccination site swelling) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were unknown.  There will be no information available on batch number for this case.