chrisvoncsefalvay/vaers-outcomes huggingface dataset:
06/05/14 - Described a "bug bite" feeling at site, 5 minutes after injection. 3 hours after injection, pt reports dizziness, blurred vision, joint pain. Reports a headache the next morning, went to an urgent care center and received BENADRYL. Patient reports no symptoms on 06/06/14. No changes in vitals on 06/05/2014. 06/12/14 - Reports dizziness within hour after injection. Reports lightheaded, lasted two days. 06/26/14 - Reports dizziness within hour after injection. Denies other symptoms.
Nausea, vomiting, muscle aches in both shoulders and in chest, chills, and tiredness. Event started about 5:15PM and symptoms subsided about 10:50PM the same day.
Patient's father phoned office approximately 1/2 hour after leaving her appointment to report puffy, swollen eyes.  Instructed to return to clinic.  Patient returned about 1/2 hour later with flushed skin, swollen face and eyelids and rash to most of body.  Patient was breathing fine.  Patient was treated with Epinephrine, ZYRTEC and monitored for approximately 1 hour.
mom reports redness, itching and pain approx. the size of a baseball, BENADRYL 25mg given by mouth 6-25-08 - redness decreased
PT DID NOT KNOWN LOT NUMBER AS SHE COULD NOT FIND VACCINE CARD, SITE NOT SPECIFIED Patient presents to clinic for ongoing "rib pain" since 4/8. Patient received Pfizer vaccine #2 on 4/7/21 at pharmacy. On 4/8 she developed "violent" emesis and "dry heaving" at least 9 times. She also experienced significant diarrhea. As of 4/9 her condition had greatly improved, however she was experiencing "soreness" under her rib cage on the right extending around side to back. Since then she has sporadically taken NSAIDs and Tylenol with only mild symptom relief. She still has soreness with turning trunk to the right. The pain is not worse with inspiration. The pain is a dull ache, sometimes sharp with movement. No rash has ever been present nor has pain been burning/stinging in quality. She was unable to provide lot number of vaccine as she could not find her card. Pain 6/10  She was placed on a course of 800mg TID ibuprofen for muscle strain of accessory muscles, instructed to use ice/heat to area to relieve inflammation. No respiratory involvement. She was instructed to follow up with PCP for further evaluation in 2 days or go to ER if symptoms suddenly worsened or changes.
Muscle spasms; Could barely walk; This is a spontaneous report from a contactable consumer (patient's child). A female patient of an unspecified age (reported as 77, unit unknown) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot/batch number and expiry date were unknown), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had muscle spasms the next day (16Jan2021). The reporter is trying to find out if this is still a side effect, because she had the vaccine the first day (15Jan2021), then on the second day (16Jan2021) she was fine when she woke up that morning but then had muscle spasms and she could barely walk. The outcome of the event muscle spasms was not recovered, while for the other event was unknown.  Information about the lot/batch number has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: el0142), in left arm, on 15Jan2021 as dose 2, single (Lot number: el3247), in right arm and on 28Sep2021 as dose 3 (booster), single (Lot number: ff8839) at the age of 52 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: antigen positive since symptoms unto present. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient did not have any other medication in 2 weeks. The patient started Paxlovid on 17May2022 for Covid-19 and stopped the treatment on 22May2022.  No follow-up attempts are possible. No further information is expected.
Initial misuse report received from a healthcare professional on 09 August 2013. It was reported that DAPTACEL was administered to a 12-year-old patient. No adverse event was reported. List of documents held by sender: none.
Pt explained the following: June 24 2021: mild chills and generally not feeling well for about 12 hours. started 24 hours after shot June 26th: severe indigestion june27: first welt was noticed on bottom of foot in the afternoon. experienced  welts primarily on hands ,feet and mouth for several days. Also had a few spots in upper thigh and buttocks. Welts would go away after 6-12 hrs. Benadryl did not help June 30: Last day experience of welts July 22: Second Moderna shot, never really felt very sick July 25; Lips swells up. Wets on hands, feet, mouth, upper thigh, buttocks primarily continues for several weeks. Splotchy red rash on torso comes and goes. Eventually gets welts on arms as well. Some welts take days to fully heal.  Most welts go away after 6-12 hours. Welts become greater in number and last longer as weeks progress. took Benadryl but did not help. Had serve indigestion twice during this period of time between July 25th-August 30.  Aug 30; Went to pcp for help to alleviate conditions Was prescribed prednisone taper pack took for a week, 10 mg cetirizine qd, 40 mg  pepsid qd. welts we're completely gone within 12 hrs of starting medication. Sept 17: woke up with swollen lip.  Had taken cetirizine and famotidine daily.  Swelling gone after 12 hours. Sept 18: Woke up slight indigestion similar to few times before contd. throughout day Sept 20: A welt on bottom of right for, welt on buttocks sept 24: swollen upper lip and welt on left hip sept 25; welt on buttocks Sept 26: welt on upper thigh sept 28: red spots on arms sept 29": spotty rash on inside of both ankles oct1st: welt on left wrist oct 3:rd swelling on top of left foot oct 4th: swelling on bottom of left foot. Welt on buttocks, stomach, right elbow
Patient called on 03/24/22 to pharmacy and stated that she had defecated in the bed over the night twice and also complained of rectal pain that started overnight as well. she states that she intends to go to the er today, but wanted to call us first to let us know.
Extreme arm pain, arm swelling the day after injection. Large arm rash and redness on upper left arm, across chest, neck and face. Benadryl was taken and relieved some of the symptoms. When Benadryl was stopped my arm would swell back up and the rashes and pain would come back. Difficulty breathing began on 1/13/22. Benadryl dose was double and breathing was normal again for 6 hours. I took 2 Benadryl and ibuprofen  every 6-8 hours around the clock for 3 days straight until symptoms eased. I currently still have moderate left arm and left should pain but is manageable with ibuprofen.
heavy bleeding with lots of blood clots; extended and heavy menstrual period/ heavy bleeding with lots of blood clots; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer product), lot no. EN5318, via an unspecified route of administration (left arm) on 19Feb2021 at a single dose for COVID-19 immunisation at a workplace clinic. Medical history included high cholesterol and anxiety. No known allergies. No COVID prior to vaccination. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (brand: Pfizer, lot no. EL9261, left arm) for COVID-19 immunisation on 30Jan2021 at age of 50 years old. No other vaccine in four weeks. The patient was experiencing extended and heavy menstrual period. Her cycle began on 05Mar2021 and was still happening as of today 16Mar2021. She had heavy bleeding with lots of blood clots. This was not normal for her at all. She is calling her doctor tomorrow. No treatment received for the events. No COVID test post vaccination. The outcome of the events was not recovered.
Exactly 1 week after receiving dose, my left arm became swollen and itchy about 2 inches below the vaccine site. The area affected was about 3 in x 1 in. The redness and swelling proceeded to get larger over the next 24 hours, and now is about 5 in x 6 in. I have started oral doses of Benadryl. Today, my throat is a little sore and feels swollen.
Approximately one week after the booster, I began experiencing a decrease in hearing (both ears), with a muffled sound. My glands under my jaw were slightly swollen. I took a Medrol Dospak for 6 days starting January 2nd. The symptoms came back. I saw Dr. on 1/26/22, and her exam revealed blocked eustachian tubes bilaterally and mild swelling in the glands below my jaw. Otherwise the rest of my ENT exam was normal. I had no other symptoms. My ears are still muffled, although getting better on a second round of steroids.
Fever, chills, shakes, headache, body aches, leg pains Please note - This date was for my second injection. I had the same side effects after the first dose in July. I will say that they were more severe in July
p/vax pt c/o numbness in the arm & @ times in the fingers;also some soreness in the arm & h/a when arm hurts;pt still exp some discomfort but much better than yesterday;
burning like fire behind knee; it itched behind knee; it was dark cranberry red; rash started to spread in dots to other parts of her body; a rash behind her right knee; ran a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning like fire behind knee), PRURITUS (it itched behind knee), ERYTHEMA (it was dark cranberry red), URTICARIA (rash started to spread in dots to other parts of her body) and RASH (a rash behind her right knee) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced BURNING SENSATION (burning like fire behind knee), PRURITUS (it itched behind knee), ERYTHEMA (it was dark cranberry red), URTICARIA (rash started to spread in dots to other parts of her body), RASH (a rash behind her right knee) and PYREXIA (ran a low grade fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ALOE VERA at an unspecified dose and frequency. On 15-Feb-2021, PYREXIA (ran a low grade fever) had resolved. At the time of the report, BURNING SENSATION (burning like fire behind knee), PRURITUS (it itched behind knee) and ERYTHEMA (it was dark cranberry red) outcome was unknown and URTICARIA (rash started to spread in dots to other parts of her body) and RASH (a rash behind her right knee) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications include stomach medications.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Telephone contact report was received on 14-JUL-2021 and contains significant information and start date of fever was updated and outcome of rash was updated to not recovered/ongoing and concomitant medications which were missed initially it was captured now and  reporter contact details were updated.
Hands-sore and itchy with skin peeling off generalized rash on body-small red spots. Very tired.
Pt Given vaccine at 1:14 pm with father in room. Father asked to receive his vaccination while his son was in the room as the mother was watching the daughter who also has cognitive impairment. Pharmacist complied with the parents request. Upon completion of the father vaccination. Pt became synoptic. Pharmacist braced patient maintining him in the chair while the father rotated to the rear of patient to support his head. Pharmacy team provided water and monitored BP until EMT arrived, cleared patient as stable. The Patient declined EMT Transport as parents did not have POA.
Possible AE; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Possible AE) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Possible AE). At the time of the report, IMMUNISATION REACTION (Possible AE) outcome was unknown.            Concomitant products were not provided. It was reported that patient received second booster. Treatment medications were not reported.   Reporter did not allow further contact
It was reported in a published article that a 12 month old, with a history of always being constipated, who in September 1993 was vaccinated with a dose of MMR (second generation). According to the patient's mother, he lost his acquired speech and eye contact by 12-15 months of age and had now been diagnosed with autism. Concomitant therapy included a dose of measles virus vaccine when the patient was 18 months old. The author noted that vaccination of women around conception may lead to stillbirths, premature delivery and vanishing twins. It cal also be frequently associated with early onset autism. It was also reported that in spite of its limitations, this study suggests that an autism/vaccine connection may exist. Upon internal review, autism was considered to be an important medical event (OMIC). It was unknown if medical attention was sought. Follow-up: A copy of the published literature was attached as further documentation of the patient's experience.
The patient received the Pneumovax injection in the Right arm and on 1/7/09 she had noticed increased pain in the arm along with 2 areas of redness and swelling. The patient also complained of genralized joint pain, weakness and a headache.
swelling and redness at injection site; swelling and redness at injection site; bad taste in mouth; chills and aches; chills and aches; pain in arm at injection site; tired, sluggish, drained; tired, sluggish, drained; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 02 patients. This is the 2nd of 2 reports.  A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EJ1689), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The reporter stated she and her mom had side effects. Reporter clarified her mother seemed like she was really sick, chills and aches, pain in arm at injection site, swollen arm, bad taste in mouth, states today she took band-aid off and it is swollen and redness at the injection site, states she is very tired, sluggish, drained. Both she and her mother received the vaccine in the left upper arm. The outcome of the events bad taste in mouth, chills and aches was resolved on 12Jan2021, while the outcome of the other events was not resolved.
FEVER,  CHILLS, NAUSEA, FATIGUE, FLU-LIKE SYMPTOMS, TREATED WITH TYLENOL 650MG BID, EFFECTIVE - SYMTPOMS RESOLVED
Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Medium, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Confusion-Medium, Systemic: Fever-Severe, Systemic: brain fog, left eye spasms, severe headache. swollen left armpit lymph node-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Nausea-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Weakness-Medium, Additional Details: Patient had a virtual consult with provider on February 23rd at 11:52am.   Was instructed to rest, take acetaminophen for fever and report any additional symptoms that persist/worsen. Pateint also reports he had similar adverse effects after the 2nd vaccination but did not report to pharmacy or provider at that time (mainly severe headache, fever/chills, brain fog and tender left armpit lymphnode).
Information has been received from a physician concerning a male who on 11-SEP-2007 was vaccinated with a second oral dose of Rotateq. Concomitant therapy included sulfamethoxazole/trimethoprim (BACTRIM) for an ear infection. Subsequently the patient experienced intussusception. The patient was taken to the emergency room and was treated with an air enema reduction. It was reported that the patient recovered. The patient's intussusception was considered to be immediately life-threatening by the reporter. Additional information has been requested.  10/18/2007 Vax record recieved and info updated in VAERS database. 10/30/2007 MR received for hospital DOS 9/27-30/2007 for D/C DX of Reduced Intussusception on air enema.  Infant presented to the ER with intractable vomiting and dark, bloody bowel movements as well as excessive sleep.  PE (+) for lack of bowel sounds, lethargy, and depressed fontenelle. (+) Currant jelly stool in ER.  Barium enema successfuly reduced IS.
Rash on arms, hands, fingers,rash is still bad,rash is discouraging; Big hives on her neck, face, shoulders, back, and chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on arms, hands, fingers,rash is still bad,rash is discouraging) and URTICARIA (Big hives on her neck, face, shoulders, back, and chest) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 022C21A and 003C21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu vaccine (Regular Flu vaccine IM Fall 2020). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Blood pressure high (In the past. prior to receiving Moderna vaccines, No changes in status recently).   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 09-Jan-2022, the patient experienced RASH (Rash on arms, hands, fingers,rash is still bad,rash is discouraging) and URTICARIA (Big hives on her neck, face, shoulders, back, and chest). The patient was treated with RANITIDINE HYDROCHLORIDE (ZANTAC) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH (Rash on arms, hands, fingers,rash is still bad,rash is discouraging) and URTICARIA (Big hives on her neck, face, shoulders, back, and chest) had not resolved.            No Concomitant product use was reported.  The patient reported that they received the first Moderna booster dose on 07-Jan-2022 and on 09-Jan-2022 the patient developed a rash on their arms, hands and fingers and big hives on their neck, face, shoulders, back, and chest.  The patient reported one month after dealing with the rash and hives, the patient went to see their physician one month after visiting the pharmacist and was prescribed a steroid dose pack. The patient mentioned the steroid dose pack didn't helped the patient's rash or hives. The patient mentioned that now the patient was using topical creams and Zantac for treatment, as the rash and hives were still bad and discouraging (ongoing).   The patient also reported that some mornings their face and neck were plastered with hives. The patient mentioned they would likely not get the second Moderna booster dose since the patient developed rash and hives after the first booster dose but would talk to their physician about it.  It was reported that the patent had no allergies. The patient never ever had COVID + test or diagnosis. The patient had never experienced a similar event in the past. The patient also reported that the symptoms had worsened.  The patient's height reported as 5 feet 3 in.  Treatment medications reported also included Steroid dose pack and topical creams.
received Trumenba instead of Bexsero; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 27th December 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 28th January 2022, the patient received TRUMENBA. In January 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the patient received inadvertently Trumenba instead of Bexsero as 2nd dose, which led to interchange of vaccine products. The reporter consented to follow up.
I recieved the TDAP Shot on Monday... I noticed a reduction in fetal movement I went in to my doctors on friday morning and after an ultrasound no fetal heart beat was found and I was told my baby had died. Later Friday afternoon I was admitted to the hospital and they induced labor. I delivered the baby early in the morning on August 2 2014. Prior to the TDAP shot I was having a "text book" pregnancy and the Baby had always been active and strong.
This initial spontaneous report was received on 23-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 09-SEP-2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 20-JAN-2015, she was treated (by an unspecified healthcare professional) at a medical group facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The female patient has been prescribed Gabapentin for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Pt recv vax on 10/20/98; on 10/21/98 pt exp red, irritated,flushed skin w/ itching & tenderness from head to toes.