chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in on Sept 1st to report that after given first shingrix vaccine she had really bad pain.  It hurt badly as it was being administered and for a week she couldn't lift her arm any higher than her shoulder. It was very painful and burning and still doesn't feel right.  She still had a red spot on her arm.
Patient fainted a couple of minutes post injection. He was "out" for less than a minute. EMS was called to monitor vitals and released. Patient indicated after the fact that he is afraid of needles
Acute Unilateral Sensorineural Hearing Loss; This is a spontaneous report from a contactable physician. A 58-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), intramuscular in left arm on 11Jan2021 at a single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies and was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient previously received the first dose of bnt162b2 on an unknown date for COVID-19 immunization. The patient experienced acute unilateral sensorineural hearing loss on 17Jan2021 07:00 with outcome of not recovered. The event caused physician office visit.  Therapeutic measures were taken as a result of acute unilateral sensorineural hearing loss that included prednisone. The patient was not tested with COVID-19 post vaccination.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, there is a reasonable possibility that the event acute unilateral sensorineural hearing loss is related to suspect vaccine BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient noticed redness and swelling at injection site with itching - area 7cm x 5cm, red and raised.  Temperature 99.
Anaphylaxis x- scratchy throat at +10 mins x- swollen tonsils at +15 mins x- difficulty swallowing at +20 mins  x- voice changed noticably at +30 mins, subsequently lost x- Some heart palpitations and chest tension at +45 mins x- Angiodema of right eye +90 mins
Initial unsolicited case received from a nurse via Merck on 05 February 2015. A patient had received a TYPHOID VACCINE (manufacturer, lot number, route and site of administration not reported) on an unspecified date "many years ago" and subsequently experienced an anaphylaxis reaction. Treatment was unspecified, and the event recovered. The reporter in this case did not wish to be contacted for further information. Documents held by sender: None.
Body ache, body chills, headache, fatigue, irregular start of period.   Took Tylenol. It lasted for about 48 hours.
knee was sore; extreme fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee was sore) and FATIGUE (extreme fatigue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00153352) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (knee was sore) and FATIGUE (extreme fatigue). At the time of the report, ARTHRALGIA (knee was sore) and FATIGUE (extreme fatigue) had resolved.            She stated that she did not report any adverse reaction. She is curious as to who could have reported this. She said she didn't have any reactions after the first shot. The knee pain happened before the vaccine. She said that she has a history of arthritis and that the sore knee doesn't have anything to do with the vaccine. The first shot was 01-Apr-2021 and not sometime in March. After the 2nd shot which was on 19-May-2021, she had extreme fatigue but she is fine now. She does not wish to be contacted further.   This case was linked to MOD-2021-089072, MOD-2021-089072 (Patient Link).
pt recv vax & exp a h/a, sore throat & devel a rash;no further details were provided;
During the visit, patient had what was consistent with a vasovagal syncope after administration of his vaccines, witnessed by his mother and the nurse administering the vaccines. He was immediately laid down, given fluids to drink.  Vitals remained stable. He was monitored for approximately 3 hours and recovered.
This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL intramuscular (dose and lot # were not reported). On an unknown date the patient experienced postural orthostatic tachycardia syndrome after receiving GARDASIL. The outcome of this event was reported as recovered/resolved. This is one of several reports received from the same reporter. Additional information has been requested.
pain in arm; stiffness of shoulder/neck; tenderness; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tenderness), PAIN IN EXTREMITY (pain in arm) and MUSCULOSKELETAL STIFFNESS (stiffness of shoulder/neck) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced TENDERNESS (tenderness). On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm) and MUSCULOSKELETAL STIFFNESS (stiffness of shoulder/neck). At the time of the report, TENDERNESS (tenderness), PAIN IN EXTREMITY (pain in arm) and MUSCULOSKELETAL STIFFNESS (stiffness of shoulder/neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
PATIENT HAD A GOLF BALL SIZE LUMP UNDER HIS RIGHT ARMPIT THE NEXT DAY FOLLOWING THE VACCINE,  SOUGHT TREATMENT FROM HIS DR 06/02/2021, PATIENT SAID DR PRESCRIBED ANTIBIOTIC AND ULTRASOUND TEST-OUTCOME UNKWON AT THIS TIME.
red swollen circle, 2 inches in diameter, body aches, hot and tight, slightly off center of deltoid; no treatment yet
Painful injection site, redness and swelling at injection site, hardness at injection site, extreme fatigue, body aches, and chills for about 12 hours the day after injection. 48 hours after injection, no more chills, fatigue, or body aches. 48 hours after injection, still redness, pain, and hardness at injection site.
Donor began feeling general malaise on 01/03/13, with congestion and cough. Generalized soreness in left extremities. Tetanus was given on 12/31/12. Donor felt fine upon leaving the center.
Patient experienced a raised, blistery looking red patch. Patient was given diphenhydramine 12.5mg x4, hydrocortisone 1% with aloe & two ice packs. She was advised to call the pharmacy if it worsened.
On the 18th she started getting swelling in both legs. She had nerve pain and swelling in both hands. The swelling in her legs became indented. By mid Jan 2022 the swelling in her legs got a little bit better but she developed pain in both shoulders, elbows and knees. She has seen her pcp and a medical naturalist doctor.
pt stated this was his first dose in his vaccine consent form so  one dose of  moderna was given per protocol. I later found out when batch filling that pt had already got 1 dose of jansen covid vaccine in April 12/2021. Pt did not provide pcp contact and unable to talk to pt to inform so voice mail was left for him to call back as this moment.
Swollen hands; Hands are Itchy; Sweating; flu-like symptoms; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen hands), PRURITUS (Hands are Itchy), HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (Chills). On 30-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen hands) and PRURITUS (Hands are Itchy). On 29-Apr-2021, HYPERHIDROSIS (Sweating), INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (Chills) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen hands) and PRURITUS (Hands are Itchy) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not reported.   Reporter did not allow further contact
While on Humira for Crohn's he developed swelling in both hands. He is being evaluated now for Rheumatoid Arthritis. He notes that he recently also had a Shingrex vaccine
Patient developed erythematous, generalized, somewhat itchy rash 72 hours after flu vaccine. Follow-up on day 5 showed a generalized, papular macular erythematous rash that was mildly raised.
pt devel fever, pruritic rash, myalgia p/vax;addtl info was recv 11OCT96;pt was treated w/Medrol & recovered;this is 1 of 3 pt from this site to have an adverse exp p/Td vax w/lot# 433355;
Fever & chills accompanied by nausea in the middle of the night after the shot,  all continuing into the next day. Did not take temperature but especially at night felt quite warm. Did not vomit, but felt very close -- nausea was intense. Taking extra strength acetaminophen every 6 hours till symptoms cease.  Mild headache and body aches.
Vaccine Adverse Event Report  May 8th, 2021. Patient, had an appointment for his 2nd dose of Pfizer Covid 19 vaccine May 8th 2021 at 10:00am. His first dose of Pfizer Covid 19 was at our Pharmacy on April 16th, 2021. At around 10:15am, patient came in with his fiancé, who is a doctor at pediatric department, shown on her name tag. After processing the paperwork needed for vaccination, Pharmacist on duty, went over the VAR to ensure the provided information was adequate before it was ready for my intern to administer the shot. Patient looked fine as I was able to have a brief conversation with him while waiting for the shot. Due to some insurance issues that needed to be resolved, at 10:40am, pharmacy intern, took the patient to Patient Health Room for immunization. At 10:45am, I was ringing up a prescription at Terminal 42 when hearing the word, Help, coming from the Patient Health Room. Within seconds later, the door was opened as I was running out the pharmacy toward the Patient Health Room to see what happened. The patient was lying on the floor, unconscious, while his fiancé was calling his name asking whether he was okay and rolled him to his side and supported his head. I reached into the cabinet and prepared to administer an EPIPEN to the patient, meanwhile, pharmacy technicians, asked and dialed 911. As his fiancé kept calling his name, the patient gained consciousness. I asked intern what had happened to clarify whether it was a reaction due to the vaccination or not. Meanwhile, the patient's fiancé stated this event was not unexpected. Patient was able to talk and confirmed he was fine. Unfortunately, it appeared that the patient bruised his nose and forehead with slight blood from a minor cut. We instructed the patient and his fiancé to stay in the room and offered assistance upon request until EMS arrived. Patient's fiancé requested an ice pack for his bruise. Later on, the patient appeared to be shaking, so I asked the fiancé whether it was okay to give him some GATORADE. His fiancé also requested a glucose meter to check his blood sugar. The EMS arrived within minutes and patient was transported to hospital Before they were leaving, I asked the fiancé if there was anything she would like us to do as well as offered a follow-up. She declined the offer. I also asked briefly if she could share his medical condition, but the fiancé only disclosed that the patient has needle anxiety. The EMS also said that they will take it from here, and there is no additional action needed from our end at this time. Each team members who were involved in the event wrote reports and kept them filed in the pharmacy records.
Headache; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache".  Additional Information: After the patient's first Pfizer vaccine dose, she had a headache for one day and that was it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021346314 Same patient and product; different dose and event
15 mo. old male admitted to hospital 5/4/12 for dehydration second to 8 episodes of emesis & 9 episodes of loose stool. 1 lb wt loss in 2 days. Poor PO intake. Stool cultures ordered, rotavirus was positive. Discharged 5/8/12 in good condition.
(L) arm swelled 2nd day after vaccine. 3rd day seen by Dr, slightly warm to the touch, redness 17 x 10 cm where vaccine was placed firm raised area 3.5 x 3.5 cm.
Chills, sweating (fever unknown, did not take temperature). Local swelling, lymph nodes swelled under right arm.
Numbness in face; Sickness; injection site got swollen; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in face), ILLNESS (Sickness), VACCINATION SITE SWELLING (injection site got swollen) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in face), ILLNESS (Sickness), VACCINATION SITE SWELLING (injection site got swollen) and RASH (Rash). At the time of the report, HYPOAESTHESIA (Numbness in face), ILLNESS (Sickness), VACCINATION SITE SWELLING (injection site got swollen) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-314553, MOD-2021-314553 (Patient Link).
Father reports that patient developed a fever of 102.6 and had redness and swelling at the site of the injection. He reported swelling was the size of a softball. He also developed sores in his mouth. The child had a red throat. He was prescribed Keflex 250mg QID.
Gave 17 & 1/2 year old  the Janssen by mistake instead of the Pfizer which is approved for the patients age group.  Called CDC and they  said the patient does not need another vaccine at this point and to fill out the vaers adverse event form.  Patient  and Grandfather were made aware of the error  and were fine with  it.  No other adverse event followed.
Swollen, red splotchy right arm, hot to touch, and child complained of itchiness and pain. ER physician prescribed antibiotic and motrin- diagnosed cellulitis based on visual inspection. Arm got worse turned purple, more swelling and area affected spread from shoulder to mid forearm. Went back to ER said spreading was expected and FU with Pediatrician. Pediatrician said reaction to Dtap vaccine not cellulitis.  Continuing on antibiotic treatment, Motrin, and added Benadryl in case of allergic reaction.
This spontaneous report was received from a 77 year old male patient regarding himself. The patient's concurrent conditions included chronic pain due to herniated disc and medical history included chronic lymphocytic leukaemia (CLL). The patient had previously experienced drug allergy while on LYRICA. On 31-OCT-2016, the patient was vaccinated with ZOSTAVAX, one shot/once, parenteral (reported as injection), (lot # unknown, expiry date: 31-OCT-2017). Concomitant therapies included bolus dose intravenous morphine, gabapentin, omeprazole and other unspecified medications. On an unknown date in 2016 (reported as with in 24 hours of administration) the patient experienced headache and pain in his feet. The pain started first and was followed by a headache. The patient reported that the pain in his feet felt like "walking on gravel" and pain lessened while he laid down which he stated was "normal when he get that type of pain". The pain was "3x more intense than it was today". The patient did not sought any medical attention and treated the pain by giving himself "a little more morphine but the morphine did not help" and he suspected that this was due to a "reaction with morphine he takes for his chronic pain". No laboratory tests were performed. The patient felt better today and described himself as fully recovered (event stop date: unknown date in November 2016). Causality was not provided by the reporter. No product quality complaint was involved. Additional information has been requested.
Fever, fatigue, body aches, irritability, jolting pain in arm given the shot
pt revcd vax & the next day exp fever, chills, sleepiness, & a rash on chest & neck; resolved 3 days later;
Patient had her vaccines and went down to the lab for blood draw. She started crying just before the blood draw and held her breath turning blue. Her mother blew on her face and she took a breath and turned pink. Started crying again and agin held her breath but this time she had a generalized tonic clonic seizure lasting 15 minutes. Required Diastat and oxygen.
c/o pain in the left ear, left side of neck, left upper motor area pains. Erythema and induration in his left arm (deltoid) injection site.
Someone who received vaccine and is experiencing blood clots; Hair loss; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Someone who received vaccine and is experiencing blood clots) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Someone who received vaccine and is experiencing blood clots) (seriousness criterion medically significant) and ALOPECIA (Hair loss). At the time of the report, THROMBOSIS (Someone who received vaccine and is experiencing blood clots) and ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported.  Very limited information regarding these events has been provided at this time. No follow up is possible.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up  added event to main portion of report.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
After the first shot of the Moderna vaccine, I had the aches and chills and fatigue all night and then I was fine. Then the next day I started filling my neck hurting. I have received two massages since then to help with the neck pain but it isn?t getting better. It feels like my neck muscles are really tight and then at the nape of my neck where my neck and my head meat is excruciating pain when I look up. I have tried multiple Massages and ibuprofen but it isn?t working.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 09:00 as dose 1, single (Lot number: EL3249), on 08Feb2021 at 13:00 as dose  2, single (Lot number: EL3249) and on 22Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FF8841) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing); "DM type2" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: OTEZLA, start date: 24Sep2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
MIS-C. Started with symptoms on 11/30 , seen 12/2, 12/3, 12/4, 12/7 and admitted to PICU on 12/7.
Caused flare of current diseases. Possible cause of migraine with unbearable pain bad enough to go to the Er
This didn't happen to way later, on the left node behind my ear, I thought it was an insect bite. I showed it to the doctor and I went back a few weeks later it was even bigger. When I went to the dermatologist it was even bigger and they thought that it could be cancer.
Per mom- 6 hours after receiving ADACEL - pt c/o headache, nausea, felt febrile -mom did not take temp. Started vomiting at 1:00 pm - mom called us at 5: PM - told to go to ER. Admitted with severe dehydration. Released 2 days later per mom, pt is now fine, back to school.
Left arm swollen, red, tender, hot. MD wrote a script for AUGMENTIN in case of infection.
Information has been received from a health professional concerning a 6 year old female patient who on 02/18/1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck).  Subsequently, on approximately 04/09/2004, the patient developed breakthrough chickenpox with less than 50 lesions.  Follow up information indicated that there was not a single report of adverse reaction following varicella vaccination.  The reporter indicated that 49 other patients developed breakthrough cases of chickenpox.  No additional information is expected.
06/06/2008 Developed, itcy rash on right leg and stomach.  Saw Physician, placed on antibotic, rash completely gone(per mom) 06/07/2008.  Patients mom denies other signs or symptoms.