chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received ZOSTAVAX on 12-28-13 at pharmacy. On (R) arm. States within 3-4 days developed red erythematous rash at injection site. When seen by physician assistant on 1-14-14, pt had developed other areas of rash with blisters predominantly on (R) upper arm not crossing hemispheres. Pt denies have history of chicken pox. Pt was prescribed acyclovir 800 mg five times daily for 7 days.
The mother of the client called stating that the client broke out in hives after taking the first dose of the oral Typhoid vaccine.
tired (first dose); This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired (first dose)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hidradenitis suppurativa (Patient has a immune condition). Concomitant products included DOXYCYCLINE for Hidradenitis suppurativa.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced FATIGUE (tired (first dose)). At the time of the report, FATIGUE (tired (first dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-321025 (Patient Link).
shortness of breath, arrhythmia.  Referred to Cardiologist.  Recommended scope to check the heart for clots, shocked heart back to normal sinus rhythm.
Information has been received from the patient's mother referring to an approximately 26 year old female patient who was not pregnant. The patient had no pertinent medical history and no drug reactions/allergies. On 20-OCT-2010 the patient was vaccinated with the first dose of GARDASIL (lot # 666598/0786Z, expiry date 18-OCT-2012), on 22-DEC-2010, the patient received the second dose of GARDASIL (lot# 666929/0331Z, expiry date 20-NOV-2012) and on 27-APR-2011, the patient was administered the third dose of GARDASIL (lot# not provided, expiry date 25-FEB-2013) (dose and route unspecified).The events began after the third dose of GARDASIL. In approximately 2011, the patient "started with stomach pain, and violent headaches". It was also reported that the patient had an "out of body feeling like she wasn't there" which was identified by her physician as a petite-mal seizure. The following summer (2012) it progressed to grand-mal seizures. She had a total of 9 grand-mal seizures between 2012 and the present day. She had a "few petit-mal ones." She was "not the same person that she was", she suffers from body ailments which they try to help with diet but never seems to be fully resolved. She had at least Magnetic Resonance Imaging (MRIs) but they couldn't find anything wrong with her brain and they couldn't do an electroencephalograph (EEG) until after the seizure." On an unspecified date, the patient spent time at a seizure disorder clinic where she was "wired for a full week 24-7." They were unable to duplicate the seizure during that week. The patient was placed on therapy with KEPPRA with maximum dosage on an unspecified date. The patient had only had one seizure this past year. The patient had been in the Emergency Room due to the seizures however she was not admitted to the hospital. The patient had no lab diagnostics studies performed. Upon internal review, generalized tonic-clonic seizure was considered as medically significant event. The outcome of generalized tonic-clonic seizure and petit mal epilepsy was reported as not recovered/not resolved. The outcome of abdominal pain upper and migraine was unknown. Additional information has been requested.
Chills and fever, uncontrollably shaking, no energy fever around 99 for four days
CLINICALLY CONFIRMED POSITIVE COVID INFECTION; This spontaneous report received from a consumer concerned a 5 decade old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On SEP-2021, the patient experienced clinically confirmed positive covid infection. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clinically confirmed positive covid infection. This report was non-serious. This report was associated with product quality complaint: 90000197951.
tightness/pressure in chest, hard to breathe, feeling of congestion, cough after a couple of days.  All of this in addition to full body aches, headache, 4 days of extreme fatigue and fever.   Chest pain last for days after all other symptoms cleared.   (no reaction to first shot other than slight headache, soreness at injection sight and slight fatigue.)
Began with fatigue, rash, aches and pains, and progressed to shortness of breath, significant chest pain, indigestion, dry cough, jaw and teeth pain, shoulder pain, back pain, inability to sleep, irritability that continues still as of today.   An appointment at an urgent care clinic resulted in an emergency room visit and later a consult with a Heart doctor who after an initial exam and test recommended over-the-counter anti-inflammatory medication and antiacid medication.  An Echocardiogram is scheduled as the next step. The Doctors diagnosed as Pericarditis.
Patient received the flu vaccine at the hospital. Patient is an employee of the hospital. Patient had no allergies and receives the flu vaccine yearly. Five minutes after receiving the flu vaccine, patient started experiencing symptoms: Dizziness, lightheadedness, clouding of vision and mild chest discomfort. He was initially given epinephrine 0.3ml IM within minutes of symptoms and was taken to the emergency department around 11:25 AM. The patient within minutes of receiving the epinephrine, symptoms began to resolve. He was later given one prednisone 20mg tablet by mouth, diphenhydramine 25mg tablet by mouth once, methylprednisolone succinate IV push once and famotidine 20mg IV once. The patient improved and was discharged from the emergency department at 4:52 PM.
her arm was sore; This is a spontaneous report received by Pfizer from a contactable other healthcare professional (HCP) (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The relevant medical history and concomitant medications were not reported. It was stated that an NP at the clinic also reported her arm was sore following the vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The following morning I woke up pretty sore as expected. By 10 AM on 6/11/21 I had an intense migraine, severe body aches, fever, ringing In the ears, and dry mouth. The day before I omitted afternoon coffee and drank an extra 3 liters of water. I went home from work early, ordered soup, and slept for another  7 hours. Awoke for two hours Friday evening, then went back to bed for another night of sleep. I woke up Saturday morning 6/12 with less of a headache and just muscle soreness, by noon on 6/12 most of the side effects had subsided.
Pain, Fever, and +3 edema starting at injection site (right arm) starting on day of vaccination and continuing into forearm 2 days later.
The pt experienced a red, swollen left arm that is so tight it looks as if it is going to burst. This is from the shoulder to the elbow. Instructed to take the child to PMD.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 18-NOV-2015 the patient was vaccinated with MMRII (lot # L001336, expiration date 13-JAN-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Had pain, redness and swelling at injection site along with muscle pain, tiredness, headache, shivering, fever (103F) and upset stomach. It was definitely from the injection I received. I did not follow up with my doctor because I knew these were the common side effects after receiving the SHINGRIX vaccine. Never have I experienced anything like this from any vaccines I have had previously.
This spontaneous report was received from a nurse and refers to a 6 month old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 11-SEP-2017, the patient was vaccinated with improperly stored vaccines, RECOMBIVAX HB (dosing details not reported) (lot # N006321, expiry date: 08-NOV-2019) and ROTATEQ (dosing details not reported) (lot # M044397, expiry date: 20-JUN-2018, orally) for prophylaxis. No adverse effects were reported. The administered vaccines underwent a temperature excursion from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA007011:
This spontaneous report was received from a certified medical assistant and refers to a 72 year old female patient. The patient did not have any concurrent condition, pertinent medical history or drug reactions or allergies. On 12-JUN-2017, the patient was vaccinated with PNEUMOVAX 23 lot # M042324, expiration date 10-JUN-2018 (dose and route were not reported) for prophylaxis. The patient did not take any concomitant medications. Approximately in June 2017, after vaccination, the patient developed redness and swelling to the right upper arm. Then patient went to a health facility and she was prescribed with Prednisone (manufacturer unknown) (dose and route were not reported) during 5 days, as treatment for the events. No laboratory diagnostic studies were performed and no product quality complaint (PQC) was involved. At the reporting time, the outcome of erythema and peripheral swelling was unknown. The reporter did not provide a causality assessment between the events and the PNEUMOVAX 23. Additional information has been requested.
Altered sense of smell for two weeks. Alteration lingering, but not overwhelming. I also had sore arm, chills, myalgia, joint pain, and fatigue after 1st shot. Second shot just had a sore arm and fatigue.
Sore arm; This is a spontaneous report from a contactable consumer or other non hcp. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number, and Expiration date not reported), via an unspecified route of administration on an unspecified date, as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Patient experiencing pain and redness that is warm to the touch.  The patient is also experiencing pain more than is normal for a vaccine. The patient was advised to go to hospital to get treatment in case signs are of cellulitis.  She is using Benadryl cream to treat but will go to the hospital.  Cellulitis has not been diagnosed and severity of reaction is unknown until she is admitted to hospital.
Large local rxn to DT, itching 48hrs post inject, 72 hrs post inject redness, swelling, inc itching; Redness 12.5cm wide by 15.5cm long;
Pain and inflammation around injection site that started immediately following injection and lasted for 7 days. No treatment. Resolved on its own.
Patient stated that she developed a rash on center of chest approximately 1 day after receiving  vaccination.  She states that the rash has now resolved after 2 weeks . She treated the itchy rash with Neosporin.
Headache, Fever of 103, vomiting, nausea, extremely tired, sore arm
Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; Immediately felt dizzy and still have bouts of dizziness 3 days later. First day was severely disoriented (got lost and confused on way home). Fatigue, mild nausea, some leg pain, diarrhea.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 14Apr2021 at 17:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to food, medications, or other products. 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. The concomitant medications taken within two weeks of vaccination was reported as  birth control (formulation unspecified). On 14Apr2021, the patient immediately felt dizzy and still had bouts of dizziness 3 days later, felt severely disoriented (got lost and confused on way home) on the first day. The patient also experienced fatigue, mild nausea, some leg pain and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event immediately felt dizzy and still have bouts of dizziness 3 days later, severely disoriented (got lost and confused on way home), fatigue, mild nausea, some leg pain and diarrhea was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. The patients were vaccinated with doses of M-M-R II (doses, routes, lot numbers not reported) which were reconstituted with expired sterile water diluent (expiration date May 2012). The nurse noted that 1 or 2 doses were administered on 01-AUG-2012 and approximately 9 other doses were administered on unspecified days. No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected.
Patient contacted pharmacy the following day to inform us of a reaction. Patient stated that she started to feel off (itching hands and feet) when she was driving home.  States around 10am was having some difficulty breathing. Patient states difficulty breathing continued and around 12pm felt like she was blacking out but was able to use her albuterol inhaler at home (estimates 4 to 6 inhalations). Patient reported she lost consciousness and had urinary incontinence. Patient slept a lot the remaining of the day. Patient states has recovered.  Reports right arm is currently red, swollen, and appears bumpy.
Headache, Arthralgia, Fever, fatigue, tender lymph nodes on side of injection  Narrative:
PATIENT RECEIVED JANSSEN VACCINE  BUT IT WAS LATER DISCOVERED HE  HAD ALREADY RECEIVED MODERNA  VACCINE; This spontaneous report received from a physician concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031 and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-APR-2021, the subject experienced additional vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of additional vaccine was not reported. This report was non-serious.
This case was reported by a nurse and described the occurrence of therapy non-responder in a 23-year-old female patient who received ENGERIX B. Co-suspect products included ENGERIX B adult and ENGERIX B. On an unknown date, the patient received the 1st dose of ENGERIX B adult (unknown) and the 2nd dose of ENGERIX B adult (unknown). In 2014, the patient received the 3rd dose of ENGERIX B adult (unknown). On an unknown date, an unknown time after receiving ENGERIX B adult, ENGERIX B adult and ENGERIX B adult, the patient experienced therapy non-responder. Rechallenge with ENGERIX B adult was positive. Re challenge with ENGERIX B adult was positive. On an unknown date, the outcome of the therapy non-responder was unknown. Additional information received on 13 November 2014: The patient completed the 3 doses schedule of ENGERIX B (on 0,1, 6 month schedule). Then, on 07 November 2014, 1-2 months after the series completion, she had titers drawn at clinic and was found to be non-responder (less than 10).
Patient here for TDAP, after injection patient began to have decreasing B/P, clammy skin, and complained of nausea. Continued to have decreasing B/P while sitting or standing only. EMS called patient transported to ER.
bright reddish pink circle on her arm; few pimples; blemishes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of   in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), VALSARTAN, SIMVASTATIN and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
2 days after receiving  1st shot the tinnitus in both ears has gotten much worse. I feel light headed and have headache surges, meaning they come and go in a few minutes.
STABLE ANGINA ANGINA, UNSPECIFIED 3/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient presented for her 2nd COVID vaccine at 17:30 and indicated she had hives after the first dose of vaccine.  She was pre-medicated with Benadryl 25 mg for her second dose at 17:37. Her second dose was given at 18:15 and was held at the vaccination site for observation.  Pt. developed symptoms at 18:32 and c/o tightness in chest, SOB, itchiness, and hot feeling across her back and upper shoulders.  Pt. indicated that she felt like "passing out", and was eased to the floor with Medical First Response activated.  Epi 0.3 mg IM into L. Thigh and Benadryl 25mg IM on L. arm was given at 18:40.  She was transported to the ED subsequently.  Pt. was treated w/ decadron, famotidine in the ED and was discharged at 20:55. 2/4/2021- Doing well today overall.  No further intervention after the ED visit.
Case was vaccinated and boosted against Covid by October 2021, then was hospitalized for Covid in January 2022. Hospitalized at: Hospital  Pneumonia due to COVID-19 virus Assessment & Plan He noted a sore throat and runny nose beginning about two weeks and resolving several days PTA. He was not tested for covid at that time but tested positive on admission. Suspect recent URI was covid. H developed mildly hypoxia after arrival. His initial CXR appeared c/w pulmonary edema due to CHF with diffuse infiltrate. He was diuresed but continued to be hypoxic. Repeat CXR on 1/23 appeared more c/w covid with patchy opacities. He has completed the Pfizer vaccine series including a booster. He was started on dexamethasone x10 days on 1/23 and we are arranging home oxygen.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, sluggishness, cold and shivers. On an unknown date, the outcome of the fever, sluggishness, cold and shivers were unknown. It was unknown if the reporter considered the fever, sluggishness, cold and shivers to be related to SHINGRIX. Additional details were provided as follows: The patient experienced a low grade fever, felt a little sluggish, shivery and a little cold. For tolerance to the 2nd dose of SHINGRIX refer case US2018GSK230529, reported for same patient.
began developing symptoms approx. 4 hrs. following administration of flu vaccine.  Began coughing,& having chest tightness.  Developed 101 temperature with chills and aches and reddened eyes.  Symptoms resolved next day except for reddened eyes.
Pt received hepatitis vaccine 07/02/02. Presented to ER with hives, hypotension. Was treated with fluid resuscitation and steroids. No other eiol of anaphylaxis found.
We went to an allergist and found out he had Dermographia, known a skin writing. Anything that slightly scratches his skin he gets raised welts or hives and marks usual disappear within 30 minutes and it could be triggered by medications and infections. He also has intense itching, itching starts from various things. He was told to take an antihistamine and if he doesn't take it, it gets worse. We were told it could last for years. He also uses hydrocortisone.
Severe body aches Chills Fever Sweats (changed clothes 4 times because wringing wet) Severe headache Fatigue (slept for 24 hours) Vomiting  Nausea Light sensitivity
Listless, drooling, not eating breast milk Nutranigen formula was changed to Similac Alumentum still not eating as well and crying all of the time even after all her needs have been met.
Pt became nauseated, 5 minutes after receiving vaccine, vomited x 1, became weak, cool cloth to face ammonia under nose. Alert and oriented when leaving clinic 25 mins later.
Shortness of breath when walking , after having the Pfizer on 25 November and just recovering back to normal w/c 13/12/21
1350 - tightness in chest, right side, started 3 minutes after receiving 2nd dose moderna vaccine, radiating to right shoulder/back. BP 180/85 SATS 97%, pulse 73. 1400 - Pt with husband in car, reports to start feeling better, water given,patient re recheck 140/85 refused EMS service, will continue to monitor patient. 1413 - B/P 140/ 85 patient and spouse instructed to go to ER or call 911 if symptoms change or increase