chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 08-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 5 years old male patient who received ADACEL instead of DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA VACCINE for Immunisation. On 09-Jul-2018, the patient received a dose of suspect ADACEL lot U5898AA via unknown route. On an unknown date, the patient received a dose of suspect DAPTACEL lot number not reported via unknown route. It was a case of actual medication error due to wrong vaccine administered. Reported that the injection was intended as dose 5th in the DAPTACEL series. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Developed fever 102 that evening of inject x 2 days, cried-very difficult to console x 24 hrs;
4/9 Shot hurt and burned going in around 5:50 pm and after the injection  for about an hour. Mild dizziness after vaccine and then foggy in the head until I went to bed around 10:30 pm. 4/10 Woke up shaking uncontrollably because I was so cold at midnight, chattering teeth.  Extreme neck, back and jaw pain the next day as a result. Fever of 103.5 started at 2 am and lasted for about five hours. I took one 500 mg Tylenol at 2 am for the fever and again at 6:30 am . Fever went down to 101.8. Then it came back at 103.5  at 2 pm that afternoon and I felt horrible.  Throughout this  I had insomnia and when I was cold (two times) numbness in fingers/toes or at the tips of them, chest congestion, mild cough, sore throat, dry mouth, fatigue, dehydration, muscle aches, achy bones and joints in lower back to knees and ankles. I had random pain on the inside of my right leg a few inches above my knee for a couple of hours that morning. I had a headache and then sweating late the morning starting around 8 am. Headache increased as the day went on. I had mild abdominal pain throughout the day. At 5 pm I basically felt fine. 4/11 Abdominal pain, headache, fatigue, sweating and vaginal spotting, mild dizziness in the afternoon snd pain on left side of neck ( not something I?ve had with a period). Period type cramps started late evening.  I am five weeks postpartum, exclusively breastfeeding. In prior pregnancy I had to supplement at two months and didn?t start period until 8 months postpartum. 4/12 3:30 am period started. 4/13-4/15 Abdominal Pain
- Received MENACTRA at "well visit" on 12/5/11. - Within two hours, started having headaches -> almost constant on day #2 now - behind both eyes.
body aches, hot and cold spells, chest tightness, nausea, headache, chills, sore throat started 8 pm day of vaccine. Lasted 3 days
Started with mild muscle soreness in rib cage area, then two bumps appeared. The bumps formed small blisters on top. A third bump appeared with some tiredness. Suspected shingles, but knew it was uncommon for my age. Went to Urgent Care on Memorial Day and shingles was confirmed. Started antiviral and other supportive supplements. The two days after diagnosis felt unwell, very tired, but it resolved rather quickly. It's been about two weeks since I first noticed the bumps and its mostly resolved aside from the scabs from the bumps.
First 36 hours: arm soreness, fatigue; one ibuprofen taken; symptoms went away on its own in 36 hours. 5 days after: pain/swollen lymph node in left armpit; no treatment. 7 days after: lymph node pain still present, new symptom of half-dollar sized red and raised rash-like reaction at injection site; utilized hydrocortisone for slight itch. Day 8: node pain still present, injection site redness no longer raised, not as red, but quadrupled in size down the arm; virtual doctor visit indicated no sign of infection, known reaction to vaccine that will go away in a few days; no treatment. Day 10: node pain and redness 85% gone; no treatment.
I began having hive flare ups during the night of the event start date. It looked and felt like mosquito bites located on both of my elbows and scattered throughout my upper body. The following day I began to develop more hives that varied from small to large that were extremely itchy during the day and painful during the night. The hives continued to spread the following day and I visited my physician who prescribed several antihistamines. I have been taking those for seven days and although I still have the hives, they are starting to fade away for the most part.
Headache Exhaustion  Muscle ache Itchiness, swelling, and warmth at injection site. Distinct red round swollen area on arm 5 days after shot
patient develop new loss of taste or smell, sore throat, nasal congestion on 07/12.  She tested positive for COVID on 07/14.
Patient is a 42 y.o. female who received the Janssen Covid Vaccine Lot#: 1805020 on 3/12/2021. The patient experienced the following reaction(s) during the immediate   of observation: Nausea Diaphoretic lightheaded Patient was treated/managed as follows:   Given a bottle of Gatorade Vital Signs: 1030: BP: 104/72 HR: 95 O2: 97% 1040: BP: 132/78 HR: 85 O2: 96% Pt reports feeling better at this time.  Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by staff
Very healthy 70yr old man who sees his doctor regularly became tired, confused, depressed and lost weight suddenly.  March and April tried to shake it off and thought he was just feeling his age.  In May he went to his doctor who treated him for depression.  He took an overdose of his anti depressant medication and was hospitalized (5/29/2021)  Went to  medical Center for treatment.  They said he was on wrong anti depressant and changed his medication to Lexapro 5mg.  On 7/6/2021 he committed suicide.  He was being treated for a chemical imbalance.  He did not have a chemical imbalance before the vaccine.  He has had the same doctor for 10yrs.  and has been on the same medications.  No reason for depression.  Best time of his life.  I can not rule out or prove the vaccine played a major part in his death.
Pt c/o swelling, tenderness, reddened upper arm occurring after vaccine, with radiation and pain to collar bone.
This case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a 78-year-old male patient who received Influenza vaccine. Co-suspect products included ADVAIR Diskus inhalation powder for asthma and emphysema. The patient's past medical history included pneumonia. Concurrent medical conditions included arthralgia multiple (airplane flying accident), emphysema (taking ADVAIR) and asthma (taking ADVAIR). Concomitant products included amlodipine, FLONASE, SINGULAIR, NAPROSYN, PROAIR HFA, Aspirin (Baby) and prednisone. In October 2015, the patient received influenza vaccine (intramuscular). In April 2001, the patient started ADVAIR Diskus (inhaled) 1 puff(s) once daily. In October 2015, an unknown time after receiving influenza vaccine and ADVAIR Diskus, the patient experienced underdose. In November 2015, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting. ADVAIR Diskus was continued with no change. On an unknown date, the outcome of the vaccination failure and underdose were unknown and the outcome of the influenza, shivering, difficulty breathing, weight loss, unable to eat, diarrhea and vomiting were recovered/resolved and the outcome of the tiredness was not recovered/not resolved. The reporter considered the vaccination failure, influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting to be unrelated to influenza vaccine. The reporter considered the influenza, shivering, difficulty breathing, weight loss, unable to eat, tiredness, diarrhea and vomiting to be unrelated to ADVAIR Diskus. Additional details were received as follows: This case was received from the consumer via the vaccine patient assistance program (GlaxoSmithKline Access). In October 2015, the patient received Flu vaccine (unknown manufacturer). In November 2015 (approximately 30 days after vaccination) and December 2015, the patient experienced the flu, with multiple symptoms. Underdose was also reported as an event, it was not clear whether it corresponded to ADVAIR or Flu vaccine and the exact reason for underdose was also not provided. The patient planned to continue follow-up with his physician on an unknown date. The patient believed that the ADVAIR and flu shot (unknown manufacturer) had nothing to do with him experiencing the flu, including the multiple symptoms as listed above. The patient was transferred from GlaxoSmithKline Access. This case was as suspected vaccination failure since the laboratory confirmation of the flu was not available.
This spontaneous report as received from a pharmacist via other pharmacists refers to an unspecified number of patients of an unknown age and gender. On an unknown dates, an unspecified number of patients were vaccinated with ZOSTAVAX (dose, route of administration, lot # and expiration date were not provided). The pharmacist reported that she had heard from other pharmacists that they have seen, on an unknown dates, injection site reactions. The outcome of swelling and redness at the injection site was unknown. The relatedness between the events and the vaccination with ZOSTAVAX was unknown. This is one of several report from the same source. Additional information is not expected because the pharmacist did not want to provide any additional information.
Recipient presented at hospital with chest pain, shortness of breath and fever. Diagnostic workup showed elevated troponin levels and sinus bradycardia with myocarditis.
2/12/10-next day started a week of lethargy, temp 95.2 and chills. 2/19 (23-24) 10-temp went to 97, cold symptoms and sinus congestion. 2/26/10 went to eye and ear doctor. Rx- amoxicillin for 14 days.
fever 100.2, chills, congestion, weak x 1 wk p/flu shots, was given ATB by MD due to bronchitis not flu react;
Pt vacc. w/ Rabies developed backache, very painful back; entire body achy w/in 2 days; no appetite, very tired, slept about 40 hrs, weak.  By 12/5, muscles achy over joints, appetite increased, but tires easily.
Patient fainted a few minutes after the vaccination.  Slumped over in chair.  Woke up within about 10 seconds.  Was pale and very shaky.  Recovered over the course of 15-20 minutes.
Patient got chills, nausea and headache along with "heart racing".  Patient couldn't sleep due to her heart racing. Symptoms started at 10:00 pm. On reporting day (1 day after vaccination date), Patient says symptom decreased but not fully gone away (8:30 am on 5/23/23)
This spontaneous report as received from a certified medical assistant (CMA) refers to a patient of unknown age. On 01-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (dose, lot # and route were unknown, expiration date 28-SEP-2014). No adverse effects were reported. Additional information has been requested.
STARTED WITH A RASH BILATERAL ARMS, THEN MOVE TO LEGS BILATERAL.
Side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.  A question was asked that have any side effects been reported 4 months after receiving both shots of moderna.
Patient recieved IM injection of the JNJ COVID vaccine in the right arm. Shortly afterwards she became diaphoretic, felt tightness in her throat 'like when I eat shellfish,' experienced tachycardia and left-sided chest/neck pain. The Diaphoresis and throat symptoms resolved with zyrtec and benadryl. The tachycardia persisted for 4 days with even slight exertion. HR was 119 bpm upon follow up with PCM on 26Mar2021.
injection site muscle pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site muscle pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was unknown.   It was unknown if the reporter considered the injection site muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix and experienced no side effects except for muscle pain at the injection site. The reporter consented to follow up. The pharmacist was retired and the patient. For tolerance of 2nd dose of Shingrix, refer linked case US2020030233.
Pt c/o generalized body pain, mild headache, runny nose, cough with greenish phlegm, fever noted 100.4F this morning since her 2nd dose Pfizer covid vaccine on 05/18/2021. Pt concerned its due to possible s/e of covid 19 vaccine Pfizer. Pt speech clear, comfortable. AO X3. Also denies emergency sx at this time. Advised pt to monitor her sx  And scheduled an appt with urgent care provider telephone f/u 5/26/21..Notified pt if any emergency sx arises call 911 or go to nearest ED, Pt assure understanding.
Information has been received from a physician (specialty: internal medicine) via a company representative referring to a 75 year old female patient. The patient's medical history, concurrent condition and concomitant medication were unknown. In 2008 the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot # and expiration date were not reported). On an unspecified date the patient developed a severe shingles outbreak of the neck and scalp. The patient was hospitalized at an unspecified facility on an unspecified date. The patient was subsequently discharged from the hospital and was recovering at the time of the report. Reporter's causality was not reported. Additional information has been requested.
Case number PHEH2012US005891, is an initial spontaneous report received from a nurse on 13 Mar 2012: This report refers to unknown age and gender patient. The patient was received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: unknown) intramuscularly, without reconstituted with Men A lyophilized powder component on 12 Mar 2012. No adverse reaction was reported following this drug administration error.
Bilateral lower leg pain and swelling (3/20/21 - 3/23/21)  which resolved with topical analgesia and rest. Patient's daughter called to report symptoms on 4/14/21.
Patient who already received their first dose was exposed to someone who tested positive for COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPOSURE TO SARS-COV-2 (Patient who already received their first dose was exposed to someone who tested positive for COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Patient who already received their first dose was exposed to someone who tested positive for COVID-19). At the time of the report, EXPOSURE TO SARS-COV-2 (Patient who already received their first dose was exposed to someone who tested positive for COVID-19) outcome was unknown. Not Provided      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.   No concomitant medications were reported. No treatment medications were reported.
Tingling of tongue and lips; Tingling of tongue and lips; Swelling of cheeks; face turned flush; rash on neck and upper chest area; This is a spontaneous report from a contactable consumer (patient) This  45-years old no pregnant female consumer received the firs dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL3247 on 21Jan2021 04:45 at left arm at single dose for Covid-19 immunization. Medical history included:allergies to medications, food or other products and high blood pressure .The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received  any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered:Other.On 21Jan2021 17:00 the patient developed Tingling of tongue and lips, Swelling of cheeks, face turned flush, rash on neck and upper chest area.The patient was treated with Benadryl. Events was reported as non serious .Outcome of the events was recovering. No Prior to vaccination, was the patient diagnosed with COVID-19. No Since the vaccination, has the patient been tested for COVID-19.
74 year old female patient heads to the vaccination Center with concern because on October 28 she received her booster from Pfizer and the next day on her left arm where she received her vaccine a water bubble with dryness formed. November 12, the area was dry and burned. Patient refers to Hospital on October 29, she was given serum with 2 injections, but only remembers Benedryl and antibiotics of the 10 medications she received.
Information has been received from a medical assistant referring to an 18 month old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 03-NOV-2016 the patient was vaccinated with a dose of VAQTA (lot #M018644, expiration date 20-SEP-2017, intramuscular; dose unknown). The patient did not take concomitant medication. Later that same day, the patient became "difficult to rouse from sleep," and the patient was taken to the emergency room. Magnatic Resonance Imaging (MRI) was performed on the patient's brain which was found to be normal. A urine test was also performed which "found that the patient had an opioid overdose." The patient was sent home from the emergency room that same night (on 03-NOV-2016). No treatment was given for the events. The patient was recovering. A lot check was requested. Additional information has been requested.
Patient received a 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 2HC42, expiry date 09-JUL-2024) for prophylaxis.   On 04-MAY-2023, the patient received the 3rd dose of Shingrix. On 04-MAY-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient received a 3rd dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 05-May-2023 The pharmacist stated the patient received a third dose of Shingrix which led to extra dose administered.  The lot number not identifying as a GSK vaccine in the lot identifier, but it was verified with the healthcare professional.  The reporter consented to follow up via postal.
Vaccines given 3/30/11. Mother removed band aid 3/31/11 evening & noticed large red raised area. Painful to touch. Took to MD for eval. was told that was allergic reaction. (Area was on (R) arm) was given antibiotic, lidocaine cream, & told to apply tea bags. Brought here 4/1/11. Area red, raised, & approx 4 cm x 5cm in size.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 05-JUL-2014 at a drug store as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-APR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles with post-herpetic neuralgia resulting in long term nerve pain. The patient was prescribed valacyclovir and gabapentin for management of her painful symptoms. 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. Additional information has been requested.
HCP reports that seven patients received a dose from an expired Moderna vial; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP reports that seven patients received a dose from an expired Moderna vial) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A and 076C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP reports that seven patients received a dose from an expired Moderna vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP reports that seven patients received a dose from an expired Moderna vial) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Dosage text was reported as first booster and second booster dose.  Treatment information was not provided.
Full body rash - small bumps the size of goosebumps, red. 12/2/12. Fever reaching 103.0 F December 4-6, 2012. Second Full body rash, this time blotchy red bumps 12/8/12.
My COVID-19 symptoms initially started having a severe sore throat, congestion, and cough. Then it developed into a headache or a fever of 100.8 degrees, and I noticed I lost my sense of taste and smell. Due to congestion, I put vapor rub on and couldn't smell it. Two weeks later, I still have no smell still. My taste is starting to come back. I'm really fatigued and have problems breathing. I've been prescribed steroid for lung inflammation.
One hour after injection: chills, headache, insomnia, nausea, vomiting, fatigue - continued over a 2 d. period.