chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired dose/Had vaccine that expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose/Had vaccine that expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
COVID  like symptoms; swollen lymph nodes; oozing lymph nodes; This spontaneous case was reported by a non-health professional and describes the occurrence of SUSPECTED COVID-19 (COVID  like symptoms), LYMPHADENOPATHY (swollen lymph nodes) and LYMPHORRHOEA (oozing lymph nodes   ) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21a and 004021a) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (COVID  like symptoms), LYMPHADENOPATHY (swollen lymph nodes) and LYMPHORRHOEA (oozing lymph nodes   ). At the time of the report, SUSPECTED COVID-19 (COVID  like symptoms), LYMPHADENOPATHY (swollen lymph nodes) and LYMPHORRHOEA (oozing lymph nodes   ) outcome was unknown.            No concomitant medications was provided by the reporter.  No treatment medications was provided by the reporter.   This case was linked to MOD-2021-283253 (Patient Link).
Mom of patient called and stated that patient had a rash around the injection site and was advised to just monitor it for a day and then call back if it got worse. Called again the next day and stated that the rash seemed to have gotten worse and it was now looking like hives. Was started on an oral steroid since it was a reaction to the vaccination and the mother was told to call back if symptoms worsen or she has any questions.
Went out to car around 25 min after with only mild throat discomfort.  Shortly after, was having difficulty swallowing, felt dizzy & face swelling.  Took quick release (dissolve under tongue) prednisolone 20 mg (have for peanut allergy).  Symptoms didn't initially improve, used albuetrol inhaler and returned to hospital.  Swelling symptoms started feeling better.  Blood pressure when first checked was very high, still at 170/118 at 21:54.  Sent to ED.  Wheezing and constant throat clearing in ED, used inhaler again & symptoms improved.  BP still high for me at 138/80 at 21:54 with patchy confluent erythema over anterior chest that blanches, non-pruritic & 3-4 hives on abdomen.  Given Benadryl 50 mg, famotidine 50 mg & dexamethasone 10 mg at 22:22.  At 23:09, chest rash resolved, but pruritis & mild urticaria to back and arms.  At 23:41, urticartia resolved & discharged.  After second dose of Decadron was delayed the following day, itchy hives returned on chest, stomach, back and left shoulder.  Same occurred on the 3rd day, along with wheezing (resolved by other meds & inhaler) and more steroids were prescribed.  This resolved the remaining symptoms.
No additional adverse events reported; M-M-R II and PROQUAD underwent a temperature excursion were administered; This spontaneous report was received from an office manager referring to a patient of unknown age an gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknonw date between 11-AUG-2021 and 12-AUG-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot# T035408 with an expiration date on 14-APR-2022) for prophylaxis  (strength, dose, frequency, and route of administration were not reported) that underwent a temperatura excursion of -10°C to 8°C (6.2°C) for 16 hours 0 minutes and 0 seconds (product storage error).    No previous temperature excursions were reported.  No additional adverse effect were reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA003904:Original Case : 2108USA003819 US-009507513-2108USA003903:Original Case : 2108USA003819 US-009507513-2108USA003819:Original Case : 2108USA003819 US-009507513-2108USA003902:Original Case : 2108USA003819
pt received Moderna vaccine. next day he had high fevers up to 103, confusion. admitted to hospital. infectious work up negative. improved off antibiotics.
patient experienced a large swelling of the upper arm without breaking of the skin, this lasted 2 weeks before subsiding
really sick,the worst sick she has ever been,pretty sick; had severe aches,pains; fever; cold chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Nov-2021 and was forwarded to Moderna on 15-Nov-2021.    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 ILLNESS (really sick,the worst sick she has ever been,pretty sick), PAIN (had severe aches,pains), PYREXIA (fever) and CHILLS (cold chills) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (really sick,the worst sick she has ever been,pretty sick), PAIN (had severe aches,pains), PYREXIA (fever) and CHILLS (cold chills). At the time of the report, ILLNESS (really sick,the worst sick she has ever been,pretty sick), PAIN (had severe aches,pains), PYREXIA (fever) and CHILLS (cold chills) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
Hives after injection on her legs, arms and traveling over full body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives after injection on her legs, arms and traveling over full body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced URTICARIA (Hives after injection on her legs, arms and traveling over full body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives after injection on her legs, arms and traveling over full body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Woke up with chills, flu like symptoms, extreme fatigue,  felt like I was 'hit by a truck'.  lethargic, tired, the whole day. fever developed around 3:00 pm. migraine headache developing at night, and lasting until 4 days later
Pt developed a benign ganglion cyst on the wrist in October 2015, doctor's could not determine cause. Pt. says within 48 hours of vaccine, the cyst had fully disappeared.
CHILD RECORD REVIEWED. NEEDED IPV AND HEP B TO BRING UP TO DATE. 3RD. DOSE OF HEP B GIVEN 1/18/05 AT MD OFFICE INVALID-PT WAS LESS THEN 6 MO. OLD SO 4TH DOSE WAS GIVEN. FEVER OF 103 AND RASH WITHIN 24 HOURS. SEEN BY MD NEXT DAY (5/12/05). TEMP RETURNED TO NORMAL 5/13/05. RASH RESOLVED BY 5/16/05 WHEN SEEN BY SCHOOL HEALTH SUPERVISOR.
Severe case of shingles developed post vaccination pt had to seek urgent treatment 5 days after vaccination. Has had to receive antiviral and pain treatment.
administration of ROTATEQ after temperature excursion; This spontaneous report as received from other reporter regarding to a patient of unknown age and gender.    Information regarding the patient's  concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 11-JAN-2021, the patient was vaccinated with an improperly stored dose of  rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1742457, expiration date 06-JAN-2022, 2 milliliter, orally  for prophylaxis.           The improperly stored suspect vaccine experienced a temperature of 13 degrees Celsius (°C) for 19 minutes. There was no previous temperature excursion reported.  The call was made due to a digital data logger.
approx 10min p/vax pt had diff breathing & passed out briefly;non cyanotic, no urticaria but had gen pruritus several hr later
arms are sore; Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case is linked to case 2020SA320485 (same reporter).  This case involves a 40 years old female patient who experienced arms are sore (pain in extremity), while she received vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent].  The patient's medical history, past medical treatment(s), vaccination(s), concurrent condition and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine (strength and formulation: unknown) (batch number: LUT7007NA and expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) after the initiation of suspect drug the patient's arms are sore (pain in extremity), and reporter was asking for recommendations with that. The pharmacist was referred to the prescribing information, and to the physician for recommendations.  No laboratory data was reported.  Action taken was not applicable.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.
Child was administered Kinrix vaccine, which is only licensed for children 4-6 years of age and for the 5th dose of DTaP and the 4th dose of IPV.  Kinrix given to a child younger than 4 years of age as DTaP count as valid for DTaP #4 and not valid for IPV #4.  No adverse event occured, only an product administration error.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 16-MAY-2013, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2015, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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.
5 min after dose my heart was racing and it hurt/ felt tight .  10-20 minutes after dose my tongue was tingling /burning feeling also felt swollen. My throat felt tight and it was difficult to swallow.  But I could breath okay.  I stayed at the location for approximately 45 min -1hr for monitoring. After leaving I had a couple episodes where my chest got tight and I couldn?t catch my breath but after 4 hrs it cleared up.  My throat hurt for 3-5 days afterward and I had a hoarse voice. My tongue still hurts, it felt tingly and burnt  shortly after 1st dose and turned paper white for 2-1/2 weeks, now  (3wks after the dose) it feels like someone ran a razor blade over it and is turning back to its normal pink color.  It is starting to feel a little better.  Last week (2 weeks after dose #1)  I reacted to wall paint, my hands broke out in hives and got itchy, which I?ve never reacted to in the past. They cleared up after washing them and waiting 2-3 hrs.  I also have a slight reaction to pasta sauce now, my lips get slightly puffy and hurt while eating it.
little achy arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (little achy arm) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little achy arm). At the time of the report, PAIN IN EXTREMITY (little achy arm) outcome was unknown.            No relevant concomitant medications were reported.  The patient only had little achy arm when he got his previous 5 doses of the Moderna vaccines. Patient queried if the Spikevax have any preservatives on it specifically thimerosal like the one in the flu shot. He said that he had his flu shot and he had a blister, red arm, this also happened to him last year when he got the flu shot. No treatment medication reported.
Make patient deathly ill; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves patient who got deathly ill (illness), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On unknown date, the patient got deathly ill (illness), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.   It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.
ED visit to hospital admission for Pneumonia due to COVID-19 virus. Patient was admitted and started on Remdesivir and dexamethasone.  Pt has had fairly rapid improvement over the last several days.  He has been off oxygen since yesterday. His strength is back to normal. This visit was within 6 weeks of receiving the COVID vaccine.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On 28-JUL-2015, the patients were inadvertently vaccinated with M-M-R II (lot # K022285, expiration date 12-NOV-2016; lot # K024038, expiration date 26-NOV-2016; lot #K018965, expiration date 15-OCT-2016; lot # L005291, expiration date 17-FEB-2017) (dose, indication and route of administration were not reported), that had been improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I started out with just a very sore arm then began having chills.  Started running a fever, got a sore throat, started coughing and by Friday evening my fever was 101.6 and I was extremely chilled and felt awful.  I had a terrible headache and no energy.   I woke up Saturday morning and my fever was gone but I was extremely congested, coughing, my throat is very sore and I feel like I have a sinus infection to be honest.  I have not gotten any better since Saturday.
Reddened, swollen, painful left arm. Severe body and muscle aches, fever. Tiredness. "Feels like I got hit by a truck". Worsened as day 1 progressed with no change in body and muscle pain on day 2. Fever presented on day 2.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On an unknown date, the patient who was supposed to receive a dose of BOOSTRIX, was inadvertently administered a dose of ZOSTAVAX vial 19400 PFU (dosing details and lot# was not reported) that was reconstituted with BOOSTRIX. No adverse effect reported. There was no Product Quality Complaint (PQC) involved. Additional information has been requested.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, chills and fatigue. pain, redness and swelling at the injection site Narrative:  Other Relevant History:
Headache; tingling in arms and hand; severe lethargy; fever 101.8; This is a spontaneous report from a contactable consumer (patient). A 53-years-old non pregnant female patient received first dose of BNT162B2 (Solution for injection, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247),via unspecified route of administration, administered in left arm on 21Jan2021 at 13:00 (at the age of 53 years) as single dose for COVID-19 immunization. The patient medical history included vertigo, migraine, asthma. The patient had an unknown allergy to medications, food, or other. The concomitant medication that the patient received within 2 weeks of vaccination included pseudoephedrine hydrochloride (SUDAFED) and ibuprofen (ADVIL). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Jan2021 the patient experienced headache, tingling in arms and hand, severe lethargy and fever 101.8. The patient did not receive treatment for the events. On 22Jan2021 the patient underwent lab tests and procedures which included body temperature was 101.8. fever. The outcome of event was recovered in 2021.  No follow-up attempts are possible. No further information is expected.
nausea; vomiting; severe headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomiting), HEADACHE (severe headache) and CHILLS (chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No medical history information informed.  Concomitant products included ATORVASTATIN, HYDROXYCHLOROQUINE, LOSARTAN, FLUOXETINE, DICYCLOMINE HCL, DILTIAZEM, CEFUROXIME, CICLOSPORIN (RESTASIS), DENOSUMAB (PROLIA), ACETYLSALICYLIC ACID (BABY ASPIRIN), CYANOCOBALAMIN, FOLIC ACID, IRON POLYSACCHARIDE COMPLEX (POLY-IRON FORTE), PANTOPRAZOLE and VITAMINS NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced NAUSEA (nausea), VOMITING (vomiting), HEADACHE (severe headache) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea), VOMITING (vomiting), HEADACHE (severe headache) and CHILLS (chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-067293 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067293:
CLIENT RECEIVED MENACTRA VACCINE ON 7/15/08 AROUND 1:00PM. MOTHER REPORTS CLIENT AWOKE AT 2:00 AM SHIVERING AND FEELING TERRIBLE. CLIENT TOOK HER TEMPERATURE, AND IT WAS 103. SHE TOOK 2 EXTRA-STRENGTH TYLENOL AND WENT BACK TO SLEEP. AWOKE AGAIN AT 7:30 AM, STILL FELT BAD, TOOK 1 MORE EXTRA-STRENGTH TYLENOL AND WENT BACK TO SLEEP. MOTHER CALLED ME AROUND 12:45 PM, SAYING THAT CLIENT'S TEMP WAS 100.2 AND THAT SHE WAS HAVING WEAKNESS IN HER LEGS. I SPOKE TO CLIENT, WHO SAID HER LEGS FELT VERY ACHEY AND WEAK, AND HAD NOT IMPROVED AFTER TAKING TYLENOL. SHE SAID HER STOMACH ALSO FELT UPSET. DENIED VOMITING. STATED SHE HAD BEEN ABLE TO EAT SOME CRACKERS AND YOGURT. I SPOKE TO MOTHER AGAIN, AND ENCOURAGED HER TO GIVE TYLENOL AGAIN AND TO MONITOR HER CONDITION, ESPECIALLY THE WEAKNESS IN THE LEGS. I GAVE HER INFORMATION ON THE RARE OCCURRENCE OF GUILLAIN-BARRE SYNDROME BEING REPORTED AFTER ADMINISTRATION OF MENACTRA. I INSTRUCTED MOTHER TO TAKE CLIENT TO SEE A DOCTOR IF LEG WEAKNESS WORSENS, OR IF SHE FEELS AT ANY TIME SHE WOULD LIKE HER DAUGHTER TO BE SEEN BY A PHYSICIAN. AT 4:30 PM I CALLED MOTHER BACK. CLIENT'S TEMP IS DOWN TO 98.3 AND SHE FEELS MUCH BETTER. HER LEGS FEEL MUCH BETTER. I ENCOURAGED MOTHER TO CONTINUE TO MONITOR CLIENT, SOLICITING INFORMATION FROM HER ON HOW SHE FEELS. I ASKED HER TO PLEASE CALL ME IF CLIENT DOES NOT CONTINUE TO IMPROVE. The client's mother phoned me thismorning to tell me that the client's temperatured has been normal since yesterday afternoon, 07/16/08, and she is no longer experiencing any weakness or aches in her legs. Late yesterday afternoon she did notice the beginning of some swelling in her left arm where she recieved the MENACTRA injection. Today, her mother states the clien't left arm is sollen all the way down to her elbow, in painful to the touch, and even hurts in the axillary area. She will administer TYLENOL,and use warm compresses to ease the pain. I asked her to please call me if any further developements.
medication error due to a 2.5 year old male patient received Quadracel, with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case from other health professional.  This case involves a 2 years old male patient who had medication error due to a 2.5 year old male patient received diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) Vaccine [Quadracel], with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  Concomitant medications included measles vaccine live (enders-edmonston), mumps vaccine live (jeryl lynn), rubella vaccine live (wistar RA 27/3), varicella zoster vaccine live (OKA/MERCK) (Proquad) for influenza vaccine both for Prophylactic vaccination.  On 25-Oct-2022, the patient received suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (MRC5) Vaccine at a dose of 0.5 ml once(lot U7526AA, expiry date: 07-Sep-2024) via intramuscular route in the left thigh for immunisation.  On 25-Oct-2022 there was medication error due to a 2.5 year old male patient received quadracel, with no reported adverse event (product administered to patient of inappropriate age, same day latency).  Action taken: Not applicable.  Outcome: Unknown.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Rash on face on face and neck, nausea, syncope. Patient refused epi, crew pushed 50 mg benadryl and oral gluacon 166/90, 100%  RA,110, blood sugar 62