chrisvoncsefalvay/vaers-outcomes huggingface dataset:
product storage error; Doses administered after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (product storage error) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism and Drug allergy (Sulfur). Concomitant products included AMIODARONE, COLECALCIFEROL (VITAMIN D 3), FEXOFENADINE, ESOMEPRAZOLE, APIXABAN (ELIQUIS), PRAVASTATIN SODIUM (PRAVACHOL), MACROGOL 3350 (MIRALAX), FLUTICASONE, FAMOTIDINE and VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 06-Apr-2022 at 3:02 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2022 at 3:02 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had COVID-19 preceding month of vaccination. On 25-FEB-2022 the vial was initially stored in the refrigerator. Vial didn't undergo any temperature excursions. It was reported that the patient did not experienced any side effects yet. No Treatment information was reported.   This case was linked to MOD-2022-545267 (Patient Link).
Swollen, red tense left arm below vaccine site all the way to the elbow. Onset 24 hours after vaccine resolved in 3 days.
Rash area burning after 2nd dose; Rash area starting to blister after 2nd dose; the rash is moving into her face; she started with a red blotching rash on her neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (she started with a red blotching rash on her neck), BURNING SENSATION (Rash area burning after 2nd dose), RASH VESICULAR (Rash area starting to blister after 2nd dose) and RASH (the rash is moving into her face) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced RASH MACULAR (she started with a red blotching rash on her neck). On 01-Dec-2021, the patient experienced BURNING SENSATION (Rash area burning after 2nd dose), RASH VESICULAR (Rash area starting to blister after 2nd dose) and RASH (the rash is moving into her face). The patient was treated with ALOE VERA (ALOE 99) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (she started with a red blotching rash on her neck) outcome was unknown and BURNING SENSATION (Rash area burning after 2nd dose), RASH VESICULAR (Rash area starting to blister after 2nd dose) and RASH (the rash is moving into her face) had not resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-403389 (Patient Link).
ZOSTAVAX given subcutaneously in left upper arm - patient immediately complained of tightness at injection site - redness at site 3cm - induration 1cm - progressed to 3cm induration in 15 minutes observed for 45 minutes.
Patient received 4 vaccines- Prevnar 20, Arexvy, FluzoneHD, and pfizer bivalent on 9/2/23. She reported on 9/17/23 that she had side effects the next day. The patient experienced headache, diarrhea, sore throat, and cough. Pt believes these side effects were due to the Arexvy since she has never had side effects with any of the other vaccines before. Patient stated she had these side effects for about 1 week, she has recovered from them by now.
Shingles outbreak for first time since original chicken pox in elementary school (pre-vaccine).  Occurred on from middle back around left side torso. Symptoms started 13 days after 2nd shot was administered.
saw a ghost while being totally awake; Arm hurt; A spontaneous report was received from a Consumer concerning a 72-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurt, saw a ghost while being totally awake.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events arm hurt. on 17 JAN 2021 saw a ghost while being totally awake. The event saw a ghost while being totally awake was considered to be medically significant.  Treatment details included For the symptoms: Acetaminophen., Other: drops for his eyes for the glaucoma., FMarasco 03Feb2021  Action taken with mRNA-1273 in response to the events was not reported.   On 15 Jan 2021 the outcome of events arm hurt was resolved.  On 17 Jan  the outcome of events include, saw a ghost while being totally awake was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events  a causal relationship cannot be excluded
The store was not crowded with consumers and I left but some hours later I felt terrible with a sourness in my right arm where the needle punctured my arm twice so to speak   I did not have symptoms of carpal tunnel for a long time, but the pain of carpal tunnel returned.  I felt hot like feverish and in the morning of the 27th I felt just as bad not unlike a hangover from an martini.  And on the 28th the right side of my head was tender and sore like a vein collapsed and was not supplying blood to my head and causing trauma. I had to take a muscle relaxers [methocarbamol] for a few days to deaden the pain  And there after right up until the present day my vision in my right eye is vague and hazy.
Information has been received from a consumer via Pfizer (manufacturer report number 2015355195), concerning his wife, a female patient of unknown age. No relevant medical history or concurrent conditions were reported. The patient recently requested a PREVNAR 13 vaccine from a pharmacy, but was vaccinated with PNEUMOVAX 23 (manufacturer unknown) (dose, route, lot# and expiration date not reported) instead (Product name confusion) on an unknown date. Concomitant therapy included influenza virus vaccine (unspecified). This is one of two reports received from the same reporter. Additional information has been requested.
Vaccinee with non-healing vaccination site, no itching, no redness, no fever. Scab persists, had two episodes of vesicle formation and drainiage and reprots allergy/iiritation to dressing. Evaluated on 5/16/2003 in ER: no evidence of bacterial superinfection, no itching, fever, lymphadenopathy.
Weakness, diaphoretic, light headed, nausea. Elevated blood pressure, all else normal. Symptoms lasted about 4 hrs. with gradual improvement. Normal at discharge with B/P still elevated.
Potentially having ongoing side effects.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Potentially having ongoing 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Potentially having ongoing side effects.). At the time of the report, VACCINATION COMPLICATION (Potentially having ongoing side effects.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication was not provided.
Ten days after receiving my fourth vaccine I had a breakthrough case of COVID-19. Severe headache, nasal congestion, alternating with a runny nose, cough, sore throat, extreme fatigue.
Information has been received from a nurse concerning "almost every single patient" (approximately 237) who was vaccinated with GARDASIL.  Subsequently the patients complained of injection site pain after the first, second and third doses of GARDASIL.  It was unknown if the patients sought medical attention.  This is one of several reports from the same source.  Additional information has been requested.
Pt reported lip and facial swelling after first dose.  Spoke with primary MD.  Was given a course of steroids and benadryl.  MD recommended second dose.  Pt took ppx steroids and benadryl.  Had similar swelling with second dose.
Tdap was administered in school setting on 4/30/09.  Mother reports that arm appeared ok that night and next am.  Child began complaining of arm hurting on 5/1/09 midmorning.  By that afternoon arm was swollen and red.  Mom contacted MD who recommended Benadryl, Advil and, if no better next am, to come into office on 5/2.  No better on 5/2.  Mom contacted MD who saw child in office.  MD ordered amoxicillin twice daily for 10 days.  Area slowly improving per Mom.
Smallpox on 9/19. Broke out with vaginal burning on 9/28. Seen 10/1 - labial ulcerations - denied sexual contact. Herpes culture negative. Admitted 10/4 for altered mental status. Negative LP, Head CT. Seen 10/6 - doing much better, no pain. Unable to swallow Valcyclovir. 12/31/08-records received-10/2/08-presented to ED with C/O vulvar burning found to have blisters consistent with herpes. Vaginal smear positive for vaccine strain vaccine virus. Male parter recently vaccinated with small pox vaccine. DX vaccine self innoculation. On overnight admission 10/4/08 acute mental status changes syncope, headache.
A couple of weeks after vaccine, my shoulder would hurt to move. I could not move my shoulder. I went to my doctor. I was told that I was giving the vaccine in the wrong place. My muscles were hurting. I waited 2 more weeks and the pain was so bad that I could not move it. I went back to my doctor and got a steroid injection. That did not help. I was referred to another doctor for sports medicine. I have seen him twice now. I had an MRI, ultrasound, and a steroid injection. That helped for maybe 2 weeks. I went back again and got another steroid injection that actually worked. I was referred to get Physical Therapy. I have that appointment tomorrow due to the pain being excruciating again.
GENERALIZED SWELLING/WHELPS 2/23; RELIEVED WITH BENADRYL; 2/24/11 AM GENERALIZED SWELLING HAS RETURNED; PATIENT WENT TO FACILITY AND SPOKE WITH MD; PATIENT STATES SHE HAD GENRALIZED WHELPS/SWELLING INCLUDING LIPS, BACK, BEHIND EARS, AND SOME WHELPS ON HER LEGS AND ARMS. WILL RECEIVE INJECTION OF DECADRON 2/24/2011 A.M. HAD TO RETURN TO FACILITY ON 2/25 WITH SWELLING AND INABILITY TO WALK.  MOM SAYS MD GAVE TWO PRESCRIPTION BUT SHE DOES NOT KNOW WHAT THEY WERE.  ALL SYMPTOMS RESOLVED 2/27/11.
I21.4 ACUTE NON ST ELEVATION MI 4/10/2023 HYPERCHOLESTEROLEMIA
Covid monitoring documentation. PT admitted 12/19/21 documented to have positive covid. PT received 1st dose Pfizer 1/20/21 Lot EJ1689, and 2nd dose Pfizer 2/10/21 Lot EL9269
Pharmacist called to report about a 15-year-old patient who received Flublok with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 15-year-old female patient who received influenza quadrivalent recombinant vaccine [Flublok QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 14-Oct-2023, the patient received 0.5 ml total dose of suspect influenza quadrivalent recombinant vaccine (strength, form: unknown) (lot: QFAA2326, expiry date: 30-Jun-2024) via intramuscular route in the left deltoid for immunization and pharmacist called to report about a 15-year-old patient who received flublok with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  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.
Swollen left with red rash that was 6 in x 6 in. Leg was hot to the touch. MOC brought pt in for appt per physician request.
ZOSTAVAX SQ 2/24/12 --> presented to occupational health cc: raised area 4 cm diameter center 6" x 4" width area of erythema. C/O HA lethargic joint aches.
24 Hours after the first vaccine shot a rash appeared on my left leg. Experienced severe itching and scratching and the rash became raw. Within 48 hours rash had spread covering a larger area on my leg and then I developed numerous random blisters on both arms , right leg and back, causing severe itching and mild burning pain. The rash on my leg became extremely red and caused pain and swelling. None of these symptoms have abated.
Left torso area skin is sunburned like with tenderness and tingling and 2 weeks out numbness occured.  Injection site was unremarkable.
Patient came to get 2nd dose of Moderna COVID-19 vaccine but stated that she had allergic reaction after the 1st dose. She had swelling on her throat, lips and tongue one hour after her 1 dose so she went to the PCP where she was treated with oral antihistamine but was not given Epipen.  Patient did not report to pharmacy about the adverse reaction. She came to receive her 2nd dose at pharmacy with an Epipen in her bag as advised by her doctor but pharmacist advised to hold on to 2nd dose as recommended by CDC  guidelines  as she had an anaphylaxis reaction after 1st dose and consult back her doctor or take 2nd dose at doctor's office
After giving the vaccine, pt was asked to wait in the waiting area for 15 minutes. Seizure occurred during that time.  Witness said it happened twice and he threw up as well. Ambulance was called and he was taken to the ER.
The same day of vax, the pt developed redness in the leg and a band around the thigh that was 2-3 inches in width. Two to three days post onset, the pt recovered. It was noted that the pt sought unspecified medical attention. Additional information has been requested.
Sore arm; Severe rash all around area where shot was administered; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE RASH (Severe rash all around area where shot was administered) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol high. Concomitant products included HYDROCHLOROTHIAZIDE, POTASSIUM, LEVOTHYROXINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE RASH (Severe rash all around area where shot was administered). At the time of the report, PAIN IN EXTREMITY (Sore arm) and VACCINATION SITE RASH (Severe rash all around area where shot was administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included calcium blocker, statin for cholesterol.  No treatment information was provided.
Rash, ErythemaMultiform, Red raised ring around injection site warm to touch right upper name Narrative:
Initially developed  lesions presumed to be warts primarily on L knee but also on other areas of his body (R wrist, torso) 3-4 weeks after vaccination which tested positive for vaccine-strain varicella by PCR with concern for superimposed bacterial infection. ~6 weeks after vaccination, presented to ED for worsening of the lesions, and began treatment for varicella. Developed respiratory failure requiring intubation and renal failure requiring CRRT, both of which he remains on today. Unclear whether his clinical deterioration was more related to infection vs nephrotoxic therapy leading to fluid overload in a patient with underlying DKC.
Pain left arm, tender left axillary nodes. Motrin and Prednisone combination.
Red spot on the arm a little bigger than a quarter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot on the arm a little bigger than a quarter) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot on the arm a little bigger than a quarter). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot on the arm a little bigger than a quarter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No treatment details were reported.
Patient was given a meningitis B vaccine. He should have gotten a MCV instead. Parents were notified on 08/18/2022
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-DEC-2015 at 15:37, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperatures were 8.49 and 5.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
About 10 weeks post vax my PHN got bad; This spontaneous case was reported by a consumer and describes the occurrence of POST HERPETIC NEURALGIA (About 10 weeks post vax my PHN got bad) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Post herpetic neuralgia and Stenosis.    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 POST HERPETIC NEURALGIA (About 10 weeks post vax my PHN got bad). At the time of the report, POST HERPETIC NEURALGIA (About 10 weeks post vax my PHN got bad) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product were not provided/unknown.  Treatment medication were not reported/unknown.  Company Comment: Very limited information regarding the second vaccination dose has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded. Additional information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Significant Follow-up  received on 06-aug-2021. patient details are updated; Sender's Comments: Very limited information regarding the second vaccination dose has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded. Additional information has been requested.
Swollen and sore at injection site, next morning, hurting all over, neck, back, arms, hips, legs, ankles.  Extreme headache and nausea .  Can barely mover
pt recv vax & returned to class approx 45min later while in class eyes became very reddened, swollen around eye orbit;eyes very reddened & states swollen;although talks of something in throat, skin sl clammy;given 02 nasal cannula;
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates in 2014 (exact date unspecified) the patients were vaccinated with ROTATEQ (therapy route defaulted to oral, dose, lot number was not reported), which was improperly stored since 28-OCT-2014. No adverse effects were reported. Follow-up information has been received from the Licensed Practical Nurse. In 2014 (exact date unspecified), unspecified number of patients were vaccinated with an improperly stored since 28-OCT-2014 ROTATEQ (therapy route defaulted to oral, lot# K001450, expiry date: 18-NOV-2015). No adverse effects were reproted. The reporter also stated that she did not have the information available at that time but she might fax the information at a later time. The reporter stated, that the refrigerator's main thermometer was broken and the backup thermometer did not show any temperature excursions. This is one of several reports from the same reporter. Additional information has been requested.
The evening of the shot I had body aches.  The following morning I still have body aches plus chills, nausea, and a fever of 99.7.
Infant given vaccine on 1/11. On the morning of 1/12, mother found child unresponsive in crib. Taken to ER and admitted. having continual focal seizures. Currently in ICU and on IV Dilantin, Phenobarbital, and Acyclovir. Still obtunded. Occasional seizure. LP with clear CSF. NL protein. MRI: diffuse inflammatory changes mostly white matter. HSV PCR negative. Routine cultures negative. Viral cultures pending. Follow up 01/25/05: Patient currently in hospital in ICU and under the care of a neurologist. Follow up 03/29/05: Patient has not recovered from the adverse event(s), she has left hemiparesis, seizures and significant loss of developmental skills. Does not ambulate, verbalize or interact with people. Per follow up report recieved on 06/14/2005:  Patient still has no use of left side and is approximately 7 months of age mentally.  Per physical, occupational, and speech therapist believes she has years of therapy ahead of her. Per follow up report: seizure disorder, recent prolonged seizure, Left hemiplegia, in physical and occupational therapy, developmental delay. Still non verbal.  Per follow up report-Patient still has no use of her left arm and she cannot speak.
During a review of the  Department of Health?s  records, it was found that there might have been a possible temperature excursion with how the vaccine was stored with our mobile vendor.
EMPLOYEE CALLED CENTER ON 2/16/14 TO REPORT SYMPTOMS FOLLOWING THE VACCINATION OF HEPATITIS B ON 2-15-14. HE REPORTED THAT A COUPLE OF HOURS AFTER RECEIVING THE IMMUNIZATION HE FELT NAUSEOUS AND HAD STIFFNESS TO HIS LEFT ARM. EMPLOYEE STATED THAT HE WENT TO SLEEP FOR SEVERAL HOURS AND UPON WAKING UP AROUND 9:00PM HIS SYMPTOMS REMAINED.  HE WENT BACK TO BED FOR THE NIGHT AND HIS SYMPTOMS WERE STILL PRESENT UPON CALLING CENTER IN THE MORNING.