chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a reaction that involved a rash/rash was worse after the 6 month dose; Initial information received on 22-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 13 years old female patient who had a reaction that involved a rash at 4 month and rash was worse after the 6 month dose while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) (lot number, strength, dose, expiry date not reported) via unknown route in unknown administration site as immunization.  On an unknown date the patient had a reaction that involved a rash at 4 months and rash was worse after the 6 month dose (rash) (unknown latency) following the administration of IPV (VERO).  It was reported "After that the patient did not receive any further vaccines. Now, the patient is going to an allergist and the allergist is requesting that the nurse send a dose of IPOL in a syringe out of the IPOL MDV so he can inject the patient with IPOL and then Boosterix to determine what the patient is allergic too and assess the reaction. The nurse asks if it is safe to send IPOL in a syringe to the Allergist's office."  No lab data reported.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
CONFIRMED COVID-19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; COULD NOT WORK AT JOB; WAS IN INTENSIVE CARE UNIT NEAR DEATH; This spontaneous report received from a parent via social media via a company representative concerned a female of unspecified age, race and ethnic origin. Initial information was processed along with additional information on 26-Dec-2021 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 (dose number in series is 1) (suspension for injection, route of admin were not reported, batch: unknown, expiry: unknown) dose, 1 total, administered on APR-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 an unspecified date in MAY-2021 the patient was in intensive care unit near death. On an unspecified date, patient experienced confirmed covid-19 infection, confirmed clinical vaccination failure and could not work at job. The patient got hospitalized for an unspecified days. The patient visited emergency room. The reporter stated that "My daughter had the JnJ in April 2021 one month later was in ICU near death and is still having affects from covid. No there was not. A lot of other people plus myself feel the vaccine caused it. She can't even work at her job she had for years and absolutely." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure, was in intensive care unit near death and could not work at job was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This report was associated with product quality complaint: 90000208728.; Sender's Comments: V0: 20211256702-COVID-19 VACCINE AD26.COV2.S- confirmed covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211256702-COVID-19 VACCINE AD26.COV2.S- confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
pt rcvd vax; pt devel idiopathic thrombocytopenic;
Expired doses administered to patients; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
tenderness at injection site; redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number CA374, expiry date 28th June 2021) for prophylaxis.   On 17th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 17th June 2019, several hours after receiving Shingrix, the patient experienced injection site tenderness and injection site erythema. On an unknown date, the outcome of the injection site tenderness and injection site erythema were unknown.   It was unknown if the reporter considered the injection site tenderness and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left arm. Several unspecified hours later receiving the 2nd dose of Shingrix, the patient experienced tenderness and redness emanating from the injection site. The size of the redness was described as 4 inches by 2 inches wide. The reporter did not wish to provide greater detail for patient number as she was busy and in a hurry. The reporter consented to follow up. The information was reported as per the pharmacist's words with no elaboration. This case has been linked to case US2019111404, reported by same reporter.
mom states some spots appeared later on the day child recv vax;also cough, runny nose, fever (never higher than 101);2/15/98 more rash;took child to MD 2/17/98 & was told had attenuated measles;prescribed ointment;
6NOV92 fever first noticed; treated w/APAP by 7NOV92 temp to 104-105; taken to ER; also had vomiting & rash on stomach; fever fluctuated for 1 wk; On 10NOV92 red spots on face & all over body; seen by MD 16NOV92 red ear drums; ATB Rx'd;
inadvertently administer  the vaccine 11 days after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 033C21A, 013A21a and 012M21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE on 01-Oct-2021. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE. Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Levaquin).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administer  the vaccine 11 days after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 27-May-2022.  The vial did not undergo any temperature excursions.  Number of doses/vials was reported as 1 vial.  It was unknown whether the patient had been diagnosed with or tested positive for COVID 19.  No treatment medication information was provided.
Error in administration.  Flu shot given prior to scheduled time. No adverse reaction noted. Pt informed. Doctor and RN manager informed.
31JUL95 45mins p/vax devel urticaria on both wrists, inner aspect of lt breast, both temples & back of neck, c/o itching in all these areas & palms of hands; 2AUG95 c/o h/a & swollen gums; Seldane given on 31JUL95 w/prescription x 3 days;
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medicines and concomitant medicines were not reported
4 day, post vax, I noticed a large lump in my left armpit. After taking Naprosyn, it died down, after 4 days.
patient is complaining of left arm pain and describes that there's a "hole" in her left arm the size of a quarter.  She is going to try to schedule a doctors appointment.
rash on arms that                                                                                                                                                                                                                                                                                                                                                                                                                                                         pt received 2nd covid vaccine on saturday 7/31/21 and noticed the next day (sunday) that he developed a rash on his arms.  Did not have this issue with first vaccine. Does not have any other symptoms or trouble breathing. Seemed to be worse when laying down.  He has took benadryl and instructed to follow up with his doctor.t com                              es and go
PATIENT PASSED OUT AFTER RECEIVING A DOSE OF 23/24 COMIRNATY PFIZER COVID VACCINE AND A DOSE OF SEASONAL FLU VACCINE. AMBULANCE WAS CALLED. PATIENT REGAINED CONSIOUSNESS BY THE TIME ANMBULANCE ARRIVED. REFUSED FUTHER EVALUATION/RIDE IN AMBULANCE OFFERED BY THE EMERGENCY CREW AS A FOLLOW UP. PATIENT WAITED FOR ABOUT 15 MINUTES IN PHARMACY WAITING AREA AND GOT A FRIEND TO PICK HER UP
tingling and a rash on their left arm; tingling and a rash on their left arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling and a rash on their left arm) and RASH (tingling and a rash on their left arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced PARAESTHESIA (tingling and a rash on their left arm) and RASH (tingling and a rash on their left arm). At the time of the report, PARAESTHESIA (tingling and a rash on their left arm) and RASH (tingling and a rash on their left arm) outcome was unknown. Not Provided          Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-063861 (Patient Link).
12-14 hrs p/vax devel chills, t103, fever, aches, severe h/a & red-macular papular rash over rt arm, face as progressed to chest, waist & back-lasted 2 days;tx w/DPH & methyl Pred decreasing dosage per pvt MD orders;
Started with Sore throat one morning (Apr 14). Thought it was maybe seasonal allergies and post nasal drip as the cause. took OTC meds and after 10 days, no change, went to GP, he gave me antibiotics since he saw fluid in my left ear.  Voice was hoarse, but still there   After 8 days on antibiotics, no voice.  Next came steroid shots with another round of antibiotics.  Finally got to an ENT, thought i was maybe acid reflux causing the inflammation around vocal cords.  Prescribed omeprazole for 30 days no difference.  Got a second opinion, this one thought Muscle tension dysphonia.  3rd ENT and 2 speech language pathologist later, paralyzed right vocal cord (at this point it's been 3 months).
This is a spontaneous report from a contactable consumer reporting for herself. This report was received via a sales representative. A 65-year-old female patient receive PREVNAR 13 Lot # N97936, exp date Nov2018, via an unspecified route of administration on 18Apr2017 at 0.5ml single for prevention of Pneumococcal Pneumonia. The patient medical history and concomitant medications were not reported. The patient stated the injection area was red, swollen and hot to the touch on Apr2017 with outcome of recovered. Symptoms lasted about 10 days.
16 YEAR OLD RECEIVED 1ST DOSE ON 5/1/21 (ER8736).  PT CAME TO CLINIC ON 5/15/21 AND RECEIVED 2ND DOSE 7 DAYS TOO EARLY.
This is a non serious spontaneous case from a registered nurse in the USA of migraine and small nodule in nose (unlabelled, USA). The reporter causality is possible to FluMist. This case is submitted according to the VAERS Safety Surveillance Accelerated reporting agreement for FluMist. MEDI00040340 is a 40 year old male that was vaccinated with FluMist intranasally on 1/6/05. Within 1-1.5 hours of received the vaccine, he developed a migraine and a small nodule (1 millimeter) inside his right nostril. There was no aura or other migraine symptoms, and he did not take anything to treat his migraine. The nurse was not able to palpate the nodule. No treatment was prescribed for the nodule and the pt reported that the nodule had been decreasing in size. The clinical outcome of this event in unknown. Follow up - Patient's DOB and vaccine lot number provided.
Moderna COVID-19 Vaccine   dizzy, lightheaded - resolved after 20 minutes
Myocarditis.  Patient initially presented with chest pain 12 hours after vaccination. No other risk factors. Patient required to be in Pediatric ICU for treatment and cardiac monitoring.
Swollen painful lump at injection site, redness, hot to touch, black and blue area. Two days after administration, patient states symptoms are getting better but are still present.  Pain is less than yesterday.
SIDE EFFECTS; THROAT SQUEEZED; TONGUE SWELLED; ITCHING; WOUND UP ON SCALP; BLISTERS ON THE SKIN AND MOUTH; HAIR STARTED FALLING OUT; This spontaneous report received from a patient concerned a female of unspecified age. 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 (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced some side effects (Dose number in series 1). The patient received non-company suspect Pfizer covid-19 vaccine (tozinameran) (Dose number in series 2) (form of admin, and route of admin were not reported, batch number: FK9896 expiry: UNKNOWN) dose was not reported, start therapy date was not reported for prophylactic vaccination.  On an unspecified date, the patient experienced throat squeezed, tongue swelled, itching, wound up on scalp, blisters on the skin and mouth, and hair started falling out (Dose number in series 2). Patient got a shot of Pfizer from the gray cap formulation. Patient was asking for a list of the inactive ingredients (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The outcome of the side effects, throat squeezed, tongue swelled, itching, wound up on scalp, blisters on the skin and mouth and hair started falling out was not reported. This report was non-serious.
strong pain in neck; muscle pain, sore arm,; hurt shoulder; nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (strong pain in neck), MYALGIA (muscle pain, sore arm,), ARTHRALGIA (hurt shoulder) and NEURALGIA (nerve pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PREDNISOLONE, APIXABAN (ELIQUIS), GABAPENTIN, LEVETIRACETAM, ALLOPURINOL, TOPIRAMATE, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), POTASSIUM, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and PARACETAMOL (TYLENOL) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (strong pain in neck), MYALGIA (muscle pain, sore arm,), ARTHRALGIA (hurt shoulder) and NEURALGIA (nerve pain). On 10-Mar-2021, NECK PAIN (strong pain in neck), MYALGIA (muscle pain, sore arm,), ARTHRALGIA (hurt shoulder) and NEURALGIA (nerve pain) outcome was unknown. Not Provided          The action taken with the drug was not applicable.
My heart kind of hurts; Diarrhea; I am nauseous; I feel like vomiting; My heart is beating like little bit more fast; I feel very tired and sleepy and no energy; I feel very tired and sleepy and no energy; I feel very tired and sleepy and no energy; This is a spontaneous report from a non-contactable consumer or other non hcp (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Aug2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Sep2021, the patient experienced my heart kind of hurts diarrhea, nauseous; and feel like vomiting, heart is beating like little bit more fast, feel very tired and sleepy and no energy. It was reported that patient experienced side effects and don't know if i can go to work tomorrow. I received my dose of vaccine tomorrow and I have side effects today. How can I work tomorrow. I have diarrhea and I am nauseous, I have diarrhea and my heart kind of hurts and I feel very tired and sleepy and no energy. I feel like vomiting, like my body is not reactive to this dose of vaccine and this is my first dose I had yesterday and this is how I feel today and my heart is beating like little bit more fast than usual. The patient underwent lab tests and procedures which included heart rate: fast on 01Sep2021, my heart is beating like little bit more fast. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
At 10:45 while sitting in Observation Room, Caregiver developed itching in extremities.  At 11:00 am she developed redness in face and chest and swelling in her throat.  Caregiver had her own Epi Pen and injected it into her thigh.  RN was at her side the entire side.  This RN arrived just after injection.  Caregiver sitting upright, alert and oriented x3.  No respiratory distress noted.  She complained of tingling in the lips and swelling in the throat.  At 11:06 she states the lip tingling was less.  Vital signs were BP: 120/66, HR:71, RR: 14, Sao2: 100% Room Air.  At 11:08 the throat swelling was less restrictive per  caregiver and no tingling felt in lips but having itching of feet and hands..  At 11:11, water given.  At 11:12, caregiver states tightness is less rating it 4/10 on a scale for tightness.  AT 11:25 BP:  130/76, HR: 69, RR:16, Sao2: 100% room Air.  At 11:36, caregiver states the tingling was much less rated 2/10 but itching still felt in hands, feet and chest. Caregiver to be evaluated by ER doctors since she injected her Epi pen and is still having symptoms.  11:52 Caregiver with unchanged symptoms but also c/o headache.  Taken via wheelchair by RN to Emergency Room.
Severe joint pain in right hand started 9 hours after vaccine administered. Slight nausea and severe headache upon awakening at 4:45 am. Slightly elevated temperature (100.1). Currently 25 weeks pregnant.
While driving home, pt started to cough, mom noted audible wheezing & stuffed up nose; Taken to pvt MD & given dose of Proventyl & Beconase nasal spray & began Augmentin for poss ear/throat infect;
1 vial of undiluted Pfizer-BioNTech Covid-19 Vaccine was administered to the patient. Patient was assess 30 minutes later, denies allergic reaction. A follow up call an hour later, to inform the patient of 1 vial  undiluted vaccine given to the patient, denies  pain or allergic reaction, Patient was told to go to the Hospital if not feeling well. Another follow up call 2x in the afternoon and patient denies  allergic reaction. Another follow up call 4/7/21 AM and PM,  patient still denies allergic reaction to the Covid vaccine but sour to the injected site.
PATIENT CALLED 1 DAY AFTER HER SHOT WITH A RASH AND ITCHING, AND SWELLING IN HER ARM.  SHE WENT TO HER DR. WHO PRESCRIBED AN  ANTIBIOTIC OF KEFLEX FOR HER.
Redness around the injection site,continued muscle pain at the injection site, warmth and numbness and tingling locally as well. Temperature taken during our call was 99.9 F. She denies hives, dizziness, face or throat swelling or any other signs of allergic reaction. Initially after having the vaccination, she did have some GI upset that resolved after a couple of days.
Headache, Arthralgia, FATIGUE, PAIN/SWELLING INJ SITE,  Narrative:
Muscle aches developed around 8 hours after injection, large red rash occurred around injection site, slightly raised and warm to the touch.  This rash dissipated in 48 hours. 1 week after the injection, large bump occurred at same site and a large, red, itchy rash appeared 24 hours after.  This rash is still present now  8 days after vaccination.
Initial and follow up information has been received from a nurse and an office worker concerning "almost all" patients (number of patients unspecified) who were vaccinated with GARDASIL (lot# not reported). The patients have been complaining of "heaviness" in the entire arm and "extreme pain" at the injection site after vaccination. It was reported that the pain occurs with all three doses. Patient outcomes were not reported. Patients reportedly sought unspecified medical attention by contacting the office. Subsequently, the patient recovered from "heaviness" in the entire arm and "extreme pain" at the injection site (not further specified). Attempts are being made to obtain additional information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.