chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (discomfort in her arm) and RASH (rash on her face) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     Concurrent medical conditions included Gluten sensitivity (Gets rash).    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (discomfort in her arm) and RASH (rash on her face). At the time of the report, LIMB DISCOMFORT (discomfort in her arm) had resolved and RASH (rash on her face) was resolving.            Concomitant medications were not reported. Treatment information in response to events was not provided. The patient had consulted Dermatologist and the HCP was unsure of the cause.
Starting around 12:30 am 10-21-21 not able to sleep - delusional all day 10-21-21 - suddenly complaining of pain which has not been present for 2 months  - inability to sleep night of 10-21-21  I spoke to the nurse practitioner for the facility yesterday as well as the administrator about his  behavior which suddenly changed on 10/21/21
POTS; autonomic dysfunction; orthostatic intolerance; presyncope; dizziness; headache; fatigue; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 15-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), autonomic dysfunction, orthostatic intolerance, presyncope, fatigue, dizziness and headache. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
1-9 Had immunization at 11 am temp. started 4 or 5 pm. Cheeks red, eyes blood shot. 1-10 rash on face and arms, 7 am left arm painful. Rash spread to legs. Better after BENADRYL. HA comes back in 24 hrs. 1-14 still having rash on and off.
36 Year old Male presents with Bell's palsy for 5 or more days ago-I took for 6 days (last day yesterday) Medrol (Pk) 4 mg tablets in a dose pack - 1 dose pk orally per package directions Subjective: Date added: 04/18/2021 at 09:14 AM (MDT)Left sided facial weakness 2 daysNo fever/ no difficulty in swallowing Had Covid19 vaccination 1 week ago as above, Moderna vaccine received 4/13/21 and developed facial paralysis left sided, cannot blink nor move face on left side, no headache, no nausea, left eye irritation as he cannot blink, no arm weakness or leg weakness.
given Varicella to early- pt only 9 mo old. Called Merck hotline Re: this incident
Initial unsolicited report received from a other non-health care professional (manufacturer) in the United States on 14-Jun-2017. This case involves a 30-year-old male patient who was vaccinated with a dose of ADACEL (batch number: C5216AB, expiry date: 06-Jun-2019, dose and route of administration was not reported), in left deltoid on 11-May-2017. Illness at time of vaccination was none and Pre-existing physician diagnosed allergies included allergy to PCN (penicillin), birth defects, medical conditions Was reported as none. Concomitant medications reported as unknown. On 11-May-2017, same day post-vaccination, since that day the patient developed pain at injection site. The patient was examine on 14-Jun-2017 by the physician assistant (PA) and PA reported that the patient had a firmness over the mid deltoid that they plan to ultrasound to rule out infection. The patient was complaining of tiredness, dizziness, nausea, diarrhea and general body aches from an unknown date. The patient required doctor visit. The patient's laboratory data reported as none. Corrective treatment was unknown. At the time of report the patient was not recovered from the events. List of documents held by sender: none.
Information has been received from a licensed practical nurse concerning a 66 year old male with a history of hypertension, impotence, hyperlipidemia, lipoprotein deficiencies, osteoarthritis and a codeine allergy, who on 09-OCT-2007 was vaccinated with varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (MSD) due to medical error not product confusion. There was no illness at the time of vaccination. It was noted that the patient's wife currently had shingles and the patient never had chicken pox in the past. No medical attention was sought. The patient's outcome was unknown. There was no product quality complaint. Follow-up information has been received from a nurse indicating that the patient received a dose of varicella virus vaccine live (Oka/Merck) (lot# 656261/1495F) instead of zoster vaccine live (MSD). The patient was noted to be doing well. The nurse stated that there was no product confusion and that it was medical error. "The doctor had ordered the wrong vaccine." Additional information has been requested.
No adverse event; Nurse reports they accidentally administered a dose of the pediatric monovalent vaccine today, 01Mar2023 which was beyond the published expiry date (11Feb2023); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse reports they accidentally administered a dose of the pediatric monovalent vaccine today, 01Mar2023 which was beyond the published expiry date (11Feb2023)) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9236B and AR9236B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) for an unknown indication.    Previously administered products included for Product used for unknown indication: DIPHTHERIA TETANUS PERTUSSIS AND HEPATITIS-B on 31-Jan-2023, ROTARIX on 31-Jan-2023 and PREVENAR on 31-Jan-2023. Past adverse reactions to the above products included No adverse event with DIPHTHERIA TETANUS PERTUSSIS AND HEPATITIS-B, PREVENAR and ROTARIX. Concurrent medical conditions included GERD and Dairy intolerance. Concomitant products included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE, PERTUSSIS VACCINE, TETANUS VACCINE TOXOID (DIPHTHERIA TETANUS PERTUSSIS AND HEPATITIS-B) for an unknown indication.   On 31-Jan-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 01-Mar-2023, the patient received second dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX) (unknown route) 1 dosage form. On 01-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse reports they accidentally administered a dose of the pediatric monovalent vaccine today, 01Mar2023 which was beyond the published expiry date (11Feb2023)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse reports they accidentally administered a dose of the pediatric monovalent vaccine today, 01Mar2023 which was beyond the published expiry date (11Feb2023)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Nurse reports they accidentally administered a dose of the pediatric monovalent vaccine today, 01Mar2023 which was beyond the published expiry date (11Feb2023)).    No treatment medications were reported.
The patient felt dizzy, had difficulty swallowing, & felt a swelling of the tongue seconds after shot was administered.
intermittent eye twitches in both of eyes; This case was reported by a consumer via call center representative and described the occurrence of blepharospasm in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th May 2022, the patient received the 2nd dose of Shingrix (intramuscular). In May 2022, less than a day after receiving Shingrix, the patient experienced blepharospasm. On an unknown date, the outcome of the blepharospasm was not recovered/not resolved.   It was unknown if the reporter considered the blepharospasm to be related to Shingrix.     Additional Information: GSK Receipt Date: 19-MAY-2022 Reporter's Comments: The patient reported case for himself. On the afternoon of 17th May 2022, the patient received Shingrix dose in arm.  The next morning on 18th May 2022 he noticed intermittent eye twitches in both of his eyes. On the day of reporting the intermittent eye twitch was only in his left eye. The reporter had nothing else to report.
10/15/2001 TC fr. MO, reporting right leg "swollen, red and warm and baby crying." 10/16/2001 TC to MO, child is improved after applying cool cloths. Given acetaminophen. No MD care sought. 10/18/2001 Improved, only slight swelling.
Patient received vaccine 5 days prior to reporting redness at injection site with warmth and itching.  Redness spreads from tricep area to wrist.  Nurse Practioner recommended starting antibiotic for infection at injection site.
This spontaneous report as received from a physician, via company representative, refers to a patient of unknown age and gender. The patient's medical history was not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported). Concomitant medications were not reported. On an unknown date, a year after receiving ZOSTAVAX, the patient developed shingles. The outcome of shingles was reported as recovered on an unspecified date. The relatedness between shingles and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Current conditions and relevant medical history were not reported. It was reported that in June 2013 the patient was vaccinated with the first dose of GARDASIL (injection, strength, dose, route, anatomical location, lot # and expiration date not reported). In November 2013, the patient was vaccinated with a second dose of GARDASIL (injection, strength, dose, route, anatomical location, lot # and expiration date not reported). It was reported that the patient had not been vaccination at the moment of the report with the third dose of GARDASIL. No adverse event reported. Additional information is not expected because the reporter did not consent for further follow up.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unspecified demographics. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On unknown dates, an unspecified number of improperly stored doses of VARIVAX (lot number L049534, expiration date 08-DEC-2017) (dose, route of administration and anatomical location were not reported) reconstituted with properly stored sterile water diluent (manufacturer unknown), were administered to the unspecified number of patients. No adverse effects have been reported. The doses were stored in temperatures from 47 Fahrenheit degrees to 77 Fahrenheit degrees (50 Fahrenheit degrees ) for 14 hours. There was no previous excursion reported. The digital data logger was not involved. The product quality complaint was not reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA007752.
Everything was fine at first. I noticed fluttering in my heart. I didn't pay much attention to it. It was some slight fluttering within an hour of getting the vaccine. Everything was okay for the next 24 hours. Then 36 hours later I started feeling a rapid heart beat. It felt like my heart was skipping a beat and it was accelerating all while I was just sitting down. I checked my blood pressure and it was elevated. It continued to go up. I felt pressure in my head and fuzziness.  On May 2, 2021, I went to an urgent care because I had an episode that lasted for about half an hour. By the time, I got there my heart wasn't palpitating the way it had been before. I still seen the doctor though, but he didn't express any concern about it. He thought that because he couldn't hear it then it wasn't significant. The doctor said it may be anxiety. I was low stress at the moment so I didn't think that was accurate. He prescribed an anxiety medication, but I didn't take it. When I went back home my heart was rapidly beating and skipping beats again. My husband could hear my heart skipping beats. The next day when I was working I had another episode, and it lasted for about 45 minutes. My blood pressure was really high. I was having difficulty with dizziness and felt like I was going to pass out. I went to the urgent care again on May 3, 2021 and my heart was back to normal. I had a cardiologist follow up appointment later on June 7, 2021. I was fine. I didn't have any other symptoms since then. The cardiologist agreed that the anxiety medication that was prescribed was the incorrect recommendation for my issue.
Patient called in morning of 9/24/14. Stated right arm was sore, a little swollen, warm to the touch and he was unable to use his right arm.  Advised him to use cold compress, take ibuprofen and Benadryl to help with reaction.  Patient stated that it seemed a little better in evening of 9/24/14.
no additional AE/PQC reported; caller is reporting an expired VAQTA that was administered; This spontaneous report was received from an other reporter and refers to a patient of unknown age and gender. There was no information regarding the patient's concurrent conditions, concomitant therapies or medical history provided.  On 04-NOV-2020, the patient was vaccinated with a hepatitis a vaccine, inactivated (VAQTA) injection, 0.5 milliliter, lot # S020241 for prophylaxis (route of administration was not reported) that expired on 23-AUG-2020. No additional adverse event (AE) or product quality complaint (PQC) was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S020241; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Joint pain. Rash - Erythema multiforme. Oral lesions. Pruritus --> ATARAX.
pt recvd vax 21AUG91 immed following vax, pt devel swelling w/o pain @ inject site; no further detials were provided;
warm around the injection site; puffiness around the injection site; sensitive to touch near the injection site; soreness on arm-injection site; pain on arm-injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm around the injection site), INJECTION SITE SWELLING (puffiness around the injection site), INJECTION SITE HYPERSENSITIVITY (sensitive to touch near the injection site), INJECTION SITE PAIN (soreness on arm-injection site) and INJECTION SITE PAIN (pain on arm-injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included UTI. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METFORMIN and LISINOPRIL for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced INJECTION SITE WARMTH (warm around the injection site), INJECTION SITE SWELLING (puffiness around the injection site), INJECTION SITE HYPERSENSITIVITY (sensitive to touch near the injection site), INJECTION SITE PAIN (soreness on arm-injection site) and INJECTION SITE PAIN (pain on arm-injection site). At the time of the report, INJECTION SITE WARMTH (warm around the injection site), INJECTION SITE SWELLING (puffiness around the injection site), INJECTION SITE HYPERSENSITIVITY (sensitive to touch near the injection site), INJECTION SITE PAIN (soreness on arm-injection site) and INJECTION SITE PAIN (pain on arm-injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment takes antibiotics for UTI  Patient did not provide consent for safety to contact HCP or the Lot number.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 54-year-old male patient who received SHINGRIX (batch number 27J4P, expiry date 12th April 2021) for prophylaxis. On 3rd December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In February 2019, less than a year after receiving SHINGRIX, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown. It was unknown if the reporter considered the shingles and pain to be related to SHINGRIX. Additional details were reported as follows: One week before the date of reporting, the patient was diagnosed with Shingles. This was further described as, no rash, just painful. The reporter consented to follow up.
Cellulitis left deltoid 4" x 3" Tx w/ Biaxin 250/5ml, 5ml PO bid x 10d
Swelling and redness of arm. Swelling approximately 5 cm, erythema > 26cm also nausea, vomiting, increase temp. This is in follow-up report (s) previously submitted on 4/6/2007. Information has been received from a 24 year old female and her physician. On 06-MAR-2007, the patient was vaccinated intramuscularly with a 0.5 ml third dose of GARDASIL. The physician reported that this was the patient's first dose of GARDASIL. The patient had no relevant medical history or illness at the time of vaccination. Concomitant therapy included YASMIN. The patient mentioned that she did not have any problems with dose 1 or 2 and that these doses were given in the outer part of her arm. She reported that the third dose was given less in the outer area and towards the inner arm but still in the muscle. On 06-MAR-2007, the patient experienced red, sore lump at the injection site. The physician reported that on 07-MAR-2007, the patient developed swelling and redness of the arm with swelling of approximatley 5 cm and erythema greater than 26 cm. On 07-MAR-2007, the patient experienced nausea, started to throw up, and she developed a fever. On 09-MAR-2007, the patient went tot he emergency room due to continued vomiting and dizziness. She was treated with intravenous fluid and was released at approximatley 04:00 pm. As of 12-MAR-2007, the patient continued to experience dizziness and nausea. At the time of this report, the outcome was unknown as per the physician. Additional information has been requested.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 28-OCT-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L018501, expiry date- 22-JUN-2017) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Day 1: itchy legs,, sore arm Day 2-4: sore arm, whole body itchiness intermittent Day5: swelling site, itchy body and at site Day 7+:  face numbing and tingling finger tips; treated with steroids: rash disappears and is healed
Pt recvd 1st dose of Engerix-B w/o an adverse event; following 2nd dose devel clinical jaundice & elevated liver function tests; hospitalized; tx surgical exploration & liver biopsy; pt has recovered;
After receiving HepB & Typhoid inject client stated, "do not feel so well." Drank water & apple juice and stated felt better. Approx. 15 min. later became diaphoretic and pale. Slumped over in chair. Aroused with ammonia inhalant. HRRR, oriented X 3. Remained in clinic until skin, warm, dry & pink and able to stand & ambulate without symptoms.  Wife to drive home. Inst. to report any further symptoms to nurse or doctor. Instructed to report incident to physician.
Severe tinnitus began the next day in both ears, right ear louder than left. Examined at ENT 03/22/2021. No physical abnormalities noted. Mild higher pitch hearing deficit in right ear secondary to aging. Prescribed Fluticasone propionate nasal spay.  Also  experiencing sweet smell  intermittently.
Very sore and swollen upper left arm  I could barely raise my arm half way up for two days. There was  stiffness in the back of my neck,.  I also had a headache,  runny nose and was very tired  and sleepy the next day.   Additionally, I  could taste the vaccine which was coming from the back of my throat and my menstrual cycle started one day late.
This spontaneous report was received from a physician via a company representative regarding a 18 year old female patient. Medical history and concomitant medications were not reported. On an unknown date 2 months ago in July 2016, the patient was vaccinated with dose 1 of GARDASIL 9 (Lot# and expiry were not reported). The physician noted that the following date after this dose in July 2016, the patient experienced a rash and hives which was treated with BENADRYL. The outcome and causality for rash and urticaria was unknown. Additional information is not expected as the reporter did not wish further contact.
Dizziness, Headache, Sedation, Myalgia, Fever, NauseaVomiting, injection site redness and swollen glands in the arm of the injection. Narrative:  symptoms persisted for >48 hours, with some lingering beyond 48 hours
Patient went stiff and went unconscious. Patient was then assisted to the floor by a staff member from the chair. Patient shortly after regained consciousness. Patient was then alert and oriented but had no memory of what happened.   Pt was shakey and light headed. EMS was called to the scene. Pt was then transported by ems to the hospital.  No epi pen was used.
Patient presented on 02April2021 requesting completion of COVID-19 vaccination series, previously received Pfizer dose one on February 25th, 2021 stateside.  As a military member transferred intermediate holding orders before proceeding on remote operational orders.  No Pfizer vaccine available overseas in this area of operation. Janssen available for administration on this date, patient beyond 28 days from initial mrnA vaccination, discussed situation with senior medical officer and region who approved administration of Janssen for vaccinating patient prior to her departure to more remote location; with direction to submit a VAERS entry.
Information has been received from an investigator concerning a 13 month old female child who received Prevnar on 5/1/00 and later that day, the child was taken to a local clinic for urticaria and angioedema. The child has since recovered. Angioedema was considered a "Medically Important Event". Both the investigator and the medical monitor agree that this event was 'possibly' related to vaccine administration.