chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm from Moderna vaccines; covid-19; Plaque psoriasis flare up located under bra line and thighs; Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19), PSORIASIS (Plaque psoriasis flare up located under bra line and thighs), SINUSITIS (Sinus infection) and VACCINATION SITE PAIN (Sore arm from Moderna vaccines) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 12-Jan-2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (covid-19), PSORIASIS (Plaque psoriasis flare up located under bra line and thighs) and SINUSITIS (Sinus infection). On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm from Moderna vaccines). In 2022, COVID-19 (covid-19) and SINUSITIS (Sinus infection) had resolved. At the time of the report, PSORIASIS (Plaque psoriasis flare up located under bra line and thighs) had not resolved and VACCINATION SITE PAIN (Sore arm from Moderna vaccines) outcome was unknown.            No relevant concomitant medications were reported.   There was no reported medical history.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the events of covid-19, sinus infection and sore arm from moderna vaccines with adalimumab solution for injection was no reasonable possibility.  The reporter's causality for the events of plaque psoriasis flare up located under bra line and thighs with adalimumab solution for injection was reasonable possibility.  Company's opinion was that the causality for the events of covid-19, plaque psoriasis flare up located under bra line and thighs, sinus infection and sore arm from moderna vaccines with adalimumab solution for injection was not provided.  No treatment information was provided.
Started vomiting hourly and refused to eat. Was submitted to ER at 1:00 PM where symptoms continued until she passed a bloody stool. Was moved to another hospital where an ultrasound confirmed an intussusception. A enema was performed and monitored via x-ray to correct the intestine at 2:00 AM the following morning. Treatment was successful and x-ray confirmed correction.
Low platelet count (109) and serious bleeding on both legs under the skin   Was told to stop taking baby aspirin until another platelet test for 05/23/2021 to see if her platelets have risen. If not, will be admitted to hospital.  Attaching a photo of her legs.
pt recv vax & exp a localized rxn w/pain & swelling as well as swelling in arm;to ER arm was iced & pt was treated w/APAP;
After receiving the vaccine, patient experienced chills and body aches all over for at least 2 days. Pain resolved after 2 day period and patient took Ibuprofen to help with the pain.
2 doses of IPV were given. Monitor site reaction - none. No abnormal reaction at site as of 6-23-11.
Dizziness, not responsive to questions, tachycardia. RRT called and taken to ER but regained normal mentation within minutes and discharged without further treatment. History of similar responses to flu vaccine.
On May 25, 1999 the pt developed chickenpox with less than 50 lesions. Subsequently, the patient recovered from the episode.
Expired vial was stored in refrigerator; No adverse event; 6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.  On 09-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine), PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 patients received expired Monovalent 6M-5Y doses of Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Expired vial was stored in refrigerator).    No concomitant medications were reported.  Vial size was unknown.  The vial was initially stored in the refrigerator 1 vial on 16-Feb-2023; 1 vial on 02-Mar-2023 and 1 vial on 09-Mar-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 5th of 6th child patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-715549, US-MODERNATX, INC.-MOD-2023-715550, US-MODERNATX, INC.-MOD-2023-715548, US-MODERNATX, INC.-MOD-2023-715545 (Linked Report). This case was linked to MOD-2023-715544 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715550:Patient 5 US-MODERNATX, INC.-MOD-2023-715549:Patient 6 US-MODERNATX, INC.-MOD-2023-715548:Patient 5 US-MODERNATX, INC.-MOD-2023-715545:Patient 5
Information has been received from a physician concerning a female pt who on 01-SEP-2001 was vaccinated with varicella virus vaccine live. The physician reported the pt scheduled an OB appointment "because the pt believed that she was pregnant as she was apparently ovulating at the time she received the vaccination". No adverse experiences were reported. No further detail were provided. Follow up information provided indicated the date of the pt's last menstrual period was 20-AUG-2001 and the estimated date of delivery was 27-MAY-2002. The pt had a diagnostic ultrasound which showed and IUP of 8.5 weeks, no fetal motion and diagnosed as a missed abortion. The pregnancy outcome was a spontaneous abortion at 12 3/7 weeks from the pt's LMP. the pt did not have any illnesses, infections nor was she taking any prescription drugs. Additional information is not expected.
Awful; Very painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feels awful (Verbatim: Awful) and pain (Verbatim: Very painful). The outcome of the feels awful and pain were not reported.   It was unknown if the reporter considered the feels awful and pain to be related to Shingles vaccine.     It was unknown if the company considered the feels awful and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and it was awful and very painful. The patient stated that wish he/she had never took that vaccine. Follow-up would not possible as no contact details were available.
facial swelling especially around the lower eyelids, subsided through the next 48 hours and is the swelling is now gone, pictures available
Intense arm pain. Could not lift arm from Jan 14 until Sunday, Jan 17. Subsiding somewhat on evening of Jan 17
Sharp shooting pain in leg and left foot Moved thru fingers, toes and body, esp left side Lessened over several weeks Still have some in fingers and toes Sciatica symptoms increased et hip
pt recv vax 18OCT96 & 20OCT96 devel Henoch-Schonlein purpura w/classic sx (rash, vomiting);
This spontaneous report was received from a nurse concerning a 4 year old male patient. There was no information about patient's concurrent conditions, medical history or concomitant medications. On 20-MAR-2018, the patient was vaccinated with a dose of improperly stored PROQUAD lot # N029673 and expiration date of 21-APR-2019, (route of administration and anatomical location were not reported) for prophylaxis, which was stored in the range of 15 Fahrenheit degrees to 46 Fahrenheit degrees (26.258 Fahrenheit degrees) for 432 hours. No previous temperature excursion was reported. No adverse effects were reported. Digital data logger was involved.
5 month old infant received adult polysaccharide pneumonia vaccine in error. Telephone contact 36 hours later reveals no adverse reaction. No fever or irritability. Minor redness at inj. site.
Had headache; Bad night; terrible body pain/my body would not stop aching/I'm aching all over it's not just my body; I'm aching all over it's not just my body even my eyes are even hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 (Lot number: EW0161) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lung neoplasm malignant" (unspecified if ongoing), notes: Verbatim: Lung Cancer; "High blood pressure" (unspecified if ongoing), notes: Verbatim: High Blood Pressure; "Blood cholesterol increased" (unspecified if ongoing), notes: Verbatim: High cholesterol; "Type 1 diabetes" (unspecified if ongoing), notes: Verbatim: Type 1 diabetes; "Osteoarthritis" (unspecified if ongoing), notes: Verbatim: Osteoarthritis, Patient has terrible arthritis. Concomitant medication(s) included: AMLODIPINE taken for hypertension; SIMVASTATIN taken for blood cholesterol increased; GLITAZONE taken for type 1 diabetes mellitus; GABAPENTIN taken for osteoarthritis; IRON. The following information was reported: HEADACHE (non-serious) with onset 23Apr2021, outcome "recovered" (2021), described as "Had headache"; INSOMNIA (non-serious) with onset 23Apr2021, outcome "unknown", described as "Bad night"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "terrible body pain/my body would not stop aching/I'm aching all over it's not just my body"; EYE PAIN (non-serious) with onset 2021, outcome "unknown", described as "I'm aching all over it's not just my body even my eyes are even hurting".  Additional information: Patient (Pt) suffer from whole lot of stuff, lung cancer, blood pressure, high cholesterol, type 1 diabetes, and osteoarthritis (and also reported as terrible arthritis), Pt have been taking shot. Pt don't take anything for the cancer, just go and see the doctor once a year, for high blood pressure, take Amlodipine, 10 mg once a day, and take Simvastatin, in night time only. Reported that Pt took the Pfizer the 1st dose which was on 23Apr and when she took it the following day which was on Saturday, Pt had headache and a bad night, ok that was on the 23rd but today (at the time of report) is the 2nd and she still have terrible body pain, she was not having the Headache but body would not stop aching and she was wondering how long will it last. It's been over week. Patient scheduled second shot of the vaccine on 14May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a physician via a sales represented and a health care professional and described the occurrence of rash in a 15-month-old  female subject who was vaccinated with HAVRIX (GlaxoSmithKline). There were no concurrent medications. On the morning of 14 May 2008 the subject received 1st dose of HAVRIX at 0.5ml (720 elisa units) in the left thigh. There hours after vaccination with HAVRIX, the subject experienced rash on her stomach and legs. The subject also developed a fever of 99.1 the subject was treated with  Benadryl. At the time of reporting the outcome of the events was unspecified. Follow-up information received on 09 June 2008 indicated that the events of rash and fever resolved. In the reporter's opinion, the events were possibly related to treatment with HAVRIX.
22 hours after being vaccinated, I fainted (approximately 7:00 AM the next day), the duration of fainting was more or less than a minute. The rest of the day I felt very weak. I had a fever of 37.5C. My blood pressure was normal (good), just my heart rate a little high (I usually monitor 70 and it was close to 100 for several hours after fainting). During the night before the event, I got up to urinate several times and usually I only get up once. I did not take any medications or supplements on the day of the vaccination. I also did not take painkillers after vaccination.
swollen lymph nodes under armpit after receiving their booster dose; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A 7-year-old patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number unknown. Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes under armpit after receiving their booster dose".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient is on day 4 of a high fever.  His fever has been between 102.6 and 103.7 daily.  On day one (7/18) he started complaining of a head ache, day two (7/19) he started complaining of a sore throat.  On day three (7/20) he was tested for and diagnosed with Streptococcus.  He  has now been on antibiotics for 24 hours.  Today is 7/21.
The patient became confused, had red arm, high WBC and had pneumonia injection day prior.  The patient was determined to have an inflammatory response and possible cellulitis from vaccination.  It was treated with Ancef and then Keflex.
Patient states my throat feels numb, rashes noted around neck and chest. Patient evaluated by paramedics on site. Monitored patient for 30 minutes. Patient referred to ER due to elevated BP. Patient refused and signed AMA. Patient A&O x3, accompanied by husband.
On 05/31/2001 this patient's mother called to report that this patient came down with bacterial meningitis on 05/27/01.
Pfizer-BioNTech COVID-19 Vaccine EUA: Soon after receiving vaccine patient felt flushed. Vital signs taken and all within normal ranges. Patient observed for thirty minutes after vaccination and at end of observation period stated they felt a sensation of throat closing. No rash, shortness of breath, or uticaria noted. Patient took one dose of diphenhydramine 25 mg by mouth and symptoms resolved. Repeat vital signs remained within normal ranges and no new symptoms developed. Patient discharged from vaccination clinic to home stable.
Developed itchy, raised rash on face and arms 15 min after being vaccinated no diff swallowing/breathing. Gave BENADRYL 50 mg and CLARITIN 10 mg po.
Dizziness, Seizures, HYPOtension & Syncope Narrative: 5 mins s/p administration 1305, light headed, syncopal issue, seizure, bp 60/31 hr 67 . epi administered per MD. 1319 bp 62/36 hr 71, 2nd ep administered per MD. EMS at 1320 bp 64/46 hr 85. IV Fluids were started, BS 123, EKG's x3, employee transported to local hospital with STEMI alert.
Mom went to put in car seat and child went limp, brought back inside Health Dept, child pale, awake, feet elevated, B/P 80/58, ambulance called to check out child. Color improved when ambulance arrived. Evaluated child, did not go to hospital, will follow-up with pediatrician today.
Pt experienced asthma exacerbation 2 days after receiving vaccine. Cough and wheeze noted. Pt started on steroids.
patient could not do much of anything; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMPAIRED WORK ABILITY (patient could not do much of anything) and PYREXIA (fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had not been diagnosed or tested positive with COVID-19.  The patient's past medical history included Skin cancer. Concurrent medical conditions included Nasal allergy (Nasal allergies). Concomitant products included METOPROLOL, ATORVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], FISH OIL, MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], CIMETIDINE (CREATE [CIMETIDINE]) and CREATININE for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMPAIRED WORK ABILITY (patient could not do much of anything) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Fever, at an unspecified dose and frequency. At the time of the report, IMPAIRED WORK ABILITY (patient could not do much of anything) and PYREXIA (fever) outcome was unknown.            Concomitant medications included Create (D) and creatinine monohydrate.  The patient and the reporter were glad that they both received the vaccinations.   This case was linked to MOD-2022-580263, MOD-2022-580266, MOD-2022-580267.
0950 Pt reported numbness and tingling of mouth and arms s/p vaccination. No SOB , HR 65, Benadryl not given per pt request. pt reported feeling better and left at 1037.
ASTHMA ATTACK; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthmatic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced asthma attack. Treatment medications included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from asthma attack on APR-2021. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Small red pustule like nodules appearing on outer aspect of Left arm near small pox vaccine site.  More nodules appeared over the past two weeks and have been noted to be on the Right arm as well.
We gave 3 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We gave 3 doses of expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received 1/2 dose ( 2nd booster ) on 14 Apr 2022. The vial was initially stored in the refrigerator was on 13 Apr 2022. The vial did not undergo any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2022: Follow-up information received contains no new information.
This case was reported by a non-health professional via call center representative and described the occurrence of syncope in a 14-year-old male patient who received BEXSERO (batch number 16D301, expiry date 28th February 2019). On 10th April 2018 16:30, the patient received the 2nd dose of BEXSERO (intramuscular) .5 ml. On 10th April 2018, immediately after receiving BEXSERO, the patient experienced syncope. In April 2018, the outcome of the syncope was recovered/resolved. The reporter considered the syncope to be almost certainly related to BEXSERO. Additional details were reported as follows: The patient received BEXSERO on left deltoid. Shortly after receiving the vaccine, the patient was unresponsive for a few seconds.
Patient said about a minute after receiving vaccine that she felt like she was going to faint. She put her head down and then fainted. I caught her and lowered her to ground. She tensed up and shook a little and was unconscious. I called 911 and she became conscious in less than a minute. Paramedics arrived and took over.
Large area erythema with induration. Nontender palpation (R) deltoid.
My toes became hard, red and swollen, difficult to bend and had to concentrate when walking. Worse on right foot and middle three toes in particular.  I went to podiatrist,  and was told foot completely structurally sound and to try GP, there it was suggested possibly COVID related. Was given gabapentin to use if too painful and as needed. I used a few times but didn't like the way made me feel in comparison to any real difference that I felt in toes.  The reactions would come and go and have lessened over the time since the vaccine. However, there are time even now that the toes still feel tingly and off in a swollen, hard manner and they get discolored. I tend to massage them often and move them around to help.
Pt states that her arm is very red and sore.  Area of redness is approximately 5inches long and she is experiencing a little tightness in her chest.
chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th September 2019, the patient received the 2nd dose of Shingrix. On 9th September 2019, 1 days after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on left arm. The patient received the second dose of the Shingrix vaccine and, after about 24 hours, on day of reporting she started to experienced chills. The reporter consented to follow up.
Patient had the vaccine on 12-2-14 and on 12-4-14 she called and left a message that she had a sore on her behind and the injection site was warm and red. We called her doctor and she was calling her to come in for a visit.
GARDASIL-series of three injections alleged to prevent HPV/cervical cancer......caused debilitating and non-treatable symptoms and side affects ongoing including seizure, convulsion, paralysis, loss of sight, hypersensitivity to foods, involuntary motor tics, etc.