chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NO ADVERSE EVENT; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (NO ADVERSE EVENT) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Hysterectomy, Tonsillectomy and Chemotherapy (completed before starting Rinvoq). Previously administered products included for Product used for unknown indication: Enbrel (Enbrel allergy). Past adverse reactions to the above products included Rash with Enbrel. Concurrent medical conditions included Dizziness since 2020, Headache (minor headache most days that came and went) since October 2020, Food intolerance since 2020, Papular rash since 2020, Stomach ache since October 2020, Fibromyalgia since 2020, Skin breakout since October 2020, Diarrhea (occurred once or twice a week) since 2020, Muscle pain since 2020, Chest pain since 2020, Achilles tendonitis since 2020, Rheumatoid arthritis flare up (Joint aches and pains before Rinvoq but improved after Rinvoq) since 2020, Swelling of legs, Potassium supplementation, Breast cancer female (remission) since April 2019, Drug allergy (ENBREL allergy), Non-tobacco user and Abstains from alcohol. Concomitant products included HYDROXYCHLOROQUINE for Rheumatoid arthritis, POTASSIUM for Supplementation therapy, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for Swelling of legs.   In October 2020, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to 15 milligram. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram. On 20-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (NO ADVERSE EVENT). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (NO ADVERSE EVENT) outcome was unknown.            No treatment medication was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-621766 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up document contains no new information.
Patient had Flu vaccine. Broke out in rash 2 days after vaccine. Observed to have fine pinpoint papular rash to chest, back, upper thighs.
when she peeled off the band-aid she had on the injection site, she noticed blood on it.; This is a spontaneous case received from a non-contactable (patient). A female patient of unspecified age received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unknown date as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient stated that she received the second dose of the Pfizer COVID vaccine and hours later when she peeled off the band-aid she had on the injection site, she noticed blood on it. The seriousness was reported as non-serious. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I received the injection, got up from the table immediately, and went to the reception desk to check out. Right after walking up to the reception desk, I had arm symptoms and passed out. I hit my head because I was standing at the desk in the doctor's office next to a door frame. I ended up having to go to the emergency room to be evaluated since I had passed out and hit my head.
Following vaccine slight discomfort but nothing more than regular flu shot. Ten days after, I woke up to swelling redness and hives covering my upper left arm to the elbow. Waited 24 hours to see if it would disappear and when it didn't, I then went to the doctors office. I was seen by the nurse/practitioner who gave me a steroid shot  and advised me not to continue with the vaccine program. Everything healed up in a couple of days and I continued with the vaccine program , receiving my second dose on January 28th. with no reaction.
Shortness of Breath      per EMS, x 1 week. Pt had COVID pt last week     HPI 45 year old female with no significant past medical history presents for SOB. Pt exposed to COVID pt at work 1 week ago and has since progressively developed many COVID symptoms incluiding fevers, chills, nausea, vomiting, diarrhea, shortness of breath. SOB worsened today so EMS was called. Pt was placed on 15L NRB by EMS satting in the 90s. On arrival pt is in the 90s on room air. Pt complaining of generalized pain. Pt is very anxious as mother died in this hospital a year ago. Pt received first dose of Pfizer vaccine 3 weeks ago. Pt feels this is a result of the vaccine.    Review of Systems  Constitutional: Positive for chills and fever.  HENT: Positive for congestion. Negative for ear pain and sore throat.   Eyes: Negative for photophobia and visual disturbance.  Respiratory: Positive for cough and shortness of breath.   Cardiovascular: Negative for chest pain and leg swelling.  Gastrointestinal: Positive for abdominal pain and nausea. Negative for constipation, diarrhea and vomiting.  Genitourinary: Positive for dysuria. Negative for flank pain and hematuria.  Musculoskeletal: Negative for arthralgias, back pain and myalgias.  Skin: Negative for pallor and rash.  Neurological: Negative for dizziness, syncope, light-headedness and headaches.  Psychiatric/Behavioral: Negative for agitation and confusion. The patient is not nervous/anxious.
ARM SORE FOR ONE DAY; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported 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, the subject experienced arm sore for one day. The action taken with covid-19 vaccine was not applicable. The patient recovered from arm sore for one day. This report was non-serious.
presented to ED with hx of positive COVID test earlier in the week; mild SOB, cough, diarrhea; pneumonia COVID related; end-stage renal disease (hemodialysis 3xwk); fld overload
MILD FEVER; ACHY MUSCLES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,)  dose was not reported, administered on MAR-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 MAR-2021, the subject experienced mild fever. On MAR-2021, the subject experienced achy muscles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever and achy muscles was not reported. This report was non-serious.
Received flu vaccine October 16,2003 around 5:30 PM.  Around Noon the next day began to feel achy - all over. Denies fever.  Saw her MD Monday 10-20-2003.  He ruled out meds and other causes per client and told her it was from the flu vaccine.  Client still has aching today, but feels it is improving.  Has had flu vaccine before without problems.
Information has been received from a physician assistant concerning several "30's" female patients who were vaccinated with GARDASIL series on unspecified date and a couple of years later test positive for HPV. There patients had gone to an office and had Pap's that came back as high risk. These were precancerous cells. The reporter mentioned most of these patients were married. The reporter thought the patients test that came back as high risk were for the HPV types that GARDASIL did not cover. One of these patient's physicians "froze the precancerous cells". The number of patients was unknown. At the reporting time the outcome was unknown. Upon internal review, precancerous cells and test positive for HPV were determined to be other important medical events. Additional information is not expected.
Pt seen in office after receiving the flu vaccine on 10/17/23, at a flu clinic hosted by HD at pt's school. Pt's LD has no redness, no swelling, no sign of puncture site, and area is not warm to touch.  PT states "unable to raise arm."  Advised to contact her PCP and that we will follow up with her.
Reddened area approx 3" diameter around both injection site - face turned red and appeared blotchy when crying.  BENADRYL 118 mg given thru Gtube observation for other signs of rxn for 60 min.  Dismissed from clinic at 1300 - redness reduced to 1 1/2".
This all happened this week. My nose started running a lot like an allergy reaction. I took over the counter Sudafed and went to bed. The next day it felt like I had a cold. My nose was running and I was sneezing. I was also exhausted. I took a COVID-19 Home Test Wednesday evening and it was positive. I called my doctor the next morning and they told me what to do at home. I have had mild symptoms. I have been dealing with congestion and a dry cough. It feels like the throat is irritated. I have been resting and drinking lots of fluid. They recommended vitamins so I have started doing that. I am not as congested and not having as much of the nasal drip. The throat has been scratchier today. I have had a little more energy today but I am trying to keep resting and doing what I am supposed to.
She got her vaccine, the injection site was OK, nothing new about it.  Later that day in the afternoon she started to get the feeling of malaise and the arm was a little bit sore, and slightly red and warm around the injection site.  The bad reactions actually started the next day and that's when she ended up with a headache, had fever, had chills, slight nausea, and around the injection site she had a lot of redness, spread to about the size of 5" in diameter.  There was swelling around the injection site as well as pain.  She took Aleve for her reaction and used ice packs on the arm throughout the day.  This did not relieve her symptoms, the ice did for a little bit, the pain of the area.  The next morning she site swelling and fever, as well as redness, swelling pain and then itchiness wanting to scratch that area.  She took Benadryl for that reaction.  On 10/28/23 the headache and fever had left.  She still had redness, some pain and itchiness which continued to this morning.  There is still some slight redness and some soreness to the area today, but it is diminishing and looks so much better this morning.    She did contact her doctor on 10/26/23 and she was the one who told her to put ice on her and to call back if she got any worse.
Patient came in 1 week later to show me a large brusing area (4x4ish) where the shot was given. Must have been a reaction as the area too large for trauma from needle. Was healing never bothered patient but he noticed it. Never itched or hurt per patient.
Patient given two FLUZONE High Dose 2016-2017 vaccines, one in each arm. No adverse events reported. No treatment needed.
Described local redness & swelling at site of injection (LA) shortly after adm. lasting 3-4 days. - Painful about 11-1-11, began developing pruritic, dense, papular rash beginning on arms, spreading to trunk, lower extremities becoming systemic, except face. Family dr sent him to see dermatologist, who decided it was "chickenpox" describing lesions as vesicles. Rx's ALLEGRA.
Narrative:  COVID INFECTION after COVID vaccine series 01/18 COVID vaccine dose #1 02/09 COVID vaccine dose #2 07/16 started with fever, chills, fatigue, nausea, rhinitis, sore throat 07/19 seen in outside ED, diagnosed with COVID pneumonia 07/20 c/o dizziness, shortness of breath, muscle weakness and tremors 07/21 c/o worsening cough, low BP 07/22 c/o mild, infrequent, productive cough w/ clear sputum, fatigue, fever 07/23 reports o2 sat 72-73% w/ pulse of 71, hands cold and discolored, 30 minutes later, o2 sat 69%, BP 90/58, HR 60, admitted thru ED to ICU; CT showed bilateral pneumonia; o2 sat improved to 93% on non-rebreather mask, received cefepime, doxycycline, IV steroids during admission 08/13 clinically resolved infection 08/18 discharged from hospital
17Apr10 -Start with huge hive, bad headache, and slight pain when breathing - only on the right side. 19Apr10- was seen by healthcare provider - administered antibiotic.
one patient was administered an improperly stored dose of PROQUAD; No adverse effects reported.; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. There was no information reported regarding the patient's concomitant medication, pertinent medical history and drug reactions/allergies.   On 22-JUL-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD)) for prophylaxis (dose and route were not reported; lot number R017802and expiration date 19-DEC-2019). The vaccine was reconstituted with a properly stored DILUENT MRK INJ (lot number and expiration date were unknown by the reporter). The temperature was from -14 Celsius degrees to -10 Celsius degrees (-10.2 Celsius) for a time frame of 1 hour and 22 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported.
2 weeks after the moderna booster I broke out in itchy hives all over my body big red itchy hives multiple  Still have them this week which is week 5 post shot tried to spot antihistamine but they returned
I tested positive for covid 19; I felt sick couple of days ago I took a home test then went to the clinic and took another test; I have been feeling ill with sore throat and cough with some vomiting and stomach aches but I can still smell and taste
Received DTaP, MMR, IPV vaccines on 3/18/03. Mother first noticed circular rash (described as hives) around vaccination sites of DTaP and IPV (left upper arm). Rash and itching decreased markedly with use of Benadryl next day.
Sometime in March patient reports having  left sided hip pain that radiated down her left leg. States it went away on its own but returned again this week. Two years ago she was treated for lower back pain after a car accident.
Should I have a knot at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other and describes the occurrence of VACCINATION SITE NODULE (Should I have a knot at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Patient medical history was not provided by the reporter.     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 SITE NODULE (Should I have a knot at the injection site). At the time of the report, VACCINATION SITE NODULE (Should I have a knot at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment medications were reported
had COVID; had COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000002650.  A patient in their 70's received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had COVID". Product was reported as Pfizer Biontech Covid-19 Vaccine. It was also reported that a patient received 2 shots of an mRNA, either the MODERNA or PFIZER, on unspecified dates.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itching/redness around site -> instructed pt to apply cool compresses and take BENADRYL called pt. 1-18-13 redness went down little still itching.
Headache, lump in right armpit, pain in right armpit unable to extend without sensation of pulling in armpit. Rash on upper chest itchiness of upper coast and left lower leg
Information has been received from a Registered Nurse concerning a female who was vaccinated with Gardasil (date and dose unknown). Subsequently the patient "passed out"after receiving Gardasil. The patient sought unspecified medical attention. Subsequently, the patient recovered from passing out. Additional information has been requested.
EXTREME MUSCLE PAIN AND LIMITED USE, DOCTOR GAVE LIDOCAINE PATCHES, PHYSICAL THERAPY MAY BE NEEDED.
Pt recvd 1st dose Hep B vax 26JUN89 next day devel fever to 104, lack of energy, sore throat, diaphoresis; pt took ASA for sx; advised to see MD; On 17JUL89 pt devel cough; pt did not receive 2nd dose of vax & 27MAR91 needle stick;
This spontaneous report as received from a pharmacist refers to a 63 year old male patient. The patient had no pertinent medical history and no drug reactions or allergies. On 22-MAY-2015, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, in the posterior left arm, inadvertently via intramuscular route, lot # L003217, expiration date 30-APR-2016. The patient was concomitantly taking multiple unspecified medications. In approximately August 2015 (reported as "about a month ago"), the patient developed a small bump on  his left side which turned into an elevated rash that looked "like hives covering his whole left side". The reporting pharmacist stated that the patient was using an unspecified topical steroid that was giving relief from the itching (onset approximately in 2015), but was not slowing down the progression of the rash and it's size. The patient sought medical attention via going back to the pharmacy. No lab diagnostic studies were performed. By the time of the report, the patient did not recover from the adverse events. Casual relationship between the adverse events and vaccination with ZOSTAVAX was not assessed by the reporter. Additional information has been requested.
3pm Left Upper arm seems swollen and hot 4pm Left Upper arm became sore and painful couldn't sleep due to pain that night 8pm Ran a fever over 101 degree for 2 days; soreness and fever gradually diminished and was gone by October 31 ( No reaction on right arm where flu shot was given)
administrated only the adjuvant portion; administrated only the adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 59-year-old male patient who received Herpes zoster (Shingrix) (batch number ga5s2, expiry date 25th March 2023) for prophylaxis.   On 7th October 2021, the patient received Shingrix. On 7th October 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The patient administered with only the adjuvant portion of Shingrix by error, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. No further events were reported. The reporter consented to follow up.
No adverse event; RN reporting that a patient received a dose of MMRII on 6/14/2022 with a labeled expiry of 6/2/2022. No additional information provided. Caller abandoned call prior to agent obtaining consent to contact. No additional AE/PQC was reported at time of c; This spontaneous report was received from a registered nurse, concerning a 58-year-old patient of unspecified gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 14-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 ml, lot # T018893 for prophylaxis. The dose expired on 02-JUN-2022 (route of administration was not reported).    No adverse events were reported.
This was my second COVID shot. My arm hurt badly the night of the shot.  I woke up in the middle of Thursday night/early morning with chills. Couldn't stop shaking.  I couldn't lift my arm past my waste.  Felt awful on Friday and I ended up running 101.8 fever.  I had a headache that day.  The fever finally broke on Saturday and I just felt weak and my arm still hurt. Today, Sunday, I suddenly have a big bright rash at the injection site on my arm, 6"x3".  During the first one my arm hurt terribly, felt flu-ish, very low grade fever and ended up with "COVID arm" a big rash 8-9 days later at site of injection.