chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient is 70 F with Type 1 von Willebrand's disease, mild hypertension, asthma, mild mitral regurgitation, and diffuse degenerative joint disease.  She has been safe at home during the pandemic tested a few times for COVID-19, consistently negative.   Approximately 1 month after the second Pfizer vaccine she developed a precipitous onset of severe acute congestive heart failure subsequently diagnosed nonischemic cardiomyopathy/myocarditis. Initially, prior to the diagnosis at the onset of the illness she was treated with 1 week course of high-dose prednisone as if this were asthma because of the primary symptom of shortness of breath.  This was of no benefit. Over the ensuing 2 months she has been seen by primary cardio
Onset vesicle type blisters evening of 7/28/08.  Symptoms itchy.  Afebrile-patient not in distress.  Vesicles clustered on neck, shoulder and abdomen.
Felt pain; This is a spontaneous report received from non-contactable consumer, the patient, through a Pfizer colleague. A patient of unspecified age/gender received a single dose (unspecified dose number) of BNT162b2 (solution for injection; batch/lot and expiry information not provided) via unspecified route on an unspecified date for COVID-19 immunisation. There was no history, concomitant medications or past drug history reported. The patient reported they felt pain after the vaccination. Treatment details, if any, were not reported. The outcome of the event felt pain was unknown.   No follow-up attempts possible as reporter declined consent to further contact; No further information expected and information about batch /lot number(s) cannot be obtained.
POTS and sleep apnea; shortness of breath, increased heart rate upon standing, blood pressure elevation, lightheadedness, fatigued easily. Did not show until months after 2nd dose.
Awoke from nap about 5 hrs p/shot w/high pitched screaming-inconsolable; lasted w/approx 1 1/4 hrs & fell back asleep; APAP given but temp only 97.5 ax;
Pt's grandmother called. Rash started on ankles, also noted rash on face and arms. Throat glands got swollen. Non painful - 'felt funny'. Also developed headache. Came in to see practitioner 4 days after immunization - had 2-3d history of cough, negative rapid strep, but culture grew moderate amt Beta Strep, not group A or group B.
This spontaneous report as received from a healthcare professional who was a quality control representative of a company refers to an unspecified number of patients of unknown age and gender. Doses of RECOMBIVAX HB that were exposed to a temperature excursion on an unspecified date may had been administered to unspecified patients (lot#, dose, dose# and route not reported) on unspecified dates since the temperature excursion. He stated that some of the improperly stored doses were administered to some patients, but he was certain that the practices that administered the doses reported the administration to Merck to request revaccination information. He was not able to provide any healthcare provider information or case numbers, nor could he provide any additional information about these scenarios. He confirmed that the was aware that the administration of improperly-stored products to patients posted a safety risk to the patients. He did not know whether or not there had been any adverse effects. This is one of several reports received from the same source. Additional information is not expected as there was no consent for follow up contact.
Information has been received from a consumer concerning her 15 year old female daughter with stomach surgery (when she was 5 years old), who at the end of June 2009 (approximately 30-JUN-2009) was vaccinated with the first dose of GARDASIL (Lot number not provided). There was no concomitant medication. The consumer reported that on approximately 30-JUN-2009 "within a minute of receiving the first dose of GARDASIL" the patient collapsed and her arms started jerking around. The patient was brought to the emergency room but she was not admitted. The patient went home the same day. The consumer reported that the patient had been experiencing shakes and heart palpitations for 3 to 4 weeks starting on approximately 02-SEP-2009. Therapy with GARDASIL was discontinued (date not specified). At the time of the report the patient had not recovered. The patient sought medical attention at the physician. Upon internal review collapsed and her arms started "jerking around" were determined to be an other important medical event. Additional information has been requested.  10/26/09 Medical records received for date 6/18/09. Pt c/ reaction after receiving varivax #2, and gardasil #1. c/o tonic clonic seizure after vaccine. bhp  12/29/2009 ER record received for DOS 06/18/2009. DX: Syncope Patient presented to ER feeling well with no weakness  or sensory deficits. Patient reported that after receiving a vaccination, her arm was hurting. Upon receiving a second vaccination in her other arm, the patient passed out for twenty seconds with jerking movements in arms and legs. When patient came to, she was alert and not confused. Discharged home.  01/04/2010 hospital records and clinic notes received for DOS 11/22/1993-10/23/2009. DX: Fainting spells, Syncope following Gardasil, Viral Syndrome   Clinic note of 06/18/2009 notes patient was observed in office post seizure and given glucose wafer because last meal was approximately 6 hours earlier. Clinic note of 09/23/09 notes complaint of fainting spells and plan/treatment notes educate patient to prevent hypoglycemia. Note of 10/23/2009 notes complaint of grumpy over last two to three days. Examination: lungs clear.
pt recv vax;devel 3 lesions on the lt side of back,thigh and leg;RN indicated grouped vesicles on L3 dermatomal distribution,"herpetic rash"; pt recovered on 27may96;
The pt received vaccine on 4/27/00. On 5/1/00, the pt called and stated he can't raise harm but halfway up. Ha pain in arm and down into hand. Pt has pain around into shoulder blade and down to waist. States he feels like muscles in knots under arm. Advised to see MD. On 5/2/00, the pt went to MD and the MD thinks the needle may have hit a nerve (per pt). The pt denies pain other than stinging of medicine at time of injection. On 5/3/00, the pt states no better today. Suggested the pt see MD again if he doesn't' improve in the near future (next 1-2 days).
This spontaneous report was received from a licensed vocational nurse refers to unspecified number of patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On unspecified dates, in 2015, reported as "since the first execution, which occurred on an unspecified date in August 2015", the patients were vaccinated with unspecified doses of VAQTA (route of administration, anatomical location, lot number and expiration date were not reported); the doses were exposed to temperatures outside of the recommended range. There were no concomitant medications reported. No adverse experiences had been reported. There was no product quality issue involved. This is one case of several cases from the same reporter. Additional information has been requested.
I had the vaccine and I got shingles/Suspected vaccination failure; Shingles/ i got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 22-Dec-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient asked that what happened if you got the vaccine and then got shingles. The patient had the vaccine and got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
pt recvd vax;w/in 48 hrs devel erythema,induration,warmth & pain at inject on lt then rxn spread;fever,chills,fatigue(serum-sickness type of rxn);unable to use lt arm x 2-3 days ;now almost resolved,but pruritic over area involved;
Initial misuse report received from a healthcare professional on 13 February 2014. It was reported that the patient (no information was provided) regarding the patient) had received a dose of FLUZONE that was exposed to too low temperature (29.8F) for 2.5 hours. No adverse event was reported. Documents held by sender: none
Information has been received from a physician concerning a 16 year old female patient who on unspecified dates was vaccinated with 3 doses of GARDASIL (no lot number given). The physician reported that the patient experienced injection site reactions after all 3 doses with the third dose being the most painful. The patient sought unspecified medical attention. This is one of two reports received from the same source. No further information is available.
This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' medical history or concurrent conditions were not reported. Since 01-MAR-2017, the patients were vaccinated with PROQUAD (which had the lot # reported as M040141, lot # M043308 and M03886, the vaccines and sterile diluent expiration dates were unknown) (dosage information and route of vaccination were not informed) for prophylaxis. Information regarding concomitant medication was not provided. There was no product quality complaint involved. It was also reported that the vaccines experienced temperatures from 6 F degrees to 14 F degrees for 22 days. There was no previous temperature excursion. The call was not because of a "data logger". This is one of two cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000004.
Swelling in left arm, 24 hours, post injection, 20mm X 120mm. Numbness at injection site, itching in local area.
Itching under bra line and inner thighs with rash. Tongue swelling, headache, fever. Lasted about 16 hours then patient was fine. Took aspirin for fever.
Patient received 2nd Gardasil injection 10/19/07 on 10/21/07 patient c/o blurred vision, headache, numbness of legs and face on 10/23/07. Pt. still c/o above symptoms and advised to see PCP.
12/17/22 presents to ED for "shortness of breath". PMHx of " atrial fibrillation on Coumadin, COPD, CHF, coronary artery disease, squamous cell carcinoma of her leg, DVT, anxiety, depression, hypertension, GERD, GI bleed, mitral regurgitation and pulmonary hypertension"
About 16 hours after injection, I began experiencing chills, fever of 101.7, fatigue/exhaustion, and nausea.  It lasted about 24 hours.
Dizziness (as if the room was rocking back and forth) 15 minutes after vaccination. Progressed to persistent lightheadedness, nausea and chest/head heaviness. Patient placed on a modified Trendelenburg position and eventually asked to lie supine. There was no resolution. BP obtained 113/70.
immed redness @ site, progressing to bluish discoloration & wheal; then swelling all over; given Epi & Solumedrol which was effective; condition resolved; 14DEC94 f/u both thigh became red & areas of bluish discoloration; 3 hives over chest
Developed severe and persistent migraines almost two weeks after the vaccine that last for a week or longer. Never had migraines that lasted for longer than a day only 1-2x per month.
Arm hurting at the injection site; Slight headache; This is a spontaneous report from a contactable consumer (patient). This 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9266) via an unspecified route of administration in the left arm on 17Feb2021 at 11:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included deep vein thrombosis (DVT), gout, high blood pressure (HBP), high cholesterol, focal segmental glomerulosclerosis (FSGS), rheumatoid arthritis, and penicillin allergy, all from unknown dates and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19. The patient reporting taking concomitant medications. The patient previously received moxifloxacin hydrochloride (AVALOX) from an unknown date for an unknown indication and experienced drug allergy. The patient had not received any other vaccines in the 4 weeks prior to the COVID vaccine. The patient experienced arm hurting at the injection site and a slight headache for a couple days on 18Feb2021 at 06:00. The events were reported as non-serious and did not require hospitalization. No treatment was received for the events. The clinical outcomes of arm hurting at the injection site and slight headache were recovered in Feb2021. It was also reported that since vaccination the patient had not been tested for COVID-19.
3 days after my first covid vaccine a developed a burning sensation on the roof of my mouth and tongue and I saw a dentist and my provider and my dentist prescribed a steriod to calm things down  It took until September of 2021 before it almost completely resolved and then when I got my 3rd dose on March 25 2022 again 3 days later the burning sensation came back and I have not seen my doctor for this,  So clearly this is a side effect to the vaccination since it happend with my first does and my third dose.
Fever and Arm swelling Friday night Pt says unable to bend arm. Today pt's arm warm to touch and swollen at injection site pt's mother advised to go to MD.
After about a few weeks after my second dose of Moderna, my shoulder pain didn't go away. It is not just the shot spot but the pain radiates to my shoulder blade down to my left arm.  It wasn't often and I have a very high pain tolerance so I dismissed it would go away. But it has been 9 months since and my pain only worsened. It is now radiating to my shoulder blade to my neck and has become even more painful. I googled and they referred to it as SIRVA. I haven't seen a doctor because of money. My insurance is basic. I need help to compensate any xrays,  or mri or steroid shot that the doctor might suggest.
I received my covid -19 vaccine at work at hospital. I sat for my fifteen minutes after vaccination and felt fine. When I got home two hours later from work and got in the shower, I noticed that I had a red, slightly raised, pinpoint and very defined red rash. The rash was all over my abdomen, my back and my neck. The areas felt warm but I did I not have itching, pain or any other anaphylaxis symptoms. The rash faded entirely in the next 48 hours.
Narrative:  76 yo male candidate for Shingrix 2nd dose in series, refused on 9/21/21 after reporting rash after first dose administered on 7/30/21.
At the time of adverse event - Rapid heartbeat.  Flushed / tingling feeling throughout my body.  Hot / sweating.  Blotchy skin in appearance on chest.  Lump feeling in my throat.  Knot in stomach.  Extreme shakiness.  Days following - heart palpitations, shortness of breath, fatigue, heavy chest. Weeks following - heart palpitations, shortness of breath, fatigue, heavy chest.
Immediate swelling and bruising at injection site, size of golf ball, 09:55 Benadryl administered (50mg/ml) IM to L deltoid, 1010 ice pack placed, no report of itching or swelling at any other site.  Swelling is reducing at 1030.
This case was reported by a healthcare professional via a representative and described the occurrence of diarrhea in a female subject of unspecified age who was vaccinated with ROTARIX (GlaxoSmithKline). On 9 June 2009 the subject received 1st dose of ROTARIX (oral). On 10 June 2009, 1 day after vaccination with ROTARIX, the subject experienced severe diarrhea. She was seen in the doctor's office. Stool cultures were taken, including rotavirus, on 19 June 2009. When the child returned on 24 June 2009, all specimens were reported to be negative and the diarrhea was getting better. Four months later, the child was not given a second dose of ROTARIX. Follow-up information was received on 02 April 2010. The subject was a 2 month old female. Diarrhea occurred on 10 June 2009, one day after receiving ROTARIX. The event completely resolved by 30 June 2009. No further doses of ROTARIX were given.
Muscle pain worsening 1 week after 2nd vaccine and continuing 2.5 weeks after 2nd vaccine
received 0.25 ml of bivalent booster 10 days apart; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (received 0.25 ml of bivalent booster 10 days apart) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced OFF LABEL USE (received 0.25 ml of bivalent booster 10 days apart) and NO ADVERSE EVENT (No adverse event). At the time of the report, OFF LABEL USE (received 0.25 ml of bivalent booster 10 days apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for OFF LABEL USE (received 0.25 ml of bivalent booster 10 days apart).    No concomitant medications were reported.  1 patient (Adult) unintentionally received a 0.25mL dose of the Moderna Bivalent Booster as a "make-up" dose 10 days later, the patient only received an additional 0.25mL again.  No treatment medications were reported.   This case was linked to MOD-2022-679099 (Patient Link).
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age who on 24-JAN-2012, was vaccinated with first GARDASIL (dose, lot # and route not provided). On 23-JAN-2013, was vaccinated with second GARDASIL (dose, lot # and route not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse stated no adverse event was reported. Additional information has been requested.
eyes swelling shut-face flushed; eyes burning-felt hot; DPH given;
mom reports about 24hr p/vax pt went into a convuls lasting 20min;to ER then adm & kept for 4 days;had t104.1;feb sz;pneumonia;resp 24;pulse 180;resp distress;positive blood cult;
Starting the night of vaccination and ending in the afternoon the day after: Headache, body/muscle ache, pain at injection site, fatigue, chills, low fever
Tested positive for Covid19 after traveling for a family wedding.  Symptoms included cough, congestion, fatigue, increased arthritis pain in knees and lasted approximately 4 days.  Was prescribed paxlovid at facility
11/3 - 11/4/2021: Fever (101 & higher at times), Extreme chills, Extremely bad headache, Body Aches, Joint Aches, Nausea, Diarrhea, Exhaustion, Ears ached, Dizzy  11/5/2021: Woke up feeling much better, but realized my upper lip hurt. When I looked in the mirror, the left side of upper lip was red and swollen. By late morning (10:00am), the swelling had spread to the left lower half of my lip, and started to swell and turn red in my left under eye area. By 2:00pm, the swelling under my left eye had continued to spread towards my nose and my lips were more swollen.  At 7:30pm I was finally seen by a doctor at Urgent Care who said that she did not recommend using a steroid because it would reduce the effectiveness of the vaccine, so she suggested taking Benadryl and watching to see if there were any other signs of anaphylaxis (swelling of tongue, throat, difficulty breathing, etc....). She said that if any of those symptoms appeared to go directly to an E.R.., but they did not.   11/9/2021: Swelling has mostly disappeared.  11/10/2021: Swelling and discoloration from face is completely gone.
intermittent palpitations; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of bnt162b2 (Covid vaccine, reported as Pfizer product) lot no: EL0142, via an unspecified route of administration in left arm on 12Jan2021 at a single dose for COVID-19 immunization. There were no relevant medical history and concomitant medications. The patient experienced intermittent palpitations on 12Jan2021. She has been having palpitations since she received the vaccine, did not start having them until about 8 hours after, stated she has had palpitations on and off since then. The patient had not recovered from the event.
4/6: Severe full body itching without rash or swelling, starting within 1 hour of injection and lasting ~ 12 hours - Treatment: 2 doses (2 tablets) benadryl at 4.5 hour interval, 1 adult dose acetaminaphen, standard evening supplements including 1 dose 24 hour allertec (generic Zyrtec)  Morning of 4/7: Moderate full body itching, mild injection site soreness, severe headache, sore throat, fatigue starting at 12 hours after injection, and lasting 24 hours - Treatment: standard morning supplements including 1 dose 24 hour allertec, ibuprofen for headache, 1 evening dose (1 tablet) benadryl, standard evening supplements including 1 dose 24 hour allertec  Morning of 4/8: Mild full body itching persisting - Treatment: standard morning supplements including 1 does 24 hour allertec
severe chills, dry stinging mouth, headache, dehydration, dry heaves,nausea, for approximately 6 hrs. The symptoms resolved then she experienced Headache, fatigue body aches until 01/06/2021 @0600.
Post vaccination day 10 patient reported to ED with malaise, and truncal rash. ROS with no HA, fever, URI, or signs of desimination, which resolved by day 12. Escar at day 12 with no appearance of overly robust reaction, forming a well healing escar. Rash was of very mild acne like appearence with approx dozen papules on anterior and posterior trunk. No evidence of erythema multiform like rash, or lesions with central clearing, as well as no vesicles or desquamation. Patient at day 12 with resolution of malaise. Smallpox vaccine manufacture Acambis VV04003A, typhoid ViCPs by Aventis A05222, Anthrax by Miles lot unknown at this time.
This spontaneous report was received from a pharmacist refers to a female 70 year old patient. On 20-NOv-2014 the patient was vaccinated with ZOSTAVAX 19400 PFU, lot # K007988; expiry: 03-SEP-2015, dose: 0.65 ml, subcutaneous in the left deltoid region. No concomitant medications were reported. A patient visited the pharmacy on Saturday, 29-NOV-2014, and showed the pharmacist that the injection site where she received a dose of ZOSTAVAX is warm, red, and swollen. The patient reported that she "feels fine otherwise." The patient did not receive any other vaccinations on the day she received ZOSTAVAX, nor has she received any vaccinations since she received ZOSTAVAX. The patient reported that she "suddenly noticed" that her injection site was warm, red, and swollen on 29-NOV-2014. The patient had not informed her physician about this injection site ear to be developing a rash. There was no treatment given for the events. Action taken was unknown. The outcome of the patient's injection site was warm, red and swollen was reported as recovering/resolving. Causality assessment was not provided. Additional information has been requested.