chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 22 year old female certified medical assistant who on 12-SEP-2006 was vaccinated IM with the first dose of Gardasil (yeast) (Lot#653735/0688F). On 13-NOV-2006 the patient received the second dose of Gardasil (yeast) (Lot#653735/0688F). Concomitant therapy included Depo-Provera. On an unspecified date in December 2006, the patient began with vaginal bleeding "on and off for several weeks. On 13-JAN-2007 the patient started with a flow that was very heavy lasting seven days, with cramping and shortness of breath. At the time of this report it was unknown if the patient had recovered from the events. Additional information has been requested.
Developed swollen area that was re, warm to the touch and itchy. Are was several inches in diameter.
After her appointment she was fine and smiley, she took a nap on the car ride home. 2 hours after her shots, we noticed she was breathing heavily and had spiked a fever, she was incredibly lethargic. We brought her into urgent care and had a pulse of 177. The nurse kept checking and said she didn't want to chart it that high, however, it was always above 160 even when she was sleeping. We saw the doctor and he said she would be fine. We left, it is now the next day and she isnt waking up, it extremely disoriented and has a 102 fever still.
A physician reported that an 18 month old female received Prevnar, Comvax (Merck) and IPV (Aventis Pasteur SA) vaccines on 6/5/00. On 6/6/00, she developed a rash. The pt was examined by a dermatologist, who described the rash as a "fine papular rash with areas or lesions of urticaria". She recovered.
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
fever 101-103.5 from 8 hours after shot to 40 hours even with tylenol, chills, sweats, ache in elbow joint in injected arm, extreme fatigue on and off headache.
On 9/25/2019, pt received the High Dose Flu vaccine at a Clinic. No other vaccines given. Pt reported pain after injection. On 09/27/2019, pt reported to the Medical Center Injection Room. Pt reported that on the morning of 09/27/2019, he had arm swelling. Nurse assessed. Erythema that was approximately 10 cm in length and 6 cm  in width on Left lower arm. It was warm to touch. No pain on palpation. Denied fever. PCP notified via Electronic Health Record.
Patient presenting for evaluation of right leg weakness. MRI Brain showed 10mm subacute to late subacute infarct in the posterior limb of the left internal capsule. Outside window for tPA -possibly cardioembolic -echo completed -lipid panel and a1c completed -Case discussed with Neurology, consult recs appreciated. After discussion with Neurology will switch to Eliquis and DC Plavix. ED visit and hospital admission were within 6 weeks of receiving the COVID vaccine.
1 - 1 1/2 hour episode of crying and irritability beginning 4 hours after immunizations given with erythema and swelling to right thigh.  Patient returned to office for evaluation, consoled in office.
cold, cough, running nose, hoarseness, phlegm duration: 27OCT93-27NOV93;
1st dose on 01OCT2021, 2nd dose was not administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on 1st October 2021 received 1st dose batch number 9435L and expiry date 8th April 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.     Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comment: The pharmacist had a immunocompetent patient who received Shingrix first dose. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Employee states she felt soreness and a knot in her arm at injection site 2 days after vaccine injection.  Then 2 - 3 days later she felt pain starting near injection site, going down her arm.  She states that her right ring and pinky fingers feel like they are going numb.  She states there is no change in skin temperature or color of the fingers.  As of the date of this report, the employee states she has not sought medical care for the problem.  She states she has had carpal tunnel in that same extremity before.
Flu Vaccine recieved on 28Oct2003-no immediate reaction. 24h later, arm bright read 1 inch around injection site, itching, cutaneous skin pain, minimal muscle pain. Progressed to 2 inch bright red area around injection site. Hot to touch severe itch resolves with Benadryl.
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ (route oral, dose not reported, lot# K010323 with expiration date 10-MAY-2016 or lot#K017576 with expiration date 12-JUN-2016). There was no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
I noticed swelling and mild pain in my left axilla on Thursday, 12/15/2022, two days after the vaccine in my left arm. I was told by the nurse that gave me the shot that common side effects are:pain at the injection site, frontal Headache, and lymph node involvement. I took the axilla pain and swelling to be lymph node response to the Covid vaccine. This is still slightly noticeable on 12/18/2022. On 12/17/2022, at around 2:00 PM, I walked into my house from an errand, and not long after, experienced sudden onset tinnitus (a high pitched buzzing), in my left ear only. This lasted approximately 6 hours constant. It seemed to disappear gradually. While I experienced the tinnitus, I also had crackling or popping noises in my ear for a very short while, maybe 15 minutes. I realized after the tinnitus started, that I had had a feeling that I could feel my heartbeat in my left ear intermittently in the day or so prior to the onset of the tinnitus. It was somewhat bothersome in that it was a strong heartbeat feel. It has not recurred since the tinnitus ended.
SIGNIFICANT ABDOMINAL PAIN FOR 3-4 DAYS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: polyethylene glycol allergy, and severe asthma attacks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced significant abdominal pain for 3-4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from significant abdominal pain for 3-4 days on MAR-2021. This report was non-serious.
2 syncopal events occurred over the course of the same evening, sought care at Hospital Emergency Room.  In first episode, sustained left flank and head trauma.
a red spot and big blotch on her arm that is 6 inches long/it was itchy; a red spot and big blotch on her arm that is 6 inches long; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 96-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 23Mar2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 96 years for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH MACULAR (non-serious) with onset Mar2023, outcome "not recovered", described as "a red spot and big blotch on her arm that is 6 inches long"; RASH PRURITIC (non-serious) with onset Mar2023, outcome "not recovered", described as "a red spot and big blotch on her arm that is 6 inches long/it was itchy". The events "a red spot and big blotch on her arm that is 6 inches long/it was itchy" and "a red spot and big blotch on her arm that is 6 inches long" required emergency room visit. Therapeutic measures were taken as a result of rash pruritic, rash macular. Additional information: Caller reports where they gave her the shot, she has a red spot and big blotch on her arm (vaccinated arm) that is 6 inches long and she still has the redness. Caller described it as "hit with a baseball" and stated that it stayed red for Saturday and Sunday. She went to the ER on Sunday and they put some hydrocortisone cream on it because it was itchy. Caller states it seems to be spreading lower than the circle they marked around it. Caller stated that the redness has gone down near the elbow. Caller mentioned that the upper part is not as red but the bottom part is still red. Caller asks, is this part of any side effect and what else can they could they do about it?   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 10:10 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 10:10 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 26.10  Concomitant products were not provided.  On 14-Feb-2021 Excursion time was reported at 9am, 10 am, 11 am,2pm and 3 pm with temperature as 32,32,32,35 and 35 degrees Fahrenheit respectively , total doses given for the day was 162 ,condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles anyways. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
1/30/21: Mild asthma attack occurred immediately after the shot was given. The coughing and wheezing continued until albuterol inhaler was taken. Hives and rash developed at 4:30 pm. A large red rash appeared in the center of my neck. Hives spread up my face. No rash or redness at the injection site. Benadryl was taken. The rash did not go away. Asthma continued to be uncontrolled as well with wheezing 24/7.   2/3/21: Telehealth appointment with a physician to discuss the reaction to the vaccine. The doctor believed the reaction was happening internally due to the vaccine. Prescribed an oral steroid and directed to take Benadryl every 4-6 hours.   2/24/21: Allergy testing to determine if I should get the second dose of the vaccine.
acute urticarial rash on chest and arms, tongue swollen, heart racing, elevated blood pressure-30 minutes after getting dose.
Red blisters rashes on the left side of the my body, right below my chest; Sharp pain at my left rib.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unknown route of administration in the left arm on 21Mar2021 at 10:30 (at the age of 52-year-old) as first single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. No known allergies reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Concomitant medication included benazepril (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN), aspirin (BAYER) and paracetamol (TYLENOL); all taken for unknown indication within two weeks of vaccination. On 21Mar2021 at 23:00, the patient experienced red blisters rashes on the left side of the body, right below the chest, and also experienced sharp pain at the left rib. The patient did not receive any treatment for the events. The clinical outcome of red blisters rashes on the left side of the body, right below the chest and sharp pain at the left rib was not recovered at the time of this report.   No follow-up attempts possible. No further information expected.
Patient received vaccine on 6/2. On 6/3 developed low grade fever to 100.6F, later endorsed his "heart hurting." Initially presented to outside hospital ED.
Mother noticed rash (small raised bumps) on arms, chest, stomach and back approx 6 hours after Flumist.  Child given Benadryl at that time with no improvement.  Child taken to PMD on 10/30/12 and Dr. advised to continue Benadryl and Ibuprofen.  Itching has stopped but some bumps remain.
Nausea, vomiting, diarrhea, headache/achy body, and, rash at injection site
Within hours of shot, child c/o fever 100.5, aching all over and what she described as a severe headache as well as dizziness. Nurse told mother to contact MD as child described headache as not being "touched" by use of Tylenol and Ibuprofen. Mother telephoned RN next day. Child was fine. Never called MD.
This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event; adminstered to patients with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 72 years old and unknown gender patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and  it was reported that this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event and administered to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date the patient developed a non-serious event that this situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data with no reported adverse event (product storage error)  On 22-Sep-2022, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation, strength, route: unknown) lot UJ899AA, expiration date: 30-Jun-2023 in unknown administration site as Immunization.  On 22-SEP-2022 the vaccine was administered to patient with no reported adverse event (poor quality product administered) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events   At time of reporting, the outcome was Unknown for all.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The first shot didn?t bother me when I got it, but with the second shot every single bone in my body hurt. I couldn?t hold anything without my arms, hands and any other bone hurting. My face  was red and I looked like I was crying for days.  I now can?t hold anything for an extended period of time in my right arm because the bones that make up my elbow start hurting.
Pt. stated, "I developed a headache 1 minute after getting vaccinated."  Vital signs taken: BP 125/76, HR80, O2Sat 100%.  At 12:47pm pt. stated, "Headache is going away, I can go home now." At 12:57 pm pt. went home.
Vaccine given 11/07/2008 (L) deltoid. 11/9 (L) deltoid area cellulitis red. Painful. Keflex and Motrin ordered. 11/10 Keflex d/cd Bactrim ordered. 11/13/2008. No complaints and redness noted.
pt is 11 years and 8 months old but was given Pfizer 12+ vaccines for booster dose.
Cellulitis right thigh (inject site) 4 x 4 inches - warmth, tenderness, erythema. Tx Rocephin 500 mg IM in office, Keflex 250 / 5 ml 2 tsp - ?? x 100
Tinnitus-I?ve had ringing in both ears since the first injection and it seemed to worsen after the 2nd shot.
BUMP AT INJECTION SITE; SLIGHT TENDERNESS AT INJECTION SITE; 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, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced bump at injection site, and slight tenderness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bump at injection site and slight tenderness at injection site was not reported. This report was non-serious.
chest tightness the last 6 weeks which started on 3/14/21 after receiving J&J COVID Vaccine (she received on 3/8., chest pain, tightness in character, noted to be intermittent, positional, occurring mostly at night,  associated with some shortness of breath,  episodes would last for about one hour in duration, then resolve spontaneously resolve. No associated fevers or chills.
She never received a second dose of the vaccine; She has a sore arm, and could not sleep on it for 2 nights after the injection; She has a sore arm, and could not sleep on it for 2 nights after the injection; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (She has a sore arm, and could not sleep on it for 2 nights after the injection), PAIN IN EXTREMITY (She has a sore arm, and could not sleep on it for 2 nights after the injection) and PRODUCT DOSE OMISSION ISSUE (She never received a second dose of the vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced INSOMNIA (She has a sore arm, and could not sleep on it for 2 nights after the injection) and PAIN IN EXTREMITY (She has a sore arm, and could not sleep on it for 2 nights after the injection). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (She never received a second dose of the vaccine). On 30-Aug-2021, INSOMNIA (She has a sore arm, and could not sleep on it for 2 nights after the injection) and PAIN IN EXTREMITY (She has a sore arm, and could not sleep on it for 2 nights after the injection) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (She never received a second dose of the vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medications were not reported.  It was reported that the patient received a single dose of the Moderna covid-19 vaccine by intramuscular injection on 28-AUG-2021. She had a sore arm, and could not sleep on it for 2 nights after the injection. She never received a second dose of the vaccine.  Treatment was reported as none.