chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 21-DEC-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R019391 with expiration date 05-JUL-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
Patient developed fatigue - generalized - 4 days after getting FLUBLOK, accompanied by itchy rash involving ears, neck, breast, neck swelling, red eyes and lower limb fatigue. She consulted PCP via phone and was managed with ammonium lactate 12% cream with symptom resolution. She was seen in OHS 12/20/13 with resolving papular rash and excoriation on right ear only.
Patient reported that her face felt like it was flushing and that her heart was beating fast. Vitals assessed :  3:00 pm: 190/95, HR: 103, 02 sat : 99% 3:05 pm: 175/89, HR: 92, 02 sat: 99% 3:10 pm: 175/83, HR: 96, 02 sat: 99 % 3: 25 pm: 176/87, HR: 82, 02 sat: 99 % 3: 45 pm: 181/94, HR: 81, 02 sat: 99%
Expired Havrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th December 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 29th December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-DEC-2022 Reporter's comment: Nurse reported that a patient was inadvertently given an expired dose of Havrix by a medical assistant at a different site and wanted to know how to proceed.  They gave information relating to patient and incomplete information about the vaccine.  They did state that they could be contacted further on for clarification.  They declined to receive the medical information which was given verbally.  Medical information declined and they did not know the exact expiration date of the vaccine. The reporter was consented to follow up. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
Donor became dizzy within a minute of getting the shot. Dizziness lasted about 5 minutes. Donor was in MSA office for about 15 minutes before he left center. No other s/s reported.
Initially, there was normal pain in my upper arm and shoulder that got better after a few days.  Then, sharp pain began in my shoulder a few days after and has lasted since then.  This pain has been persistent and limits mobility in my left shoulder.
At about 6PM the same day, I began violently shaking and experiencing severe pain in my hips, back, neck, and all of my leg muscles felt like they were about to cramp. I started having a very severe headache. Today, the next day, I still feel severe joint pain but my headache has been lessened by tylenol. I feel nauseous, am experiencing diarrhea, and am very cold and sweaty.
body ache; mimicked the flu; other symptoms but didn't elaborate on what those; Inappropriate schedule of vaccine; inappropriate site of vaccine administration; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1.5 - 2 years ago) and Flu vaccine with an associated reaction of influenza (received on an unknown date, refer link case for same). Concurrent medical conditions included epilepsy and aneurysm cerebral.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced general body pain, flu symptoms, adverse event, drug dose administration interval too long and vaccine administered at inappropriate site. On an unknown date, the outcome of the general body pain, flu symptoms, adverse event, drug dose administration interval too long and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the general body pain, flu symptoms and adverse event to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in his left shoulder, which led to inappropriate site of vaccine administration. Following day he immediately experienced complete body aches which mimicked the flu. After days, other symptoms started but he did not elaborate on what those symptoms. Two weeks prior to getting the second dose of the Shingrix, he had the flu shot. He claims that he was feeling worse by the day and he believes that the Shingrix vaccine is going to kill him. The reporter did not consent to follow up. The patient threatened legal action but refused to provide any additional details.
Information has been received from a physician concerning a 11 year old female patient who was vaccinated with GARDASIL.  The lot number was not provided.  The physician reported that a neurologist asked her if she had heard about a patient who had a stroke with GARDASIL.  It was unspecified whether or not this patient was of the neurologist.  Upon internal review, stroke was determined to be an other important medical event.  Additional information has been requested.
Reported various symptoms such as fatigue, diarrhea, headache, nausea, sweats, chills, and cough following the vaccine. These lasted several weeks and turned into wheezing, coughing, and pneumonia.
A Pfizer pediatric bivalent COVID vaccine was administered to an 8 year old patient on 12/27/22. It was realized after the fact that the vaccine had a BUD of 12/24/22. I contacted Pfizer to see if they had stability data for 73 days in the refrigerator and to find out if the patient needed to be revaccinated. They didn't immediately have an answer for me. I had to submit a temperature excursion form to their quality team. The response from the team at Pfizer was as follows: We do have stability data to support your excursion from prescribed storage conditions. Stability data supports the storage of unpunctured vials between 2-8 degrees C for up to 75 days. Based on that information, the patient's vaccine was viable and does not need to be readministered.
Headaches- main complaint x 5 days. Neck stiffness- improved, Photophobia now resolved No treatment.
13 year old was given the Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was given the Moderna COVID-19 vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C1A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was given the Moderna COVID-19 vaccine). On 12-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old was given the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Shot administered on 10/16/13 at noon. Red rash appeared around 5pm that same day. Not itchy, not raised, "looks like a sunburn" but no heat associated w/ the rash. Rash on both sides of neck and upper chest area Pt called 10/18/13 at pm.
soreness in left arm the following day along with fatigue and body aches; soreness in left arm the following day along with fatigue and body aches; soreness in left arm the following day along with fatigue and body aches; This is a spontaneous report from contactable other healthcare professional. A 33-year-old male patient received first dose of BNT162B2 (lot number: EH9899; expiry date: unknown) intramuscular (left arm), on 23Dec2020 at 14:00, at a single dose, for COVID-19 vaccination. The patient had no relevant medical history. The patient had no known allergies. The patient's concomitant medications were not reported. The patient experienced soreness in left arm the following day (24Dec2020) at 8:00 a.m. along with fatigue and body aches. The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date in Dec2020.
Allergic reaction; Large painful blister; Painful blisters, hurt/ very painful shingles; Burned so bad; This case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received Shingrix. In September 2022, 1 day after receiving Shingrix, the patient experienced allergic reaction, blister, pain and burning sensation. On an unknown date, the outcome of the allergic reaction, blister, pain and burning sensation were recovering/resolving.   The reporter considered the allergic reaction, blister, pain and burning sensation to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that patient had Shingrix vaccine 2 weeks ago. Patient reported never had chicken pox however day after vaccine broke out in large painfull blisters on upper abdomen that hurt and burned badly. The breakouts began to dry up now. The reporter reported shingles was very painful. Follow-up would not possible, as no contact, details were available. This case had been linked with US2022AMR138575, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR138575:Same reporter
PT received 2nd dose of Pfizer at 1730.  PT presented with hives down her arms in the observation room and EMS was alerted at 1735.  EMS took vitals, and PT refused Benadryl.  PT presented with hypertension (NIBP 227/116) and hospital contacted by EMS.  PT agreed to be transported to the Hospital. Medic  arrived at 1805 and transported PT to ER.
Resident had fever of 102.9, decreased appetite, body aches, fatigue, and mild shortness of breath. Her injection site, left deltoid, was reddened, swollen, painful, and warm to touch.
I took the vaccine midday on the 3rd October 2019. No adverse reaction other than a sore arm. The morning of 4 October I woke up with severe vertigo. I could not walk and had started to become nauseous. I crawled to my bathroom and vomited  several times. I crawled back to bed and slept for approximately 4 hours. After I woke up again I still had mild vertigo and vomited again. I called the insurance nurse help line and they told me to call an ambulance. Since the vertigo had begun to subside I decided to fall back asleep and woke up 2 hours later in the afternoon with lightheadedness and no nausea. For the next three days the lightheadedness remained and eventually subsided.
Tested with covid: Mar2021 / the patient tested positive for covid back in 2021; Tested with covid: Mar2021 / the patient tested positive for covid back in 2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. Other Case identifier(s): US-MODERNATX-MOC20230209000225 (Moderna).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EN6201) and on 17Mar2021 as dose 2, single (Lot number: EN6206) for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Medical History (disease / surgical procedure / etc.): Seasonal allergy. The patient's concomitant medications were not reported. Past drug history included: Compazine, reaction(s): "allergy", notes: Question: Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor., Answer: Compazine and Augmentin.; Augmentin, reaction(s): "allergy", notes: Question: Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor., Answer: Compazine and Augmentin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2021, outcome "unknown" and all described as "Tested with covid: Mar2021 / the patient tested positive for covid back in 2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2021) Positive.
This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE BRUISING (Bruising at the Injection Site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE BRUISING (Bruising at the Injection Site). On 12-Feb-2021, VACCINATION SITE BRUISING (Bruising at the Injection Site) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment information was provided.
Approximately 24 hours after receiving the vaccine, left armpit and under arm became swollen and tender to the touch.  Notified primary care physician during routine visit, PCP advised to notify her if symptoms did not resolve.  Swelling resolved 4 days after onset, arm remained somewhat sensitive to the touch.  Patient was also extremely tired for 2 days after the vaccine but otherwise fine.
No immediate adverse event, but 2 weeks later (5/28) pt was seen for abdominal pain and referred to ER. Workup showed acute appendicitis, pt was admitted and underwent laparoscopic appendectomy.   At time of follow-up (6/1), pt reportedly recovering well.
Headache, Fever, tired, pain/soreness/heaviness injection site Narrative;
Started with a red ring around injection site on left are. then on 2/14  red  flat rash started forming on arms and legs. Rash was itchy and hot. went to Primacy Care Doctor 2/5/21, the to  ER 2/16, and then finally the dermatologist on 2/16. At dermatologist they took a biopsy and gave pt. prednisone starting with 40 g with  a 12 day tapered dosing.
CoughWheeze cough for 5 days Narrative:  Other Relevant History:
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Left thigh developed area of swelling, erythema, warmth, and induration at site of injection, 5 inches in diameter.
Severe chills, shaking, severe muscle aches, high fevers? despite around the clock ibuprofen and Tylenol
No pain at injection site or anything until day 3, then after day 3 starting having issues. Burning pain, ringing, numbness in my right ear. Pain, numbness, tightness in my face. head, neck. Drooling on right side of my mouth, numbness at the back of my throat. Large lymphatic reaction around my collar bone (right side). Extreme exhaustion, body aches, hot/cold feeling running down my spine. After over 2 plus months my face/jaw are still very numb, ear is still sensitive and I can't sleep on my right side.  I then caught COVID, three weeks after the vaccine and got very sick with COVID.  Body aches, awful chills, cough, fever and was in bed for about a week.  My insurance will not pay for any treatment as there is no FDA approved treatment for this issue. All treatment has been 100% out of pocket and is expensive.
pt had red, swollen lt arm @ site of inj noted less than 24 hr p/vax given; seen by PMD & told parents arm was infected given ATB & told to warm pack
She got her vaccine, no problems other than a sore arm. All was well through the night, but the arm got increasingly sore the next day.  When she woke up she walked down the stairs, spoke to her husband, went and sat down and went to get up, fainted and hit her head on the tile floor.  She fell on her left shoulder where she got the shot, and her forehead.  She slept after that for 36 hours and her husband got her to eat something. He read the literature afterwards about the potential for fainting, but he did not know about 14-16 hours later and wanted to report it.  She is feeling better now, the arm is still bothering her a lot, but otherwise she is getting back to normal.  She only had the one episode of fainting and she never faints. She has an appointment with her PCP on Monday and he will explain the situation to him then.
got a flu shot in a week or two after and was sick; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient).  This case involves a patient of unknown demographics who got a flu shot in a week or two after and was sick (illness), while the patient received vaccine Influenza Vaccine.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine (Strength, formulation, dose, frequency, route, batch number and expiry date were unknown) for prophylactic vaccination.  On an unknown date (unknown latency), after started therapy with suspect vaccine, patient did not know if ever got the flu from the flu shot or not. All the patient know that the years got a flu shot, sure enough, in a week or two after and sick (illness). The patient also had more flus, they were worse and lasted longer than years didn't had one.  Action taken with the suspect drug was not applicable.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown.
pt recv vax 21JUN96 & 22JUN96 exp rash;irritation in mouth;23JUN96 12noon exp sore throat & numbness of lips, SOB, swollen tongue;24JUN96 throat more sore felt like flu;25JUN96 speech slurred, tongue & face swollen;c/o feeling mental effect
COVID Breakthrough. Patient asymptomatically tested positive for COVID on 2/25/22 during hospitalization for other reasons.
Patient reports receiving her annual influenza vaccine at one of the "Flu Clinics" on 10/17/22 at approx. 12:30 pm. She noticed that her legs were itching Tuesday 10/18/22 at around 8pm. She reports that the itching was also painful  and affected her sleep. RN assessed her legs and no visible rash noted, there were scratch marks noted. RN asked if it felt like "creepy crawling" under her skin and she said "yes, exactly"  She reports taking 2 tabs of benadryl to help her sleep. She stated that she also used some lotion. Itching and discomfort is increasing. She denies having had a reaction to the flu vaccine previously, however does notice some increased itching previously that she thought was dry skin related to the fall weather. She reports that she has a history of restless leg syndrome, and that the pain and discomfort now is more than her normal. She also has noticed increased swelling to ankles, more than her norm. This morning she did notice some numbness to both hands after showering which did go away. She denies any weakness. Patient has a history of Bell's Palsy several years ago and has recovered with no residual effects.  Patient has a doctor's appointment today at 3:30pm. RN discussed rare side effect with flu vaccines could be Guillian-Barre syndrom and to make sure she does follow up with her doctor and monitor for any increasing symptoms and to notify her doctor right away if that occurs even if over the weekend. RN gave handout of GB symptoms and what to watch for. RN will submit a VAERS report.
Pt febrile for 1 day - multiple red bumps followed by blisters of then open sores and finally dry, brown crusts (repeated crops for 5 days, greater than 50 lesions) - symptom tx per parent.
The night of March 10 around 11 PM, I start to feel pretty sick with a bad headache, fever, body aches, sweats, and shakes. That lasted for a full 3 days. That following Monday is when the facial reaction started where my face and lips were swelling. I went to the doctor Tuesday morning, and they put me on steroids to clear it up. Since then, I will have flare ups every once in a while, but I now cannot wear cloth masks because it will trigger right away. Since then, that's all I've had, and the rash is from the neck up into my hairline.
Pt presented with sob, diarrhea and sepsis. Dexamethasone and combivent given. Iv hydration given for acute kidney injury