chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11-6-17, patient developed redness and hives around 1500. Grandmother gave her Benadryl and they went away. Patient came to clinic on 11-7-17 with redness and hives again around 1430. Bilateral cheeks, temporal region, and forehead were red, with small welts present, especially on cheeks, bilaterally. Reports itching. Temp 99.3. SpO2 100% - denies any other complaints or concerns - no trouble breathing, no oral swelling, no abdominal pain, no nausea / vomiting / diarrhea, no sense of "impending doom."  Throat noted to be slightly red. No other abnormalities noted. Benadryl given (25mg) and rash went away within 10-15minutes. CDC and GlaxoSmith Kline were called and notified.  VAERS form filled out. Left with grandmother - instructed that if they return to seek emergency medical attention - She verbalized understanding. Will consider allergy testing if they persist. No testing done at this time.
104+ Temperature evening  high-pitched, piercing cry convulsion or Febrile seizure Daytime - projectile vomiting, screaming & severe diarrhea in office & home Mid-March patient taken to ER - turning blue, could not breathe - Had to be suctioned - The following are reactions & life like conditions: In alpha order: Anaphylaxis to peanuts, Anxiety Disorder Asthma Asthma attack Belly pain, Digestive disorders Central Auditory Disorder Chickenpox despite being vaccinated Compromised Immune System Double Pneumonia Esophageal Encephalitis Failure to thrive - required gastro & nutritionist Food allergies to fruits, dairy, & nuts Irritable Bowel Syndrome Pneumonia Severe Eczema Seizure Disorder Sensory Disorder Sinus Infections Sleep Apnea Trichotillomania Vomiting Annual EEG testing 2013 Tested & Dignosed with MTHFR Gene Mutation  Dr's office informed
At 4:30PM on Monday the 10th I received a quad dose injection.  12 hours later at 4:30AM I was awakened by an intense headache, intense nausea, muscle soreness and other "flu like" symptoms including severe mental disorientation.  This condition lasted until 4:30PM yesterday the 11th of October.
Pt c/o vasovagal near syncope sx: dizziness, blurred vision, muscle weakness, nausea. Sat pt down, applied cold packs to neck and face, instructed to lower head. Vitals taken, WNL. Sx resolved fully within 5-10 minutes.
Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 25 years old male patient who received vaccine  FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.25ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259JA. It was a case of actual medication error due to vaccine underdose. It was unknown any adverse event occurred or not. 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 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.
ADMINISTRATION OF VACCINE LEFT AT ROOM TEMPERATURE FOR UNKNOWN AMOUNT OF TIME; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 2 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096 expiry: 03-SEP-2021) dose was not reported, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the subject experienced administration of vaccine left at room temperature for unknown amount of time. On 29-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of vaccine left at room temperature for unknown amount of time and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210800576 and 20210800634.
Raised bubble 2 inches by 4 inches surrounded by a flame red 3 inch in circumfance rash.  1/17/2009, 2 weeks after the injection, a flat redish brown discoloration about 2 inches by 4 inches remains. Itching subsided in 10 days and the buble or bliseter went flat.  No scab
Blood clot in my left leg; A spontaneous report was received from a consumer concerning a 71-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced deep vein thrombosis.   The patient's medical history was not provided.Concomitant medications  was not reported.  On 14-FEB-2021 prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 030M20A)  in the left arm for prophylaxis of COVID-19 infection.   The next day after receiving mRNA-1273, the patient developed a blood clot in  left leg and extended from upper left leg  down  into his lower leg. He went to the emergency room and was treated for the event with Xarelto.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event deep vein thrombosis was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Relative of pt. called Health Dept. in afternoon of 9/22/11 stating pt had a "pinching" in (L) side of chest. Did not describe as pain, but rather "pinching". Plans ER visit. Called pt. 9/23, said she did go to ER - had X-rays, blood tests & released; no medicine - said was told to see PMD & that flu vaccine did not cause. Doing well 9/23/11.
A non-serious report of administration of expired FLUMIST has been received from a nurse in the USA concerning a seven-year old male. Neither medical history nor concomitant medications were provided. The patient received FLUMIST on 12-Mar-2008. The FLUMIST had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FLUMIST from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FLUMIST was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 10-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to following 25 other cases reported from he same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-00006659; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDRI-0006679; MEDI-0006680; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
C/O extreme tiredness, "tremors over entire body for 1 hour" per Mom.
Pt reported a hard lump measuring 8 cm in diameter that was red, painful and hot at site of vaccine about 2 days after receiving. Pt visited ER- told to put hot compresses on- has appt w/PCP tomorrow.
THIS CAUSED ME TO BE SICKER THAN THE FLU; NOSEBLEEDS; A spontaneous report has been received from a consumer. The report concerns a female patient (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date.     On an unknown date, the patient experienced nosebleeds (preferred term: Epistaxis). On an unknown date, the patient experienced this caused me to be sicker than the flu (preferred term: Malaise).     The outcome of the event(s) of this caused me to be sicker than the flu and nosebleeds was unknown.     The events were considered non-serious.     The reporter considered the following event(s) related to treatment with FluMist: this caused me to be sicker than the flu.
FEVER 99 MIDNIGHT 1/25 (TOOK SOME NYQUIL, THEN IBUPROFEN. ) FEVER 99 AGAIN NOONISH 1/26 CHILLS, WEAKNESS, NASEAU, FATIGUE. I FELT LIKE I GOT RAN OVER BY A 18 WHEELER, BAD BODY ACHES, HEADACHE STARTED 12AM 1/26, LASTED UNTIL 1/27 AM.  1/27 FATIGUE  1/28 NO SYMPTOMS
COVID Arm; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (COVID Arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (COVID Arm). At the time of the report, VACCINATION COMPLICATION (COVID Arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were provided by reporter. Pharmacist states that Patient would like to know if he can get third dose?
Information has been received from a healthcare worker (medical assistant) referring to a 6 month old baby of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 25-MAR-2016 the patient was inadvertently administered VAQTA strength 25/0.5 (unit unknown) injection (dose, frequency and route were not provided) (drug administration error and drug administered to patient of inappropriate age). No adverse effects were reported. Additional information has been requested.
On January 27th,  7  days after injection of the vaccine in my right arm,  below the site of injection my arm became red and swollen.  The red swelling spread down the arm almost to my elbow.   On January 28th,  I took Benadryl and the itching and swelling cleared up in 3-4 days.
Chest pain, fever, chills, elevated heart rate, body aches. After the other symptoms disappeared (1-2 days later) the chest pain was just as bad as ever and the heart rate was still elevated. I went to the emergency room at Maimonides 24 hours after the symptoms started.
was given flu shot and within 5 minutes arm began to itch.  it became red and swollen
left buttock and groin are tender, red, and swollen; left buttock and groin are tender/tender to touch area; left buttock and groin are tender, red; groin tender; groin swollen; injection in her left buttock instead of her deltoid; did not receive it intramuscularly but subcutaneously.; felt unwell; numbness on her leg; low back pain/lower back pain; fever of 100.9; heaviness to her arms, and legs; This case was reported by a nurse via call center representative and described the occurrence of low back pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st October 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 21st October 2020, less than a day after receiving Shingrix, the patient experienced low back pain, fever, heavy feeling in arms & legs, feeling unwell, numbness, vaccine administered at inappropriate site and intramuscular formulation administered by other route. On 22nd October 2020, the patient experienced injection site swelling, injection site tenderness, erythema, groin pain and groin swelling. On an unknown date, the outcome of the low back pain, fever, heavy feeling in arms & legs, feeling unwell and numbness were recovered/resolved and the outcome of the injection site swelling, injection site tenderness and erythema were not recovered/not resolved and the outcome of the groin pain, groin swelling, vaccine administered at inappropriate site and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the low back pain, fever, heavy feeling in arms & legs, injection site swelling, injection site tenderness, erythema, feeling unwell, numbness, groin pain and groin swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient who was a nurse stated that she received her first Shingrix injection in her left buttock (gluteus) instead of her deltoid, which led to vaccine administered at inappropriate site. The patient stated she knew that the literature said there was no research on giving in any other muscle except the deltoid, but she felt that her deltoid was too small to receive it there.   The patient felt that she did not receive vaccine intramuscularly but subcutaneously, which led to intramuscular formulation administered by other route. The patient felt unwell and experienced lower back pain, numbness on her leg, a heaviness to her arms, and legs, and a fever of 100.9 degree F at the night and woke up with fever the next morning. She has swollen and tender on the injection area. The patient stated that her left buttock and groin are tender, red, and swollen. These events were subsided.  The patient stated that she was afraid of having the vaccine liquid on her tissue and that the liquid could cause harm on her body.  The reporter consented to follow up. The patient wanted to know what she should do about this.   The reporter consented to follow up.
This spontaneous report as received from a registered nurse refers to a 4 year old patient. At an unknown date, the patient was vaccinated with MMR II, VARIVAX (Merck), Influenza Virus Vaccine (manufacturer unspecified) and DTaP given concomitantly. No concomitant medications were reported. On an unknown date, the patient experienced hives develop on arm (location unspecified) 30 minutes after vaccination. The patient returned to office the following day, and was sent to emergency room (location unknown). Hives were present for at least a week after vaccination. The registered nurse reported the adverse event to Vaccine Adverse Event Reporting Service (VAERS). No further information was provided. No treatment information was reported. The outcome of hives develop on arm (location unspecified) was not provided. The relatedness for hives develop on arm (location unspecified) for MMR II, Influenza Virus Vaccine (manufacturer unknown) and VARIVAX (Merck) was not provided by the reporter. Additional information has been requested.
-sore arm, nausea, itchy, SOB, Lips Tingly & swollen
There was no Adverse event. We are reporting according to the recommendations of the FDA , to no longer give the monovalent vaccine
Client phoned 4:30 pm said she believes she's having a reaction to yellow fever shot left her around 3 pm. Says this happens to her often from other things whether outside or home. No allergies to eggs. Told LPN This before shot was given and states Benadryl does not help. Told to go to ER or E. med. Awaiting family member in mall, will go to E. med. Itching from head to toe.
She hasn't had menopause in 10 years but is now experiencing hot flashes and menopause symptoms; She hasn't had menopause in 10 years but is now experiencing hot flashes and menopause symptoms; racing heart; very exhausted; This is a spontaneous report from a contactable consumer or other non hcp (patient) via medical information team. A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration on 27Jul2021 (at the age of 64 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has not had menopause in 10 years but on an unspecified date in 2021 she was experiencing hot flashes and menopause symptoms as well as racing heart and being very exhausted. The school district she works for was now mandating vaccines and her doctor this year was new and does not want to give her an exemption. She wanted to know if the side effects from the second dose are worse than the first dose. Patient wanted to know what information was available regarding menstrual changes, from the studies how many people were post-menopausal women and how many of them had side effects, were others having hormonal side effects. Patient concerned about my daughter who was in her childbearing years, what was this doing to her. Patient stated she knows its affecting her hormonally. Patient stated everyone was pushing the vaccine, the CDC, the TV, and the drug companies but no one gives a darn about the people having side effects. After the vaccination clinic there was no follow up about my side effects, she had to go out to report it. No one wants to hear it. Its not okay. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
This spontaneous report as received from a register nurse concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 08-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose number and route were not reported), 0.5 ml, lot # K005182, expiration date 10-APR-2014 for vaccination. Co-suspect and concomitant therapies were not reported. The register nurse reported patient experienced 26 patients received doses of (Oka/Merck) VARIVAX (from lot # K005182, expiration date 10-APR-201 only) that were improperly stored. No adverse effect reported for any of the patients. This is one (1) of twenty seven (27) reports from the same reporter. Additional information has been requested.
On day 2 and 3 had mild arm soreness and pink coloring around injection site. Skin color went back to normal and no pain on day 4.  On day 9 I woke up and the place where the pink color had been had turned red and the skin is firm.  No pain.
Vaccines listed in #13 given on 06/27/2003.  PHN enteracted by maternal great grandmother, to report child had a rash on body-generalized had "febrile seizure" on 07/06/2003 and also one month prior to vaccination.  Temperature high=101F.  Consulted FMD-not taken to ER.  Telephoned on 07/08or 07/09.  No current problems, rash resolved.
On the 3rd day, tiny red spots (the color of blood, no pain, no itchy) appeared on both arms, and a blister under the tongue. The blister disappeared in about 3 days.   The red spots (no increase in number) discolored a bit but still can be seen after 2 weeks.
Irritation of L upper arm with induration since morning. Dr's appt 3/15/03-ice/Motrin prn.
About 9:30 tongue started swelling and was flushed and itchy from waist up. Went to ER and received BENADRYL, PEPCID, prednisone.
Venus insufficiency, tendonitis, gout, bakers cyst, rheumatoid arthritis, heart palpations, body pains, auto immune syndrome daily, swollen feet
inappropriate schedule of vaccine; shivering; feeling unwell; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shivering, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the shivering and feeling bad were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shivering and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shivering and feeling bad for 2 days. The patient had missed the 6 month window for the second dose which led to incomplete course of vaccination. The reporter did not consent to follow-up. The reporter declined to provide any demographics and declined any follow up. This case been linked with the case US2019115946, reported by same reporter. There is a discrepancy between the outcome reported in the structured field "resolved with sequel" and the outcome reported in the sender's comment " shivering and feeling bad for 2 days
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 71-year-old male patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 9th August 2018, 7 days after receiving SHINGRIX, the patient experienced neck discomfort. On 10th August 2018, the patient experienced shoulder pain. On 13th August 2018, the patient experienced back pain and tightness of back muscles. In August 2018, the patient experienced pain in arm, general body pain, lethargy, lipoma, myalgia, erythema of extremities and pain in hip. On an unknown date, the outcome of the pain in arm and shoulder pain were recovering/resolving and the outcome of the general body pain, lethargy, lipoma, myalgia, pain in hip and back pain were unknown and the outcome of the neck discomfort, erythema of extremities and tightness of back muscles were recovered/resolved. It was unknown if the reporter considered the pain in arm, general body pain, lethargy, lipoma, myalgia, neck discomfort, erythema of extremities, pain in hip, back pain, tightness of back muscles and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left arm. The patient at first the only reaction experienced was soreness in the arm around the area it was administered and a red mark about an inch in diameter that went away after about a week. Since then the patient had experienced tremendous pain in the left side of his body including achiness and lethargy. Then his neck started to bother him about 7 to 8 days after the shot. On days 8, 9 and 10, the pain went down into his shoulder then on days 11,12, and 13 extended down into his arm, back and hip on the left side. The patient went to his physical therapist who said his back muscles were very tight but she worked her magic and the tightness had resolved. The patient's neck and shoulder was better.  The patient still had pain in his arm above the elbow, a little in the elbow and below the elbow. When the patient got up in the morning, he did yoga and the pain resolves but returns during the night.  Both physicians had diagnosed a lipoma above his elbow in his left arm. The patient's regular physician also felt as a result of the shot, the patient was suffering from myalgia. The patient took blood work and x-rays and all came back normal.
Fever of 104.5, inconsolable crying for hours, high pitched screams, irritability, red lump at vaccination site, red rash on his abdomen, and refusing to eat.