chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions described. The reporter stated that on multiple unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 injection (lot # L019297 with expiration date 18-AUG-2017; dose and route were not provided). No adverse effects were reported. It was unknown if the patients sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
L Shoulder pain. R Should is fine. Soreness increased 5 days after immunization. Was seen by physician on 1/28/2022, 5 days pain slightly better. Shoulder feels fine when not in motion, hurts when lifted. Physician recommended Aleve by mouth twice a day w/food.
nausea; diarrhea; throwing up; This is a spontaneous report from a contactable reporter. This consumer reported for a 68-year-old patient (Husband).   A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6200; Expiration Date: Jun2021), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 18:00 (age at the time of vaccination was 68-year-old) as dose 2, single for COVID-19 immunization. Medical history included myocardial infarction from an unknown date and unknown if ongoing. Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication (has to do with his heart) from an unspecified start date and ongoing; rosuvastatin calcium (ROSUVASTATIN CALCIUM) and losartan potassium (LOSARTAN POTASSIUM) taken for an unspecified indication from an unspecified start date and ongoing; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication (heart doctor gave it to him, started taking after the heart attack) from an unspecified start date and ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EM9809; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Left on11Feb2021 as dose 1, single for COVID-19 immunization. The caller (wife) reported that her husband experienced diarrhea, throwing up (started at 9 am or 10 am) on 10Mar2021 which was not quite as bad as it was but he still felt awful and nausea on 11Mar2021. Stated yesterday he woke up with diarrhea and throwing up. She wondered if those were side effects or if it was a stomach virus; she knew there was a stomach virus going around. Treatment medication included Imodium 2 mg for the events. Outcome of all the events was reported as recovering.   No follow-up attempts are possible. No further information is expected.
Vomiting, chills, headache, short of breath at 3:00 pm on 7/2/2021
Hives and itching that began on right arm and has since spread to left arm. Taking Benadryl and hydrocortisone cream otc.
Woke up at 2:30 am with a high fever and bad headache.   These symptoms steadily worsened until about 5:00 am.  At that point, the fever plateaued for a short while and then slowly went back down.  By about noon of that day the fever had completely subsided but the headache was still very bad.  After a couple of days the headache finally went away.
Told to report: COVID case with moderate symptoms (no hospitalization required) in 08/2022 after receiving Pfizer primary series (2 vaccinations) followed by booster (09/2021)
Recvd 2nd dose of Engerix-B & devel idiopathic thrombocytopenic purpura; Thrombocytopenia, bruising midthorax, multiple petechiae on nose; also had purpura on back; pt was admitted & is still hospitalized; attempts made by phone to clarify;
swollen feet; Soreness in bones; a lot of inflammation; felt bad; This is a spontaneous report from a contactable nurse (patient's wife). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: Not reported, Expiration date: Not reported), dose 1 via an unspecified route of administration on an unspecified date in Mar2021 and dose 2 via an unspecified route of administration on an unspecified date both as single dose for COVID-19 immunization. The patient medical history and the concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced swollen feet, soreness in bones, a lot of inflammation, felt bad. Reporter stated she is a Registered Nurse and just has a quick question that any nurse would have and could answer. She had read where Moderna vaccines had reports of patients developing cardiomyopathy after the vaccine administration. Reporter wanted to know if Pfizer has had the same reports. Reporter stated she was calling about her husband. Reporter stated her husband had the normal side effects like soreness in his bones and he had a lot of inflammation. Reporter stated what she is calling about is that she assessed him like she is always assessing patients and his feet were swollen. She stated she asked him about it and he stated that it was like that after his last shot. That is when she read that Moderna has the issues with cardiomyopathy. She just looked and he had the Pfizer. She stated she was thankful of that. Reporter stated she did not want to classify seriousness of events as she is just calling to ask a question. Reporter was unsure of dates of the adverse events, stating it happened after both doses. Event outcomes were not provided. Reporter stated she did not want to put the seriousness criteria in a category. Reporter stated that she just wanted to ask the question and did not see the need to put these down as they are the normal side effects from the shots. She stated her husband had swelling in his feet and he never had swelling before. Reporter stated again that she just wants to ask the question and doesn't see the need to put these down as they are the normal side effects from the shots. Reporter stated her husband has had both doses of the vaccine. He had bad reactions to both shots but he always has reactions. Reporter stated her husband gets the flu every year and has reactions to the shot. Reporter stated her husband had bad reactions to both doses of the Pfizer vaccine. Reporter stated she had the shot and couldn't even feel it go in they did such a good job. Outcome of the events were reported as unknown.  Information on the lot/batch number has been requested.
12 hours after receiving 2 nd vaccine I started with diarrhea for 5 hours then vomited twice within the next hour then tired the rest of the day.
Swollen lymph node above collarbone- consulted with family member who is a doctor and confirmed this is a somewhat normal reaction so I did not make a medical appointment. Noticed the swollen lymph node a day and a half after first vaccine
I woke up with a terrible, burning headache on the left side of my head and ringing in both ears on 11/21/2009.  I have seen my PCP 4 times and have been to the chiropractor 3 times.  I had an MRI and MRA of my brain.  The results were normal.  I was prescribed Butalbital/ apap/caffeine tabs but the medication did not relieve the symptoms at all.  I was prescribed Oxycodone/apap 7.5 mg-500 mg tablets for pain.  This medication made my headache worse.  My physician gave me samples of Lyrica to see if it would help but it has not.  I have a referral from my insurance company to see a neurologist and an ear, nose and throat physician.  I continue to have the burning headache and ringing ears.
patient was given Pfizer COVID vaccine for age 12 years and older instead of for age 5 years to 11 years.  was given 0.2 ml
Received vaccine on April 6, 21 and on April 10,21 I began to notice a change in my taste when I ate meat. Soon I noticed it wasn?t just meat but chicken as well. What I was tasting was not metal but a real ugly taste that I would get mid chew that would make me spit it out. As the month went by I noticed it with random foods. Now I can sometimes just smell something and know it won?t taste good especially with foods that have a strong smell. Some foods are worse than others on how strong of an ugly taste the food has.
Hives w/facial swelling from head to toe.  Given steroid treatment from other provider.
Pt developed urticaria about 4-5hrs after his flu vaccine. He had no prior reaction to flu vaccine. Urticaria were observed to be on his neck, chest, back, and groin per mom's report. No urticaria following day.
Starting 02/24/2021, I developed a severe headache behind my left eye. Also, I developed left sided numbness on the left side of my face including the left side of my nose and upper lip. I also had full body weakness, sweats and vomiting. After about 20 hours, it spontaneously resolved. I had a cranial neuropathy episode effecting the left side of my face. 5 months later I ended up testing positive for COVID. On 09/28/2021, I started being symptomatic and I tested positive with a PCR test on 09/30/2021. During this, when I lost my sense of taste and smell, I also had the same cranial neuropathy symptoms. On 09/29/2021 I received the monoclonal antibodies because they were available.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and unknown gender. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored GARDASIL (dose, frequency and route were not reported). No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Holding off the second vaccine indefinately; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Holding off the second vaccine indefinately) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery (Surgery unrelated to vaccine) on 12-Mar-2021.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced OFF LABEL USE (Holding off the second vaccine indefinately). On 16-Mar-2021, OFF LABEL USE (Holding off the second vaccine indefinately) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.
This case was reported by a other health professional via call center representative and described the occurrence of headache in a 17-year-old female patient who received BEXSERO (batch number 166901A, expiry date 30th November 2018) for prophylaxis. On 18th June 2018, the patient received the 1st dose of BEXSERO. On 18th June 2018, several hours after receiving BEXSERO, the patient experienced headache, nausea, fever and myalgia. The patient was treated with ibuprofen. On 19th June 2018, the outcome of the headache, nausea, fever and myalgia were recovered/resolved. The reporter considered the headache, nausea, fever and myalgia to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient was seen in the healthcare professional's office and advised to take ibuprofen and go to bed. When the patient woke up the following morning, her symptoms had resolved. The reporter stated that a report had been filed by healthcare professional with VAERS.
Narrative: 81 year old male admitted on July 19 2022 with sore throat. He was intially no hypoxic and started on Paxlovid, however developed hypoxia and was started on remdesivir and dexamethasone. He had received Moderna vaccine x 3 on Ferbruary 9 2021, March 18 2021, October 29 2021, June 7 2021. He was treated with Paxlovid x 1 dose  then changed to remdesivir 200 mg x 1 then 100 mg IV daily x 4 days and dexamethasone 6 mg daily x 5 days. He symptomatically improved and was transferred back to long term care on 7/27.
nurse reports 3 pt have called & c/o extreme tenderness, hardness & redness @ site of Td;sx have persisted for 2wk;
Information has been received from a registered nurse concerning a 13 month old female with no medical history or allergies who on 12-MAR-2007 was vaccinated in her left leg with ProQuad (lot# 656308/1392F). Concomitant vaccinations included Hib conj vaccine (unspecified carrier), Prevnar and hepatitis A vaccine (inactive) MSD. On 19-MAR-2007 the patient experienced quarter size red inflammed area at the injection site. Medical attention was sought. As of 22-Mar-2007 the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
pt recv vax & pt noted an erythematous, macular, papular rash w/three vesicles & pustule @ inj site;pt opened & drained the pustule;seen by MD there was no pus present but there appeared a drying lesion (3x5cm) & a smaller erythematous area
Vaccine adverse event report completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/23/2o Lot#EK9231 2nd dose01/13/21 ,lot#EL3248 Diagnosed covid positive:08/13/21 Symptom onset:08/13/21 Exposure:Community Symptoms:Fatigue, runny nose.
Information has been received from a nurse practitioner concerning a 19 week old male, with no history and no allergies, who on 06-SEP-2006 was vaccinated with a first dose of Rotateq vaccine (human-bovine). On 06-NOV-2006 the patient was vaccinated with a second oral dose of Rotateq (human-bovine) (lot#65424/0600F). Concomitant vaccinations administered on 06-NOV-2006 included a dose of Pediarix, a dose of Prevnar and a second dose ActHib. On 19-NOV-2006 the patient became fussy and vomited seven times. The patient was admitted to the hospital on the night of 19-NOV-2006 with a day history of vomiting, diarrhea, blood in the stool, fever, and cough. The patient was diagnosed with rotavirus. The patient was discharged on 21-NOV-2006. The patient was seen in the office on 22-NOV-2006 and was considered to be recovered by the reporter though the patient's mother noted that the patient had "controlled diarrhea". No other information was provided. Additional information has been requested.
Bloody stools; Pain; Cramps; Diarrhea; Abdominal pain; A spontaneous report was received from a female patient who received mRNA-1273 vaccine and experienced loose bloody stools/haematochezia, pain, cramps/muscle spasms, diarrhoea, and abdominal pain.  No medical history and concomitant medications were provided by the reporter.  On 23 Mar 2021, prior to the onset of events, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: unknown) via intramuscular route for prophylaxis of COVID-19 infection.   On 24 Mar 2021, the patient experienced loose bloody stools, pain, cramps, diarrhoea, and abdominal pain. No treatment medication was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcomes of the events pain, cramps, diarrhoea, abdominal pain were not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Blotchy, welt like appearance medial to injection site in 5 or 6 spots.  Mild itching.  Did not require treatment.
Strong tingling sensation along the left flank (vaccine given in left deltoid) that increased in intensity to the point of cannot touch it or use muscles underlying the skin. Skin appears normal.
Father presents child with swollen, erythema rt arm at inj site. No fever. Child playing and using arm. No blistering/streaking. Home care: cold pack, ibuprofen, at father choice. See if change or increase sx Dr call, no given. f/u phone call 3/14, sx resolving.
01/28/22 presents to ED for "worsening lab/kidney function". PMHx of "cirrhosis with end-stage liver disease, chronic renal disease, coronary artery disease, hypertension"
p/vax pt broke out w/full blown varicella;pt sought unspecified medical attention;
Information has been received from a pediatrician concerning a 19 year old female patient who "within the last year" was vaccinated with a dose of GARDASIL (route and lot number not reported). On an unspecified date, the patient developed warts on her head. This was reported to the pediatrician by the mother of the patient, who stated that her daughter went to see a dermatologist who stated that it was "probably a venereal wart caused by GARDASIL". the patient received unspecified treatment for the event. At the time of the report the outcome of the patient was unknown. Additional information has been requested.
Ringing in the ears, tinnitus.  Started two days after the vaccine, and continues today, 7 weeks later).
AFTER ADMINISTRATION, IT WAS DISCOVERED THAT THE VACCINE WAS BEYOND ITS BEYOND USE DATE. NO ADVERSE REACTION.
Got injection on 07/24/09.   On 07/24/09 swelled.  On 07/25/09 severe HA, chills, site hot, nausea, hard lump size of tennis ball.   On 07/26/09 continued the same.  7/26/7-27/07-28 tried cold compress 07/28 really nauseated, chills.  Tried Tylenol x + during the day.
HEARING LOSS; STROKE; BLOOD CLOTS; This solicited report received from a patient: Janssen for XARELTO concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient was treated with rivaroxaban (form of admin and route of admin was not reported, batch number: Unknown, expiry: Unknown) dose and frequency was not reported, administered on an unspecified date for an unspecified indication.  The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke causing blood clots, and hearing loss. The action taken with covid-19 vaccine ad26.cov2. s was not applicable; and action taken with rivaroxaban was not reported. The outcome of the stroke, blood clots and hearing loss was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2. s, and stroke, hearing loss was not related, and blood clots was related; and between rivaroxaban, and stroke, blood clots, and hearing loss was not related.  This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20221049846-covid-19 vaccine ad26.cov2. s- Hearing loss, Stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related. V0: 20221049846-covid-19 vaccine ad26.cov2. s- Blood Clots-The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There are no other factors more likely to be associated with the event(s) than the drug. Therefore, this event(s) is considered related. V0: 20221049846-Xarelto- Hearing loss, Stroke-The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related  V0: Xarelto- Blood clots- The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event(s) is considered not related.
altered taste-metallic taste; hungry; tired; This is a spontaneous report from a contactable consumer (patient) received via Information Team. An 83 (unit not specified) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 22Jan2021 08:00 (Batch/Lot number: not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history included immunocompromised. Concomitant medications were not reported. On 22Jan2021, that evening, the patient experienced altered taste-metallic taste which went away the next morning. The patient was also very hungry and tired after the dose on unspecified dates in 2021. The patient recovered from altered taste-metallic taste on 23Jan2021 while the outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
shoulder lockup; This case was reported by a consumer via call center representative and described the occurrence of frozen shoulder in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2018, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced frozen shoulder. The patient was treated with ambiguous medication nos (Cortisone (Nos)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the frozen shoulder was recovering/resolving.   It was unknown if the reporter considered the frozen shoulder to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 65 or 66 years. The patient received the 1st dose in left arm. The patient received 2nd dose of Shingrix in January 2019 (intramuscular). After the first dose, the patient experienced her left shoulder locking up, which was the same shoulder she received the first dose of Shingrix. The patient reported that her shoulder issue did not resolve and when it was time for second dose of Shingrix, she had it administered in right arm and had no issues.  The patient reported that she had to see orthopedic surgeon in April 2019 due to her left shoulder issues, and that he prescribed physical therapy which helped some and she then required a cortisone shot recently in the shoulder and it has gotten much better but was still not back to normal. The reporter had consented to follow up. Emergency room Visit required.
Large raised bump at the injection site that's the size of my fist and very firm. It's red and warm to the touch. It hurts to raise my arm past 45 degrees. It is getting warmer, more painful, and more red by the day
This spontaneous report was received from a nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 03-AUG-2016 the patients were vaccinated with improperly stored GARDASIL lot # K010215/expiration date-05-JUN-2016, (incorrect product storage). No adverse event was reported. No concomitant medication was reported. The call was because of digital data logger. Temperature/Time frame: 8.9C for 1 hour and 1 minute and previous excursion was 10.4C for 6 hours 18 minutes. The outcome of event was unknown. No PQC (product quality complaint was involved). This is one of several reports received from the same reporter. Additional information has been requested.