chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to a patient of unknown age and gender. Infromation about concurrent conditions and medical history were not provided. On 03-MAR-2015 the patient was vaccinated with GARDASIL (lot # K006191, expiration date 02-FEB-2017, dose, dose# and route not provided) after it was improperly stored (incorrect product storage). No adverse effects reported. The outcome of the events was not provided. This is one of several reports received from the same source. Additional information has been requested.
Redness, swelling about the size of a half dollar, warm to touch. No fever.
Rec'd call from M.O.C who reports a painful red swollen area appeared on back of Rt. arm the size of 50 cent piece-onset evening on 7/24/07-No fever or other prob
Information has been received from a immunization coordinator concerning 2 or 3 patients who were vaccinated with GARDASIL. Subsequently the patients passed out after getting vaccinated with GARDASIL. All of the patients had recovered on unspecified date. The patients had sought medical attention. Additional information has been requested.
Presents to our facility today with complaints of progressive weakness, inability to ambulate, abdominal pain, left thoracic wall paresthesias, inability to move bowels, and urinary difficulties.  Reports he was also bitten by a spider on his left side recently and did not seek treatment, but decided to seek treatment when he developed same symptoms in his right side.  Reports he has been experiencing symptoms for 1 week or more.
None. Boostrix was given instead of pediatric DTAP no symptoms no adverse reaction pt was contacted and adv to come back for re vaccination after the 20th of January.
Soreness (localized) at 4 hrs, increasing over the following 4 hours, followed by fever (99.7 F at 15 hrs, 102 F at 24 hrs, 102.5 F at 27 hrs). Acetaminophen administered (1500 mg) at 27 hrs. Fever dropped to 100.8 F at 28 hrs, and 99.8 at 29 hrs. Report filed at 29.5 hrs.
Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2016, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 2016, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Hard, red 3x3 spot on arm.; Hard, red 3x3 spot on arm.; Itching on arm; Soreness at the time the shot was given.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.), VACCINATION SITE PAIN (Soreness at the time the shot was given.) and VACCINATION SITE PRURITUS (Itching on arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history information was reported.     On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the time the shot was given.). On 20-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.) and VACCINATION SITE PRURITUS (Itching on arm). At the time of the report, VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.), VACCINATION SITE PAIN (Soreness at the time the shot was given.) and VACCINATION SITE PRURITUS (Itching on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Received Treatment including Benadryl cream. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 22-Feb-2021.    This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.), VACCINATION SITE PAIN (Soreness at the time the shot was given.) and VACCINATION SITE PRURITUS (Itching on arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No medical history information was reported.     On 13-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the time the shot was given.). On 20-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.) and VACCINATION SITE PRURITUS (Itching on arm). At the time of the report, VACCINATION SITE INDURATION (Hard, red 3x3 spot on arm.), VACCINATION SITE ERYTHEMA (Hard, red 3x3 spot on arm.), VACCINATION SITE PAIN (Soreness at the time the shot was given.) and VACCINATION SITE PRURITUS (Itching on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Received Treatment including Benadryl cream.
On 2/20/21 developed sudden onset chest pain, sob, cough. Went to ER at Hospital. Diagnosed with nodules, inflammation and infection in lungs. Prescribed azrythomycin for 5 days. Felt better after 5 days but was worse within 72 hours of finishing antibiotics. Seen in women?s clinic on 3/4/21. Received chest X-ray, atrovent inhaler, albuterol inhaler. Cough & sob improved some. Never had any wheezing at any point. 3/14/21 received second Moderna vaccine because no one connected reaction with vaccine. 03/19/21 telephone consult with primary care physician. Continue meds. Cough & sob, palpitations all worse. Tests ordered for after April 10 .  March 29 to ER at VA Medical center. Diagnosed with allergic reaction to Moderna vaccine and pneumonitis. Prescribed prednisone, doxycycline and benzoate pearls for cough.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty ban-aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reported for the same vaccine and same events. Follow-up information received on 25 October 2014: QUAL number updated.
Patient was immunized with 3 doses of shingrix, where it should be only 2 doses. Patient did not report any adverse reaction to it.
Patient given wrong dose for age.  Inadvertent temperature excursion, vaccine was stored in freezer temperatures (-50° C to -15° C)   beyond the allowable two-week excursion then administered to patient.  No patient issue to report from vaccine.
Patient reports that week of January 14, 2013 her feet began to feel numb bilaterally. Over the next few weeks progressed to calf and thigh area. Numbness progressed to buttock area. Pt hospitalized 2-11-13 thru 2-16-13 and diagnosed with Transverse Myelitis.
Information has been received from physician concerning a 15 year old female who was vaccinated with Gardasil. Subsequently the patient may have experienced encephalitis and was hospitalized. The duration of the stay was not provided. The physician reporting was not the physician who administered the vaccine but the treating physician. At the time of the report the patient had recovered. Additional information has been requested.
Child has large reddened, hard area at (LD) site of injection. Child not feverish or irritable.
Patient reported chest tightness/warmth within 15 minutes of vaccination.  Patient was transported to ER by EMS.
Similar symptoms/ but one that is not well known side effect; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Similar symptoms/ but one that is not well known side effect) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Similar symptoms/ but one that is not well known side effect). At the time of the report, IMMUNISATION REACTION (Similar symptoms/ but one that is not well known side effect) outcome was unknown.            No concomitant medications were reported.  The patient stated that the doctor deemed the symptoms not to be caused by the vaccine. However, after receiving 2 boosters and getting similar symptoms patient feel more confident that it was a side effect and, not only that, but one that was not well known.  Treatment information was not provided.   This case was linked to MOD-2021-158733 (Patient Link).
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose number unknown, single (Lot number: EW0167), in left arm, on 31Jul2021 as dose number unknown, single (Lot number: EW0158), in left arm and on 15Dec2021 as dose number unknown, single (Lot number: FD7218) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200749574 Same patient and drug, different event separated in time
Symptoms:   Tongue itching, denies swelling, airway constriction, shortness of breath. this is dose #1   Assessment: Chest clear, no visible facial or oropharyngeal edema, vital signs are WNL  bp- 136/95, p- 84, o2- 98%  Treatment:   25mg IM benadryl x1 with resolution after 30 min and released after 30 min observation, he was not the driver
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 21-MAR-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 injection (lot#, expiration date 02-FEB-2016, dose, anatomical location and route of administration were not reported). The reporter stated that, this was supported. No adverse effects were reported. Additional information has been requested.
ended up with ITP; still dealing with pain and weakness; still dealing with pain and weakness; This is a spontaneous report from a contactable other HCP. This 39-year-old female other HCP (patient) reported for herself that a 39-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 19Jan2021 (Lot Number: EL0142) at the age of 39 years as dose 2, single for covid-19 immunisation. Medical history included PCOS. Patient was not pregnant. Concomitant medications included sertraline; benzylpenicillin (PENICILLIN) and birthcontrol. Historical vaccine included the first dose of bnt162b2 (Lot Number: EK5130) on 30Dec2020 at the age of 39 years in arm left for covid-19 immunisation. Patient previously took azithromycin (Z-PAK), fluoxetine hydrochloride (PROZAC), escitalopram oxalate (LEXAPRO) and clarithromycin (MACROBID) and experienced known allergies. Patient got petechiae which she first thought was a rash. Ended up going to the ED to have it checked. Patient had 1,000 platelets and was hospitalized. Patient ended up with ITP. Was on steroids till mid Jul. Got a second opinion, ended up hospitalized again. Got Cushing Syndrome from the steroids' and was now still dealing with pain and weakness. Adverse event start date was 21Jan2021. AE resulted in: doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). Hospitalization days: 4. AE treatment: platlet transfusion, IVIG and steroids. Nasal Swab for covid-19 was negative on 12Apr2021. Outcome of events were recovering.; Sender's Comments: Based on the available information in the case, the causal association between the events ITP, pain, asthenia and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Headache, facial pain, severe tooth pain, intraoral numbness in tongue area, had symptoms from first dose of vaccine, progressively worse since second dose.
Patient passed out about 2 minutes after receiving shot and hit head on floor.  He woke up a few seconds later and was helped back to bench and stayed there until he felt better.  Patient did not want anyone to drive him home.  He stayed at pharamcy for about 30 minutes until leaving.  We had given him water and icebag when he was on bench.  He said he had passed out before after getting a shot.  I called him when he got home and he said he felt a little weak and had headache.  I told him not to take nap for at least 4 hours, and to call doctor tomorrow if he still felt bad.  I am going to call tomorrow to check on him.
At the time, I had very mild injection site pain and warmth on the site. For a couple of days. On Monday, the 15th, I had the worst flare-up of sciatica that I have ever had in my life. Left leg - it had a tremendous swelling. It was crippling. I am still using a pain. I cried because the pain was so horrific. I was able to get into the doctor early on Tuesday - prescribed Prednisone; hydrocodone; muscle relaxer. None of which touched the pain. I was unable to sleep for three days. I slept upright in a chair. I used an office chair as a wheel chair. I wasn't able to lay down. I've improved but I still can't walk to the mailbox - could walk down there - two houses down but couldn't get back. I am using a cane still. I have to elevate leg on a recliner to sleep so it will help with the continued swelling. There was nothing I did that triggered it.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: patient was sitting in chair waiting for 15 min time period and fainted. when patient fell he hit his head on the ground causing a cut. patient was attended to by clinic staff and eventually emt
acute onset of wheezing, SOB & hives about 4 hrs p/MMR treated w/Epi, Ventolin & steroids;
Headache/Head Hurts; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache/Head Hurts) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C214. and 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypercholesterolaemia (Cholesterol ). Concomitant products included EMPAGLIFLOZIN (JARDIANCE) for Diabetes.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced HEADACHE (Headache/Head Hurts). At the time of the report, HEADACHE (Headache/Head Hurts) outcome was unknown.            Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Per ER report dated 04/28/2019 patient presented with redness, tenderness with mostly warm and itching to left arm at injection(s) site.
Dizziness, Headache, flushing, fatigue Narrative:  Other Relevant History:
Initial pregnancy unsolicited literature report received on 03 Feb 2015. This case is linked to 2015SA016408 (same reported). One hundred and twelve pregnant female patients (age not reported) whose medical history and concomitant medication were not reported, had received a dose of INFLUENZA VACCINE (batch number, route and site of vaccination was not reported) on an unspecified date. Conclusion: Influenza had a greater negative impact on pregnant women than non-influenza ARIs, as indicated by symptom severity and greater likelihood of elevated temperature. These results highlight the importance of preventing and treating influenza illnesses in pregnant women. The case concerns with one hundred and twelve female patients who were identified to be influenza negative on an unspecified date. Corrective treatment and laboratory investigations were not reported. Documents held by sender: none.
diarrhea; vomiting; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), VOMITING (vomiting) and VACCINATION SITE PAIN (sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced DIARRHOEA (diarrhea), VOMITING (vomiting) and VACCINATION SITE PAIN (sore arm). On 16-Mar-2021, DIARRHOEA (diarrhea), VOMITING (vomiting) and VACCINATION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  Treatment information not provided.   Action taken with mRNA-1273 in response to the events was not applicable.
pt recvd vax & was having SOB & dizziness; took to ER & upon arrival sx more severe; pt was weak & had vomiting; blood work indicated low potassium;
Nerve pain at base of skull and right side of neck, nerve pain in hip, lethargic, chronic headaches, equilibrium problems, inability to stay awake, odd sensations in frontal lobe?,
Initial report was received from a health care professional on 19 January 2012. This case is one of a cluster of seven patients reported by the same reporter who each experienced adverse events following administration of FLUZONE (lot number not reported). The events for the other patients were captured in case numbers 2012-00770, 2012-00771, 2012-00772, 2012-00773, 2012-00775 and 2012-00776. A female patient had received an injection of FLUZONE, sanofi pasteur Inc. (lot number, route, site and date of administration unknown) and an unspecified amount of time later experienced achiness, feverish for 2-3 days, joint pain and muscle aches. Illness at the time of vaccination, pre-existing medical conditions and concomitant medications were unknown. The patient had several doses of influenza vaccines in the past. The patient also had the same reactions (achiness, feverish for 2-3 days, joint pain and muscle aches) following an influenza vaccine in the past. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: none. Follow-up information received from a healthcare professional on 21 February 2012 reported that the 51-year-old patient had no illnesses at the time of vaccination. The patient received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UH467AB, on 17 October 2011 in the AM. On 18 October 2011, Tuesday morning, the patient felt achy and took MOTRIN every four hours (q4h) and hot baths. On Wednesday she became feverish and achier. She continued with MOTRIN and hot baths. Wednesday evening and Thursday, the fever continued and "felt like a semi truck kept driving over me and backing up and driving over me again". Every muscle and joint hurt and she continued with MOTRIN and hot baths. She had no respiratory symptoms. The outcome remained recovered. No additional information was available. Documents held by sender: Medical timeline.
Muscle pain after first dose; Fever 101 F for 2.5 days after first dose; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever 101 F for 2.5 days after first dose) and MYALGIA (Muscle pain after first dose) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever 101 F for 2.5 days after first dose) and MYALGIA (Muscle pain after first dose). At the time of the report, PYREXIA (Fever 101 F for 2.5 days after first dose) had resolved and MYALGIA (Muscle pain after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f (High) Fever 101 F.     mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medication was reported.  Patient had not visited doctor, she does not have a doctor.  No treatment medication was reported.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jun-2022: Follow up received contains no new information.