chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large hematoma on my bicep; clicking; discomfort; burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (large hematoma on my bicep), JOINT NOISE (clicking), MYALGIA (discomfort) and BURNING SENSATION (burning sensation) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (4 years ago to repair a torn labrum in that shoulder).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMATOMA (large hematoma on my bicep), JOINT NOISE (clicking), MYALGIA (discomfort) and BURNING SENSATION (burning sensation). At the time of the report, HAEMATOMA (large hematoma on my bicep), JOINT NOISE (clicking), MYALGIA (discomfort) and BURNING SENSATION (burning sensation) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.
fatigue; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Viral infection.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills). At the time of the report, FATIGUE (fatigue), PYREXIA (fever) and CHILLS (chills) had resolved.            Patient reported that he might had history of COVID 19 (Several tests yielded negative results).  No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-362956, MOD-2021-363022 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up information included no new information. On 27-Oct-2021: upon follow up receipt: Event outcome was updated(unknown-recovered) and narrative was generated accordingly.
8/10/21-systemic lesions concerning for sarcoid or cancer. Myelitis pattern raises concerns for sarcoid; Sarcoidosis suspected Dx: Sarcoidosis Central Nervous System 4/10/22-Department of Neurology -Unfortunately, Patient started to decline recently with her symptoms with getting worse with weakness generally and in her legs in recent weeks but more so in the last 3-4 days. This coincided with developing black stools. She was ultimately brought to the hospital just a couple days ago and found to be very anemic at hemoglobin of 6 and received 2 transfusions. She was found to have a GI bleed due to gastritis which was felt due to multiple factors including NSAIDS recently used in the high-dose steroids that she has been treated with refer myelitis as well. She has been examined by the Neurology team in the hospital and she does appear to have some worsening weakness on her examination but the examining neurologist felt that perhaps the distribution of weakness which is consistent with some more exacerbation weakness due to her anemia and generalized feeling of weakness, etcetera. This seems to have slightly improved from what I can tell the patient certainly feels that she is doing stronger walking better from when she came to the hospital with her transfusion and treatment of her gastritis. At this point they are recommending she go to inpatient rehab. She does have some preservation of this because she has her that this facility is very bad. She had repeat imaging of her thoracic and lumbar spine of which the lumbar spine does not change with some degenerative disease and her thoracic MRI shows improvement of the T2 hyperintensity in significant improvement in the enhancement in the spinal cord lesion in the low thoracic spine.
nausea, lightheaded, abd distension, vomiting, diarrhea, joint pain, lower back pain, aching on lower lt side of spine, h/a, weakness, fatigue tx w/DPH & bed rest;elevated SGPT;
Arm became sore next day, progressed to cellulitis by 11/15/2015, required ER visit with IV antibiotics.
This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Symptomatic COVID Positive Test Post First Dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced COVID-19 (Symptomatic COVID Positive Test Post First Dose). On 02-Feb-2021, COVID-19 (Symptomatic COVID Positive Test Post First Dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: Positive.     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.   No concomitant medications reported by investigator  No treatment medications provided by the reporter.
12cm area of redness, induration, warmth on the left deltoid area at site of influenza vaccine two days ago. No stridor. No axillary lymphadenopathy.
1st vaccine Fever >100F, body aches, 2/4/21 - 2/09 - fatigue through  2/12
right arm swelling; fever; chills; body aches; mouth broke out with canker sores; fever blisters; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm). On 10-MAY-2023, less than a day after receiving Shingrix, the patient experienced injection site swelling (Verbatim: right arm swelling), fever (Verbatim: fever), chills (Verbatim: chills), general body pain (Verbatim: body aches), canker sore (Verbatim: mouth broke out with canker sores) and fever blister (Verbatim: fever blisters). On 20-MAY-2023, the outcome of the injection site swelling, fever, chills, general body pain, canker sore and fever blister were resolved (duration 10 days).   It was unknown if the reporter considered the injection site swelling, fever, chills, general body pain, canker sore and fever blister to be related to Shingrix.     It was unknown if the company considered the injection site swelling, fever, chills, general body pain, canker sore and fever blister to be related to Shingrix.   Additional Information: GSK Receipt date: 26-JUL-2023 The reporter was a patient. The reporter called and asked that she received dose of Shingrix and had a adverse reaction of right arm swelling (site of injection), fever, chills, body aches and mouth broke out with canker sores inside and fever blisters on the outside. The reporter stated that all the adverse events resolved by day 10 after receiving the Shingrix Vaccine dose. Reporter questioned getting the 2nd dose of Shingrix and was referred to HCP for advise, gave medical disclaimer. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up.
body aches; Extreme Fatigue; pain at the injection site; This is a spontaneous report from a non-contactable consumer (patient).   A 31-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Feb2021, at the age of 31-years-old, (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  Medical history included none. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. Concomitant medication included cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported; vitamin d (VITAMIN D) taken for an unspecified indication, start and stop date were not reported.  The patient experienced extreme fatigue and body aches, and pain at the injection site. The patient has not been tested to COVID-19 post vaccination. The outcome of the events was recovering. No treatment was received for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient described symptoms of fever, chills, headache, backache and minor nausea later that night after given flu shot. Doing better by the next day.
pain and swelling in arm where hadinjection; pain and swelling in arm where hadinjection; Feeling tired; This is a spontaneous report from a contactable consumer. A 45-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration in the left arm on 22Mar2021 at 14:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any medications within two weeks of COVID-19 vaccine. On 22Mar2021 at 14:00, the patient had experienced pain and swelling in arm where the patient had injection and was feeling tired. The patient did not receive any treatment for the adverse events. Adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events pain and swelling in arm where had injection and feeling tired was resolved on an unspecified date in Mar2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial information regarding an unsolicited valid non-serious case received on 11-Oct-2018 from a consumer. This case involves a 71 years old female patient who experienced could not sleep, flu like symptoms, arthritis like inflammation pain, total body joint aches, painful underarm down to elbow, possible fever and cold chills, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 10-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious could not sleep (sleep disorder), flu like symptoms (influenza like illness), arthritis like inflammation pain (inflammatory pain), total body joint aches (arthralgia), painful underarm down to elbow (arthralgia), fever (pyrexia) and cold chills (chills) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included no lab data. Final diagnosis was cold chills, possible fever, painful underarm down to elbow, total body joint aches, arthritis like inflammation pain, flu like symptoms and could not sleep. The patient was treated with OXYCODONE for Product used for unknown indication. The patient outcome was not reported. List of documents held by sender: none.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 1:06 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:06 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 70.44.   Concomitant products were not provided.  On 28-MAR-2021, Excursion time was reported at 10:00 AM with  temperature as 35 degrees Fahrenheit, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-MAR-2021, vial was moved to clinic on 27-MAR-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-APR-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored PROQUAD (Merck) (lot #, dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Shot was administered, and patient was requested to wait the allotted 15 minutes in waiting area. Patient decided to shop during that time, and prior to returning to pharmacy, patient stated that she was beginning to worry about having side-effects from vaccine (mentioned paralysis specifically). She then became light headed and returned to pharmacy. I asked the patient to sit in our clinical services room with family and authorized her to remove her mask to ensure there wasn't any swelling occuring. Patient said she just felt dizzy and slightly nauseated. She said she had a history of anxiety and thought she may have been having a panic attack. She sat for a few minutes, we offered her a bottle of water, which she accepted, and drank some of. After approximately 10 minutes of observation, and no worsening of symptoms patient said she felt better and decided to leave the pharmacy.
pt recv vax 4DEC98 & then in early JAN99 onset of sz;progressive worsening;EEG initial rt spikes-f/u EEG c/w infantile spasms; per follow-up dated 9/11/00, the pt continues to experience developmental delay and spastic quadraplegia.
Morning after shot had a pretty bad headache, ate breakfast and almost immediately had to lay down. Could barely keep my eyes open I was so tired. Slept all day, headache did not subside, tried to shower but was too tired to stand for even a few minutes and started to feel nauseous. I felt like I was on a high dose of Vicodin. Was hard to even keep my eyes open long enough to eat. Wasn?t until about 8 pm that I was able to sit up, alert, for an extended period of time. Arm was sore throughout all this but not as bad as the first shot (also it is not my dominant arm). My headache continued for about her 3-4 days.
This spontaneous report was received from a physician refers to a female patient of unknown age with medical history of panic attacks. The patent was vaccinated intramuscularly with the second dose of 0.5 ml GARDASIL on 27-JUL-2012. On 30-JUL-2012 the patient experienced intermittent, occasional tingling of both arms. On 31-JUL-2012, the patient also developed occasional tingling of both hands and both thighs. The physician stated the symptoms were intermittent and were not progressing. No treatment was given for the AE. There was no lab diagnostics studies performed. At the time of reporting, the outcome of the patient was not recovered. The patient sought medical attention by calling the office. Additional information has been requested.
Foggy thoughts, woozy, muscle aches throughout entire body, fatigue, loss of appetite . All symptoms occurred simultaneously and lasted approximately 24 hours
Starting same day sore arm, by Tuesday late/Wednesday sore shoulder and knife like pains under left shoulder blade. Pain bad enough Wednesday night/Thursday early morning to contact Dr. Thursday. He determined my pain was muscle pain. Suggested Aleve (as Tylenol and Advil weren't working) and heating pad (which I had used on Wednesday during day). Aleve helped a lot. Pain by today (Sunday) is minimal but still some minimal discomfort.
This initial spontaneous case, was received from other health professional (nurse) on 06-Nov-2017, concerning a patient of unspecified gender and age. This case refers to 02 out of 18 reports. The patient's medical history and concomitant medications were not reported. It was reported that most of the patients received the vaccine on 09-Oct-17 (as reported), the patient was administered with FLUVIRIN (dose, route of administration, anatomical location, batch number, expiry date: not reported) (explicitly coded to expired vaccine used). It was reported that, the patient had no reaction/had not experienced any adverse event after vaccination. The reporter assessed the events as non-serious.
No additional AE/PQC reported.; HCP calling to report an AE regarding VARIVAX. HCP calling to report that a patient was administered a improperly stored vaccine. Permission to contact HCP was provided. Case 02428709 filed. AE cases 02428861, 02428862, 02428865 ,02428868, 024287; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 28-JUN-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # W031810 with expiration date 05-OCT-2024 (dose, route and anatomical location were not reported) for prophylaxis (product storage error). No additional AE/PQC reported.
Reported her friend was almost killed by the COVID-19 Vaccine; The COVID-19 Vaccine damaged her friend's heart by 50% more; Attack the heart and lungs.; She lost 40 lbs., and looked like walking death; Had severe heart valve issues now.; Attack the heart and lungs.; This is a spontaneous report from a contactable consumer (patient friend). A female consumer of unknown age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN) in Jan2021 at single dose for COVID-19 immunization. Medical history included heart valve issue. Concomitant medication was not reported. The patient was almost killed by the vaccine (clarified as the COVID-19 Vaccine). The patient lost 40 lbs., and had severe heart valve issues now. Reported vaccines (clarified as COVID-19 Vaccines) attack the heart and lungs. The patient was a nurse who got the COVID-19 Vaccine in Jan2021, and the COVID-19 Vaccine damaged the patient's heart by 50% more, and she lost 40 lbs., and looked like walking death. The patient had the same heart valve issue she had. No further details provided. The outcome of all events was unknown.  Pfizer is marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
POOR QUALITY DRUG ADMINISTERED; This spontaneous report received from a health care professional concerned a 36 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAY-2021, the subject experienced poor quality drug administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of poor quality drug administered was not reported. This report was non-serious.
Patient completed Moderna series in April 2021 (had COVID in November 2020). In October 2021 while planning her son's wedding she developed bells palsy. The symptoms are lingering with no relief. "Functional Nerve Disorder" has been mentioned by her PCP in relation to receiving the vaccine.
FINGER JOINT PAIN/MIDDLE FINGER JOINT PAIN,CANNOT MAKE A FIST/LEFT FINGER JOINTS(CAN MAKE A FIST) ARE TIGHT/RIGHT RING FINGER VERY PAINFUL; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included melanoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, vaccinated in right arm,  administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAR-2021, the subject experienced finger joint pain/middle finger joint pain, cannot make a fist/left finger joints (can make a fist) are tight/right ring finger very painful. On 02-APR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from finger joint pain/middle finger joint pain ,cannot make a fist/left finger joints(can make a fist) are tight/right ring finger very painful. This report was non-serious.
Dizziness and near syncope. Fell down to the floor, hower never lost consciousness. Light headedness persisted for > 48hrs.
Patient fainted and had a short seizure roughly 5 minutes after the injection. EMT came and drove patient to hospital for further evaluation. Outcome - unknown.