chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to an 83 days old female patient with no drug or food allergies or pertinent medical history. The patient was vaccinated with a dose of 0.5 ml VARIVAX (Merck) (Lot# reported as H006538 and Exp date reported as 09-MAR-2014) and M-M-R II (Lot# 0128AE and Exp date: 10-JAN-2014) subcutaneously on 28-SEP-2012. Concomitant medications included selenium sulfide and EUCERIN creme. The medical assistant stated that the patient received M-M-R II and VARIVAX (Merck) too early on 28-SEP-2012. The patient was seen in office on 05-NOV-2012 for an upper respiratory infection, runny nose and cold. The patient presented smiling and happy. The patient did not seek medical attention. No lab diagnostics studies were performed. Additional information has been requested.
At 8:30 PM, symptoms began with strong chills, fatigue, and slight headache. Fever was noted at 11:00 PM, temperature was 99.4 F. At 1:00 AM, chills were gone and fever felt like it was going away. Woke up at 9:00 AM with moderate headache. Headache went away by 10:00 AM. Fatigue was noted throughout the rest of the day (1/21/21).
I experienced moderate pain in my arm. Also I had body ache and joint pain and what felt like a fever. I also became very tired. I did not take my temperature. The symptoms started the day after the immunization around 4 PM. I went to bed around 8:30 PM (12/31/20)and when  I woke up at 8AM (01/01/2021) the symptoms had gone away.
having Bell's Palsy symptoms; Her tongue on left side becomes numb; numbness across left side of face, nose and tops of cheek and sometimes like this morning, will go up towards the eye and when it gets severe, get to left side of the upper and lower lips; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration on 26Feb2021 (at the age of 76-year-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Family medical history relevant to AE included none. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EM9810), via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 76-year-old) as dose 1, single for covid-19 immunization. On an unspecified date in May2021, the patient experienced having bell's palsy symptoms, her tongue on left side becomes numb which is a funny sensation according to patient, numbness across left side of face, nose and tops of cheek and sometimes like this morning, will go up towards the eye and when it gets severe, get to left side of the upper and lower lips. Patient wanted to know if there had been any case studies like her experience. Patient reported that It's the nose and cheek and travels sporadically to the nose and tongue and then its more forceful and goes up the left eye. The patient underwent lab tests and procedures which included computerized tomogram: found nothing on 04Jul2021, magnetic resonance imaging: found nothing on 04Jul2021. The events resulted in emergency room visit and physician office visit. Therapeutic measures were taken as a result of events. The outcome of the event were not recovered.
I woke up 2am on 2/10 around 18 hrs from second dose with fever 100.9. I exp really bad cold, shakes, and extreme nausea. On various parts of my body exp body aches and regular headache.I was fatigue had to cancel some job projects.When the Tylenol would wear off my fever would come back into the 99 area. I continued to administer Tylenol and took Zofran for nausea.The next day on 2/11 I felt better not as severe as day before no symptoms.My OBGYN was contacted everything was normal.(estimated date of delivery 9/30/2021).
This spontaneous report has been received from a 70 years old female patient referring to herself. The patient's current conditions included high blood pressure (hypertension), arthritis, osteopenia and insomnia. The patient's historical medications included tramadol, hydrocodone and acetaminophen (+) oxycodone hydrochloride (PERCOCET) and with which the patient developed drug allergies. The patient's historical condition included drug allergies. Concomitant therapies included irbesartan and celecoxib (CELEBREX). On 25-JUN-2018, the patient started therapy with suvorexant (BELSOMRA) (lot # 1544472, expiration date was 30-APR-2020; dose, frequency and strength were unknown) orally for insomnia. On 03-JUL-2018, the patient received Zoster Vaccine Live (reported as shingles vaccine) (unknown manufacturer) (dose, route, anatomical location, lot # and expiration date not reported) as prophylaxis and patient experienced redness on her arm on an unknown date in 2018. On 03-JUL-2018, the patient experienced intense itching. The patient was hospitalized on an unknown date (reported as visited ''Med Express''). The patient had spoken with the doctor. There were no lab diagnostics/studies performed. The patient also mentioned that ''other sleep medicines didn't work for her''. Therapy with suvorexant (BELSOMRA) was discontinued on an unknown date in approximately July 2018 (reported as about a month ago). The event of redness on her arm was resolved on an unknown date in 2018 and the event of intense itching was resolved on an unknown date in July 2018. Causality assessment was not provided. Product quality complaint was not involved. Follow-up information has been received from an office manager on 18-SEP-2018 refers to a non-pregnant female patient. The patient's historical medications included valdecoxib (BEXTRA), aspirin (+) hydrocodone and unspecified antihistamines and with these medications the patient developed allergies. Concomitant medications included alendronate, hydrochlorothiazide + Irbesartan, celecoxib and cetirizine hydrochloride (ZYRTEC). On 06-JUL-2018, the patient restarted therapy with suvorexant (BELSOMRA) and on 15-AUG-2018, pruritus reappeared. On 09-AUG-2018, the patient reported about this adverse event (discrepant date reported). Medical/surgical intervention was not required. Therapy with suvorexant (BELSOMRA) was discontinued on an unknown date in 2018. The patient recovered from pruritus on an unknown date in 2018.
Feeling wobbly, shaky and sleepy; sleep a lot; forget a lot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling wobbly, shaky and sleepy), SOMNOLENCE (sleep a lot) and MEMORY IMPAIRMENT (forget a lot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feeling wobbly, shaky and sleepy), SOMNOLENCE (sleep a lot) and MEMORY IMPAIRMENT (forget a lot). At the time of the report, FEELING ABNORMAL (Feeling wobbly, shaky and sleepy), SOMNOLENCE (sleep a lot) and MEMORY IMPAIRMENT (forget a lot) outcome was unknown.            Relevant concomitant medications were not reported.  It was reported that the patient was not feeling right ever since the patient got the second shot of vaccine.  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: follow up : added dose number of vaccine and events (somnolence and memory impairment).
This is a serious spontaneous case, initially received from other health professional (nurse) on 07-Feb-2018, concerning a female patient of an unspecified age. On 11-Oct-2017, the patient was administered with FLUCELVAX QIV (route of administration: intramuscular, anatomical location: left deltoid muscle, batch number: 195250, dose, expiry date: not reported). On 07-Feb-2018, after 3 months 28 days of vaccination, the patient was diagnosed with Influenza (type A) (explicitly coded as vaccination failure). At the time of this report, the outcome of the event (influenza) was not reported.
Fever & NauseaVomiting Narrative:  Sore arm, fatigue, chills, low grade fever, body aches, nausea
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 10:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 10:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) 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 41.41.  Concomitant products were not provided.  On 28-Feb-2021, Excursion time was 9 AM and 1 PM, the temperature was 27 and 26 respectively, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  Vial was stored on cooler 1, on 28-Feb-2021, Excursion duration at 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM : 37, 3 PM: 43 and 4 PM: 45.  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).
Second reaction raised erythematous; slightly warm indurated area 12cmx7cm on left anterior thigh. The puncture site looks normal.
Guest had a new onset of rash on left arm, guests face and neck were flushed.
Notified by COVID testing unit at same church location that patient went to get rapid testing done AFTER vaccination at the Color vaccination site same day and rapid report came back positive. Patient answered ?no? to pre-vaccination questions regarding having any symptoms or exposure to COVID.  Patient notified by testing center of her positive result and will be contacted by local health department per protocol.
pt was fussy & lt leg was swollen taken to ER on 11SEP94;tx w/med for swollen leg;no fever @ time of ER visit;
sore arm; feeling sick; very nauseous/queasy feeling; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MALAISE (feeling sick), NAUSEA (very nauseous/queasy feeling) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MALAISE (feeling sick), NAUSEA (very nauseous/queasy feeling) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), MALAISE (feeling sick), NAUSEA (very nauseous/queasy feeling) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender'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.
Patient called over 2 weeks later stating that he still cannot move his arm. He is having mobility issues and cannot fulfill daily tasks.
Patient reports she went to a clinic van and was tested for COVID-19 on 5/13/2021 as she was symptomatic since 5/5. However she was also offered and given the J&J vaccine that same day (5/13/2021) which should not have happened. Her test was positive the following day for COVID-19. She has been experiencing  shortness of breath with activity and cough that not resolved for the past 2 weeks.
Information has been received from an office worker concerning a 16 year old male patient with an unspecified medical history, drug reactions or allergies, who on 08-JAN-2010 was vaccinated with a dose of VARIVAX (Merck) (route unknown, lot # 665184/1009Y). Concomitant medication was unspecified. On 09-JAN-2010 the patient experienced lump on his arm after receiving VARIVAX (Merck) which was circular, red and itchy. Lab diagnostic studies performed were unspecified. The patient sought unspecified medical attention. At the time of the report the patient had not recovered. Additional information has been requested.
I broke out in a raised, red, itchy rash on my lower arms.  (just above elbows)  This started at bedtime and by morning my chest had become covered with rash.  I went to my NP to have her check it.  She believed that this was a medicine reaction.   I took benydral for the itchiness.  I still have the rash amd it is speading ro my hands.
lt thigh area where recvd DTP became swollen-size of golf ball;1/4" high area of redness @ inj site not as large as the swollen area;screaming unconsolable for several hrs;no fever; mom brought pt in 23MAR93 to MD;nodule noted @ DTP site;
child was given 3 doses of Rotarix (Extra Dose); This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27-JUN-2023) for prophylaxis.   On 29-SEP-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 29-SEP-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix (Extra Dose)).  The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142498:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142499:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142501:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter
Severe arm pain down to fingers that where swollen & had sores instead my mouth.  Called my health insurance co. that had a 24 hr nurse on call & said to put warm  clothes & take ibuprofen. Had to take tylenol for the extreme pain & for the next day, but had eased up on the Wed.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, low grade fever, chills, runny nose, nausea, body aches, extreme fatigue, unable to sleep, lightheadedness, weakness Narrative:  Other Relevant History:
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history and concurrent condition were not provided. On unknown dates 8 doses of improperly stored (Oka/Merck) VARIVAX (lot # L006385 with expiration date of 25-FEB-2017, dose and route unknown) were administered to the patients. No concomitant therapy was reported. No adverse effects were reported. This is one of several cases that received from the same reporter. Additional information has been requested.
Mom put child down for nap p/lunch & checking 10" later found shaking & blue around mouth; Taken to clinic; Vomited; Given 02; t102R; MD stated thought sz was due to fever pt should be watched carefully when has fever & should get DT;
Pt. developed a reaction to 2nd dose of COVID-19 vaccine, symptoms described by patient as having light headedness, no nausea noted.  Pt. States that no meals were consumed prior to vaccination.  No hospital care provided at this time.  Pt. verbalizes feeling better and recovered.  VS 126/84 BP, 94 P, 98 O2Sat; standing BP 120/83, P 65, O2Sat 100%.
rash: forearms and front of abdomen; both sides,-not vesicular at this time 11 days duration-unresponsive to over the counter topical hydrocortisone and oral diphenhydramine
headache; chills; vomiting; injection arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (injection arm soreness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced HEADACHE (headache), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (injection arm soreness). At the time of the report, HEADACHE (headache), CHILLS (chills), VOMITING (vomiting) and VACCINATION SITE PAIN (injection arm soreness) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Noticed a weird rash on her right arm /unsure if it had been there longer. Did notice after receiving the Typhoid vaccine in the right arm it felt swollen and persisted until 03/26 also noticed a metallic taste in back of her throat right after the shot but unsure which vaccine it was that only lasted briefly.
8-19-2013 at 10:55 pt. comes with mother and report onset of rash on chest and back two days after Tdap vaccine (7-30-2013). Denies fever, malaise or itchiness. Rash noted on all back and upper chest. Recommend to see the doctor for eval.
Approximately (5 1/2) hours at 3:35 pm after injection my arm became extremely sore at the injection site and extended outward. At about 6 pm I started having chills, muscle, and joint aches. At 6:30 pm I took 1 600mg ibuprofen, after about 30 mins I began to feel some relief from the chills. At about 12:00 am I started having an extreme experience of chills. I started shivering at an extreme level. I had a high fever the second day. Arm is still sore and swelling at my left collar bone area.
had a rash on right leg by ankle that was itching and within a few days went up leg to arm and stomach; had a rash on right leg by ankle that was itching and within a few days went up leg to arm and stomach; little bumps, flaky bumps and they were filled with moisture; This is a spontaneous report from a contactable consumer, the patient.   A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on 23Jun2021 (at the age of 73-year-old), as single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on 02Jun2021 (at the age of 73-year-old), as single dose, for COVID-19 immunization and no reaction after the first dose. Patient stated that, had no reaction after the first dose but after the second dose she had a rash on right leg by ankle that was itching and within a few days went up leg to arm and stomach, a little petroleum jelly and cortisone cream helped, but the jelly helped better with the itching. Patient was looking for treatment recommendations. The rash started, small, the size of a 50 cent piece on her right leg. Patient had little bumps, flaky bumps and they were filled with moisture. Patient came across papers of side effects which patient was experiencing, and for a minute patient didn't realize a rash started, it was small, the size of a 50 cent piece on her right leg; was started a week ago around 08Jul2021 or 09Jul2021 to it's ongoing on her arms. persisting Treatment - No, she didn't know what it was before she came across the report. She was thinking it was psoriasis at first, which she never gets. It started itching; was started around 06Jul2021 or 07Jul2021, it is still itching even though patient put the cream, petroleum jelly on it and put on hydrocortisone for itching. It started having little bumps, flaky bumps and they were filled with moisture. Patient can't say it was water and it has grown there and has spread to her left leg; was started around 06Jul2021 or 07Jul2021, it was just a dry patch that caught her attention because it started itching. Patient wants to know what she could do, what to put on it, and advice on what treatment. On the paper it says it was a non-severe reaction like hives, swelling of the face, rash. Patient clarified patient was not having hives or swelling of the face just a rash. Patient did not require emergency room and physician office visit for events. No AEs following prior vaccinations. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Uncontrollable shaking in bed for two hours. Excessive stomach acid. Tense muscles in shoulder, neck and back. Bad migraine type headache. Nausea, throwing up next morning. Lightheaded, passing out, in AM.