chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Burning hand/burning feet; It has progressed since the second one, moved into my hands; Hot feeling in my back; This spontaneous case was reported by a nurse and describes the occurrence of BURNING SENSATION (Burning hand/burning feet), CONDITION AGGRAVATED (It has progressed since the second one, moved into my hands) and FEELING HOT (Hot feeling in my back) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning hand/burning feet), CONDITION AGGRAVATED (It has progressed since the second one, moved into my hands) and FEELING HOT (Hot feeling in my back). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Burning hand/burning feet), CONDITION AGGRAVATED (It has progressed since the second one, moved into my hands) and FEELING HOT (Hot feeling in my back) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-079703 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow-up received on 17 May 2021: Updated Reporter contact details( Address) and Event outcome. On 19-Jul-2021: Follow up received on 19 JUL 2021: No new information.
30 minutes after: nausea, dizziness, fatigue; later in the day and for days after: pain and swelling and tenderness at injection site, muscle tenstion, fatigue;  next day and multiple days after: muscle and joint aches, fatigue, some headaches and chills
rash is blotchy; believes it to be "Covid Arm"; rash is burning; feels hot; rash is itchy; rash; (rash) red; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (rash is blotchy), VACCINATION SITE REACTION (believes it to be "Covid Arm"), SKIN BURNING SENSATION (rash is burning), FEELING HOT (feels hot) and VACCINATION SITE PRURITUS (rash is itchy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced RASH MACULAR (rash is blotchy), VACCINATION SITE REACTION (believes it to be "Covid Arm"), SKIN BURNING SENSATION (rash is burning), FEELING HOT (feels hot), VACCINATION SITE PRURITUS (rash is itchy), VACCINATION SITE RASH (rash) and VACCINATION SITE ERYTHEMA ((rash) red). At the time of the report, RASH MACULAR (rash is blotchy), VACCINATION SITE REACTION (believes it to be "Covid Arm"), SKIN BURNING SENSATION (rash is burning), FEELING HOT (feels hot), VACCINATION SITE PRURITUS (rash is itchy), VACCINATION SITE RASH (rash) and VACCINATION SITE ERYTHEMA ((rash) red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Patient took ibuprofen to treat her symptoms   Reporter did not allow further contact
The vaccine was administered 6 days too early by the vaccinator. The first dose was given on 1.6.22 and the second dose was given on 1.21.22. No adverse symPtoms were observed. Patient was observed for 45 minutes. Vital signs at 1629 BP 120/78,  HR 98bPm, O2 98 %,  16resPirations. Parents were instructed to seek emergency medical services for any signs or symPtoms and to call their Pediatrician immediately for monitoring.
Treatment of COVID-19; 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 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: Gh9703) at the age of 77 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Jan2021 as dose 1, single (Lot number: PF12ER), in left arm, on 06Feb2021 as dose 2, single (Lot number: EL9581), in left arm, on 30Aug2021 as dose 3 (booster), single (Lot number: EW0168), in right arm and on 05May2022 as dose 4 (booster), single (Lot number: FM0173), in left leg for covid-19 immunisation. The patient's relevant medical history included: "Auto Immune" (unspecified if ongoing); "COPD" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; TAMSULOSIN; DULOXETINE DR; BREO ELLIPTA; LASIX [FUROSEMIDE]; LOSARTAN HCTZ. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21Mar2023, outcome "recovered" (29Mar2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Mar2023) Positive, notes: taken covid test at home, tested positive 22Mar; (23Mar2023) Positive, notes: tested again 24 hours later tested positive 23Mar2023; (29Mar2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 23Mar2023 to 28Mar2023. Started showing symptoms 21Mar2023 found out patient was exposed to family member who was diagnosed with Covid. Began taken covid test at home, tested positive 22Mar tested again 24 hours later tested positive 23Mar2023. Contacted Doctor, based on patient medical history prescribed Paxlovid. Began showing improvement within 24 hours (really worked well) Tested negative 29Mar felt great for 7 days. There were no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300152906 Same reporter/patient,different dose/AE.;US-PFIZER INC-202300152261 Same reporter/patient,different drug/AE.;US-PFIZER INC-202300154355 Same reporter/patient,different dose/AE.;
No adverse event; refrigerated products administered to the patient; This spontaneous report was received from a healthcare business professional (HBP) and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 06-SEP-2022, the patient was administered a dose of improperly stored hepatitis a vaccine, inactivated (VAQTA) syringe, intramuscular injection, lot # W002889 with expiration date 06-MAR-2023, for prophylaxis (exact dose, route of administration and anatomical site were not provided) (product storage error). The vaccine was improperly stored for 8 hours in the temperature above 46 degrees Fahrenheit (F) (62.8 F). There was no previous temperature excursion. No additional adverse event details were available (no adverse event). ; Sender's Comments:  US-009507513-2209USA002722:02242138 US-009507513-2209USA002779:
SHINGRIX shingles vaccine #1 - ~11:30am. Friday, Sept 6, 2019   - food tasted a bit off to me approx 2 hours later  - by late afternoon Extremely painful left upper arm,  by evening I could barely move that arm as it hurt so much  AND seemed unresponsive! with me having to lift it with my other hand to move it sometimes  - evening also brought on feeling chilled, shivering, but no fever.                        Sinus headache and a bit of a wet cough!!!                          waves of nausea, no vomiting  - Woke from sleep  at 1:30am: shivering, with a 100.7 degree fever WITH Tylenol already on board for arm pain. AND RACING, pounding heart beat!!!! Feeling like I was exerting myself! I couldn't count my pulse with fingers at wrist or neck, so  used my blood pressure cuff to measure  115 - 120 beats per minute for next 3 hours, measuring at 30 minute intervals. (BP normal)  -  Waves of nausea, felt like I could vomit, but didn't. CONSIDERED for some time whether heading to the Emergency Room was what I should do!!!!   - went back to bed at 4:30 am with heart rate averaging around 85 bpm Accelerated Heart Rate lasted a minimum of 3 hours -as I don't know what it was before I woke up or how long it took to raise to 115-120, nor do I know how long it took to recover other than it was normal by ~8am.  - SATURDAY - woke achy, still sinus headache, still occasional wet cough -      NO fever,        heart rate back to within my normal range - upper 60s.,       L arm feeling much better     took a 3 hour nap in the late afternoon of Saturday due to tiredness. - SUNDAY - near normal - just a bit slow thinking, and a bit body achy. - a bit body achy for another day or so
Case number PHEH2015US019100, is an initial spontaneous report from a pharmacist received on 28 Sep 2015. This report refers to a female patient of an unknown age. The patient had a known egg allergy even to cooked eggs. Historical conditions and concomitant medications were not reported. The patient was vaccinated with influenza vaccine (manufacturer and batch number unknown) on an unknown date. Post vaccination the patient had an allergic reaction described as cellulitis reaction. Outcome of the event was unknown. Seriousness and causality of the event was not reported. Seriousness assessment of "cellulitis" was upgraded based on the NVS-IMS list.
Headache, muscle aches, muscle weakness, chills, nausea, arm where shot was given very sore and armpit of left arm was extremely tender and painful as though I had shingles in that area. 48 hours? treatment was over the counter ibuprofen and rest.
6" area of redness and swelling in Lt arm.  Had Tdap & flu vaccine in same arm.
PAINFUL INDURATION AT ADMINISTRATION SITE. PATIENT ALSO FEELS PRURITUS AND "THROBBING".  INDURATION MEASURES 45 MM X 49 MM
pt recv vax & devel a fever as high as 104 for 4 days;pt broke out w/a light rash on arms, trunk, face & back @ which time the fever broke;pt ear was a little red;6/29/98 pt taken to ER;MD felt sx r/t vax;pediatrician dx roseola virus & OM;
Swollen lump at injection site. Hot to touch. Redness at injection site. Headache. bodyaches.
This spontaneous report was received from a registered nurse and refers to unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L026602, expiration date: 19-OCT-2017 and lot# L040054, expiration date: 26-DEC-2017) (dose and route of administration were not provided). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion above 46 degrees Fahrenheit and less than 77 degrees Fahrenheit (the highest temperature: 46.81 degrees Fahrenheit) for 90 minutes. Data logger was involved. There were no previous excursions reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA010895: US-009507513-1702USA002226: US-009507513-1702USA002228.
Patient came in on 10/06/2014 stating she had a rash on both wrists/arms that she thought resembled shingles. She stated they appeared on the evening of 10/03/2014 after she had received her vaccinations. She had a diagnosed case of shingles 4 weeks previously. She did not have any signs of shingles when she was vaccinated. She had been taking Benadryl 25mg OTC to treat rash.  I did not see any reaction at the vaccination sight, and recommended she go to her family doctor to be checked out.
12-25-02 CHILLS AND TEMPERATURE 102. 12-26-02 GENERALIZED ITCHING, RED RAISED RASH- FIRST ON BACK, THEN CHEST, FACE AND NECK. FEW ON LOWER EXTREMITIES. FEW VESICLES NOTED ON BACK. LESIONS IMPROVING, DRIED AND FEELING BETTER 12-30-02. TEMP ONLY FOR 2 DAYS.
6 days following vaccination patient had a left sided stroke-numbness in face arm and hand. went to ER. and stroke was confirmed
Fever; Chills; Fatigue; Body aches; Nausea / Vomiting; Nausea / Vomiting; Head ache; This is a spontaneous report received from a contactable consumer (patient) via a regulatory authority. An 18-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: ER8733) via an unspecified route of administration in the right arm on 30Mar2021 at 12:00 (at the age of 18-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 medical history was not reported. There were no concomitant medications.  The patient experienced head ache on 31Mar2021 with outcome of recovered in Apr2021.  On 01Apr2021,at 23:00 the patient also experienced fever, chills, fatigue, body aches, nausea / vomiting. The patient underwent lab tests and procedures which included body temperature: from 101 to 102.3  on 01Apr2021.  Details were as follows: On 31Mar2021, the patient experienced headache for 24 hours,  On 01Apr2021 at 23:00, noted fever (ranging from 101 to highest 102.3), chills, fatigue, body aches and nausea/vomiting. The patient did not receive any treatment for the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of headache was recovered on 01Apr2021 (for a duration of 24 hours), The clinical outcome of fever, chills, fatigue, body aches and nausea/vomiting was recovered in Apr2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a 67 year old female patient with diabetes refers to herself. There were no drug reactions/allergies. On 11-FEB-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, dose, route not reported). Concomitant therapies included glyburide. On the morning of 13-FEB-2014, the patient began to experience itching at the injection site and a lump at injection site. There was no treatment given for the events. No lab diagnostics studies performed. The patient did not seek medical attention. The outcome of the events was reported as not recovered. Additional information is not expected.
patient reported vomiting starting at 5pm on day of vaccine. at time of report to triage phone nurse on 7/27/23 at 12:50pm, patient had vomited 4 times. he felt dizzy, disoriented, and had an elevated blood pressure. the phone nurse advised his daughter to give him a benadryl and go to the er. phone nurse then called to report to us.
Patient reported a pressure on his throat as if his throat was swelling.  Patient was still able to talk and swallow so we observed him for a few minutes and asked if it was getting more difficult. His response was yes. At this time I gave the patient two 25 mg Benadryl tablets and called 911. EMS came and picked him up. Patient returned later that day and reported that the ER doctor thought he did have an allergic reaction.
A few hours later got bad headache, nausea, dizzy lasted for several hours, resolved by next day.
Pt brought to ED w/concerns for allergic rxn immediately following COVID-19 vaccine at PCP office (5/19) where w/in 15 mins, experienced significant lightheadedness, dizziness & throat swelling & itch w/wheezing.  In ED, developed brief episodes of syncope and was administered EpiPen, IV fluids, solu-medrol and famotidine w/improvement.  After multi doses of epi IM for recurrent symptoms throughout observation, was started on epi drip.  Ultimately discharged, however, returned same night with recurrent anaphylactic rxn and was again started on an epinephrine drip and claritin. Of note, pt had previously had COVID on 1/22/2021. Pt discharged w/plans to f/u w/ allergy and immunology at Hospital.
Sleepy; Taste was off; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and AGEUSIA (Taste was off) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy) and AGEUSIA (Taste was off). At the time of the report, SOMNOLENCE (Sleepy) and AGEUSIA (Taste was off) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-211538 (Patient Link).
SHARP PAIN IN HER STOMACH; NAUSEA; SHE WAS THROWING UP; This spontaneous case report (PVX2019-2703) was received from a consumer on 30-Oct-2019. Additional information was received on 01-Nov-2019. It described 25-year-old adult female consumer who had sharp pain in her stomach (PT: Abdominal pain upper), nausea (PT: Nausea) and she was throwing up (PT: Vomiting), while being on Vivotif (lot number: 3003279) for travel.  Case report: The consumer took three doses of Vivotif at midnight on 25-Oct-2019, 27-Oct-2019 and 29-Oct-2019. After her third dose, when she woke up on 29-Oct-2019, she threw up so much that she went to the emergency room (ER). In ER, she received nausea medicines and liquids and was told that it was because of Vivotif. On 30-Oct-2019, she was much better, and she had sharp pain in her stomach, but it was nothing compared to yesterday. On 01-Nov-2019, she reported that she did not take the last dose of Vivotif. She had nausea as well. It was reported that the ER thought it was because of Vivotif  The consumer had no medical history.  Concomitant medication included Yaz (Drospirenone/ Ethinyl estradiol) for birth control, which was received on 01-Nov-2019.  Action taken with Vivotif with respect to the reported events was vaccine discontinued.  The clinical outcome of the reported events sharp pain in her stomach and she was throwing up was resolving, while the clinical outcome of the event nausea was unknown.  Company's Comment: In this case, it was reported that the consumer had sharp pain in her stomach, nausea and she was throwing up after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that the consumer had sharp pain in her stomach, nausea and she was throwing up after intake of vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Hence, the causality of the events with Vivotif is assessed as possible.
Pt experienced fine rash with itching at injection sites and on neck. Pt was treated with Tylenol.
Per ER record, admitted 04/18/2003 with c/o HA, nausea. Dx with fever, altered menstration and neck pains. Temp 102.5
Patient received vaccine in the pharmacy at about 2:15PM on 11/6/2017. She says the shot itself felt like it may have "hit a nerve", but was otherwise uneventful and she left the pharmacy without pain.  By 8pm 11/5/2017, she says her left arm hurt so badly she could not lift it away from her body. She called this am (11/6/2017) to report that her arm was still so painful, she could not lift it away from her body. She denies tenderness, but still says it hurts badly enough to cause naseau. She also says she nearly fainted while showering due to the pain. I advised her to call her Dr right away and be seen as soon as possible. I also called her Dr's office to let them know, I had spoken with her and asked them to call her and determine whether and when she should seen by physician.
No additional AE reported.; Caller reports that a dose of PROQUAD that experienced a temperautre excursion was administered to the patient after the excursion occured.; This spontaneous report has been received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drugs reactions or allergies, and concomitant medications were not reported.  On 22-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 0.5 ml (lot number U039262, expiration date 09-JUN-2023), administered for prophylaxis (strength, and route of administration were not provided) after it was exposure to a temperature excursion (product storage error). The temperature excursion was of 7.7 Fahrenheit degrees for 30 minutes. It was reported that there was a previous temperature exclusion. No additional adverse event was reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2206USA007845: US-009507513-2206USA007693: US-009507513-2206USA007706: US-009507513-2206USA007527: US-009507513-2206USA007894: US-009507513-2206USA007547: US-009507513-2206USA007855: US-009507513-2206USA007710: US-009507513-2206USA007675: US-009507513-2206USA007717: US-009507513-2206USA007839:
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose VARIVAX injection, lot # L044524, expiration date 09-NOV-2017 (dose and route were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 9.9 degrees Fahrenheit for 163 hours and 30 minutes. There was no previous temperature excursion reported. No adverse effect was reported. No product quality complain (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Pt stated she started having some swelling in the afternoon after getting the shot. She didn't think much of it until the next day when the swelling got worse, warm to the touch, and had some pain. She was putting ice on it but didn't help much either. When she called on Monday, 3/14/22, it hasn't gotten worse, but the swelling is from below the injection site to the elbow. I consulted her to take benadryl, apply cream if she has, and continue icing it. She will continue to monitor and call back if it worsens. As of now, the reaction was just locally on the arm where she got the injection.
can not move; itchy arm; right testicle was swollen; painful testicle; red testicle; This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR SWELLING (right testicle was swollen), TESTIS DISCOMFORT (painful testicle), ERYTHEMA (red testicle), GAIT INABILITY (can not move) and PRURITUS (itchy arm) 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 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced TESTICULAR SWELLING (right testicle was swollen), TESTIS DISCOMFORT (painful testicle) and ERYTHEMA (red testicle). On an unknown date, the patient experienced GAIT INABILITY (can not move) and PRURITUS (itchy arm). At the time of the report, TESTICULAR SWELLING (right testicle was swollen), TESTIS DISCOMFORT (painful testicle), ERYTHEMA (red testicle), GAIT INABILITY (can not move) and PRURITUS (itchy arm) outcome was unknown. Not Provided