chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age. The patients were vaccinated with PNEUMOVAX 23 (dose and route were unknown, lot # reported as H013581, expiration date 03-MAR-2014). The reporter requested a lot # check. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced redness around injection site, rash around injection site and fever. The patients sought medical attention by an office visit. No treatment information was reported. The reporter did not have detailed individual patient information but she said 6 patients experienced redness and rash around injection site and a couple of patients experienced fever as well (patients without fever were captured in MARRS Case # 1210USA013157, same reporter link) and one patient experienced "red streak" around injection site (MARRS Case # 1211USA001593, same reporter link). the outcome of rash around injection site, redness around injection site and fever is unknown. The relatedness for redness around injection site, rash around injection site, and fever was not reported for PNEUMOVAX 23. Additional information has been requested.
This spontaneous report as received from a patient's wife refers to a 46-year-old male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date in September 2015, the 46-year-old patient was vaccinated with ZOSTAVAX (dose, lot#, expiration date and route of administration were not reported (reported as "shingles"). There were no adverse effect reported. Additional information is not expected as no contact details were provided.
pt states exp throat tightening 20min p/vax;sx lasted 5-7min, per pt & then resolved;pt was @ home, no tx x/advised to take DPH;pt called clinic p/sx had resolved;
pt recv vax;6-7 wk later lab eval revealed 11 neg titers;
Patient received an expired dose of VARIVAX; No known adverse effects.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent.  On 27-FEB-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R002056, expiration date 22-JAN-2020) as prophylaxis (strength, dose number, frequency, route of administration, and anatomical vaccination site were not provided). No known adverse events were reported.
groggy, almost comatose state for 36 hrs beginning evening of 3/9/21 until 3/11/21...Unable to walk...nauseau with some vomiting...slept mostly...no intake...then,  4 days of severe nausea, chills,  severe headache, no appetite. felt better for 2 days, then another day of several chills on  3/16/21 followed by 2 days of diarrhea. Severe fatigue for 2-3 weeks.
Started out as spots and then spread out to entire arm. Red, swollen - possible cellulitis. Pt went to hospital and treated with amoxicillin 875mg BID and steroid dose pack.
Very Itchy all over her body after booster; Rash all over body after booster; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very Itchy all over her body after booster) and RASH (Rash all over body after booster) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jan-2022, the patient experienced PRURITUS (Very Itchy all over her body after booster) and RASH (Rash all over body after booster). At the time of the report, PRURITUS (Very Itchy all over her body after booster) and RASH (Rash all over body after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2022-448167 (Patient Link).
temperature excursion of unknown cause/ the excursion lasted for 3 hours and the minimum temperature of the refrigerator reached 32.5 degrees fahrenheit with no reported adverse event; Ipol which was accessed was administered to a 7 year old child post excursion with no reported adverse event; Initial information received on 23-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 7 years old female patient and reported that temperature excursion of unknown cause/ the excursion lasted for 3 hours and the minimum temperature of the refrigerator reached 32.5 degrees Fahrenheit and Ipol which was accessed was administered to a 7 year old child post excursion with no reported adverse event , and it involved vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-Aug-2022, the patient received a  dose of 0.5 ml (first dose) of suspect IPV (VERO), with an unknown formulation, strength (lot: T1E87 ; expiry date: 10-Oct-2022) via intramuscular route in the left vastus lateralis for immunization.  On 31-Aug-2022 there was a temperature excursion of unknown cause/ the excursion lasted for 3 hours and the minimum temperature of the refrigerator reached 32.5 degrees Fahrenheit (product storage error) and Ipol which was accessed was administered to a 7 year old child post excursion with no reported adverse event (poor quality product administered) (latency: same day)  Action taken : not applicable.  Outcome: unknown for both the events   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Overall exhaustion; Low hemoglobin; Loss of red blood cells without any bleeding found; Extremely low energy. Being treated with iron sulfate, but not doing more than keep energy levels from dropping lower; Sleep interruptions; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 12:00 as DOSE 2 (Age at vaccination: 78 Years), SINGLE for covid-19 immunisation. Medical history included asthma, hip arthroplasty, arthritis, blood cholesterol increased (High cholesterol). Concomitant medications included ibuprofen (MOTRIN), simvastatin (SIMVASTATIN), vit d [vitamin d nos] (VIT D [VITAMIN D NOS]). The patient previously took clindamycin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced decreased appetite, weight decreased and fatigue. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced overall exhaustion, low hemoglobin, loss of red blood cells without any bleeding found, extremely low energy. being treated with iron sulfate, but not doing more than keep energy levels from dropping lower, sleep interruptions on 2021. The patient underwent lab tests and procedures which included haemoglobin: low hemoglobin on 2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was treatment for the events with iron sulfate, but not doing more than keep energy levels from dropping lower. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Gave patient the immunization. About 40 minutes later she came back to the pharmacy and said her chest felt tight and she was having difficulty taking a deep breath. Also bright red patchy swelling around injection site.
Patient returned to office with swelling to left arm where injection was administered. Patient advised to ice arm, admin ibuprofen or TYLENOL and to continue to monitor for other signs and symptoms and if trouble breathing call 911.
Mother stated that she took child to clinic on 8/26/01 for redness at the injection site and swelling. Child was placed on Keflex.
throat is swelled; hard for me to swallow; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she had the Pfizer vaccine for the COVID-19 on 29Dec2020. She reported that it was hard for her to swallow on an unspecified date. It was not when she was eating or drinking, just sitting down. She was having trouble swallowing on an unspecified date. It felt like something in her throat swelled. She was having trouble swallowing. She works as a lab assistant. As for the treatment, she said that she has a doctor appointment on Monday (unspecified date). She had been taking diphenhydramine hcl (BENADRYL) as treatment. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Pt vaccinated with DTP and developed fever of 105.3 had local reactions - lt thigh.
COVID-19; COVID-19; This is a solicited report based on information received by Pfizer (Control No: 21K-163-4090627-00). A contactable consumer (patient) reported that a 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly in May2021 (Batch/Lot number was not reported) at age of 36 years old as a single dose, 2nd dose intramuscularly in Jun2021 (Batch/Lot number was not reported) at age of 36 years old as a single dose for covid-19 immunisation. HUMIRA, subcutaneously from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced COVID-19 in Sep2021 with outcome resolving. The action taken in response to the event for HUMIRA was unknown.  Solicited report by a consumer of a 36 years old female with an event of non-serious COVID-19 with HUMIRA. There was no reported medical history. In Sep2021, the patient experienced COVID-19. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On May2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. On Jun2021, patient received second dose COVID-19 vaccine manufactured by Pfizer. The reporter's causality for the event of COVID-19 with HUMIRA was no reasonable possibility. Causality as per reporter for the event COVID-19 with BNT162B2 was possible.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up. The efficacy of a drug varies from patient to patient and can be affected by different factors, however, a contributory role of the suspect product BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Approximately 3 hours post vax, the pt was diagnosed with urticaria involving scalp, neck, chest, back and both arms. Pt was treated with Atarax, hydrocortisone cream and aveeno baths. 3 days post onset, pt recovering well. Pt reports similar event after 1st dose of Anthrax, but less severe.
I received my vaccine  in the early afternoon and later in the afternoon/early evening  it was still hurting and my arm up to my shoulder was swollen and all red and blotchy around my whole arm (upper arm only).  The pain has never gone away, I did physical therapy and prednisone pack per my doctor. It is almost 6 months later and the pain is as bad as the day I received the injection.
This case is a cluster of unidentified patients who experienced similar adverse events following vaccination with FLUZONE. Initial report received from a health care professional on 11 October 2010. A group of unidentified patients received (dates not reported) an injection (route and site not provided) of FLUZONE, lot number UH214AC. The patient(s) had residual black marks on skin. The needle was wiped and residue was found. The outcome was not reported. No other information was available. Documents held by sender: None.
New onset of right sided headache. Pain initially described as sharp, and throbbing starting on top of right side of head and radiating down. Intensity increases as it moves down and peaks at 3-4 hrs before it starts to ease. Pain starts late afternoons and worse in the evening. It is not associated with position changes.  Pain initially rated a 10/10. Had little relief with acetaminophen or ibuprofen, and heat or cold packs. He denies n/v, vision changes, light sensitivity, rashes, neck stiffness, or neuro deficits. He does not report tenderness but stated he can sometime feel a pulsation if he presses near his ear. Does have a hx of sinus headaches but never had a headache like this before.  He is unable to identify any triggers. He did see his PCM and was told it may be a migraine and was prescribed Sumatriptan 50 mg. He was reluctant to take at first but has taken two with improvemen
This spontaneous report as received from the patient's husband refers to his wife who was a 67 years old female patient. The patient was subcutaneously vaccinated with a dose of 0.65 ml ZOSTAVAX (Lot# unspecified) on 05-SEP-2012, "two weeks ago". The reporter explained that his wife developed a red rash at the injection site after receiving ZOSTAVAX on 05-SEP-2012, "two weeks ago". The patient did not sought medical attention. No lab diagnostics studies performed and no treatment was given for the adverse event. The outcome was reported as recovering/resolving. Additional information is not expected.
Hives, urticaria - migratory. Lasting 24 hours per day for over 1 week - and continuing.
Pink-red spots on legs and buttocks, painful to touch but not itchy.  Some pain while walking.  Went to ER - suspect Henoch-Schonlein Purpura (HSP).  Next day, (11/08/2014) spots looked better (had turned purple color) and in the PM, new sudden pain in ankles and feet that made walking painful, along with new pink-red spots on feet.  Gave ibuprofen.  Seemed to get better over a couple of hours.  Still keeping an eye on her.  Of note - she had a cough during the week before the spots, and continues to have cough on occasion.  Otherwise healthy (no fever, eating fine, active, urination and bowel movements ok).
Day after vaccine - nausea, fever, chills, body aches, headaches, intense pain in arm where shot was given. Illness lasted 3 days. arm still swollen, red and painful at 1 week out.
Vaccination left upper arm - end of day red and tender, end of Day 2 arm red almost to elbows, red rash over upper body. Day 3: Red splotches and rash spread to neck and groin, behind knees. Day 4: Physician prescribed: Prednisone tablets 5mg 6 day treatment with 6 tabs 1st day, Fexofenadine 60mg tabs one a day, Fluocinonide cream 0.05% for itching inflamed skin Benadryl 25mg caps - 1 to 2 at night.
weak; a little fever; nausea; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak), PYREXIA (a little fever), NAUSEA (nausea) and VOMITING (vomiting) 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 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weak), PYREXIA (a little fever), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, ASTHENIA (weak), PYREXIA (a little fever), NAUSEA (nausea) and VOMITING (vomiting) outcome was unknown.            Patient wants to know ,if the symptoms are contagious. If I have a fever, can I give it to my month-year-old?  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.
My mom works for the Health Department in outpatient clinics. They have been administering the Pfizer vaccine at their clinics and local long term care facilities. The first day my mom was vaccinating, her boss told her to dilute vials with 1.9mL of diluent to get 6-7 vaccines from one vial (they vaccinated >250 people that day). The next day my mom was given a sheet with the correct instructions from Pfizer that say to dilute with 1.8mL to obtain 5 doses/vial. She told her boss that she would only do what the sheet says and dilute correctly but her boss was telling all the nurses to dilute with 1.9mL and get 6-7 doses/vial. My mom talked to me and I told her to report it. She let her boss's boss know and I guess the big boss decided what the boss was doing was an ok practice. Apparently they called around to other nearby places and they were all saying that even when they added 1.8mL they would frequently get 6 doses out of a vial. These are the places.
on 2/28/2020 a patient was administered a dose of GARDASIL 9  while 13 weeks and 3 days pregnant; experienced no symptoms; This spontaneous prospective pregnancy report as received from a healthcare business professional referring to a female patient of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.     On 28-FEB-2020 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637642, expiration date 28-MAY-2022; dose and route were not reported) for prophylaxis while she was 13 weeks and 3 days pregnant (exposure during pregnancy). The patient experienced no symptoms. Last menstrual period (LMP) was assumed as 26-NOV-2019, date of conception was assumed as 10-DEC-2019 and the estimated due date (EDD) was 01-SEP-2020. Pregnancy outcome was pending. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.   devicelotnumber: 1637642; expirationdate: 28-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
varicella, drug reaction, rash - information has been received from a health care proessional concerning a 4 year old male with no significant medical history and no immunosuppression who on approximately 08 May 2000 was exposed to chicken pox at his daycare.  On 15 May 2000 the patient present to his physician with a sore throat.  culture revealed strep throat.  The patient was prescribed amoxicillin for the sore throat and vaccinated with one dose of varicella virus vaccine live (lot 634477/0090K) due to his recent chicken pox exposure.  On 21 May 2000 the patient developed pustules, which have progressed to a rash over his entire body.  The patient was seen in the office on 24 May 2000 and diagnosed with chicken pox.  The patient was noted as covered head to toe with lesions, some of which are now vesicular.  In addition to the chicken pox rash, the patient developed another rash which was diagnosed as a drug reaction to the amoxicillin.  the patient had a low grade fever with a maximum temperature of 102 degrees F and complained of itching as well.  The patients mother treated him with colloidal oatmeal (aveno) baths and he was prescribed hydroxyzine for the itching as well.  A specimen was obtained and noted to be positie for wild type vzv.  It was noted that the patient recovered.  No further information is available.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on patients' medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with improperly stored of VAQTA injection, lot # K009506, expiration date 22-SEP-2016 (dose and route of administration were not reported). No information on patients' concomitant medications was provided. No adverse effects were reported. This is one of the two reports from the same reporter. Addtional information has been requested.
pt recv vax & devel an inj site rxn characterized by redness & warmth;the reporter believed the inj may have been given ID;
Pt scheduled for 30min observation due to PCN allergy. After 20 mins post-vaccination pt c/o "tightening of throat". Pt had NO difficulty breathing. Serial VS begun. O2 saturation was 97% with room air.  Initial B/P = 162/112 P90 R20. EMS on site begun evaluation. Second B/P =158/99 P92 R 20. Pt states she feels :anxious". Pt defers transport via EMS. Pt discharged without complaints after 60 mins eval.
Immediately upon injection I felt a pain go up my neck. The neck pain subsided but my shoulder joint was very achy for several days. Instead of improving, the pain persisted and has developed to limiting my range of motion.
low gade fever for 2.days; itching on my eyelids; pain in lower back joint; This is a spontaneous report from contactable consumer (patient herself). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL9263, expiry date: unknown) via unspecified route of administration, in right arm on 31Jan2021 09:00 (age at vaccination: 56-years) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included high. bp, high cholesterol, high thyroid and mild depression from an unspecified date and unknown if ongoing. Past drug included known allergies from phenobarbital. Concomitant medications included Levothyroxine, cymbalta, gabapentin, valsartan, statin taken in two weeks, taken for unspecified indication, start and stop date not given. On an unspecified date, patient experienced low grade fever for 2.days, itching on my eyelids and pain in lower back joint. Treatment was given for the adverse events with Tylenol, Benadryl. The patient did not get covid before vaccination and was not tested for covid post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.