chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse outcomes or side effects were reported or observed by the patients who received the administered doses; HCP (nurse) called to report TE for VARIVAX (lot: W031813 expiration: 10/05/2024) that occurred on 05/11/2023; This spontaneous report has been received from a licensed practical nurse referring to a 4-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 11-MAY-2023, varicella virus vaccine live (oka/merck) (VARIVAX) (lot# W031813, expiration date 05-OCT-2024) experienced temperature excursions (TE). On 12-MAY-2023, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (0.5 milliliter, lot# W031813, expiration date 05-OCT-2024, strength, route and anatomical location were unknown) for prophylaxis. The product was stored at 10.8 degree Fahrenheit (F) for 8 hours, 23 minutes, and 0 seconds with a supported TE stability evaluation (product storage error). There were not any previous excursions. No adverse outcomes or side effects were reported or observed by the patient who received the administered dose (no adverse event). No additional AE information was able to be provided. The reporter was not made aware of the TE until 26-JUN-2023 (also reported as today).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA012560: US-009507513-2306USA012315: US-009507513-2306USA012318: US-009507513-2306USA012351: US-009507513-2306USA012355: US-009507513-2306USA012362: US-009507513-2306USA012732: US-009507513-2306USA012753:
Information has been received from a nurse via company representative referring to an unspecified patient. No medical history or concurrent condition was reported. On 16-SEP-2016 the patient was vaccinated with a dose of improperly stored VARIVAX (lot # M017290, expiration date 07-Apr-2018, dose unspecified, subcutaneous). No concomitant medications were included. No adverse effects were reported. Additional information has been requested.
severe headache, strong abdominal pain, started on right side, moved to left and then was all the way across, nausea but did not vomit, weak from pain.
Right nostral swelled shut around 12:00 pm November 14, 44 hours after flu mist administered.  Area around nose extremely tender.  Runny nose.  Taking Benadryl 50 mg every 8 hours with no improvement.
very slightly swollen and tender armpit; slightly sore arm at injection site (left arm); very mild tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Sep2022 as dose number unknown (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 11Sep2022 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary immunization series complete unknown, Manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary immunization series complete unknown, Manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2022, outcome "unknown", described as "slightly sore arm at injection site (left arm)"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "very mild tiredness"; LYMPHADENOPATHY (non-serious) with onset 2022, outcome "unknown", described as "very slightly swollen and tender armpit".
pruritus, edema, & erythema in hands & knees beginning night of vaccine and continuing throughout the next day-did not reside with Claritin or Benadryl MD visit needed
sore throat, cough, muscular aches & pains, fatigue, headache, slight fever
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 15Apr2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "tingling sensation on her arm". There were no any unaddressed medical questions referred or forwarded to Medical Information. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. Since 12-AUG-2014, improperly stored RECOMBIVAX HB was administered to an unknown number of patients (dose, dose number, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. The outcome of the event was unknown. Follow up information has been received from the office manager regarding the patients. The office manager was able to share the lot # K008986 (expiration date: unknown) for RECOMBIVAX HB that experienced a temperature excursion. The office manager had no patients information or dates of vaccination available to share at this time. This is one of several reports from the same reporter. Additional information has been requested.
PATIENT DESCRIBED THAT SHE HAD CRAMP IN HER ARM. SHE HAD MUSCLE PAIN. SHE CANNOT MOVE HER ARM SO EASILY. SHE ALSO FEELING LESS STRENGTH ON HER SAME ARM. DR RECOMMEND FOR XRAY AND REFERRED TO PHYSICAL THERAPIST. SHE IS GETTING PHYSICAL THERAPY SESSIONS SINCE 10/09/17 TILL NOW. SHE HAS SOME SESSIONS SET UP THIS MONTH AND WILL FIND OUT LATER AFTER DONE THIS PHYSICAL THERAPY SESSION. SHE IS SEEING SOME IMPROVEMENT AFTER PHYSICAL THERAPY SESSIONS.
severe muscle pain/required heating pad then ice pack for about 30 hours after the injection...was unable to lift my arm
This spontaneous report was received from a Certified Medical Assistant concerning multiple unspecified patients (demographics unknown). On an unknown date the multiple patients were vaccinated with M-M-R II (lot #, dose and route were not provided). The M-M-R II was administered post supported excursion. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient with redness around and beneath injection site (about 4cm below). Developed 9x16cm area of redness and warmth biceps to triceps.
Migraines; general body achiness; exhaustion 12 hours after receiving the shot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in left arm on 18Feb2021 13:45 (at the age of 27-year-old) as dose 2, single for COVID-19 immunization at clinic. Medical history was reported as none. Patient had no known allergies. Concomitant medications included Escitalopram via an unspecified route of administration from an unknown date and unknown if ongoing for an unspecified indication. The patient had not received any other vaccine within 4 weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in right arm on 28Jan2021 13:45 (at the age of 27-Year-old) as dose 1, single for COVID-19 immunization at clinic. It was reported that on 19Feb2021 01:00, the patient experienced migraines, general body achiness, and exhaustion 12 hours after receiving the shot. Patient did not receive any treatment for the events. The outcome of all events was resolving.  No follow up attempts are possible. No further information is expected.
2" raised "welt", slight pain, no itch 2 days post injection, reddish in color, the 1 days later irregular rash 1-2 inches away from original, no pain, no itch, pt on 7-10-13 says both rashes are lessening.
The patient was scheduled for a second vaccine.  It was discovered after the administration of the Pfizer vaccine that the patient had initially received Johnson and Johnson as the first dose.
Initial unsolicited report received from a consumer via other company (Pfizer) (Manufacturer report number: 2016554605) on 09 Dec 2016. This case involves a 66-year-old male patient who was vaccinated with a dose of FLU SHOT (batch number, expiry date, dose, dose in series, route and site of administration were not reported) and also received RAPAMUNE on an unknown date. The patient's medical history and concomitant medications were not reported. On 26 Nov 2016, 03 months following the Flu shot vaccination, the patient had flu (diagnosed on the same day). The patient was hospitalized on 27 Nov 2016 morning. The patient's laboratory data and corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none. Sender's Comments: A 66 year old male patient had Flu, three months after receiving a dose of INFLUENZA VACCINE. It was reported that the patient under treatment with RAPAMUNE, an immunosuppressant. However additional information regarding medical history, infectious work-up results, patient's immune status at the time of vaccination, exact chronology of the events as well as confirmatory investigation results (details of specific influenza A strain identified in PCR) are needed to further assess this case.
patient received menactra injection at age11 and12 years, no AE; Initial information received on 08-Jun-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves a child patient (unknown gender) who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] at age of 11 and12 year (lot number, expiry date, route and site of administration were not reported) for prophylactic vaccination on an unknown date.  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.  It was a case of actual medication error due to extra dose administered. A patient received Menactra injection at age 11 and12 years.  At the time of reporting, no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information on the batch number for this case.
SPLEEN ENLARGED FURTHER; This spontaneous report received from a consumer concerned a 19 year old male. The patient's weight was not reported and height was 71 inches. The patient's past medical history included: covid infection, mononucleosis infection, and hospitalization, and concurrent conditions included: life threatening allergy to sea food, and spleen enlarged. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, Laboratory data included: Blood test (NR: not provided) fine, and Ultrasound spleen (NR: not provided) The spleen had enlarged further, more than was previously measured. On an unspecified date, the patient experienced spleen enlarged further. Laboratory data (dates unspecified) included: Ultrasound spleen (NR: not provided) The spleen was enlarged, but stable remaining the same size. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spleen enlarged further was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates since May 2015, the patients were administered improperly stored dose of RECOMBIVAX HB (lot # K010238, exp. 14-APR-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a pharmacist concerning a female with no known drug reactions who on 30-MAY-2007 was vaccinated with Zostavax (Oka/Merck).  On 01-JUN-2007 the patient experienced soreness, erythema, swelling, pruritus and warmth around the site of injection.  The area measured 2 cm by 2.5 cm.  Unspecified medical attention was sought.  The patient did not have a temperature and her vitals were normal. No labs were performed.  As of 01-JUN-2007 the patient was not recovered.  Additional information has been requested.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a elderly patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The patient got the shingles shot and 3 months later got shingles. The patient had them (shingles) twice now. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Bell's Palsy - tx pred 60mg x 7 days, then taper x 5 days. Still in tx with prednisone. Facial droop, decreased sensation (R) face facial numbness tingling, (R) eye tearing.
Patient got red blotches on his face. The patient was given 3ml of BENADRYL, he stayed happy and playful. The patient drank a bottle of formula and the redness resolved in 30-40 minutes. 10/26/15 stayed with mom and patient 45 min till symptoms resolved. Verified w/ mom on 10/27/15.
Patient described that she became nauseous and light-headed a few minutes after receiving  vaccine. Within 2 hours she was itching and skin turning red in different places. The next day (Saturday)  patient was tired/ lethargic, aching all over, and headache. She also had loss of appetite. On Sunday all symptoms were still present as well as diarrhea.  Then on Monday the itching and redness became worse into Tuesday as well. Patient's employer had her leave work to report to a doctor. She was given solu-medrol shot and a prescription for prednisone 10mg for five days. Doctor has her retuning on Monday, November 18,2019 for follow-up and release from incident.
myalgias, fever to 101, and fatigue approx 6 hours after administration. Abdominal pain throughout the night. The next day around 3pm the patient developed severe, diffuse crippling abdominal pain, 10/10, while walking in the park. EMS was alerted by her husband because she was unable to get up or move from the spot due to pain. He gave her Pecid AC and by the time EMS arrived she was doing much better.
This spontaneous report was received from Registered Nurse regarding to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 20-JUN-2016, the patient was vaccinated with improperly stored VARIVAX (lot # L004649, expiry date 11-FEB-2017) (therapy type digital data logger) dosage regimen unknown. It was reported that the vaccine was exposed to a temperature excursion of 23 degree Celsius for a time frame of 1 hour and 29 minutes and the temperature was back in range. It was reported that the vaccine was not subjected to previous temperature excursion. Product quality complaint (PQC) was not filed. This is one of the several reported received from the same reporter. Additional information has been requested.
Patient noted that when she woke up her arm was sore at site of injection and as the day went on it was getting more red around the injection site.  She did not seek treatment until 8-19-10 when the pain got unbearable.  She tried no home treatments.  Patient was treated with Tylenlol, Benadryl and an icepack in the clinic and felt better.
Patient described pain after 1st vaccine, and stated numbness and tingling and still complains of tingling sensation in affected arm. The 2 doses were given on left arm,
Spastic weakness of both legs. HR-140, exertional dyspnea-started 2 weeks after 1st Moderna vaccine dose.
This spontaneous report has been received from a registered nurse (R.N.) reporting on an 18-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. It was reported that on an unknown date, a medical assistant administered to the patient a properly stored dose of PROQUAD (dose, and route of administration were not reported) (lot # M022402 with an expiration date on 01-NOV-2017) for prophylaxis (Drug administered to patient of inappropriate age). The patient did not present any adverse effects. There was no additional information or product quality complaints (PQC) reported.  Additional information is not expected as there was no consent to contact.
Initial fever, body aches, severe left arm pain, headache and blocked ears.           Blocked ears (full feeling) has never gone away
I had congestive in glands and ears. I had hoarseness and running nose. I tested at home on Jan 18th, negative. Two days later, I had a dry cough. On Jan 20th, I took another test and I was tested positive for Covid-19. I had lose of appetite and food did not taste good for a couple of weeks.
Right side of body went numb during the night.  After waking up on the 19th of January extremities were numb the whole day and it felt like cold blood running through my veins and as though I was radiating cold.  Over the next few days feeling came back in my arms and legs yet not in hands and toes.  For the next 3 weeks or so though the numbness continued during the night in my arms even though I would get relief during the day.  To this day I have not regained full feeling in my hands and toes.  So to clarify, I have experienced numbness in my hands and toes/feet since January 18, 2010.
Patient states he was  not able to get his sleeve up far enough but the person that gave the injection went ahead and gave the injection in the bottom part of his arm.  The patient began having pain and burning in his arm and it went into his back and neck area.  The pain and burning continued until the patient sought medical care at an ER and was referred to Neurology Clinic.
Severe soreness in left arm at injection site.  Over all weakness, shivers/chills, muscle aches and pain, headache overnight was the worse  diminished as  time went on the  next day.  I had a similar reaction on  August 25, 2020 when  I took the first dose but I had the  FLUZONE HD INJ PF 20-21 in the right arm on the same day so I wasn't sure which caused the reaction,
Information has been received from a physician concerning a 21 year old female who was vaccinated on 25-APR-2007 at 12:00 pm with a first dose of GARDASIL vaccine (lot # "03840") in the left arm. Subsequently, the patient reported feeling lightheaded and saw spots.  This is one of two reports received  from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 5/14/2007. On 25-APR-2007, at 12:00 pm, the patient reported feeling lightheaded, dizzy, and saw a few spost for about 2 minutes. The patient also experienced arm soreness for 24 hours. Subsequently, the patient recovered from feeling lightheaded, dizzy, saw a few spots, and arm soreness. This is one of two reports received from the same source. Additional information is not expected.
only pulled the green powder vial and mixed it with sterile water that comes with Varivax, did not mix it with the blue diluent that comes packaged in Pentacel with no reported adverse event; Initial information received on 10-Sep-2021 regarding an unsolicited valid non-serious case from a other healthcare professional and non-healthcare professional via Media information (under the reference 00763662).  This case involves a patient of (unknown demographics) who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] which pulled only the green powder vial and mixed it with sterile water that comes with varivax, did not mix it with the blue diluent (product preparation error).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 09-Sep-2021, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to wrong solution used in drug reconstitution (same day).  It was reported "Nurse practitioner asks what are the safety guidelines and how do I give the patient the blue liquid component?".  At time of reporting, it was unknown whether the patient had any adverse event or not and the outcome was unknown for the reported event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.  There will be no information available on the batch number for this case.
tested positive for COVID  after feeling unwell for a month, with nausea and decreased appetite. hx of chronic diarrhea and has abnormal labs for glucose and kidney function. Likely asymptomatic, incidental finding
Sore arm low grade fever chills body aches fatigue headache lymph node tenderness on the right side arm pit