chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Caller reported AE on behalf of a patient who was administered improperly stored PROQUAD. No symptoms reported. Obtained consent to contact HCP. No additional AE/PQC. Product Name: PROQUAD-- SUPPORTED Lot: X014622 Exp: 11/1; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. Information about historical condition and concomitant medication was not reported.  On 18-SEP-2023, the patient was vaccinated with improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 ml, lot # X014622 with an expiration date of 18-NOV-2024, as prophylaxis (strength, dose, anatomical location, route of administration, were not reported) (Product storage error).   There wa as temperature excursion for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The temperature was -14 degrees Celsius up to -10 degree Celsius for 4 hours 15 minutes and -8.33 degree Celsius up to 8 degree Celsius for 7 hours 45 minutes. The time frame was 12 hours. There was no previous temperature excursion. No symptoms reported and no addtional adverse event nor product quality complaint.
105.2 fever with Tylenol, fever 102 and above for 36 hours while taking Tylenol, chills, fatigue, headache, severe muscle aches, swelling at injection site
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that a patient might have received two doses of PNEUMOVAX 23 (lot#, expiration date, dose, route and indication not reported) within 24 hours on an unknown date. She stated that she was unsure if the patient had ever received any previous doses of PNEUMOVAX 23 in the past. No adverse effects reported. Additional information has been requested.
Patient received the vaccine at 220pm via IM in her Left Deltoid. She stated that 10min later her top pallet in her mouth started to swell where she couldn't eat or drink anything.  She stated it was tingly. She took 4 Pepcid and stated it felt better.  on 1/8 at 1pm she reported a sore arm, cloudy vision, shakiness and a temp of 99.8.  She reported to her PCP and her PCP stated not to get the 2nd COVID-19 injection.
5cm inflammed/red area around injection site X 4 days (DTAP site). Fever X 2 days.
This literature marketed report was received from the authors of a published article, and refers to a child of unknown gender and age. No information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications was provided. On unknown dates, the patient was vaccinated with a full series of ROTATEQ, orally (dose, lot # and expiration date were not reported). On an unknown date in 2014-2015 season, the patient experienced apparent vaccine failure and was infected with rotavirus. The outcome of the event was not reported. The authors considered the event to be related to ROTATEQ. This is one of two reports derived from the same literature article (cross-referenced in US-009507513-1801USA005022).
Diagnosed (tested positive) with Covid19; Diagnosed (tested positive) with Covid19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Apr2021, after the first dose of vaccination, the patient was diagnosed (tested positive) with COVID-19. The outcome of the event was unknown. The patient was scheduled to receive the second dose of vaccination on 13Apr2021, and was told to put it off.  Information about lot/batch number has been requested.
Pounding/pressure headache started within a few hours.  It worsened as the day went on.  By evening, I was chilled and shivering with no relief from multiple blankets.  Fever was likely 103 that night, although I didn't take my temperature until the next morning after the chills subsided. Then, it was 102.5 -- the highest I've ever had aside from the flu over a decade ago.  I slept ALL day that day -- the day after the vaccine, with my temperature gradually lowering to only 99 by the 3rd morning.  During that time, my left arm was extremely sore, and my whole body was weak and achy (just like the flu).  I did not, (thank you, Jesus) have an gastro-intestinal distress.  According to the internet, only 1 in 6 patients have this reaction.  This was my 2nd dose and I had no reaction to the 1st one, 12 months prior. A friend of mine who is a doctor said that 9 out of 10 of her patients taking this vaccine DO have this reaction.  I do believe that the public should be made aware so they can plan ahead for this debilitating shot.  I would do it all over again to avoid shingles in the future, but it would be nice to be able to plan ahead.  Thank you!
fever of 104.5 & 2 febrile seizures 8 days from vaccine.Taken to ER and checked for several things - blood work - results normal, other infection - given antibiotic, IV fluids - released 4 hours later when temp. was down.   Dr. also diagnosed a possible ear infection - not sure which was the cause.
2 months after second Moderna vaccine into L deltoid, I developed constant dull ache 6/10 in same shoulder 2 days after a trivial injury. Pain affected very little by movement. Full ROM.  Pain much worse at night when supine.  tender lymph node behind L clavicle.  No improvement or worsening over next 6 days. disrupting sleep. No benefit from topical diclofenac. No other analgesia used. Neg x-ray. not behaving like injury induced pain. I began taking prednisone 40mg qd on 5/7/21 and improving.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with ROTATEQ lot # M038846, oral for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.  Additional information has been requested.; Sender's Comments: US-009507513-1707USA000155: US-009507513-1707USA000601: US-009507513-1707USA000599:
received both doses of the Pfizer Covid-19 vaccine in Apr2021 and tested positive for Covid-19 on 09Jul2021; received both doses of the Pfizer Covid-19 vaccine in Apr2021 and tested positive for Covid-19 on 09Jul2021; This is a spontaneous report from a contactable consumer.   A 78-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on Apr2021 as dose 1, single for COVID-19 immunization. The caller reported that the patient (husband) received both doses of the Pfizer COVID-19 vaccine on an unspecified date in Apr2021 and tested positive for Covid-19 on 09Jul2021. Caller was asking how the variant type of the COVID-19 was tested for after being vaccinated against Covid-19 and testing positive. Caller asked if her husband could have given COVID-19 to their grandkids who stayed with them that weekend. Caller asked if you would get less sick and be less contagious if you were vaccinated. Caller was asking if she should isolate from her husband who was COVID-19 positive. Caller asked if there was any proof that mild cases of COVID-19 were not transmissible or transmissible. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on 09Jul2021. Outcome of the events was reported as unknown.   Information on the lot/ batch number has been requested.
Patient was immunized on 3/16/21 shortly after being discharged from the hospital.  He was readmitted with abdominal pain and complaints of bilateral hand tingling.  Neurology was consulted and working diagnosis was Guillain-Barre Syndrome (GBS).  Patient was given a 5 dose series of IVIG 0.4g/kg.
Beginning the evening of the vaccination the patient has had left side body aches and pain, focused mainly in the left arm and hip, circling around to the buttocks.  The pain is not debilitating but constant and not subsiding. Patient has also noticed that she is still able to see the vaccination site - described as not red or swollen, just a red pin prick mark.
Swelling in the lower legs and feet; This is a spontaneous report from a contactable consumer (Patient). A 82-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration in left arm on 22Feb2021 at 10:00 AM as single dose for COVID-19 immunization. Patient had historical vaccine (at 82-year-old) BNT162B2, first dose in left arm on 01Feb2021 11:00 AM for COVID-19 immunization. There was no other vaccine in four weeks. Patient medical history included glaucoma, high blood pressure, pacemaker and known allergies from Sulfa. The patient took concomitant medications (Other medications in two weeks). On 01Mar2021 at 08:00 AM, the patient experienced swelling in the lower legs and feet. There was no COVID prior vaccination and not tested for COVID post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Prescription: "Inject 0.65 mLs into the skin ONCE for 1 dose." Pharmacist: Injected me TWICE, perhaps with the SAME needle. I did have a small cluster raised bumpy rash last night; but it has subsided this morning.
After given Covid19 vaccine Pfizer 2nd dose to patient on 6/8/21, patient feels dizziness, headache and start to faint. We called 911 and paramedic came very quickly.  Patient was conscious and we continue monitored patient for about 30 more minutes and she was ok at the store.  Advice her dad to continue monitor patient when at home and report if any side effects.  We called patient to follow up in the evening and patient is doing fine.
Continuous pain in left arm since the first vaccine (1/7/21) and on right arm since the second vaccine (2/4/21)
This spontaneous case reported by a consumer, describes the occurrence of administered expired product (administered an expired dose of the vaccine) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 085D21A) for COVID-19 immunization. No medical history reported. On Dec 15, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Dec 15, 2021, patient administered expired product (administered an expired dose of the vaccine). On Dec 15, 2021, administered expired product (administered an expired dose of the vaccine) resolved. No concomitant medication or treatment information provided. Patient did not have any adverse events.
This spontaneous report was received from a nurse practitioner and refers to 2 patients of unknown age and gender. On 10-JAN-2017, the patients were vaccinated with expired doses of M-M-R II (lot # L000458, expiration date: 06-JAN-2017). There were no temperature excursions. No adverse symptoms were reported. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of leg pain in a 61 year-old male subject who was vaccinated with ENGERIX B, GlaxoSmithKline. Concurrent vaccination included seasonal Influenza vaccine (non-gsk) (Flu-shot; Sanofi Pasteur MSD; unknown) given on 3 November 2009. On 3 November 2009 at 09:30 the subject received 2nd dose of ENGERIX B (1ml unknown, left arm). The vaccine was administered at a laboratory. On 4 November 2009 in the morning, 1 day after vaccination with ENGERIX B, the subject experienced leg pain, pain specially in leg (legs), knee pain (primarily in left leg) and walking difficulty. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the leg pain, bone pain specially in leg (legs), knee pain (primarily in the left leg) and walking difficulty were worse. The healthcare professional considered the leg pain, bone pain specially in leg (legs), knee pain (primarily in left leg) and walking difficulty were possibly related to vaccination with ENGERIX B. This is one of four cases reported by the healthcare provider; see cases A0815453A, A0815870A, A0815879A for subjects who experienced adverse events following vaccination with ENGERIX B. GSK case number A0815885A is a duplicate of A1815433A. All future correspondence will be submitted to A1815433A. Follow up was received on 06 November 2009 via the reporting healthcare professional. The healthcare professional wanted to file a quality assurance (QA) report. The healthcare professional reported that she received 20 ENGERIX B vials in October 2009. She distributed six vials and four subjects developed severe reactions to the vaccinations. The healthcare professional felt that the vaccines had quality issue and she would not use the rest of the vials from lot/shipment. She would would like to return the vials to evaluate and investigate for quality issue.
Pt reports that she developed a rash 1-2hrs post vaccination.  PMH, Medications, allergies unknown to this writer
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On 08-AUG-2016, the patient was vaccinated with a dose of improperly stored ROTATEQ (lot # M019708, expiration date 25-OCT-2017, strength and route were not reported). The vaccine had been stored under the temperature of 47.2 Fahrenheit degree for 10 minutes. There was no previous temperature excursions. Digital data logger involved. No symptoms were reported. Additional information has been requested.
This spontaneous report was received from a Registered Nurse refers to a 15 month old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not provided. On 29-MAR-2018, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB, lot # N012921 (expiry date: 28-FEB-2020) and M-M-R II, (therapy type: rHA), lot #N010495, (expiry date: 31-MAR-2019) for prophylaxis (incorrect product storage). The vaccines were concomitantly reconstituted with properly stored sterile diluent (MERCK). The LIQUID PEDVAXHIB underwent a temperature excursion of 34.70 F for 0.25 hours and the M-M-R II underwent a temperature excursion of 35.00 F for 0.25 hours. No adverse effects were reported. The call was because of a data logger. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA000815: US-009507513-1809USA002916: US-009507513-1809USA002917: US-009507513-1809USA002919: US-009507513-1809USA002920: US-009507513-1809USA002921: US-009507513-1809USA002922: US-009507513-1809USA002923: US-009507513-1804USA000815.
feels much better; positive for COVID; fever 101.1; headache; chest congestion; Running nose; Coughing; slight pain at arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), VACCINATION SITE PAIN (slight pain at arm at injection site), PYREXIA (fever 101.1), HEADACHE (headache) and CHEST DISCOMFORT (chest congestion) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PAIN (slight pain at arm at injection site). On 04-Apr-2021, the patient experienced COUGH (Coughing). On 05-Apr-2021, the patient experienced PYREXIA (fever 101.1), HEADACHE (headache), CHEST DISCOMFORT (chest congestion) and NASOPHARYNGITIS (Running nose). On 07-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (positive for COVID). On 21-Apr-2021, the patient experienced FEELING OF RELAXATION (feels much better). On 21-Apr-2021, COUGH (Coughing), PYREXIA (fever 101.1), HEADACHE (headache), CHEST DISCOMFORT (chest congestion) and NASOPHARYNGITIS (Running nose) had resolved. At the time of the report, VACCINATION SITE PAIN (slight pain at arm at injection site), SARS-COV-2 TEST POSITIVE (positive for COVID) and FEELING OF RELAXATION (feels much better) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Red and swollen at injection site (R) thigh size of a softball. Pt got generic BACTRIM on 1-24-14. Script for KEFLEX on 1-25-14. D/C BACTRIM and con't KEFLEX. informed on 1-27-14.
Sudden, intense itching followed by hives at day 10 after the Modern booster shot. Hives and discomfort continuing 6+ weeks post-booster. Itching started on scalp and ears, then spread to the rest of the body.
Patient stated she experienced headache, hearing/vision loss for short period of time, faint, weakness, shortness of breath - during the day after vaccine
tender, red lump w/soreness in muscle;inc in redness, soreness;erythema >= 5cm w/redness;
there was no fluid in ear; suspected an ear infection.; he woke up with his ear blocked and he couldn't hear; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SUDDEN HEARING LOSS (he woke up with his ear blocked and he couldn't hear) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history.).    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SUDDEN HEARING LOSS (he woke up with his ear blocked and he couldn't hear) (seriousness criterion medically significant). On 05-Mar-2021, the patient experienced EAR DISCOMFORT (there was no fluid in ear) and EAR INFECTION (suspected an ear infection.). At the time of the report, SUDDEN HEARING LOSS (he woke up with his ear blocked and he couldn't hear), EAR DISCOMFORT (there was no fluid in ear) and EAR INFECTION (suspected an ear infection.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
This spontaneous prospective pregnancy report as received from a nurse refers to a 20 year old pregnant female patient. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions or allergies was reported. On 14-SEP-2016 (reported as 2 weeks ago), the patient was vaccinated with GARDASIL 9 injection, intramuscularly (dose, expiration date, lot # were not provided). On 28-SEP-2016, she had a pregnancy test and the result was positive. The patient became pregnant with Last Menstrual Period (LMP) of 10-SEP-2016 and Estimated Date of Delivery (EDD) of 17-JUN-2017. Pregnancy outcome was pending and the fetal outcome was unknown. Additional information has been requested.
Presented to ER 5/9/21 with chest pain for 2 days.  Noted fever day one and two after 2nd Covid Vaccine 5/4/2021.  T max 102. Abnormal EKG with inferior and lateral TWI.  Elevated Troponin, peak 9.69 ng/ml.  Cardiac catheterization -Normal coronaries, mild hypokinesis anterolateral wall.  Echocardiogram - normal.   Diagnosis - Myocarditis
Nausea. I never did get sick, no fever, nothing else. I still feel nausea off and on.
Patient fainted and felt hot. Patient fainted within 10 seconds of receiving vaccine. Once patient came to, she sat down for about 15 minutes and felt better. Patient stated she did not eat anything before.
Patient complaint about prolonged chest pain on the night of vaccination. Unknown cause. Symptom not-specific.
I've had it for at least 2 months now; I've had it for at least 2 months now; still hurting; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 69-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 23-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media The patient had it for at least 2 months at the time of reporting (on her butt) and still hurting. The would be 70 in about 10 days and they Still hurt. She had the new shot for shingles which was a 2-time shot. The patient stated that thank goodness she had the shot because it would had been worse. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Information has been received from a mother concerning her daughter who in approximately 2007 was vaccinated with her first dose of GARDASIL (lot# not reported). Concomitant therapy included hormonal contraceptives (unspecified). The patient received the second dose of GARDASIL (lot# not reported) between September 2007 and February 2008. During the week of 14-APR-2008 the patient experienced a lump on the side of her neck. The doctor said it was an enlarged lymph node, cause unknown. She was treated with 2 antibiotics. She also saw a dentist for 2 impacted wisdom teeth but the dentist did not think it was connected with the lymph node. However the 2 impacted teeth were removed on 25-APR-2008 because they may have caused the lymph nodes to become infected. The patient's lump on the side of her neck persisted. Additional information has been requested.
Case number PHEH2012US022819, is an initial spontaneous report received from a medical assistant on 15 Nov 2012. This report refers to 26 year old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11071, expiry date: Dec 2013) 0.5 ml, intramuscular on 12 Nov 2012.. The patient received Men CWY-135 liquid conjugate component only and did not receive the Men A lyophilized component. No adverse event was reported.