chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 5 patients were administered with the an expired Moderna vaccine on 15Feb2023 (2 patients), 17Feb2023 (2 patients), and 20Feb2023 - 1 patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients were administered with the an expired Moderna vaccine on 15Feb2023 (2 patients), 17Feb2023 (2 patients), and 20Feb2023 - 1 patient) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 20-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients were administered with the an expired Moderna vaccine on 15Feb2023 (2 patients), 17Feb2023 (2 patients), and 20Feb2023 - 1 patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients were administered with the an expired Moderna vaccine on 15Feb2023 (2 patients), 17Feb2023 (2 patients), and 20Feb2023 - 1 patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 patients were administered with the an expired Moderna vaccine on 15Feb2023 (2 patients), 17Feb2023 (2 patients), and 20Feb2023 - 1 patient).    Concomitant medications details were not reported by the reporter.  Treatment details were not reported by the reporter.  Reportedly, Pharmacist stated that 5 patients were administered with an expired Moderna vaccine on 15-Feb-2023 (2 patients), 17-Feb-2023 (2 patients), and 20-Feb-2023 (1 patient) with Lot number: AR9236B with published expiration date of 11-Feb-2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-712703 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2023: Follow-up received includes no new information (NNI) On 02-Mar-2023: Follow-up document contains no additional information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712703:1st patient case (Master case)
Circular, itchy rash around injection site occurred 9 days after injection on 4/2/2021.
stomach pain; swollen lymph nodes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Feb2022 (Lot number: FL8094) at the age of 10 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing), notes: Verbatim: Seasonal allergy. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 24Jan2022, when the patient was 10 years old, for Covid-19 immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 14Feb2022, outcome "not recovered", described as "stomach pain"; LYMPHADENOPATHY (non-serious) with onset 14Feb2022, outcome "not recovered", described as "swollen lymph nodes". The events "stomach pain" and "swollen lymph nodes" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Follow-Up (22Mar2022): Follow-up attempts are completed. No further information is expected.
Extensive erythema and swelling over prox. upper arm (approx 20cm diam) - no functional impairment - seen 48 hr following MMRV
she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 37 patients. This report is for 22nd of 37 patients. This consumer reported for a 38-year-old female patient. A 38-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN5318) via an unspecified route of administration on 26Jan2021 as dose 1, single and she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: N6203) via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunization at Public Health Clinic. The patient medical history and concomitant medications were not reported. On 01Aug2021 the patient experienced she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. the lot number provided (medically significant). It was reported that tested positive for COVID virus, after being fully vaccinated. Caller states that COVID positive was defined as having both vaccines and testing positive for COVID longer than two weeks after both doses. On 01Aug2021 the patient underwent lab tests and procedures which included body mass index (48.5) and sars-cov-2 test (positive). Reporter stated that an individual (non-HC) they are monitoring and tracking the vaccine breakthrough cases in their area and she has some concerns regarding one specific lot number that 15% of their breakthrough cases had received. The lot number provided was EN5318. The caller at the time, did not have the NDC or expiration date, however, was going to work on pulling patient information so that she would be able to have this information available to provide to DSU upon transfer. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101075254 Same reporter/drug/AE, different patients
COVID; COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Tuesday 29Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient was diagnosed with COVID on Saturday 02Jan2021. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
This non-valid spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD, recombinant human albumin (rHA), lot # N028445, expiration date 09-APR-2019 (reported as 19-APR-2019) and VARIVAX, lot # N022981, expiration date 23-AUG-2019; for prophylaxis (strength, dose, frequency and route of administration of the vaccines were not reported). The vaccines were stored in temperature range between -14 and -10 degrees Celsius for 31 hours (date not reported). There was no previous temperature excursion reported. A digital data logger was involved.
Subsequently the patient developed rash with approximately 10 lesions characterized by papular eruption with vesiculation. It was indicated that the pt was afebrile. MD believed there was an association between the pt sx and vax. No speciman will be forthcoming from this case.
Approx. 1 hours and 45 minutes, post vax, the pt experienced rapid heart beat, wheezing, congestion, heaviness in mid-chest. No history of asthma. The pt thought the room where symptoms occurred had a strong "moldy smell". The time course was 45 minutes then wheezing stopped, congestion gone and heaviness had diminished. She refused treatment.
First shot on 3/10/21 was sick  the next day with symptoms chills, sweating, body aches., pain everywhere , headache, neck and shoulder pain, low grade fever, stomach pains, nausea, diarrhea, extreme fatigue, dizziness for over 10 days got a Covid test it came back negative. On second shot 3/31 same exact  symptoms but much much  worse  and 13 days later still experiencing these symptoms.
Patient stated that her left arm is swelling since the day after the vaccination and it has been getting bigger and bigger to ten times the size of a nickel. She has to go to the workplace wellness clinic to get an antibiotic and antiflammatory prescriptions to resolve her symptoms.
Right Otitis; This spontaneous case was reported by an other health care professional and describes the occurrence of EAR INFECTION (Right Otitis) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 prophylaxis.     The patient had never been diagnosed with/ tested positive for COVID-19. The patient had no Chronic or long-standing health conditions.    On 31-Aug-2022 at 2:04 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 28-Sep-2022 at 2:20 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 18-Jan-2023, the patient experienced EAR INFECTION (Right Otitis). On 28-Jan-2023, EAR INFECTION (Right Otitis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at the time of vaccination and/ or at the time of adverse vent were reported as none.  No treatment medications were reported.   This case was linked to MOD-2023-713286 (Patient Link).
Patient reports swelling of the left side of neck between collarbone and bra strap, "I think it is a gland in my neck."    Left arm noted to have redness, about two quarter size hive-like areas (red and slightly raised) that are about inch apart from each other and tender to touch.
Itchy red rash up left side partially around stomach and back.  Small amount on nose and right hand finger
pt received 1st dose Pfizer on 2/21/21, then on 4/5/21 was given dose #2 Moderna.
after second shot for a few days my upper left arm was like a warm orange fruit  sized rash lump. Now the last few weeks I have arthritis in my hands and fingers, also lower back cramps, and the last few days my left knee is hurting for no reason. I take aleve and it doesn't help. I wrapped it today in ace bandage and am using a cane. I am very upset. I have done nothing and this is all since the last shot.
Had a slight sore throat prior to vaccination did not report it (felt it was insignificant per patient). Notes general malaise & achy all over. Right arm still sore and extends to fingers on Rt hand. Reported chest heaviness no SOB or difficulty breathing. Seeing 0B/GYN Wed 9/29 will f/u then.
He received flu shot around 4:30 pm and felt fine. Around 11:30 pm that night he came down with chills and the shakes. He said he was "freezing" and wound up throwing up. The next day he gradually felt better.
Patient consent to second booster of Moderna in Covid clinic, Answered questions before administration and verified dosage and patient. Patient provides vaccination card with 3 series doses of Moderna visible on card and Epic for verification. After administration patient explains to me that Pharmacy accidently gave the 4th dose of Pfizer on 11-12-2021 but patient appointment was for Flu vaccine at Pharmacy on that day. Patient stated the nurse explain to them that they were given the wrong shot. Patient stated she was ok. I explained to patient that this shot administered today was actually 5th dose instead of 4th dose. Patient states the extra the better. Patient was monitored for 15 minutes, no adverse reactions noted.
On the night of 09/24/2003 child was taken to ER for right arm swelling and pain.  Was advised it was a normal reaction to vaccines.  09/26/2003, patient seen at Health Department.  Right arm swollen from deltoid to elbow.  Advised Tylenol and Benadryl.
Information has been received from a physician concerning an 18 month old pt who, at 12 months of age, in approx Jan 2005, was vaccinated with a dose of varicella virus vaccine live. In July 2005, the pt experienced 30-40 lesions, a fever of 101F and a runny nose. The pt was seen in the office with the breakthrough on 19Jul05. The doctor cultured a lesion and it was positive for varicella. Unspecified medical attention was sought. No product quality complaint was involved. Outcome was unk. Additional information has been requested.
Redness, burning, swelling and itching near injection site began after the vaccination was administered and has persisted to present. Days after the vaccine, patient also developed vertigo and loss of hearing in the right ear.
Pt recv vax on 12/4/98; on 12/5/98 pt exp LA swollen/ red/ hot
patient was given dose of Pfizer past 12hr expiration time of opened/punctured vial (stored in fridge) *expired 0425 5/5
Myalgia, Asthenia, Vocal cord disorder, Myofascitis, Eye movement disorder, Tendon pain, Muscle contracture  This case was reported by a french regional center of pharmacovigilance, via another manufacturer (Sanofi Pasteur MSD) and described the occurrence of muscle pain in an adult male subject who was vaccinated with hepatitis B vaccine (Engerix B adult, GlaxoSmithKline) and tetanus and diphtheria toxoids absorbed and inactivated poliomyelitis virus vaccine (Dt polio, Sanofi Aventis MSD) for prophylaxis.  At an unspecified date, the subject received an unspecified dose of Engerix B adult (20 mcg, batch number ENG5116A6 , expired in October 2003) and an unspecified dose of Dt polio (batch number US205-3, expired in April 2002). Within an unspecified delay after vaccination with Dt polio and Engerix B adult, the subject developed muscle and tendon pain without joint pain.  The subject was treated with non-steroidal anti-inflammatory, tramadol hydrochloride and clonazepam (Rivotril), with efficacy.  As well, he presented with variable asthenia, systemically after a physical stress.  The subject experienced muscle contracture and decreased of mobility of vocal cords and ocular muscle. On 29 August 2006, muscle biopsy showed lesions of macrophagic myofascitis.  At the time of reporting, the outcome of the events was unknown.  The reporter's causality assessment was unknown.  On 29 August 2006, muscle biopsy showed lesions of macrophagic myofascitis.   LABORATORY TEST NAME, TEST DATE, TEST RESULT, LOW NORMAL, HIGH NORMAL Biopsy muscle, 29Aug2006, Abnormal
pt recv vax; exp 10-12 lesions on rt side of body; lesions disappeared after 6 hrs;
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group for a Pfizer sponsored program (159558). The reporter is the parent.  A 29 year-old male patient received bnt162b2 (BNT162B2), administration date 03Jun2021 (Lot number: EW0177) at the age of 29 years as dose 2, single and administration date 13May2021 (Lot number: EW0185) as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Dec2021) positive. Clinical course: Reporter states she tested positive for Covid at the end of Dec2021, states she does not remember the exact date, thinks it was 26Dec2021 or 27Dec2021, states she tested with a home test. Caller states her sons have the same experience, states they got both vaccines and they all tested positive the same time she did.  Reporter states her son tested positive the same day she did and got both doses of the vaccine with her, states it is the same dates and lot numbers. Reporter has no further information to provide for this patient.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure and covid-19 and BNT162B2.
Pt recvd flu vax & 25 minutes later exp allergic reaction consisting of coughing, chest tightness & SOB;
little soreness on the arm; This is a spontaneous report received from a contactable consumer via a Pfizer sponsored program. A male patient of unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated that they and their husband received their vaccines, and both had a little soreness on the arm. The clinical outcome of little soreness on the arm was unknown.   Information on lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
02/19/18 at 3:00pm Mom reports pt has hx of passing out after receiving vaccine. He was placed in exam room to receive vaccines. Laying down on exam table he received 2 immunizations. Mom reports after received vaccines he had a syncope episode and his upper extremities were rigid. This was not witnessed by a nurse. Mom encouraged to follow up with pediatrician.
PATIENT EXPERIENCED A VAGAL REACTION DUE TO ANXIETY. BLOOD PRESSURE WAS LOW. ORAL REHYDRATION GIVEN WITH WATER. BP IMPROVED. MONITORED FOR 15 ADDITIONAL MINUTES AND RELEASED WITH MOTHER
At site of immunization erythema and induration about 2x1 on Rt upper arm.
MMR & Td swelling hands & wrists BL, painful w/in 48 hrs pain inc & extended into arms BL, then knees & inner thighs became painful-sought medical help MD who ran test for lyme, lupus, CBC, rheumatoid; dx vax induced polyarthralgia;
He stated that his arm was fine immediately after the injection.  He woke up at 4:30 am and his entire arm and shoulder were swollen and painful. He also couldn't raise his arm.    He went to the emergency room thinking it was a blood clot.  They did not find a cause and said to ice it.  He happened to have a cardiology appointment, and Dr. put him on cephalexin in case there was an infection.  I spoke with patient on 5/10/19 at 7:00 pm, and his arm is getting better and he can raise it more than he did before.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 032L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-Mar-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved.            No concomitant medications reported.  Treatment information not reported.
Information has been received from a healthcare professional concerning her 20 year old daughter who was vaccinated with all three doses of GARDASIL. One week after receiving the third dose the patient experienced spiking a 104 degree fever and sometime after that the patient experienced a seizure/seizure like activity. Two weeks after the seizure like activity the patient saw a neurologist. At the time of this report, the outcome was unknown. Upon internal review, seizure/seizure like activity was determined to be an other important medical event. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding pertinent medical history, drug reactions/allergies and concomitant medications were reported. On 18-JUN-2015, the patients were vaccinated with a dose of improperly stored PROQUAD (Merck) (lot number: K020747, expiration date: 30-APR-2016) (dose and route were not reported). No adverse effects were reported. There was no product quality issue reported. Follow-up information was received on 03-AUG-2015 and 05-AUG-2015. The reporting certified medical assistant would have to search the request made for patients' identifiers, lot numbers and expiration dates and dates of vaccination. Follow-up information has been received from the medical assistant's clinic on 22-OCT-215, regarding a 2-year-old patient of unknown gender. On 08-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # was confirmed to be K020747 with an expiry date of 30-APR-2016. This is one of several reports received from the same source. Additional information has been requested. Patient, product, event information and narrative were updated.