chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days; Date the vial was initially stored in the refrigerator on 02MAR2023 and Date(s) of administration of vaccine was 27APR2023, 10MAY2023, 30MAY2023; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 02MAR2023 and Date(s) of administration of vaccine was 27APR2023, 10MAY2023, 30MAY2023) and NO ADVERSE EVENT (No adverse event) in a 75-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No medical history reported.     On 30-May-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 02MAR2023 and Date(s) of administration of vaccine was 27APR2023, 10MAY2023, 30MAY2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 02MAR2023 and Date(s) of administration of vaccine was 27APR2023, 10MAY2023, 30MAY2023) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 02MAR2023 and Date(s) of administration of vaccine was 27APR2023, 10MAY2023, 30MAY2023).    It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Health care professional explained they accidentally administered 6 doses of Moderna COVID-19 Vaccine Bivalent after more than 30 days stored in the fridge.  6 doses administered after 30-day Use By Date Product Monovalent, Bivalent BA.1, Bivalent BA.4-5: bivalent Lot number 066H22A. Individual vials or intact cartons: inside a carton Vial size were 0.4 mL, 0.5 mL, 2.5 mL, or 5.5 mL 2.5 mL Date the vial was initially stored in the refrigerator was 02 MAR 2023. Date(s) of administration of vaccine 27 APR 2023, 10 MAY 2023, 30 MAY2023. The vial did not undergo any temperature excursions. No AEs were reported. It was the 6th dose for this patient. Concomitant medication not reported.  Treatment medication not reported.
Pt exp t100 PO & sore arm w/redness & swelling; Also c/o swollen hands & feet; 3 days p/vax pt continued to have low grade fever & soreness in arm; Referred to MD who recommended no Td again;
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age or gender. Pertinent medical history or drug allergies/drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL (lot 1 # K008931, expiration date 04-MAR-2017; lot 2 # K009482, expiration date 06-MAR-2017) (dose, strength, frequency and route of administration were not reported). There was no concomitant medication reported and there were no adverse effects reported. Additional information has been requested.
Swollen lymph node above the clavicle; developed shoulde rmuscle/joint pain on same side of the injection; This is a spontaneous report from a contactable consumer (patient):  A 32 years male patient received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in left arm on 12Feb2021, 11:45 AM (Age at vaccination: 32-years old) as dose 2, single for covid-19 immunization. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration, administered in left arm on 21Jan2021, 11:45 AM as dose 1, single for covid-19 immunization. The patient medical history was not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The concomitant medications included Ibuprofen and Cetirizine. On 11 Feb2021, the patient had lab investigation on Nasal Swab and resulted as negative. On 13Feb2021 12:00 PM, the patient had experienced Swollen lymph node above the clavicle and developed shoulder muscle/joint pain on same side of the injection. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Yes, PCR covid tested post vaccination. At the time of reporting, the outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Kidney pain; Jaw lymph nodes swelling; Jaw lymph nodes pain; Fatigue; Injection arm pain; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received unknown dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetic, asthma, high bp (blood pressure high), obese (obesity), arthritis and disc problems. The patient received many unspecified medications within two weeks of vaccination. The patient previously took sulfa (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy on unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:00 the patient experienced kidney pain, jaw lymph nodes swelling (swollen lymph nodes) and pain (lymph nodes pain), fatigue and injection arm pain (pain in arm). The patient did not receive any treatment for the reported adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events kidney pain, jaw lymph nodes swelling, jaw lymph nodes pain, fatigue and injection arm pain were not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a 77-year-old female who in October 2007, was vaccinated in the right arm with a dose of ZOSTAVAX (Oka/Merck).  In October 2007, a few days after vaccination, the patient experienced an area of loss of sensation over the right lateral hip.  The patient also experienced some transient headaches and possibly some left sided chest pain but, otherwise, had no additional side effects and developed no skin rash.  On 10-OCT-2007, physical examination revealed complete anesthesia over a 6 cm area of the lateral right hip.  On 26-OCT-2007, the patient's numbness seemed to be recovering and she had some light touch sensation in the area.  Additional information has been requested.
Subsequent to receiving three doses of Lymerix, the pt experienced fever and body ache (mostly legs). No treatment was given. Symptoms resolved on approximately 08/31/2000. As of 09/08/2000 the outcome of the event is resolved.
Redness at site - quarter sized first 24 hr. By 48 hr enlarged approximately 5in x 4in redness with bruising in center. Running and playing OK but felt warm. Seen in ED - felt hematoma. By 3 days later when seen in my office resolved.
Shoulder Pain; Neck pain; Thinks it was administered incorrectly; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 20Mar2021 (at the age of 74-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient received first dose of Pfizer COVID vaccine and believes it was administered incorrectly because she was still having shoulder and neck pain that started the day after. It was reported that She wants to know if the quality was still efficient if it was given incorrectly. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
symptoms started the day after vaccine with swelling of hand, face, and collar bone, chills, body aches, tingling sensation all over body, fatigue, headache, decreased appetite, achy joints
WORSENED NEUROPATHY; This spontaneous report received from a patient concerned a 73 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included: on 21-FEB-2021 patient had neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration: unknown, batch number and expiry: unknown) dose was not reported, administered on 10-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient had worsened neuropathy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from worsened neuropathy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220221145-JANSSEN COVID-19 VACCINE Ad26.COV2.S- worsened neuropathy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE
This spontaneous report as received from a physician refers to an unknown gender 6 month old patient. On 27-AUG-2014 at the age of 6 months the patient was vaccinated with a dose of VARIVAX (Merck) (dose number, route and dose unknown). No adverse effect reported. Additional information has been requested.
Immediately after receiving the FLUZONE HD patient felt awful, listless and weak. She took BP -> 84/54 pulse 58.
8/10/99 inj site reddened & warm to touch, had malaise, nausea & h/a;8/11/99 redness went down arm more & warm;8/12/99 redness down arm more & warm;
I had a serious case of COVID-19 in 3/2020.  After the vaccine, I felt like I had the illness all over again.  I got a fever of 101, loss of appetite, slept 16 hours a day, headache, slight nausea, some pain at injection site.  This lasted about 48 hours.  I took two Tylenol 20 hours after the vaccine as the headache was so bad.  I got better within 48 hours.  No medical help was sought.
First tested positive 20Jul.; First tested positive 20Jul.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 27Mar2021 as dose 1, single (Batch/Lot number: unknown), on 17Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 02Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LOSARTAN, start date: 01Nov2021; ATORVASTATIN, start date: 01May2018, stop date: 20Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jul2022, outcome "not recovered" and all described as "First tested positive 20Jul.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jul2022) First tested positive; (26Jul2022) Positive; (28Jul2022) Negative; (29Jul2022) Weakly positive; (30Jul2022) Clearly positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: No known allergies. The patient received Paxlovid from 20Jul2022 to 25Jul2022 for the treatment of COVID-19. First tested positive 20Jul. Fatigue/aches/no fever. Started Paxlovid evening of 20Jul after atorvastatin washout. Felt much better by 5 am. Still positive 26Jul.Tested negative 28Jul. Weakly positive 29Jul slight sore throat. Clearly positive on 30Jul. Very slight congestion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug BNT162B2 to the reported events Vaccination failure and COVID-19 cannot be ruled out.
taste loss; loss of smell; dizzy; runny nose; headache; flu like symptoms; fever; Vaccination site pain; This spontaneous case was reported by a non-health professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), RHINORRHOEA (runny nose), HEADACHE (headache) and AGEUSIA (taste loss) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and VACCINATION SITE PAIN (Vaccination site pain). On 29-Jun-2021, the patient experienced RHINORRHOEA (runny nose) and HEADACHE (headache). On 02-Jul-2021, the patient experienced AGEUSIA (taste loss), ANOSMIA (loss of smell) and DIZZINESS (dizzy). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever), RHINORRHOEA (runny nose), HEADACHE (headache), AGEUSIA (taste loss), ANOSMIA (loss of smell), DIZZINESS (dizzy) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jul-2021, SARS-CoV-1 test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-248049 (Patient Link).
Upset stomach; soreness in my joints; Headache; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced upset stomach, joint pain and headache. On an unknown date, the outcome of the upset stomach, joint pain and headache were unknown.   It was unknown if the reporter considered the upset stomach, joint pain and headache to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received shingles vaccine and experienced side effects like upset stomach, soreness in joints and headache. The patient wanted to know how long these side effects might last.
day following vax pt c/o swelling; tenderness lt arm; rpt arm sore; tingling in fingers; seen at clinic; slightly edematous
LIGHT HEADED; FELT COLD; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's past medical history included full hysterectomy, and concurrent conditions included no alcohol use, and cigarette smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 19-MAY-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced light headed. On 19-MAY-2021, the subject experienced felt cold. On 19-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 101.1 F, 100.9 F, 101.5 F. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from fever, light headed, and felt cold. This report was non-serious.
Golf ball size knot noted where Menveo was administered on 10/3/16 (L deltoid). Pt woke on 10/4/16 and the knot was 3.5 inches in diameter, itching, and warm to touch. Wheezing also noted on 10/4/16.
Swelling around injection site, severe itching at the site, huge knot size of a silver dollar, bright red color, very hot to the touch, very sore and painful has been getting worse since 5-03-2012 instead of getting better we have been giving Motrin applying ice and putting anti-itch cream on the injection site due to severe itching.
Information has been received from a certified medical assistant concerning a 22 year old male who on an unspecified date was vaccinated with a first dose of MMR (lot # not reported) an on 18-NOV-1997 was vaccinated with a second dose of MMR (lot#622262/0594E). On 01-JUL-2008 the patient had titers taken for measles and was non-reactive to measles vaccine. The patient sought unspecified medical attention. No other detail was available. The patient experienced another adverse event reported in WAES #0807USA05142. Additional information has been requested.
8 hours post injection symptoms of fatigue, body aches, muscle and joint pain, dizziness, nausea, hot and cold flashes, injection site pain, near syncope, malaise, tiredness, and fever occurred. Two weeks after that and still going on all new onset : ADHD, depression, anxiety, PTSD, POTS, dysautonomia, MCAS, dizziness, syncope, shob on exertion, shingles, tremors, internal vibrations, paresthesia, neuropathy of hands and feet, zaps and shocks of hands, brain fog, decreased concentration and mental dexterity, insomnia, hair loss, cellulitis, tinnitus, hot flashes, hypertension, tachycardia, muscle mass weight loss, decreased appetite, speech difficulty, gi issues, difficulty swallowing, dry eyes and mouth.
This case was reported by a physician and described the occurrence of weakness in a 47-year-old female subject who was vaccinated with Havrix and Td for prophylaxis. On 28 June 2006 the subject received 1st dose of Havrix at 0.5 ml in the left arm and a booster dose of Td. Within weeks of vaccination with Havrix and Td, the subject experienced weakness and numbness primarily on the left side in both the upper and lower extremities. At the time, no other cause could be identified for the events other than possible multiple sclerosis. The physician considered the events were disabling. No treatment was required and the events resolved 7 to 8 months later.
Pain; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date (lot number was not reported) dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced pain after administering the vaccine. The event took place after use of product. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female who on unspecified date was vaccinated IM with all three dose of GARDASIL (lot# not provided). The patient received all three doses and later she had abnormal pap smear. Unknown medical attention was sought. The patient was not recovered. Attempts were unsuccessful to gain more information. Additional information has been requested.
Approx. 3 -4 weeks following the 2nd dose of vaccine I have had pain and the feeling of fluid that goes from ear up the left side of my face and behind the eye, temple area, and above the eye. The brow area above the eye is also puffy. I also have uncontrollable twitching in my left eye and in the morning I have to think about opening my left eye ( not due to conjunctivitis) . It feels like the left part of my face is " not right" .
Bad sore throat; swollen lymph nodes; arm pain at the injection site three hours after injection.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 01Mar2021 at 12:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, obesity and allergy to tomatoes, white potatoes, blueberries and cranberries. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), telmisartan (MANUFACTURER UNKNOWN) and ibuprofen (ADVIL); all for unknown indication from unknown date and unknown if ongoing. The patient previously received levofloxacin (LEVAQUIN) on unknown date for unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021 at 15:45, three hours after injection, the patient experienced arm pain at the injection site. On 02Mar2021, the next day, the patient experienced swollen lymph nodes. On 03Mar2021, the third day, the patient experienced bad sore throat. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain at the injection site, swollen lymph nodes and bad sore throat was recovering at this time of this report.  No follow-up attempts are needed. No further information is expected.
Difficulty breathing; continuous asthma attacks; constant coughing with heavy mucus; chest pain and discomfort; very hoarse along with sore throat; extreme headaches and body aches; loss of appetite, smell and taste; temp between 99.2 to 102.2 for 3 straight days; chills and stuffiness. Negative test reveal on 6/20/2022, then positive test on 6/21/2022. No work for days. I stayed home per employer's instruction. Began isolation immediately at home but also infected family members as well. All members fully vaccinated myself as well, came in contact with co-workers who later admitted having virus. Made visit to urgent care after returning back to work. Still was not well. They prescribed medications for me to aide with my symptoms.