chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Refridgeration excursions identified; No adverse event; Vaccines have undergone several temperature excursions and may have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 64-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Allergies to medications, food and other products were reported as not applicable. It was unknown if the patient had ever been diagnosed with or tested positive for COVID-19.     On 21-Sep-2022 at 6:09 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Sep-2022 at 6:09 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Vaccines have undergone several temperature excursions and may have been administered to patient).    No concomitant medication was reported.  Refrigeration excursions was identified, vaccine was housed in these units. There were excursions noted. Manufactures were notified and the department and made aware of the situation.  Vaccines stored in refrigerator underwent several temperature excursions going back to Aug-2022.  Patient received vaccine in deltoid. Product dose/ volume was reported as 0.5.  No adverse reactions reported for the patient.  No treatment medication was reported.
A non-serious, spontaneous report of achiness and joint pain was received from a physician concerning a 27 year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 21-Oct-2008. Within a few hours after administration the patient had symptoms of achiness and joint pain on the left side of the body. As of 05-Nov-2008 the symptoms persist.
Patient presented to the pharmacy two days after vaccination with a red rash on her upper left arm. She followed up with her primary care provider who explained she had symptoms of "COVID arm". The provider recommended OTC Tylenol.
4-6 weeks after taking his 2nd dose, he reports that he became impotent; He also observed that he became very sluggish; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (4-6 weeks after taking his 2nd dose, he reports that he became impotent) and SLUGGISHNESS (He also observed that he became very sluggish) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERECTILE DYSFUNCTION (4-6 weeks after taking his 2nd dose, he reports that he became impotent) (seriousness criterion medically significant) and SLUGGISHNESS (He also observed that he became very sluggish) (seriousness criterion medically significant). At the time of the report, ERECTILE DYSFUNCTION (4-6 weeks after taking his 2nd dose, he reports that he became impotent) and SLUGGISHNESS (He also observed that he became very sluggish) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Company comment: This case concerns a  78 year-old, male  with no medical history reported, who experienced the unexpected serious events of erectile dysfunction and sluggishness. The events occurred approximately 4-6 weeks after the second dose of mRNA-1273. Rechallenge is not applicable as the events occurred after the second dose and no more doses will be received by the patient. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a  78 year-old, male  with no medical history reported, who experienced the unexpected serious events of erectile dysfunction and sluggishness. The events occurred approximately 4-6 weeks after the second dose of mRNA-1273. Rechallenge is not applicable as the events occurred after the second dose and no more doses will be received by the patient. The benefit-risk relationship of the vaccine is not affected by this report.
got it; This case was reported by a consumer and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as the case was reported by the patient. The age at vaccination was not reported. The patient got shingles after the 1st shot of Shingles vaccine.
vaccine was put in the freezer instead of the fridge and given to the patient, no adverse reactions reported after administration.
Right arm still swollen and painful since vaccination.  1/30/21 severe headache from 8am until approx 8pm. After that, chills and severe body aches. 1/31/2021 swollen and painful lymph nodes above collar bone on right side of neck. Body aches and chills.  Present, nodes are still swollen and painful. body aches are better, just very tired.  Arm is  still swollen and painful.  No fever or cough throughout.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 16-DEC-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
Patient reported feeling dizzy, lightheaded, with facial swelling, shortness of breath Patient appeared pale and hyperventilating Patient seen by medical team and vitals were stable Patient provided water, symptoms improved Patient refused medical transport and signed form Patient will be taken home by spouse
sick to stomach; Nausea; legs felt numb; muscle pain in legs; felt bloated and was close to throwing up; sleepless evening; legs felt weak; This is a spontaneous report from a contactable consumer (patient) reported that. A 79-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 09:00 (Batch/Lot Number: EL9266) as DOSE 1 SINGLE for covid-19 immunization (Age at vaccination 79 years). The patient past Medical history included cataract surgery from 26Jan2021 to an unknown date. Concomitant medication(s) included loteprednol etabonate (LOTEMAX, Dosage text: .39%, 1 drop left twice daily) taken for cataract from Jan2021 to 09Feb2021. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 09Feb2021, Tuesday the patient was sick to his stomach. He had nausea. That evening his legs felt numb. He had muscle pain his legs from the waist down. He was bloated and was close to throwing up. He had a sleepless evening until 3:00am. He must go today to have a test. He legs also felt weak. He fell asleep last night at 2:00am and woke at 4:00am. He was feeling better. When he woke at 6:00am he felt normal. The event outcome was recovered on 10Feb2021.  Follow-up attempts are completed. No further information is expected.
pt recv vax 5SEP97 930AM & devel total body urticaria & eye swelling resolved by 230PM;given DPH;
headache; shivering; feel awful; Heart rate elevated last night to 93; myalgia; fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknwon date).   On 16th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced headache, shivering, feeling abnormal, heart rate increased, myalgia and fatigue. On an unknown date, the outcome of the headache, shivering, feeling abnormal, heart rate increased, myalgia and fatigue were unknown.   It was unknown if the reporter considered the headache, shivering, feeling abnormal, heart rate increased, myalgia and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient experienced headache, shivering, feeling awful, myalgia and fatigue after receiving 2nd dose of Shingrix. The patients heart rate elevated to 93 on the night before reporting. Further information was not reported.
Developed a rash on right side of torso and back near my waist.  Skin very sensitive to touch.   Under right arm pit and forearm also sensitive to touch but no rash at this point.
On October 26,, 2022,  I had symptoms of numbness & tingling in my right hand and above my lip (right side only).  Symptoms were  mild. Late evening I also had those symptoms plus a slight drop in right foot.
Report 20000301591 describes body aches in a male of unspecified age (birth date 11/19/1985) who received Engerix-B for prophylaxis of hepatitis B. This report was received from the vaccinee's mother and has not been verified by a physician or other health care professional. The vaccinee is allergic to Ceclor. His medical history is unspecified. He takes amphetamine sulfate/dextroamphetamine sulfate/dextroamphetamine sacchrate/ amphetamine aspartate (Adderall). On an unspecified date, the vaccinee received his unspecified dose of Engerix-B. Post-vaccination, he developed a fever of 101 degrees and body aches. The vaccinee's symptoms resolved "within one day or so." As of 09/29/2000, the outcome of the events is resolved.
Pt was very anxious when given immunization. After administration, she was sitting in a chair while waiting for others to receive flu shots. Pt stood up - collapsed into her mother's arms. She was unresponsive for approx 30 seconds. She then threw up. Placed cold compress on her forehead & she was responsive. EMS came to check her vital signs her O2 was 100% & blood pressure was 101/67. She was responsive, talking & walking. I contacted pt's home at 2:40pm (approx. 4 hours after initial event) and was told pt was normal & doing fine.
pt recvd vax; woke up 7am crying w/ inc t; cried inconsolably for more than 3 hrs;next day Lt thigh swollen & painfull; t 100.7; to MD, will discuss future immun; sxs abated 2 1/2 days later;
ACUTE NON ST ELEVATION MI 1/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
mom stated following vax pt administered APAP 1030AM; @ 330pm or 345pm pt had a sz, was seen in ER & found to have a t103.5;
Diffuse body aches; head congestion; H/A; poor appetite; chills; malaise; This is a spontaneous report from a contactable healthcare professional.   A 28-year-old non-pregnant  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE),  dose 2 via an unspecified route of administration, administered in left arm on 12Apr2021, at 10:30, dose 1 via an unspecified route of administration, administered in right arm on 23Mar2021, at 15:45, each as a s single dose for covid-19 immunization.  Medical history included anxiety from an unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Concomitant medications included sertraline hcl (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported.  The patient had a known allergy to codeine. On 13Apr2021, at 05:00, the patient experienced diffuse body aches, head congestion , h/a (hypertension), poor appetite, chills, malaise. Treatment received for the adverse events included unspecified over the counter cold medicine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient  has not been tested for COVID-19. The outcome of diffuse body aches, head congestion , h/a (hypertension), poor appetite, chills, malaise was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Swollen arm/warm/red to touch arm tight. Patient "not feeling well". Blurry vision.
Two days after the 2nd Moderna vaccine which was given on April 14, 2021, patient awoke at 7:00 a.m.   on April 16, 2021 with hives that lasted 1 day and then resolved.  Hives recurred around June 3, 2021 and prompted physician interaction and prescription for Zyrtec daily.  Singulair/ montelukast was added on June 21, 2021 for persisting hives which then resolved around July 10th 2021.  Patient received her 3rd COVID injection (Booster) Moderna lot number 091D21A  on November 19, 2021 intramuscularly in the left arm  and she experienced the onset of hives the next day which required Zyrtec/cetirizine 10 mg each evening and Singulair/ montelukast 10 mg each evening regularly.  Despite this medicine, hives occurred on a daily basis and were no longer present while on the medicine by around February 2, 2022.  She is currently hive free today on February 4, 2022 but is still taking both cetirizine and montelukast at this time.  Clarification of below:  Currently no hives but still taking medication for hives.  Medication is to be weaned off over the next several weeks  hopefully.
the day p/vax pt devel red-raised 2x2 area on lt deltoid w/red blotchy rash extending down arm; pruritis was noted; seen by MD, hives dx & DPH prescribed; rash lasted 48 hrs;
injection site reaction that was like cellulitis; felt lightheaded; injection site reaction; body aches; severe fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CELLULITIS (injection site reaction that was like cellulitis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unk) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Latex allergy. Concurrent medical conditions included Environmental allergy (dust mites).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CELLULITIS (injection site reaction that was like cellulitis) (seriousness criterion medically significant), DIZZINESS (felt lightheaded), INJECTION SITE REACTION (injection site reaction), PAIN (body aches) and FATIGUE (severe fatigue). At the time of the report, CELLULITIS (injection site reaction that was like cellulitis), DIZZINESS (felt lightheaded), INJECTION SITE REACTION (injection site reaction), PAIN (body aches) and FATIGUE (severe fatigue) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment reported included Keflex(cefalexin)  for 2 days.   This case was linked to MOD-2021-073420 (Patient Link).; Sender's Comments: This case concerns a 60-year-old female with a serious unexpected event of cellulitis, and nonserious unexpected injection site reaction, pain, dizziness and expected fatigue. Event onset with unknown latency after first dose mRNA-1273. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Case previously recorded as MA2009-4283. Initial case report received from a physician via agency, on 04 NOV 2009. A patient 9-month-old female was vaccinated with 0.5mL S-OIV FLUVIRIN (batch no. 100813) once i.m. on 02 NOV 2009. No adverse event was reported. Agency reference no.: NA09-007607.
Bowel blockage, IBS with constipation, low blood sugar, chronic fatigue, low vitamin D, muscle spasms, headaches, unexplained weight loss
Pt was waking 1/21/21 and legs calapsed. Lowered to ground by relative and taken home. Remained alert and po c/o pain. Currently @ 230pm able to walk. Daughter seeking follow up. Vaccine give at a covid 19 vaccination clinic. given by the county
I got shingles 2 weeks after vaccine and I had a really bad eczema flare and also had flare in other location I had never had before
The pt had a pale face, somewhat listless, bright red lower extremities, breathing is fine; it looks like a significant vasovagal rxn. Observation over a few minutes. Symptoms resolved. Monitor over 24 hours. No further symptoms.
Acute reaction, periorbital edema, lid swelling <2 hrs after administration of typhoid and yellow fever vaccine from the health dept.
When our facility received the COVID - 19 vaccine, I spoke to the Dept. of Health and was told that the exp. date for the vaccine was 9 months from the mfg. date on the box. Which made the exp. date 5/31/22. On 5/20/22 at the  Dept. of Health contacted me stating that we have given exp. vaccines to patients and that the exp. date was 10 weeks from the date the vaccine was received which would have been 5/2/22. Thus we unknowingly gave exp. vaccine to patient.  Patient tolerated vaccine well, no adverse effects have been reported.
Two strokes; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced two strokes on an unspecified date within a week of receiving the first dose. The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presented to the ED and was subsequently hospitalized for atrial fibrillation within 6 weeks of receiving COVID vaccination. She died on 5/26/2021.
Heavy sweating, shortness of breath, chills, and very weak also light headed with headache, and upset stomach.
Fever & chills Aches Fatigue Itchy rash around injection site  Headache
PATIENT HAD SEIZURE IN WAITING AREA AFTER RECEIVING FIRST DOSE OF COVID VACCINE. PT BECAME RESPONSIVE, EMS WAS CALLED AND MANAGED PATIENT AFTER
Information has been received from a consumer concerning a patient who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot# 644218/1027M). Subsequently the patient developed a rash. The reporter had no other information to provide. Unspecified medical attention was sought. Follow up information from the physician indicated that the patient developed pain and swelling in the deltoid and shoulder area following vaccination. The reporter indicated that the patient could not lie down on that side and could not lift the arm because of pain. The patient went to the ER and was treated with an anti-inflammatory because"they thought it was cellulitis".  The reporter indicated that two other patients developed a rash after being vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot#644218/1027M) (WAES0302USA02959 and WAES0303USA01561). Additional information has been requested.
Patient given Moderna vaccine and is only 16 years of age. No adverse reaction. Reporting a VAERS for improper age to receive this vaccine.
3:15 pm injection. Five minutes later reported blurred vision and feeling strange. Had patient sit down, reported feeling warm and nauseous. She asked for some water, gave a bottle, drank a little but did not feel any better. Did not have breathing difficulty or swallowing. 3:30 pm reported that she was having hearing difficulty.
Difficulty breathing, wheezing, extreme fatigue, shortness of breath, night sweats, and was diagnosed with asthma by healthcare professional.
Scar; Large blister; Red Injection Site; Warm Injection Site; Itchy; This case was reported by a consumer via call center representative and described the occurrence of blister in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine 2017-2018 season) for prophylaxis.   In October 2017, the patient received Influenza vaccine 2017-2018 season. In October 2017, less than a day after receiving Influenza vaccine 2017-2018 season, the patient experienced blister, injection site erythema and injection site itching. On an unknown date, the patient experienced injection site warmth and scar. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the blister, injection site erythema, injection site warmth and injection site itching were recovered/resolved and the outcome of the scar was not recovered/not resolved.   It was unknown if the reporter considered the blister, injection site erythema, injection site warmth, injection site itching and scar to be related to Influenza vaccine 2017-2018 season.  Additional details were received as follows: The age at vaccination was not reported.  The patient received flu vaccine in October of 2017. She states that within 1-2 hours she developed a large blister that led to a scar after it resolved in 2.5 weeks. she states she also developed itching (resolved in 48-72 hours after taking benadryl)and a red, warm injection site, both of which resolved within one week. The reporter consented to follow up. Consumer does not know or declined to provide any further information at this time, consents to HCP follow up. Received the injectioN. She does not know the name or manufacturer of the flu vaccine.