chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd Dose administered beyond 30-day use; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2nd Dose administered beyond 30-day use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Ophthalmic herpes zoster; This is a spontaneous report from a contactable consumer. The reporter reported similar events for 3 patients, this is the second of 3 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced ophthalmic herpes zoster on an unspecified date with outcome of unknown.    The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101529173 same reporter/drug/event, different patient;US-PFIZER INC-202101529295 same reporter/drug/event, different patient
A few days after receipt of MMR vaccine, pt had onset of memory loss, fatigue, somnolence, and depression which gradually was improving 10 days later.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 11:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 11:44 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 75.10   Concomitant products were not provided.  On 08-Feb-2021 Excursion time was reported at 10 am and 11 am with temperature as 29 and 35 degrees Fahrenheit respectively, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 02-Feb-2021, vial was moved to clinic on 08-Feb-2021. 03 vials were sent to clinic. Vaccine BUD date was 04-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Receive vaccine on 10/7 reports that on 10/9 had a sore throat, the next day had some pain upon swallowing. He continued to chill and have a low grade fever until 10/15.
rash red over chest, back & face;blister looking rxn on forehead 3 1/2hr p/vax; tx DPH;
Client awoke with hives.  Client had been having cold symptoms since 02/25/2011 including nausea and aches.  She had started taking Tylenol, chor-tabs and Mucinex.  She also took Advil on 02/27/2011 PM.  Hives were disappearing by time of report/telephone conversation in the afternoon.
Rash; Difficulty breathing; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to antibiotic (allergic to neomycin).   On 14th February 2020, the patient received the 1st dose of Shingrix. In February 2020, 3 days after receiving Shingrix, the patient experienced rash and difficulty breathing. On an unknown date, the outcome of the rash and difficulty breathing were unknown.   It was unknown if the reporter considered the rash and difficulty breathing to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist checked the patient's allergies and he did not find anything related. The patient was allergic to neomycin but the package insert didn't say anything about Neomycin. The reporter was asking if there were any allergic reports about Shingrix. The reporter consented to follow up.
Dull headache; chills; feet/toes burning and itching; feet/toes burning and itching; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 17Feb2021 at 12:45 PM (at the age of 68-years-old) at 1st dose, single, administered in left arm, for COVID-19 immunisation. Medical history included seasonal allergy. The patient had no other known allergies. No COVID prior vaccination and no COVID tested post vaccination. Other medications in two weeks included seasonal allergy shot, gabapentin and benazepril. No other vaccine was received in four weeks. The patient experienced dull headache, chills, feet/toes burning and itching on 17Feb2021 at 21:00. No treatment was received for the events.  The patient had recovered from the events in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
VIAL PUNCTURED OVER 48 HOURS WHEN ADMINISTERED; This spontaneous report received from a health care professional concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-AUG-2021, the patient experienced vial punctured over 48 hours when administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vial punctured over 48 hours when administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210838123, 20210837775 and 20210837262.
This spontaneous report was received from a medical assistant and refers to a 4 month old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 28-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, lot # L013202, expiration date: 27-JAN-2017, (dose was not reported). According to the reporter, the vaccines were stored at a temperature of 50.2 degrees Fahrenheit for 9 hours and the temperature excursion took place due to unit adjustment with the door open for stock counting. There was no previous temperature excursion reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
covid vaccine breakthrough   dose 1 Pfizer 1/14/21 EL1283 dose 2 Pfizer 2/4/21 EN9581
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 29th June 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the product supply issue was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the left arm and experienced an ache or hurting at the injection site on his left arm after the injection which resolved after a day or so. It has been unable to secure the second dose because of the backorder.
Patient had a mild case of Covid-19 in July 2022; achy injection site left arm; sore left arm; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Patient had a mild case of Covid-19 in July 2022), VACCINATION SITE PAIN (achy injection site left arm) and PAIN IN EXTREMITY (sore left arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 007B21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION SITE PAIN (achy injection site left arm) and PAIN IN EXTREMITY (sore left arm). In July 2022, the patient experienced COVID-19 (Patient had a mild case of Covid-19 in July 2022). At the time of the report, COVID-19 (Patient had a mild case of Covid-19 in July 2022), VACCINATION SITE PAIN (achy injection site left arm) and PAIN IN EXTREMITY (sore left arm) outcome was unknown.            No concomitant medications was provided. Patient had a mild case of Covid-19 in July 2022 Sore Throat and mild congestion  No treatment medications was provided.   This case was linked to MOD-2022-670187 (Patient Link).
Cerebellar stoke.  Hospitalized at Hospital for 2 + weeks ( ICU for 5 days, med/surg floor 11 days) then transferred to Sharp Rees-Steely In-patient Brain Injury for 10 days.  Significant impairment on right side of body.  Unable to return to work (Director,  Bio-Pharamceutical CRO).
memory effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MEMORY IMPAIRMENT (memory effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (memory effects). At the time of the report, MEMORY IMPAIRMENT (memory effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not mentioned. Treatment medications were not reported   Reporter did not allow further contact
Large local reaction from injection site, extending down arm 3-4 inches per history. Red and warm to touch per family.
73 yo female who took flu vaccine on 4 Oct at 1500 and had facial, lip, and neck swelling, plus globus about 2 hours later.  Was seen in ER about 4 hours after getting the vaccine and was given Benadryl, prednisone.  Her lips continued to swell the next day and she was admitted overnight for observation.  Sx resolved over the next few days.  Nothing else different in her day except getting the flu vaccine.  Has continued to take all her medications since then without any recurrence in her sx.  No associated hives, coughing, wheezing, abdominal pain, diarrhea, emesis, syncope, flushing, warmth.  Did have immediate significant fatigue.  No previous problems taking any other vaccines.
Information has been received from a registered nurse concerning a 62 year old patient who on 20-JAN-2009 was vaccinated with ZOSTER vaccine live (Oka/Merck) (Lot # not reported).  On 21-JAN-2009, the patient had a reaction.  The nurse stated the patient reported a welt that was hot, bright red and very sensitive.  The nurse stated the welt was still present in addition to neck pain that "feels like an electrical impulse".  The patient currently had a "golf ball size bump that is purple, red and painful to touch."  The patient was being treated with ibuprofen.  The patient was not recovered from the adverse events.  It was not reported whether the patients sought medical attention.  Additional information has been received from the licensed practical nurse concerning the now 63 year old patient with allergy to CODEINE, SAR, DAR, ROAD, and a history of cervical cancer in 1980, hepatitis in 1965 and osteopenia who on 20-JAN-2009 3:00 PM was vaccinated SQ with the first dose of ZOSTER vaccine live (Oka/Merck) (Lot # 662757/1622X) in her right arm.  On 21-Jan-2009 9:00 AM, the patient had reaction.  On 26-JAN-2009, the patient's swelling was 5-6 inches long, hot, bright red in middle and faded red around edges, and felt electrical impulse.  Dr.'s recommendation: Call if sighs and symptoms continued.  We would being down swelling with PREDNISONE, but would compromise effectiveness of vaccine.  On 30-JAN-2009, the patient called reaction still very sensitive, stiff neck, shooting pain down her shoulder blade right side arm.  Reaction was getting no better per patient.  Dr recommendation: office visit now, ibuprofen 200mg, 1-2 tabs BID.  Upon observation on 30-JAN-2009, the area on right arm golf ball size red was vague discomfort, the patient's arm was feeling funny with extension and adduction, and hurt to turn head.  On 5-FEB-2009, the patient stated reaction to ZOSTER vaccine live (Oka/Merck) was almost gone, but still had a "strange feeling" in upper back / neck but discomfort diminishing.  On 17-FEB-2009, the patient still got pain when changed position at night, or walked too hard on heels. "Feels strange" in neck arm large local reaction was now gone.  The patient was not completely recovered from adverse events.  No further information is available.
The  expired vaccine from the day before was mixed with non expired vaccine mixed that day.  We are unsure if patient received expired vaccine.   I f/u with pt and let them know Pfizer was testing the stability and we could redoes them per CDC guideline...however he reported having a lot of side effects over the weekend so he felt confident the vaccine he received was active and didn't want to repeat until his 2nd shot
Started feeling body aches, loss of appetite, chills no fever.  Chills and body aches lasted 24 hours.  3 negative covid test in 24 hours.  Symptoms subsided began soon after.  4 days after I developed fatigue; diarrhea; loss of appetite and nausea  .
Patient came to the counseling window on 12/4/18 at approximately 6pm inquiring about her SHINGRIX vaccination received on Sunday, 12/02/18. She asked if it was normal to experience severe pain, redness, warmth, and induration at the site of administration. She proceeded to mention how the pharmacist who administered the vaccine mentioned it was to be given SQ in the fat tissue and if this was why it hurt more than other vaccinations administered in the muscle. The area of redness was clearly visible on the posterior aspect of her upper left arm (where ZOSTAVAX would be administered). I advised that although the vaccination was to be administered IM and not SQ. The symptoms she is experiencing were common for this particular vaccine. I attempted to reach GSK for more information on what the patient should expect but they were closed at this hour. I advised Patient to take ibuprofen (as directed on package), apply a cool compress to the area, and BENADRYL (as directed on package) for the symptoms she was experiencing until we were able to get in touch with a representative from GSK.
Pt had syncope in hallway. I was able to catch her and sit her down in a chair.  I gave her a Coke and wheeled her to a clinic table where she laid down with feet elevated. Symptom resolved in 15 minutes. Pt. stated that she felt the vaccine (HPV) go in and immediately a fog filled her head.
Patients arm had erythema, hot to touch and size of a baseball. Mom took patient to the Emergency room to be evaluated. Patient was seen and diagnosed with localized reaction to Dtap.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-MAY_2016, the patient was inadvertently vaccinated with 2 doses of GARDASIL 9 (lot # L044475 exp date 12-MAY-2017) (dose and route not reported). No adverse effect was reported. Additional information has been requested.
SORENESS; CHILLS; LIGHT FEVER; This spontaneous report received from a patient via an unspecified company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. The unspecified company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced soreness. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced light fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, soreness and light fever was not reported. This report was non-serious.
pt recv vax 28JAn99 & on 15FEB99 when child awoke mom saw a rash on child stomach & in the diaper area;16FEB99 the rash had spread to the child's back & arms;late in the afternoon of 16FEB, rash spread to child neck & face;
less than one month after receiving DTaP, Hib2,OPV my child experienced a 20-30 minute long afebrile seizure event. Another episode (shorter in duration) was then witnessed in ER. Three day hospital stay resulted. Did not medicate at that point, but was urged to do so after the child then experienced many more seizures in the ensuing months. The 60 day follow up received on 9/17/03 states pt continues to have recurrent seizures which are very poorly controlled. She carries a concurrent dx of autism, has a poorly functioning immune system (IgA def, IgG sub 2/4 are just about null) x GST MI is null.  Discharge Summary received on 8/06/2003 states status epilepticus.
This case was retrieved via a search of scientific literature on 14 November 2011. This reporter also reported other adverse events, which were captured in case numbers 2011-11217, 2011-11218, 2011-11219, 2011-11220, 2011-11221, 2011-11222, 2011-11223, 2011-11224, 2011-11226, 2011-11227, 2011-11228, 2011-11229, 2011-11230, 2011-11231, 2011-11232, 2011-11233, and 2011-11234. Verbatim from the abstract: "Background: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Methods: Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. Results: CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through other searches. Causality assessment using the modified agency criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful. Conclusions: The CCCR provides advice about AEFI to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations". A 36-year-old patient (sex not reported) received an injection (route and site not reported) of Td toxoids, manufacturer and lot number not reported, on an unknown date. The patient had a history of obesity. On an unknown date, the patient developed complex regional pain syndrome less than one day after the vaccine. The causality was reported as probable. The outcome was not reported. Documents held by sender: None.
This spontaneous prospective pregnancy report as received from a 34 year old female consumer with no pertinent medical history and drug reactions refers to herself. On 11-NOV-2013 the patient was vaccinated with the first dose of VARIVAX (Merck), (lot #, expiration date, dose and route not reported) for prevention of chicken pox. On 18-DEC-2013 the patient was vaccinated with the second dose of VARIVAX (Merck), (lot #, expiration date, dose and route not reported) for prevention of chicken pox. No concomitant medication was reported. On 08-JAN-2014 ("Yesterday"), the patient found out that she was 4 weeks pregnant. The LMP (Last Menstrual Period) was 11-DEC-2013 and EDD (Estimated Date of Delivery) was 17-SEP-2014. The patient had performed pregnancy test. No treatment was given for the events. The outcome of the events was unknown. The patient had sought medical attention by talking to the physician. Additional information has been requested.
Series of events: Patient said she felt a hot flash and her neck was itchy.  She wasn't sure if she was having chest pain.  She said this was the same feeling she got before when she had an allergic reaction with hives and lips swelled.  Took vitals.  BP was elevated 212/102.  3 minutes later repeat BP was 206/95.
11/14/02 seizure, vomiting, fever. 12/6/02 blood inside head, outside of brain a shunt was placed in head to drain fluid from head to stomach.