chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A physician assistant reported the occurrence of a 31-year-old female who failed to respond after vaccination with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. The pt's medical history, concurrent medical conditions and concurrent medications were not specified. In March 2002 the pt received her 5th injection of hepatitis B vaccine recombinant (Engerix-B). Approx 8 months after the 5th injection, the pt had a "negative titer test". The pt had been vaccinated with the 1st 2 injections in January and Feb 1999. The series was discontinued after the 2 injections because the pt became pregnant. The series was repeated in Sept 2001 after the pt's pregnancy.
This spontaneous consumer report (initial receipt 08-Oct-2012) concerns a 77-year-old male patient. On 03-Oct-2012 the patient received AFLURIA (batch number was not provided). Almost immediately the patient developed chills, body ache, redness of eyes, headache and itchy throat. The patient sought medical treatment and received an unspecified injection to treat the events. The outcome for the events was recovered.
Severe itching of both lower legs ( from knee to ankles) for an hour. Rubbed Itch Relief Lotion( Eucerin) on both legs several times within the hour. Legs  finally stopped inching
Pt recv vax on 3/1/99; on 3/3/99 pt exp chills, fever, aches; swollen/hot vax site
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In February 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Heart rate is usually at 65. After 5-10 minutes, it shot up to 150.
Patient is experiencing limited range of motion in left arm since the vaccination 2 weeks prior.  Physician has ordered an x-ray, pain and steroid medicatons, and physical therapy for the patient.
Mild reaction-  -sorenesss -about 1 inch in diameter red swelling where the shot was given -aches and flu-like feeling -feel like I need lots of liquids
Information has been received from an LPN concerning a 31 year old female who on 3/23/01 was vaccinated with rubella virus vaccine live (second generation) (lot 638553/1862K). On 4/2/01, laboratory evaluations revealed a "negative titer". Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 70 year old (approximately) female patient, who on 14-DEC-2006, was vaccinated subcutaneously with a dose of ZOSTAVAX 0.65 ml, in the left arm (lot number reported as 1212F). No other co-suspects were reported. No concomitant medications were reported. The medical assistant reported that the patient had a current outbreak of shingles on her face. Unspecified treatment was reported. The patient sought medical attention, the patient's husband went to the office for a visit on 15-FEB-2013 and let them know of his wife's shingles outbreak. At the time of the report, the patient had not recovered from the adverse event. The relatedness for the adverse events was unknown for ZOSTAVAX. This is one of the two reports from the same source. Additional information has been requested.
I started itching a few minutes after I received the injection. This was during the time that I had to wait. I was getting a headache by time I got home and of course my arm was sore. Also my throat was starting to bother me and my ears When I woke up the next morning I was hoarse. Yes my arm was still sore, ears,throat and headache I still had, but not as bad. I wasn't itching anymore I'm still hoarse this morning.  Thank you
This spontaneous report was received from a Licensed Practical Nurse refers to an unknown number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored M-M-R II(lot#, expiry not reported). No adverse effects reported. The nurse stated that the vaccine was exposed to warmer temperatures. However, she had to research to determine if the vaccines were administered. This is 1 of several reports received from the same reporter. Additional information has been requested.
spinal cord modulation pain; This is a spontaneous report via a Pfizer-sponsored program, from a contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer said she received the 1st dose of the Pfizer-BioNTech Covid19 Vaccine on Wednesday. She said that she has not had any pain related to the vaccine. However, she has the condition, spinal cord modulation pain (unspecified date in Feb2021). She said she was prescribed to take hydrocodone/paracetamol (VICODIN) once every other night. She wants to know if this is okay and wants to know how long she has to wait to take the medication after receiving her 2nd dose. She is asking if she can already take the medicine VICODIN before the 2nd dose or she can take the medicine after she got the 2nd dose instead. The outcome of the event was unknown.  Information on lot number/batch number has been requested.
This spontaneous report was received from a physician via a company representative, concerning a 2 year old female patient. Patient concurrent conditions and relevant medical history was not reported. On an unknown date, the patient was vaccinated with the first dose of M-M-R II (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. The reporter stated that the patient was diagnosed with mumps (hospitalization) on an unspecified date, sometime after receiving M-M-R II. The patient was admitted to the hospital but the reporter was not sure for how long the patient was in hospital. Polymerase chain reaction (PCR) test was conducted on an unknown date and results were not reported. The reporter was also unsure if the mumps was life threatening, since the patient was currently under observation and was unsure how she was doing. The patient was being comforted in the hospital. The outcome of mumps was reported as not recovered/not resolved. The causality of the event with M-M-R II was not reported. Additional information has been requested.
Headache, fever and chills called doctor and was prescribed PAXLOVID within 24 hours was feeling better.
Arm soreness Fatigue  Appendicitis (unclear if directly related to vaccine but need to report to determine if increased risk due to vaccine)
EMERGENCY RUN TO HOSPITAL FOLLOWED BY HELICOPTER.  WAS UNABLE TO TALK AND WAS NOT AWARE OF WHAT WAS GOING ON FOR A COUPLE DAYS.  SPENT 6 DAYS IN THE HOSPITAL WITH MULTIPLE TESTS.  STARTED TO GET MY SPEACH BACK AND MOBILE ABILITY.  WAS RELEASED WITH THE FINAL DIGANOSIS BEING A MILD STROKE.  WAS ENCOURAGED BY SEVERAL MEDIAL STAFF TO REPORT THIS SINCE I HAD THE THE VACCINE JUST A FEW MONTHS PRYER.
Severe pain and inflammation in my arm where I received the vaccination,fever, severe headache, dizziness, pain throughout the entire body,nausea, and diarrhea.  I was not able to work since the onset of this reaction to the vaccine.
Pt recvd 3 doses of Engerix-B on 9APR90, 9MAY90, & 11OCT90 & mid OCT91 suffered a needlestick, described as a low risk needlestick; found to be HBSAG & HBCAG neg, non responder; pt will be given booster & titer will be retested;
1422: Pt reports  "ringing in ears and throat tightness"  1422- Pt taken to ER for further evaluation
Flare up of dry red skin around the eyes, itchiness. Flared up Eczema.
3 days later had clots in left calf, felt like blood pressure cuff inside of different places in lower leg cutting off feeling below and causing pressure up to hip.    It was only mostly resolved by taking about 1200 FU of nattokinase twice six hours apart.
Product temperature excursion issue; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, 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 an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not applicable    The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 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 (Product temperature excursion issue) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported. It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medications were reported.  This case contains information for the 57th of 77 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
Random itching throughout body - started on arms and legs and then was all over body, no hives, no rash.  Additionally sharp, random pains - feels like pins and needles - started on the next day
Patient reported chest pain shortly after having received second dose and on assessment, BP noted to be 208/102 and sustained high readings. Transported to ER via ambulance.
c/o lower bilateral arm pain and shaking of arms.  Arms did not shake when on her lap.   Denied chest pain or SOB .
Fever of 101.2 up to and including 5 days after injection; Pin prick rash all over trunk; Nausea; Vomiting; Diarrhea; Shortness of breath; increased fatigue; Muscle aches; stomach pain; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 28Jun2021 12:00 (at the age of 46-years-old) (Batch/Lot Number: EW0196) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient received Meds (unspecified) prescribed by physician within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since 29Jun2021, the patient experienced nausea, vomiting, pin prick rash all over trunk, diarrhea, shortness of breath, fever of 101.2 up to and including 5 days after injection, increased fatigue, muscle aches and stomach pain. The patient did not receive any treatment for the events. The reporter assessed the events as non-serious. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient experienced tightening of throat, blood shot, watery eyes (looked like they were bleeding). Severe chills, fever, hard time swallowing, S.O.B. Started about 1 1/2 hrs after injection. Treatment: Diphenhydramine 50mg Q 4hrs x 24 hrs.
1/10/18 9:00 PM PT TOLD MOTHER HER FACE FELT FAT. 1/11/18 PT WOKE UP WITH DROOPY LEFT EYE 1/12/18 WOKE UP WITH LEFT SIDE OF MOUTH DROOPY- ALL THREE DAYS PT FELT LIKE HER LEFT SIDE OF FACE WAS NUMB PER MOTHER.
The patient has a history of multiple myeloma and is currently undergoing therapy. He was brought to the ED by EMS on 2/14/23 for evaluation of shortness of breath, weakness, fatigue, and confusion that began two days prior. A COVID PCR test done in the ED resulted positive. He was admitted to the hospital on 2/14 for acute respiratory failure with hypoxia and pancytopenia. During admission, he was treated with steroids and on BIPAP. He continued to worsen and could no longer oxygenate with noninvasive support.  The patient passed away on 2/22/23. Discharge diagnosis was acute hypoxic respiratory failure, pneumonitis likely due to combination of med toxicity (isatuximab/carfilozamab for multiple myeloma) and COVID infection.  Of note, the patient has received the primary COVID vaccine series and one booster. The most recent booster was administered 12/22/21.
child received an IPOL post excursion with no adverse event; excursion with no adverse event; Initial information received on 06-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.   This case involves a 6 years old female patient who received an ipol post excursion with no adverse event and excursion with no adverse event was reported while receiving vaccine IPV (VERO) [IPOL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.    On 27-Jun-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml total(lot T1E871M, expiry date: 10-Oct-2022, strength: not reported) via subcutaneous route in the left arm for immunisation.   On an unknown date vaccine had excursion with no adverse event (product temperature excursion issue) and child received an ipol post excursion with no adverse event (poor quality product administered) (unknown latency) following the administration of IPV (VERO). They wanted to know if patient need to be revaccinated.   Action taken: was not applicable.   Outcome: Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
About 15 hours after receiving my booster I awoke with leg cramps. I was unsteady upon rising and nauseous. I proceeded to have diarrhea vomited 4 times within the first 18 hours. I lost 10 lbs in 3 days. I was weak and nauseous. I had to send my son to a sitter because I was so weak. The diarrhea lasted several days until I finally took an imodium. It took 6 days for me to feel 100% again. I had Moderna for my first two shots. It was not available when I went for my booster, so I got the Pfizer. It is my belief this dose also needs to be adjusted for those that had Moderna their first two shots.
pt recvd vax & mom states went home & gave APAP @ 1145AM & that pt went to sleep; pt hot & shaking 145PM eyes rolled back in head; t105.5 R; pt was sent home p/temp was below 101; mom states pt was dx w/ear infect; & was given Amoxicillin;
raised red hot area on arm; raised red hot area on arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (raised red hot area on arm) and FEELING HOT (raised red hot area on arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced ERYTHEMA (raised red hot area on arm) and FEELING HOT (raised red hot area on arm). On 05-Feb-2021, ERYTHEMA (raised red hot area on arm) and FEELING HOT (raised red hot area on arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.     Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Email information added
Pt developed chest pain on 5-1-2021, then went to the ER 5-4-2021, was hospitalized for pericarditis , elevated troponin 1 level, and hypokalemia.  DC 5-5-2021 after 1 night in the hospital.  Outcome: remains alive. TX management is colchicineo.6mg BID x 3 months and prn ibuprofen
patients received expired vaccine from the lot  that had beyond use date of 01/20/22.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received expired vaccine from the lot  that had beyond use date of 01/20/22.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received expired vaccine from the lot  that had beyond use date of 01/20/22.). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (patients received expired vaccine from the lot  that had beyond use date of 01/20/22.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  On 21-Dec-2021, the vial was initially stored in the refrigerator. The nurse stated that they had a lot  number which has a expiry date written on the box as 28-Mar-2022. However, when the lot  was moved the freezer to refrigerator the beyond use date was 20-Jan-2022. No side effect were reported by patient during the 15 minute observation time. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-457591 (Patient Link).
Pt received immunization on 3-13-07. Came back to clinic 3-15-07 to have PPD read. Mom reported redness and swelling at injection site right and left deltoid. Right deltoid area revealed approx 8 cm x 3 cm red slightly swollen area. Left deltoid area approx 3 cm x 1 cm. Non-tender.
The vial was stored in the refrigerator post expiry; No adverse event; The first dose administered on 04-Jan-2023 and second dose administered on 02-Mar-2023; It was inadvertently given a few days after expiring; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose administered on 04-Jan-2023 and second dose administered on 02-Mar-2023), EXPIRED PRODUCT ADMINISTERED (It was inadvertently given a few days after expiring), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator post expiry) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 060B22A and 052C22A) for COVID-19 prophylaxis.     The patient was not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 04-Jan-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2023 at 8:40 AM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose administered on 04-Jan-2023 and second dose administered on 02-Mar-2023) and EXPIRED PRODUCT ADMINISTERED (It was inadvertently given a few days after expiring). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator post expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose administered on 04-Jan-2023 and second dose administered on 02-Mar-2023), EXPIRED PRODUCT ADMINISTERED (It was inadvertently given a few days after expiring), PRODUCT STORAGE ERROR (The vial was stored in the refrigerator post expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The first dose administered on 04-Jan-2023 and second dose administered on 02-Mar-2023), EXPIRED PRODUCT ADMINISTERED (It was inadvertently given a few days after expiring) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator post expiry).    Concomitant medication was not provided.  Nurse reported that the vial was expired on 26-Feb-2023 and  the vial was initially stored in refrigerator on 21-Feb-2023. The vial did not undergo any temperature excursion. Treatment information was not provided.
Patient reports rash day after patient received vaccine. She reports rash on her neck. It is itchy, blotchy, and flat. She has been self treating with NEOSPORIN. Patient reported symptoms on 10/23/17 because her symptoms had not improved nor worsened.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 18-DEC-2015 at 17:20, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 8.6 and 6.2 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Pt diagnosed with Bell's palsy facial weakness left side of the face corticosteroids, maisbuy ey drops neurology f/u.
Mild erythematous patch/rash minimally pruritic. No other systems involved. Rash was anterior chest, not at injection site.
On 12/1/14 pt developed rash on torso. Consistent with varicella - discrete papules and vesicles some open. Patient did have a temp to 101 degrees F. No URI symptom. No known source of infection.
THE PATIENT HAD PASSED AWAY AND WAS UNABLE TO GET HIS SECOND SHOT TO COMPLETE THE SERIES. WE ARE UNSURE IF THE VACCINE WAS RELATED TO HIM PASSING.
Information has been received from a physician concerning a male who on 03-OCT-2005 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included cefdinir (OMNICEF). The patient developed a breakthrough case of chickenpox after receiving varicella virus vaccine live (Oka/Merck). The number of lesions is not known. It is not known if the patient recovered. There was no additional information to report. Unspecified medical attention was sought. No product quality complaint was involved. Additional information is not expected.
Egg sized, red, hard, lump at injection site. Itching. Hive-like bumps at site. Hot to the touch.
pt recv vax APR92 was vax w/pneumococcal vax; DEC94 lab eval revealed pneumococcal pneumonia & bacteremia; pt recovered from pneumococcal pneumonia & bacteremia; addtl details being requested;