chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired kinrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 03-MAR-2023) for prophylaxis.   On 09-MAR-2023, the patient received Kinrix. On 09-MAR-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired kinrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-MAR-2023 The reporter reported that the patient received the Kinrix vaccine which was expired on 3rd March 2023. Adverse event contained all reported information. HCP gave consent for safety team follow up. The reporter did consent to follow up. The patient received a Kinrix which was already expired, which led to expired vaccine used.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and sex who on an unknown date, were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # K021485, expiration date 03-NOV-2016, through an unspecified route. No adverse effects were reported. The outcome of incorrect product storage was unknown. This is one of several reports received from the same source. Additional information has been requested.
Grey dots on legs; This case was reported by a pharmacist and described the occurrence of skin discoloration in a infant patient who received DTPa-HBV-IPV (Pediarix) (batch number TS425, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) (batch number 5Y9N9, expiry date unknown) for prophylaxis.   Concomitant products included PEDIARIX and HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (HIBERIX).   On 11th October 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix. On an unknown date, less than 2 months after receiving Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device and Hiberix.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171025   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots on skin after receiving Pediarix and Hiberix. The reporter was consented to follow up. Additional supportive information: This was 1 of 19 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171062:Same reporter
5/20/05 received Comvax 5/21/05 had several 5-10 sec staring, tongue moving episodes 5/22/05 developed 30 to 45+ sec similar episodes with limpness; brought to ER and admitted.  ER and hospital staff witnessed the episodes 5/23  EEG showed seizure activity; MRI normal.  Placed on IV, then PO, Phenobarbital by Pediatric Neurologist.  Seizures stopped. 5/24  Seen by Pediatric ID specialist.  Advised not to receive Comvax or the components anymore.  Discharged  Following the first Comvax, given 3/31/05, parents had witnessed a 5-10 sec staring tongue moving episode, for which they also took the baby to the ER; the baby was observed for 6 hours and discharged with apparently no recurrence. Date of ER visit 4/1/2005
mom reports that gave pt one dose of APAP prior to vax & pt vomited this;pt temp not higher than 99 ax;pt vomited again;130PM pt started crying, screaming inconsolably until 4PM that day;
Localized 7.8cm x 9.5cm indurated erythematous hypercaloric lesion without fluctuation; mildly tender to palpation; started second day after Tdap vaccine; no systemic symptoms
Per pt, she saw an urgent care  doctor and she is on antibiotics.  Per pt she said MD told her she has cellulitis due to Covid  injection
Left arm swelling and tenderness. Happened one day after Dtap vaccine. No fever.
Pt received her vaccine, during her 15 minute post vaccine observation period, pt became pale, cool to touch, & diaphoretic. Pt had 2 witnessed syncope episodes. EMS was present at clinic & transported her to the local ED (Hospital). She was admitted to the hospital on 2/25/21 & was discharged on 3/2/21.
I have moderate swelling and redness to right upper arm where I received the vaccine. It is warm to the touch and firm all over. I have not been bit by anything to my knowledge and the redness is pretty consistent all over- also not indicative of a bite. The site is probably three inches wide. I have pictures if anyone wants them.
6/12/09 9am: Two days after vaccination, patient reported that site of injection was red, swollen and warm to the touch. Pt reported that size of area of irritation was 1 to 1&1/4" diameter. patient did not feel any pain prior to discovery of adverse effect. However, after discovery patient noted that the area was tender to the touch and her pain increased                                            4:45pm: pharmacist called patient to check on how her arm was. patient stated that the area was bigger than a silver dollar size, pain was also more obvious, and area was red and swollen. patient also stated that she felt queasy,tired and her stomach felt like she was having car sickness. Patient had some nasal congestion, sore throat and post nasal drip at time of vaccines administration and continues to have these symptoms on this day. Patient was advised to take over the counter Ibuprofen 400mg to 600mg by mouth three times a day for pain relief.                                          6/16/2009: Spoke to patient and she states that she had a fever of 101F during the weekend(06/12/09-06/14/09). She took tylenol for the pain and fever which helped. Patient also stated on this day that she had congestion of the throat within 30 minutes after receiving vaccine, which she did not mention in previous conversations.  She took some vitamin C for it and that the congestion is now cleared. Patient has no pain today.
Swelling, redness and very itchy at injection site. Hot to the touch. Swelling and redness lasted about 7 days and itching still present at day 13 post injection (severe at times).
Information has been received from a nurse concerning an approximately 18 year old female who in approximately February 2008, "last spring" was vaccinated with a dose of GARDASIL (it is not known which dose it was in the series, lot number was not available). Concomitant therapy included "other unspecified vaccinations." It was reported that the patient experienced general anxiety after the shot was given. The patient sought medical attention. Additional information has been requested.
Fever (102.5), Elevated Blood Pressure, Pulse resting 130 bpm, Red/swollen left arm, General body aches all lasting about 24 hours then all side effect subsided.
itchy; pain in the arm, itchy, and red as orange; pain in the arm, itchy, and red as orange; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy), PAIN IN EXTREMITY (pain in the arm, itchy, and red as orange) and VACCINATION SITE ERYTHEMA (pain in the arm, itchy, and red as orange) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced PRURITUS (itchy), PAIN IN EXTREMITY (pain in the arm, itchy, and red as orange) and VACCINATION SITE ERYTHEMA (pain in the arm, itchy, and red as orange). At the time of the report, PRURITUS (itchy) and PAIN IN EXTREMITY (pain in the arm, itchy, and red as orange) outcome was unknown and VACCINATION SITE ERYTHEMA (pain in the arm, itchy, and red as orange) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received Meloxicam for Sinux nasal inhaler.   This case was linked to US-MODERNATX, INC.-MOD-2021-068480 (E2B Linked Report). This case was linked to MOD-2021-148532 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Non significant follow up report was received on 19 May 2021.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068480:
Pt contacted Pharmacy on Thursday, 9/23/2021 to inquire about potential adverse effects following her second dose of the COVID-19 Pfizer vaccine.  The vaccine was given on Friday, 9/17/2021.  She stated her are was sore following the injection and the arm felt swollen and like there was a hard knot at the injection site.   On Thursday, 9/23/2021 around 4AM the arm became red and hot to the touch and she began having pain below the injection site in the area of her bicep. She described the pain as a deep ache.
pt recv vax 1JUL96 & 3JUL96 pt devel edema @ the site of inj that was 6-7cm round;the area was soft & not red or hot & then pt did not exp pain on palpation;pt tested positive for hep b on 8NOV96;
We were conducting a booster clinic.. We were told by medical staff that everyone showing up to the clinic was eligible for a booster, per their Medical Director. Individuals receiving boosters did not have access to their Covid-19 record cards for nurses to verify before giving the vaccine. Afterwards, when inputting doses into the database, it was discovered that this individual had received their booster dose too early per CDC guidelines. They were monitored afterwards per CDC guidelines and no adverse events occurred. They were eligible to receive their booster on 12/23/21, but received it on 11/18/21.
upon awakening this AM eyes w/matted appearance (yellowish drainage) & edematous both feet (bottom of feet) orangish/red w/white splotchy appearance & edema; painful to touch; rt deltoid @ inject site sl edematous & warm to touch; bruise
Information was received from a registered nurse, concerning a 4 year old male with no medical history or allergies who on 28-MAR-2003 was vaccinated into the right thigh with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 649263/0589P). Concomitant therapy, that same day, included a third dose, into the left thigh of Tripedia (lot # V1343CA) and a third dose, into the left thigh, of Pneumovax (Lot # A74404B). The patient had no illness at the time of vaccination. On 22 MAR 2007, the patient developed bumps on the face, arms, legs and back. The patient was examined and diagnosed with chickenpox. The patient presented with about 35-40 lesions on his face, upper and lower extremities. The patient was treated with acyclovir, 200mg, QID X five days. On 02 APR 2007, the patient was considered recovered. There was no laboratory test performed. There was no product quality complaint involved. Additional information is not expected.
Developed UTI symptoms the following morning after 2nd Moderna dose.  Seen at Urgent Care and received antibiotics.
Information has been received from a pharmacist and an infection control nurse referring to a 72 year old female patient. Information regarding patient's medical history and concurrent conditions were not reported. On 11-JAN-2018 (also reported as on "19-JAN-2018" by the nurse), the patient was vaccinated with the 1st dose of PNEUMOVAX 23 (lot # N019348, expiry date 08-FEB-2019) for routine vaccination. It was reported that the patient also was vaccinated with a dose of PREVNAR 13 on an unknown date more than a year prior to receiving PNEUMOVAX 23. Concomitant therapies included fluticasone propionate (FLONASE) and ipratropium bromide. The pharmacist reported that on 11-JAN-2018, the patient also experienced an unspecified swollen and tender arm after receiving PNEUMOVAX 23.  The nurse reported that the patient experienced redness, swelling, pain and heat at the injection site when she received pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The nurse stated that the patient reported back to office at 48 hours post vaccination on "19-JAN-2018", with what was termed "like a bacterial infection". The patient was treated with cephalexin (KEFLEX) and the infection was resolving. The outcome of an unspecified swollen and tender arm was unknown. At the reporting time, the causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was unknown.  The nurse reiterating requested for lot check to determine "contamination" of the vaccine.  This is one of three repots from the same reporter source, linked to cases # 1801USA007902 and 1801USA008061.; Sender's Comments:  US-009507513-1801USA008061: US-009507513-1801USA007902:
Hot painful red rash on abdominal area; Hot painful red rash on abdominal area; welts; swelling; This is a spontaneous report from a contactable other hcp.   A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration at single dose left arm on 23Jan2021 11:15 for covid-19 immunisation. Medical history included thyroid disorder, breast cancer female, migraine, allergy to sulfonamide and topamax, food allergy. Concomitant medications included levothyroxine, liothyronine (NP THYROID), multivitamin, plant based calci. The patient experienced hot painful red rash on abdominal area on 23Jan2021 18:00, welts on 23Jan2021 18:00, swelling on 23Jan2021 18:00. No treatment received. The outcome was not recovered. Information on the lot/batch number has been requested
laryngospasms; Bronchospasm; laryngospasms; Bronchospasm; This spontaneous report was received from a nurse prescriber refers to a patient of unknown demographics. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown date approximately in MAY-2019 (about 5 months ago), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (strength, dosage information, lot# and expiration date were unknown) first dose, via oral route for prophylaxis. On the same day after the first dose, the patient experienced laryngospasms that changed to bronchospasm while in office. The patient received albuterol dose likely through a nebulizer as a treatment and the patient recovered while in office. The nurse referred the patient to a pulmonary doctor, but the parent decided not to take patient to pulmonary doctor and they felt patient was recovered. On an unknown date approximately in July 2019 (also reported as "about 2 to 3 months ago"), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dosage information, lot# and expiration date was unknown) second dose, via oral route for prophylaxis. experienced laryngospasm and bronchospasm. On the same day after the second dose, the patient again experienced laryngospasms that changed to bronchospasm while in office. The patient received albuterol dose likely through a nebulizer as a treatment and the patient recovered while in office. The outcome of laryngospasm and bronchospasm was resolved. The reporter's causality was unknown. No product quality complaint (PQC) reported.
Woke up with a fever a few hours after taking the booster; not unusual for me. The next day I had chest pain at the center right side of my chest. This pain continues to the present, and also changes sides. Sometimes it?s centered and makes it hard to breathe. I had an increased heart rate over 15 beats as well for almost two months post vaccine, which has since decreased to the point where it?s now at the athlete level when I?m physically not an athlete. This has been ruled as not cardiovascular. I also have low blood pressure (80s/90s over 50s/60s) now where it used to be deemed ?textbook perfect? by my cardiologist, chronic fatigue, increased anxiety, an occasionally numb/cold left arm, cold hands and feet all the time, intense abdominal pain, a new diagnosis of IBS, and severe weight loss.
Extremely heavy menstrual cycle and cramps, period came back 11 days later even worse
About a week after vaccination I had a red itchy, swollen knot pop at the injection site.
High temp body aches nausea vomiting headache dizzy felt like i had the flu
Vaccine was given in error, based on approved age per current EUA. No adverse outcome to the vaccine was reported.
ON 5-3 PT RECEIVED MMR AND VARICELLA VACCINE, ON 5-12 PT DEVELOPED RASH ALL OVER BODY AS WELL AS FEVER OF 102+.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On an unspecified date, in 2012, the patient was vaccinated with the first dose of RECOMBIVAX HB 10 MCRG/1.0 ML, (route of administration, lot # and expiration date were not provided). Approximately, in 2015 (reported as "3 years after the first dose"), the patient received the second dose of RECOMBIVAX HB, (dose, lot #, expiration date and route were not reported), (inappropriate schedule of drug administration). No adverse effects were reported. It was unknown if the patient sought medical attention. No product quality complain was involved. Additional information has been requested.
Patient requested PREVNAR 13 but was mistakenly given PNEUMOVAX 23. She has already had this vaccine several years back. Ended up going to MD 3 days later for large, swollen, painful arm. Had began to improve after 6 days.
fever of 100.6 for 4 days, myalgia, fatigue, weakness, axillary swelling/pain, left medial breast erythema, pain, edema, firmness for 2 weeks, firmness of breast to current date
Beginning 3.17.21.  Bowel discomfort and mild diarrhea.  Nausea.  Chills.  Increased joint pain and tiredness
Patient complained of "tongue feeling heavy" and "itching in roof of mouth". 25mg PO Benadryl given at 1444 on 2/22/21.
Red, swollen deltoid area.  Recall vaccine due to cold refrigerator temperature on 01/24/03.
DEATH; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. 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, and batch number were not reported, expiry date: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. Dose number in series was 1. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection, suspected clinical vaccination failure and was dead (dose number in series was 1). The consumer reported as "my friend got covid after getting the vaccine and passed away". It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died (unknown cause) on an unspecified date, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This report was associated with a product quality complaint: 90000208523. This case, from the same reporter is linked to 20211251030 and 20211251043.; Sender's Comments: V0: 20211251833 - death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211251833 -COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Fever 100.6 F; Chills and she is Tired; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever 100.6 F), CHILLS (Chills and she is Tired) and FATIGUE (Tired) in a 70-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 15-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 16-Feb-2021, the patient experienced PYREXIA (Fever 100.6 F), CHILLS (Chills and she is Tired) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever 100.6 F), CHILLS (Chills and she is Tired) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Pyrexia: 100.6 f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
After all vaccines and booster I still contracted Covid-19 (Omicron?). It was a little more than a bad cold. Low fever, cough, and diarrhea. Lasted about three days. I credit the vaccine with making the experience less severe.
pt claims to have syncopal episode, fever (undocumented), local pain, hives; pt returned to clinic following day, but did not have any of the above sx;
Still had painful site 4 days post injection radiated to right of site where felt hard area. 3rd day post injection, a lot of itching at site.
sore shoulder starting 7 hrs after injection. Woke up to 102 F fever and chills at 2 am.  Symptoms slowly dropped away to just balance issues as of morning of 03/29.
severe cough with CXR and CT abnormalities  suggestive of diffuse bronchiolitis
Flu like symptoms. Body aches, chills, nauseous, headaches. Pain in the injection shot arm.