chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness at injection site (ten days since she got injection); swelling (ten days since she got injection); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at injection site (ten days since she got injection)) and VACCINATION SITE SWELLING (swelling (ten days since she got injection)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   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, the patient experienced VACCINATION SITE ERYTHEMA (redness at injection site (ten days since she got injection)) and VACCINATION SITE SWELLING (swelling (ten days since she got injection)).   At the time of the report, VACCINATION SITE ERYTHEMA (redness at injection site (ten days since she got injection)) and VACCINATION SITE SWELLING (swelling (ten days since she got injection)) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
pt recv vax 5SEP95 & on 14JAN97 pt devel chickenpox;
Client felt dizzy and tightness in chest. Similar reaction after first dose and she said it lasted 24 hrs. She called doctor before this dose and is to call when she gets home.  POX 98, BP 146/86, HR 66 She waited 30 minutes and said she was ok to walk out and would sleep at home .
oN DAY 10 C/O 2 DAYS OF NIGHT SWEATS, INTERMITTENT BITEMPORAL HA, GENERALIZED PINK SUN-BURN-LIKE RASH ON ARMS/FACE/NECK AND MACULAR RASH ON ABDOMEN, NOW ALSO W/ PUSTULE ON CHEST AND L INGUINAL; ALSO NAUSEA AND ABDOMINAL PAIN/VOMIT/DIARRHEA
Onset approx. 12 hours post vaccine.  dizziness, fever, achiness, nausea- (about 18 hours post vaccine), headache
Muscle pain ach in hip and legs.  Quads, hamstring area , glutes, and lateral hips ,  pain has lasted 60 days so far and still present.  Similar to intense lactic acid buildup pain  Also happened after 2nd vaccine shot, pain last approx 90 days, also similar after first booster.  All vaccine applications were Moderna
Diffuse Pox Rash all over Body. Started on Lower extremities and moved to groin, then arms, then face. Also found on torso but not as severe.
pt recv vax 25JAN96 & 26JAN96 pt exp pain @ inj site & t102;pt lt arm was also swollen down to elbow & there was discoloration @ the inj site;28JAN96 pt arm was more swollen but fever had dec;following day pt seen by MD;allerg rxn of vax;
Received Gardasil #1 on 12/18/2007, had migraine headache, vaccine phenomenon.  Has history of migraines.  Low grade 99.8 next am (12/19/07).
Patient received a 12yrs and up Pfizer vaccine instead of the pediatric 5-11 year dose. So far no adverse reactions reported.
Patient received vaccine on 8/7/07. The afternoon of 8/8/07 patient started complaining of itching in area vaccine given in the left leg. The next morning mom noted red, warm area to touch. Patient still complaining of itching. Mom brought patient to our office at 4pm - 9cm x 9cm redness, swelling and area, warm to touch. Patient denied pain.
WOKE UP IN THE MIDDLE OF THE NIGHT HURTING ALL OVER (BODY PAIN); MORE TOTAL BODY JERKING; SORE JAW (PAINFUL TO OPEN MOUTH); TREMOR; JOINT PAINS FROM ARTHRITIS WORSENED; HEADACHE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and back surgery, and concurrent conditions included osteoarthritis of all major joints, and benign essential tremor.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 23A21A, expiry: UNKNOWN) dose was not reported, administered on 11-JUN-2021 for prophylactic vaccination. Concomitant medications included paracetamol for pain. On 11-JUN-2021, the subject experienced headache. On 12-JUN-2021, the subject experienced woke up in the middle of the night hurting all over (body pain). On 12-JUN-2021, the subject experienced more total body jerking. On 12-JUN-2021, the subject experienced sore jaw (painful to open mouth). On 12-JUN-2021, the subject experienced tremor. On 12-JUN-2021, the subject experienced joint pains from arthritis worsened. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from woke up in the middle of the night hurting all over (body pain), sore jaw (painful to open mouth), headache, joint pains from arthritis worsened, more total body jerking, and tremor. This report was non-serious.
Patient had his 1st COVID vaccine on 2/24 and experienced some hives and his 2nd COVID vaccine on 3/24 and experienced hives, fever, and night sweats.
no additional AE reported; GARDASIL 9 was administered to one patient after a temperature excursion; This spontaneous report was received from the Nurse Prescriber and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 28-OCT-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #1775827, expiration date: 27-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided). The vaccine was administered after a temperature excursion (product storage error). No additional adverse event was provided.
1st lt arm swelling noc of inject & next days/swelling was severe; n/v, sweats (hot & cold), fatigue, diarrhea, h/a & shoulders ached 3rd day-h/a, sore throat; 11MAY still nausea, h/a, some dizziness, diarrhea off & on;
Patient developed chest pain on the left side with inhalation. Left shoulder had a sharp dull pain with activity. Symptoms did not improve with ibuprofen.  Patient was evaluated in the ED and her EKG came back normal.
OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: 19/AUG/2021) dose was not reported, administered on 10-MAY-2021 16:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of specification product use was not reported. This report was non-serious.
Patient states she has arm pain since vaccine was given to her, range of motion is not the same. Patient has been told to try Tylenol (since day it was given), was told about warm/hot compress. Patient was told to contact MD about this issue but has no primary prescriber. Patient refuses to try any treatment options that manager or staff pharmacist recommend.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 47-year-old female patient who received BOOSTRIX (batch number KP95K, expiry date 3rd December 2017). On 9th November 2015, the patient received BOOSTRIX .5 ml. On 10th November 2015, 1 days after receiving BOOSTRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to BOOSTRIX. Additional details were received as follows: On 10th November 2015, the patient was feverish. The patient experienced fever of 101 degree F and then it was increased to 103 degrees F. The patient has been experiencing fever for a week after vaccination.
she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,; No appetite; Left arm was in pain and red; Developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨; Strange felling on her head; Joint pains; He started feeling like ¨a car had hit me and ran over me¨/terrible body aches; Fever; Headache ( worse than the one she had with the 1st dose); Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (Headache ( worse than the one she had with the 1st dose)) and NAUSEA (nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included Thyroid Medication,   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced CHILLS (chills). On 01-Apr-2021, the patient experienced MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), HEADACHE (Headache ( worse than the one she had with the 1st dose)), NAUSEA (nausea) and ASTHENIA (she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,). On 02-Apr-2021, the patient experienced DECREASED APPETITE (no appetite), ERYTHEMA (left arm was in pain and red) and FEELING ABNORMAL (strange felling on her head). On an unknown date, the patient experienced INJECTION SITE REACTION (m developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨) and ARTHRALGIA (joint pains). At the time of the report, MYALGIA (he started feeling like ¨a car had hit me and ran over me¨/terrible body aches), PYREXIA (fever), CHILLS (chills), HEADACHE (Headache ( worse than the one she had with the 1st dose)), NAUSEA (nausea), ASTHENIA (she was in bed, ¨could not woke up from bed/she has not been able to go to work again, due to her lack of strength,), DECREASED APPETITE (no appetite), ERYTHEMA (left arm was in pain and red), INJECTION SITE REACTION (m developed a little rush on the left side of her chest and felt like needles on that area ¨felt that symptoms 6 times¨) and FEELING ABNORMAL (strange felling on her head) outcome was unknown.     Treatment details included Tylenol 500mg.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
difficulty swallowing; mouth ulcers; This is a spontaneous report from a contactable consumer via medical information team. A 17-year-old patient of an unspecified gender received bnt162b2 (Solution for injection), via an unspecified route of administration on an unspecified date (at the age of 17-years-old) as 1st dose, single dose for covid-19 immunisation. Medical history included peanut allergy. The patient's concomitant medications were not reported. On an unknown date, the patient experienced difficulty swallowing and mouth ulcers after received first dose. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
parents report p/1st shots was OK; p/2nd dose 7JAN02 fussy did not sleep well for 2 wks; MD felt pt was teething not vax related; pt recvd 3rd dose of vax 17MAR92 & 3-4 days of t102 ax, fussy;
kicked my butt for a day; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received the 2nd dose of Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling unwell. In May 2022, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine last week and felt it kicked his/her butt for a day or so but so glad to had it behind him/her. Additional supportive information: The follow-up would not possible, as no contact details were available.
adult received a pediatric dose of engerix-b (17-October-2023) inadvertently; adult received a pediatric dose of engerix-b (17-October-2023) inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 56-year-old female patient who received HBV (Engerix B pediatric) (batch number P49X7, expiry date 07-DEC-2023) for prophylaxis.   On 17-OCT-2023, the patient received Engerix B pediatric (intramuscular, left deltoid). On 17-OCT-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: adult received a pediatric dose of engerix-b (17-October-2023) inadvertently) and adult use of a child product (Verbatim: adult received a pediatric dose of engerix-b (17-October-2023) inadvertently). The outcome of the accidental underdose and adult use of a child product were unknown.  Additional Information: GSK Receipt Date: 18-OCT-2023 The MA (medical assistant) reported an adult received a pediatric dose of Engerix-B inadvertently, which led to accidental underdose and adult use of a child product. The reporter consented to follow up.
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-OCT-2015 03:07, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 16.2 (2 hours and 10 mins) and -2.4 (13 hours 23 mins) 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.
Approx 1 hour after receiving the shot, felt tightness in throat, dry mouth, thirsty, funny feeling in lower lip, vital signs stable, no respiratory distress, heart rate normal. Given 50 mm Benadryl, Returned to work after 1 hr observation.
11/4/06 Noticed large red welts with red streaks on right underarm with swelling, tenderness and pain.  Started approximately 24 hours after vaccine.  Seen at Arnot Ogden ER at 10 PM on 11/4/06.  Reaction possibly caused by vaccine per MD.  Placed on Keflex for 7 days.  Symptoms improved, now resolved.
Immediate burning in both arms. Unable to hold a pencil to fill out card after receiving vaccine. Weakness in upper extremities.  Tingling, pain and numbness in both arms, red streaks appeared on the left arm going further up on to the shoulder, the were visible and painful for about 90 mins. Sweating. Nausea. Blurred vision. Loss of consciousness. Headache behind the eyes.
Information has been received from a health care professional concerning a 12 year old male with pollen allergies who on 01/03/2001 was vaccinated SC in the left arm with a first dose of varicella vaccine. Concomitnat vaccination that day included a first dose of hep B vaccine given IM in the left arm. There was no illness at the time of vaccination. On 02/05/2001 the pt experienced severe abdominal pain for five days. There was no nausea, vomiting, or diarrhea reported or no complaints of headache. The pt presented to the ER on the 7th day with a purple rash on his feet and legs, swollen tops and sides on feet, and arthritic type leg pain. The pt was diagnosed with HS purpura. Follow-up info received from the health care professional indicated that the pt's mother reported that "the HSP can cause kidney damage and he will now have his kidney checked every 6-12 months for life." She also stated that "the damage could occur years from now." Additional info has been requested.
A non-serious spontaneous report of "administered 1/2 dose" H1N1 has been received from a registered nurse concerning 12 children. The patient's medical history and concomitant medications was not reported. The patients received Influenza A (H1N1) 2009 either on 20-Oct-2009 or 21-Oct-2009. The reporter stated "I did not read the complete instructions on how to administer the H1N1 mist and gave 12 kids only a half dose." There was no adverse event associated with this drug administration error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
Mother observed child looking to the left with eyes and head. Mom thought she was going to vomit. Child walked with assistance to the bathroom and vomited. Went back to bed and would not respond to verbal commands. Mom phoned 911, she was transported to local hospital with dx of possible seizure.
Approx 10 hours after the vaccine was administered I experienced fever (102.3 degrees), body aches, and fatigue.
instead of asking them for the pneumonia shot he asked for a flu shot so they gave him the Adjuvanted Flu with no reported adverse event; Initial information received on 07-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 66 years old male patient who experienced instead of asking them for the pneumonia shot he asked for a flu shot so they gave him the adjuvanted flu with no reported adverse event while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Oct-2022, the patient received a  dose of suspect influenza quadrival a-b high dose hv vaccine at dose of 0.7ml  lot UJ882AB expiration date:30-Jun-2023 via intramuscular route in Left Deltoid site for Immunization.  On 07-Oct-2022 the patient developed a non-serious instead of asking them for the pneumonia shot he asked for a flu shot so they gave him the adjuvanted flu with no reported adverse event (wrong product administered) following the administration of influenza quadrival a-b high dose hv vaccine.  It was reported "Medical Assistant says the consumer received the FLUZONE HIGH DOSE QUADRIVALENT at their office and wanted to get the pneumonia 20 but they do not carry that. He went to the pharmacy next door to them and instead of asking them for the pneumonia shot he asked for a flu shot so they gave him the Adjuvanted Flu  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event instead of asking them for the pneumonia shot he asked for a flu shot so they gave him the adjuvanted flu with no reported adverse event.     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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Post second dose this pt experienced swelling, warmth, pain, and redness. On an unspecified date, he recovered.
Tues 4/13/2021, pain started in my back and leg. By Sunday, I developed a rash on my back and was diagnosed with shingles.
Patient is a 49-year-old female with a known past medical history of chronic persistent asthma, hypothyroidism, and GERD that presents to the ER with shortness of breath. Received covid 19 vaccine on 3/27/21. Had wheezing two days prior to vaccination and nebulizer treatments were not working.
pt recvd 1st dose of Hep B vax on 19FEB92 & exp itching of inject arm from the shoulder to the elbow; also felt tired; 2nd vax recvd w/no adverse reaction;
pt  stated he woke up with body aches and fever.  pt states still has body aches and feels like he did when had the corona virus.
It is my belief that I have developed Immune Thrombocytopenic Purpura due to the Pfizer vaccine administered to myself on 5/3/2021 and 5/24/2021. I developed spontaneous drop in platelet counts (2,000) and was treated in the ER. I was given 40 mg of Dexamethasone everyday for four days and another treatment a week later. I'm currently in treatment as platelets have not stabilized  and I'm scheduled to start on Rituxan on 9/16/2021.
Large lump in the left armpit area with pain to the touch. In the vaccine administration area, it is hot and very itchy to this day.
olecranon bursitis in her left elbow; swelling; Elbow was "purple and green" and resulted in "puckering" of the forearm skin.; Elbow was still a little tender; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Apr2021 (Lot number: EW0126) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BURSITIS (non-serious) with onset Apr2021, outcome "recovered with sequelae", described as "olecranon bursitis in her left elbow"; SWELLING (non-serious) with onset Apr2021, outcome "recovered with sequelae", described as "swelling"; SKIN DISCOLOURATION (non-serious) with onset Apr2021, outcome "recovered with sequelae", described as "Elbow was "purple and green" and resulted in "puckering" of the forearm skin."; TENDERNESS (non-serious) with onset Apr2021, outcome "not recovered", described as "Elbow was still a little tender". The events "olecranon bursitis in her left elbow", "swelling", "elbow was "purple and green" and resulted in "puckering" of the forearm skin." and "elbow was still a little tender" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of bursitis, swelling, skin discolouration, tenderness.  Additional information: Treatment received was unknown. Hospitalization prolonged it was reported as no. Prior to vaccination the patient diagnosed with COVID-19 was unknown. Since the vaccination the patient tested for COVID-19 was unknown. Patient also received bnt162b2, administered intramuscular administration date 18May2021 (Lot number: EW0183 Expiry date: Unknown) as dose 2, single for covid-19 immunisation. Reporter met a woman at a party on 06Nov2021. who said that she experienced olecranon bursitis in her left elbow shortly after receiving the first dose of the Pfizer vaccine in the left arm. She said that she had bumped the elbow on a doorknob shortly before getting the first dose, but that the swelling didn't occur until after the shot on 14Apr2021. She said she had consulted a rheumatologist about the bursitis and possible auto-immune disorders but was not diagnosed with any such disorder.  . No follow-up attempts are possible. No further information is expected.
Client stated that she developed hives on both arms and had a headache approximately 1 hour after receiving the vaccine.  She called her doctor's office who advised that she take 25 mg benadryl.  Client stated the symptoms resolved.
pt recvd vax & devel severe pain; redness; swelling to lt arm; resulting in abnormal emg; nerve conduction studies;
pt recvd vax on 10MAR92 & exp upper resp infection; 17MAR92 devel a rash that was described as having 5 to 6 raised lesion-like pimples above rt & lt hip; also fever & malaise;