chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient contracted cellulitis in his left leg, after receiving 3 vaccinations in that leg.  He had to be treated at the ER 38 hours after receiving the vaccines.  He was diagnosed with severe acute cellulitis.  During the 38 hours previous to treatment, he had been spiraling into a worse health condition, the infection in his left leg started with a small blister, evolving into a small red and hot mass.  Within 24 hours after vaccination, the infection had spread to about 5-6 inches in diameter, hotness, and redness, including swelling were present.  Patient ran a fever of 104 F.  By day 2, after his vaccintion, his whole upper thigh on his left leg was entirely inflamed, including his left knee.  We took him to the ER immediately.  He was given two different antibiotics, 7 doses daily; an antihistamine, 2 times daily; and pain relievers around the clock.  His upper thigh on his left leg was nearly 3 times the size of his right leg.  He also had a blister at the sight of injection.  His leg was hot and severely inflamed.  Patient also ran a severe fever.  We called our insurance nurse hotline, and were instructed to take him into ER.  He was treated by foreign health care system for the infection.  He is to be on both antibiotics for at least one week.  He is showing improvements.  Patient did receive 1 other vaccination in his right leg, but had no negative affects thus far.  Only vaccinations given in left leg had caused the problem.
the diluent was given without the actual drug mixed into it/ no AE; Initial information received on 03-Dec-2021 regarding an unsolicited valid non-serious case received from physician via call center via Medical Information (MI) (Reference number- 00883763).  This case involves a 3-year-old male patient who received the diluent portion without mixing of actual drug (powder) portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Product preparation issue).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 02-Dec-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (diluent: lot number: UJ465AA and expiry date: 21-May-2021) (Powder: lot number: U6940BA and expiry date: 21-May-2021) via an intramuscular route in the right arm for prophylactic vaccination.  It was an actual medication error case due to Inappropriate reconstitution technique (latency: same day).  It was reported "he diluent was given without the actual drug mixed into it, Is there any harm in that? Should they proceed with giving another dose immediately?; Nurse asking if the diluent was just given , Will I need to give the vaccine again and is there any harm for just giving the diluent?"  At the time of reporting, no adverse event was reported.  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 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.
14 days p/vax pt devel temp 103.5 & had a febrile sz;seen in ER;tx for febrile sz;
Induration and redness in area of injection (lateral aspect) of approximately 6X6 cm
Rash approx. 4"x 2" oval shape, raised, warm, itchy.  Mother gave child hydrocortisone cream and antihistamine.  Itching stopped, rash cooled down, still quite large, raised and red.
Right hand (palm, fingers) started peeling the skin off.; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Right hand (palm, fingers) started peeling the skin off.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The medical history was not provided by the reporter.     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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SKIN EXFOLIATION (Right hand (palm, fingers) started peeling the skin off.). At the time of the report, SKIN EXFOLIATION (Right hand (palm, fingers) started peeling the skin off.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter. Treatment information was not provided
Vomited up my dinner the night I had the vaccine.  After it began I could not keep down a bite of a cracker or a sip of liquid without vomiting it right back up.   This lasted for 3 1/2 weeks.  Passed out once and was severely dehydrated.  Had a horrible hospital experience that did not help me at all, even with fluid by IV that was not properly given.  Went to see Primary a week later with same symptoms and he gave me a shot of Zofran which lasted about 1 1/2 days where I was able to eat a small amount of food and some liquids.  Severe vomiting continued for another week and a half.
Report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Report a side effect) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided by the reporter.   No treatment information was provided by the reporter.
High eye pressure; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (High eye pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pressure intraocular increased.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OCULAR DISCOMFORT (High eye pressure). At the time of the report, OCULAR DISCOMFORT (High eye pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included eye drops Treatment information were not provided
pounding heart, heart rate increased; panic; Total body flushing; Sensation of hot and cold; Shaking; lightheadedness; feelings of passing out; nausea; arm  numbness; extremity tingling; headache; exhaustion; fever; fluctuating blood pressure; racing heart ,heart palpitations; mild flushing; brain fog; A spontaneous report was received from a healthcare professional concerning a 25-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced panic, rapid pulse, pounding heart, total body flushing, shaking, a sensation of hot and cold, lightheadedness, and feelings of passing out, nausea, extremity tingling, and arm numbness, headache, brain fog, racing heart, heart palpitations, fluctuating blood pressure, mild flushing, exhaustion, and fever.   The patient's medical history, was not provided by the reporter, but patient had a tuberculosis test done in recent days prior to vaccination, reports were  not provided. Concomitant medications reported included vitamin B-12 complex and ibuprofen.  On 04-Mar-2021 at 5:55 pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) intramuscularly in the deltoid for prophylaxis of COVID-19 infection.   On 04 Mar 2021, approximately after 23 minutes after receiving the vaccine patient developed panic, rapid pulse, pounding heart, total body flushing, shaking, a sensation of hot and cold, lightheadedness, and feelings of passing out. Patient pulled over and called 9-1-1, and she was taken by ambulance to a nearby hospital. Patient had reported that the symptoms persisted during ambulance transit and continued during her three hour hospital stay. Patient reported to have  development of nausea,  extremity tingling, and arm numbness while being admitted.   Patient reported that a friend of her drove her home from the hospital, and her brother was monitoring her condition. No medicinal treatments were administered at the hospital for the patient.   On 05 Mar 2021, Patient took advil to treat the headache and brain fog that has developed. Patient reported that the symptoms headache, brain fog, racing heart, heart palpitations, fluctuating blood pressure, mild flushing, exhaustion, and fever were continuing. As treatment for events no medicinal treatments were administered at the hospital. Patient reported that she had taken ibuprofen to treat a headache and brain fog.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of events, panic, rapid pulse, pounding heart, total body flushing, shaking, a sensation of hot and cold, lightheadedness, and feelings of passing out, nausea, extremity tingling, and arm numbness was unknown and  headache, brain fog, racing heart, heart palpitations, fluctuating blood pressure, mild flushing, exhaustion, and fever were not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a physician concerning a teenager female who was vaccinated with the first dose of GARDASIL.  The patient experienced dizziness after vaccination.  Subsequently, the patient recovered from dizziness.  The patient sought medical attention.  This is one of several reports from the same source.  Additional information has been requested.
This is a spontaneous report obtained from a contactable consumer who reported for her daughter. A female patient of an unspecified age and ethnicity received, on an unspecified date, TRUMENBA, single dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced some pain and little bit of swelling. Clinical outcome of the events was unknown at the time of this report. Follow-up (10OCT2015): Follow-up attempts completed. No further information expected.
Approximately two weeks after the second COVID vaccine taken on July 16, 2021 I began to experience low back pain on the left side and knee pain on my left knee - discussed with my primary care doc an MRI was done - had previously approximately one year prior a slight tear in the meniscus and the MRI showed some arthritis I started physical therapy and kept doing PT for over a year with no improvement went to an osteopath doctor for 6 months with no improvement still experiencing low back pain and pain in both knees no falls or explanation other than a adverse reaction to the vaccine
Patient described his right arm as bright red and swollen from the site of entry all the way down to his chest. I proceeded to tell pt that it was an allergic reaction. Told him to take BENADRYL and contact his Dr for followup.
LLT no adverse effect; Wrong vaccine administered; Vaccine overdose; This spontaneous report was received from company Representative and referred to his 2 child of unknown gender, just turned 1 year old.  Concomitant medications included sterile diluent. The patient's concurrent conditions, medical history, and historical drugs were not reported.  On 19-SEP-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection; and  varicella virus vaccine live (oka/merck) (VARIVAX) injection,  (strength, dose description, lot #, expiry date, route of administration, and indication were not provided), so in essence they received an extra dose of the varicella component (overdose) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and  varicella virus vaccine live (oka/merck) (VARIVAX) (Wrong product administered) by mistake. They did not noticed any untoward effects (no adverse event).  This is one of 2 reports received from the same reporter.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 3 (booster), single (Lot number: gg6738) at the age of 21 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Left atrium prolapse" (unspecified if ongoing); "long COVID" (unspecified if ongoing); "Known allergies: Sulfa, amoxicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events Drug ineffective, Covid-19 and the use of suspect product   BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.,Linked Report(s) : US-PFIZER INC-202300220429 same patient, different drug/AE.;
Pt became lethargic with an axillary temperature of 94.6, bundled and warmed by parents while at home. Temperature slowly increased to 97 (ax) after 1 1/2 to 2 hours. History of temperature of 100.4 preceeding hypothermia.
Patient received the vaccine on 10/1/2008.  After she returned to work, had shortness of breath, tachycardia.  School nurse (work place) checked her and BP elevated 144/92.  Episode lasted 30 minutes and resolved on it's own.  No local reaction noted.  Patient called doctor just as FYI.
Injected March 3rd and she called on March 6th with adverse reactions and was seen by Nurse Practioner for evaluation. At that visit it was determined she had a moderately severe reaction and she was sent home with pain medications with instructions.  On March 8th she came to Urgent care and describes problems with intense pain, no appreciable redness,swelling but she has affected range of motion.  It was after evaluation determined she had a local muscular reaction to the immunization.
Breakthrough case admission after 3 vaccines Pfizer 4/14/21 Lot# EP6955;  Pfizer 5/5/21 Lot# EW0168;  Pfizer 12/3/21 Lot# FJ8762
Menstrual period after first injection more painful and heavy than usual; Menstrual period after first injection more painful and heavy than usual; Menstrual period after first injection more painful and heavy than usual; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to artichokes" (unspecified if ongoing), notes: allergic to artichokes. The patient's concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), DYSMENORRHOEA (non-serious), HEAVY MENSTRUAL BLEEDING (non-serious), outcome "recovering" and all described as "Menstrual period after first injection more painful and heavy than usual". Therapeutic measures were not taken as a result of menstrual disorder, dysmenorrhoea, heavy menstrual bleeding.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Patient did not received any other vaccine in four weeks. And no other mediation in two weeks. Patient did not had COVID-19 prior vaccination. Patient was not tested for COVID post vaccination. Vaccine administration time: 09:30 AM.
Pruritic pustules with some bullae. Vesicule resposule with erosion sequlin. Erythema borders. Malaise with febrile reaction (99.4 F).
Fever of 101 degrees fahrenheit for 24 hours. injection site red, swollen and hot to the touch from date of injection up through the date of event reporting.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 31st July 2018, the patient received the 1st dose of SHINGRIX. On 1st August 2018, 1 days after receiving SHINGRIX, the patient experienced chills, fatigue and headache. On an unknown date, the patient experienced fever, injection site warmth, injection site induration, injection site swelling and injection site erythema. The patient was treated with naproxen. On 2nd August 2018, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the chills, fatigue and fever were recovered/resolved and the outcome of the injection site warmth, injection site induration, injection site swelling and injection site erythema were unknown. It was unknown if the reporter considered the chills, fatigue, fever, injection site warmth, injection site induration, injection site swelling, headache and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The health care professional called from home and did not have SHINGRIX batch number and expiry date. The patient received SHINGRIX and the next day on 1st August 2018 began to experience severe chills (at 2:30) which subsided within 2 and a half hours. She additionally experienced a severe headache which lasted almost 2 full days and was not relieved by naproxen. The patient also experienced fatigue and light fever. The injection site area was slightly swollen, warm, and extremely hard.
Syncope Approx 2 minutes after injection  while still at Dr office - complained head hurt, pupils dilated then suddenly became unconscious and unresponsive for about one minute. Pulse and breathing were normal immediately upon recovery but complained of ringing in ears and had no memory of black out.
Narrative: 36 YOF who received J&J vaccine & remained in facility for 15 minutes following vaccination. Patient subsequently taken to ED by ambulance the day following vaccination due to complaints of chest pain & SOB. Patient reports that all results were normal at hospital. No additional details known.
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiration date: not reported), via an unspecified route of administration, on Feb 16, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The caller stated she received her first COVID-19 vaccine from Pfizer and did not have allergic reaction the first 15 minutes afterwards. However, after 24 hours, on an unspecified date, patient experienced swelling of tongue and face and had bumps on chin, with outcome of unknown. She asked whether she could take the second dose of the Moderna vaccine. Information on the batch/lot number requested. Follow-up attempts completed. No further information expected.
left sides facial numbness; This is a spontaneous report from a contactable Other Health Professional (patient himself). A 44-Year-old male patient received first single dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number ENG202), via an unspecified route of administration, administered in the Left Arm on 03Mar2021 06:45 (age at time of vaccination 44 years), as dose 1, single for COVID-19 immunization. The patient medical history includes, patient had known allergy to penicillin. The patient concomitant medications included Vitamins, minerals, ibuprofen. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed COVID-19 Prior to vaccination, Since the vaccination, has the patient been tested for COVID-19 as no. On 03Mar2021 07:00 the patient experienced left sides facial numbness. The patient did not receive any If treatment for adverse event and he had penicillin allergies. The outcome of event was recovering.  No follow-up attempts are possible. No further information is expected.
Pt was administered a flu vaccine and PNEUMOVAX 23 in the same arm on 11/6/18. He had redness and swelling in his arm the evening he received the vaccines. Pt received PNEUMOVAX 23 on 11/14/2017 from us, as well, so the vaccine was not needed.
Diarrhea, fever, cold chills, achy feeling for 3 days. Foggy head.
C/o red rash following Imm. 04/15/11 no fever, pain, some tenderness appx. one day after Imm. No medications given by mom. ALLEGRA given in office.