chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adverse event; missed my 2 to 6 month window; This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced adverse event and social problem. On an unknown date, the outcome of the adverse event and social problem were unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The reporter reported that when it was time to have my second dose Shingrix, COVID-19 was spreading and was reluctant to go to the pharmacy for my second shot.  The patient did not want to confuse the Shingrix side effects with COVID-19 symptoms. Therefore, missed the 2 to 6 month window and it's been 9 months at the time of reporting. The reporter asked did the patient had to start all over.
This spontaneous report as received from an other health professional refers to a patient of unknown age. On 05-SEP-2014 0.5 ml (Oka/Merck) VARIVAX (lot# unspecified) that underwent a temperature excursion was administered to the patient via subcutaneous. No adverse effect was reported. This is one of two reports from the same reporter. The other report is 1409USA004711. Additional information has been requested.
Patient received vaccine on Monday, Nov 15, 2021 at approx. 1pm without any issues. On Tuesday, Nov 16, 2021, she had a dry, itchy rash that began encompassing one side of her face. She is self treating with Benadryl and anti-itch cream. She will only seek medical care if it worsens.
The following day pt became nauseated, short of breath and dizzy and had  fall down the stairs. She has some ongoing SOA which is being investigated.
Parents reported temp of 103 at 9pm. Baby given TYLENOL & no further temp c/o. Feeding well on 11/10/10 parents noted rash on legs. Client seen 11/11/10 & papules on upper thigh noted.
Soreness, mild swelling and redness at injection site followed 5-7 days later, by mottling in the skin of both extremities, clavicle area and back of neck with prominence of veins in feet and upper extremities with temperature changes. This was  accompanied by a prickling sensations.  I got a sore inside my right nostril and a cold sore on right upper lip.  The mottling and vein prominence continue intermittently still.  Improving but not resolved entirely. Along with this, my eyes became intermittently  itchy as if I had an allergic irritation. This has also completely resolved.  I spoke with a relative who is a physician  and he felt that I may have had a hypersensitivity cutaneous vasculitis reaction.
Exactly what they warned: very sore arm, woke up in the middle of the night with uncontrollable shivering and a headache. Next day, headache, slight chills, low fever and lethargic. Gone by Friday night, with slight headache saturday and sunday.
no adverse event; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) 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. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 14-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-715570 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-715570:Adult Patient 2
DIARRHEA; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (DIARRHEA) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, TORSEMIDE, DIGOXIN, WARFARIN, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), DIAZEPAM, ACETAMINOPHEN, TAMSULOSIN and VITAMINS NOS for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced DIARRHOEA (DIARRHEA). At the time of the report, DIARRHOEA (DIARRHEA) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not treated for the reported adverse event.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Non-significant follow up as reporter states in email that its too much work and make it easier. No events mentioned in mail
Vaccine given appx. 11 a.m. 10/08/04. Arm very sore, unable to raise it by 1:30 p.m.; large red area of swelling where injection was given. By 7:00 p.m. tiredness set in with fever and severe swelling of entire upper arm with heat eminating from area. Patient wanted to sleep and rest, but  the wife wouldn't let him and finally convinced him he needed medical attention by appx. 9:00 p.m. Emergency walk-in med. center (EMO) diagnosed edema and cellulitis at site of injection, with temp. of appx. 101. Injection given of Rocephin and antibiotic; 2 Motrins; 2 antihistamines. Instructions to return the next day for re-check. At this time on 10/09/04, swelling and redness still present,still unable to raise arm, but no fever. Prescriptions given for 10 days of Prednisone and 10 days of oral antibiotics. EMO requested 3 day follow-up on 10/12/04; swelling is reduced, temp. is normal,and patient has full use of arm.  Follow up on 10/18/04 states: "Right deltoid problem site."
Sever chills; Fever off and on for 30 hours\Temperature 99.8 - 103.2 for 6 hours; Heart rate increased; This is a spontaneous report received from a contactable consumer (Patient). A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 intramuscular, administered in Arm Left on 23Mar2021 13:00 (Batch/Lot Number: EN6207) as single dose for covid-19 immunisation. Medical history included herpes zoster from an unknown date and unknown if ongoing (Had a similar reaction to shingles vaccine). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1, administered in Arm right on 02Mar2021 18:15 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. Concomitant medication included metoprolol succinate 25 mg and diltiazem hydrochloride 120 mg (DILTIAZEM CD). On 23Mar2021 05:30, the patient experienced sever chills, Fever off and on for 30 hours\Temperature 99.8 - 103.2 for 6 hours and heart rate increased. The patient underwent lab tests and procedures which included body temperature: 99.8 - 103.2 on 23Mar2021 (Temperature 99.8 - 103.2 for 6 hours), heart rate increased: 100-120 on 23Mar2021 (Heart rate increased to between 100 -120 / bpm for 6 hours). The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was recovered.  Follow-Up(03May2021): Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information which included: Deleted the event "Temperature 99.8 - 103.2 for 6 hours LLT: Body temperature" and subsumed to existing LLT: Fever.
lymph node under her left arm next to her breast swelled up/warm and red; Fatigue; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Nov2022 as dose 4 (booster), single (Lot number: GJ6665) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing), notes: Medical History (MedDRA code): Blood pressure, Continuing: true, Comments: Blood pressure; "Cholesterol" (ongoing), notes: Medical History (MedDRA code): Cholesterol, Continuing: true, Comments: Cholesterol. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (3rd dose: , Date: 06Dec2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided), administration date: 06Dec2021, when the patient was 60-year-old, for Covid-19 Vaccination; BNT162b2 (1st dose: , Date: 20Mar2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EN6206), administration date: 20Mar2021, when the patient was 59-year-old, for Covid-19 Vaccination; BNT162b2 (2nd dose: , Date: 10Apr2021 , Time: Not Provided , Anatomical Site of injection: Not Provided , Route of Administration: Not Provided , Batch/Lot number: EW0151), administration date: 10Apr2021, when the patient was 59-year-old, for Covid-19 Vaccination. The following information was reported: CHILLS (non-serious) with onset 18Nov2022, outcome "recovered" (25Nov2022); FATIGUE (non-serious) with onset 18Nov2022, outcome "recovered" (25Nov2022); LYMPHADENOPATHY (non-serious) with onset 19Nov2022, outcome "recovered" (24Nov2022), described as "lymph node under her left arm next to her breast swelled up/warm and red".  Additional information: Vaccination Facility Type was Hospital. Vaccine was not Administered at Military Facility. Patient wanted to report she had a reaction to it or a side effect. Her lymph node under her left arm next to her breast swelled up the next day and stayed swollen for about 5 days, at one time into the third day, it was warm and red. States it was in the same arm that she got the shot in. She also reports she had fatigue and chills. Treatment: she did call the CDC and spoke to a nurse specialist on 21Nov2022 and was told to drink plenty of water. Prior Vaccinations (within 4 weeks) was none. Family Medical History Relevant to Adverse Events was none.
Swelling in her hands; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling in her hands), PYREXIA (Fever) and HEADACHE (Headache) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in her hands), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PERIPHERAL SWELLING (Swelling in her hands), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
09/23/10@12:00AM - c/o nausea, fever (104.3 at 4:30am), fatigue, body aches (9),. Mom stated she gave client 2/St Joseph ASA and 2/Acetaminophen p.o. Client presented with sensitivity to light, wheezing in upper lobes, skin dry and hot to touch, Temp noted at 104.3.  Mother stated client had Rice, Pork roast with gravy and chicken noodle soup.
Patient received a 1 day expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 3E52S, expiry date 21st June 2022) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd June 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 22nd June 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 22-JUN-2022 Reporter's Comment: Medical assistant reported that a patient received a 1 day expired dose of Boostrix. The reporter consented to follow-up. Additional Supportive Information:  The patient received a dose of Boostrix vaccine which was already expired in 21st June 2022, which led to expired vaccine used.
Patient brought in prescription for Menactra  on 6-14-21 but the prescription was entered and given as Bexsero. The patient wasn't aware until she visited her Dr and they noticed the incorrect vaccine was given. Patient reported typical bruising and arm soreness for approximately 3 days, but no other adverse effects. Mom called 7-8 and reported the error to us, and the correct vaccine (menactra) was given to her on 7-8-21
Patient woke middle of the night after receiving flu vaccine with rigors.  no fever.  Symptoms abated with Motrin.  I spoke to mother on phone as MD on call for clinic.  No other symptoms reported.
Day 1- Numb/ Tingling /cold hands.  Both hands Day 2-Diarrhea  Day 4- Sore aching wrist, right side only Day 5- Terrible Headache Day 6- Extreme Fatigue , mild headache, achy,  very large swelling in right armpit (size of a lemon) Day 7- Swelling in armpit continues Day 8-Raised itching Rash on right thigh, stomach, arm and leg.  Swelling in armpit decreased  Day 9- That?s tomorrow and I am worried
Inflammation of the tissue which surrounds the heart. Pericarditis. Taking Colchicine and Indomethacin.
Fever, chills, delirium, brain fog, vomiting, diarrhea, weakness,  This continued for the entire week and I went to a walk in clinic, my primary care doctor and was finally advised to go to the hospital.  At the hospital I went into crisis as they did not believe my issues were vaccine related and did not take it seriously at first.  I  spent a week with them running tests while I hallucinated and lost down to under 100 pounds.  In the end I had an undiagnosed auto immune disease and had I not made it to the hospital when I did I would have died.  I'm thankful for the vaccine but it's very risky for those who may have undiagnosed conditions.  I am unsure how to proceed on the booster, even with treatment for my auto immune disease.  I do not believe that the vaccine cause my auto immune disease, but I do know that I should not have taken the vaccine without being treated for it.
This spontaneous report was received from a physician via a company representative referring to a 79 year old female patient. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. The physician noted that the patient had injection site reaction while on PNEUMOVAX 23. The patient was seen by the physician and unspecified treatment was given due to the event. It was not provided if the patient performed lab diagnostics/studies. The outcome of injection site reaction was reported as recovering/resolving. The causality between PNEUMOVAX 23 and injection site reaction was not provided.
developed rashes in his leg/It is a little red rash on the legs; Itchy; This is a spontaneous report from a contactable consumer (wife of patient). An 82-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 27Mar2021 at 13:00 (at the age of 82-year-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included Memory Problems. The patient has had memory problems for about a year or so. The patient's concomitant medications included medication for his memory (unspecified). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, on 06Mar2021 (at the age of 82-year-old) as DOSE 1, SINGLE for covid-19 immunization. On 30Mar201, the patient felt itchy. Then it was still itching in morning and on 31Mar2021, the patient experienced a rash on his legs. It was a little red rash on the legs. The patient never had it before. The patient wanted to know, if that would decrease the efficacy of the vaccine. The outcome of the event Erythematous rash was unknown an Itchy was Not recovered at time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was reported that a patient (4 of 4) received a Fluzone SV vaccination on 12/01/2000. Reportedly the patient developed local redness within 1 hour of the injection. No specifics were provided. Further information is requested. From additional correspondence received 03/13/2001, it was reported that the patient awoke from sleep 12/01/2000 with pain, hardness and a 3cm burgundy colored area at the injection site. The patient was treated with Tylenol and Benadryl. The symptoms were resolved within 24 hours. Additional patient, vaccine, vaccine administrator and responsible physician information were also provided.
Fatigue started at noon on 04/22/21.  Chills and temperature reached 100.2 in the evening of 04/22/21.  Cold washcloth on forehead and pulse points on neck.  Normal temp morning of 04/23/21.
pt recv 1dose varivax/1dose MMR II 3/23/98 & 4/7 devel 1vesicular lesion on chest, approx5-6 pink spots on chest. addl info from, pt devel a pustule at inject site, crankiness,1 episode of emesis, dec appetite.4/18 blister rash ER/m.d. req
I have tenitus and after a half hour my ears started ringing about 50% louder.
Right arm very sore after injection. Approximately 8 hours  after injection, fatigue and headache  developed.  12 hours after injection  extreme chills developed so that patient  had to wear flannel pajamas, wool hat , socks to bed and sleep under down quilt, 3 blankets and turn up home heat.  Temperature and  body pain followed . Temperature and fatigue persists  30 hours after injection
Pt recvd 1 dose of Engerix-B & on 21MAY92 devel sore throat, head colds, fever & diarrhea; pt also devel painful bladder infect; seen by MD for med & UA; MD advised pt against finishing the Engerix-B series; poss allergic;
Cough; Just sleeping in bed; no appetite; Sneezing; Feeling horrible; Body aches; Fever; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), BEDRIDDEN (Just sleeping in bed), DECREASED APPETITE (no appetite), SNEEZING (Sneezing) and FEELING ABNORMAL (Feeling horrible) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 COUGH (Cough), BEDRIDDEN (Just sleeping in bed), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), FEELING ABNORMAL (Feeling horrible), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, COUGH (Cough), BEDRIDDEN (Just sleeping in bed), DECREASED APPETITE (no appetite), SNEEZING (Sneezing), FEELING ABNORMAL (Feeling horrible), MYALGIA (Body aches), PYREXIA (Fever), CHILLS (Chills) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient developed a rash all over the body which started 24 hours after receiving the pediatric pfizer vaccine.  He took 7 days of antihistamines then it finally resolved.
The patient received varicella & Tdap in left shoulder. Since that day and over the past month she has had increasing pain and tenderness of her entire left upper extremity and intermittent pain and tenderness of her right arm, lumbar spine and left leg. No fever. Edema noted superior to left scapula. Normal studies: CBC, ESR, CRP, CMP, CPK, RF, 2 view xray left shoulder, urinalysis.
pt recvd vax & was unresponsive for > 1 min; pt responded to mom blowing;
redness, swelling around injection site (golfball sized circle), pain...took naproxen
On 9/17/21 at 1806 the patient alerted staff he was having a nose bleed. He reported he blew his nose and it started bleeding.  The bleeding stopped with ice pack.  At 20:42 his nose started to bleed again.  He was transferred to the ER for eval and treatment.  The resident was treated for epistaxis - started on Albuterol inhaler as needed for bronchospastic pulmonary disease and azithromycin.
Hospital discharge note of 15 Feb 2020: Patient is a 70 year old w/ h/o HTN, HLD, DM2 who presented with L sided arm weakness and sensory complaints. Patient presented with a constellation of symptoms that was initially concerning for stroke, and he was ultimately given tPA since he was within the time window and had no active contraindications. There were elements of his exam and story that were slightly inconsistent with vascular cause, but he had enough of a convincing exam and all of the appropriate risk factors so was treated as such.  He had tPA and was in the MICU for 24 hours with no adverse reactions.  He had an MRI brain which did not show signs of acute stroke and his symptoms resolved.  We are treating him as a high risk TIA.?   Patient asserts that this event, as well as other problems experienced by he and his wife, are attributable to flu vaccine they received in Sep 2019.
24 Hours after hot painful swelling at injection site. Chills nausea, sore joints, tired. It has taken 4-5 days to feel better. Dizzy feelings. Doctor prescribed Cephalexin but I did not take it at all.