chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, was received from other non-health professional on 20-Dec-2017, concerning a 32-year-old, adult, female pregnant patient with weight 116 lbs, height 61.4 cm. The patient history included, one previous pregnancy which is full term live birth. The patient had no family history of major congenital malformations. The patient had no habit of tobacco, alcohol or illicit drug use. The historical conditions included Chlamydial infection. The historical drugs included ZITHROMAX for chlamydia. The concomitant medication included VITAFOL-ONE for healthy pregnancy. The patient LMP (last menstrual period) was reported as 16-May-2017. On 04-Aug-2017, the cystic fibrosis mutation analysis had performed and the results were found to be normal (no major congenital malformations noted). On 07-Aug-2017, 1st trimester screen and panorama had performed and the results were found to be normal (no major congenital malformations noted). On 06-Sep-2017, 2nd trimester screen had performed and the results were found to be normal (no major congenital malformations noted). On 04-Oct-2017, the patient was administered with AFLURIA QUADRIVALENT (dose, route of administration, anatomical location, batch number: 00644623A (as reported), expiry date: not reported) at 20th week of pregnancy. The estimated date of delivery (EDD) was reported as 20-Feb-2018. The reporter assessed this case as non-serious.
pt had Hib r thigh on 4/24/07. MOC states she noted red nodule, that increased in size past 2-3 days. No fever, no pain, no streaking. Today, while at zoo, MOC suddenly noticed that all his clothes were covered in pus from the spot of the previous scab/red bump. Bump resolved, and no further pus. Moving legs normally. Wound culture was neg.  PT was seen by Derm and it was determined to be a granuloma.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A 45-year-old female patient received BNT162b2 (BNT162B2), on 26Apr2021 as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "fibromyalgia" (unspecified if ongoing); "allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), 6 hrs. after the suspect product(s) administration, outcome "recovered", described as "experienced a high fever of 101.5"; FATIGUE (non-serious), 6 hrs. after the suspect product(s) administration, outcome "recovered", described as "felt tired". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Verbatim and Event Description: Patient mentioned during an interview on pneumonia vaccine, that after her second dose of the Pfizer Covid-19 vaccine, that she experienced a high fever of 101.5 and also felt tired and needed to stay in bed. The reaction came on about 6 hours after receiving the dose and lasted about 24 hours. She felt back to normal after that. From information provided in the interview, the respondent has asthma, allergies, and fibromyalgia unrelated to the vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Varicella vaccine breakthrough. Diagnosed in office with varicella on 5-26-09. Had over 100 lesions no fever.
I was extremely tired for the first few days. After 2 days I felt a really uneasy feeling and began to have difficulty breathing and everything became numb. I was unable to walk due to the numbness. My son assisted me to the car and I went to the ER after the extreme feeling of apprehension. I was given IV fluid immediately and an EKG was completed. I was monitored for a few hours and discharged with no medication prescribed.
pt recv vax 4SEP96 230PM & started screaming 3:30 non-stop until 9:30 (inconsolable x/for 5min intervals of sleep) rt thigh swollen-hip to knee-temp stayed 102 w/APAP q 4hr;
Diffuse rash on bilateral upper extremities and trunk about 1 hr after, no respiratory issue, a dose of diphenhydramine 9 mg was given about 80 mins out.
This case was reported by a consumer via call center representative and described the occurrence of fever blister in a 70-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 14 days after receiving SHINGRIX, the patient experienced fever blister and generalized rash. On an unknown date, the outcome of the fever blister and generalized rash were recovered/resolved. It was unknown if the reporter considered the fever blister and generalized rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient could be around 69 years old at the time of vaccination. The patient received 1st dose of SHINGRIX in March or April 2018, the patient developed fever blisters that began about 2 weeks after the dose. The patient also reported unidentified spots around his body. After one week, the events resolved. For tolerance of 2nd dose, refer case US2019045198.
SUSPECTED VACCINATION FAILURE/had the shot /HAD THEM TWICE; had them twice; painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self- reported this case. The age at vaccination was not reported. The patient had shot and had shingles twice in 30 years. The patient stated that it was most painful misery ever. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Headache, Myalgia, CHILLS; TINGLING FACE/LIPS Narrative:
I got the original shingles shot almost 10 years ago. Turns out it only about 30% effective.; swelling, heat, and pain at the injection site; heat, and pain at the injection site; pain at the injection site; Got the Shingrix shots; This spontaneous report has been received from a female patient of unknown age via social media, reporting on herself. The patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications were not reported.  On an unknown date in 2012 (reported as "almost 10 years ago"), the patient was vaccinated with a dose of zoster vaccine live (manufacturer unknown) (reported as "original shingles shot") (dosage regimen, lot #, expiration date, route of administration and anatomical location were not provided) as prophylaxis.  According to the reporter, the dose of zoster vaccine live (manufacturer unknown) was only about 30% effective (therapy product effect incomplete); therefore, she was vaccinated with the first and second doses (reported as "it is a two shot deal") of zoster vaccine recombinant, adjuvanted (SHINGRIX) (dosage regimen, frequency, route of administration, lot#, expiration date, and indication were not provided) on an unknown date (extra dose administered), and according to the patient had a higher rate of effectiveness. On an unknown date, the patient and her husband experienced swelling (injection site swelling), heat (injection site warmth) and pain at the injection site (injection site pain). At the time of the report, the outcome of all events were not reported.  The causal relationship between all reported events, zoster vaccine live (manufacturer unknown), and zoster vaccine recombinant, adjuvanted (SHINGRIX) was unknown.
Patient presented to ER after receiving varicella immunization yesterday 7/14/08. Redness to right deltoid area. Benadryl 25mg po given. Patient discharged home. Stable
1st - 4th day - Red circle rash around shot area on right arm, warm to touch, sore, sore to touch, itchy.  5th - 8th day - Pink circle rash around shot area on right arm.  9th - 11th - Red circle rash around shot area on right arm, raised and bumpy, extremely itchy, warm to touch.  12th - present day - Pink circle rash around shot area on right arm, outer circle darker color, slightly raised, itchy,  warm to tocuh.
Patient received Tdap on 9-9-15 next day had silver dollar size swelling, redness and warmth at site. Now achy, sore throat, T 97.5 - erythema 18 x 12 cm, very warm to touch. Treated with prednisone and cephalexin.
No additional AE; an expired dose of PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-DEC-2022, the patient was vaccinated with an expired dose pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot #U010533, expiration date: 29-OCT-2022) administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional information was provided to further clarify any details. No additional adverse event (no adverse event).
On 2/25/11 pt was to receive her MMR but was given PROQUAD in error. On 3/6/11 erythema multiforme dx. On 3/18/11 hive like rash full body ZYRTEC x 2 wks.
A few hours after the patient got the injection, her arm became very red, swollen (almost twice the size of her other arm) and very painful (she reported pain level at 8-9 out of 10 on a pain scale with 10 being the most painful). The day after the arm was still red and the swelling only came down slightly with the pain around 7 out of 10. On Saturday the patient reported that the swelling was pretty much gone and so was the pain and she was feeling "great" and didn't need to even seek any medical treatment.
1st dose 5/6/2021 2nd dose 6/7/2021  On 6/8/2021 started with chest pain with nausea and vomiting.
As the nurse was administering the flu shot, the needle separated from the syringe and the entire contents of the vaccine shot into the patient's left eye. No eye wash solution was provided. A second shot was administered to patient, but was not recorded in patient's chart.Patient reported a "gritty feeling" under her eyelid immediately after the incident and for several days following. She also reported "watery eyes" and sharp pains behind both eyes a few days later.
Meningitis and encephalitis, possible Bickerstaff brainstem encephalitis
5/12 Had the vaccine on Wednesday and chest pain occurred on the following Monday Mother who is a nurse checked oxygen, which was in the 80s and pulse was elevated  5/18  Next day condition didn't resolve, went to urgent care center where nurse practitioner heard a heart murmur and EKG was abnormal  Chest pain, saturation, and increased pulse lasted for four more days Mother who is a nurse suggested decreased stressful events such as exercise and increased rest
NauseaVomiting Narrative:  0841: C/O NAUSEA 121/77 90 98.7 0853: NO CHANGE IN NAUSEA 128/79 98% 0900: D/C STABLE
Fever starting with 8 hours of injection. Fever spiking to 100-103 Fahrenheit for three days. Blisters on hands, feet and lips.  Rough, itchy rash on arms, and legs.
Within day or two of vaccine started having "muscle spasms almost like vibrating" seemed to notice especially as he would fall asleep; just not himself for about 2 weeks. Would stare off into space. As of 8/28/09 still having muscle spasms though more normal behavior other than "tremors" when falls asleep (for 2-15 seconds).
Patient to ED for evaluation of symptoms after a Covid vaccine earlier today.  She had her second Covid vaccine here at the hospital where she works about 8:30 AM.  About 10:00 she started having shakes and a headache and just not feeling right.  She has had some periods of palpitations and feeling like her heart is racing as well.  She called employee health and was referred in to see us.  At this time she says she still has some headache and overall feels weird but no other new symptoms.  No chest pain or shortness of breath or palpitations at this time.  No trouble breathing.  No fever.  No visual changes but the light does bother her eyes.  She does have a history of migraine headaches that are like this at times.  The pain is in her forehead, not globally or in her neck.  She has no neck pain or stiffness.  She did not have much of reaction after her first vaccination.  She does have a history of hypertension but has been taken off her medication because her blood pressures have been well controlled.  She states that she does check them regularly at home and they have been okay.  She denies any other recent sick symptoms.  No other significant chronic underlying medical problems. Medications administered in the ED included ibuprofen 600mg and diphenhydramine 25mg orally at 1415, and acetaminophen 1000mg orally at 1000mg. Headache was better at 1540, blood pressure was lower at 139/90, no shaking. Pt discharged home.
Lymph nodes in neck swelled up. I felt weak and faint. My head was throbbing on the left side. I also developed sciatic pain on the left side that lasted a year.
fell on the floor and she lose all the conscious; she got a kind of choke; fell on the floor and she lose all the conscious; lose all the energy; cannot breathe; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received bnt162b2 (Pfizer product, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Last Friday (unspecified May2021) she was vaccinated with the Pfizer and she got a lot of symptoms of the vaccine,  after 20 seconds she fell on the floor and she lose all the conscious and took that it was minute and half to come up and she got a kind of choke, cannot breathe and lose all the energy, it took almost 2 days to become normal again. The patient's mother did not want her to get another shot. The outcome of events was recovered.  Information about lot/batch number has been requested.
3/17 vaccination Later that evening, I got little sleep, tossing and turning. The next day I was achy, arm hurt. That night I noticed loud ringing R ear; screeching noise. As the days went on, it calmed down but there 24 hours a day. I waiting 4-5 days and then saw PCM. No infection, no blockage. Referred to ENT; hearing test. Hearing test came was fine, ears look good. No cure for Tinnitus. I did go buy a white noise machine to help sleeping at night. It is there 24 hours a day.
This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX QUADRIVALENT (batch number FS575, expiry date 30th June 2014). On 23rd October 2014, the patient received FLURARIX QUADRIVALENT .5 ml. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information received: 18 patients were involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 10/23/14.
6 hours post injection had sever shaking, low b/p, tachycardia-144 called squad temp 103, bp went as low as 70/40 only came up after iv SOLU MEDROL did not respond to 5 liters of normal saline.  Preventive antbxs but blood cultures neg at hospital.
his arm is starting to sore.; arm started getting sore where he received the injection; This is a spontaneous report from Pfizer via a contactable consumer (mother). A 69-year old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (at the age of 69-years-old), via an unspecified route of administration on 25Jan2021 as a single dose for covid-19 immunization.  The patient has no medical history and Is not taking any concomitant medications. On 25Jan2021, he experienced his arm is starting to sore and about an hour after that his arm started getting sore where he received the injection. He states that he took two Tylenol and by the next morning his arm was feeling totally better. He states that he had no other symptoms. The clinical outcome of the event his arm started getting sore was recovering; the outcome of sore where he received the injection was unknown.  Information on Lot/Batch has been requested.
Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 11 years old patient (gender not reported) who was given expired dose, while received vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies were reported. On 18-Aug-2018, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine lot number not reported (exp date: April-2018) via unknown route in unknown administration site. It was a case of actual medication error case due to expired vaccine administered to the patient. It was reported that MENACTRA was dispensed to facility and administered. Nurse noted that on the label the expiration was from APR 18. Pharmacist has not seen the label but just was informed by nurse via word of mouth. It was unknown if the patient experienced any adverse event. Lab test and corrective treatment: not applicable. Outcome: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. Documents held by sender: none.
mom told to bring child to ER had swelling on rt deltoid;mom to given child either motrin or APAP, DPH if needed to apply ice;5/14/99 mom reported arm swelled worst;mom did not apply ice;
Pt was admitted for E. coli bacteremia.  Pt was incidentally COVID positive and chest xray was negative.
when she blows her nose it bleeds more than it normally would/ Sometimes the bleeding is heavy and sometimes not; she was on blood thinner; little sick; little dizzy; she was sore with first shot, but that didn't last long; dyslexic; weak; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 (Lot number: FJ8762) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "blood thinner" (unspecified if ongoing); "blood disorder" (unspecified if ongoing), notes: She is still taking Warfarin; "thyroid problem" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: WARFARIN taken for blood disorder (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); ROSUVASTATIN taken for blood cholesterol increased (ongoing). Vaccination history included: Flu shot. The following information was reported: EPISTAXIS (medically significant), outcome "unknown", described as "when she blows her nose it bleeds more than it normally would/ Sometimes the bleeding is heavy and sometimes not"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "she was on blood thinner"; ILLNESS (non-serious), outcome "unknown", described as "little sick"; DIZZINESS (non-serious), outcome "unknown", described as "little dizzy"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "she was sore with first shot, but that didn't last long"; DYSLEXIA (non-serious), outcome "unknown", described as "dyslexic"; ASTHENIA (non-serious), outcome "unknown", described as "weak". Patient took levothyroxine, Rosuvastatin and Hydrochlorothiazide for a long time. She was still taking her blood thinners and noticed when she blows her nose it bleeds more than it normally would since taking Covid vaccine. Sometimes the bleeding was heavy and sometimes not. She had flu shot more than 4 weeks prior to getting Covid vaccine, with the first flu shot she ever got, she got sick and had to go ER. That was the first time she took the flu shot. She got very sick.  No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional via Merck sales representative and described the occurrence of blood in stools in a male subject of unspecified age who was vaccinated with ROTARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced blood in stools, diarrhea and gas. A nurse reported to a Merck representative that her son experienced diarrhea, blood in the stool and violent gas. No further adverse event information was provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified.
She reported some hives but refused to be evaluated by fire rescue.  At 10:16 am verbalized to feel better and went home.
Headache, nausea, vomiting, sore arm, temp 102.8, chills began 1/08/2021 @ 9pm and lasted for 24 hours   The next menstrual cycle was very heavy period, soaking heavy flow tampons every hour, large clots, and lasted 6 days from a typical mild flow 3 day period
Pt had #2 SHINGRIX vaccine at local pharmacy 1-x13 cm firm, red warm tender area (L) upper arm.
Information has been received from a nurse practitioner through a Merck pregnancy registry regarding a 16 year old female who on 07-DEC-2006 was vaccinated IM with the first dose of Gardasil (Lot# not reported). On 08-DEC-2006 the patient had a positive pregnancy test result (test not specified). Unspecified medical attention was sought. At the time of this report no symptoms were reported and the outcome of the event was unknown. Follow up information was received from the nurse practitioner which stated that on an unspecified date the patient experienced a miscarriage at 13 weeks. Upon internal medical review the spontaneous abortion was considered to be an other important medical event. Additional information has been requested.
Pt complained of warm and red on left side of arm where the injection site was given to her elbow.
at midnight I felt queasy and very thirsty, trying to drink water, passed out momentarily and spilled water all over bedding. then felt buzzing and faint; fainted and crashed to the floor where I lay unconscious for a short time (up to  a minute). regained consciousness and had pain in neck and left arm.
pt recv vax 25MAR98 & mom states pt has been crying throughout the day & noc;4 days later devel cough & congestion;had fever since vax;exam 1APR97 T100.5, eczema;URI, eczema;