chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client's husband called stating wife had Flu shot yesterday 10/11/10 approximately 3pm. At 11:00pm felt very achy esp in arms & legs, felt hot but temp not measured. Stated she walks without assistance (had 2 knee replacements) but today cannot event get off of commode. He has to hold on to her to walk. Bedrooms are upstairs & she cannot walk steps. TC was made by client to Dr her PP who advised bedrest & force fluids due to poss flu shot rxn. Referred clt to ER for assessment of possible neuro problem or serious Flu vaccine rxn. Advised to call back with FU information. No speech problems. Took MOTRIN 800mg today x1. 10/13/10 follow-up phone call received from client's husband stating he took her to the orthopaedic surgeon as he had performed the bilateral knee replacements in 2005. He did Xrays & also aspirated fluid from both knees (L) 40cc & (R) 60cc. He said she has synovitis & the fluid looked as if it had uric acid crystals although he will await lab analysis - also other blood tests. The Dr. stated she may have had an "immune reaction" in the knees due to the Flu shot". Client has now improved walking & climbing stairs. She she saw the physician. States she has had Flu shots yearly since knee replacements but no previous side effects. 10/21/10 FU phone call to client. Husband states his wife is doing better but still at home resting & on Ibuprofen meds. She has not yet returned to work. The lab analysis of her knee fluid from aspiration done on 10/13/10 indicated no infection and no gout but they still feel reaction is due to Flu shot. She is walking now but knees still ache.
Patient came in with a rash on (R) (arm) 9cm where she was vaccinated and it travelled down her leg.
Began spotting  on 3/29 continuing to today, 4/3.  No history of spotting.  No history of unusual periods.  No history of pregnancy. Not currently pregnant. Spotting appears brown, sometimes red, and sometimes resembling mucus.  Light flow requiring a panty liner.  Last period ended 3/16.
body went very numb like; a very uncontrollable bowel movement (diarrhea); This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 16Mar2021 at 00:30 (at the age of 65-year-old), as a single dose for COVID-19 immunisation. Medical history included heart failure, atrial fibrillation (A-fib) and diabetes and known allergies to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified blood thinners and metformin (MANUFACTURER UNKNOWN), etc; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received iodine (MANUFACTURER UNKNOWN) for unknown indication from unknown date and experienced drug allergy and received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6203) via an unspecified route of administration in the left arm on 23Feb2021 at 08:00 (at the age of 65-year-old), as a single dose for COVID-19 immunisation. On 16Mar2021 at 18:00, 8 hours after second shot, the patient's body went very numb like and proceeded to have a very uncontrollable bowel movement (diarrhea). The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events body went very numb like and a very uncontrollable bowel movement (diarrhea) was resolved on an unknown date in 2021.
This spontaneous report was received from a nurse and health professional and refers to a 4 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 18-JAN-2016, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), lot # L060586, expiry date: 10-FEB-2017 (dose and route of administration were not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Per patient, he has a history of fainting with immunization. Pt felt dizzy  after shot was given. Pt was given water and snack to eat while being monitored. Heat may have been on contributing factor. Patient felt nauseous and threw up about 15 minutes after shot was given. Patient stated he felt better as soon as he threw up. Patient was accompanied by spouse. After more than 30 minutes of being monitored, patient was able to go home to rest.
Per Dr. "15 yo female. Seen 3 days ago for WCC and received MMR and Varicella vaccines. Started y/d with rash. Started with one spot and then put her down for a nap and she woke with more and now spots are spreading all over. She is irritable. Scratching at her head and grabbing at her diaper. She has had diarrhea x 3 today and twice yesterday. Threw up once yesterday. Restless sleep. Major decrease in appetite. Went to urgent care after hours yesterday and they gave her some benadryl and by the time she left the whelps had all but gone away but then by the middle of the night one small whelp had come back. Had benadryl at 6:30 am and again at 12:30pm and tylenol today for fussiness. Also with fever to 102.7 yesterday. No stuffy nose, RN, cough or sneezing. Fevers started a few hours after the vaccines."
Chills, chest pain, nausea, severe migraine, body pain, especially in legs and feet.
Booster:  pain under arm including a slight rash.  Same arm (left) vaccine was administered.
PATIENT PASSED OUT AND FELL TO THE FLOOR, SHE HIT HER HEAD ON SIGNAGE ON THE WAY TO THE FLOOR, WHEN SHE CAME TO, WAS PALE AND COMMENCED VOMITING, EMT DISPATCHED AND ASSESSED, ALL VITAL WNL.
Pt said "everything was spinning". No chest pain, No SOB, No nausea. Dizziness resolved after a few minutes.
A medical assistant put the epired dose vial back in the fridge instead of throwing awaye on 04/30/2021.  Another medical assistant unknowingly drew up and administred this vaccine to patient.
Kinrix expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-year-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 30th September 2021, unknown after receiving Kinrix and Kinrix 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 details were provided as follows: The patient was vaccinated with an expired dose of Kinrix, which led to expired vaccine used. The reporter consented to follow up.
12/28/21 presents to EC ED for "Shortness of breath". PMHx of "pulmonary fibrosis currently enrolled in Hospice"
pain in the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in the arm of the injection) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain in the arm of the injection). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (pain in the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicines  were not included  Treatment drugs include Ibuprofen  Action taken with mRNA-1273 in response to the event was unknown
Irritability and vertigo. Patient describes looking at huis foot and seeing his had. Friend described him as "loopy," comparable to "being on acid" and colors were vibrant and shifting
Red rash on arms and legs booster moderna June 22, 2022. Occurred two days after injection.
This non-serious spontaneous case, initially received from other non-health professional (consumer) (Novartis reference number: PHEH2018US034681) on 24-Aug-2018, concerns a 43-year-old, adult, female patient. On an unspecified date, the patient received influenza vaccine [dose, route of administration, anatomical location, batch number, trade name, manufacturer: not reported]. On an unspecified date, after vaccination, the patient developed an allergy. At the time of this report, the outcome of the event was not reported.
I noticed on the 22nd of June I had severe pain in my back. I had blisters on the right side of my body from the back to the front. I did the telehealth visit on the 23rd of June. The doctor confirmed the blisters were shingles. The doctor prescribed valacyclovir (1g tid).
Patient reported feeling tingly down her arm along with soreness after vaccination.  This began later in the evening after receiving the vaccine.  She has also experienced itching and redness.
Hives appeared on my neck after the second shot of shingles vaccine. Shingles vaccine was done on 10/19/2021. Hives occurred on 11/3/2021.
Case number PHEH2015US019017, is an initial spontaneous report received from a healthcare professional on 23 Sep 2015. This report refers to an 11-years-old female patient. Past medical history and concomitant medication were not reported. She received only MENVEO without being reconstituted with Men a component on 21 Sep 2015. No adverse event was reported following this administration error. Follow-up information received on 09 November 2015: The lot number of the MENVEO vaccine was X14136 (expiry date unknown). He was up to date for the vaccination. Concomitant products included ADACEL, given on 21 September 2015. The patient never had symptoms or complications after immunization. He received only the liquid portion of MENVEO.
Admitted to hospital 7/23/21 with covid pneumonia requiring high flow nasal cannula.  Respiratory status never improved and patient transitioned to hospice care. Expired 7/30/31
Patient came in for well child check on 4/19/10 received DTAP and HIB at the same visit. Clinic contacted by Medical Examiner that patient died on 4/24/2010 of ruptured R atrium after T.V. fell on him. D. Cert attached.
No ASE reported at this time. Client potentially rcvd unmixed Menveo (diluent only).
SHORTNESS OF BREATH; CHEST PAIN; FEVER; HEADACHE; TIRED; This spontaneous report received from a vaccine facility via a company representative concerned an adult female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 16-MAR-2021, the subject experienced shortness of breath. On 16-MAR-2021, the subject experienced chest pain. On 16-MAR-2021, the subject experienced fever. On 16-MAR-2021, the subject experienced headache. On 16-MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, fever, headache, tired and shortness of breath was not reported. This report was non-serious.
inconsolable crying lasted from 930AM 23SEP97 through 2AM 24SEP97;physical exam nl;treatment supportive-APAP-fluids recheck in clinic in 24hr;
Pt says she has pain in the entire arm the vaccine was given. She says it started after the vaccination and it still hurts when she moves it. Pt saw her physician and was given Naproxen 500mg for pain. The incident was reported to VA on 10.10.2009
Prior to receiving the Moderna vaccination, I have had ongoing pain in both knees due to a fall years ago.  Post-vaccination, aside from experiencing soreness in upper left arm and other symptoms , I have began to notice less blood circulation in my lower extremities between my knees and ankles.  I have also experienced rapid heart beats at times while performing my work duties.  I realized CIPRO has at least one ingredient that is the same as what is in the other vaccines, to include the Moderna vaccine.  I have hesitated receiving the second dose of the Moderna vaccination because of these concerns.
Mother of patient was advising technician to get a Moderna booster shot.  When doing so, technician was not acknowledging the patient is under the age of 18 for a Moderna vaccine.  When came to pharmacist, the age of patient was overlooked and was given the Moderna booster shot.  Patient was stable and coherent.  Mother of patient was told of this and to be looking for any anaphylactic reactions.  If there were side effects that were developing, mother is to contact the pharmacy.
Mother reports she noted that child had some redness and a little swelling over R deltoid area on morning following the day of admin (24 hrs later). Child behavior normal offering no complaints. This AM, some swelling remains no redness minimal warmth in area. Mother administered Tylenol x1. No fever noted.
Arm blk and bl, swelling, very painful. Told wait 3 wks-4 wks later told to keep icing. 5 wks later treated w/shingle med acyclovir for 10 days. 2-10-10 w/cortisone shot in shoulder. Other body muscles affected. Arm is painful to raise.
Sore arm at injection site Severe uncontrollable shaking/cold-last 45 minutes after Tylenol was taken This was about 12 hours after the injection
Suspected vaccination failurew; Shingles; inappropriate schedule of vaccine; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2018, the patient received the 1st dose of Shingrix. On 27th March 2019, the patient received the 2nd dose of Shingrix. On 27th March 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shigrix later than the recommended schedule, which led to lengthening of vaccination schedule. After receiving the 2nd dose of the Shingrix, the patient developed shingles (dates were unknown) and current status was also not known.  This case was considered as suspected vaccination failure, since the details regarding the time to onset for event and laboratory confirmation for herpes zoster were not provided.
Patient stated that a few days after the vaccine his arm was red and swollen. By the time he came in to notify us of the ADR the symptoms had already subsided.
got it and got shingles. / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The reporter stated just another added for a worthless vaccine. The patient got vaccine and got shingles. Just like the people taking the shots now were. The reporter stated nice advertisements to make the rich richer. People were being terrified into taking shots and making their loved ones take them and not caring about side effects because of their fear. The reporter first time got covid, she got it from her face shot if that tells you anything so it was time to wise up and boost your own immune system and stop thinking you need all these shots. The reporter stated you wee just lining rich peoples pockets. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR188396 repored by same reporter.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date the patients were vaccinated with improperly stored doses of VAQTA (lot # L009445, Exp. 01-JUN-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Tinder upon my armpit and it is kind of like puffy, like it is swollen; Hurts a little bit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Tinder upon my armpit and it is kind of like puffy, like it is swollen"; PAIN (non-serious), outcome "unknown", described as "Hurts a little bit".  Additional information: The patient had vaccine shot (Pfizer Covid-19 Vaccine) on Thursday and this morning "it is like a kind of a tinder upon my armpit and it is kind of like puffy, like it is swollen. But it is puffy. But it hurts a little bit if I push on it".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & the next day pt exp lymphadenopathy & an enlarged spleen;1 day later the pt recovered;
Large area of swelling and redness in and around the injection site for Dipt-Tet injection Lot # V0817AA.
Lt. upper thigh swollen, hard, red, hot, painful. Pt was given Tylenol and Benadryl with no significant change in symptoms.
mild pain at the injection site; This is a spontaneous report from a contactable consumer (Patient). A 34-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: Et 3247), via an unspecified route of administration, administered in left arm on 01Mar2021 at 10:00 AM (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation at Workplace Clinic. The patient medical history and concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the Covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 01Mar2021 at 05:00 PM, the patient experienced mild pain at the injection site. The patient not received treatment for the event. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 23Mar2021 at 02:30 PM as dose 2, single for COVID-19 immunisation. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning her 19 year old daughter who on 09-APR-2007 was vaccinated with the first dose of GARDASIL.  On 08-JUN-2007, the patient was vaccinated with the second dose of GARDASIL and on 15-OCT-2007 with the third dose of GARDASIL.  Concomitant therapy included hormonal contraceptives (unspecified) and ALDACTONE tablets.  On 12-MAR-2008, was performed a papanicolau test with abnormal results.  On 16-SEP-2008, was performed her last PAP test with normal results.  This is one of several reports provided by the same source.  Additional information has been requested.
Pt received Pfizer vaccines on 03/05/21 and 03/26/21. Pt presented to the ED from a nursing home facility on 11/10/21 with complaints of low blood sugar, SOB, and AMS. Health care facility noted that pt was COVID positive on November 4th. CXR showed COVID pneumonia. Blood sugars found to be critically low. Pt was placed on 15L nonrebreather while in the ED and eventually intubated on 11/10. Blood cultures were positive for Klebsiella Pneumoniae.
Pt presented with SIADH and muscle weakness and was coincidentally diagnosed with Guillain Barre. She was treated with PO demeclocycline and IVIG and physical therapy.  04/20/05 Involved case final diagnosis of GBS, with URI Hx prior to flu vax, with onset of S/S 10 days' post flu vax. Pt presented w inability to stand, walk, myalgia and some worsening of low back pain. On exam strength noted to be 5/5 in all extremities but w absent DTR's in lower extremities. Pt's labs were consistent w SIADH and initial intervention focused on correcting the electrolytes. The following day, the chemistries became increasingly altered and mental status changes of hallucinations and disorganized speech. Work-up at that point included CT's of chest and head (which had unsure clinical significance or negative), LP with Protein level 159 and EMG which showed slowing of nerve conduction in lower extremities and changes in both motor and sensory nerves of upper extremities.  Pt in MICU due to Hyponatremia  & MRI of head at this time showed tiny scattered areas of deep white matter with a high C2 signal(of doubtful significance).  Questional Dx of viral meningitis and lupus cerebritis was ROed and after being transfered back to floor, pt given 4 rounds of IVIG, pt's mental status cleared dramatically, her sodium level trended upward with increased dose of Demeclocycline. She did have increase in BP, controlled w metoprolol; With these changes, pt transfered to rehab.