chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tingling and numbness on left side (arm and leg), then a week later, tingling and numbness also started on right side (arm and leg).  A few days later, I developed some facial numbness and the sensation of the skin tightening and that has stayed to some degree consistent. A week or so later, I noticed my legs and arms felt weak at times and I was incapable of normal levels of exercise, like I'd been able to do previously. Around the same time I noticed my blood vessels were more prominent. This included the blood vessels in my extremities as well as one on the left side of my neck and some around my eyes. I had a few days of throbbing pain and the feeling of inflammation around the blood vessel in my neck, but that went away eventually. I have had a feeling of tightness in my neck, that makes swallowing a little more difficult at times.
suspected vaccination failure/Had the vaccine, had a mild case; Had the vaccine, had a mild case; This case was reported by a consumer via interactive digital media and described the occurrence of 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) 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 Information: GSK receipt date: 11-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient was fortunate. The patient had the vaccine and only had a very mild case. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
No adverse event; received expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose) and NO ADVERSE EVENT (No adverse event) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 053b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received expired dose).    Concomitant medications were not reported.  It was reported that the vial was individual monovalent vial of size 5.5 ml and initially stored in refrigerator on 01-Nov-2022. The vial had not undergone any temperature excursion.  Treatment medications were not reported.
This patient was to get the booster dose of the Moderna covid-19 vaccine (0.25ml), but she received the full dose (0.5ml) instead. She was called today 11/01/21 and reports she feels fine, her arm is just a little sore.
completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:12/30/21.pfizer Lot#EL0142 2nd dose:01/20/21.pfizerLot#EL3247 Diagnosed covid positive: 03/17/21 Exposure:Home Exposure Symptoms:Developed mild symptoms, specifically  headache, nasal congestion/runny nose, body aches, and fatigue that lasted about 3 days
I tested positive for Covid-19 on July 02, 2022. I experienced fever of 102.8, headache, sore throat, gastro symptoms, vomiting, fatigue. I was taking night time cold/flu for my symptoms.
Case number PHEH2015US023327, is an initial spontaneous report received from a health care professional on 06 Nov 2015. This report refers to a 55 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: not reported) on 15 Oct 2015. After vaccination, the patient started experiencing throbbing pain in her arm. Outcome of the event was reported as condition unchanged. Event was reported as non serious and causality was not reported.
12 hrs /p time vax given, pt began crying in a high pitched tone, inconsolable for over 3 hrs. Was seen by PVT MD on morning of 21Mar91. TX-APAP gtts.
fever if 102 F; This spontaneous report was received from a health professional (Medical assistant) via company representative refers to a 2-year-old male patient. The patient's concurrent conditions, medical history and concomitant medications were not provided.             On 13-JUN-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis from varicella (Dose, frequency, route, lot number, expiry date unspecified). Other suspect therapies included sterile diluent (STERILE DILUENT) (Dose, frequency, route, indication, lot number, expiry date unspecified). The patient's temperature had been taken and was normal prior to administration.      On 13-JUN-2019, the patient developed a fever (pyrexia) of 102 degree fahrenheit, within 30 minutes of administration of his first dose of varicella virus vaccine live (oka/merck)(VARIVAX).  The patient's mother administered MOTRIN to the patient and brought the patient back into the physician's office where it was determined the fever resolved, and the patient was sent back home. The patient sought medical attention. No cancer diagnosed, no significant disability, no prolonged hospitalization, no overdose and no PQC involved. No additional information provided.      On 13-JUN-2019, the outcome of pyrexia was reported as resolved. Reporter's causality was not provided.
Patient is an 80 year old  female with a history of Myasthenia Gravis, Parkinson's disease, recurrent UTIs with admission for Sepsis secondary to  ESBL E. coli in March 2023, who presented from her SNF  to hospital 9/1/23 with weakness, fatigue, nausea and emesis. On presentation, SBP less than 90 mmHg. Tested positive for COVID-19. CXR and CT Abdomen/Pelvis  nonacute.    1. Myasthenia Gravis: concern for mild exacerbation with primary symptom generalized weakness. No dysphagia or respiratory symptoms. Likely due to COVID-19 infection. Follows with Neuro (Dr.). On Imuran, Prednisone 20 mg and Vyvgart infusions. IVIG started 9/1/23 x 5 . Held Imuran, continued Prednisone. Vyvgart will need to be delayed due to IVIG. Monitored VC/NIF Q4H while hospitalized, stable. Neurology  followed.  2. COVID-19 infection: 1 week of symptoms, nausea/vomiting  and fatigue. On 2L in ED for O2 sat of 91%, weaned to room air with sats mid 90s. s/p Decadron IV and Remdesivir in ED, no further need for Decadron or Remdesivir given lack of hypoxia, LFT elevation and onset of symptoms more than 5 days prior to admission. Admit CXR nonacute. Monitored with continuous pulse Ox while hospitalized. Pulmonary hygiene. 3. Leukocytosis: WBC 18, denied infectious symptoms. Could be reactive from above. Urinalysis  benign. Blood culture  9/1/23 NGTD. Monitored CBC and fever curve while hospitalized. Trend down slowly. 4. Elevated Liver Enzymes: AST 281, ALT 50 on admit. Admit CT Abdomen/Pelvis  nonacute. Resolved with supportive care. 5. Hypotension: SBP less than 90 on admit, lactate normal. Resolved with IVF bolus. BP higher as well, likely autonomic dysfunction. Avoid wide fluctuations in BP. BP stable at the time of discharge.  6. Parkinson's Disease: per history; continued Sinemet.  7. Overactive Bladder: home Myrbetriq was stopped as outpatient.  8. Obesity: BMI 34. Lifestyle modifications.  9. Lower Extremity Wound: present on admission. Wound care. ET RN followed.  10. Code status: Full code, discussed on admit.  11. VTE  Prophylaxis: Lovenox.
FELT LIGHTHEADED AND FELL BUT STATED WAS NOT SURE IF IT WAS FROM SHOTS OR BECAUSE HE HAD NOT EATEN YET TODAY.
This non-serious medically confirmed report (initial receipt 13-Oct-2014) concerns a male patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported) via the intramuscular route for the protection against seasonal influenza virus. The patient received only a partial dose of the vaccine. No adverse reaction was reported. Outcome was recovered.
She found passed out on the floor by a friend. The ambulance was called. She was hospitalized for 24 hours and treated for dehydration.  She had fever and diarrhea.
Patient reports a metallic taste and headache immediately after receiving the vaccine.  Metallic taste still continues 20 days post-vaccination and headache has improved.
patient was alomost died (Unevaluable event); Initial information was received on 13-Dec-2020 regarding an unsolicited valid non-serious case from the consumer via media.  This case involves unknown age female patient who was almost died (unevaluable event), after she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number, expiry date and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient developed non-serious unevaluable event (latency-unknown) following the administration of INFLUENZA VACCINE.  Case Detail: Reporter scared to get INFLUENZA VACCINE, when her mother was alive, she got one and almost died, but patient knew she never got the flu.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was not reported.  There will be no information available on batch number for this case.
Patient tested positive for Covid-19 on 09/22/2021.  Patient was not hospitalized for this illness.  It is noted that the patient expired on 11/19/2021, with Covid listed as a reason.
This spontaneous report was received from a licensed practical nurse and refers to a 5-year-old patient of unknown gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with a dose of PROQUAD intramuscularly (lot # N023969, expiration date: 28-FEB-2019) with a 1 inch needle for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # M041992, expiration date: 16-MAR-2019). No adverse effects were reported.
1 day after my modern vaccine. I almost throw up and my body feel really bad, like when I touch my body it feels really really weird.  Today my entire face is white but my nose is very red and itching none stop. I feel like I had an allergic reaction.  The first day; my body feel bad, I almost throw up, my body temperature was high. Second day: my nose turned red and itchy.. I don't know what's going to happen next.
last flu vaccine sent me to the hospital; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   It was unknown if the reporter considered the hospitalization to be related to Influenza vaccine Quadrivalent unspecified season.  Additional information was provided as follows: The age at vaccination was not reported. The patient stated that if anyone dies from the vaccine its the fault of people like you. The last flu vaccine sent patient to the hospital.
Next day, developed chills, muscle aches and extreme fatigue. Started around 4pm the day after the vaccine. Woke up next day and felt fine.
Information has been received from a physician concerning a 5 year old patient who on 12-JUN-2008 was vaccinated with MUMPSVAX instead of PROQUAD. The physician stated that the products looked the same and the names of the product were written very small. No adverse event was reported. Outcome was not provided. No product quality complaint. Additional information has been requested.  This is in follow-up to report (s) previously submitted on 9/29/2008; 9/29/2009.  Information has been received from a physician concerning a 5 year old patient who on 12-JUN-2008 was vaccinated with MUMPSVAX instead of PROQUAD. The physician stated that the products looked the same and the names of the product were written very small. No adverse event was reported. Outcome was not provided. No product quality complaint.  Follow up information received from the physician who reported that on 12-JUN-2008, the male patient was vaccinated intramuscularly with 0.5 ml of MUMPSVAX (Lot # 695616/1982U), expiration date 07-DEC-2009) instead of PROQUAD.  No reaction was reported.  No further information is expected.
Left arm deltoid area with redness, swelling, warm to touch, tender to touch, hardened red patch.
This case is linked to case number 2013-07841 and 2013-07842 (same reporter after MENACTRA). Initial misuse report received from a healthcare professional on 01 July 2013. An adult patient had received MENACTRA in 2009 for traveling. On an unspecified date after 4 years, the patient again received another MENACTRA dose. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Difficulty sleeping; Generally feel gloomy, down; in slow motion; some loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Aug2021 10:00 (Batch/Lot Number: FC3182) (at the age of 66 years old) as single dose for Covid-19 immunisation; influenza vaccine (FLUZONE [INFLUENZA VACCINE]), via an unspecified route of administration on 26Aug2021 (as reported) (Batch/Lot Number: UJ689AA) dose 1, single for immunization. The patient medical history was not reported. The patient has no known allergies. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 05Aug2021 10:45 (lot number: FA7485) (at the age of 66 years old) via an unspecified route of administration in left arm for Covid-19 immunisation and the patient experienced dull headache across front lobe forehead including right and left side temples. Concomitant medications included simvastatin (SIMVASTATIN); ezetimibe, simvastatin (VYTORIN); both taken for an unspecified indication, start and stop date were not reported. After the second jab on 26Aug2021, the patient experienced difficulty sleeping, generally feel gloomy and down, in slow motion, and some loss of appetite. The patient did not receive any treatment for the adverse events. The patient was not tested for Covid-19 post vaccination. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 details were provided as follows The age at vaccination was not applicable. The reporter stated that, it was not a guarantee that you would not get shingles just because you got the shots. People did get shingles inspite of having gotten the Shingle shots. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR175872, reported by the same reporter.
Sore arm for two day, slight fever and body aches and then I felt fine.  Then on July 26 both of my hips started to feel sore and achy. I thought if my be the office chair i was sitting in so I switched to a better chair.  Since then they just always ache.  They feel inflamed.  It hurts more to sit and stand but not by much.  If I jump it does not hurt any worse... they same with stretching... it doesn't hurt anymore, they are just achy.  On scale of pain  it's low (maybe 3) but its a dull constant pain.
This spontaneous report was received from a nurse practitioner referring to multiple unspecified patients of unknown age. On an unknown date the patients were vaccinated with VARIVAX. On 09-NOV-2015, via telephone call the nurse report that the patients received doses of improperly stored VARIVAX. No adverse event was reported. Additional information has been requested.
Irritability, unconsoled, unable or unwilling to move freely body or neck for 24 hours, swelling at the injection site.
Patient received the vaccine and fainted after receiving. He was in and out of consciousness for several minutes. He was sweating profusely and had some seizure-like movements. His wife was present and said it has happened before, but not to this extent. EMS was called. The patient was evaluated. He did not want to go to the hospital. His BP was a little low and blood sugar was normal. Patient was given a snack and water.
Pt developed redness, pain on 5-23-18, increased redness, warmth and painful. Pt seen 5-26-18 given 1grm ROCEPHIN IM and started on Cephalexin 500mg 1 tan 3x/day F/U as needed.
The morning following my first Pfizer shot, I woke up with numbness in my arms, starting from my middle finger and continuing distally, all the way to my shoulder.  I still feel the numbness now, 8 months later.
This spontaneous report was received from a registered nurse refers to an unknown number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were inadvertently vaccinated with improperly stored GARDASIL 9, (strength, dose, frequency, and route of administration not reported). No adverse effects reported. No product quality complaint (PQC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient reported small hive-like rashes down the entire left arm (arm that received the vaccine). The rashes were itchy, red, and blotchy.
Possible myocarditis (progressive chest pain and dyspnea starting the day of the second vaccine), currently 9 days out with lab results as listed below.  At the time of this submission, patient is being admitted to the hospital for further diagnostic work-up, to include echocardiogram and cardiac MRI.  He
I began with a severe headache on the evening of 11/10/2021 with the vaccine shot. I had a very restless night with headache, body aches, and fever which continued through the next day, 11/11/2021. Today, 11/13/2021 I noticed a red rash on my left breast and my left lymph node is swollen. That is the side of my vaccine shot.
itching was worse; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 23Feb2021 (Lot Number: EN6202) as dose 2, single for COVID-19 immunisation.  Medical history included type 2 diabetes, hypertension, and osteoarthritis. The patient was not pregnant at the time of the events. Concomitant medications included topiramate, losartan, ibuprofen, propranolol, and vita. The patient previously took the first dose of BNT162B2 (Lot Number: EL0264) administered in the right arm on 01Feb2021 at 16:00 for COVID-19 immunisation and experienced systemic itching. On an unspecified date, the patient experienced itching was worse second time, but tolerable. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
he got sick/he got Covid last week; he got sick/he got Covid last week; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), in Jan2021 as dose 1, single (Batch/Lot number: unknown), in Feb2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "he got sick/he got Covid last week".   The caller reported that he took both of the Pfizer Covid vaccines originally and then two booster shots. He stated the first booster came out and he immediately took it and then when the bivalent came out he took that as well. He took the first Pfizer Covid vaccination in Jan2021, second Pfizer Covid Vaccination in Feb2021, Booster Pfizer Covid vaccination in Oct2021, Pfizer Bivalent Covid vaccination in Sep2022. He stated that he went on a trip/cruise and was not wearing a mask and about a week ago, halfway through the trip, he got sick. He stated he got Covid last week. He wanted information on the isolation period and testing.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.