chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a reaction to the something in the vaccine; My nose started running profusely; nose became completely blocked; I could not stop sneezing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 31Aug2021 (Lot number: FC3183) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I had a reaction to the something in the vaccine" (unspecified if ongoing), notes: it is also with the other injection I had many years ago, that caused the same issue; "My nose started running profusely" (unspecified if ongoing), notes: it is also with the other injection I had many years ago, that caused the same issue; "nose became completely blocked" (unspecified if ongoing), notes: it is also with the other injection I had many years ago, that caused the same issue; "I could not stop sneezing" (unspecified if ongoing), notes: it is also with the other injection I had many years ago, that caused the same issue. Concomitant medication(s) included: MULTIVITAMINS [VITAMINS NOS]. The following information was reported: REACTION TO EXCIPIENT (non-serious), outcome "unknown", described as "I had a reaction to the something in the vaccine"; RHINORRHOEA (non-serious), outcome "unknown", described as "My nose started running profusely"; NASAL CONGESTION (non-serious), outcome "unknown", described as "nose became completely blocked"; SNEEZING (non-serious), outcome "unknown", described as "I could not stop sneezing". Therapeutic measures were taken as a result of reaction to excipient, rhinorrhoea, nasal congestion, sneezing.  Additional Information: The patient took antihistamine as treatment medication. Events were probably for 6-7 hours. Within two hours the patient had a reaction to the something in the vaccine. Her nose started running profusely and her husband was a physician he thought it was moderate to severe was not, like she could breathe but her nose became completely blocked and she went to the whole box of the tissues. She could not stop sneezing and her nose was running continuously probably for like 6-7 hours. The patient had that happen only one other time when she had some injections in leg and she thought that injection caused the same thing (Further clarification unknown) otherwise it never had in her whole life like that for any kind of shot."  No follow-up attempts are possible. No further information is expected.
pain, warmth, myalgias  @ site;no hematoma;no cellulitis;sx persisted x 1mo;labs CPK, aldolase normal;sed rate 18 (on NSAIDS) negative paresthesias;
My legs are swollen all way up to my hip; They are twice as big as they should be; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 26Feb2021 01:00 (Lot Number: EM9809) (at the age of 81 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included high blood pressure and cholesterol. Concomitant medications included simvastatin (10 mg strength), taken an unspecified indication, and hydrochlorothiazide;triamterene (TRIAMTERENE HCTZ, 25mg/5mg strength), taken for hypertension. The patient previously received the 1st dose of a COVID-19 Vaccine (MANUFACTURER UNKNOWN) for COVID-19 immunisation. The patient experienced "my legs are swollen all way up to my hip; they are twice as big as they should be" on 26Feb2021. When the patient came home at around 3 or 3:30, the patient went to the bathroom. When the patient pulled down her pants, the patient noticed that her legs were super swollen but doesn't hurt. The patient was not taking anything for the events and was keeping her legs elevated up over the heart, hoping that the swelling would go down. The patient has not undergone any lab tests as she canceled all her appointments with the doctor due to the virus. The patient has not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Redness, swelling, itch at site. Rapid strong heart beats for 2 days.
Stinging in arm; tenderness to the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Stinging in arm) and TENDERNESS (tenderness to the arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 043B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced PAIN (Stinging in arm) and TENDERNESS (tenderness to the arm). On 19-Mar-2021, PAIN (Stinging in arm) had resolved. On 21-Mar-2021, TENDERNESS (tenderness to the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Patient he felt stinging in the arm for 3 days and then tenderness to the arm for 5 days. No treatment information was provided.
pt here for booster dose, chose Pfizer, previously had Moderna Previous vaccine was from (Privacy) pt previously felt similar sx with 2nd Moderna shot and was sent to urgent care, discharged after 1549: flushed sensation, tingling, 4/10 generalized HA     1550: HR 103, BP 168/114, 98%, 97.9 F, RR 22 1555: HR 85, BP 177/110, 100%, RR 20                                 1605:  HR 95, BP 167/107, 99%, RR 18 1620: HR 82, BP 166/100, 99%, 98.8 F, RR 22                      1637: HR 75, BP 164/91, 99% 1657:  BP 164/91, HR 75, 99% pt advised to go to the ER    1700:  Pt brought to ER by wheelchair, in no acute distress, still feels 3/10 HA, all over tingling and flushed sensation 1710: in line for ED check in
This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. Since 12-AUG-2014, improperly stored RECOMBIVAX HB was administered to an unknown number of patients (dose, dose number, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. The outcome of the event was unknown. Follow up information has been received from the office manager regarding the patients. The office manager was able to share the lot# K006682 (expiration date: unknown) for RECOMBIVAX HB that experienced a temperature excursion. The office manager had no patients' information or dates of vaccination available to share at this time. This is one of several reports received from the same reporter. Additional information has been requested.
Typical symptoms: whole body aches, headache, nausea, chills, sweats, high temp, burping, vomiting, fatigue   Adverse:  chest pressure, shortness of breath, bluish nails   Pediatrician was called, advised to call 911. Paramedics came?could not catch breath and was having chest pressure, she was crying in pain. They found oxygen level good, elevated heart beat. Within 30 mins, back to normal. Told to go to ER if it continued.  Spiked high temp 101.8 for a while and sweating profusely. Then felt better.
The next day I started having lower back pain.  The back pain continued daily.  I made an appointment with my primary care doctor.  The appointment was set for June 29, 2021. When I woke up that morning, the pain was so severe that while on the way to the bathroom, my left leg collapsed and I collapsed on the floor. My wife had to call an ambulance to pick me up and take me to the ER.  I was diagnosed with sciatica and told it would calm down and improve but it (my leg) never improved.  The back pain improved but the leg pain never did. I continue to have numbness and pain daily in the left leg despite numerous treatments (injections, chiropractor, physical therapy, acupuncture).  None of the specialists, including the neurologist, can give me a conclusive answer to my pain. They "suspect" inflamed nerves or impingement on the nerves but none of my xrays show anything conclusive except continued deuteriation in my spine.  No one can give me an answer to why this sudden pain and decline. Prior to this, I was healthy with the exception of an occasional muscle ache that other people get.  I strongly suspect it is related to my vaccine since the pain started immediately the next day.  Since then, I have talked to numerous people that have nerve pain related to their vaccine, some of which have been documented as such.
chicken pox; This spontaneous report as was received from a medical assistant referring to a 57 year old male patient, with no pertinent medical history, no drug reactions/allergies and no concomitant medications.    On 02-FEB-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously for vaccination (dose, vaccination site, lot number and expiration date were not reported).         On 28-FEB-2019 (also reported as on "02-MAR-2019"), the patient developed chicken pox (varicella).  The patient saw the physician who recommended unspecified labs, but the patient declined to have them performed due to cost.  An unspecified treatment was given for the event.  The patient was seen a t the office on 08-MAR-2019, and was determined to have recovered.  The reporter did not assess the causal relationship between therapy with varicella virus vaccine live (oka/merck) (VARIVAX)and the event.
Visit to our health clinic on 7/10/2000. 1x1 firm lump on left thigh where comvax was given. Some redness at site.
Sore arm; headache; fatigue; A spontaneous report was received from a consumer, concerning a female patient of 78 years old, who received Moderna's COVID-19 vaccine and experienced Headache, Fatigue, Sore arm/ Pain at extremities.  The patient's medical history was not provided. Concomitant product use was provided by the reporter as Potassium, Cholesterol medication, High blood pressure medication, Levothyroxine used for unknown indication.  On 21 JAN 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis and experienced sore arm.  On 22 FEB 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route in right arm for COVID-19 infection prophylaxis. On 22 FEB 2021 , after second dose of vaccine, the patient experienced events Headache , Fatigue and the events were resolved on the same day. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.
Information has been received from a nurse concerning a 67 year old male with no drug reactions/allergies and with hypothyroidism and hypercholesterolaemia who on 24-JUN-2010 was vaccinated intramuscularly into left deltoid with the second 0.5 mL dose of PNEUMOVAX 23 (LOT# 665902/1426Y, expiration 02-JUL-2011). Concomitant medication included simvastatin (MSD) and SYNTHROID. On 25-JUN-2010 the patient experienced redness, warmth, and tenderness at the injection site of the left upper arm. The patient was seen in the office on 25-JUN-2010 and was diagnosed with cellulitis. He was administered ROCEPHIN 1 gram injection while in the office and prescribed a course of KEFLEX. There was no lab diagnostics studies performed. The nurse added that the patient was administered his first dose of PNEUMOVAX 23 on 22-JUN-2009. At this time of reporting, the patient was not recovered. Additional information has been requested.
nausea & vomiting p/each of 3 doses;p/4th dose also c/o dizziness;last dose due 30NOV94;bitten in ear by a stray cat
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a female patient vaccinated with improperly stored VAQTA (lot# N008823 with expiration date 26-MAY-2018) on 26-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981).
Throat felt tight, patient unable to swallow. Benadryl given, 12.5mg PO at 1330. Repeat dose of Benadryl 12.5mg PO given at at 1334. Vitals 1330: B/P: 146/99, PR: 109, RR: 24, Temp: 98.8, O2 Sats: 100% Vitals 1345: B/P: 140/95, PR: 97, RR: 20, Temp: 98.4, O2 Sats: 100%  Throat no longer felt tight after two doses of PO Benadryl.
I developed a rash in my whole body with a very severe pain in my right side of my body. It is very hard for me to breath and do normar activities. The rash I don?t have anymore.
A/P: 29 yo male with PMH of recurrent PE/DVT, HTN and anxiety/depression who is transferred from the medical facility for management of PE/DVT.  He has a reported history of protein C deficiency diagnosed at the medical facility.   1. Recurrent PE/DVT; acute PE and LLE DVT -first VTE 2017- RLE, placed on Xarelto -had covid vaccines at outside facility in mar and apr of 2021 -2nd and 3rd clots, both legs, after missing a few doses -4th clot in LLE march/april 2021- changed to coumadin. INRs were hard to control -5th clot LLE September 2021- back to Xarelto -? Protein C def -currently quitting smoking- uses patch and gum  -adopted, doesn't know FH -reports might have missed 3-4 doses in the past month -OSH CTA chest: multiple b/l lower lobe PE, and infarcts -11/1/21 BLE U/S:  Acute, occlusive deep venous thrombosis in the left iliac vein extending into the popliteal vein and tibioperoneal trunk. There also appears to be acute thrombus in one of the left peroneal veins. 2.  Near occlusive thrombus in the lower IVC, without definite mid or upper IVC thrombus.  No evidence of deep venous thrombosis in the right lower extremity. There is decreased pulsatility within the right lower extremity consistent with the lower IVC clot.  -11/2 IR tPA + heparin drip stopped 11/4 w/ iliac vein stent    -By history it seems he has recurrent clotting after missing only a dose or two of anticoagulation, although he was also not taking the Xarelto consistently with food. We recommended Lovenox 1mg/kg BID after thrombolysis completed and then ok to discharge on Lovenox 1.5 mg/kg once daily but he is concerned re: compliance.  Therefore will avoid shots, add ASA to Xarelto as that may be the best change as he is young and active and has trouble remembering to take his pills, highly recommend compliance every single day and to get a pillbox and to make sure that he has taken his daily doses of Xarelto and aspirin, can take with food
elevated t105 R w/in 6 hrs; APAP & cool bath given;
Onset of rash and severe plaque psoriasis.  Severe pain, burning, itching all over my body.
Tuesday- received ZOSTAVAX. 20 minutes after she left, muscle in front of arm started cramping. Arm is swollen (not itching or burning). Still cramping.
There was a syringe malfunction which caused a drop of the Janssen Covid 19 vaccine to spill out.
Left shoulder pain around actual humeral head; anterior, posterior, and superior since receiving  injection.  Limited AROM and PROM as well.  Patient did apply heat with minimal, temporary improvement.  PCP did evaluate on 5/31/19 where PT and Naproxen was prescribed.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279745, 2018SA279746, 2018SA279747, 2018SA279740 and 2018SA279743 (Same reporter). This case involves a 60 years old female patient who received vaccine FLUBLOK QIV which was in shipping excursion. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none reported as no other vaccine was given. On 02-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1829 via intramuscular route in the left deltoid. It was case of actual medication error due to incorrect product storage. No symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Fever, muscle pain, joint stiffness, joint pain, headache, nausea, light headedness, tingling in my hands and legs.
Per mom, while he was sitting his arms started to shake & eyes rolled back. Also urinated on himself
Pt says that he has an occassional feeling of "getting the vaccine".  Described it as dejavu.  "spreading over the arm"
pt passed away at home; cause of death:  multi-organ failure, general debility stroke, cardiovascular disease, dementia, coronary artery disease, coronavirus infection; name of PCP not listed; no other medical information
Soreness; Had little pain the same day, mainly in her arm; Chills / Shivering; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 56-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Mar2021 13:00 (Lot number: EN6199) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu shot (The patient did not provide name, manufacturer, national drug code (NDC), lot, expiry date or dose.), reaction: "Little Dizziness". The following information was reported: PAIN (non-serious) with onset 05Mar2021, outcome "recovered" (Mar2021), described as "Soreness"; PAIN IN EXTREMITY (non-serious) with onset 05Mar2021, outcome "recovered" (Mar2021), described as "Had little pain the same day, mainly in her arm"; CHILLS (non-serious) with onset 05Mar2021, outcome "recovered" (Mar2021), described as "Chills / Shivering".  Additional Information: The main reason that the patient received COVID-19 vaccine was to reduce the risk of getting the COVID-19 virus and there were other reasons also. The patient stated that her experience with the vaccine was not bad. She had soreness and a little pain with the first dose. She got chills later in the evening (05Mar2021) for a brief time and that was it. She got her first vaccine on 05Mar2021 and the soreness started shortly after receiving it around 13:00 and had a little pain the same day, mainly in her arm. Chills started the same day later in the evening (05Mar2021) and that was strange. She started shivering and supposed it was chills but they didn't last very long. The patient stated that all were already completely resolved. She was sore the next day or not the next morning but she believed that they all resolved within 24-28 hours. She stated that the pains here and there were for different reasons. She had vaccines way back in junior high and she felt like she was going to pass out. She thought that they gave her three different things, one might had been measles mumps rubella, and it may had been two vaccines and one oral thing. She had spots before her eyes and felt like she might pass out and they had her put her head between her knees and did not think she passed out. She did not have names, manufacturer, NDC, lot, expiry date or doses to provide. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to emergency or physician office. The patient did not receive prior vaccinations within 4 weeks.The patient did not have relevant tests done.  No follow-up attempts are possible. No further information is expected.