chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POTENTIAL MEDICATION ERROR (JASSEN VACCINE RECEIVED AFTER PFIZER VACCINE); This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, and other pre-existing medical conditions included: Patient had other underlying health conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on JUL-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included bnt 162 for prophylactic vaccination. On JUL-2021, the patient experienced potential medication error (jassen vaccine received after pfizer vaccine). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential medication error (jassen vaccine received after pfizer vaccine) was not reported. This report was non-serious.
Fever, Aches, Runny nose, some kind of rash/hives on his right cheek...gave Tylenol & fluids
Developed a headache on 12/2 within hours of receiving the Flumist.  Have had recurrent migraines for the last 3 and a half days leading to dizziness, blurred vision, nausea, vomiting, etc.  Am currently still suffering and have had to miss work.
Pain in the upper arm which it continued to increase after 24 hours then on Monday morning I found a large lump under the left armpit. The size is approximately the size of a ping pong ball.
Multiple arthralgias, fatigue, paresthesias. Has had many tests and consultations with specialists as well as an acute hospital stay. Continues to have ongoing symptoms requiring medical management.
May 17 awoke with extreme headache and Vomiting.  Treated for migraine in ER several days later but did not respond to treatment. Had Dose 1 of Pfizer on 6/9 and had fatigue, headache, GI upset. Had dose 2 on 6/30.  Had leg pain and fatigue 7/1.  By 7/3 was bed ridden - SOB, Heart racing, dizzy.  Has seen Cardiology who evaluated for POTS. Since then has an array of symptoms - Ringing in ears, jaw pain, constipation, debilitating fatigue, joint pain, low B12 Similar symptoms to Long COVID.  No known diagnosis, but now suspects episode in May was COVID
Body Aches, Fever, Head Ache, Eye Pain, Injection Site Pain, Chills
patient reported that he received the dose yesterday and this morning at 10 am passed out while sitting on the toilet. Woke up slumped over the bath tub
can barely walk or go anywhere; with same problem with balance; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "can barely walk or go anywhere"; BALANCE DISORDER (non-serious), outcome "unknown", described as "with same problem with balance".  Additional information: She stated that she got the Pfizer COVID vaccine and now her independence is gone. She can barely walk or go anywhere unless someone is with her. Another lady that got the vaccine at the same time as her has the same symptoms and also a friend of hers said the same thing. She's heard 3-4 others with same problem with balance, walking and everything. Her doctor has done all kinds of tests and nothing is coming up, so it must be the vaccine that did it. It is hard to do anything. She has gone from a cane to a walker. It's getting worse all the time. It's your stupid vaccine. It does damage to people. People got it and still got sick. She stated that she is very ticked off multiple times.She also said she's gonna do something about this and she is about to get a lawyer because her life is a mess.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300051026 same reporter/drug/AE,different patient;
Sore throat; went into a more allergy like symptoms and then went into a sinus infection. Patient portal consult - with Doctor. When I started treating the sinus infection with antibiotic it went to upper respiratory. I get this twice a  year every year. Had to do two rounds of antibiotic and with the second one the doctor also gave 2 zpacks and a prednisone pack since it settled down into the chest. It helped resolve the symptoms finally at the very end of the antibiotics and prednisone. It's only been in the last few days now that it was cleared up. I had had an ear infection in January - and I went to the doctor for meds.
Patient had some swelling (lump) at deltoid injection site that appeared to have resolved/lessened in about 10 minutes. No difficulty breathing or other side effects in 25-30 minutes of monitoring. This report is precautionary.
Fever, chills, nausea, body aches, fatigue, headache, swollen lymph nodes morning following injection
Patient had pneumonia vaccine applied to (L) upper arm on Friday, October 7, 2016. Developed redness and pain and swelling on Sunday October 9, 2016 at site of injection. Pain, swelling and redness have increased since then. Patient evaluated on 10/11/16. Area of swelling measures 16cm x 18cm *not at site of Influenza vaccine*.
Initial report was received 16 February 2011 from a health care professional. A 26-year-old female patient, who had a past history of lupus, anemia, hypertension and allergies to sulfa and penicillin, had received an intramuscular injection of ADACEL, lot number C3727AA (site not reported) on 14 February 2011 and one day later, she experienced intermittent faint tingling in her fingers and she blacked out for a second. The injection site was also noted to be red, swollen, tender and warm to touch. The events required a doctor's visit. The patient had no concurrent illness and she had not received any other vaccines within four weeks of ADACEL. Laboratory and diagnostic testing had not been performed. Concomitant medications consisted of Acyclovir, "COZAR", NEXIUM, PLAVIX, Vitamin D and B12. Outcome was not recovered. No additional information was provided at the time of the report. Documents held by sender: None.
Pt presents 10/16/02 with 3/5 redness and swelling at inj site-warm to touch, extends to below elbow. C/O no pain or fever. Temp 97.6. No s/s of SOB, swollen nodes or diff breathing/seizure activities. To use Benadryl.
Severe ongoing headache for 4 days, sore throat, congestion, copious mucous, lethargy, developed sinus infection due to severe nasal congestion.
2/24/2023 Pain started in right ear and then went down into upper teeth, followed by lower teeth, and then jaw and then into the neck. This happened over the course of 5 days. Saw Doctor 3/1, upon examination, diagnosed as a sinus infection. Proscribed Amoxiclav for 14 days. This did clear up slowly over the course of the month.
I contracted COVID and had symptoms: congestion, coughing, extreme fatigue. On the last day of quarantine (after about 2 weeks) I had some chest pain and went to Urgent Care
Employee received influenza vaccine 10/20/14. On 10/21/14 am left dentoid area red swollen and hot to touch. Area is 7 1/2 cm x 5 cm. Employee took 650 mg of TYLENOL prior to am work.
Per ER discharge paperwork: Vaccines administered to patient. Approximately 4 hours after vaccines were administered, patient became very weak, poor muscle tone and vomiting. Patient was taken to the ER and given IV fluids and Zofran. Patient was admitted to the hospital for 24 hours for observation because of neurological status/altered mental status.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 17-SEP-2013 the patient was vaccinated with M-M-R II (lot # H015829, expiration date 24-AUG-20140. The vaccine was exposed to temperature of 52F, on 29-AUG-2013 for 40 minutes, on 09-SEP-2013 for 1 hr and 25 minutes, on 10-SEP-2013 for 15 minutes and on 17-SEP-2013 for 35 minutes. No known adverse effects. This case is linked to case 1310USA008366, 1310USA008367,  1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399,1310USA008400,  1310USA008401, 1310USA008402, 1310USA008403,1310USA008404,  1310USA008405, 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Left side of face started hirting very bad and I could barely open and close my mouth.  Jaw was very sore too.  I took 2 Advils and in 20 minutes the pain was gone and never returned.
pain; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PAIN (pain) and HEADACHE (headache). At the time of the report, PAIN (pain) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
General neck and shoulder pain, and tingling sensation down left leg.  Woke up 2nd morning at 2:45 am (9/13/2021) after the shot with shortness of breath and chest pains.
01/10/2022: 64-year-old female with history of COPD normally on 3 L presents for worsening shortness of breath overnight.  She states she was here few days ago for similar symptoms and diagnosed with COVID-19.  She has had to use 4 L of oxygen at home over the past few days.  She complains of cough.  Denies any chest pain or lower extremity edema.  No fevers.   Tested externally as per patients report.  Not tested at facility 01/12/2022: Agree with remdesivir and baricitinib as the patient is requiring BiPAP/high flow. -Daily decadron for 7-10 days
ITCHY RASH TO CHEST, BACK AND SHOULDERS/ RASH AND HIVES HAVE SPREAD TO  BOTH UPPER ARMS; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no previous medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 at approximately 15:00 hr on left arm for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021 18:00, the subject experienced itchy rash to chest, back and shoulders/ rash and hives have spread to both upper arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itchy rash to chest, back and shoulders/ rash and hives have spread to both upper arms. This report was non-serious.
Pfizer Dose 1 2/11/21 (EN5318) Pfizer Dose 2 3/11/21 (EL9266) Pfizer Dose 3 10/7/21 (30145ba)  10/13/21: Patient is a 70-year-old female who presents to the emergency room with a roughly 3-4 day history of some intermittent chest discomfort with some increasing shortness of breath and dyspnea on exertion.  Within the last 6 weeks the patient did have a right ACL repair which was essentially uneventful.  Patient has been attending regular therapy sessions and notes that she has been very mobile over the last 6 weeks and denies any prolonged periods of immobility.  Patient does have a history of a blood clot within her family as her mother did have a history of a blood clot but the patient openly notes that the blood clot was only diagnosed after her mother was diagnosed with a malignancy.  Otherwise there is no known family history of a bleeding or blood clot disorder. Patient denies any previous history of blood clots and denies any blood clots in her lower extremities and also denies any blood clots within her lungs.  Most recently the patient did just within the last few days receive her COVID booster vaccine which she believes was the Pfizer vaccine. We discussed reviewed the patient's medical history, current medications, imaging studies, vital signs, laboratory studies and emergency room records.  Answered the patient's questions as best I could and also discussed the reasons and diagnoses that she is being admitted to the hospital. Briefly discussed the possible length of stay which for this patient may be 2-3 days.  10/15/21: Patient is a 70-year-old female with recent history of orthopedic surgery to the right lower extremity, who was admitted on 10/13/2021 with acute bilateral PEs, DVT of right lower extremity, and hypertension.  She was also mildly hypoxic in relation to the PEs.  She was started on therapeutic Lovenox and admitted to the intensive care unit where she was monitored closely.  Her echocardiogram showed no right heart strain.  She was transitioned to Eliquis yesterday.  There has been no drop in her hemoglobin.  The patient has remained stable, though slightly hypertensive.  She was started on amlodipine 5 mg p.o. daily to be paired with her benazepril 20 mg p.o. daily.  This improved her blood pressures.  The patient was transitioned to the med surge floor yesterday.  She has had no red or yellow alarms on telemetry.  Her vitals have been stable.  She has been able to transition off of supplemental oxygen.  Today she denies shortness of breath at rest, dyspnea on exertion, chest pain, palpitations.  She is requesting to go home.
tongue was swallen and redden, burning sensation after drinking alcohol, no problem to eat or dring anything else
Autoimmune reaction flare-up, going on 3 weeks; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received the first and second doses of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot numbers and expiration dates were not reported) via an unspecified routes of administration on an unspecified dates at single doses for COVID-19 immunisation. Medical history included Ehlers-Danlos Syndrome, Postural Orthostatic Tachycardia Syndrome (POTS) and Mast Cell Activation Syndrome (MCAS). The patient's concomitant medications were not reported. The patient experienced an autoimmune reaction flare-up, going on 3 weeks. No other specific details were provided. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt's underarms developed a whelp-like rash, and is swollen.  Both arms pits are involved, but the left underarm  is more red and itching, while the right arm is more swollen.
Severe arm and shoulder pain has not subsided now two months after the injection. My shoulder and neck hurt when I lift my arm. I have limited range of motion in my left arm since the vaccine. I also have a supraclavicular lump on my left side that appeared 5 days after the shot.
Diffuse pustular rash with erythematous bases over buttocks, hips, and thighs. Minimal spread of similar rash over shoulder where vaccine was administered. Rash accompanied by pruritus over affected region. Both rash and pruritus present by day 6 after immunization.
Pt recv vax on 5/6/96; on 1/29/99 pt exp shingles
On the 6th day at night I got hives on my legs; noticed red very tiny dots on my upper thighs; It's been almost 24 hours and still itchy and has sporadic hives appear and then slowly resolved; This is a spontaneous report from a contactable consumer (patient herself). A 29-years-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left in Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included Bronchial Asthma, Endometriosis, allergy to cat, allergy to Dog, Seasonsonal allergy, Papaya allergy and hazelnuts allergy. Concomitant medication included escitalopram oxalate (LEXAPRO); alprazolam (XANAX); ibuprofen (ADVIL).  The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced known allergies, dicycloverine hydrochloride (BENTYL) and experienced known allergies. On the 6th day, on 07Mar2021 at night 12:00 patient got hives on her legs and also noticed red very tiny dots on her upper thighs. It's been almost 24 hours and still itchy and has sporadic hives appear and then slowly resolve. The patient received Benadryl/allegra as a treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Reporter contacted manufacturer indicating that the caller had received notification of an AE possible associated with administration of BIOTHRAX vaccine. The subject military service member about to be deployed. The service member was seen at a private physician's office on Fri., 12-19-08 for a small (4mm) red raised lesion on the L forearm. The 26 yr. had received 4th anthrax vaccine in the R deltoid, and Typhoid and Influenza injection in the L deltoid at the military clinic. The physician's major concern was in regards the potential communicability of an "anthrax lesion." The reporter had also contacted the DoD and CDC for information and was satisfied that the lesion was not communicable.
pt devel swelling of entire arm 3 days p/inject was given; arm was swollen 3 times nl size, non-tender; pt was using arm completely normally; resolved p/4-5 days w/o further tx;
In December 1999, the patient developed varicella and a fever. Additional patients had similar experiences following exposure to varicella virus vaccine live. No further information is available.
Was unable to eat or drink most of the following day and had difficulty getting up. slept most of that day and the following day. did not get back to 100% until late the third day after vaccination. Had Syncope episode 03/10/2022, resulting in tests leading to a stent in the left coronary artery.
Information has been received from a physician concerning a 12 year old female who on 23-MAY-2007 was vaccinated with Gardasil (Lot #656051/0244U).  On approximately 24-MAY-2007 the patient experienced bruises on her body, especially her legs.  It was reported that the patient sought unspecified medical attention.  No further details were provided.  Additional information has been requested.
diarrhea; aches all over; My stomach became very distended; Severe upper back pain; nausea; shortness of breath; pain radiated around to the front,chest (directly under breast); pain radiated around to the front,chest (directly under breast) andstomach.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153), via an unspecified route of administration in left arm on 10Apr2021 at 15:00 (at the age of 35-year-old) as single dose for COVID-19 immunisation. Medical history included diabetes type 2. The patient did not have allergies to medications, food, or other products. Concomitant medication included Metformin (MANUFACTURER UNKNOWN), Glipizide (MANUFACTURER UNKNOWN), Ranitidine (MANUFACTURER UNKNOWN) and MULTI-VITAMIN all from an unknown date, for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 10Apr2021 at 23:00, the patient experienced severe upper back pain (directly under shoulder blades). Back pain was so severe, it caused nausea and shortness of breath. After 2 hours the pain radiated around to the front, chest (directly under breast) and stomach. The patient stomach became very distended and was hard to the touch. The pain was extreme!! Pain that patient would not expect from a vaccine. The pain lasted 5 hours then became much less. April 11th during the day, the patient had manageable back pain, aches all over and diarrhoea. April 12th, she continued to have back pain, aches all over and diarrhoea. She was expecting not to feel well, soreness in the arm and possible aches and pain but what she experienced was so painful and so severe that she was worried that she had an unexpected reaction to the vaccine. She was now worried about getting the next dose and she would not be recommending her family members to get vaccinated until science knows more about this vaccine. The patient wanted to know if this was a normal reaction. If people in this much pain after receiving this vaccine. The patient asked for advice. No therapeutic measure were taken as a result of the adverse events. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the event back pain, nausea, shortness of breath, pain radiated around to the front, chest (directly under breast) and stomach, manageable back pain, aches all over, diarrhoea and distended stomach were recovering at the time of report. The clinical outcome of the event general body pain was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous reprot was received from a registered nurse and refers to an unspecified number of patients of unknown age and sex who on an unknown date, were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K008334, expiration date 09-JUN-2016, through an unspecified route. No adverse effects were reported. The outcome of incorrect product storage was unknown. This is one of several reprots received from the same source. Additional information has been requested.
Pt experienced erythematic papule lesions on right cheek and nose. Pt mother complained of weakness and fatigue with fever prior to Pt re-evaluation. Pt mother also complains of swollen feet and cheeks.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-JUL-2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) administered by a physician, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-MAR-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed tramadol, acyclovir and prednisone for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expense, and pain and suffering, and other damages. Additional information has been requested.
Moderna COVID-19 Vaccine EUA  muscle pain/joint in the right arm, body aches
The patient was administered a shot that had been reconstituted and drawn up beyond the six hour window that is required to give the vaccine. No adverse event reported.