chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was recently discharged from Hospital on July 30, 2021 after receiving treatment for community acquired PNA and pleural effusion.  Sent home on ABX and completed that course on August 5th.  Daughter reports since discharge patient has been very fatigued with no energy and sleeps most of day, with increasing bilateral lower extremity weakness and has fallen which prompted a call to EMS.  On arrival to ED patients BP was 79/42 and HR in 50's.  A sepsis bundle was initiated and was started on Levophed with an ICU admission.  Patient tested positive for Covid 19 on 8/11/2021.  Patient expired on 08/19/2021.
a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL, PROGESTERONE and TRAZODONE.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced VACCINATION SITE RASH (a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together). At the time of the report, VACCINATION SITE RASH (a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
8/13/10 Left deltoid warm & edematous. Limited ROM. Given protocol for local vaccine reaction. 8/16/10 swelling gone still redness using arm. (per Mom).
painful lt arm-also pain in elbow since inject-aching & throbbing-has not gotten any better-has been taking Advil;
Took #2 Shingrix on 6-11-19. started 6-12-19 @ 1230 "starting having dizziness with N & V." vomited x1 Instructed to lie down with feet up & call M.D if no improvement BP taken by husband 155/89 P-68
fever; Nausea; injection site was sore / normal pain; mass at the injection site is smaller but still present / the mass / began to ache; not feeling well for 2-3 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site mass (1st dose received on 13th September 2020. please refer the case US2020226609).   On 12th November 2020, the patient received the 2nd dose of Shingrix. On 12th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, injection site mass, feeling unwell and nausea. On 16th November 2020, the patient experienced fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site mass, fever and nausea were unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site mass, feeling unwell, fever and nausea to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was not feeling well for 2 to 3 days following the 2nd shot. The injection site was sore but not as bad as the first time. She described it as the normal pain associated with a vaccine administration. She also reported that the mass on her left began to ache after she received the 2nd vaccine in her right arm. The reporter consented to follow up. This case has been linked with case US2020226609, reported by the same reporter.
No adverse effects; one separate dose of an improperly stored vaccine, PEDVAXHIB was administered to one separate patient.; Information has been received from a medical assistant, referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported.    On 27-JUN-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 milliliter (one dose, lot# R021077, expiration date: 11-JUN-2021, frequency was unknown) intramuscularly for prophylaxis (incorrect product storage). No adverse effect was reported.  The vaccines were exposed to temperature of 34.2 Fahrenheit (F) for 4 hour 54 minutes. The temperature excursion was detected by a data logger. No previous excursions were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674:
I started having pain in my left leg april 16th 2021. The next day april 17th I had what looked like rash on my left leg. April 19th I had unbearable pain in left leg along with rash and went to urgent care. Was diagnosed with shingles .
panic attack; their heart rate go up (after 15-30 minutes); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2023NVX-US-000001192 (Novavax).  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 immunization, reaction(s): "heart rate go up (after 15-30 minutes)", "panic attack". The following information was reported: PANIC ATTACK (non-serious), outcome "unknown"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "their heart rate go up (after 15-30 minutes)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: the patient reported that they started treatment on unreported dates with four doses of the Pfizer BioNTech COVID-19 vaccine (primary series and two boosters) for COVID-19 immunisation. It was reported that after the last two boosters, on unreported dates, the patient had their heart rate go up (after 15-30 minutes) and had a panic attack.  The information on the batch/lot number for [BNT162B2 OMI XBB.1.5] has been requested and will be submitted if and when received.
She had fever, fatigue, dizziness, slept for 12 hours and had rashes on half of body.
8 days post injection developed swelling, redness and heated arm approximately 3"x3" around injection site. This is day 9, it may be a bit worse. Going to visit urgent care today.
stomach cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach cramps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach cramps). At the time of the report, ABDOMINAL PAIN UPPER (stomach cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was mentioned. No Treatment medication was mentioned.
Pain at injection site, swelling at injection site, redness at injection site, fatigue, nausea
Developed extremely sore arm at site of injection within first hour after vaccination; red rash developed (3 inch diameter) with localized swelling. Mild fatigue for first two days following vaccination. Beginning on Day 3 after vaccination, developed severe fatigue, muscle pain, back pain, joint pain, hot/cold chills, abdominal pain, nausea and diarrhea. Symptoms were severe for three days (Day 3-6 after vaccination) requiring bed rest and supportive care with OTC ibuprofen, benadryl and promethazine. Rash, swelling and muscle pain at injection site persisted through Day 5 following vaccination. Fatigue, muscle and joint pain persisted at moderate intensity through Day 8 following vaccination. Moderate nausea and abdominal pain persisted through Day 8 following vaccination. Still experiencing mild to moderate fatigue on Day 12 following vaccination.
Client reported red, blotchy, mildly itchy rash on his upper and lower extremities. Then on 09/02/2012 he reported that he developed a fever on 102.9 which persisted for 4 days.
1 day after vaccine had area at site of vaccine administration that measured 5cm in diameter and was red, raised, warm and painful.
Recently 2 admissions for bacterial pna.  He comes to ED for one week of cough and weakness and dyspnea.  He has had mild fevers and a good appetite.   In the ED, he is requiring oxygen at 4L nc.  He feels better on this.  He denies chest pain, but the cough has been troublesome.
After MENACTRA was given - small wart was frozen with histofreeze - He became pale very dizzy -( vaso-vaadl spell) got better in 20 min. However had  mild headache at 2am. Experienced pain RT upper chest stiffness all over the body more with both upper and lower extremities very warm which lasted til 6am there for feet-better - no further symptoms or soreness. PT urimacular so far. CNS with oriented in space and time-Caredinal - motor- reflexes and symptoms lasted for 3 days and doing well since then. No residual symptoms.
administered concomitantly a Pediarix and Ipol; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 3-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number BY247, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE (IPOL) for prophylaxis.   On 24th June 2022, the patient received Pediarix, Pediarix Pre-Filled Syringe Device and IPOL. On 24th June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose 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 Information: GSK Receipt Date: 18-JUL-2022 Reporter's Comment: The other healthcare professional inadvertently administered concomitantly a Pediarix and Ipol non GSK polio to the patient. The nurse stated the other healthcare professional who administered the doses did not know that the Pediarix contains the Polio. The reporter consented to follow up. Additional supportive information: The patient received Ipol and Pediarix on same day, which led to overdose. This case was linked with case US2022107757, reported by same reporter. As it is not clear we are considering reported batch number belongs to Pediarix, Please provide confirmation in further follow up.; Sender's Comments:  US-GSK-US2022107757:same report, other patient
blistering rash around nose, on cheeks, up around eyes, and extending behind ears; itching and burning;
bell's palsy; This case was reported by a pharmacist via sales rep and described the occurrence of bell's palsy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   The reporter considered the bell's palsy to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient developed Bell's Palsy 3 to 4 days following receipt of first dose of Shingrix. The reporter thought this was related to Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
Initial SAE report received on 08/Dec/2003. Additional information received on 16/Dec/2003. This subject is a 77 year old male, who was admitted to the hospital due to SOB and peripheral edema while enrolled in a study. The subject received a dose of RSV or placebo and flu vaccine on 21/Oct/2003. The subject developed increased SOB and peripheral edema, 42 days post immunization. A CXR confirmed CHF and subject was admitted to ICU the same day, 2/Dec/2003. Subject was transferred to the floor and continued to have burning substernal chest pain and unstable angina. Treatment included a cardiac catheterazation on 10/Dec/2003. Subject developed acute renal failure possible secondary to the dye. A hemodialysis catheter was inserted on 15/Dec/2003 and dialysis was started. The subject's outcome is ongoing. It is unknown if they continued in the trial. The SOB and peripheral edema was reported by the investigator as unrelated to the study vaccine. Additional information received on 10/Feb/2004. The subject's spouse informed the investigator that her husband died while in the hospital on 8/Feb/2004. Subject died 68 days after admission to the hospital and 110 days post immunization. Cause of death is unknown at present. Information will be forward when available. The death was reported by the investigator as unrelated to the study vaccine. The hospital discharge summary received on 2/26/04 states respiratory failure and septicema.
This was the seasonal flu shot for the 2020 season. Muscle and arm pain at site of injection since December 1st, 2020. Still cannot place pressure on the site of injection, cannot lay on that arm (right arm). At times I struggle lifting my arm above my head due to sharp pain in the arm at injection site. Arm will have a slight pain at the injection site even as the arm is in a resting state.
Headache, Myalgia, Fever, NauseaVomiting,  chills, fatigue, stomach cramps, body aches, migraine Narrative: Day 2 through 4 - fever 101F, chills fatigue, stomach cramps, nausea, body aches self admin OTC meds with good effect on fever
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 26-DEC-2012, the patient was administered with a dose VARIVAX (Lot # 1909AA, expiry date unknown) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
The patient was inadvertently administrated a dose of VARIVAX on 12/5/2019, that had been improperly stored; No additional adverse effect reported; This spontaneous report has been received from a vaccine coordinator who is also an office manager, referring to a patient of unknown age and gender. Information about the patient's past drug and medical history, as well as concomitant therapies and allergies were not reported.  On 05-DEC-2019, the patient received improperly stores vaccine of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection, 1 dosage form, lot number S021926, expiration date on 15-JUL-2021 (concentration, frequency, route of administration, and anatomical location were not provided) as prophylaxis; that was reconstituted with a properly stored sterile diluent. No adverse events were reported. Additionally, it was reported that the vaccine experienced a temperature of 1.2°C degrees Celsius, for 3 hours and 9 minutes, the temperature was recorded by a data logger. The was not previous temperature excursion reported.   The outcome of the event was not reported.
In September of 2021, I started have a skin rash with discoloration and hyperpigmentation.
Initial case was received on 25 June 2010 from a consumer who is also the mother of the patient. A 6.5 month old female patient received an injection of FLUZONE No Preservative 2008-2009 (lot number not reported) and DTAP/IPV/Hep B (manufacturer unknown, lot number AC21B163BC) in November 2008. Immediately, half of her face swelled up and half of her face was droopy. In 2009, the patient stopped talking and "lost progress in development." No pre-existing medical conditions, allergies or concomitant medications were reported. Mom filed a VAERS report. Outcome status of events not reported. Documents held by sender: None.
Left upper arm redness, swelling, and itching. Warm to touch. 30x45m in size.
a dead arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "a dead arm".  Additional information: Event verbatim : His wife received her second dose today, 05May2021. However, when the shot was administered, it was administered in the rear part of her arm near her triceps and he is suspecting it was injected subcutaneously instead of in the muscle. It has been 6 hours now since she had received the vaccine but she has not had any side effects or dead arm or anything. Caller stated his wife had experienced immediate side effects from the first dose and a dead arm. Caller had reached out to PCP and DPH and had no response yet. Caller is asking are there any safety concerns with having to inject subcutaneously and is the shot still effective?  Caller declined warm-transfer and did not want to provide further demographic details as his wife wanted to consult with the doctor first before providing further details to report AE. Thus, AE e-transmitted. Age and HCP information not gathered. Response: Responded per CONS document and spoke from EUA fact sheet under "2 DOSAGE AND ADMINISTRATION". Told caller we are unable to speak for the efficacy of the vaccine outside of intramuscular injection as Pfizer did not specifically study the vaccine as subcutaneous use. Told caller it is the HCP's discretion whether the dose was administered as an invalid dose and the HCP does have available to them information from CDC regarding inadvertent administration of a subcutaneous injection.  No follow-up attempts are possible. No further information is expected.
Left thigh appx 4 cm redness/swelling at injection site, some improvement day 2.
After 1st and 2nd shot Mild flush face sore arm same night  no other problems   Until on or about 5/1/21  Headaches dry throat rapid heart beat legs angels swelling  cold not flashes can not sleep  every night and sometimes in morning
Got home on Saturday morning, no problem after having the shot. Sunday noticed a rash on trunk. Treated herself with Benadryl. Got worse over the next few days, belly, back, groin and armpit. Went to ER, started IV, Solumedrol, Benadryl, Prevacid, followup with pcp.  Seemed to get better. Today, it's worse.  . PCP stated if not better she is to go into the office for an injection.
I received the second vaccine on 1/27/2021, at 255pm.  Around 730pm that night I started to feel very lethargic.   My normal temperature is usually around 95-97 degrees.  When I woke up at 430am, my temperature was 99,  the lethargy was much worse, I had the chills.  I called into work, and then went back to bed until around 10am, when I woke,  and was drinking coffee,  i suddenly started having visual hallucinations (only had this once with a on old antidepressant as a teenager). I took my temp and it was 100degrees.  By 130pm, my temperature was 103 degrees, with severe chills, lethargy.  I slept 20 hours total that day.  I eventually took 1000mg of Tylenol sometime the evening of 1/28/2021.   I was very ill the entire night, but welt 98 % better on 1/29/2021.   Following the first vaccine, on 12/29/2021 at 605pm,  I was very tired for 7 days. The 5th day after the vaccine, i had coughing, chest heaviness, sinus congestion fairly significantly. I felt like I was on the verge of becoming ill.  The Tuesday following the vaccine, I got a COVID19 test out of concern, but it was negative. Eight days after the vaccine,  I had a sudden severe migraine at 930 am the caused immediate double vision and extreme pain.
The evening of 12/09/2021, the day after vaccination, the patient started experiencing tingling and itching of face and lip.  The following morning the patients lips were markedly swollen with angioedema.   Patient took benadryl and ibuprofen and symptoms improved.  The following day, 12/10/2021, the patients lips were extremely swollen with angioedema, itching, and tingling.  Patient took benadryl every 6 hours.   The condition worsened until 12/13/2021.    Finally on 12/14/2021 the swelling came down and angioedema symptoms improved greatly.   Patient continued to take benadryl for a few days as lips were still chapped, burning and tingling.     Patient symptoms have completely resolved.
BACK HURTS; FEELING FATIGUED, TIRED; BODY CHILLS; HIGH FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, batch number: Unk) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 19-MAR-2021, the subject experienced body chills. On 19-MAR-2021, the subject experienced high fever. On 19-MAR-2021, the subject experienced headache. On 20-MAR-2021, the subject experienced back hurts. On 20-MAR-2021, the subject experienced feeling fatigued, tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, body chills, headache, feeling fatigued, tired and back hurts was not reported. This report was non-serious.
On October 15, 2019, patient woke up with left arm swollen and very red and a knot at the injection site.  She also felt nauseated.  Since then, it has improved slightly, but is still swollen and red.  On October 17, 2019, she went to her primary care physician and was told it looked like it was becoming infected and was given an antibiotic shot and dispensed Keflex oral capsules.