chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; COVID-19 Virus; COVID-19 Virus; This is a spontaneous report from a Pfizer sponsored regulatory authority. A contactable consumer reported for herself that a 79-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered in upper left arm on 27Jan2021 11:00 (Lot Number: EL9262) at the age of 79 years as single dose and the first dose of bnt162b2 via an unspecified route of administration administered in upper left arm on 06Jan2021 (Lot Number: EL3246) at the age of 79 years as single dose for covid-19 immunisation. Medical history included heart surgery. Concomitant medication included paracetamol (TYLENOL) around the dates of vaccination. Patient experienced COVID-19 Virus on 09Sep2021. Contracted COVID-19 virus 30 days ago, a month ago. She wanted to know how long, when can she receive the COVID-19 vaccine booster shot. Clarified she had a very mild case of COVID-19 virus. As soon as she got the COVID-19 virus, her physician sent her to a local hospital to have an antibody infusion. Asked the hospital when she should get the booster. Hospital stated they are getting conflicting information. She was 30 days out from having COVID-19 virus. She was going to be leaving the country. Needed to be sure and wanted the maximum protection. Treatment: 10Sep2021 received the antibody infusion. She knew how she contracted COVID-19 virus. In contact with an infected person. Stated that was how she got it. Tested positive on 09Sep2021. Patient did not go to Emergency Room. Went to hospital for outpatient antibody infusion. Was not admitted to the hospital. Patient had sore arm following prior vaccinations, but didn't think that qualified, so no. Heart surgery after receiving both COVID-19 Vaccines. She tested positive for Covid on 09Sep2021, and wanted to know when can she take the booster shot. She was given convalescent antibody therapy at the hospital, it had been 30 days since she received it, and had found conflicting information about when she should be able to get the vaccine. She was advised by the hospital to call Pfizer for this information. Patient is also pressed for time, as she was going to be traveling out of the country, and needed to be vaccinated prior. Outcome of events were unknown.
This spontaneous report was received from a pharmacy technician referring to a patient of unknown age and gender. The patient had no medical history, concurrent conditions, drug and allergy history to be reported. On 19-MAY-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # M047660, expiration date 02-DEC-2018 (dose, route were not provided) for prophylaxis. The patient's concomitant therapies were not reported. On an unspecified date, VARIVAX was exposed to a temperature excursion of 14F (Fahrenheit) during a time frame of 2 hours 15 min, and with a previous temperature excursion of 14F during 1 hour. No adverse effects were reported. Digital data logger was involved. Additional information has been requested.
Chills, severe aches, pains, bed bound, no appetite, diarrhea, no apatite, spacey, bloated
Itching sensation in hands at least 2 times per day - no relief when occurs. Can feel it coming on. Also in feet. No pain. Wakes her up during night. Symptoms started with couple days of vaccination.
On 3/25/09 at 1030 the pt received the TDAP and IPV in her right arm.  The pt woke at about 2230 with the sensation that her throat was swelling.  The pt had no wheezing or difficulty swallowing.  She noticed a rash on her arms, chest, abdomen and legs.  The rash was non raised, non pruritic, pinkish/red dime to nickel size lesions.  The pt took 3 (three) 25mg BENADRYL tabs and feel asleep within 20 minutes.  At that time her throat felt better.  When she woke in the am the rash had resolved and her throat felt itchy.  The itchy throat sensation resolved later that day.  The pt has had no symptoms since.  Symptoms: Rash, diffuse, Pruritus.
got the shot still get shingles/ Suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a adult 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 details were reported as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient received shingles vaccine still got shingles. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for shingles and time to onset were unknown.
Information has been received from GlaxoSmithKline (Other Company manufacturer # A0665589A) from a consumer concerning her 0-9 year old son who on an unspecified date was vaccinated with PedvaxHIB. Concomitant vaccination included the first dose of Pediarix on an unspecified date, the second dose on 03-JUN-2004 (Lot # 21899C9), and the third dose on 23-JAN-2004 (Lot # 21899A9). The patient's mother reported that after receiving almost all of his childhood vaccines, the subject developed gut issues and was reacting to wheat containing products. The subject additionally developed encephalitis (date not reported). A physician or health care professional has not verified this report. Upon internal review autism and encephalitis were determined to be other important medical events. At the time of reporting autism was unresolved and the outcome of the other events was not known. Additional information has been requested.
got the vaccine in my upper left arm and it began to swell up and run fever within the 2 hours after to itching at spot and down the arm and it became all over to the point of itching till blood came in spot of scratching. By the night fall, I had began a headache and vomiting and couldn't sleep. I have ran up to 99.8F and up and down. Felt days and dizzy.
Pt developed on and off stomach pains beginning 11/15/2021 and had severe vomiting and explosive diarrhea on 11/16/2021
had numbness in both hands for 2 days; had a lighter weight facial fillers that swelled and were painful (around the eyes but not on the lip fillers); had a lighter weight facial fillers that swelled and were painful (around the eyes but not on the lip fillers); fever; This is a spontaneous report from a non-contactable consumer or other non-hcp. A patient of unspecified age and gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, following the second dose, the patient had numbness in both hands for 2 days and on day 2, the patient had fever. On an unspecified date, the patient had a lighter weight facial filler that swelled and were painful (around the eyes but not on the lip fillers). The eyes had a mix of JUVEDERM products which spontaneously resolved after 1 day with a subjective loss in overall volume. The outcome of the events hypoaesthesia, pyrexia, swelling face, pain was unknown. No follow-up attempts are needed. No further information is expected.
Shots given 6-8-11. Several seizures beginning 6-11-11 --> 6-15-11. No fever noted. Hospitalized 6-11-11 --> 6-15-11.
Information has been received from a physician concerning a 7 year old female who on 14-JAN-1999 was vaccinated with a dose of varicella virus vaccine live (Lot# 628037/1252H). It was reported that on 22-JUL-2005 the patient was seen in the office with breakthrough chickenpox. Subsequently the patient recovered. The patient's brother experienced chickenpox following vaccination with varicella virus vaccine live (WAES0508USA03161). Additional information has been requested.
bad rash on one leg below her knee; This spontaneous case was reported by a consumer and describes the occurrence of RASH (bad rash on one leg below her knee) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RASH (bad rash on one leg below her knee). At the time of the report, RASH (bad rash on one leg below her knee) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
felt fine except for immediate arm pain. Within a few hours (by 6 pm) started having uncontrollable shaking and chills and was freezing. I was extremely tired. so went to bed at 9 but was feeling quite nauseas as though I had food poisonings and freezing. Wore 3 fleece jackets and two pairs of paint 2 pairs of socks.  . At 11 pm woke up feeling extremely hot and my temperature was 104.5. I called my local physician and my physician.  I tried getting the fever down with ice packs and cold drinks and no luck.  The local doctor got back to me right away and said take 2 tylenol.  At midnight it was still 104.3.  By 1 am it went down to 103.  By 2 am down to 102.  Next day was weak and exhausted and still had a 102 fever.  Took tylenol twice during day due to feeling like I had the flu. Exhausted went to bed at 9 pm and slept for 12 hours. Woke up today exhausted low grade fever, still have mild stomach ache and nausea.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 28-JUL-2017, the patient was vaccinated with ZOSTAVAX lot # M041510 for prophylaxis. Concomitant therapies included sterile diluent (STERILE DILUENT). On 28-JUL-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date, the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX.      Additional information has been requested.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 11-MAY-2015, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. Shortly after receiving ZOSTAVAX, the patient experienced sudden hearing loss in her left ear, leading to total hearing loss in her left ear. 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 expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was considered related. Upon internal review, sudden hearing loss in her left ear leading to total hearing loss in her left ear was determined to be medically significant. Additional information has been requested.
Patient is immunocompromised and I thought that she was to receive 0.5ml for the 2nd booster but patient should've received the 0.25ml dose.  Patient has no adverse events or problems with the 0.5ml dose that was given.
Patient was administered concentrated covid pfizer dose. Technician did not dilute correctly according to package directions.
In order to decrease his anxiety, his mother consented to receive vaccine (MMR and QUADRICEL) at the same time. He received the subcutaneous MMR and the person injecting the IM vaccine thought she had the QUADRICEL in her hand and instead had another dose of MMR (despite the labeling on the syringe) and he received a sub-cutaneous dose and an intramuscular dose of MMR at the same time. So he received two doses of MMR; one was Sub-Q and the other IM. Despite offering to delay to another date/meet Mom and child based on her work schedule, his Mom asked to proceed with giving the QUADRICEL. He is a twin hence having two of each vaccine prepared for administration.
This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered in left arm on 06Mar2021 at 12:15 (at the age of 64-year-old), at a single dose for COVID-19 immunization in other. Medical history included asthma, high cholesterol and patient previously had Covid and was diagnosed 65 days ago. Patient did not have known allergies. Concomitant medications included clarithromycin (CLARITIN) and rosuvastatin calcium (CRESTOR). Patient did not receive any other vaccine in four weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient felt fine after the injection. On 07Mar2021 at 12:30, (reported as almost exactly 24 hours), later patient was so fatigued, had chills and body aches. Patient did not receive any treatment for the events. Patient was wondered if she should wait and should get the 2nd dose. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Patient fell about 7 minutes after receiving vaccine, did not lose consciousness, kept for 30 minutes under observation, requested water, left after 30 minutes; said he felt better; had been anxious about receiving vaccine; had no primary care prescriber to follow up with per pt.
Information has been received from a registered nurse concerning herself, a 26 year old female with no known allergies, who in approximately August 2007 (possibly September 2007), was vaccinated, SC, with the second dose, of Gardasil (lot # not provided).  It was noted that the first dose (date not specified) had also been administered SC.  Following the second SC dose (August or September 2007), the patient developed an injection site reaction that was red, mildly painful and warm.  She spoke with the pharmacist for medical advice (details not provided).  The symptoms lasted for "about 3 weeks," and the nurse then recovered.  On 08-JAN-2008, a third dose of Gardasil was administered, IM, with no adverse effect reported.  Additional information has been requested.
Headache, BODY ACHES!!!!!, fever, chills,  day 2 (2/11) huge auxillary lymph node swelling left arm, larger than golf ball size, painful. right auxillary slight pain not swollen
pain in in the injection site; This is a spontaneous report from a contactable consumer reporting himself (patient) and from a Pfizer sponsored program COVAX US Support.  A 60-year-old male patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: EN6208), via intramuscular, administered in left arm as dose 1, single for on 12Mar2021 09:30 covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got his first shot of the Covid 19 vaccine and experienced pain in the injection site on unspecified date in 2021. Patient scheduled to get his second dose on 02Apr2021 but would like to confirm as he has a friend who got very ill, vomited and ended up with pneumonia after getting the vaccine. Patient asked that how many people might have experienced feeling ill and vomiting after getting the second dose of the vaccine and about the prevalence of side effects experienced after receiving the 2nd dose of the Covid-19 vaccine because he knew from her wife that her coworker had nausea, vomiting, pneumonia, and was sick for a week. Patient's wife didn't want him to get the second shots as she was worried, he may get sick, patient talked to two different people each of which asked me a list of questions. Beyond a sore arm patient had no ill affects fall upon him, no vomiting, nothing, the co-workers he referred to were the ones that had reactions after his first and second dose of vaccines. At the time of this report, outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
20JUN95 pt exp t100; 23JUN spots head to toe, starting on hairline, neck spread to whole body;arms clutched toward body, turned beet red w/in 10 sec p/shot;no convuls;shot site swelled up double the size;stayed beet red overnoc;
Pt (L) upper arm broke out in hives on 3/8/12 in am. Pt stated she noticed it when she got up in the morning because it itched. Pt came to office, red raised areas noted to (L) upper arm. DECADRON 10 mg IM given, MEDROL dose pak ordered and pt instructed to take BENADRYL 50 mg. Spoke to pt on 3/9/12 and she was feeling better.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. On 09-MAY-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J000436, exp. 10-APR-2014, 0.65 ml, subcutaneous. In May 2013 the patient experienced "bad swelling, warm to touch and redness" of upper arm after the patient received ZOSTAVAX, at the pharmacy. The patient sought medical attention by contacting physician and was treated with BENADRYL and ice topically. At the time of reporting, the outcome was unknown. The pharmacist explained adverse event was reported to VAERS. Pharmacist requested lot checker for ZOSTAVAX (lot # J000436, exp. 10-APR-2014). This is one of the several reports from the same reporter (MARRS #1305USA009034, 1305USA008554 and 1305USA008498). Additional information has been requested.
patient experienced a delayed local reaction. approx 9 days after vaccination patient experienced local redness, warmth, and mild pain in the area of injection. she did not have local reaction immediately post vaccination,  it was delayed by about 9 days per patient. she did not take any medication to treat and she reported resolution approx 3 days later.
Severe abdominal pain followed by appendectomy.  Hepatitis B shot administered at 9:00 am on August 4th, 2008 , abdominal pain after lunch.  Pain subsided then returned by 2:00 pm the following day, August 5th, 2008. 9/2/08-records received for DOS 8/6-8/7/08-DC DX: Acute appendicitis. Laparoscopic appendectomy. Presented to ED with C/O abdominal pain beginning afternoon of day prior. Nausea and vomiting.
Pt received TD Intrathecally in LFA rather than PPD. Pts arm showed induration, heat and redness 24 hours post injection lasting about 1 week.
Pt complaining of sore throat and "bottom" itches and says it hurts to urinate. On exam, throat is red with anterior nodes. Was exposed to strept. Treated with Amoxicillin. Return if not better in 2 or 3 days.
Site very sore, red and swollen for 8 days.  First 2 days had headache, lethargic, nausea, very dizzy,  weak , shivers
Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of upset stomach 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, unknown after receiving Shingrix, the patient experienced upset stomach. On an unknown date, the outcome of the upset stomach was recovered/resolved.   It was unknown if the reporter considered the upset stomach to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced upset stomach after receiving 2nd dose of Shingrix. The reporter believes this may be due to his mass since he was taller and reportedly weighs 100 pounds more. No more information provided. For tolerence with 2nd dose of Shingrix refer linked case US2019AMR233005. This case has been linked to the case US2019232431, reported by the same reporter.
During a yearly audit 2 yellow fever diluents were found without the yellow fever. This had us further investigate. The last two yellow fever vaccines that were given by CMA who was questioned to figure out what happened as her patients were the last to given them and charted by her. After discussion it was found CMA gave the two patients the yellow fever vaccine with the wrong diluent. Sterile water was given instead of sodium chloride.
2pm felt mild tired, muscle soreness. 8:30pm developed severe fatigue, chills. 10pm developed swollen golf ball size knot. Tired but couldn't sleep. For 2 days severe hip bone pain, couldn't walk. day 2 H/A. Had constant severe urination.  SOB, Low back pain. Entire skeletal system felt like she was in a car accident.  Took 800mg ibuprofen. Had no energy 48 hours. 3rd day started to recover.  Could not eat meals for 2 days.
Upon injection patient stated itching at site of injection. Became very red and began to spread. Applied ice and redness was reduced to only injection site. Within 30 min only minimal swelling & redness at that location.
sterile abscess @ site erythema 2cm diameter w/central furuncle 2cc expressed pus;