chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7/26/21 New allergy to bug bites-2 bug bites on lower left leg -both became  painful/swollen/red/hot within 24 hours;  treated at  urgent Care/diagnosed w/cellulitis/started 5 day course Doxycycline/symptoms resolved over 1 week.  8/3/21  2 bug bites right lower leg/foot-became swollen/red/hot; self-treated w/Cortisone cream, Benadryl topical spray and po Benadryl (4 tabs in 24 hours)/symptoms resolved over 1 week.
This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak) and VOMITING (Vomiting for 12 hours) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2020, the patient experienced ASTHENIA (Weak) and VOMITING (Vomiting for 12 hours). At the time of the report, ASTHENIA (Weak) outcome was unknown and VOMITING (Vomiting for 12 hours) 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.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.    This case was linked to MOD-2021-072681 (Patient Link).
Patient received GARDASIL and DTaP in left arm. Patient had allergic reaction to GARDASIL, come in on 7-29-09 to report. small red rash and soreness at injection site.
Very lethargic; Severe chills; fever up to 101; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 13:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient was allergic to sulpha drugs. The patient previously also received BACTRIUM and experienced drug allergy.   Concomitant medications included olmesartan 20 mg (MEDOXOMIL), naproxen (MANUFACTURER UNKNOWN) and Fexofenadine hydrochloride (FEXOFENADIN) for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced severe chills, fever up to 101 (unspecified unit) and patient was very lethargic. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events severe chills, fever up to 101 and very lethargic was resolved on an unknown date in Mar2021.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a registered nurse (R.N.) referring to a 3 month old female patient with no pertinent medical history or drug reactions/allergies. On 17-AUG-2018 the patient was vaccinated with PEDVAXHIB for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On the same day, other suspect therapies included ROTATEQ for prophylaxis (dose, route of administration, lot number and expiration date were not reported), an unknown hepatitis vaccine (manufacturer unknown) for prophylaxis (dose, lot number and expiration date were not reported), an unspecified pneumococcal vaccine "PCV"(manufacturer unknown) for prophylaxis (dose, route of administration, lot number and expiration date were not reported), unspecified "DTAP" for prophylaxis (dose, route of administration, lot number and expiration date were not reported), and poliovirus vaccine inactivated ("IPV") for prophylaxis (dose, route of administration, lot number and expiration date were not reported). There was no concomitant medication. On 17-AUG-2018, within 5 to 10 minutes after vaccination, the patient experienced facial urticaria. The patient sought medical attention by an office visit. No treatment was given for the adverse event. No laboratory diagnostic test were performed. The outcome of urticaria was reported as recovered. The reporter did not assess the causal relationship between suspect therapies and the event.
c/o itching and hives, benadryl 25 mg po given, continued to monitor, improved with benadryl 15 minutes post administration.
Information has been received from a pharmacist referring to a female patient of unknown age. In 2011 the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and route were not provided). The patient came down with shingles recently (date unspecified). The pharmacist did not keep record of vaccination as far back as 2011 and could not provide lot # for ZOSTAVAX). The outcome of the event was unknown. The relationship between the event and ZOSTAVAX was not reported. It was unspecified whether the patient sought medical attention or not. No product quality complaint (PQC) was involved. Additional information has been requested.
Cough  Increase fluids. Can honey and honey tea as needed. Can use OTC allergy medications like Claritin, Zyrtec and Allegra as needed.    OTC Tylenol or ibuprofen for fever, discomfort.  Recommended saltwater gargles, nasal saline sprays, humidifier and vapor rub at night.
My son is ONLY 16 and should NOT have received the J&J vaccine at all.  He was supposed to receive the Pfizer vaccine only.
Sharp pain up and down left side of body.  This was experienced after both the first and second dose of the vaccine.
Rash (papular, vesicular, pustular and crusting lesions scattered over body) mainly over diaper area, and extremities as well as lesions in oral mucosa.
suspected vaccination failure; got them; This case was reported by a consumer via interactive digital media  and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. The patient's doctor said that, they would have been much worse if he/she not had the shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
This case was reported by a consumer (the subject's mother) and described the occurrence of swelling injection site in a 4-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  There were no concomitant medications and no relevant medical history.  The subject had not experienced adverse events following previous vaccinations, including influenza vaccine.  Previous vaccination included influenza virus vaccine, manufacturer unspecified given on an unspecified date.  On 4 August 2009 at 10:00 the subject received KINRIX (.5 ml, unknown route, left arm) as the 5th dose in the series.  On 4 August 2009, less than one day after vaccination with KINRIX, the subject experienced swelling injection site, injection site rash, injection site pruritus and red skin at injection site.  At the time of reporting the events were improved.
I basically passed out, felt drugged around 10pm with no other side effects except arm was a bit sore. Then In middle of night my body felt like I had been hit by a truck. Whole body aches rest of the night, all day Saturday and into Sunday. Arm sore. Just felt very sick and whole body hurt.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (first dose received in November, 2018. For tolerability of the first dose of SHINGRIX, refer case US2019GSK027086). On 4th February 2019, the patient received the 2nd dose of SHINGRIX. On 4th February 2019, less than a day after receiving SHINGRIX, the patient experienced pain in arm and erythema of extremities. On 5th February 2019, the patient experienced headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms. The patient was treated with TYLENOL and ibuprofen. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm, erythema of extremities, headache, feeling hot, nausea, activities of daily living impaired and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. In the evening after vaccination, the patient experienced pain, soreness, and redness in her arm. On the day of reporting (5th February 2019), she woke up and felt like she had the flu. Her arms and legs were achy, she had a headache, she felt like she had a mild fever and had mild nausea. The reporter did not provide the consent to follow up. The reporter was tried to be contacted but they got answering machine and therefore were unable to obtain any additional details. For tolerability of the first dose of SHINGRIX, refer case US2019GSK027086.
Patient came into the office for a nurse visit for his first Hep A and first HPV vaccine per PCP Vaccines were administered in opposite arms  After vaccines were given, I went over VIS and return dates for #2 of each vaccine Noticed patient was getting clammy and pale Asked if he was ok Eyes glassed over and rolled into the back of his head Patient then leaned forward becoming limp, I was able to catch him and lay him down on exam table Patient began full body convulsing and drooling  I turned him onto his left side and called for Dr. to assist Convulsions lasted approx 10 seconds Dr. entered room and patient regained consciousness He was dazed and confused Unsure who we were and asked for space We gave him space as he regained consciousness Dr. stayed with patient and his mom while I got him a cup of water Mom denies prior history of seizures, fainting or reactions from vaccines  Patient drank water and felt better Dr. (patient's pcp) came in to see patient and follow up was made for next week Mom will call if there are any concerns or questions in the meantime  Patient walked out of office unassisted and stable
Not sure if caused by vaccine?  On about 10-20-21 threw up a few times and sick to stomach, on 10-31-21 a submandibular gland swelled slightly and has remained that way since.  It was checked out by a ENT surgical Onocologist and CT showed no reason for swelling.  They think it could be mechanical.  Around mid december strated getting very mild frontal tension type headaches and still get them daily for part of day.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose and frequency, route were not reported). Concomitant medications were not reported. On an unknown date, the patient developed shingles like rash. The outcome of shingles like rash was unknown. The causality of shingles like rash was not reported. Additional information has been requested.
In the middle of night all bones acheing.  Very weak.  Fever of 101.7 From Friday late night early Saturday, Slept all day until Sunday morning at 6am  Treatment Tylenol Extra Strength, Hot Bath, slept, fluids only (ginger ale)
Patient fainted, but patient mentioned that he does faint after needle exposure. Patient also ended up vomiting.  Laid patient on floor and observed for 40 minutes took blood pressure and patient stated that it was normal for him.  After 15 more minutes we let patient leave and wife drove him home. Called at 2:40 and confirmed that patient made it home safe.
Fever for one day post vaccine.  Headache and tired one day post vaccine and lasting for at least 5 days.  Stiff neck started 3 days after- paraspinal.
On the 5th of March, in the morning, I was going about my normal day and I noticed that I didn't feel right. I did my normal morning routine. I started to drink my coffee and it started dribbling out of my mouth. I went to the bathroom and saw my face in the mirror. It appeared as if I could not smile on the left hand side of my face. I stuck my tongue out and it came out straight. Since it came out straight, I thought that maybe I was in the beginning stage of a stroke. I got in my car and drove myself to ER. I was taken to the back right away after explaining that I thought I was having a stroke. They performed a CT scan and knew right away that it was not a stroke that I was having. I was released with a prescription for prednisone and diagnosed with Bells Palsy. When I spoke with my pharmacist, and told her about my prescription, she told me that she has not ever seen this many cases at one time of Bells Palsy. I am currently having persistent double vision. I will see my optometrist again in November.
patient developed extreme fatigue, rash, fever  , chills and swelling of lower extremities within few days of receiving vaccine. Also had red rash scattered on lower extremities extending from knees down to her feet.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medications reported. On multiple unspecified dates in 2015 (reported as "since November 2015"), the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L025205, expiry date 07-JUL-2016 (dose and route of administration were not specified). No adverse effects were reported. Additional information has been requested.
Pt received second dose of COVID vaccine on 01/20/2021 at 1430. At 1600 Pt developed a wet productive cough with coarse crackles. Pt ate dinner at 5 pm cough persisted. At 18:30 the nurse went to Pt's room to give him his medications. Pt still had a cough, denied shortness of breath. Pt was in a good mood and joking with staff. Pt asked to be shaved. At 19:45 Pt was sitting in the lounge and a CNA noticed that Pt was pale/white in color and clammy. 02 Sat was 85%. Respirations were labored. Pt was placed on 4 L of 02. Increased to 5 L via face mask and 02 sat was 89-90%. Ambulance was called at unknown time. Pt arrived at Medical Center at 2120 and was pronounced dead at 2127.
pt states that tinnitus volume has increased by 4 levels, states previously having mild tinnitus but it has worsened.
On 12-22-08 Patient received PNEUMOVAX around 230. At midnight woke up left arm sore at injection site at 2am woke up pain at injection site radiating down arm to hand , fingers unable to lift arm. Patient took 2 MOTRIN at 2am by 8am pain gone, showed no problems since.
a cyst develop after receiving a GARDSIL 9 vaccination; This spontaneous report was received from a physician and refers to a non-pregnant female patient of unspecified age. Her pertinent medical history, current conditions, past drug reactions or allergies, and concomitant medications were unknown by the reporter.  On an unknown date, the patient was vaccinated with one (1) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered intramuscularly (strength, exact dose, vaccination scheme frequency, and anatomical site of application were not provided; lot number and expiration date were unknown by the reporter, however, reported as syringe formulation) used as directed to prevent human papilloma virus infection (prophylaxis). The physician stated that the patient was the daughter of one of her nurses and remarked that the patient had a cyst developed after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination. It was unknown by the reporter if the patient was given any treatment for the event. Additionally, it was unknown by the reporter if the patient sought for medical attention, or if any lab diagnostics and studies were performed. The event was reported as cancer no and overdose no.  The outcome of the event was reported as recovered. The causality assessment between the cyst and rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.    This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA000527:
In July 2021. After 1 month after my 2nd moderna dose on June 2nd. I started getting bloated every day. I had swelling in my legs and feet and abdomen suddenly. My stomach had hardened. 2 prev medical professionals told me to take metamucil and prolosic for heartburn. My 3rd and 4th doctors did ultra scans on my testicles which were swelled . Then a ct scan that showed the abdomen swelling( the prev docs would not believe me). I was diagnosed with heart failure on 10/7/21, then a cancer doctor told me on 11-09-21 that my lymph nodes were swollen and i had myocarditis. I never had any medical issues my whole life until i took this moderna shot. Now i have heart meds the rest of my life.
Upon administering vaccine, contents leaked out of syringe due to faulty luer lock connection. Pharmacist explained what happened and that CDC guidance is to repeat vaccination if less than have the dose was administered. Pharmacist administered second dose successfully.
Chest pain, shortness of breath and fatigue began 2 weeks after 2nd dose; and continued for 10 weeks.  ECHO & MRI with contrast confirmed LVEF of 45%.
suffered sinusitis; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (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: SINUSITIS (non-serious) with onset 2021, outcome "unknown", described as "suffered sinusitis"; DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness".  Additional information: Patient states, she want to know if Pfizer's covid-19 vaccine might cause the symptoms (sinusitis and nausea) that she experienced and also wants to know how long would this side effects last.  No follow-up attempts are possible. No further information is expected.
Mother called school nurse 12/18/2001 to report child had been itching all night with hives. Pt was given Benadryl with some relief. In school on 12/18/2001. Sand paper rash on back of arms and still itching. History of allergic reactions reported by Mom and also has mild asthma. No medical treatment sought.
Flushing, lightheaded, chills within 10 min of vaccine. Did not return to report symptoms until 2:20 pm. Returned to work. 10-6 Follow up - Pt at work - c/o sore arm. Said she called her Dr last pm - he felt that this was a possible reaction to N1H1.
Unusual behavior change- Extreme fussiness, crankiness, throwing a fit, from an otherwise, happy content toddler.
Patient was given undiluted Pfizer 5-11 years old vaccine on 2/25/22. The vaccine given was 0.2 ml of undiluted Pfizer (5-11 years old). upon follow up on 2/26/22, patient is doing well and she has no symptoms.
Within 8 hours of administration, experienced fever of 103, nausea, vomiting, diarrhea, and fatigue. Fever resolved with acetaminophen within next 8 hours. Diarrhea, nausea, and vomiting resolved as well within 12 hours.
About 24 hours after 2nd dose of vaccine, I experienced profound hypotension marked by complete loss of sight, dizziness, nausea, and vomiting upon standing and increased activity for periods lasting from 3-30 minutes at a time. Event occurred 4 separate times within 2 hours and resolved on its own. No medical advice or treatment was required.
swab test and tested positive for Covid/symptoms such as chills, aching, headache and fatigue; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 52-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: ER8733, expiry date not reported) via an unspecified route of administration, administered in right arm on 12Apr2021, as first dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. Patient had no prior vaccinations (within 4 weeks). Patient reported being exposed and testing positive for covid in between his first and second dose of the Pfizer COVID-19 vaccine. Patient wanted to know how he should proceed regarding his second dose of the Pfizer COVID-19 vaccine since he tested positive for COVID-19 before receiving his second dose. He stated that he had monoclonal antibody treatment when he tested positive for COVID-19. He would like to know the recommended interval of when he can receive the second dose of the Pfizer COVID-19 vaccine. COVID-19 antibody test on 17Apr2021 was positive. He received the first dose of the COVID vaccine by Pfizer. Before his second dose, he tested positive for COVID, 5 days later. He was positive for monoclonal antibodies in Apr2021. Patient asked if he should wait to get the second dose, or change the date of the second dose. It was then stated that he had the 1st dose of the vaccine on 12Apr2021 (also reported as 05Apr2021, pending clarification). Then last Apr2021 Wednesday, (also reported as 07Apr2021) he was experiencing symptoms such as chills, aching, headache and fatigue. His second dose was scheduled on 03May2021 (more than 3 weeks). He then was tested positive with Covid on 17Apr2021; he went for a swab test and tested positive for Covid (also reported as 10Apr2021, pending clarification). Therapeutic measures were taken as a result of the event which was reported as he had Monoclonal shot on 23Apr2021, and he asked how long he needs to wait before he could get the 2nd shot. Patient talked to physician at the clinic described his symptoms (also reported that no visit on the physician office; pending clarification) and he sent him to ER.  The outcome of the event was unknown.   Information on the lot/batch number has been requested.
3 days post vax pt had transient edema & redness of distal extremities migratory;w/o tenderness;temp nl;13APR96 some redness of forehead;acting well;no other sx;nl by 14APR96