chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at injection site (arm)/arm was sore/ arm pain went away in a day or two; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 13-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain at injection site (arm)/arm was sore/ arm pain went away in a day or two". Clinical course: The patient's mother stated the patient had pain at injection site (arm) after a second Covid shot, that her son's arm was sore after getting a Covid vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pediatric Covid vaccine administered at 9:57am. Patient put on her shirt and began to walk towards her mom. at 9:58am patient began to gag and vomit. Vomiting lasted for 90 seconds and patient was evaluated by RN and Medical director. Given A cup of water and observed by LPN and CMA for 30 minutes no additional symptoms observed at during this time and vomiting stopped . At 10:30am mom and patient agreed that patient was feeling better and patient was allowed to leave.
Information has been received from a physician concerning an approximately 64 year old male patient who on 01-MAR-2010 was vaccinated SC with a 0.65ml ("mg") dose of ZOSTAVAX (Merck) (lot # 665294/1197Y). The patient experienced shingles after being administered ZOSTAVAX (Merck). The patient sought unspecified medical attention. At the time of reporting, the patient did not recover. It was reported that the AE did not improve. Additional information has been requested.
I was constipated and it became extremely painful. I went to hospital and had to get digital disimpaction. The gave me IV fluid and pain medicine.
Guillain Barre Acute severe bilateral leg pain (3/30/2021), tingling, subsequent foot drop (4/13/21)
4 hrs subsequent to the 3rd DTP immun. Patient was noted to be hypotonic, hyporesponsive, pale feverish & /w perioral cyanosis 30 min. duration.
Pt presented to ED 1/2/22 with pelvic/abdominal pain. Tested positive for COVID-19, but asymptomatic.
Temp was 99.4. At 6 pm temp was 100.6; shivering uncontrollably; nauseaus; began to ache all over; Hands very cold rest of body hot; body hot; Arm was sore within a couple of hours; Patient received booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 09:45 (Lot number: Tf2590) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE), administered in arm right, administration date 29Dec2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "mild depression" (unspecified if ongoing); "post concussion syndrome" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CELEXA [CELECOXIB]. Past drug history included: Known allergies=codeine, reaction(s): "Known allergies=Codeine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ez3249, Location of injection: Arm Left), administration date: 26Feb2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Ez3249, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 05Feb2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021 09:45, outcome "unknown", described as "Patient received booster dose"; PERIPHERAL COLDNESS (non-serious) with onset 30Dec2021, outcome "unknown", described as "Hands very cold rest of body hot"; FEELING HOT (non-serious) with onset 30Dec2021, outcome "unknown", described as "body hot"; PAIN (non-serious) with onset 30Dec2021 14:00, outcome "unknown", described as "began to ache all over"; PAIN IN EXTREMITY (non-serious) with onset 29Dec2021 16:00, outcome "unknown", described as "Arm was sore within a couple of hours"; CHILLS (non-serious) with onset 30Dec2021 16:00, outcome "unknown", described as "shivering uncontrollably"; NAUSEA (non-serious) with onset 30Dec2021 16:00, outcome "unknown", described as "nauseaus"; PYREXIA (non-serious) with onset 30Dec2021 18:00, outcome "unknown", described as "Temp was 99.4. At 6 pm temp was 100.6". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information included: Patient's Arm was sore within a couple of hours of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Three hours after the injection, my arm is so sore that I can barely move it. I'm now developing body aches, headache, and diarrhea. This vaccine is AWFUL and I seriously doubt that I will get the second injection of the series.
Four hours post vax, this pt experienced burning and pulsating in arm, moving into chest, with palpatations. Aso experienced sore neck, swollen glands in neck and leg muscle spasms.
Stabbing abdominal pain for 18 hours, brain fog, fatigue, headache, sinus congestion, mild pain at injection site. Symptoms started 2.5 hours after injection and lasted 30 hours.
24 y/o F reported onset of skin changes approximately 12 hours post-vaccine receipt on 30 Dec 2010. She has a history of skin changes between her fingers and on her hands (small blisters and peeling skin), so when she noted similar changes on her hands the evening of vaccine receipt, she did not think much of it. The next morning when she awoke, she reports increased lesions on her hands, forearms, and new lesions noted on her feet (both blister-like and some "red dots"). She described a "splotchy" rash on her arms too - nonraised, pink, and pruritic. She denies facial angioedema, cardiovascular, respiratory, GI or other systemic symptoms. She denies fever/chills, headache, fatigue or generalized body aches, but did report "typical" arm soreness following immunizations. The following morning, 1 Jan 2011, when she awoke, the pruritic macular rash was noted from mid-thigh to her feet and on her forearms up to her elbows. It was pruritic and areas were becoming sore from scratching during the night. She also said her fingers and hands were swollen, but denies redness or swelling of joints. She had not self-treated until afternoon of 1/1/2011 when she took a couple of BENADRYL without significant change in symptoms. On the afternoon of 1/1/2011, after climbing a flight of stairs, she reported feeling winded, and her friend urged her to seek evaluation. Patient went to ER where she  was treated for an allergic reaction. She received Epinephrine and BENADRYL IM and received a dose of oral Prednisone. She continued to c/o itching and skin crawling. An IV was initiated and she was given additional medications intravenously; she is not sure what she received, but thinks there were 3 separate medications. The itching improved, but the splotchy rash continued. She was released and instructed to take OTC ZANTAC and was prescribed an oral Prednisone 10 mg taper (4tabs x 2 days, 3 tabs x 2 days, 2 tabs x 2 days, & 1 tab x 2 days), as well as another medication (not sure of name , but it was a pink and yellow capsule). Notes from visit not visible, but discharge instructions noted prescriptions for Prednisone and VISTARIL. Reports rash and pruritus continued to improve over the weekend and for the most part, was gone by Monday, 1/3/2011, when she was seen at clinic. She was prescribed Cetirizine 10 mg daily, but patient did not take as symptoms were almost gone. SM felt well on 30 Dec. prior to vaccine receipt. Denied new medications. Patient denied other known exposures. No allergies to medications, food, latex or insect stings. Denies previous adverse events following receipt of vaccines prior to December 2010.
Fever, lethargy, grunting, gagging, irregular breathing-lasted less than 1 hour.
Narrative: COVID infection following COVID vaccine series 01/29, Pfizer, dose #1 02/22, Pfizer, dose #2 08/31, Pfizer, dose #3 09/14 COVID swab, result: detected 08/17 pt cc: cough, fatigue, runny nose, tired and diarrhea exposure: unknown 09/14 cxr Impression: No acute cardiopulmonary abnormality. 09/15 clinically resolved
pt was given adult pfizer dose instead of peds pfizer dose for his 2nd dose vaccine. Pt had to be held, distracted. Dr. was notified, no adverse reaction post vaccine.
The customer reported 1 dose of VARlVAX that was stored outside of the recommended storage range was administered to a patient.; No other adverse event reported.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient received one dose of varicella virus vaccine live (oka/merck) (VARIVAX), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not reported; lot number S038698, which has been verified to be valid, expiration date reported and validated as 01-DEC-2021). The vaccine administered experienced a temperature excursion of -4.9 degrees Celsius (C), for a time frame of 2 hours. There was no previous temperature excursion reported, and there was no data logger involved in the report. No additional adverse events were reported.
pt c/o body aches, h/a, fever, sore throat day p/vax;
This spontaneous report was received from an 88 year old female patient regarding herself. Current conditions of the patient included thyroid cancer and seasonal allergies. On 11-APR-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route unspecified). Concomitant medication included an unspecified antibiotic. Since 11-APR-2012 (also reported as since 01-JAN-2013), the patient developed extra fat around her hips and pain in her joints and muscles since she received ZOSTAVAX. The patient also stated that she preferred to use prescription products rather than over the counter products because over the counter products were hard on her organs. The patient sought an unspecified medical attention. She was treated with antibiotics (unspecified), ALEVE (dosage unspecified). No lab tests were performed. The patient was not recovered from the events at the time of report. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
This spontaneous report as received from a other health professional refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with GARDASIL 9 lot # N002720 for prophylaxis. On an unknown date the patients experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. This was one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1708USA004079: US-009507513-1708USA004080: US-009507513-1708USA004081.
Fever (afternoon and evening), chills (middle of the night until mid-morning), headache (2 days), fatigue/sleepiness (2 days), loss of appetite (2 days).
One day post vas, pt experienced redness, edema and warmth at and below site approximately 6 inches.
X1 Hive on site of administration 18mm W X 15mmL. Redness around Hive.
administration error: upon pushing out the liquid inside the syringe, it leaked out of the junction between the needle and syringe
On 5/8/2023, I came to work feeling a little warm and little bit queasy. I drank more water than usual, because I hoped it would make me feel better. It didn't really help, though. I just felt off-kilter, and I thought that it was probably allergies causing it. I went home after work that day and took some Tylenol and lay down. I woke up about two hours later at around 6:30 PM. I still didn't feel well, and I thought it would probably be a good idea to take a COVID-19 test. I took a home antigen test and very quickly got a positive result. I informed my boss and messaged my doctor and then went to bed. When I woke up the morning of 5/9/2023, I had headache, runny nose, dry cough, mild muscle aches, and diarrhea. I went to the bathroom upon waking up and then went back to bed. I then saw on my phone that my doctor had tried to reach me. She left me a message informing me that she had prescribed me Paxlovid, which I began taking the evening of 5/9/2023. Ever since then, I have been sleeping a lot, drinking plenty of water, and trying to eat a little, even though I haven't had much of an appetite. Today is the first time that I have felt significantly better since getting sick. I don't feel as weak. I slept ten hours last night, which was an improvement, because I have lately been able to sleep only around two or three hours at a time. My appetite came back today. I ate an entire steak and was able to keep it down. I still sometimes get diarrhea, though it's not as frequent now as it was at the beginning. Whenever I make bowel movements now, it's typically diarrhea rather than solid stool. I still have intermittent headaches, though they are not as frequent now. On the night of 5/8/2023, I had a fever of 102, for which I took Tylenol. When I woke up the following morning, my temperature was 99.5. On 5/9/2023 at 6:45 PM, I had a temperature of 101, which I successfully treated with Tylenol. Ever since then, my temperature has vacillated between 98.8 and 99.1. My baseline temperature is usually 97.1, so those temperatures are still above average for me.
At doctor's office well check visit on 8/1/01 showed sleep issues and potty training issues. Also, on return to clinic, the pt is still lethargic and has a persistent fever even after antibiotics were started for strep throat. On 8/1/01, child received DTAP and varicella vaccines. On 8/2/01, mom reported redness and swelling at varivax injection site and was told to apply ice or cold cloth every 15 minutes. No fever per doctor. She was told to call if no better on Friday and to see in office. On 8/3/01, per mom, pt is doing great, swelling and redness is all gone. On 8/9/01, child has rash (bumps around varicella vaccine site) came back yesterday as bumps (was initially a rash, post vax). Child says "ouch" and holds it. Ice applied. Child is irritable but has no fever. Child has 20 vesicular lesions at the site of injection of vaccine, lumps and a 2cm nodes/mobile. Ears are now clear. Pt was dx'd with chickenpox at right thigh administration. Treating with Aveeno and Benadryl. Call if symptoms of infection, fever or increased cough or any other questions. On 8/10/01, pt has rash around injection site and it seems worse today, per mom and lotion applied. Pt had periods of rapid breathing since noon today, as though he is out of breath and does this off and on. Benadryl and Motrin given last night but fever increased to 101.6F (ax). On exam; left TM with hard cerumen and right pearly grey TM. Oral pharynx 2+ tonsils and erythema, few small cervical nodes. Extremities with 4cm circular area of erythema at vaccination site with 3 clusters of vesicles. Dx'd on 8/10/01, with vaccine related, localized varicella at right thigh; cold with pharyngitis and tonsillitis (probably viral) and self limited rapid respirations causing NAD, possibly secondary to fever. Treated with Augmentin. On 8/14/01, mom reported child taking water and white grape juice this AM, had diarrhea X 2 this AM and bright orange urine (1 semi-wet in 13 hours). He is now refusing grape juice and milk. Admitted and given IV fluids and recovered, uneventfully with no antibiotics.
This spontaneous report was received from a doctor of pharmacy concerning an unspecified number of patients of unknown age and gender. It was reported that on an unknown date, patients may have vaccinated with a dose of PNEUMOVAX 23 (lot number, expiry date, dose and route unspecified) which was exposed to 28 degrees Fahrenheit (F) for possible one month. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Child had rash started on arms, then face, trunk which on 9/14/02 five days after receiving immunization. Pt seen in ER 9/15/02-Dx'd with "urticaria-unknown etiology." Pt seen in clinic 9/16/02, rash with target lesions, erythema multiforme. No mucus membrane?.
Patient experienced a Transient Ischemic Attack approximately 4 weeks after the second shot; Lost sight in 1 eye for about 5 minutes during the attact; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 57-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 2, single (Lot number: ER8734) at the age of 57 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Ehlers Danlos Syndrome" (unspecified if ongoing); "Leidens Factor V" (unspecified if ongoing).  Patient had no known allergies. The patient took concomitant medications. Patient did not receive other vaccine in four weeks but had other unspecified medciations (concomitant drug) in two weeks. Vaccination history included: BNT162b2 (Dose 1, Pfizer, lot number ER8734, vaccine location Right arm), administration date: 23Mar2021, when the patient was 56-year-old, for COVID-19 Immunization. The following information was reported: AMAUROSIS FUGAX (medically significant) with onset 13May2021 at 14:30, outcome "recovered", described as "Lost sight in 1 eye for about 5 minutes during the attact"; TRANSIENT ISCHAEMIC ATTACK (medically significant) with onset 13May2021 at 14:30, outcome "recovered", described as "Patient experienced a Transient Ischemic Attack approximately 4 weeks after the second shot". The events "patient experienced a transient ischemic attack approximately 4 weeks after the second shot" and "lost sight in 1 eye for about 5 minutes during the attact" required physician office visit. First patient was visit to Optometrist. Then patient was seen by primary care, neurologist, and cardiologist. Therapeutic measures were taken as a result of transient ischaemic attack, amaurosis fugax.   Follow-up attempts are completed. No further information is expected.
Fever 101 F; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 23-Apr-2021.    This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever 101 F) and CHILLS (Chills) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cardiac disorder NOS (Using medications for Heart condition since 20 years) since 2001. Concomitant products included ATORVASTATIN, METOPROLOL, RAMIPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced PYREXIA (Fever 101 F) and CHILLS (Chills). At the time of the report, PYREXIA (Fever 101 F) and CHILLS (Chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive COVID-19 positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information reported.
p/vax pt started hacking cough, burning on chest like a bad cold;1hr later ha chill, dizzy & nauseated;cont chills & fever all noc;bad h/a, aching, felt hot;
administrated with Shingrix subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 75387, expiry date 26th August 2023) for prophylaxis.   On 12th July 2022, the patient received the 1st dose of Shingrix (subcutaneous). On 12th July 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 14-July-2022 Reporter's comment:  The patient was administrated with Shingrix subcutaneously. No adverse event was reported. The reporter consented to follow up. Additional supportive information: The patient received the Shingrix vaccine subcutaneously which led to incorrect route of administration.
No adverse events. Client received Heplisav-B at 4 years of age.
Patient received vaccine and upon leaving the immunization room, walked about 15 feet into an aisle and experienced syncope.  This resulted in the patient briefly losing consciousness and falling to the floor where he hit his cheek.  Pharmacist went to patient's aid, sat  him down, gave him water and monitored for any further issues. 911 was called and patient assessed in store, ambulance ride/hospital visit was declined by patient's mother.  Patient waited the remaining 15 minutes and left with mother.
Pt called @ 6:30pm 11/4/19 to let me know she was having some discoloration around the injection site almost like a rash, as well as it being warm to the touch. She states she had put some hydrocortisone and ice on it but it didn't help. She said she hadn't taken any benadryl yet as she didn't think it was that bad yet. She said she's having no trouble breathing and no swelling anywhere. I instructed her it wouldn't hurt to take benadryl if in fact the rash was an allergic rxn. i told her to go to express care or ER in case of worsening rash/hives/allergic reaction etc. She said the feeling was starting to affect a larger area of her arm. She states she had a sore arm with previous flu shots, but this felt worse. At that point, I told her it wouldn't hurt to go to express care and have them look at it since it's warm to the touch, just to make sure there was no infection. She said she did not have a fever.
A report was received from a healthcare professional on 30 October 2003 concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 29 October 2003. On 29 October 2003, a vaccinee under 4 years of age inadvertently received Fluvirin vaccine.  The vaccinee had not experienced any adverse reaction at the time of the report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02 January 2004: Further information was received from a healthcare professional on 02 January 2004 indicating that the vaccinee did not experience any adverse reaction. No follow up pending, all information received.
Information has been received from a consumer, who in February, 2000 was vaccinated with one dose of varicella vaccine. Subsequently, the pt developed a rash 2 weeks after vax. The pt had 5 lesions, smaller than a dime on the arm, back and one on the face. The pt sought unspecified medical attention. The physician noted "it looks like chicken pox." The lesions have subsided and scabbed over. Additional information has been requested.