chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 11-AUG-2020, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 injection, lot # 1660991, expiration date 27-APR-2021 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursions of 1.1 degrees Celsius for 27 hours and 45 minutes and 9 degrees Celsius for 1 hour and 15 minutes on 04-AUG-2020. There were no previous temperature excursions. Digital Data Logger was involved. No further adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Information has been received from a consumer concerning her daughter a female patient who was vaccinated with 3 dose of GARDASIL (lot numbers not reported) "about a year and a half ago". "Currently" the patient had bumps at the injection site. Neither her physician nor her dermatologist knew what the cause was but the patient may be getting a biopsy. No other details. The patient was not recovered. On unspecified date, the patient sought unspecified medical attention via office visit. Additional information is not expected.
intermittent pain at injection site...slight pain in AM but gets worse in the evening...X-ray by Dr. shows nothing At present taking course of treatment by therapist at Clinic.....No improvement shown yet
Client stated that within a few hours of her SHINGRIX vaccine being administered, her deltoid region was reddened and warm to touch. Stated that over the next 24 hours the entire outer aspect of her left upper arm was affected (reddened and warm to touch), from her elbow to her shoulder. Stated that arm remained red, warm to touch and slightly swollen for at least one week, but that it eventually (in a week to ten days) became mostly just bruised. Stated the bruise did not completely disappear for up to 6 weeks post vaccination. She continued to use arm and did not describe any limitation in ROM to affected deltoid.
tested positive for Covid-19; This is a spontaneous report from a consumer (Patient) via Pfizer- sponsored program. A male patient of an unspecified age received first dose of BNT162B2(Pfizer Covid-19 Vaccine, solution for injection, Lot# unknown), via an unspecified route of administration on 11Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 22Apr2021, the patient was tested positive for Covid-19. The patient underwent lab which included SARS-CoV-2 test: Positive on 22Apr2021. The patient was wondering if this would affect his second dose that was scheduled on 02May2021 and if he needs to reschedule. The outcome of the event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient had reported onset of symptoms 03MAR21 @1900 following 1st Dose of Moderna on 02MAR21. Patient reported to Emergency Department at 0000 04MAR21 with the symptoms of Vertigo, Lightheaded, Nausea, Chest Tightness, and SOB. EKG, UA, and Chest X-ray ordered by ED Provider. ED Provider notated that "CXR and ECG Normal". ED Provider diagnosis: "Acute Pleuritic Chest Pain, Dizziness, Immunization Side Effect". Patient received APAP and Ibuprofen in ED and reported that chest/pleuritic pain improved following administration but complete resolution did not occur for another 24hrs. Patient discharged from ED on 04MAR21.
Interchange of vaccine products; contracted COVID-19; contracted COVID-19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier: 02245892.  A male patient received BNT162b2 (PFIZER COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "contracted COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Unknown results, notes: contracted COVID-19 around May2022. The patient received two of the elasomeran and BNT162b2 booster shots contracted COVID-19 around May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received 2nd dose of the Moderna series. Explained that he had COPD and a post traumatic event from a hospital but received previous dose with no issue.  After receiving the vaccine, patient stated he was hot and dizzy. An another associate gave the patient water. Patient still had complaints of dizziness and I confirmed that the patient was not having an anaphylactic shock (patient was still able to breathe, talk, and no signs of swelling, hives, or itching). Proceeded to place patient to lay down with his feet elevated with feet with pillows and fanned him while store management and 911 was called. Continued to fan patient until ER services came to assist.
1 of the 3 pts who recvd 1st dose of pnu-imune & devel swelling of approx 3 inches in diameter @ the inject site;
On January 9 there were significant redness and swelling at the vaccination site as well as fatigue. The redness And swelling decreased slowly but continued for about five or six days. As the redness went down itchiness increased. By the seventh or eighth day there?s no longer any sign of redness or symptoms. On the morning of January 19 the redness at the vaccination site returned and by the evening redness warmth and swelling had increased. After a telehealth visit I was advised to take Benadryl that night which I did. The following morning after a cup of coffee which I have ervery day, I had the onset of intermittent palms and soles of my feet sweating and later in the morning had jaw/mandible and tongue tingling.  This tingling lasted about 10 to 15 minutes. On January 21 the redness and swelling started to go down and in the evening I had three hives appear, one at a time on my back and buttock. They only lasted a short period of time and we?re gone by the time I went to sleep. On January 22 I had one more short episode of tingling of the mandible which lasted a short period of time . Over the next several days the redness and swelling went down and as that happened the itchiness returned and is still mildly present today January 24. There is no longer any redness or swelling though
CLOT; COVID-19 POSITIVE; This spontaneous report was received from a patient (nurse) of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number and expiry date were unknown) dose, start therapy date were not reported, 1 total, for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following vaccination, the patient developed clot, and was coronavirus disease (COVID-19) positive. The patient underwent thrombectomy and was given Xarelto (rivaroxaban) for treatment of the clot. However, on an unspecified date, the patient developed another clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from clot, and the outcome of covid-19 positive was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210628109-covid-19 vaccine ad26.cov2.s-clot. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE
He felt slightly unwell after the first dose of vaccine but recovered after a day or two On evening of 2nd dose, he developed severe chest pain, shortness of breath, and generalized malaise, without fever or cough.  He requested to see me after 5 days of symptoms getting worse such that he felt short of breath doing very little, like walking just up a few steps, or talking,  I saw him on 7/19. his physical exam was grossly normal, although he reported presence of pressure on the chest and shortness of breath with walking and talking.  After blood test finding elevated BNP, I tried to get him to schedule an echo, and sent Rx for diuretic. But he got too short of breath at home and called 911. When the ambulance arrived, he was not to the hospital I was affiliated with, but another hospital nearer to his home, so I have no direct assess to his record, but at the time of discharge 4 days later, I spoke to his discharging hospitalist to obtain the full medical course, in addition to his own account.
12/30/20, developed high fever (103), body aches, and ringing in the ear.  These sx resolved after 48 hours.  On 1/6/21, developed right-sided numbness and tingling on face.  Felt heaviness in right eye.  On 1/7/21, smile was uneven with right-sided droop and facial swelling on right.  Presented to primary care physician.  She was diagnosed with Bell's Palsy and started on treatment to include prednisone, acyclovir, cefuroxime all orally.  She continues these medications currently.
Patient is still experiencing arm pain, muscle and joint pain, fever, chills and moderate fatigue 13 days post-vaccination
Breakthrough case admission after 2 vaccines Pfizer 3/12/21 Lot# EN6205; Pfizer 4/2/21 lot# ER8732
pt recvd vax & was pale, pt's jaws was fixed & hands clenehed, legs extended & body rigid; pt was unresponsive & is diaphoretic & remain unresponsive;
Complete dose not given. I?m an experienced RN of 30 yrs. pharmacist who administered pulled syringe to early and some of dose streamed down my arm I contacted CDC asking questions out of concern of not receiving full dose and they told me to fill this form out and that they are trying to fix the problem of ?administrator error?
Muscle aches and pain in various places on left arm extending from collar bone to above elbow.  Front of arm, back of arm, side of arm, shoulder, shoulder to collar bone.  Varies from ache to sharp pains, to excruciating pain.  3 of my friends who were vaccinated at the same location are also suffering the same symptoms.  None of us have knowingly hurt our arm or shoulder.
Person was given 0.3cc dose of Janssen Booster dose instead of standard 0.5 cc. Regulatory Authority notified and Manufacturer (Janssen) notified and all persons reported to Janssen Manufacturer for their Pharmacy department, recommendations from the Manufacturer and with agreement from Regulatory Authority are to notify all of the recipients that received an incorrect dose and submit a VAERS report for each.
sore arm  onset 12 hrs lasting about 12 hours  headache onset 12 hours lasting about 36 hours 12 cm x 8 cm red itchy dermatitis onset 48 hours still lasting 4 days later slight improvement
manufacturer-filled syringe on which the seal was broken and a needle attached 2 days prior was administered to patient; manufacturer-filled syringe on which the seal was broken and a needle attached 2 days prior was administered to patient; No adverse effects was reported; Information has been received from a medical assistant referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  The reporter reported hepatitis a vaccine, inactivated (VAQTA) (lot# R034340, expiration date was 23-NOV-2019, indication: prophylaxis; strength, dose and route were not reported) manufacturer-filled syringe on which the seal was broken (Product container seal issue) and a needle attached 2 days prior was administered to patient on an unknown date (reported as 23-NOV-2019, which is a future date and did not being captured) (Product storage error). No adverse effects was reported.   The outcome of the product container seal issue was unknown. The causality between the product container seal issue and hepatitis a vaccine, inactivated (VAQTA) was not reported.
Patient experience pin needle sensation all over the body including arms, legs, hands and feet. Symptoms started on 01/04/2021 is still present, however, patient admits to symptoms  improving. Patient  received medical care from primary care provider however they could not determine any causes and was advised to keep monitoring the symptoms.
Patient unsure if her symptoms are related to this vaccine. Patient reports that she has some diarrhea, hot and cold chills and no other side effects. Patient reports that these symptoms lasted for 24 hours and then went away.
Pt. received 2 mo immunizations PEDIARIX ROTATEQ PEDVAX PREVNAR 13 on 8/24/16. I have no information on autopsy or documented cause of death only that pt. was declared deceased on 8/25/16.
16 hours, inconsolable cry. Zero sleep. 100 degree max temp, no other signs of infection. Started 30 minutes after injection.
Day 13- pain in arms and hands. Itching sensation. No fever. No rash. Day 14- pain increased in hands and arms with swelling of hands. Pain in legs and feet. Day 15- pain intensified-pt unable to sleep, crying, swelling of hands increased- 11:00am Urticaria of right hand. No rash noted at this time Treated with Zyrtec and Vioxx.
bad body rash; shingles; This is a spontaneous report from a contactable consumer (wife). An 80-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL0142) via an unspecified route of administration in the right arm on an unspecified date (about three weeks ago) at a single dose for COVID-19 immunisation. There were no medical history and no concomitant medications. The reporter noted that both she and her husband took the Covid vaccine about 3 weeks ago, stated is time to take the second part. She read the pamphlet that came with it when we got the vaccine, said that a person could have a bad body rash. She stated her husband has had a bad body rash on an unspecified date. Noticed the rash right away, maybe the day or two after and it has persisted since, it was a nightmare for him, that she thought it was shingles on unspecified date. They went to the dermatologist and he told them it could be attributed to him eating red meat. The reporter wanted to know what they should do for it. Investigation assessment was noted as no. The outcome of rash was not recovered and of shingles was unknown.
STREP  A RAPID (POSITIVE)   given  penicillin  and released 3/24/21 Called back to ER Bacteria in blood system  admit from ER to inpatient stay  24 hr introverts  penicillin  3/24/21 given pick line  14 days home  care  penicillin to be released from hospital  03/26/2021
anaphylactic response, lasted 5 to 10 minutes only: very sudden/rapid onset of full-body vasodilation, heart palpitations, chest tightening/difficulty breathing
Burning/stinging sensation on tongue, roof of mouth,back of throat - started 1 hour after shot - treatment: oral rinse - symptoms ongoing Nose bleeds- almost daily - started 8 hours after shot - treatment : applying pressure, naso gel, neosporin - symptoms ongoing Hands itching - started 1.5 days after shot -treatment: antihistamine - symptoms ongoing
Severe shooting pain in injection site, traveling thru upper arm, shoulder and neck.  Pain is now much lower but it has adversely affected the range of motion in my left arm.  Cannot lift beyond a certain point.
Headache, nausea, no appetite, hot/cold flashes. 4days so far. Loss of energy n strength.
Red, warm itchy rash with some swelling on 2nd day after injection. Still here on 4th day. No treatment as yet.
Pt reports severe HA and tinnitus on day 6-9 after immunization.  Slowly improving since day 9.
Sore arm; Rash was 2 inches wide, 3 inches long and very red; Itches every once in a while and is not painful but a little tender underneath; Itching at the injection site; Rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Rash was 2 inches wide, 3 inches long and very red), TENDERNESS (Itches every once in a while and is not painful but a little tender underneath), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE RASH (Rash at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, TELMISARTAN (TELMISARTAN HCTZ), EZETIMIBE, DILTIAZEM, FLUVASTATIN and METOPROLOL for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), RASH ERYTHEMATOUS (Rash was 2 inches wide, 3 inches long and very red), TENDERNESS (Itches every once in a while and is not painful but a little tender underneath), VACCINATION SITE PRURITUS (Itching at the injection site) and VACCINATION SITE RASH (Rash at the injection site). On 28-Feb-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, RASH ERYTHEMATOUS (Rash was 2 inches wide, 3 inches long and very red) and VACCINATION SITE RASH (Rash at the injection site) had not resolved and TENDERNESS (Itches every once in a while and is not painful but a little tender underneath) and VACCINATION SITE PRURITUS (Itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
About 1/2 hour of the vaccination, I felt mild tingling of the lips.  Very gradually, that got worse (over the nest few hours) and I had tingling of hands and feet.  I gradually developed facial swelling (my lips were enlarged and felt firm, as did my nose).  I checked my pulse ox, and it remained above 97%.  I never had rash or trouble breathing.  But  about 5 hours after receiving the immunization, I took some Benadryl, and over about 1/2 hour I could feel that things were improving.  Over the next 24 hours I took Benadryl again two times, due to return of the tingling sensation of my lips.  I also felt very cold, and had a hard time getting warm.  This also improved with the Benadryl.
Fever, Shakes, Head ache  then eventually chest cold.  Felt like got flu from the shot itself.
Patient stated her arm became red and hot to the touch April 2 (vaccine was administered March 29).  The rash appeared to spread over time and was still very visible when she presented to the pharmacy April 5.  She stated it was not itchy or painful.  Patient had been applying ice which she said helped some.  I recommended she continued icing her arm and take an antihistamine (pt bought loratadine 10mg) and call her doctor.  Spoke with patient later in the day - she stated the loratadine and ice seemed to reduce the redness and she was improving.  She had not yet called her doctor (as of 8 PM on 4-5-21).
the patient has been having all kinds of issues with her mensuration  and everything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003008.  A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "the patient has been having all kinds of issues with her mensuration and everything".  Additional information: On 16Aug2022, it was reported that a patient started treatment on an unspecified date with mRNA Covid-19 Vaccine or (Name withheld) as unknown dose for unknown indication. It was reported the patient has been having all kinds of issues with her mensuration and everything. No further follow-up is anticipated.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had body aches, loss of appetite, nauseous, fatigue, sore arm, and fever of 101. I slept all day and it felt like I had the flu. I felt better the next day. Later on, I also developed deep bruising on my fingers which never been there before. I have strong black and blue points on my ankles as well.
At 1500 started having chills, running a fever and was very shaky.  Took Tylenol and rested.  Around 2100 woke up feeling even worse and felt like heart was racing with frequent pauses (3-5 PVC's/minute).  Following ER visit continued to feel tired, achy, and occasional SOB.
Pt had 2nd booster (4th dose) afternoon of 5/17/22, notable only for arm soreness. Next evening, ate a typical dinner, went to bed, woke up around 2am in excruciating pain - chest & abdomen. Couldn't breathe. Went to ER via ambulance, opioids didn't help. CT scan revealed marked paralytic ileus, etiology still unknown, otherwise unremarkable. Was admitted to surgery ward, decompressed via NGT for 4 days, discharged home. Of note, her 97yo mother died several days prior to admission, but it was not unexpected and she was managing the grief.
Information has been received from a medical assistant concerning a 16 month old male with no known drug allergies or medical history who on 15-Aug-2002 was inadvertently vaccinated subcutaneously in the right thigh with a second dose of varicella virus vaccine live (lot # 640726/0211N). On 15-Aug-2003 the patient was also vaccinated intramuscularly in the right thigh with a fifth dose of diptheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) )(lot # U0856BA) a fourth dose given intramuscularly in the left thigh of pneumococcal 4 6B 9V 14 18C 19F 23 F conj vaccine (CRM 197) (Prevnar) (lot #491272) and a fourth dose given intramuscularly in the left thigh of hepatitis B virus vaccine rHBsAG (yeast) (lot # 64366/0054N). There was no other concomitant medication. There was no known illness at the time of vaccination. The patient had no adverse events following prior vaccinations. It was reported that the patient had already been immunized on 14-Apr-2003 with a first dose of varicella virus vaccine live. As of 20-Aug-2003 the patient "denies any side effect but was slightly irritable". There were no diagnostic tests performed. No medical attention was sought and no prescription drug was required. subsequently, the patient recovered. No product quality complaint was involved. It was also reported that on 08-Oct-2003 the patient was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast), and on 14-Jul-2003 the patient had received the following vaccinations: a fourth dose given intramuscularly in the left thigh of diptheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot #U0850DB1), a third dose given intramuscularly in the left thigh of pneumococcal 4 6 B 9V 14 18C 19F 23F conjugate vaccine (CRM 197) (lot # 491272), and a fourth dose given itnramuscularly in the right thigh of Haemophilus B conjugate vaccine (test toxoid) (ACTHIB) (lot # UA808AA).  No further information is expected.