chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 13 years old immunocompromised female patient. On an unknown date the patient was vaccinated with a dose of VARIVAX (Merck) (dose, frequency, route and lot number not reported). In approximately 2014 (reported as "currently"), the patient was hospitalized with a rash which they suspected to be varicella. The patient had lesions on her face, arms and legs and had been treated with acyclovir for 2 weeks. The reporter mentioned that the patient was also treated with VARIZIG on 30-MAR-2014. The reporter did not have the patient's vaccination information but stated that would follow-up with her primary care physician to see when she was vaccinated with VARIVAX (Merck). Submitting samples to the program were discussed and VZVIP program information would be faxed to the reporter. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present, to identify if it is associated with the wild-type (WT) VZV strain or with the Merck vaccine strain. The outcome of the event was unknown. The reporter did not provide causality assessment between the event and VARIVAX (Merck). Additional information has been requested.
Patient began developing a rash the night of the vaccination. The next day (11/12) she developed Henoch Schonlein Purpura. She had the purpura rash, ans swollen joints. We are still dealing with it...waiting to see if it progresses further.
Right arm redness, warm and tender. Hardness around area where vaccine was given. Bloodwork ordered, Augmentin ordered. follow up next day.
Narrative:  Patient developed a headache that lasted for several weeks after receiving the first COVID-19 dose that he reported was dull, moved around, and felt like it was in the spine/neck and radiating to behind the left ear. Patient denied any known injury and was able to turn his neck from side to side with some pain when turning to the left and no pain when tucking chin to chest. Symptoms resolved and did not occur with the second COVID-19 vaccine.
fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-304502 (Patient Link).
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. There were no concomitant medications, concurrent condition and medical history reported. On unknown dates, the patients were inadvertently administered with 6 doses of improperly stored GARDASIL lot # K005881 exp. 14-JAN-2017 (dose was not reported). No adverse effects were reported. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised and didn't get the full third dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised and didn't get the full third dose). On 28-Dec-2021, ACCIDENTAL UNDERDOSE (immunocompromised and didn't get the full third dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medications were not provided. Patient received the half dose booster on 28-Dec-2021 after receiving the first two primary series. Reporter did not allow further contact
Hives on arms, legs, trunk 3 days after (started 1/2/21) vaccination.  Itching controlled with Benadryl.
At 6pm on day of second vaccination the patient suddenly developed a fever, HA, and widespread myalgias. His fever has been from 100f to 104f. He has been alternating Tylenol and ibuprofen to bring down the fever, then it will go right back up. He was covid tested today and was negative with a rapid covid test.
On Friday 04/23 evening patient noted bumps on the right side of her head, (weren't itchy or painful). Saturday started feeling R-sided ear pain,, and r-sided burning sensation of my head over my ear, so I thought I had an ear infection. (I do have seasonal allergies) Went to the Minute clinic on Sunday 04/25 to see if I had a ear infection, and was informed that I had some ear wax. During that visit I was diagnosed with hay fever and prescribed Zyrtec, and encourage to utilize Debroxs drops to clear out some ear wax. Zyrtec was taking right away on Sunday, and Debroxs was utilized also right away ono Sunday. Also during the Sunday visit the clinician assessed the bumps noted on my head and reported that it was noted to be red and irritated. Monday. Sharp pin and needles pain was noted on the right side of my head. Itching was also noted on Monday. Ear pain had subsided.   On Tuesday I returned to the Minute clinic, able to get in sooner then my PCP. Assessment of the bumps were noted again, I did notice there were more, and at that point was diagnosed with Shingles
headache and mild fatigue started the next day. They dissipated within a few days. Tinnitus started on June 20. I noticed it at 2 a.m. It's still going 3 days later.
Mom reported an unwitnessed event - similar to a possible seizure 24-30 hours after pt received 3rd dose of PEDIARIX (DTAP, HEP B, IPV) & 3rd dose of PCV-13. ER physician noted that unwitnessed event was determined to a "childhood seizure".
Day after large swelling in R upper outer quadrant of breast/ upper chest wall, tender, swollen, no redness.
Patient was inadvertently given SHINGRIX as a subcutaneous injection, instead of the recommended intramuscular route.
Body rash; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198), via an unspecified route of administration in the right arm on 17Mar2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient was not reported. Concomitant medications included temisartan 80mg (MANUFACTURER UNKNOWN), valacyclovir 1gm (MANUFACTURER UNKNOWN) & citalopram 10mg (MANUFACTURER UNKNOWN), for unknown indications from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9265), via an unspecified route of administration in the left arm on 08Feb2021 at 19:00hours as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 19Mar2021 at 06:00, the patient experienced body rash. The patient did not receive any treatment for the adverse event. The clinical outcome of the event body rash was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
MMR II and VARIVAX given 9/8/09. Child with maculopapular dermatitis 9/14/09.
Pt began to have swelling of tongue, difficulty swallowing and numbness to face. Initial reaction of facial numbness 2 mins after vaccine administration
Intentional drug overdose. Patient taken to ED and admitted to hospital. Left immediately upon waking up. Hospital admission within 6 weeks of receiving the COVID vaccine.
11NOV93 h/a; 12NOV93 tired/h/a/temp/nausea/neck stiff; 13NOV93 convuls admit hosp viral meningitis, encephalitis, sinus infect;
Beginning January 30,2021, I began to develop a rash on my right leg then within a few days  it spread to my left leg.  Today, February 8, 2021, the rash is still there . I am taking an antihistamine to control the itch.
It started out with a cold little bit of a headache runny nose and a cough and then I got worse. Incredible runny nose with green stuff, fatigue and an increase in appetite, congestion, and headache. I was just really tired. My Dr. prescribed Paxlovid and I took Ibuprofen. I was sick over 2 weeks, no trouble breathing.
This spontaneous report was received from a grandfather regarding his grandson (who the patient) of unknown age. On an unknown date, the patient was vaccinated with a dose of M-M-R II, (lot number, expiry date and route was unknown). On an unknown date, the patient developed a reaction that started with fever and typical swelling and redness around the injection site. The patient the developed autism like symptoms that evolved into a Tourette syndrome. The outcome of the reported events were unknown. Additional information is not expected.
This spontaneous report as received from a health care worker refers to a 21 year old female patient. The patient's medical history was not reported. Approximately in 2007 (reported as when she was 14 years of age) the patient was vaccinated with first dose of GARDASIL (dosage/frequency was unknown, Therapy Route: Unspecified). Concomitant medications were not reported. The healthcare worker reported that the patient would like to receive remaining doses of GARDASIL (reported as INJ 120 Y) approximately in 2014 (reported as now at 21 years of age). No adverse symptoms were reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
feel itchiness; This case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (years before the date of reporting).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-Apr-2022 Reporter's comments: This case was reported by patient via interactive digital media. The patient had Shingle years ago but doctor still recommended shingle vaccine. After one week of vaccination, the patient felt itchiness almost same as when had shingles.
Information has been received at manufacturer on 9/12/02 concerning a 21 year old male pt who was administered with a dose of Menomune and typhoid vaccine on 7/23/02 at a clinic. No lot numbers were reported. Manufacturer for the typhoid vaccine was unknown. Pt reportedly became hyper, nervous, had severe nightmares, paranoia, and panic attacks on 7/29/02. Pt has history of using Risperdal and Accutane. On 9/4/02, pt was admitted to the hospital where he remains for 4-6 weeks of treatment due to an inflamed thyroid and definite psychological problems. The reporter, pt's mother, believes that a combination of the medication pt's on and the vaccine together caused the problems. Additional info received from reporter on 9/17/02: The typhoid vaccine received by pt was Typhim VI (lot number UB211AA). From telephone contact to physician's office on 9/18/02: Office nurse was unable to confirm any information regarding this pt, pt unknown to them. Also see report U2002-00738. From additional info received on 9/29/03, from a registered nurse, it was reported that the pt received Menomune, lot UB2111AA, given SC in the left deltoid and Typhim IV, number U1157-2, given IM in the left deltoid. The lot number for Menomune was previously reported as the lot number for Typhim VI; however, the reporter confirmed that the lot numbers are correct as indicated in this follow up. The reporter called back later that same day and provided the physician's name and contact info. She also reported that the pt had recovered. Adverse event coding was updated.  Follow up on 11/25/2003: "Internal memo on 11/17/2003: it was reported that numerous attempts to obtain additional information for this case have been unsuccessful.  No further information is anticipated, this case is considered closed."
Day of immun given, began w/inc temp that night had convuls & hive; taken to ER & felt rxn to immun; given DPH in ER: temp x 3 days; hives persisted x 2 wks;
Left deltoid injection site erythema extending to mid-shaft of humerus. Localized warmth.  Occurred immediately after injection per patient.
Child with inconsolable crying approximately 1 hour after vaccines per mother's statement. Sleeping 15-20 minutes, awakens crying "in pain". Brought to clinic Temp. 99, lungs clear, no swelling noted. Slight erythema (L) thigh, mild. Phoned radio MD, ibuprofen given to child 2 ml, once, per MD orders. Call clinic for any concerns. Spoke with parent 12/12/12 in AM approximately 0830 child slept through night, no other issues noted.
Have been very sick ever since; Extreme tiredness; coughing; Could not stay awake; This is a spontaneous report from a contactable consumer via a Pfizer sponsored program. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 27May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. It was reported that, patient have been very sick ever since on an unspecified date in 2021. On an unspecified date in 2021, the patient experienced extreme tiredness, coughing and could not stay awake which are the major side effects. Went to two different doctors already and had major testing. Patient was now scheduled to see an infectious doctor. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Initial unsolicited report received from a consumer via social media on 10 Oct 2016. This case was linked with cases 2016SA188144, 2016SA188556, 2016SA188803, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851, 2016SA191730, 2016SA191735, 2016SA191739, 2016SA191741, 2016SA191743 (Same vaccine). This case involves a patient (gender and age not reported) who was vaccinated with a dose of Flu shot (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified day of 1965. Patient's medical history and concomitant medications were not reported. On an unknown date, unspecified timeframe following the vaccination, the patient got sick. Laboratory investigations and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Sore arm; started to have fever (101.5)  after 10 hours and fever lasted for 24 hours.  After confirming no fever on Saturday morning (45 hours after 2nd dose), I went out for a very slow run on Saturday morning. But I felt dizzy after stopping from a slow and shot run, then I had no consciousness for seconds. I found myself on the trail ground with people around me. I rested the rest of day and felt better on Sunday.
Six hrs after injection I began to feel a malaise that intensified such that the following morning, I had to cancel a meeting.   About 24 hrs after injection, I began to experience intestinal distress with periods of cramps. The distress came in the form of either diarrhea or constipation where each alternating symptom would last for several days. The severity of the symptoms became less intense after about 30 days. However, the symptoms 60 days later are less severe but still continue. There is also a lack of energy that persists, and tiredness.  The feeling is my sense that I'm not fully free of the effects that began after the injection. On the day of the injection, my wife also had the shingrix and fluzone vaccine, and my son had just the fluzone. My wife has experienced similar symptoms to myself which also continue 60 days later. My son did not have any symptoms from which we inferred the Shingrix was the cause of our symptoms and not the Fluzone.
DTaP and flu given on Friday. Yesterday small, red areas. Lateral side on left leg. This AM larger than lemon (red knot). Now at office (3:30) size of baseball, very red. 103 this AM on Motrin/Tylenol. Last dose Motrin/Benadryl at 2:00. Temperature now 99.7 rectal.
This spontaneous report as received from a nurse refers to a 6 months old patient of unknown gender. The patient's current conditions or medical history were not reported. On 09-JAN-2014, the patient was vaccinated with a dose of VAQTA route, lot and expiration date were not reported. No adverse effects reported. At the time of the report the outcome was unknown. Additional information has been requested.
according to mom pt had 103 ax temp the evening of the immun; temp cont & 2 days p/vax seen by MD & was noted to have ear infect, placed on ATB; 15MAY92 had sx taken to ER; ER records stated pt had BOM & it was noted started on ATB that AM;
Increased fatigue with dizziness. On the 3rd day at around 2130 I walked into my home and woke up on the floor. EMS was called and I was sent to the emergency room. Bruising to my left eye with a short LOC.
red rash; redness at the site of the injection after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash) and VACCINATION SITE ERYTHEMA (redness at the site of the injection after the first shot) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash) and VACCINATION SITE ERYTHEMA (redness at the site of the injection after the first shot). At the time of the report, RASH ERYTHEMATOUS (red rash) and VACCINATION SITE ERYTHEMA (redness at the site of the injection after the first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history  and relevant concomitant medications weren't reported Treatment information was not provided
pt seen by FMD c/o lt ear pain; dx: otitis externa;7/26 c/o lt ear pain;h/a;off balance;dx OM;tx:Bactrim DS; 7/28-severe h/a,neck pain;difficulty walking;change in mental status,+ Kernig's sign;hosp;IV Claforan, Vanco, Acyclovir; expired 8/
Hives light headed weak, also low-grade fever and sick to stomach. Hives were off and on for last few days.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of M-M-R II (dose, route, lot # and expiration date were not reported) for prophylaxis. The vaccines were reconstituted whit a properly stored sterile diluent (DILUENT MRK) (lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 56 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA010748: US-009507513-1704USA015114: US-009507513-1704USA015112: US-009507513-1704USA015113:
I started getting symptoms of low grade fever of 99 and a tickle in my throat. The next morning, I had a slight cough. Then on 5/20/2022 I received a positive COVID-19 test which was done at home. I contacted my doctor and I was offered PAXLOVID but I refused due to having mild symptoms. For 2 days, I had an irritation in my left eye like there was sand in my eye.
This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 38-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included dialysis and hypertension. Concurrent medications included EPOGEN, VENOFER, NEXIUM, PHOS-LO. On 1 October 2008 at 15:00 the subject received 3rd dose of ENGERIX B at 40 mcg, intravenously. This was the wrong route of administration. ENGERIX B should be given intramuscularly. On 1 October 2008, less than one day after vaccination with ENGERIX B, the subject experienced headache. At the time of reporting the event of headache was unresolved. The healthcare professional considered the event of headache to be unrelated to vaccination with ENGERIX B and related to the subject's dialysis.
Shaking chills, fever, pounding headache, pounding heartbeat, muscle aches, vomiting, loss of appetite, inability to sleep, minor injection site soreness. So bad the first 24 hrs. that I thought I'd have to go to ER, but didn't. After 48 hours symptoms improved. After that time came down with mild sore throat and cough which lasted a week. Still have worse muscle aches than before injection.
Got 2 part shingles shot and got the 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 patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had the 2 part shingles shot and a few years later got the shingles.  The patient had a mild case because he/she had the vaccination. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming shingles were unknown at the time of reporting.