chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE details; patient was inadvertently administered an expired MMR-II vaccine; This spontaneous report was received from a medical student referring to an unknown age and gender patient. The patient's medical history and concurrent conditions were not provided. The patient's concomitant medication included sterile diluent (STERILE DILUENT).  On 10-JUN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, for prophylaxis (strength, dose, route of administration, anatomical location, and vaccine scheme were not reported; lot number T016198 was determined to be a valid lot number, the expiration date was reported and established as 11-MAY-2022). No additional adverse events (AE) were reported.
pt recvd vax & devel pain, warmth, swelling, & erythema @ inj site;
Patient reports limited range of motion to L arm, unable to lift arm above head or extended, patient reports he has to use his R arm to help raise his L arm. Patient reports ice pack/heat pack are not helping with pain. First documentation of "left upper extremity glenohumeral"  by physical therapy on 1/31/2020. Patient has bruise to anterior side of L axillary/deltoid area, documentation of flu vaccine to L deltoid on 1/28/2020.
Loss of consciousness; Lethargy; Feeling abnormal; Decreased Appetite; Dizziness; Abdominal pain upper; Fatigue; Headache; Nausea; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PROGESTERONE, ESTRADIOL (ESTROGEN) and DULOXETINE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), LETHARGY (Lethargy), FEELING ABNORMAL (Feeling abnormal), DECREASED APPETITE (Decreased Appetite), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Abdominal pain upper), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea).   At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), LETHARGY (Lethargy), FEELING ABNORMAL (Feeling abnormal), DECREASED APPETITE (Decreased Appetite), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Abdominal pain upper), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.      Patient's treatment information include Tylenol for headache.   This case was linked to MOD-2021-061582 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events two days after second dose of vaccination, a causal relationship cannot be excluded. Further information has been requested
Bruise, swelling, no redness, tender and swollen lymph node on neck, left side.
I had very bad gas and stomach pains and it was intestinal distress. I would eat and my stomach would hurt and it caused chest pain. I have GERD but I didn't have loss of appetite and I was also having sinus issues that were bothering me with congestion I guess that is what you would call it. The stomach issues were worse. The following Friday on 9/15/22 I called my doctor and they prescribed pantoprazole sodium 40 mg. I am good today after about 4 to 5 days of that and I stopped taking the medication.
only the adjuvant was administered; only the adjuvant was administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number 354DD, expiry date 06-OCT-2024) for prophylaxis.   On 13-MAR-2023, the patient received the 1st dose of Shingrix. On 13-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: only the adjuvant was administered) and inappropriate dose of vaccine administered (Verbatim: only the adjuvant was administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 13-MAR-2023 The nurse called to report only the adjuvant portion of Shingrix was administered to a patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via phone call.
Patient with onset of of chest pain and palpitations noted with standing and activity. Symptoms have been present for 1 month.
12-7-10 patient received DTP/AP, Hep B, PREVNAR, Polio at health department 12-9-10 mother state c/o pain in arm, fever 103, seizure, projectile vomiting, and became unresponsive. Pt taken to ED via ambulance. 12-10-10 patient saw PCP on F/up from ED visit.
About 12 hrs after the vaccination I woke up with unbelieveable shakes and chills like tremors with a 102 temp which I could not get to break until about 12/27 with the use of tylenol. I had to change clothes several times because I kept sweating it out but it kept returning.  I was extremely nauseous, fatigued and severly tired for about 2 weeks.  And now neuropathy has developed in the bottom of my feet it feels as if prickles are at the bottom of my feet still to this day.  I got tested for COVID-19 and was negative. I visited the Urgent Care is where I got the test performed at
Nurse administered inadvertent sub-cutaneous injection; A spontaneous report  was received from a pharmacist concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the nurse administered inadvertent subcutaneous injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot number 037K20A) on 28 Dec 2020 subcutaneously for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the pharmacist called and stated that the nurse administered an inadvertent subcutaneous Moderna vaccine injection to a patient. The patient did not experience any adverse reactions. The pharmacist also wanted to know the efficacy and if there was any data about this route of administration.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, the nurse administered inadvertent subcutaneous injection was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 037K20A. There were no reported AEs associated with this case of incorrect route of product administration.
Dry hive  like patches that started on  arm, back, chest and torso.; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN0153) via an unspecified route of administration in the arm left on 06Apr2021 at 15:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unknown date to unknown date. Concomitant medications included restylane filler (MANUFACTURER UNKNOWN) started on 04Feb2021 for unknown indication. The patient had no known allergies. Prior to vaccination, the patient was 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 vaccination. On 09Apr2021, the patient experienced dry hive like patches on arm which extended to back, chest, and torso. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of this event. The clinical outcome of the event dry hive like patches on back, chest, and torso was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
1) Body pain x 36 hours 2) Positional Vertigo. Vertigo with change in position from lying down to standing up  and from from lying supine to lying prone. Started around day 3 post second dose and continuing until at least 2 weeks post vaccine (at the time of this report symptoms are ongoing).  3) Headache on and off which started around day 7-10 post second dose of vaccine and ongoing at time of reporting (2 weeks post vaccination).
A 10-year-old patient received FLUBLOK QIV with no AE; The nurse advised that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent no AE; Flubloks are similar to the colors used for Fluzone Quadrivalent no AE; Initial information regarding an unsolicited valid non-serious case was received from a nurse via consumer/non-health care professional via agency (Reference number- 00807209) and transmitted to Sanofi on 11-Oct-2021.  This case is linked to case 2021SA337747 (same reporter).  This case involves a 10-year-old male patient who was received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age), instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered) as FLUBLOK QIV and FLUZONE QUADRIVALENT were similar to the colors (Product appearance confusion).  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2128, expiry: 30-Jun-2022) via unknown route in unknown administration site for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  It was case of actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered and product appearance confusion (latency same day).  It was reported "Two children under the age of 18 years old were administer with Flublok. The nurse (reporter) advised the Sanofi Representative that the colors used for Flublok are similar to the colors used for Fluzone Quadrivalent. It was reported that the children's parents have been notified. Both children were administered a dose from the same lot number."  No other adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a consumer concerning a pt who, on an unknown date, was vaccinated with a dose of MMR vaccine live. Subsequently the pt developed autism. It was noted that at the time of the report, the pt was being treated for autism. The reporter stated that the pt's family "believed that it was the thimerosal in the vaccine that caused the autism." The pt had not recovered. Autism was determined to be an other important medical event (OMIC). Additional info has been requested.
Based on lot # recording- appears that DTap was administered instead of Hep A.  Unable to confirm if DTap was actually given instead of Hep. A.  Recommended re start Hep A series.  Mother stated there were no adverse side effects following vaccines, told  to wait minimum 6 mos after any Td/Tdap dose.
Pt developed localized redness, warmth at left deltoid injection site. Area 2.25 in x 3.5 inch. Given BENADRYL.
Fever, rash on nasal area, eyelids, earlobes & neck, swollen eyelids; vomiting.
Initial reaction - bone and joint pain, muscle pain, chills occurred in first 48 hours.  3 days after injection, started with lines of rash on scalp that are painful, similar to shingles, 4 days after, rash developed around torso and arm, first available healthcare on day 5, prescribed valtrex and to watch rash in case it spread to stomach or groin area, would add steroid if so
Devel apnea in 24 hrs followed by sz, intubated transferred to hosp in birmingham stayed on the ventilator for few wks;
11/27/21 34 year old woman who presented to the ICC with complaints of non-productive cough and sinus pressure/drainage. Yesterday she noticed that her senses of taste/smell were absent. She is vaccinated against COVID, has not received booster yet. She traveled with her husband last week, but had no known COVID exposures.     Denies fever, diaphoresis, fatigue, shortness of air, cough, orthopnea, nausea, vomiting, diarrhea, constipation, melena, hematochezia, hematemesis, visual changes, lightheadedness, dizziness, headache, syncope, confusion, chest pain, dysuria. Review of Systems  Constitutional: Negative.   HENT: Positive for postnasal drip, rhinorrhea, sinus pressure and sinus pain.   11/27/21  Review of Systems   Loss of senses of taste and smell.   Respiratory: Positive for cough.   Gastrointestinal: Negative.   Genitourinary: Negative.   Musculoskeletal: Negative.   Skin: Negative.   Neurological: Negative.
STING TO INJECTION SITE; LITTLE SORE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included tetanus shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOW) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced sting to injection site. On MAR-2021, the subject experienced little sore. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sting to injection site on MAR-2021, and the outcome of little sore was not reported. This report was non-serious.
Information was received from a medical assistant concerning a patient of unknown age or gender. No information was reported regarding the patient's past medical history, concurrent conditions, or concomitant medication. The medical assistant reported that on 11-APR-2017, the unspecified patient received an expired dose of M-M-R II (recombinant human albumin) (lot #L012482, expiration date 10-APR-2017) (route of administration not provided) and sterile water diluent (unknown lot #, unknown expiration). No adverse effects reported. No further details provided. Additional information has been requested.
Client received Pfizer on 3/19/21 as a first dose, but then received the above Moderna vaccine on 4/13/21 (medication error)
Shoulder/arm pian, limited ROM, numbness down arm, radiating pain up (L) side of neck and down (L) arm, "popping" in (L) shoulder. Tx: chiropractic adjustment, ultrasound therapy, steroid pack, ice, ibuprofen then ALEVE, GP care. Scheduled orthopedic Dr visit, scheduled nerve conduction study.
Muscle aches , headache, lethargy, red swollen firm and  tender circle approximately 5 cm in diameter at injection site
On 8APR or 9APR p/using a tanning salon pt had red & blotchy area on front thigh & groin; very itchy; lasted about 12 hrs; reappeared p/next session of tanning; no change in soaps,lotions, etc. This never happened prior to receiving vax;
Case number PHEH2011US06146 is an initial spontaneous report received from a consumer on 05 Oct 2011: This case refers to 27-year-old male patient. He was vaccinated with FLUVIRIN (batch number: unknown) on 01 Oct 2011. After vaccination his sugar was 1500 because of flu shot. The flu shot raised his blood sugar to a diabetic coma that he did not wake up. The patient received care at hospital. The critical team worked on him for 12-hours and he expired on 03 Oct 2011. No other information was provided.
Initial information received on 09-Nov-2018 regarding an unsolicited valid serious case received from an Office Staff. This case involves female patient of an unknown age who experienced children passed out, while she received vaccines MENACTRA and ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (batch number, expiry date, route and site of administration were unknown). On an unknown date, the patient developed a serious children passed out (loss of consciousness) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant. It was reported that the patient hadn't slept well or eaten anything prior to the visit. State this happened maybe during the summer. Other relevant tests included no lab data. Final diagnosis was children passed out. It was not reported if the patient received a corrective treatment. The outcome of the event was reported as unknown. List of documents held by sender- none. Sender's Comments: This case involves female patient of an unknown age who passed out post vaccination with MENACTRA and ADACEL. Time to onset is unknown. Moreover, it was reported that the patient hadn't slept well or eaten anything prior to the visit and this maybe during the summer which could be the possible cause of the event. Additional information including patient's medical history, history of similar episode, lab test excluding alternate etiology is needed to complete assessment. Based upon the reported information, the role of the vaccine cannot be assessed.
Seven days after vaccine was administered Patient started having symptoms of difficulty breathing, rapid heart rate, and breaking out in a rash all over  his torso and upper arms.  His lips also got quite swollen.  The rash eventually spread down both his legs.  He was taken to the emergency room at Hospital, as he was visiting there at the time.  He was given benadryl, and prednisone once his Covid test came back negative.  Blood work, chest x-ray, CT scan of both stomach and chest, EKG and blood work all came back normal.  His resting heart rate was 120 and above, and he required two liters of oxygen to stay in the mid 90's saturation level.  He spent five days in the hospital before the rash was mostly faded on his torso and his lip swelling had come down.  He was discharged on 3/24/21 with the advice to see his primary care physician, and to be monitored carefully for oxygen saturation and heart rate.  The family could not think of anything he had eaten or come in contact with that would have caused any reaction.  At this time we think it was a reaction to his Janssen vaccine based on all the tests at the hospital coming back normal.
Rash consisting of red bumps on arms, face, between breasts, and a little bit on legs and feet. Also a terrible migraine-type headache on the left side with an unusual (for me) ocular disturbance. The rash seemed to appear first on my left arm, and the rash was worse on my left side (left arm worse than right, left side of face more covered than right). I cannot say exactly when on Saturday I noticed it. The bumps on my face itched terribly. I took Benedryl at night, by Tuesday morning it began to fade. The migraine appeared at approximately 2 PM on Saturday, July 10. I took my usual migraine medication, Sumatriptan. The headache presented with a sudden blurring and sense of pressure in the left eye. This headache and change in vision also persisted until Tuesday morning, July 13.
Waxing and waning rash on upper torso and arms that started the morning after she received the flu shot. She had a flu shot last yr which was he same formulation as this yr. She reports having a sensitivity to all medications.
When I had the vaccine, two nights later I couldn't breathe and my chest was hurting. I got the shot about 2 weeks ago, and patient stated that she did not go see doctor about Adverse Reaction.. Patient has recovered from Adverse Reaction.
There were no adverse effects, Dtap was given but should have been Tdap as patient was over 6 years but was behind on his vaccines
Individual given influenza vaccine (as is in high risk group) on 10/4/04 in left deltoid without difficulty. Later that day, developed diffuse maculopapular rash on stomach, sides, back armpits, and down arms and mild itching. 2 days later swelling to tongue. Doctor prescribed tapering doses of Prednisone for 6 days; still requiring Allegra. Symptoms are decreased in severity but still persist as of this date 10/18/04. Follow up 02/4/05: symptoms resolved entirely after several days, no complaints since then.
mom called MD evening, 21ARP92 pt had fever 104 & was very cranky; @ well pt clinic had URi w/clear rhinorrhea, t99.2 (TM-R); seen by MD 22APR92 t99 (TM) cont APAP was prescribed & d/c pertussis;
IMMEDIATELY POST VACCINES PATIENT COMPLAINED OF LIGHT HEADINESS, NAUSEA, BECAME SWEATY, PALE, AND BEGAN VOMITING. 1ST AID TREATMENT PROVIDED. PATIENT REMAINED IN CLINIC FOR FURTHER OBSERVATION AND STABILIZATION. AT APPROX 2:20 GUARDIAN REPORTS APPEARANCE OF  RASH TO BOTH ARMS.  AT 2:20 PM RASH WITH HIVE LIKE APPEARANCE NOTED OVER BOTH ARMS AND CHEST/TRUNK OF PATIENT'S BODY. AT 2:21 Public Health Nurse administered 50mg/1ml of DiphenhydrAMINE administered into the right leg via IM injection.   EMS ACTIVATED AT 2:23 PM PATIENT TRANSPORTED TO HOSPITAL AT 2:37PM.
lymphadenopathy/Lymphadenopathy in neck persisting more than 10 days.; This is a spontaneous report from a contactable Other Health Care Professional (patient) via Medical Information Team. A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318), via an unspecified route of administration, administered in arm left on 01Feb2021 at 08:45 (age at vaccination was 28-year-old) as dose 1, single for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was other. The patient medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. On 07Feb2021, the patient experienced lymphadenopathy/ lymphadenopathy in neck persisting for more than 10 days as it was still there as of 19Feb2021.The patient reported that she saw in the study that participants experienced this adverse event for around 10 days with some still experiencing the event. Wondering if you had follow-up data about those participants if they had recovered and the time frame. The patient had submitted an adverse drug reaction (ADR) report via your website already. Since the vaccination, the patient had not tested for COVID-19. No treatment medication was received for the event. The outcome of the event was not resolved.   No follow-up attempts are possible. No further information is expected.
Wheeze on same day. Progressed to arthralgias and temperature to 102. Maintains respiratory symptoms and temperature for 10 days later. Had similar, but never reached to first of hepatitis B series, excused it was flu and did not report.
Waves of a sunburn like sensation or chaffing sensation on skin of entire left shoulder blade and under armpit of left arm.  Lasting 3+days.  No rash.