chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 13Feb2021 as dose 2, single (Lot number: EL9267), in right arm and on 09Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 80 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Macular Degeneration" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: Jan2009, stop date: 27Sep2022; AREDS 2 PLUS MULTI VITAMIN, start date: Jan2018; VITAMIN D3, start date: 01Jan2019.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid for COVID 19 Treatment from 28Sep2022 to 03Oct2022. Other medication received in 2 weeks. Known allergies: None known.
numbness on my arms and legs; All of the sudden i started having cramps on my arms and legs; tingling, that it is not continuous, it comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on my arms and legs), MUSCLE SPASMS (All of the sudden i started having cramps on my arms and legs) and PARAESTHESIA (tingling, that it is not continuous, it comes and goes) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037D214) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced HYPOAESTHESIA (numbness on my arms and legs), MUSCLE SPASMS (All of the sudden i started having cramps on my arms and legs) and PARAESTHESIA (tingling, that it is not continuous, it comes and goes). At the time of the report, HYPOAESTHESIA (numbness on my arms and legs), MUSCLE SPASMS (All of the sudden i started having cramps on my arms and legs) and PARAESTHESIA (tingling, that it is not continuous, it comes and goes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. -Treatment information not provided.
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 female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by reporter's mother. The age at vaccination was not reported. The reporter stated she got Shingles 3 weeks after been treated. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Headache, body aches, pain at injection site,, nausea, exhaustion, chills.  All symptoms severe enough to prevent me from going to work. Taking Ibuprofen helped very little.
Three doses were left out at ambient room temperature past there beyond use date; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jul-2021 and was forwarded to Moderna on 28-Jul-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date). On 12-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Three doses were left out at ambient room temperature past there beyond use date) to be not related.    No Concomitant Medications were provided. No Treatment Medications were provided. Three doses were left out at ambient room temperature past there beyond use date. There was a possibility that this individual as well as two others may had received one of these doses. There had been no physical adverse effects reported due to the possible excursion. However, it was possible that this individual did not receive a viable dose. Patient was made aware of the possibility that he might not had received a viable dose. After following up with the patient, he did not feel that further action was required at this time.
Huge rash and itching at site of injection. Rash has spread to  5? in diameter around arm and itches and painful to touch.
Lightheadedness and a headache 15minutes after vaccination.  Also found to be mildly hypertensive.
This case was reported by a physician and described the occurrence of elevated liver enzymes in a 18-year-old female subject who was vaccinated with HAVRIX, GlaxoSmithKline.  Concurrent medical conditions included fatigue.  Concurrent vaccination included GARDASIL, Merck given on 8 April 2008.  On 8 April 2008 the subject received 1st dose of HAVRIX (unknown).  On 9 April 2008, 1 day after vaccination with HAVRIX, blood work was done on the subject (due to concurrent condition of fatigue) which revealed elevated aspartate aminotransferase (AST) at 129 (0-40) and elevated alanine aminotransferase (ALT) at 223 (0-40).  A mononucleosis test was also done which returned positive.  The physician questioned the HAVRIX vaccine for both elevating the liver enzymes and the possibility of giving a false positive mono test.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the events was unspecified.
This case was reported by a physician via call center representative and described the occurrence of Guillain-Barre syndrome in a 64-year-old female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. Concomitant products included Albuterol, Flonase, Levothyroxine, ranitidine hydrochloride and Singulair. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 31st May 2018, 8 days after receiving SHINGRIX, the patient experienced Guillain-Barre syndrome (serious criteria hospitalization and GSK medically significant), tingling of extremity (serious criteria hospitalization) and upper back pain (serious criteria hospitalization). On an unknown date, the outcome of the Guillain-Barre syndrome, tingling of extremity and upper back pain were not recovered/not resolved. It was unknown if the reporter considered the Guillain-Barre syndrome, tingling of extremity and upper back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine at 10:00 in the left deltoid. The physician stated that the patient presented with symptoms of upper back pain and arm tingling on 31st May 2018. On 1st June 2018, the patient went to the emergency room due to worsening of symptoms and was then discharged the same day. Due to continued worsening of symptoms the patient re-visited emergency room on 4th June 2018, and later that day was transferred to tertiary care hospital. The patient was currently hospitalized and was being treated for Guillain-Barre syndrome at the time of reporting. The healthcare professional gave permission to contact them for any further information required.
Approximately, 4 hours after the vaccination, I began developing a rash on the arm where the vaccine was administered.  Within 24 hours, the rash had spread over my whole body and I began to experience tightness of the chest, shortness of breath, lip and throat numbness.  I was sent to the ER and was given medications to combat the allergic reaction.  I'm now on a steroid and several antihistamines to combat the allergies.
Hot, nauseous, fainting feeling with sweating a few minutes after receiving the vaccine. the symptoms resolved within a few minutes with a cold compress
Stroke - small area of acute ischemia along right anterior margin of the pontomedullary junction
No additional AE reported; Improperly stored vaccine was administered to patient; This spontaneous report was received from a medical assistant and refers to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported  On 08-FEB-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) injection, administered intramuscularly in right thigh for prophylaxis, lot #W019627, expiration date: 19-DEC-2023 (lot #W019627 has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live recombinant human albumin [rHA] [PROQUAD]). Administered vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) had undergone temperature excursion on 20-JAN-2023 (product storage error). There were no adverse events reported (no adverse event).  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2304USA007822: US-009507513-2304USA007836: US-009507513-2304USA007843: US-009507513-2304USA007837: US-009507513-2304USA007931:
Reaction after MMR-V on 2/23/21  with  possible  convulsion  2 days   after  the vaccine.
101.0 fever - caregiver reports rash (hive like on trunk of body) about 2 hours after immunizations. Mild erythema and induration (app skin) at each of the injection sites for the immunizations temp 99.4 degrees.
Patient was administered an extra dose of Menactra instead of the Meningococcal B; Patient was administered an extra dose of Menactra instead of the Meningococcal B; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 18 years old male patient who experienced patient was administered an extra dose of menactra instead of the meningococcal b while he received vaccines MENINGOCOCCAL VACCINE B and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Aug-2019, the patient received a 0.5ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6220AA via intramuscular route instead of MENINGOCOCCAL VACCINE B not produced by Sanofi Pasteur.  It was a case of actual medication error due to extra dose administered and wrong vaccine administered.  It was unknown if any adverse event occurred.  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 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.
This is a spontaneous report from a contactable consumer received via a sales representative. A 16-year-old female patient received TRUMENBA, via an unspecified route of administration first dose on an unspecified date at a single dose for immunisation, MENACTRA, via an unspecified route of administration second dose on an unspecified date at 1 DF, single for immunization, HEPATITIS A, via an unspecified route of administration on an unspecified date at 1 DF, single for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness, swelling, ring looking red circle that came and went over the course of 3 weeks. The outcome of the events was unknown. Information on the lot number has been requested.
Dose 1: Janssen/ Dose 2: Moderna/ Dose 3: Pfizer; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 as dose 3 (booster), single (Lot number: UT7751KA) at the age of 61 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 14May2022 as dose 2 (booster), single (Lot number: 071F21A) for covid-19 immunisation; covid-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 30Oct2021 as dose 1, single (Lot number: 1805020) for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing); "diabetes insipidus", start date: 2015 (ongoing), notes: my comorbidity is diabetes insipidus since 2015; "hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 1: Janssen/ Dose 2: Moderna/ Dose 3: Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 02Oct2023 to 03Oct2023. Clinical course: The patient had no known allergies.  The information on the batch/lot number for (BNT162B2, BNT162B2 OMI BA.4-5), has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product to the reported events drug ineffective and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300318207 Same reporter/patient, different drug, different event.;
Moderna COVID-19 Vaccine EUA  In the morning after the first injection of the moderna vaccine I started feeling very tired, my arm (where I got the injection) was hurting and I had a headache. I took an ibuprofen in the evening and the symptoms went away. On the 13-Jul-2021, in the morning, I was feeling irritated in my stomach. During the day, this got worse. I had stomach pains and did not feel like eating. This symptom resolved on the 14-Jul-2021 in the evening. I also experienced diarrhea during the 14-Jul-2021. Also around 2-3 days after the vaccination, my arm pit was hurting very much and I suspect swollen lymph nodes to have caused this. This symptom resolved after a few days. One week after the injection (18-Jul-2021) the side of injection was swollen, red and warm. This symptom resolved after a few days.
Pfizer-BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 3/11/2021 and 4/8/2021. Presented to ED on 8/11/2021 with complaints of shortness of breath for last 7 days. Supplemental oxygen was initiated in the ED. Admitted with COVID 19 pneumonia with ARDS and ongoing respiratory failure. On 8/22/2021 patient had cardiorespiratory arrest and required mechanical ventilation. Medications administered during hospitalization include: dexamethasone, cefepime, levofloxacin, micafungin, and remdesivir. Support withdrawn after discussion with family about poor prognosis. Patient expired at  on 9/1/2021.
Information has been received from the pregnancy registry for GARDASIL vaccine from an 18 year old female consumer, who started therapy with GARDASIL vaccine "last year". On 01-May-2008 she was vaccinated in the arm with third dose of GARDASIL vaccine. On 12-May-2008, the patient found out she was pregnant, she does not know her exact trimester but does know she's very early in her pregnancy. Unspecified medical attention was sought, but no date of last menstrual period, or due date was reported. Follow-up information has been received from a physician's office concerning the patient's pregnancy outcome. It was reported that on an unknown date the patient delivered prematurely a normal infant weighting 4 lb and 13 oz. No congenital anomalies were noted. The patient's and and baby's final outcome was not reported. Additional information has been requested.
SEVERE reaction with 101 degree fever; chills; migraine-type headache; muscle weakness; dizziness; disorientation; strong metal taste in the mouth lasting in full intensity for 19 hours straight.  Subsided by 48 hours later.  Although patient experienced lesser reactive symptoms after first and second dose  with 8-10 hour duration, the third dose was, by far, more extreme!
Injection site was high on shoulder, soreness at injection site has not resolved and has worsened and migrated to shoulder joint as of today 12/28/2015.
Immediately post vaccination patient complained of heart rate increase to the high 90's, low 100's.   Patient waited an additional 15 minutes and heart rate normalized back to the 80's.
Fever of 101F started 8 hours after Shringrix.  This was my second dose.  The 1st dose being 5 months previous.  Even with Tylenol fever was 100F.  Fever lasted about 8 hours.  Injection site was so sore I couldn?t lift up my arm for several days.  I used a heating pad at the injection site for several days.
Administration to a child under 4 years of age (Medication Error, Medication Error) (Med Error) - not reported  A report was received from a health care professional on 25 November 2003, concerning a 3 year old female vaccinee who inadvertently received Fluvirin on 20 November 2003. On 20 November 2003 the vacinee inadvertently received 0.25ml of Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 1, 11 March 2004: Further information received from a health care professional indicated that the vaccinee did not experience any adverse reaction at the time of the report. No follow-up pending, all information received.
I started developing Transverse Myelitis on August 22nd 2021(30th day after my second covid shot).  It started with weakness (numbness, tingling, lack of sensation, difficulty to walk ) on toes, feet, legs, thighs and reached upto abdomen. MRI of spine showed 2cms inflammtion on Throacic part. I am still on treament for it having doctor appointments etc.  Consutled my PCP and My Neuro.
Hives spread in waves throughout the body.  Started with hives across the jaw line.  Outbreaks very itchy as child scratched at them.
Wrong vaccination given. Mother only wanted straight MMR. No treatment received. Mother called regarding error and verbalized understanding.
Cellulitis at site of injection treated with Augmentin 8.75 mg BID X IOD
Pt started having itching, no signs of hives or respiratory distress. Gave certirizine had patient wait.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 15-DEC-2015, the patient was inoculated with ZOSTAVAX at a county health department as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated at a medical center for a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I woke up feeling hot. I had a temp with chills, cold, no appetite that went on for several hours. Then, I had heart palpitations. I knew it was A-fib so I knew it was serious and finally it went away.
9 days after vaccines given, child very fussy, cutting molars. On Tylenol/Motrin. Sudden onset 102.8 rectal temp and congestion. Febrile seizure lasting 4-5 mins. ER DX ear infection? 911 was called. Parent transported. F/U visit office 3-16-06 no ear infection noted.
flu-like symptoms; A little achy; A little sore throat; Tired; Constant ringing in both ears; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (A little achy), OROPHARYNGEAL PAIN (A little sore throat), TINNITUS (Constant ringing in both ears) and FATIGUE (Tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 024A21A) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (A little achy), OROPHARYNGEAL PAIN (A little sore throat) and FATIGUE (Tired). In April 2021, the patient experienced TINNITUS (Constant ringing in both ears). The patient was treated with PARACETAMOL (TYLENOL) for Flu-like symptoms, at an unspecified dose and frequency. On 02-Apr-2021, INFLUENZA LIKE ILLNESS (flu-like symptoms), PAIN (A little achy), OROPHARYNGEAL PAIN (A little sore throat) and FATIGUE (Tired) had resolved. At the time of the report, TINNITUS (Constant ringing in both ears) had not resolved.             Patient reported that she went to the doctor but they did not say anything, now she took  an appointment to look more into this problem.
Large blisters formed at the injection sites for both my COVID-19 second booster and my Flu vaccine. They both popped and are now permanent scars on my left arm. I have never had this reaction to any vaccinations in the past.
Vertigo 3 days after vaccination. It is intermittent and still occurring  2 weeks after vaccination.  I also got vertigo  3 days after my 2nd shot in February but was unsure if it was due to the vaccination.  It last for a six weeks. It is intermittent and often depends on my position.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT TIBIAL VEIN
Patient has shown no signs of adverse reaction to vaccine. Vaccine was not age appropriated; per CDC recommendations.