chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Her fever was 100.4; fatigue; sore throat; stuffy nose; This is a spontaneous report received from a contactable consumer reported for herself. A 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 06Apr2021 as single dose for COVID-19 immunisation. No pregnant at the time of vaccination. There was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included high blood pressure, allergy. Concomitant medications included blood pressure and allergy medicine; received within 2 weeks of vaccination. Historical vaccine included the first dose of BNT162B2 via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunisation. The patient experienced fever was 100.4 degrees, fatigue, sore throat, stuffy nose on 08Apr2021; no treatment received for the adverse events. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered. The events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Abdominal spasm as I have IBS, this is the second day in a row in addition to contractions as I am giving birth!
Pt was given DTaP on 2/9/16 and was brought in by mother on 2/11/16 because pt's leg was bright pink in color and felt warm at touch.
temperature excursion due to leaving the door ajar. The maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees Celsius with no reported adverse event; two patients received the vaccine post excursion with no reported adverse event; Initial information received on 07-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17-year-old female patient who received the vaccine post excursion with no reported adverse event and there was temperature excursion due to leaving the door ajar. The maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees celsius with no reported adverse event. The vaccine used was IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); HEPATITIS A VACCINE (HEPATITIS A); HEPATITIS B VACCINE (HEPATITIS B [HEPATITIS B VACCINE]) and DIPHTHERIA VACCINE TOXOID, TETANUS VACCINE TOXOID (TD) all for Immunisation.  On 22-Jun-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) (formulation, strength: unknown) lot V1A024M, expiration date: 17-Feb-2024, via intramuscular route in the left deltoid as Immunisation. The patient used the product previously.  In JUN-2022 there was temperature excursion due to leaving the door ajar. The maximum time of all the excursions was 59 minutes and the maximum temperature of the refrigerator reached 10.62 degrees Celsius with no reported adverse event (product storage error) (unknown latency) following the administration of IPV (VERO).  On 22-JUN-2022 the two patients received the vaccine post excursion with no reported adverse event (poor quality product administered) same day following the administration of IPV (VERO). This situation was reported as a medication error due to temperature excursion exceeded the stability data documented in the local labelling and additional supporting stability data and was due to human error. This situation was reported as a misuse as per local labelling due to administration post excursion  Action taken was not applicable.  At time of reporting, the outcome was Unknown for all.  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 guidelines. 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.
Within two hours of vaccination, a taste/sense of chemicals appeared in mouth/nasal.   Still ongoing as of the date and time of this report.
Information has been received from a physician concerning a 16 year old female who on 25-MAR-2008 was vaccinated IM with Gardasil (lot# not reported).  It was unknown if this was the patient's first dose.  On 25-MAR-2008 the patient experienced syncope.  The patient sought unspecified medical attention and it was unknown if the doctor was going to continue with the vaccination series.  Subsequently, the patient recovered from syncope. Additional information has been requested.
Very sore arm.; Chills; Horrible body ache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 9th July 2021, the patient received the 1st dose of Shingles vaccine. On 10th July 2021, 1 days after receiving Shingles vaccine, the patient experienced pain in arm, chills and general body pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, chills and general body pain were unknown.   It was unknown if the reporter considered the pain in arm, chills and general body pain to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for himself /herself. The age at vaccination was not reported. The patient received first dose of shingles vaccine and experienced horrible body ache,chills and very sore arm. On the day of reporting ,the patient was not good at all. The patient took Tylenol and slept for 4 hours.
While on the phone, patient mentioned she fell; This spontaneous case was reported by a consumer and describes the occurrence of FALL (While on the phone, patient mentioned she fell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (While on the phone, patient mentioned she fell). At the time of the report, FALL (While on the phone, patient mentioned she fell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
whooping cough; This case was reported by a consumer via interactive digital media and described the occurrence of whooping cough in a female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, immediately after receiving DTPa vaccine, the patient experienced whooping cough (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the whooping cough was unknown.   It was unknown if the reporter considered the whooping cough to be related to DTPa vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient expereinced whooping cough right after receiving infanrix. The patient was in intensive care unit for days.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated by at a medical facility for a persistent vesicular rash, which was diagnosed as chronic herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, 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 significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This case was reported by a healthcare professional (medical assistant) and described the occurrence of allergic reaction in a 55-year-old female subject who was vaccinated with FLULAVAL, (GlaxoSmithKline). Concurrent medical conditions included asthma. Historic vaccination included FLULAVAL (GlaxoSmithKline) given on an unspecified date. Concurrent medications included PROAIR HFA. On 4 December 2013 the subject received a dose of FLULAVAL (.5 ml, intramuscular, left deltoid). On 4 December 2013, 90 minutes after vaccination with FLULAVAL, the subject experienced allergic reaction, injection site redness, injection site pruritus, swelling injection site and injection site warmth. Per the medical assistant, the subject contacted the physician's office on 9 December 2013. Per the medical assistant, the subject reported that "within 90 minutes of the vaccination she had redness, itching and swelling of the site and also warmness at the site down to her elbow." The subject was treated with BENADRYL. Per the medical assistant, the subject was advised to use over the counter BENADRYL pills or cream for the itching, redness and swelling. The subject was advised by the physician's office to "seek medical attention if swelling of the tongue or airway occurred." At the time of reporting the outcome of the events were unknown. There has been no further contact from the subject to the physician's office; therefore, the outcome was unknown. Follow-up information received on 08 January 2014 via healthcare professional who reported the subject previously received FLULAVAL on 16 January 2013. No action was taken with FLULAVAL administered on 04 December 2013 via intramuscular injection. The events resolved on 07 December 2013. The reporting healthcare professional did not consider the events to be serious. At the time of the report no other information was provided.
Rash, UrticariaPruritus, injection site pain, redness, swelling Narrative:
child received 2 Daptacel immunizations 2 weeks apart/no AE; child received 2 Daptacel immunizations 2 weeks apart instead of Hepatitis B/no AE; Initial information received on 13-Jan-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 6 months old male patient who received two DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of HEPATITIS B VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation, Lot number- C5621AA, expiry date- 5/23/2021.  On 26-Dec-2019, the patient received 0.5mL third dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5621AA via intramuscular route in the left vastus lateralis and recieved one more dose of DAPTACEL in 2 weeks apart instead of HEPATITIS B VACCINE for prophylactic vaccination .  It was a case of actual medication error due to inappropriate schedule of product administration and wrong vaccine administered.  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 and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim.
I started getting symptoms of a scratchy throat, slight cough. The first day, my throat was very sore and had a runny nose. Then it developed into a deep and heavy cough. I felt very tired but no fever. I did an at home COVID-19 test that was negative. So, I went to a clinic and did a PCR COVID-19 test that was positive. I was prescribed PAXLOVID. The PAXLOVID really helped, and I was feeling better the next day after two doses. My symptoms lasted for about 5-6 days. I still do have somewhat of a cough but I do have allergies.
IPOL multidose vial vaccine. 11 doses from this vial had been administered from this 10-dose vial with no adverse event; Initial information received on 02-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patients and other health professional reporters that poliomyelitis vaccine (inactivated) ipol multidose vial vaccine IPV (VERO) [IPOL], 11 doses from this vial had been administered from this 10-dose vial with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patients received a dose of suspect IPV (VERO) suspension for injection (lot: V1A024M) with unknown strength, dose, batch number & expiry date via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patients received ipol multidose vial vaccine. 11 doses from  this vial had been administered from this 10-dose vial with no adverse event (incorrect dose administered) (unknown latency) following the administration of IPV (VERO).  It is unknown if the patient experienced any additional symptoms/events.  It is unknown if there were lab data/results available.  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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 guidelines. 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.
I received the vaccine on 1/13/21.  On 1/21/21 I felt itchy on my right arm.  When I looked it had hives, very red & itchy, swollen and hot.  On  1/22/21 I went to a walk in clinic and was told to take Benadryl.  Currently it is still swollen, not so red with slight tenderness.
vial was initially stored in the refrigerator on 01-Sep-2022, administration of vaccine on 13-Oct-2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 01-Sep-2022, administration of vaccine on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 28-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 28-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 01-Sep-2022, administration of vaccine on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 01-Sep-2022, administration of vaccine on 13-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 01-Sep-2022, administration of vaccine on 13-Oct-2022).    No concomitant medication were reported.  BUD was 01-Oct-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.
redness all the way down to her elbow; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was unknown.   It was unknown if the reporter considered the erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced redness all the way down to her elbow. The reporter did not have any patient information and did not know the date of vaccination, lot, and expiration.
Patient is reporting pain and swelling at the axilla area.  Could be related to swollen lymph nodes.
Diagnosed with severe immune thrombocytosis purpura, likely adverse reaction to Moderna Vaccine. Patient reported  a local rash around injection site  3 days after injection. It progressed to a full petechial rash  on 4-29-21  with platelet count of 3K. Sent to ER and it was 1K. Admitted. Treated with IVIG and 60g and 1 unit of platelets.  Had 3 total doses of IVIG. On Prednisone 60mg a day on discharge. As of 5-25-21 pt has had dosage decreased to 40mg a day and platelets were 197 on 5-25-21.  She continues hematology follow up at this time.
pt slept excessive for 24hr-fine p/24hr;no fever or local rxn;
12 hours after vaccine experienced headache, nausea and injection site pain. Symptoms gradually resolved with Motrin 1600 mg/day and full recovery by 6 pm 4/11,
Shortly after receiving the first dose of this vaccine I felt a mild tingling of my tongue but did not experience any difficulty breathing or other worrisome symptoms. I did have a significant soreness of the left upper arm for approximately two weeks post vaccine. My symptoms worsened subsequent to receiving the 2nd dose of this vaccine Lot# FA6780 on 6/23/2021. The following day I had the same left upper arm soreness, flu-like symptoms with mild fever and severe joint and muscle pain, headache and fatigue. After the 2nd shot I have had several months of unusual widespread joint and muscle pain with both shoulders and upper arms being quite severe, both hips with significant joint and muscle pain, increased water retention and swelling which exacerbated my underlying condition of dilated cardiomyopathy. The entire summer I had all this severe pain, increased swelling with decreased activity tolerance. I have also had symptoms of depression and impaired sleep. I feel most of my adverse symptoms have been present since the 2nd dose more so than the 1st dose. Of note also starting 10/01/2021 I had an illness which I strongly believe was Covid-19. I isolated for 10 days and treated myself at home, did not require medical visits or hospitalization but still have lingering symptoms subsequent to that acute illness. This indicates that the 2 doses of Covid 19 vaccination did not appear to protect me from a Covid 19 infection and I had a breakthrough infection while still experiencing adverse effects from the 2 doses of vaccine.
I received the booster Moderna injection on the evening of August 18, 2021.  This was 8 months after the second injection. The following morning the body aches, low fever and fatigue set  in.  I had experienced the same reaction after the second injection in February, 2021.  The body aches and low fever resolved in about 12 hours after onset.  The injection site was very red and hot, this lasted until approximately August 27.  I am still fighting the fatigue although it is better than it was.  I walked 3 miles at a time 3 to 4 times a week and I haven't attempted this since the injection as I'm too fatigued.  As I stated, I am feeling better, but not over this reaction yet.
Received shot approx 10/5/02. One wk later flu Sx's. Body ache, pain in joints. Hip flexor shoulders.
I had been traveling with friends and while we were, one of our friends indicated that they did not feel well and then tested positive on a home test. By Wednesday after returning home all of the people on my trip had tested positive. So I did a home test but was negative but with all of my friends being positive my doctor wanted to test me and it was positive. I have really only had a runny nose. I am drinking lots of fluids and doing really well.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. On unknown dates the patients were vaccinated with improperly stored GARDASIL (strength, dose, frequency and route were unknown, lot # K008931, expiration date 04-MAR-2017). No symptoms were reported. This is one of several reports from the same reporter. Additional information is not expected as the reporter asked not to be contacted.
Unbearable pain to right arm. Pain level greater than 10. Patient had limited ROM. Decreased grasp in right hand. Patient has not been able to pick up child or drive due to decreased movement.