chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 26-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004889: US-009507513-1907USA004890:
Unable to lift arm for 4 days; This case was reported by a consumer via call center representative and described the occurrence of mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased to be related to Shingrix.     Linked case(s) involving the same patient:  US2022177868   Additional Information:  GSK Receipt Date: 28-Nov-2022. Reporter's Comment:  The reporter stated that  the first dose of Shingrix she was unable to lift her arm for 4 days. Patient date of birth and lot number and expiry date was not requested. The reporter gave consent to follow up. Additional supportive information: For tolerance to the 2nd dose refer case US2022177868.; Sender's Comments:  US-GSK-US2022177868:Same reporter
Lack of Drug Effect; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of Drug Effect) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 014MOA) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) 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 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of Drug Effect). At the time of the report, COVID-19 (COVID-19) and DRUG INEFFECTIVE (Lack of Drug Effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient was exposed to COVID-19 on 20-Jun-2021 and tested positive on 29-Jun-2021. She had nausea and loss of smell as COVID-19 symptoms. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable.; Sender's Comments: This is a case of lack of efficacy of the vaccine with an associated adverse event of Covid-19, therefore causal association between the event is assessed as not applicable.
pt recv vax 10AUG97 & on 30SEP97 pt devel mucus membrane (internal) hives;given DPH & rxn stopped;
Patient reported headache, muscle spasms in right arm, jerking muscles, and nerve pain in the right arm. Primary care provider prescribed Cyclobenzaprine 10mg three times per day as needed for muscle spasms and Tramadol 50mg every 6 hours if needed for pain.
In left arm where Pneumovax was given, pain began within 1 hour.  Pain and swelling within 4 hours.  Client says left arm was 1 1/2 inches larger than right arm.  Client took Advil every 4 hours times 1 day, then once on day 2.Tylenol take once on day 3.  Blanchable redness in 3-4 inch round area descended from shot site to elbow over 6 days.
Large local reaction with redness, mild swelling and achiness (but no tenderness) around the injection site. Approximately 6cm in diameter. Treated with topical steroid and oral antihistamine.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a fever. Three days later the pt developed a rash on trunk, arms and face.
Flublok was inadvertently administered to a 17yo male patient, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 17 years old male patient who was vaccinated with a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (frequency once) lot QFAA114 via intramuscular route in the right deltoid on 26-Sep-2019.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to inappropriate age at vaccine administration.  At the time of reporting, no 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 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.
Five minutes after receiving these 2 immunizations patient vomited, had decreased BP from 134/82 to 99/57, became pale. Symptoms resolved within one hour and patient discharged home with father.
no reported adverse effects other than sore left deltoid (as a result of the needle) during phone conversation Feb 17, 2023 4:50PM
Severe swelling, redness of arm, pain and stiffness. Developed small blisters around redness. Headache, nausea, muscle ache all joints. Slight fever. Later after 4 days-developed severe itch. It still itches.
Currently have a change in my taste; Change in smell-Some things smell rancidor like rubbing alcohol, any type of cleaning/soap products like Lysol cleaning agent all smell exactly the same; Cookies, soup, sun butter, pretzel and certain chips also have the same terrible taste.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included migraine, kidney stones and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19.The patient did not have any known allergies to food, medications or other products. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) for unspecified indication started from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On an unknown date in 2021, the patient experienced change in the taste and smell. Some things smell rancid or like rubbing alcohol and any type of cleaning/soap products like Lysol cleaning agent, all smell exactly the same. Cookies, soup, sun butter, pretzel and certain chips also had the same terrible taste. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events change in the taste and smell and cookies, soup, sun butter, pretzel and certain chips also had the same terrible taste was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient experienced tiredness and fainted for a few seconds after injection, a few seconds of twitching occurred before waking up. Paramedics were called, once arrived, patient was evaluated and denied transport.
Arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The medical history was not provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurts). At the time of the report, PAIN IN EXTREMITY (Arm hurts) outcome was unknown.            Treatment medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-Jun-2021 contain significant information about the second dose of moderna vaccine.
hand palm felt itching; red dry skin; red dry skin; This is a spontaneous report from a Pfizer-Sponsored program received from a contactable consumer (patient). A male patient of an unspecified age received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced hand palm felt itching (non-serious) on an unspecified date with outcome of unknown, red dry skin(non-serious) on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
24 - 30 hours later the pt developed a fever of 101+, chills, swollen, red injection site, joint pain and muscle aches.  Eight hours later to pt experienced sharp chest pain and was unable to sleep.
hard to breath/  trouble breathing; shaking; feeling feverish; increased heart rate; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included carcinoma excision (Basal cell carcinoma removal from right arm on 8th July 2019 (prior to receiving the vaccine)). Concomitant products included pneumococcal vaccine (Pneumonia Vaccine).   On 8th July 2019 13:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 8th July 2019 23:00, 10 hrs after receiving Shingrix, the patient experienced difficulty breathing, tremor, feeling hot and heart rate increased. On an unknown date, the outcome of the difficulty breathing, tremor, feeling hot and heart rate increased were recovered/resolved.   It was unknown if the reporter considered the difficulty breathing, tremor, feeling hot and heart rate increased to be related to Shingrix.  Additional details were provided as follows: The caller was a patient.  The patient received Shingrix and before the date of reporting he had trouble breathing, felt feverish, heart rate increased to 125 and it was hard to breath.  The patient stated that these symptoms lasted for approximately 1-2 hours. The patient also received the pneumonia vaccine at the same time and in the same arm.  The reporter consented to follow up.      Lab Comments: lab test performed on unknown date
This spontaneous report has been received from a licensed practical nurse referring to a unspecified patients of unknown ages and genders. Information regarding medical history, drug reactions, allergies, concomitant therapies and concurrent conditions was not provided. Since 03-JAN-2017, the unspecified patients were vaccinated with improperly stored doses VAQTA lot# M033611 and expiration date 02-MAR-2018 (route of administration, strength, dose and frequency were unknown by the reporter), for prophylaxis. The reporter stated that the temperature excursion of the vaccine was 0 Celsius (C) to 2 Celsius (C) and the time frame was 10 hours, also she stated that a previous temperature excursion was not involved, this information was registered in a digital data logger. No adverse effect was reported. This is one of several cases received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA010881: US-009507513-1702USA011538:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 74 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
This spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 (lot#, expiration date, dose, frequency, route and indication not reported). The following day, on an unspecified date, the same patient received a second dose of PNEUMOVAX23 (lot#, expiration date, dose and route not reported) by accident. The pharmacist stated that the patient was hospitalized, in an unspecified hospital, on unspecified dates, prior to the patient's demise. The patient, on an unspecified date, died. Additional information has been requested.
Erythema, tenderness, and heat at injection site developing approx. 24 hrs after injection.
about 8-9 days after, I developed a large red, itchy welt on my arm below injection site, which lasted about 2-3 days
Information has been received from a physician concerning an approximately 57 year old female with an unspecified allergy who approximately 6 years ago was vaccinated at another health care provider's office with a dose of pneumococcal vaccine 23 polyvalent. Within a few hours of vaccination, she developed a local reaction. It was unknown if medical attention was sought. Additional information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 03/7/21pfizer,Lot#EN 6205 2nd dose 03/28/21Pfizer,lot#ER8733 Diagnosed covid positive:08/02/21 Symptom onset:07/31/21 Exposure:Travel Symptoms:muscle aches,headache , fatigue
Sick; Activities of daily living impaired; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of malaise (1st dose received in August 2019, refer case US2020009077).   On 14th January 2020, the patient received the 2nd dose of Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced feeling unwell and activities of daily living impaired. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the feeling unwell and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the feeling unwell and activities of daily living impaired to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported but it could be 50 to 51 years. The patient experienced very sick, after vaccination. For about 3 days he could not function well. The reporter Consented to follow up.
Unable to move or use left leg for 1 month.  Swollen L/thigh/leg.  Unable to move or bear weight for some time.  Pt developed fever and was agitated.  Pt taken to ER and admitted for 1 week had 2 surgeries for extensive thigh abscess, still unable to bear wt on leg.  Follow-up: 02/11/00 1320 - 1st attempt to reach reporter - Message left on answering machine requesting call back. 2/14/00 910- Spoke to reporter who had sent a signed consent form with VAERS report. Letter and consent form sent to hospital. Diagnosis according to reporter was cellulitis - debrided x 2. Child admitted to hospital 1/9/00 and treated with antibiotics - He is still unable to bear weight on L leg - will be having physical therapy start after F/u MRI. Other missing info (13) - MMR #1 Merck 1087J - L thigh. HIB #3 - Lederle - 530453A L thigh - Child did not receive Hep B #3 according to nurse in DR office where vaccines were administered. (14) - No other vaccines given within 4 weeks prior.
received Shingrix at 10:00am; developed high fever of 103 degrees Fahrenheit at 9:00pm with shaking from 9:00pm-12:00am; took Tylenol and did not go to hospital or call doctor.  at 7:00am on 7/30 temperature was low grade at ~100 degrees Fahrenheit and patient was feeling better.  Pharmacy was called at 10:00am on 7/30 with report from patient and she was encouraged to call her doctor with the report as well
Pain at injection site. Fever and chills. Swelling at injection site. Tx: Ibuprofen and ice packs as needed. Documented on chart to no longer give Tdap but Td.
Information has been received from a physician concerning a 16 year old female with no pertinent medical history or illnesses at the time of the medication who on 09-JUL-2007 was vaccinated with a first dose of GARDASIL (lot# unknown) 0.5 mL. On an unspecified date the patient experienced an adverse event after the initial injection of GARDASIL. Medical attention was sought via telephone by the patient contacting the office. The type of adverse event that occurred was not specified. Follow-up information was received. On 09-JUL-2007 the patient experienced nausea, diarrhea and lost of appetite for 2 weeks. Subsequently, the patient recovered from nausea, diarrhea and loss of appetite. On an unspecified date the patient received a second injection and the patient did not have any adverse side effects. Additional information has been requested.
Information has been received from a nurse concerning a 2-month-old female who on 01-DEC-2006 was vaccinated PO with the first 2.0 mL dose of rotavirus vaccine. The nurse reported that on 02-DEC-2006, the patient developed diarrhea.  Unspecified medical attention was sought.  On 05-DEC-2006, the patient's diarrhea resolved. It was note that the patient did not receive the second dose of rotavirus vaccine. Additional information has been requested.
A report has been received from a Health Professional concerning a 1 year old, female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 06-Nov-2012. Nurse INADVERTENTLY GAVE FLUMIST TO AN 18 MONTH OLD on 06-Nov-2012. The outcome of the event of INADVERTENTLY GAVE FLUMIST TO AN 18 MONTH OLD is unknown. The report was considered to be non-serious.
Started after first vaccinnation of COVID-19 Moderna - symptoms occur about 90 minutes after beginning of eating. Just Sushi with tuna causes issues 04/01/2021 - Gastro-Intestinal issue - barely made it to bathroom - had sushi with Blue Fin Tuna 04/08/2021 - Violent Gastro-Intestinal issue - no warning - pooped my pants - had sushi with Blue Fin Tuna 04/15/2021 - very mild Gastro-Intestinal issue - made it to restroom - buddy had same - buddy had no issues - regular sushi - no Blue Fin Tuna 05/13/2021 - no Gastro-Intestinal issue - had Bento Box (chicken katsu with four salads Cali Roll) 05/28/2021- no Gastro-Intestinal issue - had Cobra Kai roll (shrimp, avodcado cumcumber) with Miso Soup 7/30/2021 Issues still exist if any of the tuna (Ahi, Yellow Tail, Blue Fin) are included with the sushi.   Other foods are OK to eat - Italian, Outback, Red Lobster, Thai, Chinese, Mexican and Burgers & Fries are OK - just Sushi with Tuna(s) yields varying degrees of GI issues.  Additional invesigations point mainly to the Miso Soup - leaving the Miso Soup drastically reduces the lower GI symptoms!!  Second vaccinnation for COVID-19 Moderna:  With clear lungs, a sudden build-up of mucus occurs three or four times a day with a large amount phlem & mucus being spit out.    No other symptions!!
Information has been received from a physician concerning a 10 year old male who, "as an infant", in approximately 1995, was vaccinated with a dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live. It was reported that the patient has developed autism. No product quality complaint was involved. No other information was provided. Autism was considered to be an other important medical event (OMIC). Additional information has been requested.
Fluzone vaccine administered by accident.  Patient had local reaction at age 19.  She has never had the flu vaccine since.  Patient reacted with redness and itchiness.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOTENSION ACUTE HYPOXEMIC RESPIRATORY FAILURE
By 6:30pm had fever (102); patient could not lower fever even with Percocet. Took aspirin and cool shower.    Up all night long, still have fever until now.  Fever is coming down; continues taking aspirin.   Patient has not called doctor yet.   Barely can lift arm and it is severely swollen.  Patient putting ice packs on area, area is hot to the touch. Patient vomiting and has light sensitivity like if had migraine.  The Percocet worsens the migraine patient is even wearing a mask to help.  Patient reports that hearing is sensitive and is hearing a high pitch. Patient is just throwing up green at this point since there is nothing in stomach.  Per patient, she is dizzy, everything hurts, and busted blood vessel onface. Patient is exhausted and fatiguedcannot even sleep. Patient continues with meds normally except for avoiding Percocet and adding the aspirinper nurse's instructions. Patient has a rash all over body
Patient called pharmacy 12/19/14 and reported adverse event occurring later in the evening on the day the vaccine- Pneumovax- was administered (started 12/18/14). Severe pain at injection site with pain radiating down sides of arm. Went to bed and slept without a problem, woke up in the morning still with arm pain but it had improved. Called pharmacy to report. Counseled patient to take Tylenol and ice arm 12/19/14. Called patient's primary MD to report adverse event 12/19/14.