chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 10:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 9:58 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 20.39 for dose administered on 14-Feb-2021 and 20.49 for dose administered on 21-Mar-2021.  Concomitant product use was not provided by the reporter.  Batch number 031L20A administered on 14-Feb-2021 underwent temperature excursion with temperature range of 32, 35 degrees Fahrenheit at 09:00 AM to 03:00 PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021.  Batch number 003B21A administered on 21-Mar-2021 underwent temperature excursion with temperature range of 32, 34 degrees Fahrenheit from 09:00 AM to 11:00 AM. This vial was moved to fridge on 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Lightheaded, hypotension, tachycardia the day after dose #2, similar to what I experienced during and following COVID infection in 3/2020. These symptoms lingered x 9 months (~ December) then fewer episodes of intermittent tachycardia (120?s at rest) w/o lightheadedness or hypotension.
6 days after the vaccine (2/17/2021), patient c/o sore throat, severe right ear pain, swollen right face, swollen lymph nodes and was seen at Urgent Care. On 2/19/2021, patient c/o difficulty swallowing, unable to open mouth, continue to have severe right ear pain, severe sore throat, swollen lymph nodes and was seen at facility by APRN. Patient was advised by APRN to go to ER due to throat pain, swelling, abscess and needed ENT Consult. Arrived at ER at 1 p.m., CT Scan confirmed swollen cervical lymph node, Tracheal Deviation with AIRWAY OBSTRUCTION. Rocephen and Steroid IV given. Patient transferred to second ER by Ambulance at 5 p.m. where he was admitted and hospitalized for 4 days(2/19/2021--2/22/2021).
flight diarrhea; fatigue; nausea; light headache the first day, then stronger headache the following day; Had a sore arm later the day of the shot and it hurt more the next day; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (flight diarrhea), HEADACHE (light headache the first day, then stronger headache the following day), VACCINATION SITE PAIN (Had a sore arm later the day of the shot and it hurt more the next day), FATIGUE (fatigue) and NAUSEA (nausea) in a 40-year-old female patient who received mRNA-1273 (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced HEADACHE (light headache the first day, then stronger headache the following day) and VACCINATION SITE PAIN (Had a sore arm later the day of the shot and it hurt more the next day). On 30-Dec-2021, the patient experienced DIARRHOEA (flight diarrhea), FATIGUE (fatigue) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (flight diarrhea), HEADACHE (light headache the first day, then stronger headache the following day), VACCINATION SITE PAIN (Had a sore arm later the day of the shot and it hurt more the next day), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.   For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. Patient state they do not take any medication regularly.
dizziness, light headedness, severe nausea, rash/hives over chest and back and forearms, severe chills/shivering
Approx 5 minutes p/being vax pt fainted &  hit head upon falling; VS & neuro assessment taken every 5 minutes were WNL; mom counseled & given instructions; mom of pt called 24 hrs later; mom verbalized pt was fine & had no c/o;
For about 3 weeks after the first dose, my blood pressure became extremely low with the lowest reading at 85/39. I check my blood pressure regularly due to a history of high blood pressure. I am on no medication for high blood pressure since, nearly 2 years ago, lifestyle changes brought it to a normal range, but it occasionally is high, but never low. I experienced falling asleep while working at the computer during the day which never happened before, inability to wake up and stay awake, light headedness, and serious fatigue. The day of the shot, only hours before, it was 155/90. I consumed food high in sodium, drank extra water, walked, and it gradually came up, but is still lower than usual with today's reading at 100/60. I just received the second dose today at 4pm.
Cardiac arrhythmia; This case was reported by a pharmacist via call center representative and described the occurrence of cardiac arrhythmia in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number 9JG52, expiry date 27th September 2021) for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE HD).   On 16th September 2019 09:26, the patient received the 1st dose of Shingrix .5 ml. On 17th September 2019, 1 days after receiving Shingrix, the patient experienced cardiac arrhythmia (serious criteria GSK medically significant). On an unknown date, the outcome of the cardiac arrhythmia was recovered/resolved.   It was unknown if the reporter considered the cardiac arrhythmia to be related to Shingrix.  Additional details were provided as follows: The patient also received Fluzone HD vaccine at the same time as Shingrix. The patient received Shingrix on left arm. The patient experienced cardiac arrhythmia.  The patient had experienced the event for 2 and half hours when the pharmacist called GSK.  The reporter consented to follow up.
pt states fatigue, joint & muscle aches that move from muscle to muscle;pain is mostly in the upper body;some pain radiating across chest diagonally;
Large localized area of redness half-way between shoulder and elbow.  Warm to touch, very sore.
Moderna shot 2 was yesterday.  Joints around injection site started hurting within just a few minutes.  Heavy pain at injection site.   Overnight started getting body chills and heavy pain at joints and body aches.  This morning I have a low grade fever and nausea and a cough.   .
HEADACHE, PAIN RIGHT SIDE STARTED IN ARM WORKED ITS WAY TO MY NECK, BACK AND HEAD, SORENESS THROUGHOUT BODYACHES, LIGHTHEADED, NAUOUS FEELING, FEEL OUT OF SORTS, HOT HUMID FEELING, TIRED AND OUT OF SORTS JUST DONT FEEL LIKE MYSELF
Acute acid reflux, joint pain in knees and ankles, massive rashes on feet, rashes up legs to waist and on inner upper arms. Went to ER Sunday, 10/4 at 10:30 PM and received cocktail of lidocaine, Maalox, and something else that took the chest pain away. Went through a battery of heart and blood tests. Received prescriptions for Prednisone and Ondansetron. Saw doctor Monday PM and received prescription for Pantoprazole Sodium for acid reflux. Today, 10/8/15 I still have mild acid reflux, but also rashes on my body.
Presented w c/o abdominal pain, n&v; admitted for acute pancreatitits; incidental COVID-19 finding but asymptomatic
hypotonic-hyporesponsive collapse; extremely sleepy; dec in + loss of muscle tone, flaccid, pale, blank stare, difficult to arouse, lethargic, favoring neck toward shoulder would not straighten it out; shallow breathing; weak
Patient reports that 3 hours after vaccination was given, her left arm began hurting from shoulder to elbow.  It became swollen and remained swollen at the time this report was taken.  Patient became nauseated and faint feeling approximately 6 hours post-vaccine, but had no vomiting.  At time of report, the nausea and faint feeling had passed, but arm remained swollen and sore upon movement.
Started with small pimple like area 24 hours after immunizations. Then 24 hours later started with large red area around injection site- very pruritic. Itching lasted 5 days along with redness. Small bull at site of injection. Persisted 10 days after immunizations.
increased size, distribution and intensity of daily "hives" within 2 days of vaccine. Resolved within 1 week.  No other systemic symptoms
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider/healthcare providers recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-JAN-2014, a healthcare provider, at a pharmacy, administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-JAN-2017, the patient was treated by a healthcare provider at a medical office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Causality assessment considered events to be related to the use of ZOSTAVAX. Additional information has been requested.
This spontaneous report was received from a register nurse concerning an unspecified number of patients of an unknown age and gender that were vaccinated with a dose of PROQUAD (Merck) (dose, dose number, lot number, expiration date and route were not reported), that were improperly. No adverse effects reported. Medical history and concurrent conditions of the patients were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of three (3) reports from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 28-AUG-2017, the patient was vaccinated with improperly stored VARIVAX (exact dose, dose number, route of administration were not reported; lot # M035687 with the expiration date of 10-AUG-2018), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot # and expiration date were not reported). No adverse effects were reported. The administered dose of VARIVAX underwent a temperature excursion between 6 and 14 degrees Fahrenheit for 20 days. There were no previous temperature excursions reported. Digital data logger was involved to capture the temperature excursion. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA012775.
Felt like when he had COVID, had a hard time breathing; Hands were aching, like arthritis; Had a sore arm at the injection site; Had a high temperature; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Felt like when he had COVID, had a hard time breathing), PAIN IN EXTREMITY (Hands were aching, like arthritis), VACCINATION SITE PAIN (Had a sore arm at the injection site) and PYREXIA (Had a high temperature) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (At the end of February 2021.) in February 2021. Previously administered products included for COVID-19: Oxygen (He was on O2 now because of Covid- 19.) since an unknown date. Past adverse reactions to the above products included No adverse event with Oxygen.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced DYSPNOEA (Felt like when he had COVID, had a hard time breathing), PAIN IN EXTREMITY (Hands were aching, like arthritis), VACCINATION SITE PAIN (Had a sore arm at the injection site) and PYREXIA (Had a high temperature). At the time of the report, DYSPNOEA (Felt like when he had COVID, had a hard time breathing), PAIN IN EXTREMITY (Hands were aching, like arthritis), VACCINATION SITE PAIN (Had a sore arm at the injection site) and PYREXIA (Had a high temperature) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-406178 (Patient Link).
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Patient's pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. The pharmacist reported that about 4 years ago, the patient gave an account of receiving ZOSTAVAX (vaccination date unknown), via intramuscular for prophylaxis at an unspecified pharmacy (strength, dosing details, anatomical location, lot# and expiration date were unknown). On an unknown date patient had a "strong reaction" to the vaccine which produced unspecified symptoms. The pharmacist reported that the patient did not appear to be experiencing any adverse effects at the time of their interaction. No product quality complaint was involved. Additional information is not expected as the reporter did not wish to be contacted.
A report has been received from a Health Professional concerning an 11 year old, Male subject, who had been receiving FLUMIST QUARDIVALENT (intranasal). FLUMIST QUARDIVALENT started on an unknown date. The patient experienced expired FLUMIST which started on 13-Jan-2014. The outcome of the event of expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
This spontaneous report was received from a physician via a company representative, and refers to a female patient of unknown age. It was unknown if the patient had concomitant medications, medical history, concurrent conditions and drug reactions/allergies. On an unknown recent date, the patient was vaccinated with the second dose of GARDASIL 9, intramuscularly, for prophylaxis, (dose, frequency, lot number and expiration date were not provided). On an unknown date (reported as "afterwards"), the patient developed athlete's foot and "a rash spread all over her body shortly after receiving the dose" of GARDASIL 9. Furthermore, it was reported that on an unknown date, the patient was seen again by the physician and was prescribed an unknown treatment for the rash. At the time of reporting, the outcome of tinea pedis and rash generalized was unknown. The causal relationship between GARDASIL 9 and the reported events was not provided.
My daughter received the HPV Vaccine Gardasil on Tuesday, July 14th at 6pm.  On Wednesday July 15th she woke up with pain at the injection site and difficulty breathing.  She had this on and off all day.  She slept for 6 hours which is highly unusual.  Later she experienced a headache and neausea.  She is otherwise healthy.  This was her second dose and she will not be getting a third.  There was no reaction after the first dose.
Initial report received on 30 May 2012 from the Investigator participating in the post-marking study under the reference number M5A16. A case of pertussis disease in a two-year-old male subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3579AA received on 19 February 2010, lot number C3591AA received on 15 April 2010 and lot number C3579AA received on 16 June 2010 and 1 dose of DAPTACEL; lot number C3577AA received on 17 June 2011 (routes and sites of administration not reported). The subject developed a cough on 30 April 2012, approximately 10 months after the last dose and a paroxysmal cough without whoop on 02 May 2012. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 May 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 21 May 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Evening of July 22 was itchy, but about 11PM became unbearable and throughout the whole body. Severe itching from neck down to feet, after 2AM. Did not go to ER due to heavy rain and disabled daughter. Did not want to leave her. On July 23 AM became less itchy and more bearable. By late morning rash faded, wasn't as severe. No cause for alarm - I thought it was just one episode. By midnite the rash and itchy came back worse, again from my neck traveled down to my feet, chest, back, breast, waist, groin, buttocks, thighs, legs, feet. Also pain of hands and sole of feet were hot and burning. Like my body was on fire, no fever - I checked. Left side of lip became swollen and inside left cheek was swollen - like novocaine from dentist. Have not gone to dentist in a year. During the nite experienced breathing congestion like wheezing. July 24 afternoon rash somewhat faded and minor itching. Went to physician she established hives but would not accept reaction to MMR. She said it was detergent - I have not changed detergent in years and have not eatten any different diet. She advised Benadryl which I took for 5 days, hoping this reaction would not re-occur. Was given MMR since blood test showed rubella titer was low-.2 results. Nurse advised no adverse reaction and gave me a paper to read! I had these illness 60+ years ago!
extremely tired; arm pain; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EP7534, expiration date: 31Jul2021) via an unspecified route of administration at arm right on 20Mar2021 14:00 at age of 50-year-old at single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2018, ongoing high cholesterol from 2018. Patient had no history of previous immunization with the Pfizer vaccine, no additional administered vaccines, no prior vaccinations within 4 weeks. Patient had no family medical history relevant to the events. Concomitant medications were not reported. It was reported that patient took high blood pressure and cholesterol medication. During the original call, patient's husband mentioned wife had the first shot and her arm was killing her, he thought the guy who gave it hit an artery or something. Caller handed the phone to his wife and she reported her symptoms of the Pfizer COVID vaccine. Patient stated she had arm pain on 20Mar2021 and felt extremely tired on 10Apr2021. It was explained she couldn't shake the tired feeling and it lasted for the week. She said she was still tired but not as tired as last week. Caller stated she has recovered with lasting effects. Patient did not treat her symptoms in any way. Patient received second vaccine in the right upper arm on 10Apr2021 14:00 (Lot number ER8734, Expiration date 31Jul2021). Outcome of arm pain was recovered on 22Mar2021, of extremely tired was recovered on 16Apr2021.  Follow-up attempts are completed. No further information is expected.
On the morning of 07/26/2021 I noticed a lump in my throat that turned out to be a nodule on my thyroid. They confirmed that and it is benign so it's a large 3 cm nodule. My period totally changed immediately after my normal one which was the day after the vaccine and it lasted an additional four days.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, those patients were vaccinated with a dose of RECOMBIVAX (lot # H015537, expiration date: 09-JUL-2015, units, route of administration, anatomical location were not reported) that were improperly stored. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.