chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A medical assitant reported PROQUAD was improperly stored and administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.  Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was not provided.  On 19-MAY-2021, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) with lot number T008281 and expiration date 05-SEP-2021 (both verified as valid) for prophylaxis (dose, vaccination scheme, route and anatomical location of administration were not reported).  On an unspecified date, Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was improperly stored at a temperature of -14 degrees Celsius for a time frame of 35 hours and 43 minutes. There wasn't a previous temperature excursion, and this was called because of a data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA001739: US-009507513-2106USA001761: US-009507513-2106USA001914: US-009507513-2106USA001941: US-009507513-2106USA001959:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 12Oct2021 as dose 3 (booster), single (Lot number: FF3580) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 02May2022 at 11:00 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "diabetes" (unspecified if ongoing). No known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.
Started with some chills about 18 hours after injection. Progressed to severe chills, teeth chattering & shivering I was so cold 20 hours after injection.  Had fever of 102.27 (checked multiple times with 2 thermometers).  Next day (approximately 41 hours after injection) had chills/hot and cold on and off. Had fever of 101.2. During entire time I was feeling weak, tired & no energy. Slept a lot of the time during adverse event.  Woke up 63 hours after injection feeling better, no fever or chills.
Two hours after my second injection my balance was restored to normal; My legs still don't work very well but my balance has been restored.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "MS" (unspecified if ongoing), notes: I have had MS for 20 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Two hours after my second injection my balance was restored to normal"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "My legs still don't work very well but my balance has been restored.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per mother statement: On 03/22/18 afternoon patient began with low grade temperature. In the evening 103 temp. around 4 AM on 03/23/18 patient had a seizure, was taken to ER. Labs done, viral respiratory panel negative. Patient was diagnosed with febrile seizures and sent home. To continue TYLENOL and MOTRIN. Seen in our office for follow up. Patient stable.
Intense muscle ache/soreness in lower back and pelvis regions.  Generalized body ache throughout the upper torso.  Fuzzy/thick headedness with neck muscle ache.  Intermittent  low key headache.  Moderate skin sensitivity overall from head to toe.
Around 10:55, patient described having sharp left chest pain during inhalation with pain scale of 8 out of 10. Patient stated prior chest pain every 2 to 3 days, usually feels similar chest pain after work while trying to sleep. Most recent occurrence was last night. Patient stated he does not take any medication for chest pain. Gave patient water to drink. Nurse took patient's vital signs. BP: 111/71 mmHg, HR: 69 bpm, O2: 97%, Temp: 36.4 C/97.5 F. Patient's face looked red due to outside temperature. Nurse suggested calling 911, however patient refused. Advised patient to visit Hospital if chest pains becomes worse and for information on healthcare plans. Patient left around 11:30 am, stated no longer feeling chest pain.
Three days after dose one on 1/14/2021, the patient became very out of breathe and extremely fatigued.  He knew something was wrong when he could not stand taking a shower.  He literally had to lie down in the shower.   They started a number of doctors visits and he had an abnormal chest x-ray, he got a CT scan, and started to see a pulmonologist.  He is on oxygen 24/7, without it, his oxygen stats are in the 70s and 80s.  He got his 2nd shot on 02/23/21.
3/18/2021 12:00 PM- numbness in lower part of left arm from armpit to little finger, ended at approximately 2:00 PM 11:00PM-severe chills, severe pain in shot location, body muscle aches followed by nausea- took 1 Advil, chills went away 2:00 AM -severe chills, body aches,  followed by nausea-took 1 Advil, chills went away, able to sleep 5:00AM - nausea, body tried to vomit but nothing in my stomach so had dry heaves, lasting for about 30 minutes and profuse sweating                      body felt hot, nausea, and body aches continued for about 1/2 the day.  I took an Advil sinus and cold caplet that made me feel better.  5:00PM began feeling sick once again, body aches, chills, sweating.  took temperature 100.5.  (didn't take temperature before because too sick to look for thermometer.  Tried to sleep but too restless.  Took 2 Advil, fever went away as well as body aches and nausea.  slept through the night.  3/19/2021 Woke up approximately 6:00AM, left arm hurt about an 8 out of 10, very sore to move and swollen.  I felt very tired and lethargic.
I woke up in the middle of the night having pain in my right leg. It was bothering me to walk on it. It felt like I had a spike in my hip joint. 10 hours later my right leg blew up, and it felt hot to the touch. I couldn't walk on it at all. I was diagnosed with lymphedema in my right leg. My medications that I am on shuts off my immune system because my immune system attacks myself. So the vaccine triggered my immune system, which caused an opposite reaction for what the medications were used for. I am doing occupational therapy with a lymphedema specialist.
Patient's wife exited from car screaming for help reporting patient passed out. Upon arrival of RN, patient had regained consciousness and was A&O x 3. He was sweating, pale, with active pilomotor reflex.  VS: BP 80/55, temp unable to obtain, HR 67, RR 24  EMS called and repeat vitals at their arrival BP 152/121, HR 67-70, T 96.5, RR 24.  Patient's brother is MD and spoke with EMS reporting extensive hx of vasovagal syncopal events at dentist in past as well as with high stress events. Patient decline transport to ER and wife elected to drive home.  Patient remained at cognitive baseline without complaints at time of departure from site.
Breakthrough case of Covid - positive test result 05/27/2022. Sx onset 05/25/2022, It started with a scratchy throat. The next day 05/26/2022, I still had a scratchy throat and a mild headache, I tested negative that day. On Friday 05/27/2022, I had a low-grade fever like 99, along with scratchy throat, headache, runny nose, sinus congestion and sneezing more. I took a home test that showed positive test result. I called telehealth and spoke to an APRN and was prescribed Paxlovid. I was able to start the Paxlovid 05/27/2022 so my sx slowly got better. I was taking Tylenol to control the fever and by 05/28/2022 it broke, and the congestion kept getting better. I feel as though I have recovered.
I received my third Pfizer covid vaccine on 1/25/22 at 10AM.  I had extreme chills while sleeping that night.  When I got up, I suddenly became very lightheaded and sat down in a chair, putting my head on the table.  I passed out and landed on the tile floor, lacerating my skull, with a pool of blood.   I also injured my L ankle, with swelling and bruising.   I then went to the ED.
vomit,diarrhea, throat & roof of mouth red, fever 100, rash in groin area & up lower abd both sides chapped lips that peeled lost 6 pounds;contacted MD 20OCT-said take DPH antihistamine it helped 30OCCT97 still fell a little weak;
no adverse event; PROQUAD that had undergone temperature excursion was administered; This spontaneous report was received from a medical assistant and referred to a 4-year-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  Temperature excursion occurred on 10-DEC-2022. On 22-DEC-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: recombinant Human albumin (rHA)), anatomical location: right thigh, lot #W019628, expiration date: 19-DEC-2023; strength, and dose were not reported) intramuscularly for prophylaxis, which undergone temperature excursion (product storage error). There was no adverse event. There was no product complaint.
Patient was fainted for 2 seconds, pale and labored breathing. 911 was called and paramedics came, patient gradually become normal after 5 seconds, color come back and breathing normally.  All vitals are normal per paramedics and patient refused to go to ER. Patient admitted that he has fear of needle and did not had anything to eat or drink in the morning. Paramedics think that patient is having an anxiety attack due to needle.
Headache (Severe) Stopped around 1130 pm 3/2 and resumes on 3/3 5:30 am and still have headache. Took topimate 3/3/21 @ 3:50pm and left message with Neurology to see if I can mix Tylenol with migraine medicine. I have not received a response. Nausea (constant) just drinking water, I don't want to eat because I don't feel well. started about 10 mins after dose. Chills (on and off)  started 10 mins after dose.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 64 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6201), on 24Mar2021 as dose 2, single (Lot number: EN6205), on 07Oct2021 as dose 3 (booster), single (Lot number: Ff2589) and on 01Apr2022 as dose 4 (booster), single (Lot number: Fk9895), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes, on insulin pump" (unspecified if ongoing) and no known allergies. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 26Nov2022 to 01Dec2022.  Clinical course: No known allergies
Vaccine administered subcutaneously; A spontaneous report was received from a consumer concerning a 72-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced administration by subcutaneous route (: Incorrect route of product administration).   The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 016M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 09 Feb 2021, after administration of the vaccine, the patient asked the provider how the vaccine was administered, and the provider said subcutaneously. Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event, administration by subcutaneous route, was considered recovered/resolved on 09 Feb 2021.; Reporter's Comments: This case concerns a 72-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 016M20A), reporting Incorrect route of product administration without any associated adverse events.
Moderna Vac on a thursday .. 4 days later woke up enlarged lymph nodes on right side of body. Neck, under arm.... 5 days after that I had red bulging lymph on my groin..  uncomfortable for over 10 days now much better. Reported to my Doc n then went to urgent care ... neither of them could produce any explanation..
stroke; stroke; This is a spontaneous report from a contactable nurse (reporting for her husband). A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 (at the age of 65years) as single dose for Covid-19 immunization. Medical history included diabetes from an unknown date and unknown if ongoing, stroke from 03Dec2018 to an unknown date, and cancer from an unknown date and unknown if ongoing. Concomitant medication included unspecified medication (He is taking medication for his diabetes, his stroke the 2nd stoke that he had in last 2 weeks he is taking medication). It was reported that the patient had a Covid vaccine this month on 11Mar2021. That was the 1st vaccine the patient had. Next day on the 12Mar2021, the patient stated having some unbalanced in walking and in his train of thinking. The reporter (nurse) ended up on 15Mar2021 taking the patient to Emergency room, and he had a stroke. The reporter stated, "Now, he had a stroke 2 year before. I called to let you know I talked to the neurologist he has sent him to his family doctor for checkup and his family doctor wanted me to let you know that this happen. Does not know if there is any relation or not but just to let you all know and this coming Thursday, he is supposed to get his 2nd vaccine. I am, just calling to let you know". The patient was taking medication for his 1st stroke and now he is taking medication for his 2nd stroke (treatment). He is taking physical therapy and occupational therapy and for his cancer, he is taking medication for that. The patient was hospitalized for stroke from 15Mar2021 to 17Mar2021, then he was discharged. The outcome of event was not recovered.  Follow-up needed; further information has been requested.; Sender's Comments: Event stroke represents an intercurrent medical condition and unrelated to BNT162B2 .  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Information has been received from a nurse practitioner concerning a 70 year old female who on 13-APR-2009 was subcutaneously vaccinated with a dose of ZOSTAVAX (Merck). On 15-APR-2009, a day and a half after the vaccination, the patient experienced flu like symptoms. She had achy, fever and lethargic. At time of reporting, the patient was recovering. The patient sought unspecified medical attention. Additional information has been requested.
1/12/21 - At around 7pm, I noticed a dull headache coming on and it persisted as I retired for the night. 1/13/21 - Went to work but felt sluggish, it was cold that day and I couldn't seem to stay warm. My eyes felt very heavy and headache persisted in the back of my eyes. Both symptoms worsened within the next 4 hours. I left work early. I took my temperature just to check and was running a fever at 101.2.  1/14/21 - Fever at 100.7 but no headache 1/15/21 - Fever fluctuating between 99.7 and 100.4 but no other symptoms. 1/16/21 - Fever fluctuating between normal and 100.2. No other symptoms. 1/17/21 no longer running fever
Fatigue and headache two hours after dose Armpit lymph node tenderness and pain two days after dose, lasting two days Adenoid lymph node tenderness and pain beginning three days after dose, lasting three days (ongoing at time of reporting) All treated with over the counter ibuprofen
Redness, swelling at injection site. The patient reports hive-like areas on her arm below the injection site. The area is 10cm wide, red, hot to the touch. She notes swelling of the arm to the point of difficulty moving her wrist the night of the vaccine.
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. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for the 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.
This is a spontaneous report from a noncontactable consumer (patient). A 19-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 19, via an unspecified route of administration, on Mar 12, 2021, at 04:45, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. No known allergies to medications, food or other products. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine.  On Mar 14, 2021, patient experienced sore throat. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of the reported event. Since the vaccination, patient has not tested for COVID-19. The outcome of sore throat: recovering (at the time of this report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Rebound infection; Rebound infection; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Dec2020 as dose 1, single (Lot number: EL3247), in left arm, on 20Jan2021 as dose 2, single (Lot number: EL3247), in left arm and on 23Sep2021 as dose 3 (booster), singe (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hx asthma" (unspecified if ongoing); "hx of high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: 31Dec2021, stop date: 07Jun2022; SERTRALINE, start date: 31Dec2021, stop date: 07Jun2022. The following information was reported: COVID-19 (medically significant) with onset 18Jun2022 at 09:00, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Rebound infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jun2022) Negative; (13Jun2022) Negative; (14Jun2022) Negative; (15Jun2022) Negative; (16Jun2022) Negative; (17Jun2022) Negative; (18Jun2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: Rebound infection. Starting from official first symptoms being day 0. Started paxlovid day 2. First negative test day 6. Ended paxlovid day 6. Negative tests from day 6 through 11. Second positive test day 12. Anti-viral treatment included Paxlovid started on 08Jun2022 for COVID 19 Treatment and stopped on 12Jun2022. Other medication in 2weeks products included Levothyroxine and sertraline started on 31Dec2021 and stopped on 07Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Fever; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient was just wondering how high the fever could get as a side effect of taking the Shingrix. The patient thanked and asked how high the fever could get low grade or 102.
After 33 hours became lathargic/tired, injection site red and hard, and tongue  = dark red areas, perimeter circles with raised dots, burning, tingling, and cracks formed on tongue surface. No change to sense of taste. Painful when talking, eating, tongue touches any other part of mouth. New affected areas appeared on surface and edges of tongue over next 5-6 days. Tongue problems slowly improved over 3 weeks time until tongue looked and felt normal. I tried to rince 3x/day with Crest alcohol free mouthwash.
82-year-old female with a history of congestive heart failure, diabetes mellitus and hypertension was brought to the ED for the complaint of a weakness that started 3 days ago.  The patient has been having a productive cough for the last 1 week.  She denies any fever, chills, nausea, vomiting, chest pain or diaphoresis.  She had 1 loose bowel movement today.  In addition, she felt short of breath today.  Her oxygen saturation was 88% while breathing room air upon arrival.