chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective / COVID 19 Treatment; COVID-19/ COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown", described as "COVID-19/ COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown", described as "Drug ineffective / COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (Treatment start date: 14Apr2023, Treatment stop date: 18Apr2023).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported drug ineffective / COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202300168532 Same reporter/patient, different product/AE.;
Headache, Fever, Constipation, NauseaVomiting, Fever 101.8 Narrative:
He was sore and uncomfortable for about 36 hours; He was sore and uncomfortable for about 36 hours; He was fatigued and worn out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: PAIN (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "He was sore and uncomfortable for about 36 hours"; FATIGUE (non-serious), outcome "unknown", described as "He was fatigued and worn out".  Additional information: It was reported that when patient got his second dose of the covid vaccine Pfizer vaccine, he was sore and uncomfortable for about 36 hours. It was further reported that patient was fatigued and worn out after he got the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Underdose; Patient recived a pediatric dose of engerix-b; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 55-year-old female patient who received HBV (Engerix B pediatric) (batch number YM444, expiry date 22nd May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   It was unknown if the reporter considered the underdose to be related to Engerix B Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 01-Aug-2022 Reporter comment: The pharmacist reported that a patient received a pediatric dose of Engerix-b. The reporter consented to follow up. Additional Supportive Information: The patient 55-year-old received Engerix-b pediatric, which led to underdose and adult use of a child product.
Large Swelling of the supraclavicular on the left hand side of the body with pain. Fever, chills, joint pain, bone pane, teeth pain, inability to sleep.
I had a rash the size of a closed fist on injection site for a few days. I had a rash on the tip of my tongue that looked red and raised for a week and change. The lymph node in my left arm pit was swollen and sensitive to touch. I felt anxious the whole time until all these symptoms cleared away by the 3rd week of March 2021.
After vaccine (2nd dose) on 3/04, patient resumed normal activities, running errands, etc. In the evening of 3/05, patient complained of extremely sore arms (not alleviated by painkillers) and nausea. Additionally, patient felt extremely cold. She went to bed early, at 7:00 pm, and was found dead the next morning 3/06 at 7:30 am. She had vomited. The coroner (not a medical examiner) declared cause of death as 1) cardiac arrest 2) hypertension and 3)hypercholesterolemia, based solely on medical records. There was no autopsy. Due to or despite medications, patient's blood pressure readings were typically low (last one 118/70), pulse normal (89), BMI 25.29, cholesterol levels normal (166/LDL 82), blood sugar 95.
pt had been seen at hospital for laparoscopic cholecystectomy; pt had a positive COVID test on 2/1/22; pt was dc'd to home on dexamethasone and ABX for recent COVID pneumonia; pt was found unresponsive in hotel room; EMS notified; CPR; pt intubated; regained spontaneous circulation after a period of PEA; anoxic ischemic brain injury; drug screen positive for fentanyl, ETOH, THC; family desired hospice care for pt; DNR; pt passed away in hospice; death certificate and med records sent to per VAERS request
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with VARIVAX (Merck) (dose, route and lot number were not provided). On an unknown date, the nurse reported that since unspecified date, improperly stored VARIVAX (Merck) (lot # J009726, expiry date: 07-AGU-2015) was administered to patients and no adverse effects were noted. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report received from a contactable consumer or other non-HCP. A male patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient experienced headache (mild headache) and fatigue (tiredness), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Patient within 10 min "felt funny" took 3 ibuprofen now experiencing flushing- hot skin on arms- hives on neck 11:45 108/94-92-24 clear nose running on site. Co nurse gave BENADRYL 25 mg and took over care BP down 128/87 12:15.
A blotchy red rash appeared on my left upper arm at the injection site and outward one week after the first dose. The arm feels warm and dimply. NO other symptoms.
I had a runny nose. I had some allergies that I had never had before. My eyes had some stuff in them. I went to the eye doctor and they gave me allergy drops. I thought I had pink eye, but I didn't. I have been having problems with my stools. They have been really greasy. My legs were swollen really bad. My legs are still swollen. I went to the urgent care for my allergies on May 22, 2021. I was extremely tired after getting my vaccine and I am finally starting to have my energy back. I was also kind of depressed. I usually don't feel like that.
Symptoms occurred with 2nd covid dose. Pfizer lot number is unclear and may not be correct  due to sloppy handwriting.  Days 1-5 with increasing left arm soreness at injection site. Also increasing left wrist joint pain, left elbow joint pain, and left shoulder joint pain. Day 5 and 6 were the worst for joint pain.  Very uncomfortable.  No fevers. Day 7 with swollen left arm pit and swollen left breast.  Arm pit and breast with mild pains and painful to touch or move. Joint pains subsiding .  Days 8 -14 continues with the same symptoms of left arm pit swelling,  left breast swelling and pains.  No skin discoloration and no warmth. No change in swelling , discomfort or pain from days 8-14, but not any better.  Can?t wear bra or do yoga.
Pt recvd 1st dose of Hep B vax on 9APR92 & on 10APR92 exp fluu-like illness, general malaise & a flare-up of arthritis; presented to MD on 3 occasions; exp lack of energy;
Decreased loss of taste; This spontaneous case was reported by a consumer and describes the occurrence of HYPOGEUSIA (Decreased loss of taste) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HYPOGEUSIA (Decreased loss of taste). At the time of the report, HYPOGEUSIA (Decreased loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not mentioned.
Pt received Moderna COVID on 12/28/2020 without event. She returned 45 minutes later complaining of chest tightness and  "feeling weird". A code A was called and she was triaged by anesthesia. No angioedema noted.  She was moved to nurse stat bay and 911 was called.
Red, large lump under skin the day after vaccine. Lump got bigger the following day. Was give KEFLEX and BENADRYL.
1230PM grandma calledfrom pt's home w/episode of listlessness, difficulty breathing, unable to cry paramedics called; 1330 PM paramedics report pt stable & able to be seen @ clinic; 1400PM pt seen by MD condition improved pt sent home;
Tired and dizzy within 10min, lasted for 7 hrs until bedtime. The next morning, no longer dizzy but full body joint pain/ache and injection site pain/ache.
red dots & bruise @ inject site are reported in a pt receiving 1 dose of fluogen vax given 4NOV93; on the same day pt exp bruise @ inject site w/ a rash of pinpoint, bright red dots around the inject site w/no itching;
Numbness, shortness breath, weakness in the extremities, fuzzy head, slurring words still having symptoms
Patient received 2nd dose of Pfizer vaccine on 2/2/21 and on 2/6/21 he died in his sleep in the a.m. No other signs or symptoms were observed prior to death.
pt states vax 14JAN97;states beginning having reddened, rash bruising @ inj site w/severe itching;this started 2-3 days p/vax then rash spread to breast, neck, & back w/inc itching;rash evident on both arms, breasts, neck & back today;
The injection site was hot to touch and a dime sized hard lump formed when I woke up about 11 AM Friday. I looked up reactions and thought it just needed more time to go away. It progressed and Saturday (10/31) my upper right arm was sore, the lump had grown to 2 inches in diameter, it was still hot, and it hurts to wear clothing (I can feel the rubbing on the injection site). I took naproxen and Benadryl to hopefully help. Sunday (11/01) it had gotten bigger again but not as red, I thought it was improving. I had bouts of nausea and was lightheaded off and on and slept for 6 hours later in the day. Monday I was seen by my doctor. She didn't know anything about reactions, she said she hadn't come across one before and just to take naproxen regularly along with Benadryl and give it another week to go away. My white blood cell count was taken but she will not dispense antibiotics or other meds until the blood work comes back. It is Tuesday (11/03), 5 days after my shot, and the injection site is still sensitive to clothing, the red area is about 3 inches in diameter, the hard lump is about an inch in diameter, and it is still hot to touch.
(L) thigh turned red, hot and painful the day after shot was given. Fever 101.4 all weekend. Very irritable. Better by Mon 7/23/07
It started with a cough that would not go away. I do have environmental cough for years, but after this vaccine the cough changed to wheezing. I do not know if it was environment or it was triggered by the vaccine or maybe the vaccine made it worse, but I cannot shake off this cough.
Runny nose, cough, and fever began on 2/7. Rash developed around injection site and on left face on 2/8. On 2/9 patient presented to ER for suspect measles with rash that began on ears and legs and spread to the entire body. Patient was ill with RSV and pneumonia prior to vaccination. Patient continued to had continuously had coryza and cough.
A non-serious spontaneous report of H1N1 LAIV administered to patient nine days before age of two years was received from a nurse/health professional concerning a 23-month-old female. The patient had no medical history and she was not taking any concomitant medication. On 04-Dec-2009, the patient received H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are applicable, and the event was considered resolved. Additional information was received on 29-Dec-2009 and incorporated into the narrative: Medical history and concomitant medication.
This spontaneous report was received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients was vaccinated with ROTATEQ, (strength, dose, frequency, route, anatomical location and lot number were not provided), which was improperly stored. Other suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of several reports received form the same reporter. Additional information has been requested.
My shoulder joint began to feel very stiff and sore. The pain migrated to my elbow and wrist as well as my left upper chest and towards my upper back. The pain was very bad. I called the pharmacy where I got the shot and they said to take Aleve or analgesic and apply ice packs.  I could not lie down so I sat up all night on my sofa. Horrible pain. Today is 4/8/17 and I still have pain in my shoulder and elbow. It's hard to bend them.  I reported this to my doctor and the nurse said to apply ice packs, take Aleve. She explained that my body is fighting the vaccine.  I had no problems with the first shot. This was my final shot.  I hope that the pain will dissipate before next week.  I think patients should be advised that this can happen before taking the shots. Thank you.
01/30/2015 Started with runny nose, 1/31 cough, congestion, no fever.  2/1 listless, lethargic, gasping for breath. Went to ER., dx with pneumonia. Pt. mother read on VIS Varicella it could cause pneumonia.
pt recvd vax & exp sluggishness, a swollen upper arm, & devel a 3 inch area of rednesss at inject site;
Pain at injection site beginning @3 hours after shot. Tenderness remains if site is pressed 5 days later.  Fever and fatigue beginning @6 hours after shot. Low of 99.2 until 9 pm.    100.2 to 102.3 from 9pm to 8 am Headache beginning @6am. One 650 mg Tylenol at @9 am relieved headache Return to normal temp and feeling pretty good, except for injection site ache, @9 pm (@36 hours after injection)
26 y/o male sent to HC on walk-in basis by occupational health. No official consult placed in system. Pt walks into HC at 3:15PM (10 OCT12) c/o "fever, chills, muscle aches & pains in knees and lower back, nausea and HA at 27.5 hours s/p receipt of AFLURIA IM, placed in Rt deltoid around noon on yesterday (09 OCT 12). He denies any difficulty swallowing or breathing, angio or periorbital edema, lip swelling, thickening of tongue, wheezing or hives in the first 3 hours s/p receipt of the vaccine. No other vaccines administered at the same time, other than PPD, which is non-contributory. No other vaccines received in the previous 30 days. Denies prior viral or GI illness in the past 30 days.  Felt fine until bedtime last evening around 9-10PM, when low grade fever of 99.6F and chills began, accompanied by general malaise, HA, nausea (no V or D), muscle/joint aches- bilateral knees (no redness, swelling or warmth of knees or other joints) and lower back ache. Went to bed. Sx have continued throughout the day today. Pt has not taken any OTC ibuprofen or TYLENOL. Denies personal hx of RA, lupus or arthritis. No eczema, asthma, psoriasis, sickle cell or G6PD deficiency. Denies numbness or tingling in feet or extremities. Denies mental confusion or blurred vision. Pt states he feels this way every time he gets the flu shot.
Patient had a dull pain when turning and lifting her arm for 3 weeks after receiving vaccination.
I have now had ovarian cysts form and rupture in the days leading up to my menstrual cycle two months in a row. I have never had an ovarian cyst prior in my life.
This is a spontaneous report from a non-contactable consumer (patient's mother). A 5-year-old female patient received PREVNAR 13, (batch/lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient had been getting multiple infections about once per month. The patient's immunologist did a blood test and found that her "Pneumo AB" level was low and her neutrophils and WBCs were high. The patient had an IgA level that was slightly low. The physician recommended a booster of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) for this child. The mother had concerns about giving her a booster. The mother wanted to know if this was commonly done and why the patient might need one. The patient must have had the pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) series as an infant as she was up to date on all of her immunizations. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
A huge knot raised on my arm and was incredibly sore to the touch and painful.  The knot diminished, but the pain at the injection site did not and continues, although diminished compared to initial intensity at this time, which is six weeks from the time of the shot approximately. I still cannot raise my arm above my head or take it to my back as to unhook a bra with normal motion range and without pain. If I lay on that arm while I am sleeping, it can be in pain when I go to get up. The shot went in effortlessly with absolutely no pain at the time of injection. I have not had a similar reaction or intensity to any other flu shot I typically take the flu shot, but I would guess that this one was stronger than those I typically take. I did have some reaction of similar nature to shingles shots, but that did not last as long or limit motion. I believe I have correctly identified the shot I was given above, as it is the only high dose quadrivalent listed.
Patient presented to the ED and was subsequently hospitalized for UTI and suprapubic abscess within 6 weeks of receiving covid vaccination.
None, patient received 0.25ml dose instead of 0.5ml dose since she is immunocompromised. She called backed 3 weeks after dose. Per CDC guidelines we recommended patient come back and receive 0.5ml dose. Patient has not returned to receive dose.
fever all day; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever all day) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, the patient experienced PYREXIA (fever all day) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever all day) and FATIGUE (tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included blood pressure medications and antidepressant.  Action taken with mRNA-1273 in response to the event was not applicable.  Patient took second dose on 20 Mar 2021 and lot number was 048A21A.   This case was linked to MOD-2021-054344 (Patient Link).
An expired Covid-19 pfizer vaccine was administered to the patient on 4/26/22.  The vaccine expired on 4/18/22 at 10am.  The error was discovered on 4/29/22. On 5/3, a COVID-19 Vaccine temperature related enquiry form was filled out and emailed to Pfizer.  On 5-9-22 at 7:51am, we received an email from Pfizer's quality team stating they do not have stability data to support our excursion from prescribed storage conditions. We have reached out to our affected patients informing them of the situation and offered to revaccinate them if they choose to. Spoke with patient's daughter on 5-9 and they will consider getting revaccinated.
Pain, redness, swelling at injection site. Tiredness, fever, chills, stabbing headache in eyes and head, nausea, very weak muscles, fatigue, cold extremities (both hands and feet). Took Advil for headache and to get fever down.  Headache better on 5/6/22. Fever broke on 5/7/22. still fatigued and weak.
Chills, fever, headache, sore muscles, sore left arm, nausea. 10 hours so far.
This spontaneous report refers to a female patient (age unknown) concern to herself. On 16-MAR-2011, the patient was vaccinated with ZOSTAVAX. It was reported that her husband had the illness several years ago and the patient saw how painful and debilitating it was to him so there was no resistance on her part. However, the patient had just recently been to the doctor due to a rash under her arm that then presented on her chest too. There was itching and a fiery redness to the rash as well as blisters. The physician diagnosed her with shingles. Although the patient thought the vaccine was supposed to prevent her from getting this illness, the patient and her husband were surprised at the diagnosis. It was localized, and the physician said, probably to a lesser degree than she would have had without the vaccine. The physician prescribed both VALTREX and a topical steroid ointment to remedy the rash. Both were working well, and the patient had no further complications or spreading. At the time of the report, the outcome of herpes zoster was recovering/resolving. Additional information has been requested.
Redness, swelling and tenderness at injection site also swelling of leg at the level of the knee.
Non itchy rash to chest/abdomen. Noted 6 Oct 09. No other symptoms stated. Seen by provider 9 Oct 09 at 1000.
pt recv vax & exp enlarged liver, damaged gall bladder, malfunctioning-swelled so extensively that protrudes;
Left-arm shot area very sore first 24 hours.  Slight headache.  Left work nauseous feeling day after.  Slept very heavily 2nd night 2nd day woke up with hives on my left arm as the day progressed had a rash on my chest, stomach, back, and arms causing my anxiety to spike.  Went to urgent care.  Informed that I have hives,/rash, anxiety and that it had been day 2 of vaccine from pharmacy on Thursday
Body chills, low grade fever, headache, nausea, light headed, joint and muscle aches, couldn?t sleep due to headache, vomited twice, fatigue.   Started about 11 hours after shot, and lasted until about 9 am the next morning then slept the entire day and evening.
itching to face and facial flushing. hypertensive 151/108,78, 16,99% RA. After some time the patient Blood pressure improved 146/92. refused transport
Repetitive vomiting and diarrhea (nonbloody) for several hours on the morning following vaccination.  Symptoms had resolved by the afternoon