chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was having shortness of breath and not been able to breath well. At this time, I had lost a lot of weight, I was down to about 80lbs or so. I ended up going into to an urgent care because I did not have a PCP and they sent me to the hospital. I was diagnosed with COPD and was given oxygen. I then went to a rehab and had physical therapy at the conclusion I was sent home with oxygen. I do not have to use that much now and am mostly off the oxygen. My blood pressure was also high, so I was put on a blood pressure medication. I ended up developing a blood clot in my leg when I was the rehab facility. My leg is swollen from this clot, and I do have pain when I am exercising and when I overdo it and move a lot. I keep getting sent for tests and to meet with other specialists as well. Recently I have started struggling with acid reflux and this started a few months ago. It was mild at first but has gotten increasingly worse. I have an appointment to look at my upper GI to see what is going on and this could also be due to a new medication but at this point we are not sure. The appointments are coming up soon and I will learn more and be able to start something to manage this.
?COVID Arm? the night of the 25th I felt small ?knot? in the injection site, I massaged it for a bit the next morning when I woke up a I had a bright red circular  rash about 1.5 inches in diameter.  The rash itched mildly, but otherwise did not bother me.  It went away in approximately 3 days.   I also suffered from a headache for approximately 2 days after the vaccine.
This spontaneous report as received from a registered nurse refers to a 6 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 08-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain, our arms both hurt so bad) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In July 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain, our arms both hurt so bad). At the time of the report, PAIN (We are in constant pain) and PAIN IN EXTREMITY (arm is in constant pain, our arms both hurt so bad) had not resolved. No concomitant were reported. No treatment were reported.
Seen 2 days after vaccine with progressively enlarging red, blanching rash 5 x 6 cm mildly tender, 1 x 1 1/2 cm induration @ site of injection. No other SE's
Mild itching began around injection site within 5 minutes  of receiving vaccine then resolved. After another 20 minutes, mild itching noted on hand, forearms, stomach, leg (not all at the same time). Itching resolves after scratching then starts up in a new location minutes later. Itching still ongoing 24 hours after vaccination.
Stroke / right CVA (Cerebrovascular accident); Left side instability when walking; Cognitive memory a little unsure; left side face affected; Rash was itchy / Knees were very itchy; Rash was red; Feet drooping on left side / Feet more slurred than usual; Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) (seriousness criterion medically significant), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment information mentioned.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Patient had presented these reactions a month after their second dose of the vaccine.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a medical assistant and refers to a patient of unknown demographics. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in May 2017 (reported as last week), single dose of improperly stored VARIVAX lot # L034369, expiration date 08-SEP-2017 (dose, route of administration and anatomical location were not reported) reconstituted with properly stored sterile water diluent (MRK) was administrated to the patient. No adverse effects were reported. The vaccine was stored in temperature 8 degrees Fahrenheit for 10 minutes (supported). There was no previous excursion reported. The digital data logger was involved. Product quality complaint was not involved. Additional information has been requested.
INCREASED LIBIDO DUE TO HORMONE CHANGES; BURNING OF LEGS AND RIGHT TOE; TINGLING LEGS; NUMBING LEGS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: thyroid disease, and other pre-existing medical conditions included: Patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced increased libido due to hormone changes, burning of legs and right toe, tingling legs, and numbing legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from numbing legs, increased libido due to hormone changes, tingling legs, and burning of legs and right toe. This report was non-serious
Vaccine administered at 11AM. Severe flu symptoms began at 4PM (5 hours later) - difficulty breathing as throat tightened (found rescue inhaler outdated and used, it relieved) rapid palpitations of heart, back pain, runny nose, sore throat, severe headache. Took aspirin and 5 hour nap. Feels much better but still mild symptoms. Never had adverse event with influenza vaccine in past.
HEART PALPITATIONS FOR ABOUT 5 MINUTES ON SATURDAY AT 1:30 AM ALONG WITH HEADACHE FROM FRIDAY AT 10 PM AND DULLED WITH ALEVE, BUT HAS NOT GONE AWAY. GOT WORSE ON SUNDAY, BUT BETTER TODAY.
This spontaneous report as received from an administrator refers to multiple patients of unknown ages and genders. On an unknown date in 2016, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) (lot # L034367, expiry date: 08-SEP-2017, lot #L045954, expiry date: 17-NOV-2017) (route: subcutaneous) throughout the temperature excursion beginning 06-JUL-2016 (incorrect product storage). The outcome of the events was unknown. Additional information has been requested.
red whelps at injection site for about 3 days Unsure of which flu vaccine project Pharmacy used
08/03/2021  08/31/2021   GOT COVID  01/10/2022
Initial information received from a consumer on 20 January 2014. An adult male patient, date of birth not reported received a dose of IMOVAX (batch not reported) intramuscularly into the right deltoid for post exposure from an animal bite on an unreported date. On the same day, (date not specified) the patient experienced "hard to breath" within 20 minutes of receiving the vaccine. he felt "like he was going to die". The patient denied having any allergies, medical conditions and illness at the time of vaccination. The patient was seen by a cardiologist that he knew who gave him a tetanus shot (manufacturer, batch, date of administration and route were not reported). He was not sure of the timeframe. The tetanus shot made him feel better. The patient drank respiratrol, Vit B6 and took vitamin enhanced waters. The patient also experienced pain down his right arm from the injection site to his hand and he thought he lost some dexterity in his hand. The patient stated that he saw lots of air bubbles in the syringe and associated this with not "repressurizing" the vaccine before administration. He was now "ok" except for arm pain and dexterity problem. The patient was advised to see his family doctor for an evaluation. The patient's outcome was not recovered. No further details were available at the time of this report. Documents held by sender: None.
fever 101-102 x 2 days, chills, body aches, headache, rash
Pt received vaccine on same day as Flu shot in same arm and within 24 hours developed itching progressing to large red area 4-5" in diameter with swelling causing skin sagging and firmness and heat.
This spontaneous report was received from a Certified medical assistant and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. It was reported that improperly stored doses of VAQTA Lot # J007800, expiry date 15-JAN-2016, (dose and route were not reported), were given to unspecified patients on unspecified dates, between 22-JUL-2015 and 31-DEC-2015. No adverse effects were reported. No product quality complaint (PQC) was involved. It was also reported that GARDASIL 9 and PNEUMOVAX 23 were included on the list of questionable temperature stability vaccines, but no doses were administered. This is one of three reports received from the same source. Additional information has been requested.
Around 4pm my left breast developed a very hard and painful lump about 6? in diameter on my upper breast. As a result, my breastfed baby was having a very hard time latching correctly and extracting milk. Additionally, my breast had been leaking milk throughout the day (normal) and it stopped once the lump developed. This persisted for more than 24 hours and started to resolve the following evening. The lump took about 2-3 days to fully go away, but the milk started flowing within 24 hours of first developing the lump. It resolved itself without treatment, but did effect my milk supply.
Per patient started experiencing injection site reactions a day or two after receiving vaccine.  Patient reported symptoms of swelling, itching, stinging, a circle of redness with a red line through it.  She called two days after receiving vaccine to report the adverse reaction and the pharmacist on that day advise her to watch it and to call back a couple of days later if symptoms remain. Patient called on 2/20 to report continue symptoms. I advised patient to call her primary care provider to inform them of the reaction and possibility to be seen.
TINNITUS AND RINGING IN EARS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced tinnitus and ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tinnitus and ringing in ears. This report was non-serious.
Pt received vaccine dose in left deltoid on 12/31/2021 Developed warm extremity demarcated rash which continued to spread across left upper extremity on 1/10/2021
p/ pt recv vax approx 13 days later pt exp a varicella-like rash at inject site which was 4'' in diameter
Hives; Itching; This spontaneous case was received on 29-Nov-2021 from certified pharmacy technician (CPhT) via agency (reference number: SEQW21-05707) and concerned a 70-year-old, female patient.  The patient had no relevant medical history and no allergies. The patient was not taking any concomitant medications (reported as 'not on regular medications').  On an unknown date in 2020, reported as last year, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular (IM), anatomical location: deltoid, arm) for influenza prophylaxis. The batch number reported was 281833 and expiry date: 30-Jun-2021.  On an unknown date in 2020, reported as last year, an unknown amount of time after receiving Flucelvax Quadrivalent, the patient experienced hives and itching. It was unknown if the patient receive any treatment measures.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: The events were assessed as related to Flucelvax Quadrivalent.; Sender's Comments: The events were assessed as related to Flucelvax Quadrivalent.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The reporter stated that a patient was administered a third dose of (Oka/Merck) VARIVAX (dose, route, lot number and expiry date were not reported) instead to a second dose of MMR II (dose, route, lot number and expiry date were not reported). No adverse events were reported. The outcome of the events was unknown. Additional information has been requested.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/27/2022 CANCER METASTATIC TO MEDIASTINUM J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/27/2022 ATHEROSCLEROSIS OF AORTA
She got her vaccine, the arm was very, very sore, and she felt "Punk".  In the evening she started shivering, and possibly had a headache.  Then in the middle of the night she noticed heavy pain underneath her armpit and felt like there was a lump that was very painful.  She felt it was in her lymph nodes.  She went to get her booster of COVID the other day and the pharmacist told her to give us a call and report it.  The lump lasted a couple of days, and it did make her nervous.    She never had any reaction with any of the COVID vaccines, and nothing with the first Shingrix vaccine either.
Pt. came in to pharmacy and asked that I look at her arm. About 1-1/2" below inj site was a raised light red patch about 3" in diameter. It felt warm.. Pt said it was painful. I recommended she see her MD.
sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's father. The age at vaccination was not reported. After vaccination with Shingrix, the patient experienced sickness for a week and then it went away. No further details were provided.
Pt came in and received TDaP (R) /flu (L)/Zoster (R) around 1540. Pt was told to sit and wait 15 mins. Pt started to report she was hot, itchy scalp and tight throat around 1552. Cold blue was called and pt was given O2 at 1655. 911 was called 1559. Vitals was given thru out and ambulance arrived at 1603.
90 hearing loss rt ear occurring 48-72* post injection (reported to us 4/12/2021)
AREA AROUND VACCINE SITE, RED, ITCHY. SPREAD TO NECK, ARMS, LEG APPROX 1 WEEK AFTER VACCINE. AREA SLIGHTLY RED, PUSTULES, NOT ALL AREAS ITCHY. NO TX
Legs and muscles ached, mind racing, couldn't sleep, restless, not & sweaty,damp, dizziness back ached. Hallucinations at school next day.
person then became symptomatic and tested positive within 7 days of receiving the vaccine; person then became symptomatic and tested positive within 7 days of receiving the vaccine; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (at an unknown age) at an unknown dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient became symptomatic and tested positive within seven (7) days of receiving the COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The clinical outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Lot number: EN6205) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tiredness".   No follow-up attempts are possible. No further information is expected.
Observed client in waiting room with facial redness. Asked how she felt, client became pale, complained of headache and stomach ache and itchy eyes. Had bilateral red eyes and dilated pupils. Brought into exam room and seated to observe. Given an apple juice, no symptom change. Given oral diphenhydramine & 3ounces of water. Skin warm  to touch, pink, w/ 3 sec CRT. Temp 97.8, Pulse strong, 68bpm. BP 96/48. Regular, even breathing.  Had child lay on exam bed with feet up and ice pack at back of neck. Observed 10 mins.  BP 98/64, hr 70. Client stated not dizzy, no nasea, continued headache and stomach ache. Oriented. Sit up & observed 10min.  Child responded to questions. Eyes dilated but clear. Milder headache & stomach ache.  Encouraged grandmother to go to ER if symptoms worsened or persisted. Escorted to restroom. Had mild dizziness  that improved after small void. Escorted to family vehicle and discharged in care of grandparents.    Client was given shot, observed for several minutes then in waiting area for intial waiting period. Observed 35 minutes more back in exam room after the intial waiting period.   Follow up call on 5/24/2022 spoke with grandmother. Grandmother reported, taken child home, child had a meal, a tylenol dose,  and rested. Still had complaint of mild headache and stomach ache with occasional mild dizziness through the evening. Went to bed around 9 pm.   Grandmother stated child was fine in morning went she awoke. No headache, stomach, ache, or dizziness. Went to school. Was acting fine when returned from school.
A couple weeks after the vaccine I started my menstrual cycle which lasted 21 days with the flow much heavier than normal. It left for 1 or 2 days and came back and stayed for 6 days. Left and came back again at the end of April and this time lasted for 11 days which went over into May. Left for 4 days and came back again for 3 more days. Left and came back 6/8 and lasted for 7 days.  Gone for 5 days and came back for 2 days. Gone again until 7/17 and bleed until 8/22. I got a 4 day break during that time but it came right back with severely big clots, painful and just uncomfortable. Went to see my Gynecologist on 9/8 because things were so off and on with the cycle. CBC was done but was normal and shows that I was not in menopause.  Pap smear and various women's testing were done and everything came back normal with no clue as to why my cycle all of the sudden went hay wire. A Hystosonogram was done and it shows the uterine wall was very thick and was not contracting to stop the flow of blood. 8/29 my cycle came back and lasted until 9/9. On 9/28 the cycle came back and lasted for 6 days which seemed normal and left on 10/6. I had a break thru bleeding on 10/9 which lasted that day and no more since then to. The bleeding during that time was so heavy and clotty I could not even go anywhere.
Right deltoid with 2.5 cm area of edema, erythema heat and tenderness. Prescribed BACTRIM/SEPTRA and BENADRYL.
Constant daily headaches located at front of head, on/above eyebrows. Light sensitivity and pain when pressing around eyes. Headaches started on 4/12 and have continued daily since.
Hives aprox 2 hours after injection, treated with antihistamine  Headache nausea starting a few days after injection continuing for 2 weeks