chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 81-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious) with onset Jun2022, outcome "unknown"; PYREXIA (non-serious) with onset Jun2022, outcome "unknown", described as "low fever"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "positive rapid test/infection". The patient underwent the following laboratory tests and procedures: Pyrexia: (Jun2022) 100.6; SARS-CoV-2 test: (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Critical information: Are you reporting any issue (side effects, complaints, etc.) with the product: Yes. Did the reported issue occur after use of the product: Yes. Event information: Patient has a hemorrhoid condition that seems every time she goes to the bathroom is bleeding started on 28Jun2022. Patient was not admitted to hospital due to the event. Treatment was received and its improved. Patient experienced abdominal discomfort on 29Jun2022. Patient was not admitted to hospital due to the event. Patient was not admitted to hospital due to the event. Treatment was received and patient is fine now. Product information: Name of the product: pf-07321332 ritonavir (PAXLOVID), Reason for taking: Positive rapid test, Dosage and how often taken: 150mg BID, Date started: 27Jun2022, 28Jun2022, 29Jun2022 (Am only), Lot/Batch number: GC8236, Still taking: No, 29Jun2022 PM dose. Name of the product: Hemorrhoidal ointment, Reason for taking: Heavy bleeding, Dosage and how often taken: As needed, Date started: 28Jun2022, Still taking: Yes. Name of the product: Ibgard, Reason for taking: Abdominal pain, Dosage and how often taken: 1 capsules TID, before meals, Date started: 29Jun2022, Still taking: No, 02Jul2022. Name of the product: Colace, Reason for taking: Stool softeners, Dosage and how often taken: Daily, Date started: 29Jun2022, Still taking: Yes. On 11Jul2022 additional information reported that I have no existing medicine condition, my symptoms included low fever (100.5), cold, cough, No sore throat, headache etc. After day 1 of paxlovid I developed severe rectal bleeding, abdominal pain, metallic taste in mouth. I had 2 Pfizer vaccinations without any side effects. This medication was worse than the infection. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After his shot he became inconsolable. Screaming and crying almost non stop for days. I called his GI and we thought it was silent reflux so we got reflux meds took first dose about 5pm on the 5th. On October 5th about 7pm he stopped breathing while awake, 3 hours after eating. Looked like he was choking his face turned red and he was waving his arms. I flipped him face down and was patting his back. It took about 1 minute to get him breathing again. He coughed up spit when he started breathing.  For over a month after he would stop breathing one or more times a day while awake. Haven't noticed any while sleeping. The reflux medication isnt helping this problem so his GI has us adding rice to his formula, but that isnt helping either.  As of this week 11/26/16 he has started only doing it a couple times a week instead of every day.
My cognitive function started to get foggy and I couldn't remember information that was given to me and reiterate information that was given to me. I had a hard saying certain words, nausea, dry heaving, my heart and metabolism started to go out of control, full body pain down to bone pain. Normally I walk to school or ride bike and was unable to do that because of muscle twitching and pain. I had to quit my job because I was unable to type because my eyes would twitch, had to take leave from school because of the fatigue of just walking to class. New symptoms of left side facial numbness that goes into the palate of my mouth.
Nurse inadvertently administered tetanus instead of PPD-has IV 12cm hard red arm.
The patient experienced severe chest pains and was taken to the emergency room; This spontaneous report was received from a nurse practitioner concerning  to a 39 year old female patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 20-MAR-2019 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).        On 22-MAR-2019, (reported as within 3 days of the injection) the patient experienced severe chest pains and was taken to the emergency room.   The outcome of chest pain was unknown.   The nurse did not think the chest pain was related to  HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9).
Flu vaccine administered at 11:43 AM. Client waited 10 minutes for monitoring and left.  Returned at 2:10PM stating she had vomited around 1:30PM. Reported chills and feeling queasy. No other signs/symptoms of reaction. Denies dizziness, HA, itching. 2:20PM BP 150/92. 2:25PM BP 2:25PM 130/90, P 80.  Advised patient to seek medical evaluation. BP 2:35PM 152/98, P 84. 3:20PM denied any symptoms.  Patient states will see doctor.
I got a message on my phone that I may have been exposed on 6/1/22. I tested positive for COVID-19 on 6/1/22. I had a sore throat, and just felt yuckie all around. I am still dealing with this at this time.
Patient received second dose of Moderna COVID-19 vaccine at approximately 0935 at the vaccine clinic on 4/19/21 in left arm.  Patient reports experiencing pain immediately upon receiving the vaccine, and states "it felt like it was going into the joint." At approximately 1200, patient began having trouble moving his left arm and began experiencing pain 4/10 at rest and 10/10 with exertion.  ROM of left shoulder significantly limited. Patient went to Emergency Dept at approximately 1600 due to inability to move left arm.  Patient reports Dr stated vaccine was administered in wrong location (too high), x-rays were taken, Dr advised patient to follow-up with orthopedic surgeon if pain doe
Breakthrough Case of COVID-19: Tested positive for COVID-19, I had a severe sore throat. I had a virtual health appointment and was given the antibody infusion.
This is a FU to my initial report. My second dose I had same events as outlined in initial report. May 8, 2021 developed severe weakness, chills no fever, chest tightness, fluttery feeing in chest,  loss of appetite, abdominal discomfort. Had a near syncopated  episode on May 29,2921 and admitted overnight for observation with holter monitor, 2D echo,  carotid Doppler with no findings found other than hyponatremia which was treated with IV fluids. Had a loop recorder inserted on July 9,2021 to rule out a fib. Stress test, nuclear stress test and 3 lower extremity tests have been done with no findings. Referred to neurology with EEG and numerous lab tests done to rule out a neurological condition. 9 months out from second dose continue to have these same events at unpredictable intervals,  intermittently but severity is getting better.  I have been advised not to get a booster until they all resolve which is now problematic with changes is what is considered fully vaccinated.
I received the vaccination 4/2/21 at 11am and at about 6pm the same day - I felt a sudden flush and felt like I was going to faint in the middle of Grocery store. Got very clammy and sweaty and weak - immediately left the store and started projectile vomiting outside the store and all night the first night. Had extremely joint/bone pain throughout my entire body for 4 days straight in bed, very weak, chills and night sweats, day 2 I had a little energy and drove about an hour and immediately started vomiting again  for day 2-day 5. Day 5 I woke up with swollen eye lids and hands and thought it was an allergic reaction to something in my house so took benedryl, but didn?t help. The swelling went down on day 6. I?ve had no energy and very foggy brain and been very down. My chest has felt like an anxiety attack 24/7 all week. I am on day 10 since the vaccination and my chest pain has increased. I still have foggy brain and been very out of it and weak still. I vomited day 1-day 5. Really bad pain in my hips and arm where I received the shot.
3/20/23 I went in for my annual exam and my doctor found a lump in my right breast. I had a mammogram, ultrasound and biopsy and I was diagnosed with Breast Cancer in April. I am currently working with an oncologist and a surgeon to start treatment.
Lower extremity muscle weakness, thigh pain. Admitted to hospital with presumed Guillain Barre Syndrome. EMG's suggestive of GBS. No progression of symptoms. Treated with prednisone.
patients was given "diluent versus the vaccine" for Pentacel/no AE; Initial information was received on 22-Jun-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA162245. (same reporter)  This case involves a 6 month old male patient who had received "diluent versus the vaccine" for DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (product preparation error).   Medical history, medical treatment, vaccination and family history were not provided. Concomitant medication if any, not reported.  On an unknown date, the patient received concomitant medications as PREVNAR (PNEUMOCOCCAL VACCINE CONJ 7V (CRM197)) and ROTATEQ (ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V).  On 19-Jun-2020, the patient received a 0.5 mL third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [carton: UJ230AAA, lot UJ315AA, expiry date: 04-Apr-2021] via an intramuscular route at the right thigh for prophylactic vaccination.  It was a case of actual medication error due to Active ingredient not added to diluent.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Vaccine given at 7:05am 12:00noon, 5 hours later, I started experiencing severe chest pain, jaw pain and shortness of breath in which EMS was called and I was taken to the hospital.  Since then, I lost feeling in my hands and feet, numbness and tingling.  I've improved however, during my recovery suffered with spinal pain, shortness of breath, very winded, muscle pain and loss of appetite to especially meat.
I felt fine during my 15 minute wait, when I left, the best way to describe is, over medicated/drink feeling. Kinda dizzy, goofy, should not have been driving kind of feeling. By 12:30 that afternoon, I had a severe headache, was starting to get really tired and body aches were starting. By 3:00 pm, I was extremely nauseous, had chills, headache was worsening,  I was crying from exhaustion. I was given a ride home from work as I did not feel safe to drive. This continued for 2 1/2 days. On May 5, chest tightness/pain started, went to ER on May 6 for the chest pains, was diagnosed with Costochondritis; was given Hydrocodone for pain. May 7, all over body aches, headache and exhaustion came back, this felt like a severe Fibromyalgia flare, to which I had not had one in 5 years and I could not and still cannot find any relief for this pain and exhaustion.
ONE WEEK AFTER INJECTION, PT DEV ACHING AND STIFFNESS IN JOINTS OF HANDS, ELBOWS, SHOULDERS, KNEES AND HIPS.  CONTINUAL PAIN HOWEVER GRADUALLY DECREASING.  AS OF 5-14-90 STILL HAS JOINT PAIN.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 01-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
blisters on right hand, left leg thigh, left side back neck after 1st vaccine.  numbness on right foot toe (5 days after 2nd shot)  and blisters on tongue (12days after 2nd shot)
About three weeks after the second dose my left arm seized up and in considerable pain for about 5 minutes.  Since then my Left arm is continuously sore at the injection point as well as the length of the arm into the wrist and hand.  Additionally it is noticeably weaker than the right arm.  Both arms are used on a regular basis, although I am right handed.
Information has been received from a registered nurse concerning an approximate 9-year-old patient who on 08-AUG-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. At the time if the report the patient's status was unknown. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & was crying x 4 hrs, 1/2 hr p/DTP inject; no temp or resp problems; pt consolable; ?sl swelling @ inject site;
Left lymph node swollen and tender 1 hour after vaccine.  Tenderness inside mouth on L side. Swelled to size of golf ball when eating on Thursday and Friday.  Saw a PCP who diagnosed bacterial infection in gland and prescribed antibiotics.
Felt fine for about 6 minutes after receiving vaccine.  Then started feeling sick and got worse quickly.  Told nurse felt bad and also pulse was fast.  When nurse took my pulse it was 100.  Regularly my pulse is around 60.  She then took my blood pressure and it was 179/?  My B/P is normally 106/65.  The nurse said my color was bad. Gradually over an hours time started feeling better and went home.  Next day I felt  malaise and tylenol helped.  Today I am a bit weak but better. That was my 1st shot
I had a high fever and it lasted for a couple of days and I had pain all over my body.  A couple of days later I had COVID-19.
A case of shingles broke out in the usual location - my low back. The vaccine was given in my left outer arm. This was the booster (the second of two parts).
Information has been received from a nurse practitioner referring to 4 year old male patient with dermatitis atopic and no know drug allergy. The patient had no illness at time of vaccination. Concomitant therapies included (Oka/Merck) VARIVAX and KINRIX. On 23-MAY-2016 at 13:03, the patient was vaccinated with (wistar ra 27-3) M-M-R II (rHA lot # L032044  dose 2, subcutaneously in the left thigh). The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested.
post injection patient reported chills headache, runny nose sneezing and coughing for 2 weeks. at day 15 reported coughing up sputum with bright red blood for last 2 days of coughing
I was unsure whether to report this, and I will preface this by stating that as a child I got nosebleeds frequently. However, I had not gotten a nosebleed in 15+ years and on the day I received the first dose of the COVID-19 vaccine I got a nosebleed that lasted about 10-15 minutes.
Hiberix reconstituted with other diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 5Y9N9, expiry date 27th July 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 8-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received Hiberix dose reconstituted with a diluent from another vaccine, which led to wrong solution used in drug reconstitution.
10/31/12 - Fever, chills 101 Temp. (Lt.) arm very sore, redness, swelling. Dx. cellulitis. ER medical center.
Approximately 2 weeks after the vaccine, I broke out in severe shingles. Severe pain at first, then 3 days later the blisters. All over my left chest, side and back. Extreme pain and still experiencing 5 weeks later. I was told to report this to the CDC as I have an autoimmune disease and there is medical evidence of patients with AI presenting with shingles after their first mRNA vaccination.
Patient had a temperature of 101.7 ax on Wednesday night.  Had seen the doctor earlier in the day for his 4 month checkup.  Doctor advised to give Tylenol to patient and come in on 2/15/08.
lt upper arm swelling, red, sore & also noticed lt eye outer corner discomfort & lt outer ear 2 days p/vax; much improvement by 5 days p/vax;
I have stage 3 chronic kidney disease, and my glomerular filtration rate has consistently  been 50  the last two years.  I had to go to the lab to have bloodwork done for my kidney function a week after getting the vaccine, and my GFR Rate has dropped to 46 after getting the vaccine.  I know that 4 points doesn`t look like a significant number, but when you have stage 3 kidney disease, it is significant,  The drop in my GFR rate directly correlates to getting the vaccine.
Major pain in her joints/bones, in her hands and in her knees, her back, lower back; Major pain in her joints/bones, in her hands and in her knees, her back, lower back; Arthritis; Tiredness; Joint pain in hands and knees (throbbing and stabbing pain; throbbing and stabbing pain; Hands and knees have the most severe pain; Swelling of hands; Harder and harder to walk; Migraine/migraine headache; This is a spontaneous report from a contactable pharmacist. This pharmacist reported for a 62-year-old female patient that received bnt162b2 (BNT162B2 Formulation: Solution for injecction), dose 1 intramuscular, administered in Arm Left on 01Jun2021 13:00 (Batch/Lot Number: EW0177) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history was not reported. concomitant medication(s) included estradiol, norethisterone acetate (COMBIPATCH) taken for an unspecified indication, start and stop date were not reported. Patient not received any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination, was the patient diagnosed with COVID-19 was no and Since the vaccination, has the patient been tested for COVID-19 was no.The patient experienced joint pain in hands and knees (throbbing and stabbing pain), throbbing and stabbing pain , hands and knees have the most severe pain , swelling of hands, harder and harder to walk, migraine/migraine headache on Jun2021 (Unspecified day) major pain in her joints/bones, in her hands and in her knees, her back, lower back, major pain in her joints/bones, in her hands and in her knees, her back, lower back, arthritis, tiredness on an unspecified date. Caller states she had almost immediately after the shot came a major migraine headache, it didn't last very long, it went away, and since then it comes and goes, but not an every day occurrence. Caller states what is an every day, constant occurrence, which had her concerned, which has been affecting her work, she works on a computer with a keyboard and mouse is there's major pain in her joints/bones, in her hands and in her knees, her back, lower back. Caller states she has arthritis in lower back and have had injections done there so that's no surprise. Caller states she has had some tiredness. Caller states she's constantly working with her hands etc. so her hands get tired. Caller states what she's never had before is this constant throbbing pain, pain in her joints that are in her hands, knees, and she has a constant pain across her back, is that her clavicle the back part? Caller states the upper part of her back where her shoulders connect together, that whole section is a throbbing pain. Caller states her hands and knees are throbbing and in pain constantly, it keeps her up some nights. Caller states she is right now rubbing her knuckles and hands. Caller states she does have a high pain tolerance and she pushes through it until she clocks out. The patient not received treatment for the events. The outcome of the events Major pain in her joints/bones, in her hands and in her knees, her back, lower back, Arthritis and Tiredness was unknown and other events was not resolved.
Multiple Herpes Outbreaks in a short time span many of which were resistant to normal  prescription / therapeutic protocols Shingles outbreaks
The next day I had a sore arm and I was tired. Three weeks after the vaccination I developed a lot of mucus. I contacted my doctor. They increased my inhaler which did seem to improve.  After a week I had pain in my right side of chest, the pain was not regular. That is when I contacted my doctor and after that my doctor gave me steroids. The pain went away a couple of days later.
Information has been received from a health professional concerning patients (number of patients not specified) who were vaccinated with varicella virus vaccine live (Oka/Merck) and may have received doses that were "other than indicated dosing", and/or doses that were prepared with "sterile water" instead of the diluent in the vaccine administration. It was indicated that the administering physician's office and number of population involved was not specified. There were no adverse events reported. A product quality complaint was not reported. Follow up information indicated that information reported had been part of a conversation, and she has no further information available. She indicated she wanted to say that there are physicians out there that think they can use sterile water. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
11/11/14 father noticed red, swollen area, about quarter size on (L) deltoid. Gave 5 mL BENADRYL at 8pm. 11/12/14 father notified office red, swollen from armpit to almost elbow. No fever or SOB.