chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a respiratory or breathing episode; did go into cardiac arrest; complaining of pain; breathing issues; This is a spontaneous report from a contactable consumer (patient's caregiver). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as 1st dose, single (patient was 60 years old at the time of vaccination) for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that on an unspecified date, Friday or Saturday, the patent was complaining about breathing issues all of a sudden, he had respiratory or breathing episodes. The reported stated that that they called 911 right away, and they came and picked the patient up. The patient had trouble breathing and was complaining of pain, and he did go into cardiac arrest, but they checked, and it was not a stroke or a heart attack, none of those things, they cannot figure it out. It was reported that nothing was wrong with the lungs, and the hospital was treating the patient by currently having him sedated and treating his pain. The outcome of the events was unknown.
Patient felt numbness and tingling on the right side of her face, she also reported having a rash behind her right ear.
Pulled out the wrong vaccine from the Omnicell, pulled out Pfizer instead of Moderna. patient receiveedn first dose Moderna, second dose Pfizer. Re-assessment, patient was fine when he left the clinic.
Redness at injection site at 24 hours, doubled in size at 48 hours. Went to nurse and was prescribed BACTRIM for indication of cellulitis.
Information has been received from a registered pharmacist concerning an 82-year-old female with hypertension and hypercholesterolaemia who on 07-FEB-2008 was vaccinated subcutaneous with a 0.65 ml dose of ZOSTAVAX. Concomitant therapy included ACUPRIL and LIPITOR. In April 2008, the patient started to have "spells". During these spells she would feel hot and "trembly", and in some cases fainted. After the patient's most recent incident she was hospitalized. MRI and CAT scans of her head and chest were negative. However, she did have an increased white blood count. The patient was treated with IV antibiotics LEVAQUIN and over the counter MUCINEX. At the time of the report the patient's status was not recovered. A product quality complaint was not involved. Additional information has been requested.
Infection with Hepatitis A virus--syptoms include: fever,vomiting, loss of appetite, stomach ache, and jaundice.  1/2/09 MR received for DOS 11/30-12/01/2008 with DX: Hepatitis. Pt presented with fever, abdominal pain, diarrhea, decreased appetite and fatigue. Recent cough, cough, sore throat, facial swelling with dx of strep throat. PE (+) for  periorbital swelling, cervical lymphadenopathy-slightly tender, systolic ejection murmur, abdominal distention with slightly enlarged liver. (+) pyuria. Tx with IVF and d/c for outpt f/u.
Swelling, warmth to touch, redness, and development of hardened, raised circle developed ~ 24 hours post administration. Treated with ice and 1dose ibuprofen 400mg. In 7 days after, swelling and other symptoms have slowly gone away.
Heart palpitations and shortness of breath starting around 11 this morning. Received vaccine yesterday at 4:30.
Burning feeling in left lower leg.  The burning moved around to my thigh and foot the next couple of days with tingling pain and a numb feeling in my entire leg and small of my back.  No rash or discoloration of leg or foot. Burning, tingling, numbness, and muscle weakness continues.
Experienced the colloquial "COVID arm" symptoms on the morning of 1/21/21, approximately 8 days following my first COVID moderna shot. Skin was slighty raised, itchy, hot to the touch, and red. Symptoms subsided throughout the day and were not present the next day, 1/22/21. No other discomfort or side effects felt.
PT ran a high grade temperature of 106-  9 hours after receiving vaccine. Fever included chills and night sweats. Continually had to apply cold compresses and cold showers' to keep his temperature from getting higher. Fever continued through the night. Fever remained at 103 the following day followed by a low grade fever which broke on the third day.
No shortness of breath. 1x3 inch red raised area surrounding infection site. Ibrurofen, Motrin for worsen one
Daughter began having chest pain, severe fatigue, overall malaise, rapid heart beat, headaches
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/23/2023 AORTIC VALVE REGURGITATION
Patient reported red lesion on the front of her body under her breast 6 days after getting the Shingrix vaccine. She described it as red and itchy. She then noticed smaller spots that had blisters leading her to believe she had shingles. The patient has had shingles twice in her lifetime and described the pain and itching as shingles. She had taken Benadryl to rule out allergic reaction. The patient contacted her primary care physician who did not prescribe any antiviral medication and told the patient to monitor. She continued to monitor the lesions and used antihistamine to relieve itching. The patient stated they did not spread and after 1 week of having the lesions she has not fully recovered but they are fading and the itching is decreasing.
All over muscle aches. Body so cold I could not get warm or comfortable. May have been running a fever. Needed to sleep. Everything seemed to resolve late that evening.
The pt was found at sitter's around 14:00 not breathing and cyanotic on Thursday. He was brought to ER in asystole. Advanced life support provided but child did not respond.
This spontaneous report as received from a registered nurse refers to a 33 years old female patient. The patient was vaccinated with a dose 1 and dose 2 of RECOMBIVAX HB (lot #, dose and route not reported) on 24-JAN-2012 and 16-AUG-2012 respectively. No other co-suspects were reported. No concomitant medications were reported. The registered nurse reported that the adult patient received a pediatric dose for her second dose of RECOMBIVAX HB on 16-AUG-2012. No adverse symptoms were reported. Additional information has been requested.
High fevers x 4 days; t102-104; lethargic x 10 days; arm discomfort x 4 wks;
Monovalent pfizer 12+ labelled as bivalent and given when patient was to receive bivalent, not monovalent
Vaccine had been in the fridge >30 days and was considered expired based on the BUD of 02/10/23
patient complaines  of headache fever body aches fatigue and nausea continuing into the second day unable to work
Muscle aches, headaches, migraine, sore eyes, facial tingling, severe dry eye, foot nerve pain and numbness.
Information regarding PREVNAR13 was received from a healthcare professional regarding a patient who experienced redness around the injection site. The patient received a dose in 2010. Relevant medical history was not provided. Product was administered in 2010. Dose regiment was 1 dose 1 time per day. Concomitant medications  were not reported. The patient experienced redness around the injection site (injection site erythema) in 2010. As of 13 OCT 2010, it was unknown if the patient has recovered from the redness at the injection site. No additional information was available at the time of this report.
site of body where the vaccine booster was administered is ''somewhat'' puffy it is not solid like other side; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization.The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "site of body where the vaccine booster was administered is ''somewhat'' puffy it is not solid like other side"; IMMUNISATION (non-serious) with onset Jan2022, outcome "unknown", described as "booster".  Additional information: As the patient is the reporter stated that question on COVID booster possible side effects that the patient experienced roughly four days ago and still experiencing some side effects namely the site of body where the vaccine booster was administered is 'somewhat' puffy it is not solid like other side, puffy is the best way like the stomach for example it jiggles on the one side of Pfizer shot was not administered side (Further clarifications unknown hence event captured as per verbatim)." reporter was informed about the role of Pfizer Drug Safety and Pfizer Medical Information department and offered the number. Further probing could not be done as reporter was unwilling to further answer the questions. Hence, other details were unknown and limited information was available over the call.   The lot number for bnt162b2 was not provided and will be requested during follow up.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 25-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were reported.
pt recv 1 dose of varivax 2/97 & on 4/98 the pt devel ``mild case'' of pox lesions
This spontaneous report as received from a physician refers to a female patient of unknown age who on an unknown dates, was vaccinated with an unspecified number of doses of GARDASIL (doses, routes and lot numbers not reported). The physician reported that on an unspecified date a Pap smear was performed and the result was diagnosis of unspecified strains of high risk HPV. At the time of the report, the patient's outcome was unknown. The relatedness for unspecified strains of high risk HPV's and GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
Fever up to 102.8 (Ax) started 9/25/09 --> 9-27-09 (L) cheek hard, swollen - 2 episodes of diarrhea RASH developed 9/28/09 - all over body until 10-1-09 excessive tiredness.
patient states that he injured his shoulder and developed cellulitis which required cephalexin to treat.
This case was reported by a nurse via call center representative and described the occurrence of fatigue in a adult female patient who received FLUARIX Tetra (batch number JC9E9, expiry date 30th June 2018). In October 2017, the patient received FLUARIX Tetra. In October 2017, less than a week after receiving FLUARIX Tetra, the patient experienced fatigue and generalized urticaria were unknown. It was unknown if reporter considered the fatigue and urticaria to be related to FLUARIX Tetra. Additional details were reported as follows: The patient who was also an employee within the facility received a dose of FLUARIX Tetra on Thursday and developed fatigue and welts all over body. The patient visited physician, however it was reported that the doctor did not believe symptoms were related to patient receiving the vaccine. No further information was reported regarding this event. This case has been linked with case US2017159875, reported by the same reporter for same events.
Pt is a 16yo F at time of vaccination which is under the approved age limit for Moderna vaccine. She experienced only a mild headache and body aches x 1 day following vaccination and  was subsequently feeling well.
By 8pm my left arm and shoulder was in pain. By the next morning at 8am, my arm felt like it was trying to be ripped off my body. I was running a fever, had a halo migraine, body and joints felt like I had been in a severe accident with excruciating pain. Had to take Excedrin Migraine and 800mg of ibuprofen every 6 hours with very little relief. Also had chills and hot flashes. Then later that day I started having diarrhea and severe stomach pain. Whole body pain got worse over night and I couldn?t sleep. Today, after 3 hours of sleep, I woke with a migraine again, severe stomach cramping, heavy feeling in my chest and now have a cough. Body aches and pains have continued with barely any relief. Nothing is working for my migraine.
Initial report received from a healthcare professional on 18 September 2013. A 51-year-old male patient, who had no medical history and concomitant medications were not reported had received an intradermal dose of FLUZONE ID (Batch number: UT4721AA, anatomical site of vaccination was not reported) on 09 September 2013. On 09 September 2013, the patient had pain at vaccination site, redness, knot and swelling of two inch in diameter at the vaccination site. Patient had dull pain radiating downward to his elbow for about 2 days. Laboratory investigations and corrective treatments were not reported. As of 18 September 2013, the patient had not recovered from the events. List of documents held by sender: none. Follow up information received from a healthcare professional on 28 July 2014. Responsible physician details were updated. Follow-up information received from a healthcare professional on 15 September 2014: The patient was vaccinated with first dose of FLUZONE intradermal in left deltoid. The patient had no illness at the time of vaccination. No laboratory tests were performed. The events resolved approximately 2 weeks with no lasting effects.
pt recvd vax & died; per TARS: child awoke at 6:00AM, did not follow usual habit but appeared well then several abnormal cries, child then appeared in extremis;
Patient called and reported feeling painful burning sensation developing in her calf muscles in her legs that started day after vaccine administration (Monday). She also described it feeling like restless legs. On Tuesday, it went up to her hips. She said she had to constantly walk to help manage the discomfort. When asked, she reported no other ss - no rash, no swelling, no itching. Neither at the injection site, nor at the area of concern. I called her Wednesday to follow up and she reports that everything is gone and back to normal as of this morning.
vaccine leaking out during an injection and syringe has been disposed of at the time of this report, no AE; spraying into a consumer's left eye due to the vaccine leaking out during an injection and the vaccine spilled on the left eye, no AE; the vaccine spilled on the arm and clothing, no AE; consumer did not receive a full dose, no AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves patient (unknown demographic) who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] During administration time the vaccine leaking out during an injection and syringe has been disposed of at the time of this report (syringe issue), spraying into a patient left eye and the vaccine spilled on the left eye (exposure via eye contact), the vaccine spilled on the arm and clothing (exposure via skin contact) and did not receive a full dose (underdose).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ471AB and expiry date: 30-Jun-2021) via an unknown route in the arm for prophylactic vaccination.  It was actual medication error case due to underdose and exposure via eye contact and exposure via skin contact (latency on same day). It was reported that Fluzone Quadrivalent spraying into a patient left eye due to the vaccine leaking out during an injection. The Pharmacist reported that the needle was on tight; that after the event the needle was checked and was tight; that there was no damage noted to the syringe on inspection after the event; that the syringe has been disposed of at the time of this report; that she knows the needle was injected into the arm and the vaccine was being administered; that the consumer did not receive a full dose; that the consumer reports the needle never penetrated his arm or that the injection was not in all the way; that the consumer is a physician; that the vaccine spilled on the arm, clothing, and the left eye.  It was also the case of Syringe issue.  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 holders 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.
Pt reported having mild tingling in left hand a few minutes after injection; while waiting in the pharmacy area, patient ended up having a seizure
Vaccinated pt with 1st dose Moderna.  Pt had waited 15 min after getting vaccine without incident, but remained near event.  After about 20 minutes, pt approached staff saying that he was having chest tightness.  VS taken: SaO2 98%, HR 61, BP 144/80.  Pt stated that he has had intermittent chest tightness after contracting COVID about a year ago, in which he was doing breathing tx's 3-4x/day but stopped 3 months ago. Physician was then contacted.  Staff continued to monitor pt until nurses arrived, who also spoke with physician.  Directives were given to nursing staff to monitor and do VS on pt at 30 min, 1 hour, and at 4 hours.
pt recvd vax & devel hive like rash on face; was itching & red in color;
Moderate severe pain at injection site that has increased in duration since vaccination 7 months prior.  Symptoms include decreased mobility, joint tenderness, muscle spasms , stiffness and radiating pain  to tips of the right upper extremity.  Patient has dificulties with ADLS dues to limitations and pain as a result of injury sustained from vaccine
Red splotch rash, warm/hot sensation at the injection site. Both adverse events appeared 7 days after injection. No treatment.
Vague RLE discomfort 3/16/21-4/4/21, DVT RLE greater saphenous vein discovered in the ER 4/9/21.  He is on eliquis and may need to continue this for his lifetime given this is a second thrombotic event
Flu shot 3 pm 7:30 P.M - Sore throat / Tongue felt like it was burnt (from hot drink) Gums were sore. Cheeks felt wind burned/ Sublingual (under tongue) swelled (felt like 2nd tongue). Took Zertac and Ibuprophen. By 1am 9-17-09 swelling under tongue half the size. By noon 9-17-09 - All symptoms were gone.
felt like he could collapse, He felt like he was going into cardiac arrest; heart beat increased really fast; He felt his heart beating up to his neck; had slight chest pain; feeling uncomfortable in his chest; anxious; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 13:50 (Batch/Lot Number: EW0178) (at the age of 31 years old) as 1ST DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history was none. There were no prior vaccinations within 4 weeks. There were no family history and no relevant tests. The patient's concomitant medications were not reported. Patient took the first dose of the COVID vaccine. About 25 minutes after, all of a sudden, his heartbeat increased really fast. He could not figure out what was going on. He had slight chest pain as well. It started out with him feeling uncomfortable in his chest. He told his wife that something was wrong. He was driving and had to pull over on the side of the road. The total episode lasted two to three minutes. He felt like he was going into cardiac arrest. His wife called 911. Within five minutes, they were there. They checked him out, and everything was normal. He thinks that normally his heart beats 70 to 80 beats per minute. His heart felt like it was beating 200 beats per minute. He felt his heart beating up to his neck. He felt like he could collapse. He clarifies that his heart was beating very fast for about 30 seconds. After that, his heart was still beating fast, but it started going down. Then after two minutes, it started going back to normal. His heart was still beating fast because he was still very anxious. He thinks the anxiety after ward was making his heart pump very fast. He was going to talk with his doctor next week to get checked out and find out if he has any underlying heart problems. He has never had any heart issues in the past. The outcome of events was recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On an unknown date in 2012 the patient was vaccinated with the first dose of GARDASIL series (strength, route, lot # not reported). On 29-JUL-2014, the patient was vaccinated with the second dose of GARDASIL series (strength, route, lot# not reported). No adverse effect reported. The outcome of event was not reported. Additional information has been requested.
Rash starting at 8am on 3/26/21 at her feet and ankles bilaterally, itching and painful, spread to face and elbows. Lips began to swell and become painful at 1pm on 3/26/21. Pt treated with diphenhydramine 50mg  and epinephrine 0.3mg. Her rash and lip swelling improved starting 10 minutes following these medications. She was monitored for 1.5hrs and at time of discharge her rash was 80% improved and lips were no longer swollen. Pt did not have throat tightening, shortness of breath or dyspnea. She was given epinephrine for signs and symptoms of angioedema.
Patient complained of dizziness describes as "not feeling right like I could feel something in my body that's not supposed to be there." PT was assisted to private area and  after resting she reported that all symptoms have subsided. Total contact was approximately 10 minutes.
Papular rash in dermatomal distribution of C5 on left side extending to lateral of midline on left to volar left wrist. No vesicles or pustules. No crusts.
This is a spontaneous report from a contactable pharmacist.  A 50-year-old female patient received the third dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on unspecified date, single dose, for COVID-19 immunisation. The patient's medical history included breast cancer. Concomitant medications not reported. Historical vaccines included dose 1 and dose 2 of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), received on unknown dates, for COVID-19 immunization. Patient experienced injection site reactions for 2 weeks including bruising, blistering, turning to hypopigmentation with dermatitis and itching. Event took place after the 3rd dose of BNT162B2. The outcome of the events unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.