chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terrible sore throat after the first dose; This is a spontaneous report from a Pfizer-sponsored program from a contactable Other HCP report for husband. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The Other HCP asked to cancel the scheduled appointment for her husband's 2nd dose. Her husband had been hospitalized. He has a terrible sore throat after the first dose. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on data provided, the causal association between sore throat and the Pfizer -Biontech Covid 19 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient was 16 years of age at time of vaccination. Moderna is not indicated for patients under 18.   Patient reported no adverse events when seen for second dose on 5/12. (She did not receive second dose at that time, but will get it next week on 5/19)
Father states about 24 hours after receiving vaccines, developed pain and swelling at site, rt. deltoid. Provided no relief in interventions and today noticed swelling increased. On 8-15-14 returned to clinic. Ice applied to rt deltoid area 10 cm in diam. red, swollen and warm to touch. Child left with father in gd spirits, ambulatory.
Shortness of breath even when resting, feeling of a weight in my chest, difficulty with aerobic exercise. I was lifting weights shortly before symptoms began, with no symptoms prior.
Hidradenitis suppurativa flare up of Hurley Stage 2.  Developed a day after vaccine and got progressively worse until receiving a steroid injection on Friday April 16th. It still hasn?t resolved yet as of today, April 18th.
Within 24 hours post vax, the pt developed an injection site reaction characterized by an area of redness, swelling, and induration the size of a baseball. As of 10/18/99, the redness and swelling had subsided some.
The reaction began with itchy/red eyes and progressed to extremely red & itchy with discharge to almost swollen shut. Pain progressed from a dull ache/soreness to excruciating muscle, joint and bone pain. I also became extremely exhausted and could not move, and I could barely speak. My tongue became thick, swollen and I developed a headache that was the worst I had ever felt. I also lost all sensation of taste, only some of which has returned. I wanted to go to the ER but could not voice the request. My husband talked to my doctor who suggested Motrin which did not help. The pain was worse than natural childbirth. I was curled up on the couch in a fetal position for hours.
Received DTaP 5, IPV 4, MMR 2 on 06/05/02. Started developing rash on 06/06/02 rash itching. Pt then had increase in rash-maculopapular then urticarial with mild angioedema on trunk/exe.
Headache, Arthralgia, Fever UrticariaPruritus, fatigue, chills, injection arm pain Narrative:
an unexpected benefit outcome; no AE; This spontaneous report was received from a male patient of unknown age reporting on himself. He had no concurrent or historical conditions, no drug allergies or reactions and he didn't take any concomitant medications.   In March 2009, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) dose 1 (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis.  On an unknown date, the patient reported unexpected benefit outcome (no further specified). He also mentioned that he knew several people that needed booster shots of the vaccine, but he did not need booster dose himself and he had no issues after receiving his dose in March 2009. No further information was provided.
After being vaccinated I was a little nauseous after breakfast. I vomited and was still nauseous. I laid down and when I did, I got very dizzy. I stood up and the dizziness went away. I related the process three times, and it kept happening, so I decided to go to urgent care. I was prescribed medication for nausea, but I didn't take it. They couldn't diagnose anything but thought it might have been positional vertigo.
Breakthrough case. He felt bad with a headache fatigue, sore throat and cough with a lot of phlegm and tested positive for COVID-19 on 7/8/2022. Quarantined for 5 days. then started feeling better within 10 days. Never felt the need to get retested. Still fatigued easily.
10/25/10 Immediately after injection arm sore down to (R) wrist - sharp pain rest of the day - pain got worse as day progressed & numbness (R) hand - Pain kept pt. awake, unable to sleep on (R) arm - Pain continues - Sat. AM 10/31/10 could not move (R) arm up or out Sun. AM 10/31/10 - Continued pain with numbness from wrist on down. 3:15p 11/2/10 saw PMD - based on assessment Dr felt bursa got punctured/inflammation - Given steroid injection - Rx for primidone 50 mg (PRN: No improvement by Monday 11/8/10 to see PMD again (Note: No firm grip with (R) hand - pt. did mention she was able to fasten bra (able to lift arm behind back).
Tiredness, Headache, Muscle pain, Chills, fatigue and pain at the injection, enlarged lymph node in the right side, pain around the lymph node, under arm and shoulder
4 mos p/ vax pt revealed negative varicella titers. rpt felt lack of response was not related to therapy w/varicella
MOTHER REPORTED THAT THE CHILD HAD SEIZURE AND SHE WAS TAKEN TO THE HOSPITAL
3 1/2" x 4 1/2" area of redness, hot to the touch, slight swelling and pt. report itchiness.
10/13/2011 Mom called and stated child has welts all over and a high fever. Mom called his doctor who told her to call the Health Department.
Facial, neck, and chest flushing, hypertensive, tachycardia, dizzy, nausea, anxious.  EpiPen administered at 1128.
High fever-102, dizzy, chills, short of breath, severe headache, vomiting within 12 hours of shot and lasting 48 hours, then weakness, and coughing for next four days.
On Jan 6th,  I had fatigue and malaise. On Jan 9th, I had a lymph node reaction that  had swelling and I was unable to move my arm without significant pain.
Sense of smell has changed where I often smell things that are not there often its the smell of burnt toast or Marijuana. My sense of taste has also changed drastically to the point I don't eat I don't like food anymore.I have also developed a need to organize and clean and reorganize almost constantly and unorganized settings as well as places that aren't clean cause anxiety. My sleeping habits have changed drastically as well I become more alert at night and am only able to sleep around 4 to 5 hours a night. Throughout the time that I've gotten vaccinated I have lost over 150 pounds without trying and I continue to lose weight. I have not been to a doctor because I can't afford a Dr,it has been 10 months with no change for the better at first the weight loss was great it was needed but if I continue to lose weight at the same pace I will be underweight in a few weeks.
REBOUND OF COVID; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) 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 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805031 expiry: UNKNOWN) dose was not reported, 01 total administered at left arm on 02-APR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received booster dose of non-company suspect vaccine Spikevax Moderna Covid-19 Vaccine (Elasomeran) (Dose number in series 2) (batch number: 019F21A expiry: UNKNOWN, form of admin, route of admin, and were not reported) dose was not reported, administered at left arm on 05-OCT-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with booster dose of Spikevax Moderna Covid-19 Vaccine (Elasomeran) (Dose number in series 2). The patient additionally received booster dose of non-company suspect vaccine Pfizer Biontech Covid-19 Vaccine (Tozinameran) (form of admin, route of admin, and batch number were not reported, expiry unknown) dose was not reported, administered at left arm administered on 15-APR-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). No concomitant medications were reported. On an unspecified date in 2022, the patient had COVID-19 infection for which patient took paxlovid (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered from 23-SEP-2022 to 27-SEP-2022 for covid-19 treatment. On 03-OCT-2022, the patient experienced rebound of covid (suspected covid-19 infection) (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, tozinameran was not applicable and with paxlovid was treatment discontinued. The patient was recovering from rebound of covid, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
pt called has tenderness & swollen arm fr the pneumovax shot; swollen & redness 6cm; 3MAY95 swelling & warmth 3cm; administered Pred 4MAY95 no more swelling;
Information has been received from a registered nurse concerning a 13 month old white female with no allergies and no medical history who on 12Apr04 was vaccinated in the right anterior thigh with a first dose of varicella virus vaccine live (lot 647708/1246N). Concomitant therapy included fourth dose given in the left anterior thigh of poliovirus vaccine inactivated (Ipol) (batch X0707) and a first dose given in the right thigh of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 645519/0295N). There was no illness at the time of vaccination. On 07May04 the pt developed a wide spread rash of about 15 tiny vesicular lesions to her forehead, hairline, right ear, trunk, and extremities. No other symptoms were reported. The pt was seen by a physician and no treatment was required. The pt was diagnosed with modified chickenpox. Subsequently, the pt recovered. No product quality complaint involved. No further information is expected.
Pt recv vax on 3/10/98; within 24 hr pt exp fever, flu-like sx, felt lousy, tired, swollen right knee
Severe swelling of lower legsPain in entire legs constant worse when using stairsCramping severe tonightIrregular heart beatTired  other pains off and onThis has been on going since my vaccine an; Severe swelling of lower legsPain in entire legs constant worse when using stairsCramping severe tonightIrregular heart beatTired  other pains off and onThis has been on going since my vaccine an; Severe swelling of lower legsPain in entire legs constant worse when using stairsCramping severe tonightIrregular heart beatTired  other pains off and onThis has been on going since my vaccine an; Severe swelling of lower legsPain in entire legs constant worse when using stairsCramping severe tonightIrregular heart beatTired  other pains off and onThis has been on going since my vaccine an; Severe swelling of lower legsPain in entire legs constant worse when using stairsCramping severe tonightIrregular heart beatTired  other pains off and onThis has been on going since my vaccine an; This is a spontaneous report from a contactable consumer (Patient). A 38-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot Number: Unknown) via an unspecified route of administration in right arm on 01Jun2021 at 07:30 as dose 1, single (at the age of 38-years-old) for COVID-19 immunization at Doctor's office/urgent care. Medical history included Penicillin allergy from an unknown date and unknown if ongoing. Concomitant medications included acetylsalicylic acid (ASPIRIN (E.C.), Baby Aspirin) and LORAZEPAM taken within 2 weeks for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and not received any other vaccines within 4 weeks. On 01Jun2021 at 08:00, the patient experienced severe swelling of lower legs, pain in entire legs constant worse when using stairs, cramping severe tonight, irregular heartbeat, tired other pains off and this has been ongoing since she took the vaccine and is not getting better. The adverse event leads to visit Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. No prolonged hospitalization and no treatment received for events. Since the vaccination, the patient has not been tested for COVID-19. Patient was not recovered from events.  Information on the lot/batch number has been requested.
Area near injection became red and hot and an area about the size of 5X7 inches.  At time reported to me the rxn was improving and was significantly better.  No treatments was sought.  As of 07/16/2015 pt is recovering.
Unsure of when exactly event happened - child reports feeling weak/dizzy, body aches for about 1month after each vaccination.
they accidently gave a patient QUADRACEL instead of ADACEL /No AE; they accidently gave a 35 years old patient QUADRACEL instead of ADACEL /No AE; Initial information was received on 21-Jul-2021 regarding an unsolicited valid non-serious case received from an other health care professional via phone Inquiry Number: 00692015).     This case involves a 35 years old female patient who was accidently given DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) [QUADRACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) [QUADRACEL] lot number and expiry date not reported via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  It was reported "Caller said that they accidently gave a 35 year old patient QUADRACEL instead of ADACEL. Is there any side effective and does she need to get an Adacel vaccine. No agent was available at the time of call."  At the time of reporting, 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 the 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.  There will be no information on the lot number for this case.
Swollen lymph nodes in left armpit - baseball sized lump, tenderness in left armpit
Information has been received from a registered nurse concerning an 8 year old male on 12/10/96 was vaccinated with a dose of varicella virus vaccine live (lot # 617313/0769D). The RN reported that on 5/7/04, the patient developed a chicken pox rash of abut 40 lesions mostly on his torso. No other symptoms were noted. Unspecified medical attention was sought, but treatment was not required. At the time of this report, the outcome was unknown. No further information is available.
Really bad headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Really bad headache) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced HEADACHE (Really bad headache). On 09-Jun-2021, HEADACHE (Really bad headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Information has been received from a physician's office staff, concerning a 13 year old female patient with hypothyroidism and a history of no reaction on previous exposure to vaccine (dose 1 on 16-NOV-2007) who on 12-FEB-2008 was vaccinated with the second dose of Gardasil (lot #659439/1267U).  Concomitant therapy included SYNTHROID.  On 12-FEB-2008, following the vaccination, the patient called the office to report she had developed a rash behind her knees, ears & on her abdomen following the vaccination with Gardasil.  She described the rash as: "looks like small bites and some are the size of a quarter."  Treatment was not specified.  At the time of this report, the patient had not recovered.  Additional information has been requested.
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # M003435 with expiration date 19-JUL-2017) (strength, dose, frequency and route were not reported). No adverse effect was reported. Additional information has been requested.
She got the vaccine, she went home, had no reaction.  The next day she woke up and her arms was sore, and swollen (huge).  Later on she started to have fever, cough, and then headache.  She then went to bed and slept 7-8 hours, all day long.  The swelling stayed for almost a week in her arm.  Then approximately 4-5 days later on 3/21/21 the right side of her face, the lower part of her ear to the lower part of her face started swelling, and her lip was numb.  Fearing she had Bell's palsy which she had about 10 years ago she went to see her doctor and the doctor said that it was a reaction from the vaccine.  The right side of her face and the swelling is almost gone, but her face is still feeling numb.   Her doctor did not give her anything, and since her swelling was almost gone and was improving he didn't want to give her anything for it.  He told her to watch it and if it worsens to get back to him, and to report to VAERS.
Chest pain with NSTEMI - troponin elevated to 6, downtrended. No EKG changes. TTE without reduced EF or wall motion abnormalities. Left heart cath did not show any significant CAD. Therefore, we believe this was a case of mRNA myocarditis from the 2ns Moderna dose 48 hours prior
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drugs were reported.  The pharmacist call about the administration of expired Moderna vaccine that were given as booster shot to patient around 490 to 500 people on the date last 20 Oct  2021 to 29 Nov 2021. Rx Number was 803772.
10 yo with history of COVID but no serious drug/food/vaccine allergies got his first Pfizer (5-11yo) vaccine on 11/12/21-- waited the 15min then drove away, then felt dizzy and had lip swelling and erythema around his eyes and mouth. Seen in our ED and treated with Epinephrine, Benadryl, Famotidine and steroids for an allergic reaction. No other new exposures that day.
Post vax, pt developed an injection site reaction characterized by redness and swelling. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune-23. Manufacturer's Comment: The reporter indicated that 4 pts developed an injection site rx; however, only 3 are presently identifiable. An additional report will be generated when identifying info is provided. Follow-up info recvd from MD on 4/3/01 indicated the pt recovered.
Arm swelling; Arm is red and itchy; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Arm swelling) and RASH ERYTHEMATOUS (Arm is red and itchy) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling) and RASH ERYTHEMATOUS (Arm is red and itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm swelling) outcome was unknown and RASH ERYTHEMATOUS (Arm is red and itchy) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Pt states that 2 days p/recvd vax noticed a knot w/discoloration @ inject site which over the course of the next day extended into redness, warmth, & edema of the entire deltoid region; denies having fever, dyspnea, etc; Pt taken DPh;
Patient received her 2nd dose of Moderna vaccine on 06/21/2021 and began feeling ill that evening with body aches and fever on the third day she had hives and went to the ER and was sent home. She progressed into body aches, itching,  joint pain and throwing up. By the 7th day she could not move, she felt like she was paralyzed.She was admitted into the Hospital on 07/03/2021 and was released on 07/11/2021. She currently still has a fever, whole body aches , coughing, itching and weakness.
Patient who was vaccinated earlier in the day was on staff's list to offer patient vaccination. Patient accepted and received another dose of Moderna booster shot. provider notified and pt was monitored for any side effects.