chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swollen lymph nodes/swollen lymph nodes in armpit of injection site; Nausea; Tired; Sore armpit of injection site; Nighttime cough; Sore arm of injection site; Mild headache; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself. A 35-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: FF2588), via an unspecified route in the left arm on 02Sep2021 at 12:45 (age at vaccination: 35-year-old), as a single dose for covid-19 immunization. Medical history included HBP, Obesity, Migraine Headaches, Asthma and Known allergies to Amoxicillin, Ragweed, Dogs and Cats. Concomitant medications included hydrochlorothiazide, lisinopril (LISINOPRIL/HCTZ) 10/12.5 mg QD; hydrochlorothiazide, lisinopril (ESTARLLYA) QD and cetrizine. It was unknown if prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Sep2021 at 20:00, patient experienced sore arm of injection site, Mild headache (day 1); on 03Sep2021 (day 2) sore arm of injection site, Mild headache, Nausea, Tired, Sore armpit of injection site, Nighttime cough; on 04Sep2021 (day 3) Sore arm of injection site, Nausea, Sore armpit of injection site (toward end of evening she could feel swollen lymph nodes), Nighttime cough and on 05Sep2021 (day 4) Sore/swollen lymph nodes in armpit of injection site - about marble size, tender with touch & movement, Nighttime cough. Patient did not receive any treatment for the events. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Bruised within one hour of vaccination. Pain under arm pit started within one day of vaccination. No enlarged lymph nodes notef. Swelling, redness, and itchiness occured 3-4 days later. Raised area is very warm to the touch. Circular.
On 5/23/2021, one week after having the covid19 vaccine, patient had a tonic clonic seizure. Patient had a febrile seizure 10/13/2010 and besides that was a healthy boy. He did not take medicines. The only health event was he would get a common cold. Since the seizure on 5/23/2021, patient has had 12+ tonic clonic seizures. He has seen 3 Neurologists. I don't know if the seizures are attributed to the vaccine but I felt the need to report. 5/23/2021 -1st tonic clonic seizure, went to hospital CT scan, blood work, urology test performed 5/28/2021 - 1st EEG met with Neurologist (no medicine prescribed) retiring 1 week. 8/25/2021-met 2nd Neurologist (no medicine prescribed) 10/07/2021-met with 3rd Neurologist (no med 11/23/2021- 2nd tonic clonic seizure 11/24/2021- started antiseizure med 11/30/2021 - 3rd tonic clonic seizure 12/1/2021 -4th tonic clonic seizure 12/21/2021- 5th tonic clonic seizure 12/22/2021-6th and 7th tonic clonic seizure 12/28/2021-8th tonic clonic seizure 12/30/2021- tested positive for covid - minor symptoms stuffy nose and congestion), slight fever 02/09/2022-9th tonic clonic seizure 4/1/2022-10th tonioc clonic seizure 5/23/2022-11th tonic clonic seizure  The 3rd  neurologist is who patient is under her care. She has inclreased dosage of medicine and has added a second medicine to find the correct dosage to stop seiures.
Patient received the vaccine at 5pm on Monday 3/22/21. She states starting on Tuesday 3/23/21 around 8 pm she started to feel bad, starting throwing  up a few hours later. Started running a fever but did not take her temperature. She felt hot and her face and chest red.  As on this morning at 3/24/21 at 940am she still feels hot and red. She is not throwing up but feels nausea. No trouble breathing or swelling. No headaches but has body aches. Feels pain all over her body.
cold; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 21Jan2021, as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took shingrix and experienced rash, swelling and had past drug- ibuprofen. On an unspecified date, the patient reported the details of her cold, which she thinks was unrelated to her Pfizer-BioNTech COVID-19 vaccination. The patient stated she took her first shot on 21Jan2021. Two hours before, she took 600mg Ibuprofen, now the patient seeing that it was not recommended, nobody told me and asked a doctor at the facility where the patient got vaccinated and she said it was okay, she was not my personal doctor. The patient had a little bit of a cold right now, I got it on the 29th, I already reported it to Safety, got a little cold and have an appointment with my doctor on Monday at 3 o'clock. The second dose was scheduled for Tuesday at 1 o'clock. Ok so it's okay to take Ibuprofen but after your vaccine. The reason why I'm asking was not for me; 3 years ago, or so, I had Shingrix first shot of 2, and got a big rash on my arm, and was swollen. Doctor said it was not a normal response, so that was the first shot. After that the doctor told me that don't go for the second shot. I did not like that doctor very much, so I called somebody, a nurse practitioner who gives vaccines for when you travel and she told me to take an Ibuprofen and Benadryl before, so that's what I did and had no reaction no problem. It was not considered an allergic reaction. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt c/o tinnitus after last anthrax vaccination on 8/12/03.
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 48-year-old male. The patient's height, and weight were not reported. The patient's past medical history included: a lot of surgeries, and concurrent conditions included: autoimmune disease.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A and expiry: UNKNOWN) 1 total, dose was not reported, administered on 09-JUN-2021 to left arm as prophylactic vaccination (Dose number in series 1). No concomitant medications were reported.  The patient then had an antibody test which showed that he had no antibodies. On 28-OCT-2021, SARS-Doz-2-nucleocapsid IgG test result was 0. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed immunological vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000208297.; Sender's Comments: V0:20211251085-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Unconsolable crying for 3 1/2 hrs last pm 07/01/04
No additional AE; Product was 2 days post expiry date and administered to a patient.; This spontaneous report was received from a Licensed Practical Nurse (L.P.N), referring to a patient of unknown age and gender. Information of the patient's medical history, concurrent condition, drug reaction/allergy and concomitant therapy was not reported.  On 21-MAR-2023, the patient was administrated with the 1st dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection (lot #U029319, expiration date: 19-MAR-2023, strength, anatomical location and route of administration were not reported) for prophylaxis (expired product administered). No additional adverse event (AE) occurred.
Started with local swelling of left upper arm --> then became whole upper arm. ER note on 8-17-2011 - no fever, chills, or chest pain. Treated with antiinflammatories & antihistamines.
Patient came as a walk in to get her flu shot. Gave her the questionnaires and VIS form for her to fill out. After giving her the vaccine patient left. I went to lunch and after coming from it I was documenting the vaccine and I realized the vaccine FLULAVAL had preservatives on. Since at the clinic I was working at, they didn't have FLUARIX QUADRIVALENT which is the vaccine that is preservative free and is for private insurances, I gave FLULAVAL which according to RN it is private at the moment. I asked him what could we do and I filled out an incident report. After that the RN working at the moment called HC for further assistance.
tiredness; cramp like pain from between the right hip and the right knee; flu-like symptoms; muscle / pain all over the body / right leg muscle started to hurt / pain had increased; joint pain all over the body; difficulty sleeping; he cannot walk and cannot weight bear on the right leg; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 12th November 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 12th November 2020, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced influenza-like symptoms, muscle pain, generalized joint pain and difficulty sleeping. On 14th November 2020, the patient experienced tiredness and muscle cramp. In November 2020, the patient experienced mobility decreased. The patient was treated with paracetamol (Tylenol), naproxen (Aleve) and non-drug therapy (Warm Compress). On an unknown date, the outcome of the influenza-like symptoms, generalized joint pain, difficulty sleeping, tiredness, muscle cramp and mobility decreased were unknown and the outcome of the muscle pain was not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, generalized joint pain, difficulty sleeping, tiredness, muscle cramp and mobility decreased to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: This case reported by patient himself. The patient received shingrix in the right arm and a flu vaccine (name-unknown) in the left arm. On the same night of vaccination the patient had flu-like symptoms, mostly muscle and joint pain all over the body and the patient took Tylenol. The patient had difficulty sleeping and then on 13th November 2020, he did sleep well. The patient had some tiredness, but his right leg muscle started to hurt, cramp like pain from between the right hip and the right knee. The patient contacted the health care professional and told him to take Aleve and apply ice alternating with warm compressor. The patient states the pain had increased that he could not walk and weight bear on the right leg. The reporter consented to follow up.
2/23: Cellulitis of left thigh: fever, pain, redness admitted for IV antibiotics. 03/05/07-records received from facility for DOS 02/23-02/26/07 DC DX: Cellulitis left anterolateral thigh, resolving. Immunization reaction  Patient needs subacute bacterial endocarditis prophylaxis.  Hospital course-24 hours after pneumovax vaccine developed progressive pain, reness and swelling around the injection site.
Initial case retrieved from the scientific literature on 22 September 2011. The authors evaluated clinical-pathological features of 37 infants/children whose parents alleged a relationship between vaccination and death or permanent central nervous system (CNS) damage, and sought compensation through the National vaccine Injury Compensation Program during the years from 1990 through 1999. CNS tissue was available for evaluation by a pediatric neuropathologist in these 37 cases: 23 males (62%) and 14 females (38%) ranging in age from 1 month to 17 years at the time of death or biopsy. Thirty-three of the 37 patients were dead at the time the case was evaluated. Most commonly implicated vaccines were DTP or DTAP (33 cases), followed by MMR and IPV/OPV (25 cases each). The authors concluded that there was no obvious relationship between type of vaccine (or vaccines simultaneously administered) to time of onset of symptoms, nature of symptoms, or the lesions found. No CNS lesions were found in 5 of 37 cases. There were a variety of CNS lesions amongst the 32 remaining cases, but pathogenesis of the majority was apparent and not considered a complication of vaccination. Of the 37 patients described in the article, the vaccines received by eight of these patients were specified. This case captures one patient; and the other seven patients are captured in case numbers 2011-09242, -09243, -09245, -09247, -09248, -09249 and 2011-09250. An unidentified patient (infant/child) had received a DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (DTP) vaccine (manufacturer unknown) and OPV vaccine (other manufacturer) at four weeks of age (lot numbers, routes, sites and dates of administration were not reported) and an unspecified amount of time later, manifested seizures and mental retardation. A lobectomy was performed at 22 months which showed chronic meningitis and phlebitis, grey matter heterotopias and gliosis reflecting both developmental and acquired inflammatory lesions. CNS lesions were diagnosed on brain biopsy. Pathological diagnosis was unknown. Outcome was not reported. Of note, this case involved misuse (inappropriate age at vaccine administration). Documents held by sender: None.
After my shot Inhad a lot of energy and felt fine during the day. At night I was shaking uncontrollably. drank water and took  tylenol. Fell asleep and woke up soaking wet. Next day I still had a fever. Had chills and my body got warm. This went off and on throughout the day. I was exhausted. At night I had a bloody nose. Went to bed and woke up wet again but not as bad as the first night. Morning time I felt fine. Went to the gym and the sauna. Started to exercise and felt lighted headed and cloudy. Went home laid down. I still feel weird on and off.  Went to the bathroom and had black stool. My right arm is still sore.
Patient presented to EC with Stroke/CVA and Afib; unknown if caused by vaccine; also newly diagnosed with lung CA
On June 4, 2008 in our immunization clinic, six children received their second dose of VARICELLA.  We are assuming one of them received a ZOSTAVAX instead of VARIVAX due to the count at the end of the day.  All parents of the children were reached by 06/11/2008.  None of the children had any adverse reactions, even a local one at the site of the VARIVAX.  Since we are not positive that one of these children received a ZOSTAVAX, we are only giving you the names and birthdays of these children as instructed by the state Immunization Program.  If you need more information, please contact me.  I called CDC on 6/11/08.  In response to this situation, there was no specific answer in the literature, but the "expert" that was consulted stated that the dose of ZOSTAVAX, if given, should be "counted".
She was given the ZOSTAVAX in the back part of her upper R arm. It became swollen, red and very painful. It hurt so bad that she was unable to sleep at night. It is very swollen and hot to the touch, over a large area of her arm, up from her elbow.
Immediately after the shot was administered my daughter had soreness and warmth, but nothing else. Exactly 48 hours after the injection was given Hives developed at the injection site, and the area was warm to the touch. I took her to the after hours doctor who measured the welts as being 2 1/2" x 3.25".  She drew a circle around the welts, and gave my daughter Benadryl in the office. Welts lowered. Exactly two days later... on 8/24/15 at 6:00 pm.  The welts reappeared in the same area as the injection (left upper arm), but were in a larger area than on the first revisit.  She also had a new symptom of a stiff neck with the hives this time.  I contacted the doctor and they said that it wasn't a worry unless she was screaming in pain trying to lower her head to her chest. Gave her topical and oral Benadryl.  Welts went down, but she had a stiff, hurting neck for about 3 days longer.  Pain didn't go away from the stiff neck until then. 9/7/15 - she developed hives in a new place, around 5:00 pm.  Rash on her upper chest area.  Applied topical Benadryl and the hives went down.
COUGHING; SORENESS; THROAT HURTS; WEAKNESS; NOT FEELING WELL; FACE IS SWOLLEN; TIREDNESS; This spontaneous report received from a consumer concerned a 60 year old male. 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 for prophylactic vaccination vaccinated on left deltoid. No concomitant medications were reported. On an unspecified date, the subject experienced coughing, tiredness, soreness, throat hurts, weakness, not feeling well, and face is swollen. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the coughing, tiredness, soreness, throat hurts, weakness, not feeling well and face is swollen was not reported. This report was non-serious.
No adverse reaction. Child received Pfizer for 1st dose of COVID-19 on 7/7/2022, then Moderna 9/1/2022. Contacted Pfizer, Moderna and health department following instructions. No reaction on 9/1/2022 or 9/2/2022 so far.  Following-up with parents daily. Parents communicating and will keep us informed. Instructed by company to fill out this form.
She woke up saying her legs were weak, had headache and nausea. By 7:00am she ate a good breakfast but complained of a mild headache.
This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown demographics. The patient's concurrent conditions, medical history and drug reactions and allergies was unknown. The patient's concomitant therapy included sterile diluent (MRK INJ). On an unknown date the patient was vaccinated with improperly stored dose of ZOSTAVAX (dose, units and frequency were unknown) (Lot # M040146 and expiration date 26-DEC-2017), (Lot # N020943 and expiration date 26-OCT-2018) for prophylaxis. Reporter informed that, there was multiple temperature excursions for the ZOSTAVAX (Lot # N020943 and expiration date 26-OCT-2018), on 09-NOV-2017 temperature excursion was at 6 F to 14 F (14 F) for 9 hours 30 minutes, on 15-DEC-2017 temperature excursion was at 6 F to 14 F (7.9 F) for 15 minutes and on 31-DEC-2017 temperature excursion was at 6 F to 14 F (13.1 F) for 1 hour. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. The outcome of events product storage error and no adverse event was unknown. The causal relationship between the events product storage error, no adverse event and ZOSTAVAX was not provided by the reporter. There was no product quality compliant reported.
red, swollen area @ site of inject, irritable, crying 3 hrs, wouldn't take bottle; given APAP & cool compresses to area;
Saturday noc 11OCT97 ran 104 fever x 6 hr;fever broke around 11Pm Saturday noc;ran fever again Sunday noc-not as high;fever free Monday & felt well enough to go to work;no other sx other than fever;
Pt exp a burning sensation & discomfort (pain) @ inject site immediately p/receiving Influenza vax; sx subsided 15-25 seconds p/inject & no other problems were noted;
Metallic taste to mouth; Flushing of face; Burning of throat; :ghtening of throat; vasovagal dizziness; Dryness in arms; Burning in most of my arms, legs, neck, mouth,; This spontaneous case was reported by a health care professional and describes the occurrence of DYSGEUSIA (Metallic taste to mouth), FLUSHING (Flushing of face), THROAT IRRITATION (Burning of throat), THROAT TIGHTNESS (:ghtening of throat) and PRESYNCOPE (vasovagal dizziness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hashimoto's thyroiditis (Start year :1984) since 1984, Glaucoma NOS (Acute Angle Glaucoma: Start year:2008) since 2008, Penicillin allergy and Sulfonamide allergy. Concomitant products included LIOTHYRONINE, LEVOTHYROXINE, TAFLUPROST (ZIOPTAN), VIT D [VITAMIN D NOS] and ASCORBIC ACID (VIT C) for an unknown indication.   On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste to mouth), FLUSHING (Flushing of face), THROAT IRRITATION (Burning of throat), THROAT TIGHTNESS (:ghtening of throat), PRESYNCOPE (vasovagal dizziness), DRY SKIN (Dryness in arms) and BURNING SENSATION (Burning in most of my arms, legs, neck, mouth,). The patient was treated with PREDNISONE at a dose of 40 mg; FAMOTIDINE (PEPCID AC) at a dose of 20 mg; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; GABAPENTIN (GABA [GABAPENTIN]) at a dose of 1 dosage form and MELOXICAM at a dose of 1 dosage form. At the time of the report, DYSGEUSIA (Metallic taste to mouth), FLUSHING (Flushing of face), THROAT IRRITATION (Burning of throat), THROAT TIGHTNESS (:ghtening of throat), PRESYNCOPE (vasovagal dizziness), DRY SKIN (Dryness in arms) and BURNING SENSATION (Burning in most of my arms, legs, neck, mouth,) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (Inconclusive) Increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products:Fish oil( start year :2020 , daily ,oral) , CBD (10mg, oral spray , as needed, start year on 2020). Action taken with mRNA-1273 was not applicable   This case was linked to MOD-2021-085373 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow-up document appended on 1-JUN-2021: N ew events , Concomitants and Treatment drugs are added. On 02-Aug-2021: Follow-up information included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.