chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. was given PCV13 and should have been given PCV20.  Pt. previously received PCV23 vaccine.
Erythematous area of skin on deltoid of right arm, some warmth palpated, no drainage or induration.
headache; pain in arm; dizziness; This is a spontaneous report from a contactable consumer. A female patient (wife) of unknown age received on 21Dec2020 11:15 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. In Dec2020, she reported headache, pain in arm and dizziness. Outcome was unknown. Information on the batch number has been requested.
Seen in ED- Physician note "cellulitis". "Pt with swelling/erythema post-injection. Possible reaction from injection but more likely cellulitis based on duration of symptoms and timing of injection.
By 10.30pm started to feel fatigue and went to sleep. During night had temperature, chills, body aches, dehydration. In the morning still had 99.5 temperature, body aches and headache. After breakfast took some Tylenol around 10am and symptoms eased and temperature went down to 98.5. After a few hours some body aches and tiredness are still felt but overall feeling better.
At approx. 1540 CMS gave patient her third Hep. B vaccine. Following the vaccine the CMS waited the 15 minutes to watch for possible reaction to the vaccine. Patient did not display any signs at that time. Approx. 1610 she approached the same CMS saying she was going home and that she did not feel great. She told him that she was light headed, warm and had shortness of breath. Another CMS tried to call the nurse number. We were on hold for about 20 minutes and a message came on to put in the number to have the nurse return the phone call but no return call was returned. Employee was advised to lie down for a few minutes and was given a granola bar and Capri sun. The symptoms persisted for about 15 minutes when patient started feeling much better and was back to normal. She had called her husband to come pick her up "just in case" and went home feeling well. No medical treatment was needed as the symptoms had subsided. Patient was advised prior to leaving if the symptoms come back or get worse to come call the center. Patient later that evening felt sick and vomited. She went to the emergency room. They said they were not sure if it was a reaction to the shot. She received saline and during that time started to get a tight feeling in her chest and felt her airway closing. They gave her two doses of epinephrine 15 minutes apart. After that she felt fine and the observed her for a couple hours. Today patient is feeling better.
Amplitude of existing tinnitus increased in both ears and has not returned to its prior level as of 2022-10-16. Very concerned that amplitude of Tinnitus may never return to its prior level as this has happened with other medications.
Chills, fever 100.1 deg F, headache, stiff neck, loss of appetite,  joint and bone pain, sciatica, throbbing kidneys, unable to sleep
syncopal event outside medical office building. Pt lowered to ground by father. EMS called. Improved mentation and able to go home
received an extra dose of Fluzone Quadravalent, with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from an other health care professional (Reference number- 00356778) and transmitted to Sanofi on 12-Nov-2020.  This case involves a 4-year-old male patient who received an extra dose of influenza quadrival a-b vaccine [Fluzone Qiv], with no adverse event (extra dose administered).  Medical history, concurrent conditions, vaccination(s) and family history were not provided. Concomitant medication was unknown.  On 12-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE 0.5 mL (lot number: UT7065LA) via an unknown route as prophylactic vaccination.  On an unknown date, received an extra dose of Fluzone Quadravalent, with no adverse event.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as not applicable for extra dose administered.  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.
Chills; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) at the age of 80 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 10Apr2022, outcome "recovered" (Apr2022); FATIGUE (non-serious) with onset 10Apr2022, outcome "recovered" (Apr2022). Therapeutic measures were not taken as a result of chills, fatigue.  Additional Information: Dose received 3 Administration date=16Apr2022, If COVID prior vaccination: No If COVID tested post vaccination: No If Other vaccine in four weeks: No Device timestamp: 18Apr2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
myoclonus neck area began few hrs p/shot & ankle clonus (which maybe nl); pt may have benign myoclonus of infancy & DTP unmasked this;
Received 4 COVID vaccines since 2/11/21 all were Modera #024M20A,  date 2/11/21 # 031A21A date 3/16/21 #017C21A date 10/27/21 #005M21A date 4/6/22 Experience swollen knot at site of injection, headaches, body aches.  The first 2 caused more reaction than the boosters Received a positive rapid test for COVID 6/27/22. Symptoms began 2 days prior COVID symptoms: cough, headache, body aches.   Lingering Symptoms after paxloid: headaches, listlessness, depression  Paxlovid gave a bad taste  Received Paxlovid treatment program 6/28/22. & completed on 7/1/22
1530 - Full feeling in throat, progressing to heart palpitations around 1600. Started feeling anxious. 1700 - symptoms continued, 1730 - facial flushing, heart beating faster, short of breath.
Heavy sleeping,  sore and stiffness in arm that was injected,  chest pains and tightness of chest,  nose bleeds and  severe headaches
Upset Stomach; Chills; Headache; Muscle aches; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th September 2019, the patient received the 2nd dose of Shingrix. In September 2019, less than a week after receiving Shingrix, the patient experienced upset stomach, chills, headache and muscle pain. On an unknown date, the outcome of the upset stomach, chills, headache and muscle pain were unknown.   It was unknown if the reporter considered the upset stomach, chills, headache and muscle pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, however it could be 69 or 70 years. The age group was captured as adult as per Shingrix indication.  The day before reporting, the patient received the second dose of her Shingrix vaccine. The patient experienced upset stomach, chills, headache, and muscle aches. The patient did not want to provide her entire birth date, but she stated her birth year was 1949. The reporter did not consent to follow up.
Pt recvd vax on 27JUL92 & 6 hrs following vax pt exp weakness, facial flushing, diarrhea, dizziness, sweating, muscle aches & one eye was swollen; seen by MD dx w/poss allergic react to burning shrub;
No additional adverse events reported; one patient received a dose of expired PNEUMOVAX 23; This spontaneous report was received from a pharmacist and refers to a female patient of an unknown age. There was no information about the patient's concurrent condition, concomitant medication and medical history provided. The report refers to one patient and one combination product.  On 01-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot number: R034249, expiration date: 07-AUG-2020, for prophylaxis (exact dose and route of administration were not provided) which was properly stored. No additional adverse events reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: R034249; expirationdate: 07-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt went to ER with cellulitis in right arm.  Was given cephalexin 500mg 1 bid x7days
On May 31, 2021, I went into A-Fib and was hospitalized for four days.  I did go back into sinus rhythm with medication.    On July 5, I thought I having either a stroke or TIA.  It turned out to be Bell's Palsy.   Prescribed prednisolone, then prednisone.  The palsy is almost all gone.
Fainted multiple times several hours after receiving vaccine. Loss of muscle control and difficulty standing up. Intense head ache and confusion.
Employee reported redness and swelling to Right Wrist. She also noted itching to left neck/back area. Employee was taken to ED for further evaluation and treatment.
After almost 15 minutes of receiving vaccine, my mouth, inside and outside, tongue and face wer very tingly and cold. It came from no where. I could even feel it on the top of my mouth. I did not have any trouble breathing or swallowing, it felts like everything fell asleep and that I chugged ice cold water. It lasted for about 40 minutes.
Patient stated she felt like fainting, wanted oxygen, claims she was having an anxiety attack and "throat closing". Given 0.3mg EpiPen, 911 called, patient taken to ED.
20 minutes after receiving moderna vaccine - patient noticed numbness to the left side of face.  This lasted two hours.  Event was similar to a reaction patient had "Years" ago where patient had numbess to arms, side, and legs unilaterally.
Dizziness, light headed, headache, fever, chills, rapid heart beat, fatigue, aches, red and swollen arm 3"x5".  It is now the third day and the symptoms have largely subsided.  Although, this morning I slept under a single sheet and sweated.  I was able to moderate the headaches and fever with Tylenol.
Red, hot, itchy, painful at injection site. This happened 9 days after the vaccination. My husband as of yet has not done any ice or Benadryl. He did not want to get tired from Benadryl so he will wait until tonight to treat it.
NAUSEA  LIGHTHEADED .  CHEST PRESSURE.  CONSTANT BELCHING.  SAW PRIMARY PHYSICIAN ON 9/13/21 . EKG SHOWED ABNORMAL HEARBEAT . WA REFERED TO CARDIOLOGIST .  SAW CARDIOLOGIST ON 9/14/21 REQUESTED LAB AND TEST
This case was reported by a healthcare professional and described the occurrence of cellulitis in a 4-year-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included MMR II (non-gsk); Merck; unknown; unknown given on 9 April 2010; VARIVAX (non-gsk); Merck; unknown; unknown given on 9 April 2010. On 9 April 2010 between 1500 and 1600, the subject received 1st dose of KINRIX (.5 cc, unknown, right thigh). On 12 April 2010, 3 days after vaccination with KINRIX, the subject experienced red bump, hardness and cellulitis. The subject had a hard, red bump on the thigh, approximately three and half to four inches. The Physician diagnosed the subject with cellulitis and was placed on antibiotics. This case was assessed as medically serious by GSK. The subject was treated with antibiotics. At the time of reporting the outcome of the red bump, hardness and cellulitis was unspecified. The healthcare professional reported two other cases, see case A0855353A and A0855336A.
CDC revised administration of Covid vaccine by eliminating the monovalent and advising to administer with first dose bivalent. Days later it was advised to increase the initial dose of 6 months- 5 years bivalent Moderna to the 6 years and up. This vaccine was administered prior to the increase being communicated to us. It was only recognized when we attended a Moderna information session. This was not communicated until April 28th through the Department of Health.
My arm started to get very itchy right after the vaccine and then I had a welt on my shot spot. Then my elbow was red. Despite taking Advil the swelling didn't go down.
On March, like the next day after getting the vaccine, I had muscle pain, headaches, body aches, and it was just general pain. Now, I have very deep pain. My hips, legs, knees, feet, and back hurt. If I twist to the right, I have trouble breathing. On 08/27/2021 I went to the doctor, they did hematology tests, chemistry tests, blood tests, and urine test. Everything came back normal except for high cholesterol and high blood pressure. The pain is very deep and very intense. I have to keep monitoring my blood pressure. On Friday I am seeing my doctor again to see if my blood pressure has improved.
- Right after patient said goodbye (15 min after vaccine) she felt dizzy and lightheaded.
In the the first week patient  felt like electric shock with certain movement. And then it progressed sever pain in the shoulder with certain movement with numbness. That continued for 6 weeks and then patient went to doctor. As per doctor it could be tendonitis from injection. Md prescribed Naproxen and then Physical Therapy
SORE THROAT, SEVERE INDIGESTION, EXTREME FATIGUE, SLEPT FOR 15 HOURS, STILL FATIGUED, TEMPERATURE 97.6 AND BLOOD PRESSURE 140 80 60  PHONED DOCTOR
pt recv vax 8MAY95 & w/in a few hrs, pt devel fine macular rash; w/in 72hrs pt devel varicella-like rash which had 2 lesions; 15MAY95 devel full-blown varicella; No further details were provided;
pt developed chills/sweating the day after the immunization, as well as sore/red arm. pt took ibuprofen which helped the fever/chills, but did not completely eliminate them. on 7/18/20 when he called the pharmacy, he said the sweating/chills had lessened as well as the redness and soreness in the arm. he was continuing to take ibuprofen, which helped.
On the day of vaccination 11/06/2021, it was discovered the patient would be turning 12 years of age within the timeline of receiving his second dose. The vaccinator decided to give the child the adult vaccine instead of the pediatric vaccine. The child had turned 12 years of age before receiving the second dose of vaccine on 12/04/2021. He presented to receive the vaccine with no adverse reactions to report. The Local Department of Community Health just recently was made aware of this deviation from the standing order. We have found there were no issues reported by the patient up to date, the creation of the VAERS report is to document the deviation from the standing order.
Convolution below stomach; Diarrhea; Vomiting; Queasy feelings; Rumbles in Tummy; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL SOUNDS ABNORMAL (Rumbles in Tummy), ABDOMINAL DISCOMFORT (Convolution below stomach), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and NAUSEA (Queasy feelings) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced GASTROINTESTINAL SOUNDS ABNORMAL (Rumbles in Tummy) and DIARRHOEA (Diarrhea). 18-Mar-2021, the patient experienced VOMITING (Vomiting) and NAUSEA (Queasy feelings). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Convolution below stomach). At the time of the report, GASTROINTESTINAL SOUNDS ABNORMAL (Rumbles in Tummy), ABDOMINAL DISCOMFORT (Convolution below stomach), DIARRHOEA (Diarrhea), VOMITING (Vomiting) and NAUSEA (Queasy feelings) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported  No treatment medication was reported  In the second follow up it was reported that all the symptoms had settled within one day and patient  had the second dose of vaccine  without any issues   Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Event added, event intensity updated On 03-Jun-2021: Second dose details provided, outcome of the event updated
Atrial Fibrillation 30 hours after first injection. 4 days in hospital before returning to sinus rhythm. Shingles of the head/neck on right side 30 hours after first injection
The day after her vaccination, later in the day, she developed very itchy hives starting on her left forearm. The hives spread in about five minutes to her wrist, upper arm, shoulder, back, upper legs and face (chin, left cheek, and forehead). We gave her 1.75 tablets of children's Benadryl and the hives went away in about 20 minutes. We called her pediatrician's office to get advice a few minutes after we noticed the hives. The hives didn't come back overnight or today.
The patient's L upper arm is red, swollen, warm to the touch, and itchy. Mom has been giving him BENADRYL and Ibuprofen as needed for pain and swelling.
came in for her second dose of the Pfizer covid vaccine, but tested positive for covid 19 yesterday; came in for her second dose of the Pfizer covid vaccine, but tested positive for covid 19 yesterday; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The pharmacist reported that a patient came in for her second dose of the Pfizer COVID vaccine, but tested positive for COVID 19 yesterday (14Apr2021) and asked if they need to start the series over. The outcome of the events was unknown.  Information about the lot/batch number requested.; Sender's Comments: Based on the limited information in the case report and known drug safety profile, A possible causal relationship between event Covid-19 and suspect drug BNT162B2 cannot be excluded.
No additional adverse effects reported; An improperly stored dose of PROQUAD was administered to a patient.; This spontaneous report has been received  from an office manager concerning a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, historical drugs and conditions were not reported.   On 30-JUN-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA)  subcutaneous injection, Lot # S030206 and expiration date 25-MAR-2021 for prophylaxis (strength,dose and patient route of administration were not provided). The office manager, who was in charge of vaccine storage,  stated that the vaccination took place with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD). No additional adverse effects were reported. The storage temperature was reported to be 22.3°F for a period of 4 hours and 25 minutes. A previous temperature excursion was reported with temperature at 8.6°F for 1 hour and 51 minutes. Informationwas reported via data logger.
Rash on both legs, Made her feel faint. Vomiting. Diarhea. Back hurts in the middle. Loss of taste.
Slight fever; chills; This spontaneous case was reported by an other and describes the occurrence of PYREXIA (Slight fever) and CHILLS (chills) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Slight fever) and CHILLS (chills). At the time of the report, PYREXIA (Slight fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Left arm pain in armpit.  Constant pain but especially whenever I move my arm or lift it.  Pain is in the center of the armpit
Headache developed day after shot.  Persisted one week later.  Fever developed 5 days later with no other obvious cause.
after received the pfizer vaccine. Within a day, I have a swollen Lymph Nodes on the side of the arms that Vaccine was injected.   It hurts when close left arm to my body.
Chills, headache, fatigue, aches starting 57 hours after 2nd dose. No reaction after first dose.
Patient's right arm is swollen and warm to the touch. The injection site has a small bruise the size of a pea. Pt cannot raise or extend arm and is experiencing pain. Pt is applying cool compress and taking ibuprofen over the counter to help relieve the pain and inflammation/swelling.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2007, the patient was inoculated with ZOSTAVAX at physician office as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of shingles, or severe herpes zoster. In 2015, the patient was treated at physician office for the onset of rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient suffered and continues to suffer painful and ongoing injuries and damages, and required and continues to require extensive medical care and treatment. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Vasovagal reaction within 20 min of vaccination. Had never had previous reaction to vaccine or injection.