chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 4MAY95 & exp facial flushing;24MAY95 pt devel fever & joint swelling in the lt elbow;devel pain in the lt elbow & hip;cont to have migratory arthralgias for 1wk & hosp;lab eval showed ESR 48, CBC 13,800 & neg ANA & rheumatoid
Pt was admitted on 1/27 for reoperative sternotomy and aortic valve replacement. She had a COVID test on 2/14 due to admission to the inpatient rehab unit. She was asymptomatic at the time, but the COVID test was positive.
Pediarix given instead of Infanrix; This is extra, 5th dose of HEP B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number GT39Z, expiry date 03-DEC-2024) for prophylaxis.   Previously administered products included Hepatitis B (received 4 doses of Hepatitis B on an unknown date) and IPV vaccine (received 3 doses IPV vaccine on an unknown date).   On 31-MAR-2023, the patient received Pediarix. On 31-MAR-2023, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: Pediarix given instead of Infanrix) and extra dose administered (Verbatim: This is extra, 5th dose of HEP B). The outcome of the wrong vaccine administered and extra dose administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 31-Mar-2023  CMA stated that patient received dose of Pediarix instead of Infanrix.  The patient received 4 Hepatitis B and 3 Polios, so this was extra (4th dose of IPV and 5th dose of Hepatitis B).  This was supposed to be the patient's 4th dose of Infanrix.  The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The patient received dose of Pediarix instead of Infanrix, which led to wrong vaccine administered, extra dose administered for the hepatitis B component.
never completed either series; never completed either series; This case was reported by a nurse and described the occurrence of incomplete course of vaccination in a 38-year-old male patient who received Hepatitis A vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis A (received 1st dose on an unknown date) and HepatitIs B (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Hepatitis A vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine and not applicable after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination and incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination and incomplete course of vaccination were unknown.  Additional details were provided as follows: The age at vaccination was not applicable. No dates for the 1st doses of Hep A and B vaccines were known. The patient received 1st doses of Hep A and Hep B but never completed either series, which led to incomplete course of vaccination. They wanted to complete both series with Twinrix. The health care professional did not know which hep A or B vaccine the patient had received prior, follow up. The reporter consented to follow up.
Sore arm- 2 hours after vaccine, lasting for 72 hours   Early menstrual period-  one full week before expected period, extremely heavy, 209% more painful than typical period.
Pt came in requesting a pneumonia shot. However, upon presenting her paperwork, she also brought out her immunization card as well and the nurse ended up giving her her third booster of Pfizer. Pt just had her second dose of Pfizer on 8/29/21 so pt is too early for it.
Fever 103.8, rapid heartbeat, pulse 104, respirations 20, blood pressure elevated 142/86 normally 90s/50, vomiting, chills, body aches, headache, chest pain, right sided abdominal pain, dizziness, no appetite, fatigue, unable to ambulate
Patient presented to the ED and was subsequently hospitalized for pneumonia of right lower lobe due to infection within 6 weeks of receiving covid vaccination.
SOB; dizziness; warmness, tingling on left arm (started before vaccination per patient)
Child was in office on 8/10/07 for routine WCC, child had no symptoms of illness.  Child received the following immunizations with MD order.  Infarix,IPV,Comvax.  Child came to office again on 8/15/07 as Mother reported that within 24 hours of child being given the immunizations she developed increased warmth at the injection site, indurated hive like lesions surrounding injection site.  Over the next few days child developed hives over the upper and lower extremities, at no time did the child experience shortness of breath. There was no compliant of the hives being itchy as well as the inject sites were not bothersome in terms of itching.  There has been no other reactions noted for this child with previous immunizations.  Patient does have a documented allergy to PCN and Sulfa based drugs which she had not received.  Treatment plan was to apply warm compresses over the injection sites, benadryl prn (dosing chart provided), and MD prescribed Prelone15/5, 5ml B.I.D. x 5days. Also mother was instructed on the symptoms that would require child to go to the ER department. Also Mother was asked to call office in 48 hours even if child was better.  Mother expressed understanding of instructions given.  This date writer spoke with child's Mom.  Mom reports child is much better "welts" remain but seem to be fading.
Red, swollen. Left voice mail to use cool compress, TYLENOL/MOTRIN for discomfort, use black marker/pen draw line around area, if worse to contact our office ASAP.
Information has been received from a physician concerning a female patient with oral cancer who was vaccinated with a dose of Gardasil. It was reported that the patient may have been immunocompromised because she had oral cancer. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. 10/08/07 This is in follow-up to report(s) previously submitted on 7/16/2007. Follow up information from the physician stated that he was not aware of any adverse reaction with GARDASIL in his patients. Additional information is not expected.
COVID Breakthrough case Symptoms began: 09/04/21 Lab confirmed: 09/08/21
Elevated heart rate 179 bpm which lasted about one minute and then returned to normal; received other vaccine on same date as first vaccine date on 25Feb2021; This is a spontaneous report from a contactable consumer (patient). A 73-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration, administered in arm right on 25Feb2021 at 07:30 AM (age at vaccination: 73-year-old) as dose 1, single for COVID-19 immunization; also received other vaccine (unspecified name) via an unspecified route of administration on 25Feb2021 (age at vaccination: 73-year-old) as dose number unknown, single for an unknown indication. Medical history included high blood pressure. The patient had no known allergies. The patient was not pregnant at time of vaccination. Concomitant medications included propranolol hydrochloride (INDERAL); telmisartan, both drugs received within 2 weeks of vaccination. No other vaccines were administered in four weeks. The patient did not have covid-19 prior vaccination and was not tested for covid post vaccination. The patient received other vaccine on same date as first vaccine date on 25Feb2021. On 27Feb2021 at 19:00 PM, the patient experienced elevated heart rate 179bpm which lasted about one minute and then returned to normal. No treatment was received for the event for the event of heart rate increased. The outcome of event elevated heart rate 179 bpm which lasted about one minute and then returned to normal was recovered on 27Feb2021.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Mild pain in arm muscle for about 72 hours then went away ... 2 weeks later, excruciating pain in left arm/shoulder ... have been sleeping with a heating pad ... doctor's office suggested I notify who gave me the vaccine... called my local pharmacist and advised them of the situation ... he advised, by my symptoms, that it's possible whomever gave me the vaccine nicked my bursa sack in my arm ... he strongly suggested that when I get my 2nd vaccine (04/22/21) that I use my other arm and ask the injector to give me the vaccine a little lower than they did
Muscle aches, joint aches, chills, fever, head ache,  muscle spasms
My lymph nodes are still swollen and causing mild discomfort in my left chest and shoulder as well as making it a little hard to breath
The following symptoms started in the evening, peaked during the night and gradually diminished over the following 24 to 48 hours: Pain, redness, and swelling at the injection site Muscle pain Fatigue Headache Chills Fever Gastrointestinal symptoms (nausea)
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 74-year-old female patient who received Shingrix (batch number DD43M, expiry date 7th March 2021) for prophylaxis. On 14th September 2018, the patient received the 1st dose of Shingrix (intramuscular). On 14th September 2018, less than a day after receiving Shingrix, the patient experienced feeling unwell and tremor. On 15th September 2018, the patient experienced pain in arm and mobility decreased. On 14th September 2018, the outcome of the feeling unwell and tremor were recovered/resolved. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the mobility decreased was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, feeling unwell, mobility decreased and tremor to be related to Shingrix. Additional information received as follows: The patient received Shingrix on the left arm. The healthcare professional reported that the patient experienced shakes that lasted for 4 hours then resolved. She did not feel good after but that had also resolved. Additionally, the patient's arm got so sore and she almost could not lift it. The arm soreness was resolving but till the time of reporting, she could not lift her arm fully.
Woke up on 11/27 covered head to toe in hives and a rash. Went to the ER, got put on steroids. Went back to the ER on 11/29,  hives covering body, swollen arm, swollen lips.
A spontaneous consumer report had been received concerning a female patient. Lack of relevant history. No concomitant medications reported. The patient received FLUMIST QUADRIVALENT (intranasal), 0.2 millilitres, unknown on 31-Oct-2015. Mother of patient stated that according to the physician the vaccine triggered an autoimmune response and a development of a streptococcal infection that attacked her brain. She had developed several neurological tics and psychiatric issues. Patient was currently being tested for PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections). At the time of reporting, the event of streptococcal infection that went into her brain, streptococcal infection, autoimmune response triggered with a rapid advancement, she developed several tics, being tested for PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections) and has develop psychiatric issues was ongoing. The company physician assessed the events of streptococcal infection that went into her brain, autoimmune response triggered with a rapid advancement, she developed several tics, being tested for PANDAS (pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections) and has develop psychiatric issues to be serious with the seriousness criteria of important medical event. The company physician identified the event of streptococcal infection from the source document and assessed it to be serious with the seriousness criteria of important medical event.
client vaccinated with pfizer covid-19 vaccine that had not been reconstituted. Error was caught, and PHSC aware.
I get these skin lesions annually, I got them again at the end of May. It got more intensified in severity by the first and second week of June. Started in my lower extremities and came up to my buttock area and thigh. After the buttock area the lesions started to come up on different parts of my body. At that time, it was significantly affecting my life. I was unable to sleep. I continued with my basic allergy medicine. I would occasionally take Benadryl. I started at that point on prednisone for a week and a half. The symptoms did not get better. I doubled up on my Zyrtec. When I was on prednisone, I started seeing typical hives lesions that come and go in about 15 minutes in a day or 2. Which are different to my typical lesions. I thought it might be a drug reaction, so I started to decrease my prednisone, but symptoms persisted. After that, the hives lesions started to decrease but they did not go away. I still have the lesions and Dermatographia. And I did not have these lesions prior to taking prednisone. Last year when I had these symptoms, they all resolved by middle June. For the week I took prednisone I experienced loss of appetite, increased depression and anxiety. After stopping taking prednisone those symptoms resolved. I went to see my dermatologist and she thinks these are the same lesions and it might be chronic urticaria. I did a chronic urticaria lab with my immunologist. Normal except for thyroid disease. My labs were borderline abnormal after taking prednisone. But they were normal after stopping prednisone at one point during these I was taking Zyrtec once a day. I experienced tachycardia when I took that high dose of Zyrtec and or Xyzal, but that resolved. My rash is ongoing but very mild now and not bothering with my daily life.
c/o h/a, abdo pain, sweats, fever, chills, cough, difficulty breathing, dizziness, anorexia, was feeling ill 3 days later still admitted to hosp & was dx as having pneumonia;
On the morning of the 8th day after vaccination, I woke up with moderate vertigo - significant dizziness. During the course of the day, the vertigo has diminished to mild, but has persisted the entire day. There were no side effects prior to this point from this second shot. There are no other side effects noted
Patient was given FLUZONE HIGH-DOSE 2016-17 on 01/26/2017. Patient come back to the pharmacy 01/28/2017. The area around the injection site is red and very warm to the touch. The red area is approx. 6 inches in length and 3-4 inches in width. The injection site is very tender to the touch and there is a lump at the injection site.  Patient said that when given the shot it hurt immediately.
10dys prior to this hospital admission, pt was diagnosed positive with COVID; presents with increasing SOB, pain with breathing, nausea and fever; O2 supplementation via NC; pt kept pulling  O2 off, was placed on NRB with high flow NC to maintain O2 sats; pt continued to remove O2; was found nonresponsive with emesis on body, PaO2 of 40; intubated and transferred to ICU; pt's condition continued to worsen and he coded; pronounced dead in the hospital
Severe muscle pain at injection site, radiating down the entire length of the arm. Pain has gradually subsided over the last 24 hours, but is still noticeable.
Pt recv vax on 3/30/99; on 4/5/99 pt exp vesicle/ pustules on trunk & neck
Patient in today with left upper arm deltoid swelling approximately 80 mm's.  Painful to touch.  Reports temp 101 last pm.  Today 11:00 am 98.9.
11/13/2021- Participant begin very sleepy, had extreme arm pain and a bump on the injection site, and very sweaty. 11/13/2021- Telehealth consultation was informed to give plenty of fluids and rest.
Muscle aches all over, chills, nausea, fatigue. Started the afternoon of the shot, fatigue and nausea persisted for days. I am still very tired today. Five days later. I have been taking Extra Strength TYLENOL every day.
The morning after the 2nd dose, I got up to make coffee.  I had just started and felt a bit light-headed.  I was going to go sit down, but I passed out and fell onto the kitchen floor for a few  seconds.   I have never passed out before or felt such light-headedness.  I went to lay down.   I vomited a bit of liquid.  I lay down and several hours later my husband drove me to the emergency room.  After many tests they said I had suffered a Syncope and had a slight concussion.
Patient said she had noticed a red rash on her arm on 9/20/19. She also said she wasn't sure how long it had been there. She said it wasn't bothering her.
Headache, ErythemaMultiform, 12/28/20 & 12/29/20 Pt notice a rash appear in shower the morning after vaccination was administered.
pt at home in hospice care since 8/2021 with Hospice; pt had a positive COVID test on 2/7/22; pt passed away on 2/17/22
Patient was vaccinated being 16 years old; A spontaneous report was received from a 16-year old, female consumer who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. Concomitant medications were not provided.  On 21 Jan 2021, the patient received her first dose of two planned doses of mRNA-1273 (Lot Number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, the patient received the mRNA-1273 vaccine at the age of 16-years old.  No treatment for the event was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, patient was vaccinated being 16 years old was considered Resolved on 21 Jan 2021.; Reporter's Comments: This case concerns a 16 year old female who received her first dose of two planned doses of mRNA-1273 (Lot Number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events after vaccine was administered in this case of product administered to patient of inappropriate age.
I had a sore arm for about a day after receiving the vaccine.  I was exposed to COVID-19 while on a cruise. I tested positive after we got home on 03/25/2023. I had a sore throat, swollen gland, stuffy head, cough, chills and I lost my sense of taste. I contacted my doctor and got a prescription for Paxlovid. It left a terrible taste in my mouth, but I tolerated it.  As of today, I do not have any lingering COVID-19 symptoms.
excessive swelling @ site of inj lt upper arm, minimal tenderness;some itching;no fever;seen in ER & treated for possible cellulitis;
5.5 Inch by 4.5 inch swelling, hardness, redness, and pain. Patient vaccinated on 8/23/17 and reaction did not occur until the next day on 08/24/17. Provider states it looks to be a local reaction with or without cellulitis to right upper arm. Reaction could be local and based on increased response or a true cellulitis, so will cover with Bactrim and oral steroids.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-OCT-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two separate temperature excursions (dates unspecified): one lasting for 72 hours, with the lowest recorded temperature of 28 degrees Fahrenheit (-2.222222222 degrees Celsius) and another lasting for 32 hours, with the highest recorded temperature of 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
At approximately 4:05pm, pt reported immediate dizziness after administration of flu vaccine. Reported name and DOB however unable to make eye contact. Pt advised to rest for 15 min. Mom present. Given H2O by RN and gummy candy by mom. Pt also reported sx of had HA and sweating. Cool to touch. After few min, pt report no HA, no dizziness, and feeling OK. Appeared in no distress. Pt left at approximately 4:45 pm with mother. Mom stated no previous reaction to flu shot.
red, swollen and itchy area (about the size of a large grapefruit) surrounding the vaccination site.  Also caused some muscle twitching.  The next day, the area of swelling grew larger and wrapped around her bicep.  She is now taking Benadryl and has started to apply a topical steroid cream.  she will follow up with the office if her symptoms do not dissipate.
Mycelitis occurred in legs after second dose; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 19-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: CVS 5195 and Expiry date was not reported) via unspecified route of administration in left arm on 06Apr2021 at 16:45 (at the age of 19-years-old) as a single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient does not have COVID, prior vaccination and has not been tested for COVID, post vaccination. Patient has previously received first dose of vaccine on an unspecified date. It was reported that, on an unspecified date, patient has experienced mycelitis occurred in legs after second dose and visited emergency room and physician office. The outcome of event was not recovered.  No follow-up attempts are possible. No further information is expected.
rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hearing impaired. Concomitant products included METOPROLOL, SIMVASTATIN, PARACETAMOL (TYLENOL), ZINC, VITAMIN B3, ALLOPURINOL, OMEPRAZOLE, PROBIOTICS NOS, PLANTAGO OVATA (METAMUCIL [PLANTAGO OVATA]), OXYBUTYNIN, VITAMIN B12 NOS, DIAZEPAM and FOLIC ACID (FOLATE) for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, RASH (rash) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Significant facial flushing and burning sensation that developed just hours after administration. Possibly febrile during this episode. No reaction from first vaccine. Has had similar reaction to other medications and possibly a previous vaccine but patient is not certain. On day three saw provider with symptoms improved. No treatment needed. Monitoring.
This spontaneous report as received from a pharmacist via a company representative who was aware of the information from one of the direct reports of the pharmacist, refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (route of administration, dose and lot number were not reported) for prevention of shingles. No other concomitant medications were reported. The patient developed shingles on an unknown date, reported as 2-3 weeks after vaccination with ZOSTAVAX. The outcome of shingles is unknown. No product quality complaints (PQC) were filed. The causality of the event was not reported. Additional information has been requested.