chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 12 year old female with no pertinent medical history and no drug reactions/allergies who on 02-OCT-2008 was vaccinated with the first dose of GARDASIL (Lot# reported as 660557/0072X), 0.5 milliliter intramuscular in left deltoid. Concomitant therapy included DTaP, varicella virus vaccine (MSD), hepatitis A vaccine (inactive) and MENACTRA, all these vaccines were received at the same office visit as GARDASIL. The patient developed a seizure within 3 minutes of receiving the first dose of GARDASIL on 02-OCT-2008. The seizure was described as follows: "The patient's limbs shook, the eyes rolled back, and the patient was unresponsive for about one minute". Subsequently the patient recovered from the seizure. The patient sought medical attention at physician's office. No other symptoms or treatment was reported. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
This spontaneous report as received from license practical nurse refers to a patient of unknown age and gender. On 11-FEB-2014 the patient was vaccinated with expired dose of RECOMBIVAX HB with lot # 0231AA and expiry date 14-OCT-2013 (dose unit and route unknown). No adverse event was reported. The outcome of received a dose of expired RECOMBIVAX HB and no adverse event was unknown. No further information was provided. Additional information has been requested.
My symptoms began on 12/1/2022 a few short days after receiving my booster shot.   I had left class after my final on 12/1/22 and became lightheaded with pain in my chest where my heart is located. I spoke with my PCP and she believed it was anxiety.   The symptoms have only gotten worse and I often feel pain in my heart area. I am not under any stress or anxiety but have continued to have complications since. This week has been challenging and my heart feel very unconfutable. I am also having trouble exercising and cannot run as long as I use to.
c/o pain across lt back-scapular area; pt report MD said had tendonitis & a pulled muscle;
This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 (Batch/Lot number was not reported) at the age of 29-years-old as dose 1, single for covid-19 immunisation. Medical history included ADHD (attention deficit hyperactivity disorder), clinical depression and allergy with almonds from an unknown date and unknown if ongoing. The patient is not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has the patient has not been tested for COVID-19. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient experienced caused heavy, elongated cycle in addition to 2 weeks of heightened PMS symptoms. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 15Oct2021. The event required physician office visit and patient received talk therapy and medicinal adjustment as treatment for the events. The outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
fever between 104 and 99.9, body aches, chills, night sweats, migrains
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 74-year-old female patient who received SHINGRIX (batch number MY2B2, expiry date 28th February 2021) for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 21st September 2018, 2 days after receiving SHINGRIX, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were not recovered/not resolved. It was unknown if the reporter considered the shingles and rash to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The patient developed a rash on her neck which was diagnosed with shingles at primary care on 24th September 2018. The health care professional stated she did not know what treatment or interventions were prescribed to the patient.
COVID breakthrough case. I received my 2nd booster shot on 06/15/2022 and my COVID symptoms started on 06/17/2022 in morning I had runny nose, sore throat, cough and by Saturday it was the same. And on Sunday I had diarrhea. I called my doctor and he said just to treated like a cold. I took ROBITUSSIN MD and drink a lot of fluid. 06/17/2022 I tested positive. Am feeling better now. I have less symptoms now.
Developed purple-like rash/petechiae. Otherwise acting OK. Happy. Eating and drinking. No fever. No outside travel.
Patient had a vasovagal response. She recently stopped breastfeeding. She had not eaten and only had one cup of coffee that morning before the vaccine. She had a history of passing out 1 other time when having the flu.  I elevated her feet and got her water. Observed her for over 30 minutes. Called patient later that day and she was feeling completely fine.
The patient came in to pharmacy to claim that he had soreness at injection site with a little redness and so had pressure at raising arm.  He said he will take Advil or Tylenol to see if it will relieve.
Around 7 hours after receiving the vaccine I started to get a fever. It was 99.6 at 11:30pm, 102.2 at 2:15am, 102.7 at 3:25am. It started going down at 4:00am after taking 1000 mg naproxen and Tylenol. Fever came back around 1:15pm today at 100.7 and has been up to 101.7 as of 5:30pm. The fever has come along with relentless shaking due to the chills. A migraine has also persisted despite taking NSAIDs to help with that as well.
disorientation, difficulty talking, difficulty walking, exhaustion. This has happened before, for instance as a result of flu. She recovers in a few days.  This is NOT a stroke or heart related event.
on 1/31/2021 at 11am, I woke up raised red rashes all over my body.  my primary doctor advised to take zyrtec in Am and bennadryl at night. everytime antihistamine meds wears off, i seen coming back again the hives all over my body, face and lips. hives all over body and face shows up again today 2/1/21 at 1am, 11am, 9:30pm. antihistamine meds helps but keep coming back the hives. no known allergies my entire life. no changes in my diet or taking any supplement. `no pet in my house. no laundry soap changes. my doctor sent consult to allergy.  waiting for response.
Pt. states that arm started hurting & burning immediately.By p.m. she was sore all over.Next day she had difficulty lifting arm, had stiff neck and elbow aching and she felt warm.Two days post vacc. she had redness & enduration.
Extreme nauseau, Extreme headaches, extreme fatigue, dizziness, extreme lethargy.
Information has been received from a physician concerning a male patient who was vaccinated with a single dose of Zostavax. Subsequently, one month post vaccination, the patient developed shingles and post herpetic neuralgia. Unspecified medical attention was sought and the patient was hospitalized for an unspecified amount of time. No outcomes were reported. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a licensed nurse practitioner regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with one dose of improperly store MMR II (dose and route were not reported), lot# M002419 and expiry date: 12-JAN-2018. The storage detail for the vaccine was a temperature excursion to 22.6 C for 48 hours 30 minutes. No adverse effects were reported. There was not product quality complaint involved. Additional information is not expected as the reporter did not want to be contacted.
Had dose #1 on 2/11/2021--on 2/15/2021 experienced 9 hrs of severe gas pains (like labor pains).  Had to use controlled breathing to get through. Also experienced chills, sweating and vomiting.  Reports feeling weak at the end of the episode.  PMH: +COVID early October 2020
Itching, welts, hives, depression, speech dificulty, impaired balance; fatigue;
Patient developed mild rash immediately around vaccine administration site.  It improved after a few minutes.  Approximately 10 minutes later the patient complained of nausea, chest pain, feeling warm and clammy.  EMS was summoned, evaluated her on site, her vitals were normal and she was discharged to home.
1APR91 unable to wake child fr nap, non-responsive to stimuli, WBC 25,000, no fever, CXR WNL, Urine OK, hx skull fx JUL90, r/o sz 2APR91 WBC dec, lo grade fever 101, Urine Cult = UTI, started on antibiotic;
Extremely large red, solid and hot lump that has grown in size since injection. In addition to feeling very sick.
I am an RN and also the patient. I noticed pain in my right axilla approx 30 hours after recieving vaccine. I visually examined and palated enlarged lymph nodes in axilla, forming a lump approximately 3 cm in diameter in my axilla, same arm where vaccine was recieved.  In the injection site, I observed a red welt-like swollen area that was approximately 5 cm in diameter. Today, 7 days after the vaccine was obtained, the axilla pain and lymph node swelling is now completely resolved, and the vaccine site reaction is mostly resolved.
I had general fatigue and headaches. The after I woke up my left arm was red and puffy. Overnight the area had doubled in size, itchy and painful. The area was circular and 2-3 inches in diameter. I went to Urgent care and they gave me Benadryl and a Steroid to take. The area is still painful and swollen and is starting to improve. It has been seven days and the area is still red swollen, warm and itchy. I have three more days of Steroid medication left. I just had a headache and fatigue for the first couple of days.
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown ages and genders. On unknown dates the patient were vaccinated with ZOSTAVAX (routes, dosages, concentrations, and lot numbers unknown) for prophylaxis. The reporting pharmacist stated that some clients developed rash, or a small knot, at injection site post vaccination with ZOSTAVAX. The patient received treatment with BENADRYL. The outcomes of all events were reported as resolved. Additional information is not expected.
Sore throat, then it became Laryngitis then a really loose cough. I couldn't stop coughing and had no voice. I then had a fever and felt terrible. I felt short of breath and used my rescue inhaler, I've had exercise induced asthma in the past. I went to the doctor and she tested me. I was told it was a respiratory virus that when to bronchitis. I got a steroid shot and other medications. Eventually I got better after 12 days of feeling bad.
Fatigue for over four days. Pain in arm for four days. Left arm falling asleep. Fear of clotting
Moderna EUA Injection site & left upper arm hot to touch turned red & itches. The red rash has continued down to my elbow. On Sunday the 28th at approximately 1:30 I started shivering very hard for about 2.5 hrs temperature shot up to 102.5 while taking acetaminophen. It was up and down most of the night from 100.1 to 102.5. My left upper arm continues to be hot and the red rash is still there & continues to itch. Continuing acetaminophen temp is from 98.8 to 99.9
pt c/o numbness in both hands off & on several times a day since having hep B inj;
pain in the right nipple/ pain in the nipple feels like a first degree burn; he felt scratchy on knee caps; Tingly legs; swelling (Lymph node) to the right of the nipple; This spontaneous case was reported by a consumer and describes the occurrence of NIPPLE PAIN (pain in the right nipple/ pain in the nipple feels like a first degree burn), SCRATCH (he felt scratchy on knee caps), PARAESTHESIA (Tingly legs) and LYMPHADENOPATHY (swelling (Lymph node) to the right of the nipple) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic.    On 14-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In November 2022, the patient experienced NIPPLE PAIN (pain in the right nipple/ pain in the nipple feels like a first degree burn), SCRATCH (he felt scratchy on knee caps), PARAESTHESIA (Tingly legs) and LYMPHADENOPATHY (swelling (Lymph node) to the right of the nipple). The patient was treated with CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, NIPPLE PAIN (pain in the right nipple/ pain in the nipple feels like a first degree burn) and LYMPHADENOPATHY (swelling (Lymph node) to the right of the nipple) had not resolved and SCRATCH (he felt scratchy on knee caps) and PARAESTHESIA (Tingly legs) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient stated that this was patient's 4th shot. Patient did not have his vaccination card handy. About a week after the bivalent booster, felt scratchy on knee caps and tingly legs. Patient used Topical Cortisone, and it went away in a couple of days. But what was still bothering him was pain in the right nipple and swelling (Lymph node) to the right of the nipple. The pain in the nipple feels like a first-degree burn. He had seen a doctor and he was going for a sonogram.   This case was linked to MOD-2022-686252 (Patient Link).
HUGE red knot developed on arm the next day.  Warm to touch.  Can barely move arm.  It?s been three days and I?ve had a fever every single day.  I vomited the first day six times.  I couldn?t keep food down.  Horrendous chills, body aches, fatigue, insomnia, diarrhea on day 3, headache.  Cannot get rid of fever.  I have to constantly keep taking Tylenol or Ibuprofen.  This shot sucks and y?all do NOT know the full extent of what will happen.  I feel like a guinea pig and I?m pissed off.  I feel as bad as I did when I had COVID.  My arm three days later now is red all the way down to my elbow and itches; however, that started the next day - not several days as every article I have read about COVID arm.  I am SERIOUSLY considering NOT getting the second shot.  It will probably kill me.  My only co-morbidly is age and weight.  I wear a size 12 yet I?m obese somehow by antiquated BMI standards.  I don?t have high blood pressure, don?t have diabetes, don?t have heart disease, nothing.  I?ve never been so miserable in my life.
The site swelled up in size, became hard and red and hot to touch. Area of swollen red, hot bullseye was 5mm top to bottom and 8 mm across.
Respiratory failure; Hypoxia; This serious case was reported by a other health professional via sales rep and described the occurrence of respiratory failure in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 9B432, expiry date 05-NOV-2024) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 10 min after receiving Arexvy, the patient experienced respiratory failure (Verbatim: Respiratory failure) (serious criteria GSK medically significant) and hypoxia (Verbatim: Hypoxia) (serious criteria GSK medically significant).  The outcome of the respiratory failure and hypoxia were not reported.   It was unknown if the reporter considered the respiratory failure and hypoxia to be related to Arexvy.     It was unknown if the company considered the respiratory failure and hypoxia to be related to Arexvy.   Additional Information: GSK Receipt Date: 12-OCT-2023 The reporter reported that the doctor prescribed Arexvy and pharm d administered, and the patient had respiratory failure with hypoxia 10 to 15 minutes following the administration of a dose of Arexvy. The reporter consented to follow up.
I had a very sore arm could barely lift it for 3 days, headache for 2 days. Then the next morning a big red lump that grew for almost a week that was hot and itchy and sore. Even 6 weeks in the spot is gone but that area is still itchy at times.
Mild side effects in the hours after the injection (headache, sore throat, muscle aches, chills). Mild enough to not need any medications. At 1:30am, I woke up needing to urinate. I went into the bathroom and lost consciousness, finding myself with one hand in the toilet and one on the side. I felt nauseous and thought I would vomit, but didn't and believe I lost consciousness again. I was able to make it to the sink to try to wash my hands, and I fell down on my knees. I knew I was bleeding somewhere but didn't know from where (my right pinky was cut on an item in the bathroom when I fell). My wife made it to me, and I lost consciousness a couple more times while talking with her. I laid on the bathroom floor for a
burning, stinging pain on my eyebrow; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (burning, stinging pain on my eyebrow) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced INJECTION SITE PAIN (burning, stinging pain on my eyebrow). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (burning, stinging pain on my eyebrow) was resolving. Burning , stinging pain on her eyebrow 2 days post injection. On 27-DEC-2020, it moved into her eyeballs and up the left side of her face and top of her head and a little bit in her left arm, but only on the left side. No visible rash or burn. It peaked that week. On 19-JAN-2021, it comes and goes sometimes in her eyebrow, but most of that resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
swelling in upper right arm.......large lump in arm muscle.....extreme pain......ive been to 2 drs....so far am starting pt 3times week.....hot paks massage and ultra sound.....dr says he doesnt know how to treat me........cant do yoga classes......can hardly lift arm........
On 3-14 had low fever and extreme fatigue, on 3-15 felt better but had a migraine headache with aura and transient loss of vision.  I have had similar migraines in the past but rarely--less than once per year.
09/13/02 back pain (persistent). 9/2/02 numbness L thumb. Approximately 9/26/02 both hands and feet numb; face pain. Approximately 10/10/02 weakness both hands. 10/14/02 weakness? stable/no leg weakness. EMG/NCV=demyelinating neuropathy c/w Guillain-Barre syndrome
Vaccine expired on September 28, 2021. Administered September 29, 2021.
unable to move lt arm p/inject upper area swollen red from shoulder to elbow; hot to touch mom called clinic; pt t103.5 taken to MD; MD states was poss infect in arm; large local reaction;
This spontaneous case reported by a consumer, describes the occurrence of injection site pain (sore at the injection site) and COVID-19 (she tested positive for COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 2, 2021, patient experienced injection site pain (sore at the injection site). On Feb 13, 2021, patient experienced COVID-19 (she tested positive for COVID-19). At the time of the report, injection site pain (sore at the injection site) and COVID-19 (she tested positive for COVID-19) outcome: unknown. Diagnostic results: On Feb 13, 2021, COVID-19: Positive. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications or treatment information reported.
pt recv MMR vax 28DEC94; encephalopathy w/sz, movement disorder, blindness subsequent w/onset of sx 1JAN95;
sore arm; little fever; local reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; PYREXIA (non-serious), outcome "unknown", described as "little fever"; LOCAL REACTION (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information : The patient's wife and he took four regular doses of the Pfizer BioNTech COVID-19 monovalent vaccine. They also had one bivalent booster. They experienced nothing more than a sore arm and a little fever maybe but no rash or no breathing problems. Just a local reaction. They were eligible for the second bivalent booster however, his wife started taking Miralax for digestive problems one or two 17gram capsules a day and it was pure polyethylene glycol. She might have developed a rash with itching with it, because it started when she started taking it and went away after she quit taking it. They think there was a risk of rash with the Pfizer BioNTech COVID-19 bivalent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300180008 same reporter/product/AE, different patient;
received two doses of the Pfizer COVID vaccine and ended up getting COVID; received two doses of the Pfizer COVID vaccine and ended up getting COVID; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, and first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included immunocompromised, arthritic condition. The patient's concomitant medications were not reported. Consumer mentioned her friend who was immunocompromised had received two doses of the Pfizer COVID vaccine and ended up getting COVID. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
(L) deltoid swelling, redness, tenderness approximately 3 cm. Arm = full ROM.
Patient called into to say he received a rash on hos chest. He also received muscles aches and extreme fatigue. He stated that the rash has left but the fatigue has not.