chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 41-year-old female patient received bnt162b2 (PFIZER COVID VACCINE, solution for injection, Lot Number: ER8737, Expiry date and NDC number: Unknown), dose 1 via an Intramuscular route of administration, administered in the Arm Left in the muscle on 10Apr2021 at 18:00 (at the age of 41-year-old), as DOSE 1, SINGLE for COVID-19 immunisation. No investigation assessment was done. Medical history included Pain in left arm from injection, family medical history: none. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the pfizer suspect. Diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity was reported as none. Concomitant medication(s) included paracetamol (TYLENOL) taken for Pain in left arm from injection from 10Apr2021 to an unspecified stop date. No other vaccines were given within 4 weeks. On 10Apr2021 at 18:00, the patient experienced left arm sore. On 11Apr2021 at 08:00, the patient experienced throat hurt, chilly and cold, body achy. On 12Apr2021 at 08:00, the patient experienced chest pain, stomach pain, leg left numb. The events  Chest pain, Stomach pain, Throat hurt resulted into Physician Office Visit.The patient underwent lab tests and procedures which included blood test resulted throat hurt (Physician checked her and did blood work and said her throat hurt). Therapeutic measures were taken as a result of stomach pain, throat hurt and included with treatment Naproxen 375mg. Take 1 tablet twice daily by mouth as needed. She only took one and she had a pain in her stomach. Dicyclomine 10mg Take 1 tablet and she stopped because the pain was worse. Amoxicillin 500 mg one capsule by mouth 3 times daily. The doctor said not to stop this one, so she was still taking it. Reporter stated she has another appointment on 01May2021 to get second dose. She does not want to feel the way she felt the past couple of days. She wanted to get it but if she gets the second shot, will it be worse. She said she understood the flu shot will make you sick like the same thing. She did not have any prior flu shots and did not have a personal issue to report. The clinical outcome of the events chest pain, stomach pain, throat hurt, chilly and cold, body achy was reported as resolving and leg left numb was reported as not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
This is the spikevax  50  - Within a few hours, sore arm.  By the next morning (+14 hours) injection site is inflamed, hot to touch, red  and itchy.  Area is 4"x4" and spreading.  Took acetaminophen 1000mg morning and 6 hours later for minor decrease in redness, pain, and itchiness.  Area is sore, red, itchy for 4 days.  5th day and redness has diminished.  Still slightly itchy and sore.
Fever (102), chills, severe body and joint pain, swollen, red & painful at the injection site, (right arm, flu like symptoms for 48 hours, then minor discomfort and coughing.
Headache, Arthralgia, Weak armpit, swollen/pain Narrative:  Other Relevant History:
I had some arm pain and some fatigue with a headache but it wasn't that bad. Three days after the vaccine I collapsed after I got to work.  I had just completed a long walk in to my work place. I did not have any energy and I was very short of breath and I managed to get home.  I had severe headaches that it felt like my head was in a vice. I was diagnosed with Mononucleosis which I had had 18 years ago. On that occasion I slept for a week straight. I am still having problems with fatigue , headaches and problems making it through my work day. I was unable to work for eight weeks and I had to work back up to a full work day. I was in good physical health before this event. I am scheduled with a Rheumatologist at the moment.
Initial report received from a health care professional on 28 January 2011. A 57-year-old male patient received on 28 December 2010 a left deltoid intramuscular injection of FLUZONE SV 2010-2011, lot number UH182AC. The patient had no known allergies, no medical history, no other vaccinations within 4 weeks of the FLUZONE and no illness at the time of vaccination. The patient's concomitant medication was reported as valcyclovir. On 18 January 2011, the patient began experiencing a tin taste in the mouth and drooping of the left side of the face. The patient's symptoms have slightly improved as of 28 January 2011. The outcome was reported as unknown. Documents held by sender: None.
muscle soreness; This is a spontaneous report from a contactable physician (patient).  An adult patient (Age: 44; Unit: Unknown) of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: not provided), via an unspecified route of administration on 14Dec2020 at SINGLE DOSE for COVID-19 immunization.  Medical history and concomitant medications were not reported. It was reported that the patient had side effects that were minimal - muscle soreness in Dec2020 for 24 hours, that's about it. The patient recovered from the event in Dec2020.   No follow-up attempts are possible, information about batch number cannot be obtained.
Screaming uncontrollably for several hours; could not be consoled. Did not return to normal behavior until 2-3 days.
Muscles in throat were tense; Face felt funny; This spontaneous case was reported by a patient and describes the occurrence of THROAT TIGHTNESS (Muscles in throat were tense) and FACIAL DISCOMFORT (Face felt funny) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023m20a and 006321A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LOVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID) and AMITRIPTYLINE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced THROAT TIGHTNESS (Muscles in throat were tense) and FACIAL DISCOMFORT (Face felt funny). At the time of the report, THROAT TIGHTNESS (Muscles in throat were tense) and FACIAL DISCOMFORT (Face felt funny) outcome was unknown. Not Provided          Concomitant medications also included unspecified blood pressure medication. Treatment information was not provided. Action taken with mRNA-123 is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: information regarding 2nd dose added. action taken was updated.
Localized welt, fever, arthralgias <24 hrs after injection. No diffuse rash or oral edema.
patient was administered the IPOL that was expired with no reported adverse event; Initial information received on 25-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 9 years old male patient who was administered the IPV (VERO) [IPOL] that was expired with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 24-Oct-2022, the patient was administered 0.5 ml dose of suspect IPV (VERO), suspension for injection (lot T1E87; Expiry Date: 10-Oct-2022) via intramuscular route in the left deltoid for Immunization that was expired with no reported adverse event (expired product administered) (latency: same day). It was asked if the IPOL dose is valid and whether the patient should be reinjected and if so, when and what they should look out for in regards to potential side effects after the patient receives the second IPOL dose. It was reported that Medical Assistant mistook the expiration date on the IPOL MDV that read 10Oct2022 and thought that it meant that it expires in Oct2022 (meaning the last date of the month).  Action taken : not applicable.  Outcome : Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
2 days post vax, injection site became inflamed and redness increased. Seen by a physician who prescribed Augmentin for diagnosis of vaccine abscess. Recovered with no ill effects.
syncope; POTS; fatigue; dizziness; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a 19-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, lot#, expiry date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient experienced postural orthostatic tachycardia syndrome (POTS), syncope, fatigue, and dizziness. Reported date of injury was unspecified date in 2013. The outcome of the events was not reported. The lawyer considered all events to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  Upon internal review, the event of syncope was determined to be medically significant.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
The patient is a 6 month old boy was brought to the emergency room for evaluation of a rash. The patient had a hepatitis vaccination earlier today in the doctors office and later developed this rash over the abdomen. No difficulty breathing. No cough. No sputum production. He does not seem ill in any way. There has not been any vomiting. The rash is red and raised. It does not seem particular pruritic. Apparently he went to urgent care and was sent here for evaluation. Final diagnosis: Acute allergic reaction manifested by rash, probably secondary to immunization.
Information has been received from a mother concerning her 6 yr old daughter who at over 15 months of age in approx 2000, was vaccinated with a dose of varicella virus vaccine live. Yesterday, on 16May05, the pt experienced pox like bumps and also a rash down her arm and buttocks. Medical attention was not sought. No product quality complaint was involved. Additional information is not expected.
The rash started on her palms, and migrated to different parts of her body; arm pain; hives and some redness on her belly; hives and some redness on her belly; "back of her ear looked swollen" and also involved her knees and toes.; "back of her ear looked swollen" and also involved her knees and toes.; "back of her ear looked swollen" and also involved her knees and toes.; This is a spontaneous report from a contactable consumer or other non hcp via medical information team. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch Number: EN6201) via an unspecified route of administration, administered in left arm on 15Apr2021 at 14:30 (at the age of 53-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. The reporter stated that his wife is healthy and does not take any other medications. Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. Patient family medical history was reported as none. Patient Medical History including any illness at time of vaccination reported as none. It was reported that both parents have the vaccine and are fine. It was reported that she received her first dose of the Pfizer-BioNTech Covid19 vaccine and developed a rash a week later on 21Apr2021. He reported that her rash showed up out of nowhere and had nothing to do with the arm that she received the vaccine in. The rash started on her palms and migrated to different parts of her body including hives and some redness on her belly and the back of her ear looked swollen and also involved her knees and toes. The rash was short lived and resolved within 24 hours after treating with an antihistamine. It was reported that his wife noticed the rash at 10:00 pm that night. It was reported that she also had arm pain on 16Apr2021 that lasted for 2-3 days. Reporter stated that she is due for her second dose this Thursday and they are asking if she should still receive that dose or not. Patient received treatment with antihistamine for rash. Patient relevant Tests reported as none. The outcome of the event the rash started on her palms and migrated to different parts of her body was recovered on 22Apr2021 and the outcome of event arm pain was on unknown date in Apr2021. The outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Received flu and COVID shot in left deltoid on 10/11/2023 8 am.  Pain increased throughout day, but worse next morning. Pain continue to worsen with limited range of motion of left arm.
Patient had two tonic-clonic seizures 8 hours apart and was unconscious for up to 10 minutes.  Seizures were closed eye seizures that started upon falling asleep.  Patient had no prior history of seizures before the vaccine.  Both times patient was transported via Emergency Paramedics to ER.
sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Keflex with an associated reaction of oral candidiasis, Biaxin with an associated reaction of rash, Sulpha with an associated reaction of myalgia and Morphine with an associated reaction of nausea. Concomitant products included esomeprazole magnesium (Nexium), gabapentin and estrogens conjugated (Premarin).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Shingrix injection a couple of years before reporting and experienced sore arm. The patient received unspecified BioNTech COVID Vaccine. The patient got the Pfizer vaccine and was getting the second one on 21st February 2021. They did not get her the vaccine card. She just knew it was Pfizer BioNTech COVID vaccine. The unusual side effects she experienced were deep fissures in her tongue, sensitivity in her tongue, and sensitive pallet. She had a reddish sensitive pallet. She was spitting blood for 4 hours before she realized she had fissures in the tongue. She could not contribute it to anything except she had the vaccination. She noticed it 3 nights after the vaccine. The fissures could have been developing, but she did not examine it until it started bleeding. Her tongue was examined frequently during the year by her dentist and her doctor. She got the vaccine on 31st January 2021. The symptoms could have started between 31st January 2021 and she noticed the bleeding on 3rd February 2021. It was before six or so when she got the injection and she was spitting blood about 6PM on 3rd February 2021. The bleeding lasted for 4 hours and she was about to go to emergency room , but the bleeding stopped. She had not bled again. The fissures were not cleared. The entire tongue had groves they were deep. There were still fissures there. Her pallet was still sensitive but it was not bleeding. It was red and the doctor told to use a Q-tip to apply hydrogen peroxide. That was all she suggested. Some days the fissures seem more irritated. Her dentist looks at her tongue closely twice a year. She saw the dentist in December and saw her primary care doctor in January. All labs were good. She hopes this did not happen with the second dose. She would say her tongue was slightly swollen. It was not preventing her from breathing, but the swelling was from the fissures. She get rashes from medications. She did not take the medications anymore.  The reporter consented to follow up. For tolerance of 2nd dose of shingrix, refer case US2021AMR045165.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR045165:same patient
Felt nauseated and sweaty at 11:30. VS 11:45 120/80 p70 r 16 breath sounds normal. Are and drank water.  11:55an 120/80 p64 r 16. Felt better. Left at 11:57 ambulatory without assistance.
p/vax on 7/30 had localized react erythema 4''circ, possible pox marks at area, pain at area
Pt sat up from sleep and was unresponsive.  Eyes rolled to the back of his head.  Left side of face was "twitching," as were left upper and lower extremities.  Seizure later generalized.  2mg Ativan was given IV by ambulance which did not break seizure.  Seizure finally broke 45 minutes after onset after loading dose of Cerebyx given.
Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 4:34 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 4:34 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 82.92 years.  Concomitant products were not provided.  On 05-Jan-2021, the vaccines were moved to fridge. On 07-Jan-2021, six vials were moved to clinic. On the same day between 09 AM to 10 AM, the vials underwent temperature excursion with temperature 34 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 27-Jan-2021. It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Parent-Child Link).   See case MOD-2022-566976 for details regarding the child case.
STOMACH PAIN; PAIN IN TOES; PAIN IN FINGERS; PAIN IN JOINTS; SWELLING AROUND INJECTION SITE; REDNESS AT INJECTION SITE; ITCHY RASH AT INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis, asthma, and inflammatory bowel disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at 10 AM for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced itchy rash at injection site. On MAR-2021, the subject experienced pain in toes. On MAR-2021, the subject experienced pain in fingers. On MAR-2021, the subject experienced pain in joints. On MAR-2021, the subject experienced swelling around injection site. On MAR-2021, the subject experienced redness at injection site. On 10-MAR-2021, the subject experienced stomach pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, was recovering from pain in fingers, and had not recovered from swelling around injection site, pain in toes, pain in joints, redness at injection site, and itchy rash at injection site. This report was non-serious.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Additional Details: patient heart rate, blood pressure and oxygen level within normal range. Checked by clinic nurse.
Moderna COVID-19 Vaccine EUA  chills, fatigue, headache, soreness
lightheaded, anxiety at 0850, BP 178/92, HR 79, RR 20, POX 96%. Symptoms resolved quickly.
Information has been received from a pharmacist concerning a 59 year old female patient with no pertinent medical history and no known drug reactions/allergies who on 05-OCT-2009 was vaccinated with a 0.5ml dose of PNEUMOVAX 23 (lot# 662785/1124X) SQ in the left arm. Concomitant vaccination administered on the same day included a dose of influenza virus vaccine (unspecified) in the left arm but at a different site. On 08-OCT-2009, the patient called the pharmacy to report redness, warmth and swelling at injection site. The date of onset of the symptoms was unknown. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. Additional information has been requested.