chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Report completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose03/29/21 2nd dose04/16/2021 Diagnosed covid positive:09/02/21 Symptom onset:09/01/2021 Exposure: Symptoms:cough, fatigue,chills,runny nose,headache
Pt devel a red, raised rash w/itching, described as  "hives", over body five days post vax; Td also given; Pt had no rxn to 2nd & 3rd injects given on 13DEC90 & 20DEC90;
Patient started having pain and swelling at injection site approximately 6-8 hours after injection, the next morning her left arm had increasing swelling and pain along with fevers and chills. Took tylenol and ibuprofen. Continued worsening over the course of the day then 2 days after injection noticed redness going up side of arm and continued fevers and now myalgias. Was seen 2 days after injection and prescribed antibiotic Cephalexin due to possible infection at injection site.
Woke up the following morning with my entire body aching, chills, hot/cold and sweating. Mind was very very foggy and felt dizzy. Very hard to describe but it almost felt as if I was hallucinating and separated from my body. Seemed to feel a little better that night. Symptoms were still there and 22nd and 23rd and started to worsen around noon on the 24th. Legs ached very bad and felt as if I was hallucinating again. Tried to finish some last minute Christmas shopping but had a hard time driving, was also very hard to focus or think about anything. I went into a store for about 5 minutes and felt as if I was going to pass out while I was checking out, along with intense sweating and what I would describe as hot flashes. Tried to rest for the next few hours into the evening, but even though I was exhausted I could not sleep. As the night went on the symptoms peaked. Around 1AM on the 25th I found myself shaking, sweating, and my legs gave out two times as I tried to stand up. My face was pale and my head was so cloudy and could not think straight. I tried splashing some water on my face and to focus, and almost decided to go to the ER. At this point it felt as if I was drugged, but the feeling that was in my head is so difficult to describe. I finally fell asleep around 3am and when I awoke around 10AM the symptoms were weak and by the end of the night I felt OK again. Still don't feel 100% right though as of today 12/28.
soreness in her left arm; Tiredness; Joint pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, tiredness and joint pain. On 13th June 2020, the outcome of the pain in arm was not recovered/not resolved. On 29th July 2020, the outcome of the tiredness and joint pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness and joint pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and experiencing joint pain, tiredness and soreness.  The reporter wanted to know if she should get the 2nd injection.   The provided medical disclaimer and referred her to her HCP. The reporter did not consent to follow up. Limited information obtained.   Caller did not provide demographics.   No LOT or EXP date was available.
pt recvd vax & w/in 1 hrs began to exp joint pain; 3-4 hrs had onset swelling of ankles & mild prostration; sx were treated w/Pred;
This spontaneous report as received from a nurse refers to patients of unknown age and gender. Medical history and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with VARIVAX stored above 14 F for greater than 6 weeks, lot # reported as H018762 expiry date not reported (dose and route not reported). Concomitant medication was not reported. No adverse effects reported. The reporter stated than 10 unidentified patients received unspecified frozen or refrigerated vaccine doses that were improperly stored. This is one of several reports from the same source. Additional information is not expected.
On way home, I realized my face was somewhat numb, like when you?ve had dental work. It lasted about 40 hours, gradually lessening in intensity
Mother stated that the child had had soreness and swelling in the left upper arm, left shoulder & left upper back. (Tdap was given by Health Dept staff to a child less than 11 y.o.).
1 of 2 pts recvd 2nd HIB vax & w/in 48 hrs had vomiting & diarrhea x 10 days;
After immunizaion of prevnar in right arm had numbness and tingling that extended from the right side of her neck all the way down her arm and extending the right torso and down the right low back to the right knee.  Currently aching in the upper arm and numbness from the right shoulder to the right elbow.  The rash is characterized by pain and redness
Presents to the emergency room with complaints of dysuria and increasing shortness of breath.  Says she began to have symptoms of COVID on Wednesday 1/12.  Husband also positive.  She has gotten progressively more short of breath and feeling poorly.  Some fevers at home.  Some cough.  She has turned up her oxygen and remains short of breath.  In the emergency room she is currently 92% on 5 L.
vertigo; fifth cranial nerve pain; headache; TMJD; pinched nerve sensation in the maxillary and facial areas; possible skin reaction; This case was reported by a physician via call center representative and described the occurrence of vertigo in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. In May 2019, 10 days after receiving Shingrix, the patient experienced vertigo, nerve pain, headache, temporomandibular joint dysfunction, facial paresthesia and skin reaction. On an unknown date, the outcome of the vertigo, nerve pain, headache, temporomandibular joint dysfunction, facial paresthesia and skin reaction were recovering/resolving.   It was unknown if the reporter considered the vertigo, nerve pain, headache, temporomandibular joint dysfunction, facial paresthesia and skin reaction to be related to Shingrix.  Additional details were provided as follows: The case was reported by the reporter for himself. The age at vaccination was not reported, but it could be 81 or 82 years. The patient experienced vertigo, fifth cranial nerve pain (including a pinched nerve sensation in the maxillary and facial areas), headache, and a possible skin reaction in the same area. The symptoms were improved, but till the time of reporting, they were not resolved. The reporting physician was given a dental device for temporomandibular joint dysfunction (TMJD) after seeking dental attention. The reporter consented to follow up. The reporter permitted for follow-up.
On 5/4/98, the vaccinee received his 1st dose of Havrix. On 8/17/99, he was found to have an AST of 192 U/L. He was found to have an ALT of 157 on 8/24/99. On 8/8/00, the pt received his 2nd dose of Havrix. Subsequent AST values were 173 U/L on 8/24/99 and 43 U/L on 3/23/00. Physician stated that the increased liver function tests were possibly related to alcohol consumption. The vaccinee was never symptomatic, reported the RN. As of 10/5/00, the pt's lab values were improving.
Information had been received from Pfizer, Inc (manufacturer report# 2016505408) on 14-NOV-2016 regarding a case for PNEUMOVAX23 (MARRS# 1611USA007354). Information had been received from a nurse who reported that a female patient (age unknown) received PREVNAR 13 shot and experienced severe arm pain (date not reported). On an unknown date, the patient was given prednisone and her arm pain had resolved. The reporter clarified that the patient received PNEUMOVAX23. This is one of two reports from the same reporter. No further information is anticipated.
Stomach was still feeling uneasy; stomach ache; diarrhea; dry heaving; achiness; a lot vomiting (it was frequent),dry heaving; extreme fatigue; headache; freezing chills; flu-like symptoms; sweatiness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERHIDROSIS (sweatiness), ABDOMINAL DISCOMFORT (Stomach was still feeling uneasy), ABDOMINAL PAIN UPPER (stomach ache) and DIARRHOEA (diarrhea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Chronic fatigue syndrome since 1985, Chronic interstitial cystitis NOS since 1993, Hypertension since 2019, Chronic back pain since May 2003 and Arthritis since 2007. Concomitant products included HYDROXYZINE for Chronic interstitial cystitis NOS, PARACETAMOL (TYLENOL) for Pain, GABAPENTIN for an unknown indication.   On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 50 mcg. On 27-Oct-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERHIDROSIS (sweatiness), NAUSEA (dry heaving), MYALGIA (achiness), VOMITING (a lot vomiting (it was frequent),dry heaving), FATIGUE (extreme fatigue), HEADACHE (headache) and CHILLS (freezing chills). On 28-Oct-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach was still feeling uneasy), ABDOMINAL PAIN UPPER (stomach ache) and DIARRHOEA (diarrhea). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), NAUSEA (dry heaving), MYALGIA (achiness), VOMITING (a lot vomiting (it was frequent),dry heaving) and FATIGUE (extreme fatigue) had resolved, HYPERHIDROSIS (sweatiness), HEADACHE (headache) and CHILLS (freezing chills) outcome was unknown and ABDOMINAL DISCOMFORT (Stomach was still feeling uneasy) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication information was provided.   This case was linked to MOD-2021-374828, MOD-2021-374847 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2021: Significant Follow up received, include race information, new events and medical history
Monovalent mRNA vaccine administered for a bivalent mRNA dose. Patient was given the monovalent mRNA vaccine, as I was not aware at the time, that the EUA had been withdrawal by the FDA.  My supervisor received noticed on 05/01/2023 from County Health Department with a link to the Department of Health and Human Services  which announced updates to Covid-19 vaccines.  That the Bivalent Moderna & Pfizer BioNTec vaccines were to be used for all doses administered to those 6 months of age and older.  In the announcement, NO where did it state that this change had gone into effect the month prior. I was forwarded the email announcement  on 05/02/2023 and it was read on 05/03/2023 as soon as I returned to the clinic office from doing vaccinations I destroyed all remaining doses of our Pfizer monovalent mRNA FP7136 vaccine.  The patient suffered NO adverse affects and had NO adverse events following his vaccination. This patient was notified on 05/24/2023 regarding the need to have his vaccine repeated with the updated Pfizer Bivalent vaccine and the patient stated that right now he isn't interested in taking another vaccine but that if he changes his mind he will let us know.  Patient still remains incarcerated in our custody and will be offered the Updated Pfizer Bivalent vaccine again later this month..
4.5 x 4.5 area of induration at site of administered. Given TEMOVATE ointment with relief.
Breakthrough COVID-19 infection. Pt received Moderna on 2/13/21 and 3/13/21
MOC presented w/child @ clinic; lt arm swolen & red;the swelling & rednes was down the arm 1/2 wasy & almost to the shoulder;20AUG mom states pt arm is worse & reddness & swelling is to the shoulder & elbow;
2nd dose of Moderna vaccine 8 days early; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine 8 days early) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included No adverse event.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine 8 days early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose of Moderna vaccine 8 days early) had resolved.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown,  with no associated AEs.
Patient experienced nausea and vomiting after receiving the booster Pfizer vaccine for COVID 19. The patient was treated with ondansetron and released home from the ED. The patient still required ondansetron on 4 February 2022.
Headache, NauseaVomiting, (L) sore arm Narrative:
Patient described severe flu-like symptoms: Myalgia, lethargy, headache, weakness, chills, fever and very sore arm. He experienced these symptoms after 1st dose too but it was far worse after second dose. It started about 12 hours after administration and lasted about 4 days. Patient is normally really fit and healthy - very similar to another patient who had a similar experience (same age too).
Information has been received from a health professional concerning an eight year old patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 29-MAY-2007, the patient was diagnosed with chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. This is one of several from same source. Further information has been requested.
Initial report was received on 11 January 2011 from the Investigator participating in the post-marketing observation surveillance study under the reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 14 month old, female subject (initials not collected) was identified by the investigator based on review of data. The subject's vaccine history included one dose of DAPTACEL (lot number not reported) received on 21 January 2009, and dose one of PENTACEL (lot number C2999AA) received on 23 March 2009, and the second dose of PENTACEL (lot number not reported) received on 08 May 2009 (route and sites of administration not reported). Nearly 9 months after the last dose, on 28 January 2010, the subject developed a cough. Six days later, the subject developed a paroxysmal cough with whoop. The subject also experienced cold-like symptoms and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 05 February 2010. Chest x-ray findings were negative for pneumonia. Corrective treatment was not reported. The subject was not hospitalized. At the time of final contact on 12 February 2010, the subject's cough was still persisting after 15 days. Investigator causality assessment is not required as per protocol. No vaccine protects 100% of individuals against infection. It is therefore not unexpected to find cases of pertussis after vaccination. In this particular case, no medical history has been provided so it is unknown if the child had an underlying medical condition or was taking concomitant medications that could have increased vulnerability to infection or inhibited immune response to vaccination. As nearly 9 months had elapsed since the child's 3rd dose in the primary series and she was soon due to receive her booster dose, it is possible that waning immunity may have been a factor in this case. Documents held by sender: None.
Patient noticed bruising around vaccine injection site - states he is concerned about bruise. Denies any other symptoms other than bruise.
vasovagal syncope after getting up in the night to use the bathroom , momentary blackout with spontaneous recovery
Extreme chills and fever and body ache, dizziness and fatigue. After I got the shot my auto immune disease was kind of triggered.
Fever; Chills; Headache; Loss of energy; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the left arm on 18Apr2021 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history (also reported as not applicable). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733) via an unspecified route of administration in the left arm on 28Mar2021 at 11:00 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. On 18Apr2021 at 23:00, the patient experienced fever, chills, headache and loss of energy. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were taken as a result of the adverse events and included treatment with TYLENOL from an unknown date. Since the vaccination, the patient had not  been tested for COVID-19. The clinical outcome of the events fever, chills, headache and loss of energy were recovered on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
01/18/22 presents to Cardiology for "right and left heart cath". PMHx of "CAD, HTN, hypothyroidism"
Patient diagnosed with bilateral PE in august 2021.  Patient tested positive for COVID-19 on 2/16/22 and presented to the ED with cough, SOB, chest heaviness on 2/28/21. She was found to be afebrile with leukocytosis and CTA negative for PE.
A report was received from a health care professional on 16Oct02, concerning a 22 month old male vaccinee who was inadvertently administered 0.25ml IM into the vastus lateralis on the 15Oct02. On 15Oct02, the vaccinee suffered a medication error by receiving 0.25ml Fluvirin into the vastus lateralis. The vaccinee had not experienced any adverse events at the time of the report but was being closely monitored. There was insufficient information to determine the reporter's causality assessment. PJP200200609, PJP200200671, PJP200200670, PJP200200669, PJP200200668, PJP200200667, PJP200200666, PJP200200665, PJP200200662, PJP200200663.
2 hours post vaccine, itching and hives on arms. Hives spread throughout entire body.
pt recv vax 7JUN97 & 21JUN97 pt devel a vesicular rash around inj site w/about 10 lesions;
A non-serious spontaneous report of "patient received only half a dose" was received from a registered nurse concerning a 34-year old male patient. On 23-Oct-2008, the patient received only half a dose (0.1 ml) of FLUMIST because the divider clip was not removed. upon inquiry, the reporter confirmed that there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was obtained on 06-Nov-2008 and incorporated into the narrative: confirmation from the reporter that no adverse events occurred from the medication error.
Noticed excessive Bruising for 7-10 days prior to onset of petchiae rash which appeared on 02/19/2010 covering faces, arms, and legs. Brought to see Dr. on 2/22/2010 which then was sent to hospital for STAT lab work. Then sent ER based on labs (platelet count of 48) and was diagnosed with Thrombocytopenia on 2/22/2010. AS of current date of 3/5/2010 we are having blood drawn every 3-7 days and will see a hematologist within next week in addition if platelets fall lower then 30 we are to revisit the ER. Dr has also mentioned bone marrow aspiration and other courses of treatment.
patient convulsing; This case was reported by a consumer via interactive digital media and described the occurrence of convulsion in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In August 2019, the patient received Boostrix. On an unknown date, less than 9 months after receiving Boostrix, the patient experienced convulsion (serious criteria GSK medically significant). On an unknown date, the outcome of the convulsion was not recovered/not resolved.   The reporter considered the convulsion to be related to Boostrix.  Additional details were provided as follows: The patient received one doseof boostrix and experienced convulsion. The patient is having prolonged side effects and includes a video of the patient convulsing. The patient was still suffering from the vaccine injury he sustained in August 2019. The batch and lot number were unknown. The reporter consented to follow up. No further information was available.
48 hr fever, 72 hr muscle pains, headache, eye pain ( severe flu symptoms) slight cough with asthma symptoms
Patient was given dtap/IPV immunization. Patient is was not in the correct age frame for that immunization to be given. ages for vaccine are 4-6 years of age. Patient's guardian was notified before she left. Patient did not show any adverse reaction to the vaccine.  Provider was notified of this, she checked CDC guideline for adverse reactions.
LOW BLOOD PRESSURE; TIREDNESS; SLIGHTLY LIGHT HEADEDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination.  The batch number was not reported and has been requested.  No concomitant medications were reported. On 10-APR-2021, the subject experienced slightly light headedness. On 10-APR-2021, the subject experienced tiredness. On an unspecified date, the subject experienced low blood pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tiredness, and slightly light headedness, and the outcome of low blood pressure was not reported. This report was non-serious.