chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed intense itching/burning at and around the injection site, hive- like and localized to about a 3 " diameter after 3 days.  Kept me up all night, by next day was controllable with the topcial Benadryl that hadn't worked previously. Continued about a week, coming and going, but also felt like it was under the surface area. Has continued to flare up over the past several weeks, although the hives and redness went away and not as severe. The chills and extreme fatigue I experienced initially have continued all month- I am 4 days from my second dose and over the weekend experienced the worst fatigue of all- was out running and literally felt like I wasn't moving forward. I also suddenly developed joint and muscle pain with the recent extreme fatigue, especially back of neck. Occasional mild dizziness in the evening.
On March 17 I developed herpes Zoster on the left side of my nose. My NP ordered valacyclovir  1gram which I am taking three times a day for 10 days.
trouble breathing; This is a spontaneous report from a contactable consumer (patient reported for herself). A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6202; Expiration Date: 30Jan2021) via an unspecified route of administration, administered in left arm on 04Mar2021 16:30 (at the age of 64 years old) dose 1, 0.3 mL, single for covid-19 immunisation. Patient mentioned wanting the vaccine as she wanted to start living her life, she has had enough. There were no concomitant medications. There were no prior vaccinations within 4 weeks. There was no family medical history. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing (reported as diagnosed 10 years ago or probably more); she broke her foot on an unknown date (prior to COVID-19 vaccine) and reported that normally when she goes anywhere she uses a scooter and instead of using her scooter, she used a walker with feet on it (date unknown). Patient mentioned she was on oxygen (ongoing) and thought she was having trouble breathing and thought she brought this on herself. She had episodes where she has to get prednisone. At the time of the report, patient felt like she needed prednisone. She was walking fast with the walker with her mask on and oxygen underneath. She hasn't left her house in a year. There was so much walking and it was stupid on her part. Patient thought she would let Pfizer know just in case it is a side effects. The nurse she spoke with thought she brought this on herself. She was walking fast. She was having no other symptoms. Patient was having trouble breathing just doing the walking to get the COVID-19 Vaccine. By the time she sat down, she was told to catch her breath. It was awful. Trouble breathing began before the vaccine (ongoing). The patient also experienced trouble breathing on 04Mar2021 (as reported; pending clarification). She spoke with her pulmonologist's nurse and will probably be sent prednisone. Patient did not go to physician office or emergency room and stated trouble breathing was not that bad. At the time of the report patient stated the trouble breathing was better. She stated she was fine and walking around the house just fine. She just needed the prednisone. She confirmed she has not started the prednisone yet. She stated in a few days she will be fine. There were no relevant tests. She stated she will take prednisone and if that didn't work then she will have to go to the doctor. Right now, she didn't feel a need to get to the doctor. She confirmed has not started the prednisone yet. Patient asked if she will she be called and told she cannot receive the second dose since this report is filed. The outcome of the event was recovering.   No follow-up attempts are possible. No further information is expected.
Registrant  was 17y9m received first dose of Moderna Vaccine inadvertently.  Registrants parent and physician have been notified by nursing supervisor   VAERS report submitted
I had a return of symptoms and a positive rapid antigen test; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (I had a return of symptoms and a positive rapid antigen test) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     The patient's past medical history included Nephrotic syndrome. Concurrent medical conditions included Depression, Hypercholesterolemia and Penicillin allergy. Concomitant products included LEVOTHYROXINE from 01-May-2022 to 17-May-2022 for an unknown indication.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I had a return of symptoms and a positive rapid antigen test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (I had a return of symptoms and a positive rapid antigen test) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 16-May-2022, the patient had a return of symptoms and a positive rapid antigen test 8 days after stopping treatment with Paxlovid.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a 56-year-old male patient with reported medical history of Nephrotic Syndrome, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, patient tested positive using rapid antigen test for COVID-19 8 days after stopping NIRMATRELVIR, RITONAVIR (PAXLOVID) which was his treatment for COVID-19 from 04-May-2022 to 08-May-2022 for COVID-19, no other clinical or treatment details were given. The medical history of Nephrotic Syndrome remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 56-year-old male patient with reported medical history of Nephrotic Syndrome, who experienced the unexpected non-serious adverse event of special interest, COVID-19 which occurred on an unknown date after receiving the third dose of mRNA-1273 Vaccine. As reported, patient tested positive using rapid antigen test for COVID-19 8 days after stopping NIRMATRELVIR, RITONAVIR (PAXLOVID) which was his treatment for COVID-19 from 04-May-2022 to 08-May-2022 for COVID-19, no other clinical or treatment details were given. The medical history of Nephrotic Syndrome remains a confounder. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
I received a vaccination at my job which I thought was a series of flu shots but ended up being hep A, Hep B, flu, pneumonia and booster. The very next day I had to go to the hospital because I had severe headache, delusional, fever of 103 and a serious infection on my arm called cellulitis. The antibiotics they gave me did not work so I had to go back to the hospital the next day. They prescribed me stronger antibiotics which finally did work but that night I had severe stomach pain. So I went to the hospital again. The doctor told me I had a bile duct stone which can be caused by infection and trauma. I had to get surgery and stay in the hospital for 2 more days. I ended up missing a week from work amongst other problems. I have reoccuring headaches that I never had before. Now I'm receiving thousands of dollars of hospital bills. I talk to my store manager and the people from the pharmacy and they dont want to help me and I dont know what to do.
Vaccines 11/11/13. C/o painful site, fever, joint pain, swelling at site.
Numerous bumps, hives. Muscle ache/pain, inability to turn head fully, fever. Puss filled nodules all over body although generalized. Allegra, Motrin, Vicodin as needed for severe aches. - 01/06/2006 Received ER record. Pt was in hospital for 4 hours then confined to quarters for 2 days. Final impression was listed as post smallpox vaccination folliculitis and myalgia.
Medication variance: Delay and/or omission of administration of pneumococcal vaccine on day of discharge as per pre printed orders. Action: Considering placing vaccine in the refrigerator to be accessed through automated cabinet to decrease delay when order is processed by the pharmacist early in the hospitalization as per preprinted order, give on day of discharge.
This spontaneous report was received from a physician via a company representative and refers to a 19 year old non-pregnant female patient. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On unknown date, the patient was vaccinated with the first, second and third dose of GARDASIL injection (lot # expiration date, site and doses were not reported), intramuscularly. On an unknown date, the patient had a positive Papanicolaou (PAP) smear test and she was tested positive for HPV. It was reported that the patient sought medical attention, she saw her physician. The outcome of the events was unknown. The relatedness between the events and GARDASIL was not reported. Additional information has been requested.
I have already received my first shot. But i won't be able to get my second shot; 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 PRODUCT DOSE OMISSION ISSUE (I have already received my first shot. But i won't be able to get my second shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I have already received my first shot. But i won't be able to get my second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I have already received my first shot. But i won't be able to get my second shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided  No treatment medications provided
87y.o. female who presented to the hospital with relatively recent onset pronounced fatigue as well as change in mentation.  Patient has been provided information over the phone and reported patient feeling increasingly weak on waking up.  Ros to the hospital, patient tested positive for COVID-19 viral infection.  Patient has been afebrile, minimal symptoms were reported at home. According to the husband patient was in her usual state of health the day prior when they at out.  There was no reported fall. According to additional history obtained from the primary care physician that has been declined in the recent past, and patient husband was suggested to consider addition of hired help at home. Patient is on anticoagulation with Xarelto having a history of a pulmonary embolism.  Patient was undergoing a slower steroid taper receiving prednisone 7.5 mg most recently, having a history of temporal arteritis. The patient was evalauted by infectious disease, completed a 3 day course of remdesivir Neurology, rheumatology evalautions were obtained. Encephalopathy imrpoved, patient feels significantly improved today The patient daughter yesterday anad patient's significant other have reported today that patient had diarrhea in the recent past. Over the last 3 days, 1 bowel movement was reported daily by nursing. I have offered continued monitoring in the hospital and GI evalaution . The patient requests discharge home today Home care was recommended at discharge, family informed me of their plans of hiring additional help at home With history of lung and bereast CA, hematology oncology evalaution was requested, no additioanl inpatient workup was recommended.
extreme fatigue, nausea, vomiting, diarrhea, throwing up blood and blood clots, severe pain in the lower left back/flank area, unable to eat any food or keep down water for over a week after receiving the vaccine
Felt off balance, extreme lethargy, muscle aches above knee, slight slur of speech. On Wednesday October 29th, went to doctor, all blood tests came back normal. On October 30th next day, went to emergency room, Cat scan showed no signs of stroke. Symptoms are worse, twitching in legs, complete exhaustion.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 PFU. Lot number, dose, route and frequency were not provided). On an unknown date the patient was taking VALREX when he received ZOSTAVAX. No adverse effect was reported. The action taken regarding ZOSTAVAX was unknown. The outcome of patient was taking VALTREX when he received ZOSTAVAX was unknown. The reporter causality was unknown. Additional information has been requested.
Pt came in w/ rash all over body on 6/19/09, pt also had low grade fever x 2 days.
May 15 - cycle started 3 days late July 21 - cycle is 1 week late and has not started   (Multiple negative pregnancy tests)
The patient developed progressively worsening dyspnea, GI symptoms and fevers starting 5/16/2021, 3.5 weeks after receiving second Moderna vaccine. She was admitted 5/22/2021 with ARDS requiring intubation, found to have severe systemic inflammation with acute DVT of right right subclavian, axillary, brachial, and upper arm radial veins, chronic DVT of left subclavian, and possible thrombus tricuspid valve. Remains intubated with ongoing evidence of systemic inflammation. Working diagnosis EVALI.
Second H1N1 vaccination given too early after first at Dr. office. DOH gave third vaccination at H1N1 clinic to make up for early second shot.
Headache (3 hours after vaccine), Fever (6 hours after vaccine), chills(6 hours after vaccine), vomiting (12 hours after vaccine.
I?ve had chronic headaches and horrible menstrual cycles since getting vaccine and had zero issues prior and it is still ongoing
Pain at injecting site. Currently ongoing. Upon xray, bone island present that was not previously there. PT ordered, as pain is so great no longer can put on jacket or shirt without starting with injured arm. PT is protocol before pursuing additional treatment.
get covid; get covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "get covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: have been fully vaccinated but did get covid.  Clinical course: Supplier/Reporter Information Accompanying a Product Safety Report. Branded Concepts. She thought of her family son and grandkids how she want to enjoy time with them too. She have been fully vaccinated but did get covid but it could have been much worse. The respondent indicated that her initial series was Pfizer, and that she has received a Moderna booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received a dose of vaccine that may be less than completely effective due to storage conditions.  No adverse effect noted.
Swollen lymph node in left armpit, slight pain in armpit area where shot was. Lasted a few days. Did not go to dr.
I have had my period since March now. At this point I?m severely anemic and my blood pressure is very low.
fully vaccinated with the Pfizer vaccine/patient tested positive; fully vaccinated with the Pfizer vaccine/patient tested positive; This is a spontaneous report from a non-contactable consumer via a Pfizer sales representative. This consumer reported similar events for 3 patients. This is the first of 3 reports.   A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on Dec2020 (Batch/Lot number was not reported) as 1st dose, single, dose 2 (Batch/Lot number was not reported) on an unspecified date as 2nd dose, single both via an unspecified route of administration for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. In April, their 6-year-old daughter contracted COVID-19 through an outbreak at school. This occurred after spring.  The patient was fully vaccinated with the Pfizer vaccine in Dec2020. She had the worst symptoms. None required hospitalization. They all self- treated at home. The patient tested positive shortly after their 6-year-old daughter tested positive in April. The outcome of the event was unknown.   No follow-up attempts are possible, information about batch/lot number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021539650 same reporter, same drug, similar event, different patient;US-PFIZER INC-2021539644 same reporter, same drug, similar event, different patient
This report describes a vaccination error. The IMOVAX rabies vaccine was injected into the quadriceps, which is not an acceptable site for administration of a rabies vaccine in adults. As explained in the prescribing information document for IMOVAX, for adults and older children, the vaccine should be injected into the deltoid muscle. There are no data demonstrating adequate immune response following injection of IMOVAX into quadriceps in adults. This vaccination error is serious because incorrect injection sites of rabies vaccine have been associated with failed prophylaxis, as explained in the prescribing information document for IMOVAX.
Initial report received from a healthcare professional on 19 MARCH 2013.  A 24-year-old female patient whose medical history and concomitant medications were not reported, had received an intramuscular dose of ADACEL (batch number: U4567AA) in left deltoid on 18 MARCH 2013. The patient had received an intradermal dose of APLISOL (Manufacturer: JHP Pharmaceuticals, batch number: 293238) in left forearm on 12 MARCH 2013. The reporter denied providing information about patient's pre-existing physician diagnosed allergies, birth defects, and illness at time of vaccination. On 19 MARCH 2013, the patient developed what appeared to be petechiae on the left forearm. The petechiae were localized to the left forearm area and had not spread to other areas of the body at time of report. Laboratory investigations and corrective treatment were not reported. At the time of this report the outcome of event was unknown. Documents held by sender: None.  Follow-up information received from a healthcare professional on 24 MAY 2013. On an unspecified date, the patient had recovered.
76 years old male (12/19/1944) called to report an adverse reaction after receiving his second moderna dose on 03/10/2021 @0948. patient reported on 03/13/2021 @0800 developed a rash (60% of his body) including: over the head, neck, arms, the upper middle of the back, buttocks. patient reported that he contacted his primary care physician and he was prescribed prednisone due to the rash. patient denies any allergies. patient reported no medical history. patient reported no current medications. patient was instructed to take his prescribed prednisone as directed and to apply cold compress to help with the rash. patient was instructed to seek medical attention if the symptoms got worse. Adverse events experienced and are they still occurring now:  rash and still occurring    patient reported that he contacted his primary care physician and he was prescribed prednisone due to the rash
This non-serious initial spontaneous case, was received from a pharmacist on 28-Sep-2017, concerning a 73-year-old, elderly, female patient. On 28-Sep-2017, the patient was administered with FLUAD (TIV) (batch number: 179002, expiry date: May-2018, dose: less than 0.5 ml (as reported), route of administration: intramuscular, anatomical location: deltoid). It was reported that, as the intern tried to screw the needle, to administer the vaccine after letting out the air and began to inject the vaccine, all leaked out from around the needle itself (explicitly coded to syringe issue). Partial dose of the flu vaccine was administered to the patient (explicitly coded to incomplete dose administered) and no adverse event was experienced by the patient after the administration of partial dose of the vaccine. However, the patient was re-vaccinated, as she was previously vaccinated with a partial dose of the flu vaccine. It was stated in the PTC (product technical complaint) report that, no damage was observed in package condition, stored in the original box until usage, the leakage was around the needle (25-gauge 1 inch, syringe type: Luer lock), however the needle was attached tightly. No signs of damage were seen. It was reported that, the defect occurred prior to administration. The outcome of the events was not reported. The reporter assessed the events as non-serious. Follow-up report received from the reporter on 04-Oct-2017 (PTC number: 1024854): PTC report received and updated. Amended narrative accordingly. Follow up report received on 05-Oct-2017: The route of administration (intramuscular), anatomical location (deltoid) of the vaccine were updated. It was reported that, no adverse event was experienced by the patient after the administration of partial dose of the vaccine. Non-significant follow up report received on 18-Oct-2017: Batch number (179002) was updated. Amended accordingly.
After my first Pfizer shot, that arm was sore for the rest of the day and the following day, with no other symptoms.  After my second Pfizer shot, that arm was sore the next day. For three days I felt ill: the fatigue, body aches, and general malaise of an immune response. These symptoms subsided in intensity after 3 days but persisted approximately a week.  The primary complaint is this: before my second shot, I was exercising (running 2.5 miles, then going to the gym) almost every day (at least 5 days a week). After the shot, I developed tightness in my chest, elevated heart rate, persistent shortness of breath, etc, and I was only able to exercise a few hours per week in total before becoming fatigued and winded. These symptoms persisted strongly for approximately 1 month, but it took approximately 3 months before I began to feel as strong as I had felt prior to the second shot.
Information has been received from a registered nurse concerning a 10 year old female patient who on 27OCT1997 was vaccinated with a dose of varicella virus vaccine live (lot 624062/0809E). The reporter indicated the patient developed a rash on 29-MAR-2003, and subsequently she was seen at another location of this physician's office on 31-MAR-2003, and was diagnosed with varicella (also reported by registered nurse as mild chicken pox diagnosed on 01APR2003). Follow up information received from the registered nurse reported there was no "follow-up" in this case of "mild" chicken pox break through post vaccination with varicella virus vaccine live.