chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 people have had issues with water retention; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization; botulinum toxin type a (BOTOX), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at for an unspecified indication. The patient medical and concomitant medication history were reported. Reporter dermatologist said 2 weeks ago that 2 people have had issues with water retention after Botox and COVID vaccine. He said one patient had second dose in January and it was still going on 7 months later. He had no idea how long it would last. Mentions that chiropractors use natural medicine, and they did not know what could be done with that (water retention). The outcome of the event was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
lots of diarrhea; experiencing cramping; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (lots of diarrhea) and MUSCLE SPASMS (experiencing cramping) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 DIARRHOEA (lots of diarrhea) and MUSCLE SPASMS (experiencing cramping). At the time of the report, DIARRHOEA (lots of diarrhea) and MUSCLE SPASMS (experiencing cramping) had not resolved. Not Provided          No Concomitant medications were provided by the reporter. No Treatment information was reported. Patient stated experiencing the symptoms for about 5 days now.   This case was linked to MOD-2021-235448 (Patient Link).
At end of 15 minute observation period, pt asked how is he feeling , pt slow to response and appeared confused, pt complained of nausea, unsteady gate noted, VS taking at 10:18 am Bp-200/140, P-86,o2-97% ,  pt complained of SOB and chest pains, at 10:23am 1mL of epinephrine given IM in right deltoid, 911 called. At 10:25am pt SPo2 decreased to 90%  pt sweating profusly patient advised to deep breathe, mental status decreased set of vital signs taken at 10:32am Bp-168/138, P-86, 911 arrived at 10:33am  Bp-201/147, Hr-82 patient left at 10:39am with EMS.
sick; Initial information received on 19-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional .  This case involves patient (unknown demographics) who got the sick (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer and lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got the sick (illness) for 4-weeks following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for illness.  There will be no information available on the batch number for this case.
Swollen; Sore; Itchiness; Redness on the left arm extending to the elbow; Low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (Sore), PRURITUS (Itchiness), ERYTHEMA (Redness on the left arm extending to the elbow) and PYREXIA (Low grade temperature) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), MONTELUKAST SODIUM (SINGULAIR), HYDROCHLOROTHIAZIDE, METOPROLOL, CLOPIDOGREL BISULFATE (PLAVIX), ACETYLSALICYLIC ACID (ASPIRIN 81), PREDNISONE, ONDANSETRON (ZOFRAN [ONDANSETRON]), HYDROCODONE and COLECALCIFEROL, MENADIONE (VITAMIN K+D) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (Sore), PRURITUS (Itchiness), ERYTHEMA (Redness on the left arm extending to the elbow) and PYREXIA (Low grade temperature). At the time of the report, PERIPHERAL SWELLING (Swollen), PAIN IN EXTREMITY (Sore), PRURITUS (Itchiness), ERYTHEMA (Redness on the left arm extending to the elbow) and PYREXIA (Low grade temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also include CARDIO-B. The patient has 4 stents in the lung and 1 in the heart. Treatment details include Benadryl and Aleve.
Patient was accompanied by his grandmother with an appointment to get vaccinated with dose 1 of the Pfizer pediatric COVID vaccine (lot FK5127). The grandmother was not willing to restrain the patient to create a safe environment for vaccination. RN went to vaccinate but the patient pulled away after the needle had punctured the skin. RN advised the grandmother to take the patient to the pediatrician's office. The grandmother agreed. RN reported the situation to PHN who instructed her to waste the dose.
21MAR97 mom arm lt extremely swollen red & hard-no fever noted 21MAR96;using arm -refused to FMD;25MAR97 tc from mom didn't go to MD arm OK
painful hip; sore arm; This is a spontaneous report from a contactable consumer (Patient's wife).  A 84-years-old male patient started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 12Jan2021 at single dose (Left arm) for COVID-19 immunization (for coronavirus). The patient medical history was not reported. There were no concomitant medications. The reporter was calling about the Covid-19 vaccine. The reporter stated that her husband had a sore arm from the covid-19 vaccine on an unspecified date and that he had a different reaction. She said that he ended up with a painful hip and it was a side effect that was listed on the paperwork. She said that he is in really good shape for his age and that he is much better now. She said that he has very little soreness in his arm still. The pain in his hip has resolved. The outcome of the event painful hip was recovered and sore arm was recovering.  Information on the Lot/Batch number has been requested.
Received a flu vaccine provided by my employer via Hospital mobile bus. Immediately after my shot was given, had a throbbing pain in my upper right arm where shot was given. Have had constant pain in my upper right arm since date of vaccination and am unable to move my arm straight above my shoulder without it hurting. Have taken OTC pain meds and prescribed muscle relaxers and still neither help.
Information had been received on 20-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient of unknown age was inoculated with ZOSTAVAX vaccine (dose, route, site of administration, lot # and expiration date were not provided) on or about 31-MAR-2011 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The patient's medical history, concurrent conditions and concomitant medication were not provided. The lawyer reported, the ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused patient to contract a persistent strain of Herpes Zoster. On or about 29-APR-2015, the patient was treated at a facility (internal medicine) for a painful rash that was diagnosed as shingles. While the shingles virus is incurable, the female patient was prescribed Lidocaine, and Hydrocodone-acetaminophen to manage her symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Approximately on 24-NOV-2014 (reported as "probably yesterday"), the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, route were not reported) that expired on 29-AUG-2014). Additional information is not expected due to no consent for follow up.
Later that afternoon, she felt like she was getting chills. By 10/06/2012 evening, her temperature was 100 degrees and she was having chills/hot feelings back and forth. Fever at 0100 10/07/2012 was 101.7 degrees and at 0400 10/07/2012 was 101.4 degrees. Fever lasted until mid-afternoon on 10/07/2012. She was very tired and pretty much slept on and off the entire time. Required her to call in sick from work on 10/07/2012.
SOB, feeling hot, red face, chest and shoulders covered in huge red blotches lasting for several hours.  Did not seek any treatment.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of upper left arm), MASS (Big, rock-hard wheal under the skin of upper left arm, described to be by the next day huge as big as a closed fist or open hand), FATIGUE (Tired) and NAUSEA (Nauseated) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to insect sting (Swelling/ histamine reactions to bee and wasp stings). Concomitant products included SIMVASTATIN, VITAMIN D NOS, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ), LEVOTHYROXINE and BUPROPION for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swelling of upper left arm) and MASS (Big, rock-hard wheal under the skin of upper left arm, described to be by the next day huge as big as a closed fist or open hand). On 21-Mar-2021, the patient experienced NAUSEA (Nauseated). On an unknown date, the patient experienced FATIGUE (Tired). On 20-Mar-2021, PERIPHERAL SWELLING (Swelling of upper left arm) and MASS (Big, rock-hard wheal under the skin of upper left arm, described to be by the next day huge as big as a closed fist or open hand) had resolved. On 22-Mar-2021, NAUSEA (Nauseated) had resolved. At the time of the report, FATIGUE (Tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication details was reported.
Muscle aches and pain.  Headache. Sinus congestion. Chills.  Taking Advil Cold and Sinus.  Day three of symptoms and not improving.
This spontaneous report was received from a registered nurse regarding a 37 week and 4 day old female patient. The patient's medical history, concurrent conditions, drug reactions or allergies were not provided. On 24-MAY-2016, the patient was vaccinated with the third dose of ROTATEQ orally, (lot # L038536, expiration date 19-AUG-2017) (dose was not provided). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
administrated with only the diluent; administrated with only the diluent; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amaa64oz, expiry date 30th November 2022) for prophylaxis.   On 2nd August 2022, the patient received Menveo. On 2nd August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 4-Aug-2022 Reporter's comment: The patient was administrated with only the diluent of Menveo.  No adverse event was reported  The reporter consented to follow up. Consent to follow up by fax or phone Lot number provided was from the powder component. Additional Supportive Information: The patient received a dose of only the diluent portion of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Headache, Fever (100.2), severe chills, severe body aches starting 12 hours after injection.  Severe symptoms lasted 8 hours.  Ibuprofen lessened symptoms.  Symptoms gone 48 hours after injection.
Pt was very nervous about vaccination, even though this was now her third dose. Hours after receiving, patient fainted outside of store in parking lot. Paramedics arrived; outcome unknown at time of submission.
Woke with pink pinpoint rash (non raised) on chest and abd. Fever 11/15 - resolved 11-16. Rash resolved 11-17-13.
Patient record in system reflect that the patient received the first PCV-13 vaccine on June 1 2022.  However, in system, that record is not shown, making the patient due for the 6 month PCV-13 dose.  Documentation error across platforms resulting in incorrect scheduling.  Cross referencing across platforms took place to ensure there is no extra administration or lack there of.
pt recvd vax & felt dizzy; turned pale; started to feel chilly & shivering; t 97.4; BP 95/60; pulse irregular; slightly clammy; ectopic beat; frequent yawning; ekg done x 2, meds given;
broke out in bright  red confluent rash that started on the face and spread to rest of the body within 1hr- and then high fever - tmax 104.4 occurred about 1 hour after rash started-and holding head like pain - very irritable and hard to console - also had febrile seizure
Patient returned to Pharmacy on 3/14/2017 and returned that he broke in to hives and shown bumps similar to shave bumps in multiple locations all over his body, patient stated that allergy started 7 to 10 days after he got ZOSTAVAX vaccine. He thinks it was from the vaccine. Patient was given oral BENADRYL tablets to treat allergies. Advised patient to report his medical doctor and also told the patient we will follow up next day (3/15/2017) to see how he was doing after taking BENADRYL.
Pt received MMR, varicella and PREVNAR 13 vaccines on 7/13/16. Mom returned to clinic on 7/28/16 for reddened area centered on injection site of varicella about 1 cm in diameter. No pain, rash, or induration noted. Reassured localized reaction is not dangerous indicates strong immune reaction to vaccine. May use topical creams or TYLENOL for symptomatic relief. Re-check if worse. Current reaction not problem for future vaccines.
Vomiting; Sudden onset Diarrhea; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on 12 Mar 2021 (at the age of 39-years-old) at 12:00 in the right arm for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included birth control and celexa medications. Patient was allergic to sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 15 Mar2021, the patient experienced sudden onset diarrhea for several hours, chills and vomiting (once). The patient did not receive any treatment for the adverse events. The clinical outcome of the events was recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Fatigue; Stuffy nose; Runny nose; Sore throat; Cough; Muscle aches; Headache; Chills; Fever; This is a spontaneous case from, initially received from other non-health professional on 24-Oct-2018, concerning an adult female patient of unspecified age.  The patient's current condition included bipolar disorder. The patient's concomitant medication included Lithium (lithium carbonate).  On 14-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml route of administration: intramuscular, batch number: YF38407 (reported as YF3H407), anatomical location and expiry date: not reported) for influenza prophylaxis.  On an unspecified date in Oct-2018, 3 days after the vaccination (reported as exact time frame not known), the patient experienced systemic fever, chills, sore throat, muscle aches, fatigue, cough, headache, runny nose and stuffy nose. The patient administered Nyquil (dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol) as a treatment measure for the events.  At the time of this report, the patient was recovering from the events.  This case is linked with 201804858 due to same reporter.  The reporter assessed the case as non-serious.  Follow up report received from the reporter on 27-Nov-2018: The reporter confirmed that the exact onset dates could not be obtained. The outcome for all the events was updated from not recovered' to recovering'. The narrative was amended accordingly.  Non-significant follow up received from the reporter on 03-Jan-2019: The reporter reported that the consumer started that saying the information requested was not related to the AE itself, it was inappropriate and that she didn't know the reporter and to never call again. Med info number (SEQ19-00036) was updated in the additional information tab. No changes were made in the narrative.  Follow-up received from the med communications on 26-Feb-2019: The reference number (Med Info Number: SEQ19-00111) was added in the additional information tab. It was stated that, the reporter refused to provide any further information for the case. Hence this case was considered as lost to follow up. No changes were made in the narrative.  Case re-opened for completion of full data entry: 26-Feb-2019; Reporter's Comments: An adult female patient of unspecified age experienced fever, chills, sore throat, muscle aches, fatigue, cough, headache, runny nose and stuffy nose, 3 days after vaccination of Afluria Quadrivalent. The causality of the events was assessed as related due to plausible temporal relationship between the events and suspect vaccine.
I had no reaction from vaccine, but roughly 2 or 3 weeks later I developed atrial fibrillation. I have never had  heart issues before, and no one in my family history has had it as well.  I was in the hospital for 3 days. They did the cardioversion to get my heart back on a normal rhythm. After that I left the hospital and I was just on medications.  About two weeks later the atrial fibrillation came back. Today I went into the hospital for nuclear stress test to make sure I don't have any clogged arteries.  I am now in the process of getting a cardiac ablation. I am usually active, but now I am more exhausted and tired since being diagnosed with atrial fibrillation.
Patient experienced adverse event from the first dose of the Moderna COVID-19 vaccine.; 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 VACCINATION COMPLICATION (Patient experienced adverse event from the first dose of the Moderna COVID-19 vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient experienced adverse event from the first dose of the Moderna COVID-19 vaccine.). At the time of the report, VACCINATION COMPLICATION (Patient experienced adverse event from the first dose of the Moderna COVID-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Difficulty breathing,  rapid heart rate, dizziness and weakness. Treated with oxygen and normal saline.
Almost immediately I felt off after the vaccine I wanted to get it to protect my son since I work in a public place not even an hour after I got it I fell asleep unable to keep my eyes open I thought it was okay but here it is Friday and I'm still having trouble staying awake ill be okay for a few hours at a time then have a uncontrollable need to sleep I never ever nap in the daytime and im a very energetic person but I can seem to wake up for more than a little at a time I have to fight it for work but fined myself dozing off standing up I just wanted to report this for it to be known I hope the feeling goes away I really wanna have high hopes for this vaccine
Lethargy, weakness, diagnosis: Guillain Barre Syndrome. Patient diagnosed and treated while on vacation - no details yet except diagnosis.
Received the flu vaccine with my 15 year old daughter. She has experienced no symtoms. I had a series of not previously ever experienced  seizures. 2 back to back. Was taken via ambulance to the hospital. Checked out and then it happened again on the way home from the hospital. I was admitted two days and given meds there. Now I'm on Keppra 500 mg 2x a day. The only thing I changed was the flue shot. I have never had a seizure in my life. Is there a link?
Reaction to Hep A vaccine 2 year health female presents to ER nine 7/28/06 days after hep A vaccination, Pt with fever to 102.8, fatigue, fussiness, anorexia, and poor urine output. ON exam pt appeared well, non toxic, appropriate. Pt was taking good oral fluids, and was afebrile. Family was given assurance and education. Pt was discharge after appropriate follow up. (OMIC).