chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient recieved the COVID vaccine when they wanted the flu shot. Patient called on Wednesday (10/4) and scheduled the appointment over the phone. Patient states that they requested a flu shot but the person putting in the appointment scheduled them for the COVID19 shot. Patient came for the vaccine appointment and it wasn't until after the vaccination was complete was it noticed the wrong vaccine was scheduled.  No reactions to the vaccine as of yet but patient did not wish to receive the vaccine.
Notification received on 04.22.2021.After the second dose of COVID-19 vaccine, given on 04.08.2021,  patient presented common adverse reactions. Patient indicated having headache, tiredness,  fever, pain on right arm (site of vaccination). On 04.10.2021 patient notice generalized rash (except on face and mouth) with severe itching and sensation of itching of internal organs. Patient visited her primary physician who administered diphenhydramine IV and anti-inflammatory (could not recall the name) and was recommended to continue with Claritin and Calamine.  Rash resolved. CBC, PT and INR performed on 04.14.2021; On 04.22.2021 patient notice petechia like marks on right side of mouth (interior). No other area involved. Patient will visit her primary care physician today.
@ 7PM recv vax & MN took 1st dos of vax & 15min later devel dizziness & tremors (lt sided);had taken lodine & advil in past;adm to hosp & later dx w/serum sickness;
feeling like he had the flu; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (brother-in-law).   A male patient of an unspecified age received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number and Expiration date: Not reported), dose 2 via an unspecified route of administration on an unspecified date as 2nd dose, single; and patient previously received first dose of BNT162B2 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported patient was fine after first dose but he had few symptoms after second dose, patient felt like he had the flu after second dose on an unspecified date. The outcome of event was unknown.   Information about lot/batch number has been requested.  Follow-up (19Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient developed Bell's Palsy 4 days after receiving Sanofi Pasteur Influenza vaccine.  01/16/2008 MR received for DOS 12/18-19/2008 with DX: Left Bell Palsy.  Pt presented to ER with c/o L sided facial weakness since that morning.  Numbness of the tongue x 2 days.  PE (+) L Cranial Nerve VII impairment, otherwise WNL. Tx with Valtrex and prednisone and D/C.
Marked mood changes including lability and depressive symptoms.  Should the two doses of the vaccine have the same lot number?
2-3 hours after hi-dose FLUZONE, the pt. experienced stomach upset, nausea, & sweating. She also work up 2x during the night (1st night after shot) with muscle cramps in legs. She took ALEVE.
Shoulder (site of injection) became very sore.  Put ice on it intermittently throughout the evening. By morning it was so sore, I could not raise my arm.  This lasted for 4 days.  When I called the clinic on 03/09, the nurse suggested I come in to be seen, but I didn't want to pay for Urgent Care. She suggested "heat or cold, whichever feels better."
Mild erythema from acromion process on R down to olecranon process, dorsal surface of R upper arm. Very hot to touch. Moderate swelling of deltoid in comparison to L arm. Symptoms started within 6 hours of vaccine administration on 06/08/22. Family scheduled appointment and was seen approximately 24 hours later. No fever or other signs of systemic infection/inflammation.
Within ten seconds after completion of injection, lightheadedness, nausea, clammy skin.  I'm not sure how long it lasted.  Over the next half hour, very small waves of lightheadedness would return.
COMPLAINED OF DIZZINESS AND SLIGHT HEADACHE.  (TIME OF ADMINISTRATION MUST HAVE BEEN AROUND 9:30 AM).  ALLOWED TO REST THEN CALLED MOTHER WHO CHOSE TO TAKE HIM TO HIS DOCTOR.
Less than 48 hours after her second dose, she felt severe ovary pain on both sides and fainted.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with (Merck) VARIVAX (dose, route of administration were not reported) lot number: K002049, expiry date: 10-FEB-2016 that had been improperly stored. No adverse effects were reported. Additional information is not expected because the nurse did not give a consent for the follow-up.
Patient experienced red rash at injection site that was tender to the touch.  The rash size did grow larger from Saturday to Sunday.
This spontaneous report was received from a nurse practitioner refers to a female patient of unknown age. The patient had no drug reactions or allergies. On an unknown date, the patient was vaccinated with dose 1 of GARDASIL, (lot number, expiry date and route was not reported). Concomitant medications were not reported. On an unknown date, the patient experienced vomiting 5 minutes after receiving the injection. The outcome of vomiting was reported as recovered. The patient sought medical attention (patient was in the office when AE occurred). Additional information has been requested.
pt recvd vax 5 mins later facial color pale, head down to knees for 2 breaths then sat up & lost consciousness;back & legs, neck all stiffened, eyes rolled back;pt assisted to floor had snoarous resp x 1min then stiffened arching back; sz;
Headache, myalgias, fever up to 100.4F, erythema and swelling of injection site.  Seen at family medicine clinic day 7, improving.  Prescription for prednisone and recommended Benadryl
A wheal was not present after the first attempt. The second attempt was done by an expert in intradermal administration, a wheal was formed, and the attempt was successful
Started with Chills, headache, aches and pains in joints and muscles.   Body feeling heavy.   Got up to use the restroom around 2:45am and got nauseous and very hot and passed out for about 15 seconds.  Woke on the floor which cooled me down, drank some water and went back to bed.  Next morning I got woozy and had trouble standing.  Slept most of april 8.   April 9th felt better.
Just after MMR was given and PPD test, pt slumped forward and lost consciousness for 10 seconds - awoke, clammy and pale not fully oriented. Had 2-3 convulsions while unconscious. Pulse regular, laid flat for 20 minutes. No further difficulty.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-OCT-2011, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 03-JUN-2016, the patient was treated by a physician for the onset of a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
I just had a migraine and high blood pressure. I was throwing up from the headache as well.
BREAKTHROUGH COVID 19 who presented to the emergency room via EMS with generalized weakness for the past 1.5 weeks.  Patient was recently discharged from the hospital because of UTI and COVID-19.  Patient has failed treatment of oral antibiotic and stated that he needed some inpatient care by his primary care physician. FIRST DOSE JAN 21, 2021
13 x 9 cm area of mild erythema and swelling on left upper arm - circular.
Patient was 16 years old when they received the shot and it has not been approved to be given till a patient is 18 years old. Patient has experienced no know adverse effects at this point in time.
Extreme soreness to arm and fever as high as 102-103 lasting 2 days. Vaccine was given as results from high water from hurricane.
Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old male patient who received expired dose of vaccine MENACTRA (lot number: U5839AA, expiry date: 05-Mar-2019) (dose, dose in series, route not reported) in left deltoid on 08-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was unknown if the patient had any adverse event following the vaccination. 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 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. Documents held by sender: none. Initial information received on 11-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old male patient who received expired dose of vaccine MENACTRA (lot number: U5839AA, expiry date: 05-Mar-2019) (dose, dose in series, route not reported) in left deltoid on 08-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was unknown if the patient had any adverse event following the vaccination. 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 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. Documents held by sender: none.
Pfizer 8/30/21, 9/20/21, 3/3/22. Positive on 12/3/22
Patient who received a booster dose at .5mL; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient who received a booster dose at .5mL) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Diabetes and Asthma.    On 02-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 02-Dec-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient who received a booster dose at .5mL). On 02-Dec-2021, ACCIDENTAL OVERDOSE (Patient who received a booster dose at .5mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
PATIENT HAD A GRAND MAL SEIZURE, WHERE HE URINATED ON HIMSELF AND LOSS CONSCIOUSNESS WITHIN MINUTES OF VACCINE.
her arm hurt for about a week and she had redness at the injection site; her arm hurt for about a week and she had redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rheumatoid arthritis. Concomitant products included certolizumab (Cimzia) and methotrexate.   On 4th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 6 months after receiving Shingrix, the patient experienced pain in arm and injection site erythema. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the injection site erythema was recovering/resolving.   It was unknown if the reporter considered the pain in arm and injection site erythema to be related to Shingrix.  Additional details were reported as follows: The patient received 1st dose and experienced pain in arm  for about a week and she had redness at the injection site. The patient stated that she had a history of rheumatoid arthritis and that she took several medications that cause her to have a similar rash or reaction when she is exposed to the sun. The reporter consented to follow up. This case has been linked with US2020AMR047260, reported by same reporter.
Patient presented to the clinic with left upper arm redness with light induration, warmth to touch, tenderness. Temp=98.5 (2 days after administration).
ON 4/7/2021 AT 1600, PATIENT HAD INITIALLY REPORTED BEING OK POST VACCINE. PATIENT THEN BECAME PALE. NURSE ASKED PATIENT IF SHE WANTED TO LAY DOWN FOR A LITTLE WHILE. PATIENT REFUSED AT THIS TIME. COLORING RETURNED TO PATIENT'S FACE. PATIENT CONTINUED TO TALK WITH NURSE. THEN BECAME PALE AGAIN. AT THIS TIME, PATIENT REPORTS SHE THINKS SHE NEEDS TO LAY DOWN. NURSE ASKED ANOTHER NURSE TO RETRIEVE A WHEELCHAIR WHILE THIS NURSE STAYED WITH PATIENT. AFTER OTHER NURSE WALKED AWAY, PATIENT STATED SHE FELT LIKE SHE WAS ABOUT TO PASS OUT. PATIENT THEN SLUMPED OVER IN CHAIR TOWARDS NURSE. NURSE HELD PATIENT'S HEAD AND UPPER TORSO AND ASKED FOR FURTHER ASSISTANCE FROM OTHER STAFF. PATIENT HAD A PULSE. VS TAKEN. SEE VITALS. PATIENT HAD NO RESPONSE TO VERBAL CUES. STERNAL RUB GIVEN. PATIENT IMMEDIATELY WOKE. PATIENT SET UP AND WAS ORIENTED X3. PATIENT REFUSED TO LAY DOWN ON STRETCHER. PATIENT SET AT NURSES STATION. PATIENT WAS GIVEN ORANGE JUICE AND CRACKERS. COLD PACK APPLIED TO PATIENTS NECK. UPON FURTHER ASSESSMENT, PATIENT REPORTS FAINTING IN PAST TO BLOOD DRAWS AND REPORTS LOW BP AND HEART RATE AS NORM. PATIENT CONTINUED TO BE AS COHERENT AS PRE VACCINE. PATIENT SET WITH NURSE FOR 30 MINUTES POST EPISODE. PATIENT DID EAT MORE CRACKERS AND ATE MORE JUICE BUT REFUSED ANY MORE POST INTERVENTIONS OR ASSESSMENT. PATIENT ALSO REFUSED TO CALL OR LET STAFF CALL ANYONE TO REPORT EPISODE AND ALSO REFUSED ANY TRANSPORTATION TO HOME STATING SHE JUST HAD A 10 MINUTE WALK PATIENT WAS AGREEABLE TO AT LEAST TEXT COWORKERS OF HER WHEREABOUTS. PATIENT WAS INFORMED OF RISKS. PATIENT REPORTS UNDERSTANDING BUT LEFT ON HER OWN ACCORD AT THIS TIME ON 4/7/2021 AT 1631.
Vomiting started with in several hours of receiving the vaccine, had a 4 oz. weight loss which lead to a work-up for vomiting and weight loss to rule-out pyloric stenosis and intussusception. Pt. did have a documented ileus on abdominal x-ray developed diarrhea 2 days later.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: patient almost fainted bp66/40-Medium, Systemic: Headache-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
Pt reported dizziness. Vitals: 164/73, 64, 20 Pt stable and released from the vaccination site.
Since I got the vaccine my menstrual cycle has been completely messed up. My cycle used to be 29-31 days and since I got vaccinated they have almost DOUBLED. My current cycle is at 58 days so far. My period was supposed to start 23 days ago, but I?m still waiting on it. My last cycle was 46 days. The one before that was 51 days.  My husband and I want to start trying for a baby soon, I?m very concerned how this is going to affect that. I wasn?t going to report this even, but after dealing with this for a year now I thought it would be a good idea to report it. Even though it?s not life threatening, if it affects women?s ability to conceive a baby then it is a big deal.
Red raised patch below the injection site; Raised patch below the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown.   It was unknown if the reporter considered the localized erythema and local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that the patient experienced a red raised patch about 2 to 4 inches below the injection site following Shingrix administration.The patch was oval in shape. The reporter consented to follow up. The registered pharmacist had no further details regarding this patient.  Similar adverse event reported by this registered pharmacist earlier on the reporting date.
This spontaneous report as received from a pharmacist refers to a 50 year old female patient. On 24-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J004266, expiry date 12-JUL-2014, (dose and route not reported). There were none concomitant medication. On 25-AUG-2013, reported as the morning following vaccination, the patient experienced injection site reaction, red warm to the touch area at the injections site of the ZOSTAVAX. The patient sought medical attention by contacting the pharmacist. There was no treatment given for adverse events. The patient's outcome was reported as not recovered. The relatedness between ZOSTAVAX and adverse events was unknown. Additional information is not expected.
1/5/21 at 1512, employee was having cold like symptoms prior to getting vaccine.  REcieved vaccine and next day was feeling SOB on 1/6/21 and progressively SOB worsened.  1/7/21 called in due to severity of symptoms and went to Urgent Care that day.  TEsted + for STrep but negative for Covid.  Other symptoms are cough, scratchy throat and low grade fever off and on (high was 100.4).  On 1/8/21 employee went to ER for increased SOB.  Tested negative again for Covid but had an elevated D-dimer.  No diagnosis was given.  Employee was discharged home.  As of 1/11/21 still continues with SOB due to unknown etiology.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/1/2022 HX OF LARYNGEAL CANCER R09.02 HYPOXIA 1/26/2023 HX OF LARYNGEAL CANCER
After receiving his flu and HPV vaccine, patient became diaphoretic and lost consciousness. Patient was transferred to the exam room bed and cold compresses were applied to neck and forehead. Pulse ox was put on and constantly observed.
Patient was given meningococcal vaccine, Menveo.  Was given the liquid C-Y-W135 component without being reconstituted with the lyophilized A component.
I now have a red and itchy rash with a lump by the injection site it?s  8 days since I received the first shot of the moderna vaccine
103.8 fever , rapid heart beat, vomiting , diarrhea , headache. Advil brings fever down
She has started getting rashes all over her body; Cough; Sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7-year-old female patient received BNT162b2 (BNT162B2), on 28Sep2022 as dose number unknown (orange cap), 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: COUGH (non-serious) with onset Sep2022, outcome "unknown"; ILLNESS (non-serious) with onset Sep2022, outcome "unknown", described as "Sick"; RASH (non-serious) with onset 29Sep2022, outcome "not recovered", described as "She has started getting rashes all over her body".  Additional Information: Patient had taken the Pfizer COVID 19 Vaccine for 5 to 11 years of age on 28Sep2022 and after around 24 hours she had started getting rashes all over her body followed by some cough. She was 07-year-old so reporter wanted to report the side effect and also wanted to check if it was a or can it be a side effect of COVID vaccine. It was further reported that it happened on 29Sep2022 (reported as yesterday) the episode of rashes and now (at the time of this report) again it was happening again. Patient was sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy and redness on abdomen, trunk. Maculopapular type rash.
Syncopal episode with loss of consciousness approximately 36 hours after vaccine. Unknown length of loss of consciousness as patient lives alone. Pt experienced dizziness, fatigue and decreased appetite the day of adverse event.
LA appears red, swollen and hot to touch. Advised to apply cool compress and give Motrin for discomfort.
Local soreness started at 11:00 am on 11-09-11. Took 2 ADVIL in afternoon & 2 ADVIL before bed. Did not sleep on arm, but arm sore in morning & took 2 ADVIL. Mammogram technician noticed redness & swelling and edema at 2:15 pm 11-10-11 & advised to see doctor. There was red and  no itching. Doctor said severe reaction rx for prednisone (20mg 2 x day) day & nite antihistamine. 4 ADVIL 2x day & ice.
This spontaneous report was received from a medical assistant referring to a 18 year old male patient who had had unspecified difficulties with vaccines in the past. The patient's current conditions included hyperthyroidism and hypersensitivity to AUGMENTIN. Concomitant therapies included levothyroxine sodium (manufacturer unknown). On 06-FEB-2017, the patient was vaccinated with the first dose of hpv GARDASIL 9 (lot # M024261, expiration date: 30-JUL-2018) subcutaneously, for prevention of human papilloma virus (hpv). It was stated that, at the time of vaccination, he had a cold and was already not feeling well. On 06-FEB-2017, immediately after receiving the dose, the patient experienced convulsions. After that, he was monitored and his stats were good, so he was sent home on the same day (reported as "soon after"). 07-FEB-2017, reported as "on the next day", the medical assistant called the patient's mother, who stated that he was tired and not feeling right. On 08-FEB-2017, the patient was recovered from the events (reported as "now back to normal"). Causality relationship between the events and GARDASIL 9 vaccination was not reported. Upon internal review, the event seizure was determined to be medically significant. Additional information has been requested.