chrisvoncsefalvay/vaers-outcomes huggingface dataset:
IPOL vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event; Initial information received on 15-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient who experienced ipol vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunisation; and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation.  On 09-May-2022, the patient received a 0.5ml  dose of suspect IPV (VERO) (batch lot U1C572M Expiry date :17-Jun-2023 )(unknown strength and formulation)via intramuscular route in right thigh for immunization.  On 09-May-2022 (latency :same day)the patient developed a non-serious event of  ipol vaccinations from 2 separate multi-dose vials that were each the 11th doses drawn from their respective multi-dose vials with no adverse event (incorrect dose administered) following the administration of IPV (VERO).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01148369:
I now have blisters on my left arm. My arm has pus at the injection site. A little peeling skin on my left arm. It feels hot . It's very red and sore. Now I'm applying antibacterial cream.
Initial report received from a consumer (acquaintance of the patient) on 03 Dec 2009: This patient with medical history of Seasonal vaccination, sick and low grade fever, received Influenza virus vaccine-Pandemic INN on 01 Dec 2009. The patient experienced much more sleep than common, needed extra two hours sleep than usual eleven hours per night, uncharacteristic sleepiness and tiredness on an unspecified date. It was reported that, the reporter was not sure about whether the vaccination caused the events or the pre-historical conditions. The outcome of the events was not reported.
This spontaneous report as received from a consumer concerning her 11 year old daughter. The patient's historical drug included HUMIRA for knee swelling, but had not used since December 2015. She is allergic to amoxicillin. Concomitant medications were not reported. On 07-JUN-2016, the patient was vaccinated with M-M-R II via subcutaneous route (lot # lot L044058, expiry date and dose not reported). Subsequently, on 10-JUN-2016, the patient knees began to swell. On 28-JUN-2016, the patient developed swelling in her right and sought medical attention-went to physician's office. The physician stated the patient had arthritis in her eye and treated with prednisone drops. The outcome of the events was reported as recovering. The patient's physician believed that all of her symptoms are as results of the vaccine. The reporter did not assess the relatedness between the events and the vaccine. Additional information has been requested.
Janssen COVID-19 Vaccine EUA  Numbness on left side of body, numbness in fingers, chest feels heavy, no shortness of breath
small red raised itchy rash at site of injection, hives to arms and legs within 24 hours. 2nd vaccine worse. left arm redness and itching, general body itching, wheezing, entire upper left arm red and itching
This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Received a  full dose instead of a half a dose for the first booster/Received 0.5ml from Red Cap Vial instead of 0.25ml for first booster dose) and NO ADVERSE EVENT (No adverse event) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2022, the patient experienced ACCIDENTAL OVERDOSE (Received a  full dose instead of a half a dose for the first booster/Received 0.5ml from Red Cap Vial instead of 0.25ml for first booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Received a  full dose instead of a half a dose for the first booster/Received 0.5ml from Red Cap Vial instead of 0.25ml for first booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Received a  full dose instead of a half a dose for the first booster/Received 0.5ml from Red Cap Vial instead of 0.25ml for first booster dose).    No concomitant medication reported. No treatment medication details reported.
10cm x 6.5cm red, swollen & hardened arm on lt deltoid;
violent heavying, sweating for 2 hours; pain in chest; diarrhea; chills; sore; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 06Mar2021 14:00 as a single dose (at the age of 61-years-old) for covid-19 immunisation. The patient had known allergies to flu shot, contrast dye, aspirin and codeine. She had a major reaction to flu shot so was scared to have this. She took Pepcid and Zyrtec 3 days prior and 1 week following. The patient was not pregnant at the time of vaccination. The patient had no COVID prior vaccination. There were no other vaccine in four weeks. There were other medications in two weeks. The patient received the first shot, day 1 and 2 was fine. On day 3 (09Mar2021 11:00), diarrhea started, day 4 (10Mar2021) - violent heavying, sweating for 2 hours then pain in chest. The patient thought she was having a heart attack. After many test it was not her heart, then more test that would not cause these issues. The physician determined it was the vaccine. On Mar2021, she still feel chills and very sore. The patient was scared to get her second dose. It was unknown if the patient received treatment for the reported events. The reported events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not tested post vaccination. The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Client c/o slight stiffness and pain in the back of neck.  Client seen and assessed by EMT and VS are: BP 153/87, HR 78, O2 97.  Client voice that symptoms occurred minutes after receiving vaccine.  Client cleared to go home by EMT after verbalizing her was feeling a decrease in sensation.
worst case of flu; This case was reported by a consumer via other manufacturer and described the occurrence of influenza in a 67-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza. On an unknown date, the outcome of the influenza was unknown.   It was unknown if the reporter considered the influenza to be related to Shingles vaccine.     Linked case(s) involving the same patient: US2022AMR053663   Additional Information: GSK Receipt Date: 24-Mar-2022 Reporter's comment: The case was self reported by the patient. The patient experienced worst case of flu after taking Shingles vaccine. The reporter consented to follow up. Additional Supportive Information: This case is linked with case US2022AMR053663 reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR053663:
Significant dirty metal taste that impacted all food consumed; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the right arm on 23Mar2021 at 13:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included depression, gout, penicillin allergy and COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO), allopurinol (MANUFACTURER UNKNOWN) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); all from an unknown date for unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 06:00, the patient experienced significant dirty metal taste that impacted all food consumed. It was unknown if therapeutic measures were taken for the reported events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event significant dirty metal taste that impacted all food consumed was resolving at the time of reporting.   No follow-up attempts are needed. No further information is expected.
This spontaneous reprot as received from a clinical medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On 01-MAY-2015, 05-MAY-2015, 11-MAY-2015, 21-MAY-2015, 22-MAY-2015, 26-MAY-2015, 27-MAY-2015, 02-JUN-2015, 03-JUN-2015, 08-JUN-2015, 09-JUN-2015, 15-JUN-2015, 16-JUN-2015, 17-JUN-2015, 22-JUN-2015, 26-JUN-2015 and 01-JUL-2015, the patients were vaccinated with improperly stored doses of VAQTA (strength, dose, route of administration, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
Swollen joint between thumb and wrist (not at injection site); very painful, had terrible night. MD could not explain reaction - asked if patient bruised it there and answer was no.
Fever approximately 12 hour after the shot, soreness in left arm, chills and difficulty sleeping.  48 hours after the shot a red blotch appeared on my arm and became warm to touch.
significant dizziness, light headed, hot, weakness. Monitored and Resolved without treatment in 30 min.
Immediately after injection, I could feel the vaccine or some associated sensation spreading slowly throughout my body. When the sensation reached nerve endings (tip of fingers, tip of toes, tip of penis) I got a sharp sensation like being stabbed by a needle. I also tasted something on my tongue. This process took a few minutes to occur. After that, I felt dizzy and weak for a day or two.
One week after first shot of Moderna, my left arm started swelling and remain swollen at the area of injection. There are red dots at beginning follow by large red area of itchiness, heat, and pain.  The swollen area at first is 2 inch by 1.5 inch, and now grow to  6 inch by 3 inch.
Pt noticed redness, swelling, and warmth at injection site. complains of some itching
exhausted/tiredness; She says she feels a little fuzzy, like she is not thinking clearly; Discomfort; mild malaise; Trembling; This is a spontaneous report from a contactable consumer (Patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6202; Expiry Date: 30Jun2021), administered in left arm on 03Mar2021 (at the age of 79-years) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced discomfort, mild malaise, trembling, on an unspecified date she says she feels a little fuzzy, like she was not thinking clearly and she says she was not able to do anything due to exhaustion. she has been having three days of discomfort and mild malaise for a week. The patient says she was not able to do anything due to exhaustion, so she thought Pfizer would want to know. She says that she could not type due to trembling to complete a report online. Patient second dose was on 26Mar2021, and they did not ask for her vaccine card, so she does not have and was not able to provide NDC/LOT/EXP from the second dose. She says that the NDC was not provided on her vaccine card for the first dose. The patient mentions a COVID test, but says that this was just a paper, she had forgot that she had a card, the test was to do a job. Patient says it was the second dose that she had a reaction after. She says she got both doses in her left arm. She says her reaction was discomfort and mild malaise beginning Saturday. Patient said that it has not got better or worse, she was having intermittent trembling periods where she would feel ok but then start shaking and be exhausted again, so it has been about the same since Saturday. Patient said that she will be ok for a couple hours, and then it will all start again, and she will shake all over. Patient felt a little fuzzy, like she was not thinking clearly, and so tired and trembling. The patient said that her prolonged reaction was not enough to go to the hospital, but she was not feeling so good, and thinks maybe people should be warned. The patient did not receive any treatment for adverse event. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
did not keep us the allotted 15-30 minutes after receiving vaccine. On the drive out, I immediately got a headache, hot/sweaty, blurred vision and felt faint. We were unable to pull over and the high curbs and single car line we were in, my husband pulled over when he could but thankfully my symptoms only last 2-3 minutes. I used a cold compress and had a fan on me when I arrived home about 10 minutes later. About an hour and a half later, my arm hurt bad enough to use a cold compress for two days.   Today, 4 days later, my arm has a slight pain to the touch.   I did report this to my family doctor, via email.
After I took  the 1st Covid shot I was due for my period and ended up being 7-8 days late. This did not happen after the 2nd dose.  Then recently I got my Pfizer booster shot 1/11/22 FL3197 and again it made me late 5-6 days. I am normally very regular. My period was normal flow and cramping but I thought it was something to report that it made me late both times.
Fever to 100.8 22 hours later with headache, abdominal pain, body ache and vomiting
Patient given a PFIZER COVID booster in error-patient was not old enough to receive booster at this time.
Pt reported dizziness after shot @1:50 PM. Per patient request called her mother whom she talked to on phone. The dizziness was resolved w/in 15 minutes and patient was oriented X 3 and reported being well enough and had confidence in her ability to safely get home. She was given permission that if she felt well enough she can go if she's comfortable. Followed up with phone call same day at 6:15pm and pt was safe and feeling well.  Pt's vax consent form did not report having felt faint in past. After shot was administered she reported that she has had this effect in past. Furthermore, before administration pt was offered an opportunity to ask questions about questionnaire and/or vaccination.
post injection: 8 minutes-heart pounding so strong I could hear it, continued for 5 or 6 minutes 8 minutes-slight drop in blood pressure (I've gone as low as 32/18 during a bad reaction so I know this time was a much smaller drop) 13 minutes-stomach pains started, these would continue throughout the night waking me, and lasted approximately 17 hours 30 minutes- sudden feeling of lightness in my body, and that a light had gone on 60 minutes-odd sensations in throat but did not feel swelling, simultaneously at 60 minutes-dizzy the next day, 10 bowel movements until 2 pm
pt took a nap on 4MAY96 @ 2PM & woke up 3PM c/o wrist & arm pain;small red swollen bumps were all over trunk & arms;hands & feet were swollen;woke up @ 2AM 5AY96 & face & neck was swollen & diff bending ankles & fingers;taken to clinic 5MAY
Had my second covid vaccine 2/12/2021 at 11:55am and woke up 4:30am 2/13/2021 with irregular heart rate, shortness of breath, wheezy, achy, and so weak I could barely move.  My Mom is a Nurse Practitioner, checked my pulse and felt an irregular beat, my heart rate was fast 105 beats/min at rest and 142 beats/min with exertion, oxygen was 91% and I had a fever 100.5F orally.
Hospitalization 8/11/22-8/14/22 paranoia, delirium, psychosis, agitated, drug overdose, acidosis, AKI, decreased appetite,
This spontaneous report as received from a nurse refers to a patients of unknown age and gender. A nurse reported that an unspecified number of unknown patients have been administered doses of RECOMBIVAX HB lot # J007946, expiration date 24-MAR-2016 and lot # J14855, expiration date 16-APR-2016, intramuscular that have underwent a temperature excursion. It was reported that RECOMBIVAX HB was stored at both 47.1 Fahrenheit degrees for 96 hours and -5 Celsius degrees for 48 hours. RECOMBIVAX HB lot # J007946 was given on 08-OCT-2014, 10-OCT-2014, 21-OCt-2014, 24-OCT-2014, 30-OCT-2014, 10-NOV-2014 and on 21-NOV-2014. RECOMBIVAX HB lot # J014855 was given on 11-DEC-2014, 12-DEC-2014, 30-DEC-2014 and on 20-JAN-2015. Additional information has been requested. This is one of several reports from the same reporter.
1/19 vaccination 1/20 At about 3pm, I had symptoms of having my period. I started having really bad pain on lower back, I could not stand. I could not pick my baby up. I called my husband to come home. The pain was extremely bad, I could not walk. I took Ibuprofen, called clinic and they said you should call CDC or wait. I went to bed and around 6am I felt like I had to go to the bathroom. Walking back, I went to sit on edge of bed, I was in so much pain. I started feeling so bad, I fainted. When I woke up, my husband was asking me questions. We called 911, took vitals, transferred to ER.  Gave Ibuprofen and did ultra sound. They discharged between 11-12. They said to follow up with PCM.  It was so scary. Symptoms lasted for 4-6 days after. It became better each day.  *still have not had second vaccine
Headache, Myalgia, HA, muscle aches, chills, sweats, fatigue, arm soreness  Narrative:  Took OTC acetaminophen for above sx
A non-serious spontaneous report of 'administered H1N1 to pregnant female' and wound was received from a nurse/health professional concerning a 26-year-old pregnant female, subsequent to H1N1 Vaccine Live, Intranasal. The patient neither had any relevant medical history nor any concomitant medications. The obstetrical history of the patient included gravida one and para zero. The patient was nine weeks pregnant at the time of vaccination. The EDD of the patient was 15-Jun-2010. On 03-Nov-2009, the patient received H1N1 Vaccine Live, Intranasal for an unknown indication. The reporter stated that she had seen the patient on 21-Jun-2010 for a wound check. The reporter then indicated that she could give no further information but gave the name and phone number. The outcome of the event of 'administered H1N1 to pregnant female' was considered resolved and the outcome of the event of wound was unknown. Additional information was received on 22-Dec-2009 and incorporated into the narrative are patient's medical history, concomitant medications and obstetrical history. Additional information was received on 08-Jul-2010 and incorporated in the narrative: adverse event of "Wound" was added. Other additional information received was patient's full name and physician name and phone number.
12MAR96 pt recv vax 830AM & 1- 1 1/2hrs post vax pt began uncontrollable crying w/emesis;parents took pt to ER;pt had t101R some local redness,swelling rt thigh;improved by PM;d/c w/APAP,clear fluids;seems better
I had a severe headache and muscle soreness after the vaccine. I was 6 months pregnant with my second child. They were born full term on May 30th, normal, healthy, weighing 8lbs 15oz.
This spontaneous report as received from licensed practical nurse refers to a female patient of unknown age. The patient was vaccinated with M-M-R II (lot# unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient's recent titer revealed a "borderline" (0.80) titer for rubeola. No treatment information was reported. The outcome of the event was unknown. This is one of two reports regarding the same patient. The other report is 1212USA006317. Additional information has been requested.
muscle soreness in the arm at the injection site; muscle soreness in the arm at the injection site; fatigue; This is a spontaneous report from two contactable nurses (one of reporter was patient). A female patient of an unspecified age received two dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date respectively at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient received two Pfizer COVID-19 vaccination shots. The patient experienced muscle soreness in the arm at the injection site, that was much worse after the second shot. In addition, she experienced fatigue for 24 hours after the shot. The outcome of events was unknown.  Information about lot/batch number has been requested.
Swelling, fever, itching, rash,  redness, pain at  injection site
Left swollen, painful and red sub clavicular lymph node on same side of injection site.