chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 14 month old female with congenital neutropenia and no known allergies who at "12 months old", in March 2006, was vaccinated with Varivax. The patient had two episodes of chickenpox after receiving Varivax. The first episode of chickenpox with vesicles occurred in April 2007, "one month" after she was vaccinated with Varivax. The vesicles were sent to the lab and tested positive for varicella zoster virus. She was hospitalized for 10 days due to the rash spreading and her neutrophil count went down. The patient was treated with intravenous acyclovir for 10 days and then discharged after the rash was resolved. Earlier this month the rash reappeared on her arm. At the time of this report, the  patient was considered recovering from the events. No product quality complaint was involved.  Upon internal review, chickenpox and neutrophil count went down were determined to be other important medical events. Additional information has been requested.
My vision started getting blurry/hazzy like my vision was without glasses on, but I HAD my glasses on! And as I listened to the nurse and my father talking I noticed that it was getting harder and harder to hear until I was only able to tell the speaker's gender and not what they were saying. Then the world seemed to be moving and my wind pipe started to close up.... I started to slip down the wall. This lasted until I as injected with 25mL of Benedril. However, my arm has become numb and I've recently started wheezing.
This spontaneous report has been received from a Licensed Vocational Nurse (LVN) referring to unspecified number of patients. On unknown dates the patients were vaccinated with improperly stored dose of GARDASIL (dose and route not reported, lot# L006549, expiration date: 26-APR-2017, lot# K011562, expiration date: 28-APR-2017). No adverse event. This is one of several reports from the same reporter. Additional information has been requested.
Rash appeared the following morning 02/12/2014. Pt. Father states pt. had fish for dinner also.
menstruation period stared 7 days early for 3 months in a raw; little tenderness; her menstruation is heavy for first 2 days and then bleeding completely stopped; terrible cramping compared to normal; felt like someone punched her in the face; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (menstruation period stared 7 days early for 3 months in a raw), TENDERNESS (little tenderness), HEAVY MENSTRUAL BLEEDING (her menstruation is heavy for first 2 days and then bleeding completely stopped), DYSMENORRHOEA (terrible cramping compared to normal) and FEELING ABNORMAL (felt like someone punched her in the face) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and Acne medication  that is diuretic for an unknown indication.   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (menstruation period stared 7 days early for 3 months in a raw), TENDERNESS (little tenderness), HEAVY MENSTRUAL BLEEDING (her menstruation is heavy for first 2 days and then bleeding completely stopped), DYSMENORRHOEA (terrible cramping compared to normal) and FEELING ABNORMAL (felt like someone punched her in the face). At the time of the report, MENSTRUAL DISORDER (menstruation period stared 7 days early for 3 months in a raw), TENDERNESS (little tenderness), HEAVY MENSTRUAL BLEEDING (her menstruation is heavy for first 2 days and then bleeding completely stopped), DYSMENORRHOEA (terrible cramping compared to normal) and FEELING ABNORMAL (felt like someone punched her in the face) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided.  Concomitant medications included Adderall, Acne medication  that is diuretic but do not remember the name of it.  The Action Taken for mRNA-1273(Moderna COVID-19 Vaccine) was unknown     This case was linked to US-MODERNATX, INC.-MOD-2021-231618 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-231618:1st Dose spon. case
currently has a head cold; nasal congestion; sore left arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (currently has a head cold), NASAL CONGESTION (nasal congestion) and VACCINATION SITE PAIN (sore left arm injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left arm injection site). On 14-Dec-2021, the patient experienced NASOPHARYNGITIS (currently has a head cold) and NASAL CONGESTION (nasal congestion). At the time of the report, NASOPHARYNGITIS (currently has a head cold) and NASAL CONGESTION (nasal congestion) had not resolved and VACCINATION SITE PAIN (sore left arm injection site) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-410410, MOD-2021-410335, MOD-2021-410313 (Patient Link).
Had close contact with a person who has a laboratory confirmed case of COVID-19 in the past 14 days? Yes. Patient never had symptoms.
No Adverse Event; patient received a monovalent Moderna COVID-19 Vaccine booster (0.5 mL) instead of the bivalent; 0.5 mL Monovalent booster administered; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a monovalent Moderna COVID-19 Vaccine booster (0.5 mL) instead of the bivalent), ACCIDENTAL OVERDOSE (0.5 mL Monovalent booster administered) and NO ADVERSE EVENT (No Adverse Event) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Dec-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 06-Dec-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a monovalent Moderna COVID-19 Vaccine booster (0.5 mL) instead of the bivalent) and ACCIDENTAL OVERDOSE (0.5 mL Monovalent booster administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a monovalent Moderna COVID-19 Vaccine booster (0.5 mL) instead of the bivalent) had resolved and ACCIDENTAL OVERDOSE (0.5 mL Monovalent booster administered) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (patient received a monovalent Moderna COVID-19 Vaccine booster (0.5 mL) instead of the bivalent) and ACCIDENTAL OVERDOSE (0.5 mL Monovalent booster administered).    No concomitant medications were reported. No adverse events were reported by the patient. No treatment medications were reported.
Pt. would start crying inconsoluably, and said that his legs hurt. He started shaking (had the chills) and sweating (soaking his hair and beads of sweat on his nose). His temperature was on the low side (96.5°F). After a while, he would fall asleep and wake up again with the same symptoms. He had 4 bouts of this before falling asleep for the night 5 hours later.
On day after vaccine, developed redness and swelling of Lt arm from injection site to elbow. Itchy from elbow. Slight warmth to touch. No pain. Seen 9/8/17.
Severe pain for a few weeks as expected at injection location of my right arm at the top.  I didnt do any psychical activity due to the pain and the stitches in my left thumb. After pain subsided I had limited movement in the right shoulder and shoulder blade area the injection was administered. I have seen my physician who referred me to a neurologist who ordered an MRI and performed in office test. The neurologists suggests the vaccine attacked the healthy proteins in my shoulder nerve endings and I now need physical therapy. I have 50% use of my right arm when lifted straight out and half way up. Once at approximately 75% raised I have about 10% strength and am unable to perform the duties I need to on a regular basis and at work.
fully vaccinated 12 year old patient was administered DAPTACEL instead of ADACEL with no reported adverse event; fully vaccinated 12 year old patient was administered DAPTACEL instead of ADACEL with no reported adverse event; Initial information received on 08-Aug-2023 and live follow up received on same date both were processed together regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a fully vaccinated 12 years old patient to whom daptacel was administered instead of adacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, fully vaccinated 12 years old patient was administered diphtheria, tetanus and acellular pertussis vaccine (daptacel), suspension for injection instead of adacel with no reported adverse event (wrong product administered) (Product administered to patient of inappropriate age) (latency same day) (strength, dose, route, site, batch number and expiry date: unknown) Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event wrong product administered.   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.
Tenderness at injection site with intense pain in upper arm emanating down the arm with an inability to move or raise my left arm without excruciating pain.
Pt c/o pain in the Left Arm.  BP 108/73, HR 84.  Pt stable and released from the vaccination site.
Patient reported pain and redness around injection site. Patient also reported it was warm to the touch. She tried a few courses of bendryl and over the counter pain relievers to aid but it did not change. Patient also reported heart palpitations. She went to emergency/urgent care and was prescribed a course of antibiotics.
Lg red area to Lt deltoid 60 mm. Induration 40 mm. BENADRYL elixir. TYLENOL elixir.
SEVERE PAIN ALL OVER BODY, PERSONALITY CHANGES, INSOMNIA, AND TACHYCARDIA.  ALL SYMPTOMS REPORTED LASTED ~20 HOURS.
I am suffering from pain that started after getting my first Pfizer vaccination shot on 3/19/21.  The pain has not gone away and so I went to see my doctor . My first Pfizer dose was given to me at Church: CDC Booking # 169333 03/19/21 @3:30pm.  I have pain in my right arm since my vaccine and have limited motion in my arm before pain increases
Swollen lymph node under left arm pit; This is a spontaneous report from a contactable other hcp (patient).   A 34-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration, administered in the left arm on 19Feb2021  (at the age of 34-years-old) as a single dose for COVID-19 immunisation.  Medical history included allergy to penicillins from an unknown date and unknown if ongoing.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162b2 on an unknown date (Lot Number: unknown) via an unspecified route of administration for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced swollen lymph node under left arm pit on 19Feb2021 with outcome of unknown.  The patient did not receive any treatment for the event. The outcome of the event, swollen lymph node under left arm pit was unknown.
I was alerted that patient was fainting and feeling weak after giving Moderna vaccine. I had my store manager call 911 immediately. I kept talking to patient to keep her conscious. Patient breathing was fine, no anaphylactic shock persent. I placed an ice bag behind her head. I took her blood pressure, 90/48 and pulse of 60. Paramedics arrived and took over. Patient got better and refused to go to hospital.
had shingles after 1st dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date unknown) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix in the left deltoid. The reporter wanted to know, how to proceed with 2nd dose. The reporter did not consent to follow up.
pt recv vax 8NOV95 & on 10FEB97 pt exp 15 lesions;
Patient had no immediate reaction, vital signs remained stable, resident condition did not change, 4 days later became lethargic, O2 sats dropped and sent to the ER.
12/01/09- had pain at injection site and over course of 2 days. Erythema and vesicle at site developed no fever. doing better as of 12/04/09
Headache, stuffy nose, sore throat, nausea and vomiting. Sore arm.  overall fatigue  child had covid 19 in October 2020 confirmed positive with parents test
Information has been received from a consumer concerning her 2 year old son who was vaccinated with the 3 dose series of Hep-B vaccine and subsequently, she sought unspecified medical attention and was found to have elevated liver function tests. Additional information has been requested.
DEEP VEIN THROMBOSIS; PULMONARY EMBOLISM; This spontaneous report received from a patient concerned a 77 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose not started, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 28-MAY-2021, the patient developed deep vein thrombosis and had pulmonary embolism throughout the body. The patient was prescribed with xarelto ((but had not started) to treat deep vein thrombosis and pulmonary embolism. The patient stated that she had no health conditions or concerns before the vaccine. The patient took no medications nor she did any pharmacy coverage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pulmonary embolism and deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210558443-covid-19 vaccine ad26.cov2.s -pulmonary embolism ,deep vein thrombosis . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Case number PHEH2015US001351, is an initial spontaneous report from a physician received on 14 Jan 2015. This report refers to a 26-year-old female patient. Medical history and concomitant medications were not reported. On 11 Jan 2015, she was vaccinated with FLUVIRIN (batch number: 1413901) via intradermal route in error. On the same day, after vaccination, the patient experienced swelling at the injection site. Outcome of the events was not reported. Seriousness and causality of the events was not reported.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. It was reported that these patients were administered doses of improperly stored PEDVAXHIB (dose and route not reported). Lot number and administered date was reported as following: Lot# J014281 expiration 16-SEP-2016): 1 dose was administered on 09-FEB-2015 and 1 dose on 16-FEB-2015: Lot#k002746 expiration 09-DEC-2016): 1 dose was administered on 25-FEB-2015, 1 dose on 11-MAR-2015 and 1 dose on 25-MAR-2015. This is one of the several reports with the same reporter. Additional information has been requested.
I had a sore arm/shoulder after receiving the vaccine. I started to not feel well on 06/01 and on 06/04 I tested for COVID-19. My fever, sore throat, cough and runny nose. My doctor recommended that I do not take the anti viral medication.
Started w/sore throat, fever, headache, tiredness, muscle aches, sinus pain, slight stuffy nose. progressed to drycough, shortness of breath, tightness in chest w/ inability to breeth.
tasted very bad and appeared oily; not able to swallow full dose due to spitting out; not able to swallow full dose due to spitting out; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 5-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 13-APR-2023, the patient received Rotarix lyophilized formulation. On 13-APR-2023, less than a day after receiving Rotarix lyophilized formulation, the patient experienced regurgitation of medication (Verbatim: not able to swallow full dose due to spitting out) and accidental underdose (Verbatim: not able to swallow full dose due to spitting out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: tasted very bad and appeared oily). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.  It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth , which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR059645:Same Reporter US-GSK-US2023AMR058971:Same Reporter US-GSK-US2023AMR059808:Same Reporter US-GSK-US2023AMR059807:Same Reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060497:Same reporter
rash occurred p/vax given;stomach upset, sl rash on inj site;rash cleared up w/in a few days;
Soreness in lymph node in armpit on side where shot was given, began on 1/17/21, continued to 1/20/21. Swelling and hive like rash on site of injection (size of a quarter), appeared on 1/20/21. Claritin taken in response to hives.
Slight nausea, moderate tiredness after twenty-four hours after shot administered, lasting 36 hours hence.  Then no further reactions..
Like an anaphylactic reaction; Tested positive for Covid 19; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced the events, tested positive for COVID-19 and like an anaphylactic reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the next day following vaccine administration, the patient began to experience increased pulse, acceleration in her heart beat, difficulty breathing, and other symptoms like an anaphylactic reaction. The patient also tested positive for COVID-19, although she was asymptomatic prior to receiving the mRNA-1273 vaccine. Treatment for the event included intramuscular Benadryl.   Action taken with mRNA-1273 in response to the events was not reported.  The events, tested positive for COVID-19 and like an anaphylactic reaction, were unknown.; Reporter's Comments: This case concerns a female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown),  and who experienced the serious unlisted event of Anaphylactic reaction and the non-serious unlisted event of SARS-CoV-2 test positive. Very limited information regarding this event of anaphylactic reaction has been provided at this time.  Based on improvement of symptoms after treatment with Benadryl and temporal association between the use of the product and the start date of the event on the day following vaccination, a causal relationship cannot be excluded making the event of anaphylactic reaction possibly related to the vaccine.  Based on the latency of infection with SARS-CoV-2 prior to testing positive for the virus, the temporal association between the use of the product and the start date of the event tested positive for COVID-19 on the day following vaccination, the event is assessed as unlikely related to mRNA-1273.
Headache, Fever (101.6) chils, body aches, fatigue, loss of appetite. The headache lasted about 30 hours, the Fever about 40 hours, the body aches about 8 hours, the loss of appetite about 40 hours, and the fatigue 40 hours. I still don't feel 100%.
PPSV23 ordered, PCV13 given. Age of patient at time of event: 65 years.
Heavy menstrual cycle which lasted 14 days.  After 3 days, I became dizzy and had extremely low energy.  I had to take time off work.
Local symptoms at the injection site: Pain-discomfort. General symptoms: left supraclavicular lymphadenopathy-painful Narrative: