chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lower left quadrant pain; Did not have bowel movement for over 24 hours; Constipation felt like a stone; itching in my face/Itching/pruritus; Abdominal cramp; Facial rash; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation felt like a stone), BOWEL MOVEMENT IRREGULARITY (Did not have bowel movement for over 24 hours), ABDOMINAL PAIN LOWER (lower left quadrant pain), PRURITUS (itching in my face/Itching/pruritus) and ABDOMINAL PAIN (Abdominal cramp) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013C21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Rash) and Pollen allergy (sneezing, sniffles). Concomitant products included ATENOLOL, ASCORBIC ACID (VITAMIN C ACID), CALCIUM and HYDROCHLOROTHIAZIDE for an unknown indication.   On 16-Jul-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced CONSTIPATION (Constipation felt like a stone) and RASH (Facial rash). 16-Jul-2021, the patient experienced PRURITUS (itching in my face/Itching/pruritus) and ABDOMINAL PAIN (Abdominal cramp). 16-Jul-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 17-Jul-2021, the patient experienced BOWEL MOVEMENT IRREGULARITY (Did not have bowel movement for over 24 hours). On an unknown date, the patient experienced ABDOMINAL PAIN LOWER (lower left quadrant pain). The patient was treated with DOCUSATE SODIUM 16-Jul-2021 for Constipation, at a dose of 100 mg four times per day; DOCUSATE SODIUM 16-Jul-2021 for Constipation, at a dose of 100 mg and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) 16-Jul-2021 at a dose of 25 mg four times per day. On 17-Jul-2021, CONSTIPATION (Constipation felt like a stone), PRURITUS (itching in my face/Itching/pruritus), ABDOMINAL PAIN (Abdominal cramp) and RASH (Facial rash) had resolved. On 18-Jul-2021, BOWEL MOVEMENT IRREGULARITY (Did not have bowel movement for over 24 hours) had resolved. On 19-Jul-2021, VACCINATION SITE PAIN (pain at injection site) had resolved. At the time of the report, ABDOMINAL PAIN LOWER (lower left quadrant pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered CONSTIPATION (Constipation felt like a stone), BOWEL MOVEMENT IRREGULARITY (Did not have bowel movement for over 24 hours), ABDOMINAL PAIN LOWER (lower left quadrant pain), PRURITUS (itching in my face/Itching/pruritus), ABDOMINAL PAIN (Abdominal cramp), RASH (Facial rash) and VACCINATION SITE PAIN (pain at injection site) to be possibly related.    Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: F/U received on 21-SEP-2021: New events added, event outcome, treatment and concomitant medications updated.
6.45pm: started with chills and being very cold including blue lips 8pm until 1am: chills got worse and were uncontrollable. Body was shaking heavily. At some point, body was very hot and I developed headaches and some back/neck aches. Chills continued during that time. I was very thirsty but drinking resulted in nausea. I had one thought over and over again which I couldn't break out of.  1am: Vomitted  1:30am: Admission to ER
My back felt hot and itchy. I looked at my back and there was a rash all the way from my neck and biceps down to the top of my butt.
got Vx, months later got shingles/ suspected vaccination failure; Shingles, horrible; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, several months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient got the Shingles vaccine and few months later got shingles and stated that they were horrible. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding completion of primary vaccination schedule and laboratory test confirming shingles was unknown at the time of reporting. The follow-up would not possible as no contact details were available.
DIZZINESS; HIGH BLOOD PRESSURE; BODY ACHE; FEELING SICK; LACKING ENERGY; HEADACHE ON ONE SIDE OF HEAD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness, high blood pressure, body ache, feeling sick, lacking energy, and headache on one side of head. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, feeling sick, and lacking energy, and had not recovered from headache on one side of head, dizziness, and high blood pressure. This report was non-serious. This case, from the same reporter is linked to 20210440783.
Ever since getting the Covid 19 vaccination, I have been getting my period every 2 weeks, consistently.
This spontaneous report was received from a medical assistant refers to unspecified number of patients with unknown demography. On an unknown date, unspecified number of patients were administered improperly stored VARIVAX (Merck) (dose, route and frequency were not reported) with temperature excursion. No adverse effects reported. No additional information provided. Additional information has been requested.
last week June start with short of breath also feel like my hearth going to stop working and get desperate, happened at lease 5 times since that date, never happened before.
Swelling of her lower lip within 24 hour. Gradual onset of myalgias-somewhat stiff neck over 48 hour.
Patient with known allergies in observation area following injection noted flushed cheeks, chest tightness, and reported to clinical manager.(10:16)  Given 25mg PO Benadryl and continued observation.  AT 10:30, no resolution of symptoms-telehealth visit initiated.  Vital signs stable, Oxygen sat at 97%, patient with c/o cough and scratchy throat.  Order given and medication administered.  Solumedrol 125mg IM.  Additional 1 hour observation-symptoms resolved, and patient was discharged to home.
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 23-MAR-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) (lot #: T013204, expiration date: 03-DEC-2021 or lot #: T013546, expiration date: 28-OCT-2021 (two lot# of vaccines have been reported, no information of which one was administrated to the patient); dose, strength and route were not reported) for prophylaxis.          The vaccines underwent temperature excursions and were stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002974: US-009507513-2104USA002973: US-009507513-2104USA002971: US-009507513-2104USA002963: US-009507513-2104USA002972: US-009507513-2104USA002976: US-009507513-2104USA002978: US-009507513-2104USA002980: US-009507513-2104USA002981: US-009507513-2104USA002982: US-009507513-2104USA002983: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Received vaccine at 2:15pm , waited 15 minutes as recommended left the facility driving home started receiving warm tingly feeling, lost consciousness, drifted off the road crashed my vehicle into a tree head on collision 2:45pm. Cannot hear out of my left ear.
I felt like I was drugged; I was slow and I was swaying.; I was slow and I was swaying.; I had trouble getting my feet to step up into the garage.; This is a spontaneous report from a contactable consumer (reporting herself).  This 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Apr2021 at a single dose for COVID-19 immunization. The patients medical history and concomitant medication were not reported. The patient received the 2nd shot of the Pfizer vaccine last Friday. Everything was good until 2 and 3 hours into. The patient was outside felt like the patient was drugged. The patient was slow and the patient was swaying. The patient had trouble getting my feet to step up into the garage. Through the rest of the night, stayed in bed, did not like that feeling and did not want to fall. Everything was fine except that feeling. That lasted most of that day, that evening. when the patient woke up the next day felt ok. The patient no issues after that. The patient did not have control of her body. The patient had trouble getting into the garage. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Additional soreness at vaccination site with increasing soreness to today?s  date (03/25/21).  Current level at 7-9 on 1-10 scale. Also seems to be increasing  in area to upper shoulder and beyond. Has on several occasions caused sleep interruptions.
COVID-19 TEST POSITIVE; This spontaneous report received from a parent via a company representative concerned a 22 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19 test positive. Laboratory data (dates unspecified) included: COVID-19 virus test positive (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as  non-serious.
no furlher AE; Dose/Frequency: 0.5 mL IM; Caller reported that the data logger report that was run on 21 Sep 2020 noted that the stock of frozen vaccines experienced a temp excursion on 16 Sep 2020 due to hurricane.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patients' pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 16-SEP-2020, it was noted that the stock of frozen vaccines experienced a temperature excursion (product storage error).  On 18-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 5 milliliters (ml), administered intramuscularly (incorrect route of product administration) (formulation, strength, vaccination scheme and anatomical site of vaccination were not reported; lot number T010288, which has been verified to be valid, expiration date reported and validated as 20-SEP-2021) as prophylaxis.  On 21-SEP-2020, the caller reported that, the data logger was run, and the vaccine administered experienced a temperature excursion of 28.6 degrees Fahrenheit (F) for a time frame of 2 hours and 22 minutes, as recorded by a data logger. There was no previous temperature excursion reported.
Loose stools, about 15 per day, starting 2 days after receiving ROTATEQ vaccine and lasting 2 weeks.
Patient received a 2nd dose of Moderna only 21 days after the 1st dose. 1st dose on 5/7/21 and 2nd dose on 5/28/21.
lt deltoid is sore, very red, swollen around the inj site;size of baseball-area hard & warm to touch;
Immediately upon receiving the injection I felt a tingle in my throat which grew into a lump resulting in a coughing attack where I could not catch my breath or stop coughing. It lasted for about 10 minutes but then subsided however the discomfort or feeling of something in my throat lingered for a couple of hours
I had a mild rash on my stomach and really across the abdomen actually. Just little bumps across there and I first noticed it I think on the 12th of June 2021, and I still have it. I've had no treatment; I saw the doctor about it and he said it was just an allergic reaction to something. I have been trying to eliminate possibilities and have not found it to get better yet.
At the time of the shot, I just had increased fatigue.  However, I believe the shot has caused a severe case of rheumatoid arthritis as I had an intense flare-up of severe pain in every joint for nearly 2 months, starting in February.  I have joint pain in my knuckles, wrists, elbows, hips, knees, feet, etc.  I am in the process of changing Medicaid providers and establishing a new primary care doctor.  The bulk of my medical records are with the Health Department.
Anaphylactic reaction; Tight in my throat; Little bit of pain in my arm; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) from 01-Sep-1995 to an unknown date, BUSPIRONE HYDROCHLORIDE (BUSPAR) from 01-May-2015 to an unknown date and LAMOTRIGINE (LAMICTAL) from 01-Jun-2018 to an unknown date for Depression.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-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 ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), THROAT TIGHTNESS (Tight in my throat) and PAIN IN EXTREMITY (Little bit of pain in my arm). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) and THROAT TIGHTNESS (Tight in my throat) had not resolved and PAIN IN EXTREMITY (Little bit of pain in my arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.  It was reported that patient was diagnosed with Anaphylactic reaction symptoms included sensation of throat closing.  Throat tightening occurred 6-7hours a day which started at morning and lasted up to lunch time.   This case was linked to MOD-2021-240799 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up information received on 26-Jul-2021 and included Newreporter details were added, New event Anaphylactic reaction was added, patient demographics updated, concomitant medications indications and dosage details were added, outcome of the event Throat tightness was updated from unknown to recovered and Case was upgraded from non-serious to serious.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information is requested.
Initial misuse report received from a healthcare professional on 23 May 2013. A 05-month-old patient was inadvertently administered ADACEL instead of DTaP as second dose in Dtap vaccine series. No adverse event was reported. Documents held by sender: none.
This spontaneous report was received from a Registered Nurse refers to a patient of unknown age immunized with GARDASIL, and another patient of unknown age immunized with MMR II. On an unknown date in MAY 2014, that one patient was vaccinated with GARDASIL. Another patient vaccinated with MMR II, both reported to be stored improperly. The outcome of incorrect product storage and patients receiving improperly stored MMR and GARDASIL is unknown. Additional information is not expected.
3:20 APRN called for approval and received.3:21 Dose given. Patient taken to Observation room. 3:24 patient reports itchy mouth and throat. Having difficulty swallowing. Patient reports feeling dizzy when trying to stand. Adverse reaction protocol started. Vitals taken and recorded on Medical Emergency Response Document per protocol. EMS Called at 3:29 and arrive at 3:47. Patient agrees to benadryl injection but declines epinephrine. Patient refuses EMS transport to hospital.
This spontaneous report as received from a certified medical assistant and from a healthcare worker refers to a patient of unknown age and gender. On 22-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose, units, route of administration, anatomical location were not reported) which had been exposed to a supported temperature excursion on 15-AUG-2014. No adverse events were observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Dizziness began 24 hours after vaccine given and lasted for 4 days. Local reaction surrounding injection site that encompassed large area upper arm (20 x 14 cm).
Both ears have very high pitch noise. Bad headaches. Dizziness/Vertigo.
This case was reported by a consumer via call center representative and described the occurrence of loss of consciousness in a 70-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (and light headedness after receiving 1st dose on 2nd July 2018, refer case US2018GSK167116). Concomitant products included fish oil. On 4th September 2018, the patient received the 2nd dose of SHINGRIX. On 5th September 2018, 1 days after receiving SHINGRIX, the patient experienced loss of consciousness (serious criteria GSK medically significant) and fainting. On an unknown date, the outcome of the loss of consciousness and fainting were recovered/resolved. It was unknown if the reporter considered the loss of consciousness and fainting to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient for himself. The patient queried if there was any fainting issues as a side effect following the 2nd dosage after waiting for 2 months. The day after the second dose, the patient blacked out twice within a 20 minute time period. He was unconscious for about 2 seconds but the second time he fainted, he fell and hit his head and had bleeding on the back of his head. He had been preparing hot tea and dropped it on his stomach and had 2nd and 3rd degree burns. He also hit his hip and had a bruise.The primary care provider and other physician details were provided.
No adverse event; Patient was administrated with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administrated with expired vaccine) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administrated with expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administrated with expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Patient was administrated with expired vaccine).    No concomitant medications were reported.  Number of doses administered was 35 from 4 vials. The vials were initially stored in the refrigerator on 07-Jun-2022, they had not undergone any temperature excursions. It was reported that the dates of vaccine administration were 01-Apr-2022, 05-Apr-2022,06-Apr-2022, 08-Apr-2022, 11-Apr-2022, 12-Apr-2022, 13-Apr-2022, 14-Apr-2022, 22-Apr-2022, 09-Jun-2022, 10-Jun-2022, 13-Jun-2022, 18-Jun-2022 and 22-Jun-2022. The date of the patient vaccine administration was not known, and it was also unknown whether patient took first, second or first and or second booster doses.  No treatment medications were reported.
I had a normal period already at the beginning of the month that lasted for 7 days and was the same as always. Very regular cycle and very easy and predictable typically. But after the shot , in the next 24 I began to bleed again like a full cycle of menstration for another full 7 days but this time very heavy. I am still bleeding abnormally and so heavy I am losing mass amounts of blood and looking into a hysterectomy or ablation surgery to stop the bleeding. I am anemic , lethargic and sore often  now. My arm still hurts at injection site and the pain and lack of movement and swelling affects me daily.
24MAY91 MD visit & hosp w/resp illness 103.2R & fever;