chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Iit is been one year and 5 months between doses; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 7Y359, expiry date 15th November 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th December 2019).   On 2nd May 2021, the patient received the 2nd dose of Shingrix. On an unknown date, the dose was an unknown dose. On 2nd May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follow: The patient received 2nd dose of Shingrix after 1 year 5 months of receiving 1st dose, which led to lengthening of vaccination schedule. The reporter consented to follow up by fax. No further information was provided.
the spot where I was injected keeps getting bigger and bigger; more pain; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE SWELLING (the spot where I was injected keeps getting bigger and bigger) and VACCINATION SITE PAIN (more pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2022, the patient experienced VACCINATION SITE SWELLING (the spot where I was injected keeps getting bigger and bigger) and VACCINATION SITE PAIN (more pain). At the time of the report, VACCINATION SITE SWELLING (the spot where I was injected keeps getting bigger and bigger) and VACCINATION SITE PAIN (more pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   I had my booster shot on friday and since then the spot where I was injected keeps getting bigger and bigger with more pain, is that normal? AE submitted. Consent for follow up accepted.  No concomitant products were reported. No treatment drugs were reported
Tiredness; This is a spontaneous report from a contactable consumer (patient's daughter).  A 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL8922), via intramuscularly, administered in Arm Left on 27Jan2021 at 08:30 (at the age of 81 year) as, single dose for Covid-19 immunization at Hospital. Medical history included ongoing hypertension diagnosed probably 20 years ago, pericardial effusion from Jul2020 and ongoing, and urinary tract infection from an unknown date and unknown if ongoing. Family Medical History Relevant to AE reported as none and no relevant test was performed. The patient concomitant medications was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect reported as none. The patient was not received any other vaccine prior four weeks of vaccination. The patient experienced tiredness on 27Jan2021. It was reported that, Consumer calling for her mother that got the first shot on 27Jan2021. They read about some of the side effects and one of them was being tired. Caller said that her mother is experiencing the tiredness and it has been about a week and 2 days and she is still experiencing tiredness. She stated that she is calling on behalf of her mother because she can't hear well on the phone. The patient was not visited to Emergency Room/Physician Office for the event. The patient underwent lab tests and procedures which included X-ray: bad UTI on unspecified date. The outcome of the event was reported as not resolved.  Follow-up attempts are completed. No further information is expected.
There were no immediate adverse events such as flu like symptoms, arrhythmia, breathing issues etc. We did notice that following his 3rd dose, his blood pressure was running high for the next number of weeks until as recent as 10/5. He has been taking medication and PRN benazepril for any reading with diastolic of 85 or systolic is 150 or higher. He has had to take these multiple times. Over this time starting on 9/30, because the pain in his legs were so severe, he was put on 25mg tramadol. It did not help so it went up to 50mg. It went up again to 75mg which caused nausea. He was taken off of tramadol.  He is now on Zanaflex. His gabapentin has also been increased from 1500 to 1800mg. He is also experiencing progressively bad nausea. It started lightly and then gradually got to dry heaving and retching. We work with a mental cognition program for about 33 days straight. I have noticed over the last week that Norman's cognition has dropped a little. Also his response rate has decreased. His dexterity has also been affected in both hands. His finger in his right hand has tingling and numbness. His oncologist has stated this is some kind of neuropathy and can be unrelated to his cancer. She has even put this in writing. It leads to question if the vaccine could be linked to the pain he is experiencing.
Breakthrough case after 5 vaccines Moderna 1/13/21 Lot# 026L20A;  Moderna 2/10/21 Lot# 031L20A;  Moderna 11/5/21 Lot# 058F21A;  Moderna 4/3/22 Lot# 083J22A;  Moderna 11/17/22 Lot# 013H22A.
Pt recvd 2 doses of Hep B vax w/no noted problems; On 19FEB92 pt recvd 3rd dose of vax & 24 hrs following vax devel shaking chills, sweating, fever, eye pain, exp a severe frontal h/a over lt eye; 29FEB92 devel non-productive cough;
8/10/21: He developed SOB, cough, and muscle aches, starting 3 days ago. He was referred to ER, where he was admitted on 8/10/21. Tested positive for COVID-19 on 8/10/21. 8/18/21: waxing and waning mentation, requires non-rebreather mask and desaturates quickly. In the afternoon of 8/18/21, he was found in cardiac arrest, PEA and code was called. Family requested to stop resuscitation given his age and poor prognosis. Time of death was called at 1628.    Note: He received Pfizer vaccines on 2/3/21 and 2/25/21.
Approx. 5 minutes later patient developed hives and itching above and below injection site (left deltoid) 5-10 minutes patient felt itches all over (stomach area). I gave her a diphenhydramine 50mg/ml injection on her right deltoid and called 911. EMT came and took her to hospital. 10/08/16 4:58pm patient called us and said she came home last night and she is ok now.
The pt experienced edema with a hard lump in the right upper extremity deltoid. The pt had a fever of 104 which came down with Tylenol. No neurological symptoms.
This spontaneous report was received from a vaccine coordinator referring to an unspecified number of patients whose on an unknown dates were vaccinated with improperly stored doses of VAQTA, (lot # M033611, expiry date 02-MAR-2018). The vaccine was stored in refrigerator at a temperature of 47°F to 77°F (48 °F) for current excursion, but data not available for prior excursions. The time frame was 45 minutes. No previous temperature excursions were reported. No datalogger reported. No adverse effects reported. No adverse effects reported. The outcome of incorrect product storage and no adverse event was unknown. This is one of five cases from the same reporter source, (linked to MARRS # 1704USA013566 to 1704USA013569). Additional information is not expected as no information to obtain follow up was provided.; Sender's Comments: US-009507513-1704USA013566: US-009507513-1704USA013567: US-009507513-1704USA013568: US-009507513-1704USA013569:
This spontaneous report was received from a license practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and past drug reactions/allergies were not reported. The patient's concomitant therapies included sterile diluent(MERCK). On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD one single injection, lot # N008824 with expiration date: 28-OCT-2019 (strength, route and anatomical location were not reported), for prophylaxis. The reporter denied any adverse effects reported by the patients. The temperature excursion occurred between 6° F to 14° F (9° F) with a time frame of 48 hours. No previous temperature excursions occurred. This is one of two reports received from the same reporter.
Patient was given a pfizer shot but already had a J& J shot in March the 9th
LOW FEVER, R ARM PAIN, VOMITING, DIZZY, NAUSEA, SEVERE MIGRAINES - LASTED 3 DAYS  DIZZY AFTER VOMITING, HIT HEAD ON CABINET AND HAD TO GO TO ER FOR STITCH TO FOREHEAD LAC
I was positive for COVID-19 on 21MAR2023, I had chills, runny nose, sore throat and had a low grade temperature. I contacted your doctor and they prescribed PAXLOVID, I started feeling better about the next day after taking it.
BREAKTHROUGH COVID: PT FULLY VACCINATED WITH 2 BOOSTERS: PT HAD FAMILY EXPOSURE AND SYMPTOMATIC WITH POSITIVE AB FOR COVID.   She has tested multiple times negative for COVID in the last week.  All her family has been testing positive.  She took Paxlovid as an outpatient and is almost done.  She has felt very weak for several days and has had a constant headache.  She has been taking naproxen, zofram around the clock.  She has only had nausea and vomiting today.    Denies seizures, denies diarrhea.  Positive cough, hard to bring any secretions which are clear.  Positive rigors and chills. ED lab results showed critical Na+ at 114. Patient was admitted to the ICU due to critical hyponatremia.
On Thursday afternoon 11/4/2021 I noticed a few bumps on my scalp with a small pink patch just below them on my forehead. The patch burned at times and my scalp was itchy.  On Saturday morning, I noticed two other pink bumps, one above my right eyebrow and a large on on my right temple. I was also very tired and feel asleep in the afternoons these days. Via a telemedicine appointment I was diagnosed as having shingles. I was otherwise healthy except for some nasal congestion. I had not yet received a shingles vaccine.  I began a course of Valacyclovir HCL 1g 3x/day on 11/6/2021. By Tuesday 11/9, the fatigue and the pink patch was gone and the bumps greatly reduced in size and itchiness.
Servere left hip pain at injection site which restricted ability to walk for 4 days then moderated.  Chills, hot flashes for 7 days.  Did not experience fever.  Flu type symptoms for 7 days.
Localized rash, that spread to rest of body, face, neck, chest & a few on back, papulomacular, not confluent, not pruritic rash.  Pt does not appear to be bothered by rash.
ARM PAIN; HEADACHE; TIRED; MUSCLE ACHES; FEVER; PAIN AT SITE(LEFT ARM); This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1808978, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain at site (left arm). On 08-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced tired. On 08-APR-2021, the subject experienced muscle aches. On 08-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced arm pain. The outcome of the headache, tired, muscle aches, pain at site(left arm), fever and arm pain was not reported. This report was non-serious.
Five minutes after receiving a Zostavax vaccine injection I suddenly felt faint while standing in the waiting room. I do not usually feel faint.   I was taken back to the treatment area, where I sat down and rested about 5 min more and then, feeling OK, I left.  I note that on the same morning I also got a Pneumovax injection in a different arm, but I believe that was maybe half an hour before the Zostavax.
Father reports child awoke crying at 4:30 A.M. and again at 5:30 A.M which is unusual for child. Each time he went back to sleep. Child vomited at 6:30 A.M. and was put back to bed. Father called center at 9:30 A.m. because he is unable to arouse or awaken child. Center instructed him to call childs DMD now. Father reports child does not have a fever and his breathing appears normal.
pt had flu vax 11OCT95;lt arm devel redness, swelling around site x 12hrs;
No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    No concomitant medications was reported. No treatment medications was reported.  This case contains information for the 13th adult patient out of 15 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-658139, US-MODERNATX, INC.-MOD-2022-658159, US-MODERNATX, INC.-MOD-2022-658149, US-MODERNATX, INC.-MOD-2022-658161, US-MODERNATX, INC.-MOD-2022-658150, US-MODERNATX, INC.-MOD-2022-658154, US-MODERNATX, INC.-MOD-2022-658155, US-MODERNATX, INC.-MOD-2022-658156, US-MODERNATX, INC.-MOD-2022-658157, US-MODERNATX, INC.-MOD-2022-658160, US-MODERNATX, INC.-MOD-2022-658168, US-MODERNATX, INC.-MOD-2022-658173 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658149:Adult patient 2 US-MODERNATX, INC.-MOD-2022-658159:Adult patient 10 US-MODERNATX, INC.-MOD-2022-658139:Adult patient 1 US-MODERNATX, INC.-MOD-2022-658161:Adult patient 12 US-MODERNATX, INC.-MOD-2022-658150:Adult patient 3 US-MODERNATX, INC.-MOD-2022-658154:Adult patient 5 US-MODERNATX, INC.-MOD-2022-658155:Adult patient 6 US-MODERNATX, INC.-MOD-2022-658156:Adult patient 7 US-MODERNATX, INC.-MOD-2022-658157:Adult patient 8 US-MODERNATX, INC.-MOD-2022-658160:Adult patient 11 US-MODERNATX, INC.-MOD-2022-658168:Adult patient 14 US-MODERNATX, INC.-MOD-2022-658173:Adult patient 15
Minutes after receiving vax, the pt passed out and broke out in bright, diffuse hives over his entire body. A school physician was present at the time and thought the pt had likely experienced a vasovagal reaction. A pediatrician later saw the pt. Hives resolved without treatment. The most recent information, reports the condition of the pt is resolved.
I have a very heavy period. It stops for a week then starts again with a very heavy period for 2 weeks with huge clots. This has been going on for 2 months now
expired dose of Pentacel was given to a patient with no adverse event; Initial information was received regarding this unsolicited valid non-serious case from other health professional via Medical Information (Reference number- 00323656) and transmitted to Sanofi on 20-Oct-2020.  This case involved a 10 weeks old female patient who received an expired 0.5 ml dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number UI992AA and expiration date 30-Sep-2020) (Expired product administered) via intramuscular route in the right thigh on 19-Oct-2020 for prophylactic vaccination.  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant vaccine included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13).  It was a case of actual medication error as patient received an expired vaccine (Latency: Same day)  No relevant laboratory data was reported.  Disclaimer: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.  No further relevant information was reported.
got the shingle shot, ended up with shingles/suspected Vaccination failure; shingles; 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, unknown 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: 31-JAN-2023 Reporter comment: This case was reported by a patient via interactive digital media. The reporter reported that, the patient got the shingle shot and ended up with shingles. The follow-up could not be possible as no contact details were available. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting
Firmness and Redness  around injection site on left arm. Itching and Rash which  spread to shoulder, chin and chest.  Gradually worsened and has subsided.
Urticarial rash within one hour, no known reactions with egg or neomycin.
Shortness of breath, on bending over, or exertion, low PO2, headache, fatigue, low energy,   Worsening symptoms afer 2nd. dose 3/1/21
Patient admitted to hospital with positive covid-19 breakthrough case. Generalized weakness, cough, fever. O2 saturation 84% on room air. Increasing SOB. Currently on 3 L NC.
Itching & redness at site of vaccine within hours, then hives on (L) arm & (R) back lasting x 3 days. Also, with concurrent brief sore throat and nausea.
negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; negative measles, mumps, varicella, hepatitis A and hepatitis B titers; the patient was vaccinated with PROQUAD on 6/20/2019; subsequently developed T cell acute lymphoblastic leukaemia; Information has been received from a registered nurse referring to a currently 25 years old male patient. The patient's concurrent conditions included avascular necrosis of bilateral hips. Besides, the patient was allergic to oxycodone and had seasonal allergies. He did not have any concomitant medications. His historical conditions were not provided.  On an unknown date when he was a child, the patient was vaccinated with an unspecified number of doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II); varicella virus vaccine live (oka/merck )(VARIVAX); hepatitis a vaccine (manufacturer unknown) and hepatitis b vaccine (manufacturer unknown), all of them administered as prophylaxis (dose, route of administration, anatomical injection site, lot number and expiration date were unknown by reporter).  In May 2015, the patient developed T cell acute lymphoblastic leukemia. On 20-JUN-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) as prophylaxis (dose, dose number, anatomical injection site, lot number and expiration date were not provided; route of administration was unknown by reporter) (product administered to patient of inappropriate age). On an unknown date, the patient had negative measles, mumps, varicella, hepatitis A and hepatitis B titers (measles antibody negative, mumps antibody test negative, varicella virus test negative, hepatitis A antibody negative and hepatitis B antibody negative, respectively). No adverse symptoms were reported in regards to the patient receiving measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The patient sought for medical attention in a office visit, but it was unknown by reporter if he received any treatment for the event. It was reported that a blood work was performed, but the results were not provided.  At the time of the report, the patient had not recovered from the events. The causality assessment between all the suspect vaccines and T-cell type acute leukaemia, measles antibody negative, mumps antibody test negative, varicella virus test negative, hepatitis A antibody negative and hepatitis B antibody negative was not reported.  Upon internal review, t-cell type acute leukaemia was determined to be medically significant.
Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Systemic: Shakiness-Mild, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: A couple minutes after administration, patient felt light headed, dizzy, and reported vision changes. Advised patient to lay down or but patient declined, took his blood pressure and it was 174/80 with a pulse of 148.  Called EMS and monitored patient while waiting for EMS, during which time patient remained conscious but still appeared pale, clammy, and felt extremely light headed.  EMS arrived and assessed patient blood pressure eventually normalized to 128/70 after about 30 minutes.
SEVERE inflammation, clotting in left arm. Numbness in arm continuing down to wrist. Loss of motion in left arm. Paralysis at times. Throbbing pain at night. Tightness in neck and corresponding shoulder.
This spontaneous report as received from a pharmacist refers to a 51 year old female patient. No medical history and no drug allergy were reported. On 03-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot# J013135, expiration date 17-JAN-2015), 0.65 ml, subcutaneously for prevention of shingles. No concomitant therapy was reported. On 04-MAY-2014, the patient experienced injection site was swollen, warm and approximately four inches, in diameter, after patient received ZOSTAVAX. VZV packet was not sent as there was no rash or redness. No treatment was given. No lab diagnostics was performed. The patient sought medical attention by seeing pharmacist. The outcome of adverse event was not reported. The causality between adverse event and ZOSTAVAX was not reported. Additional information has been requested.