chrisvoncsefalvay/vaers-outcomes huggingface dataset:
was administered Pentacel that was reconstituted with sterile water diluent instead of the supplied Pentacel diluent (HIb portion) with no reported adverse event; was administered Pentacel that was reconstituted with sterile water diluent instead of the supplied Pentacel diluent (HIb portion) with no reported adverse event; Initial information received on 07-Feb-2023 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case involves a 3-month-old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that was reconstituted with sterile water diluent instead of the supplied pentacel diluent (hib portion) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7V (CRM197) (Prevnar), rotavirus vaccine live reassort oral 5V (ROTATEQ) and Hepatitis B Vaccine (Hepatitis B [Hepatitis B Vaccine]) all for Prophylactic vaccination.  On 06-Feb-2023, the patient received suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine at a dose of 0.5 ml once (lot UJ789AA, expiry date: 18-Sep-2023) via intramuscular route in the right thigh for prophylactic vaccination (immunisation).  On 06-Feb-2023 the patient developed a non-serious was administered pentacel that was reconstituted with sterile water diluent instead of the supplied pentacel diluent (hib portion) with no reported adverse event (product preparation error, single component of a two-component product administered, latency: same day).  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
This spontaneous reprot as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 25-NOV-2014 the patient was vaccinated with the second dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored (incorrect product storage). There were no concomjitant medications reported. No adverse efect reported. There was no product quality complaint (PQC) involved. The outocme was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
PATIENT TENSED UP DURING THE SHOT, INDICATED IT WAS PAINFUL.  ABOUT 5 MIN LATER, HER BACK STARTED SPASMING FROM NECK TO HIP LEVEL, PATIENT BECAME NAUSEOUS AND VOMITED.  PATIENT WAS GIVEN COOL COMPRESSES AND STATED THAT SHE HAD JUST COME FROM HER PHYSICAL THERAPIST (WHOM WE CALLED AND  WHO INDICATED THAT PATIENTS THERAPY WAS MORE INTENSE THAN PREVIOUS SESSIONS)  PATIENT SAID SHE HAD NOT BEEN LIFTING QUITE RIGHT.   AFTER ABOUT 15 MINUTES THE NAUSEA AND SPASMS SUBSIDED, SHE FELT BETTER AND DECIDED TO GO HOME.SHE CALLED HER FAMILY MEMBER AND WAS GOING HOME TO NAP. AND MANAGEMENT HELPED HER OUT.  PATIENT DID NOT INDICATE ANY BREATHING PROBLEMS WHEN SPECIFICALLY ASKED. PATIENT APPEARS TO HAVE RECOVERED FROM INCIDENT WITHOUT FURTHER INTERVENTION.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 at 15:30 as dose 1, single (Lot number: EN6198), in left arm, on 14Mar2021 at 14:30 as dose 2, single (Lot number: EN6206), in left arm and on 13Oct2021 at 18:30 as dose 3 (booster), single (Lot number: FH8020) at the age of 51 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 1 year 9 months 19 days 8 hrs 30 min after the suspect product(s) administration, outcome "recovered" (11Dec2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Dec2022) Negative, notes: Tested negative on an antigen test four days after finishing last dose of paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Dizzy, weak, fevers, arm painful top to wrist, needle entry hot - painful, swollen. Fever 99.4, lower range was upper 98's. Weekend, no car or driver. Too weak to go to clinic. Headaches. TYLENOL helped, migraine med helped fever and headaches, rested slept. Lasted 4 days approx.
About 30 minutes after vaccination, patient went to rest room and noticed a large red patch on her right anterior thigh.  This became a few red bumps and disappeared within 1.5 hour.  No sob, swelling or airway symptoms were noted.
No adverse effects; the patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 18-MAR-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, lot number R002806, expiry date: 29-SEP-2019 (dose was not provided) for prophylaxis. The vaccine experienced temperature of 9 (also reported as 8.5) Celsius degrees for 25 minutes. There was previous temperature excursion: 12 hours in 20 Celsius degrees. Digital data logger was not involved. No adverse effects were reported.
Child seen 3/26/04 temp 97.9. Diagnosed with shingles on left upper anter. arm & palm & middle finger of left hand.
he developed a pins and needles sensation in the same arm; This spontaneous report was received from a male patient of unknown age who refers to himself. No information regarding the patient's current condition, medical history and concomitant medication was provided.   On unspecified date in December 2019 (reported as two and a half weeks ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, in the right arm (dose, strength, route of administration, lot # and expiration date were not reported) for prophylaxis (reported as vaccination). On unspecified date in December 2019 (reported as the following day), the patient developed a "pins and needles" sensation in the same arm.   The outcome of the event was reported as not recovered. The relatedness between the event and the vaccine was not provided.
RASH ALL OVER THE BODY; This spontaneous report received from a patient concerned a male 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, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-APR-2021, the subject experienced rash all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash all over the body was not reported. This report was non-serious.
experienced cold chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (experienced cold chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 029A21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced CHILLS (experienced cold chills). At the time of the report, CHILLS (experienced cold chills) outcome was unknown.            No concomitant medications were provided by reporter.  No treatment details were provided by reporter.   This case was linked to MOD-2021-311061, MOD-2021-311210 (Patient Link).
PATIENT RECEIVED COVID VACCINE FOR 12 AND UP INSTEAD OF 5-11 DOSE.
Arm is a little warm; Allergic reaction; Injection site redness; hot; Arm was sore the first few days after the infjection; painful; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), LIMB DISCOMFORT (Arm was sore the first few days after the infjection), SKIN WARM (Arm is a little warm), INJECTION SITE PAIN (painful) and INJECTION SITE ERYTHEMA (Injection site redness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product LEVOTHYROXINE for Hypothyroidism.    Concurrent medical conditions included Hypothyroidism and Allergy to arthropod sting (Allergic to bee sting.).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started LEVOTHYROXINE (unknown route) dosage form. On 08-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm was sore the first few days after the infjection) and INJECTION SITE PAIN (painful). On 15-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE WARMTH (hot). On 22-Jan-2021, the patient experienced SKIN WARM (Arm is a little warm). At the time of the report, HYPERSENSITIVITY (Allergic reaction), SKIN WARM (Arm is a little warm), INJECTION SITE PAIN (painful), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE WARMTH (hot) outcome was unknown and LIMB DISCOMFORT (Arm was sore the first few days after the infjection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.    Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: No specific follow-up information recorded.
Information has been received from a registered nurse concerning a 29 year old male with who on 23-JUL-2007 was vaccinated with a 0.5ml SC dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On approximately 23-JUL-2007, the patient developed 10 varicella-like lesions on his abdomen and 1 on his neck. Unspecified medical attention was sought. No labs or diagnostic studies were performed. Subsequently the patient was recovering. There was no product quality complaint. Follow-up information has been received from a nurse indicating that the patient was not their patient. Follow-up information has been received from a registered nurse concerning a 32 year old (also reported as 29 year old) white male financial consultant with no drug allergies who on 23-JUL-2007 was vaccinated with his first dose of varicella virus vaccine live (Oka/Merck). In July 2007, the patient developed 24 varicella-like lesions which started on the chest, spread to arms, legs, face and scalp. The patient also experienced a fever of 100 degrees F. In August 2007, after 3 weeks, the patient fully recovered. It was also noted that the patient received a second dose of varicella virus vaccine live (Oka/Merck) 8 weeks after the first dose with no adverse effects. Additional information has been requested.
I was asleep and it woke me up out of a dead sleep and it felt like someone kicked me in the stomach and I was extremely nauseated and didn't know if I was going to vomit or have diarrhea.  I started having chills and it last an hour from 2 A.M. to 3 A.M. and as fast as it came on it left  after an hour almost to the minute.  I couldn't move at all.  Just because I felt so bad because my stomach was hurting.  I didn't take any medication for it. I told my physician about it on a follow up appointment.
I received a shingles vaccine last week, 2 days later I developed hives on my right thigh area. States he had area of hives left thigh, itches, some spots have broken open and are draining - no urticarial elsewhere. States injection site right arm looks great. Patient didn't answer telephone calls to follow-up. No further information received 11 days from when patient reported possible ade to us.
No additional AE; PROQUAD and VARIVAX inadvertently administered to a 1 year old patient concomitantly; 0.25 mls subcutaneously/ first dose; This spontaneous report has been received from a nurse and refers to a 1-year-old male patient. The patient's pertinent medical history included plagiocephaly. Concurrent conditions and concomitant medications were not reported.  On 11-OCT-2023, the patient was inadvertently concomitantly administered with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection (0.25 mL, subcutaneously, lot #x18570 was not valid, expiration date was reported as 05-JAN-2025) (Incorrect dose administered) and first dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (0.5 mL, subcutaneously, lot #x010534, expiration date 11-APR-2025) for prophylaxis (Accidental overdose). Patient did not experience any symptoms. No additional details provided. No additional adverse event (AE) or product quality complaint (PQC) (No adverse event).
8 days later on 01-30-2021 red, swollen, itchy bulls-eye reaction at injection site.  now the morning of 01/31/2021 getting a bit larger , red and slightly swollen and itchy.  notified by text and sent pictures to my primary and was told to contact him in 2 days and if necessary take Benadryl
Patient displays a large red rash at injection site that began the night after injection.  It is itchy and hot to the touch.  Injection was given lower in the arm than normal.
Started off with chills fever around midnight. Body aches severally coughing couldn't breath very well just felt awful.  Slept 22 hours very nauseas. Arm felt like I got punched at the injection site, bruise and the arm is still sore.
Lethargy, injection site pain, low grade fever ~100, headache, backache, extremely swollen and sore axillary lymph nodes on injection side, swollen and sore supraclavicular and epitrochlear lymph nodes on injection side.
COVID ANTIBODIES LOW; This spontaneous report received from a consumer concerned a 60 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included jerking, restless legs, cane use, walker use, wheelchair use, and sinus infection, and concurrent conditions included high blood pressure, progressive multiple sclerosis, enlarged prostate, diabetes, blood thinner, vitamin D deficiency, stiffness, spasms, and loosen feet. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Acetylsalicylic acid, Amlodipine besilate, Baclofen, Clonazepam, Colecalciferol, Fampridine, Glipizide/metformin, Losartan potassium, Ocrelizumab, Pramipexole, Semaglutide, and Tamsulosin.  On 21-JUN-2021, the patient had COVID-19 antibody test and result came as low antibodies.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low antibodies. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210733845-Covid-19 vaccine ad26.cov2.s-Covid antibodies low. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Given FLUMIST on 9/1/11 woke up 9/2/11 with hives and headache. Mom gave ZYRTEC.
Five minutes after the vaccine was injected, I became dizzy, my eyes teared and face swelled up and throat tightened.  The EMT's came, checked my lungs, etc.  and talked me through the episode which lasted about 15 minutes.  Then the swelling subsided.  I suspect it had, because I had dermal fillers approximately a year ago.  I had no other adverse affects, except for tiredness that evening.  People should be warned about this because it is a frightening event.  I have never had an adverse reaction to a vaccine before.
This spontaneous report as received from a medical assistant regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 22-SEP-2015 the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # L004754, expiry date- 10-NOV-2016) (dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
This case was reported by a physician via call center representative and described the occurrence of fever in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced fever, pain and pain in arm. On an unknown date, the outcome of the fever, pain and pain in arm were unknown. It was unknown if the reporter considered the fever, pain and pain in arm to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The patients had experienced fever, sore arm, aches and pain after vaccination with the 1st dose of SHINGRIX. The reporter would not provide any additional information in regards to the patients.
Body aches; Muscle pain; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer reporting for herself. A 28-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BionTech), via an unspecified route of administration, on 18Dec2020 at 12:00 PM, at single dose, for Covid-19 immunisation. Medical history was none. Concomitant included an unspecified birth control medication within 2 weeks of vaccination. The patient experienced body aches, muscle pain, chills, headache and fatigue all on 19Dec2020 at 07:00 AM with outcome of recovering. No therapeutic measures were taken as a result of the events. The events were considered non serious.  The information on the lot/batch number has been requested.
SEIZURE LIKE ACTIVITY; BP 87/64; DIAPHORETIC; PULSE RATE 50; NOT FEELING WELL; This spontaneous report received from a health care professional concerned a 49 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: unknown) dose was not reported, 1 total, administered on 12-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-JUN-2021, health care professional (HCP) reported that patient received Janssen Covid-19 vaccine. About 2.5-3 minutes after receiving the injection, the patient began having seizure like activity. HCP described that as full postured seizure like in the upper extremities and chest, and the eyes had been nystagmus. This activity lasted approximately 45 seconds. Emergency medical services (EMS) staff was on the scene and when they came to, the patient self-reported that he was not feeling well and the HCP described him as diaphoretic and was appearing shaky. EMS took his vitals initially (Blood Pressure, BP 87/64 mmHg, Pulse rate 50 unit unspecified and oxygen saturation 100 percentage). Vitals at 5 Min (Blood Pressure, BP 124/80 mmHg, Pulse rate 76 unit unspecified, oxygen saturation 100 percentage and blood glucose level 125 unit unspecified). An ambulance was called to transport the patient to the ER, and upon arrival vitals were taken again at about 10 Min. Post-ictal (Blood Pressure, BP 115/76 mmHg and pulse rate 76 unit unspecified). Patient was taken to the ER for further evaluation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizure like activity, not feeling well, BP 87/64, pulse rate 50 and diaphoretic was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210627629-covid-19 vaccine ad26.cov2.s-seizure like activity, BP 87/64 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).
Pain in both arms after injections. Patient states pain has increased over the past 2 months since vaccinations. Has pain when lifting even small objects. She states pain is not constant, but comes and goes.
mild headache; left arm soreness; This is a spontaneous report from a non-contactable consumer (Patients brother). A 38-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on an unspecified date as single dose for Cvoid-19 immunisation. He was administered his first vaccination of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE on an unspecified date with no AE. Medical history and concomitant medications were not reported. After vaccination, the patient experienced mild headache and left arm soreness on an unspecified date in second day after taking second dose. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Muscular and surface pain (worse than the previous week), mild swelling, red skin, then itching a few days later.  Itching is still present