chrisvoncsefalvay/vaers-outcomes huggingface dataset:
adacel being administered to a pregnant female twice in one month with no adverse event reported; adacel being administered to a pregnant female twice in one month with no adverse event reported; Initial information was receivedon 25-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 39 years old female patient who was exposed to vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] in context of adacel being administered to a pregnant female twice in one month with no adverse event reported.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported adacel being administered to a pregnant female twice in one month with no adverse event reported and adacel being administered to a pregnant female twice in one month with no adverse event reported occurred at unknown gestation periodthe gestation period at onset and gestation period at exposure data needs to be populated, if available  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 03-Jan-2023, the patient received a 0.5 ml dose of  suspect diphtheria-2/tetanus/5 ac pertussis vaccine (Suspension for injection) (lot U75611AA) (with unknown strength, expiry date) via intramuscular route in the deltoid for immunization. On an unknown date she also received a dose of the same vaccine lot U7627AA.  On 03-Jan-2023 the patient developed a non-serious event of adacel being administered to a pregnant female twice in one month with no adverse event reported (exposure during pregnancy) (latency: same day) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  On 24-Jan-2023 the patient developed a non-serious event of adacel being administered to a pregnant female twice in one month with no adverse event reported (Extra dose administered) (latency: 21 days) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine. Relevant prenatal testing after exposure included  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Adacel) was not applicable.  At time of reporting, the outcome was Unknown for the event adacel being administered to a pregnant female twice in one month with no adverse event reported. Additionally, at time of reporting, the outcome of the pregnancy is unknown.  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 report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, the patients received an improperly stored doses of ZOSTAVAX (lot # L036823 with expiration date: 24-DEC-2016 and lot # L032397 with expiration date: 26-NOV-2016; dose and route of administration were not reported). The administered doses of vaccine were exposed to a temperature of 27 Fahrenheit (F) degrees for 30 minutes. No previous temperature excursions were reported. It was unknown if data logger was not used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Patient received her Moderna vaccines on 2/2/21, 3/2/21, and 11/15/21. Following immunization, family noted a "brain fog" - mildly increased confusion which persisted for months into the summer of 2021. Following the administration of the booster dose in November, patient's hypertension seemed to become more labile, culminating in a hospitalization for hypertensive encephalopathy (admitted 12/31/21). Blood pressures have improved but remain labile.
headaches; runny nose; back of the throat/sore throat; swollen lymph nodes/Lymph nodes started swelling in the throat and then lymph node under the arm; she washes it hurts and she noticed a lump in the arm pit; noticed a lump in the arm pit; elbow pain and she thought she broke her elbow; bad rash; itching and scratching/It starts on the back of her neck and is by the arm pit in the back/The same thing on the leg; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, within 4 hours after vaccination, patient had a little headache, but not bad. Then she got runny nose, but it did not come out of the front. It went back of the throat. Within 3 or 4 days she got a sore throat.  Her lymph nodes in the throat and under the arm were started swelling. When she washes, it hurts, and noticed a lump in the arm pit. It was okay if she leaves it alone and doesn't bother it. Also reported, she had elbow pain and she thought, she might break her elbow. She had no fever and can get out of the bed. At the time of report, patient had no headache. Then she got a bad rash. She had been itching and scratching. It was reported that she looked like a mangy dog, where rash started on the back of her neck and by the arm pit in the back, also in the trunk where the arm connects to the trunk of the body and found on the leg, below the buttock, where the limbs connect to the body. Patient wanted to know whether she can use cortisone cream  that has been prescribed for her and also could receive 2nd dose in next 2 week. The outcome of the event rash was not recovered, and of headache and swollen lymph nodes was recovered and of all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Stated she was allergic to vaccine, gave BENADRYL 12.5mg PO prior to injection. Pt went home after injection.
Pt. was due for the second dose of the Monovalent Pfizer (6month-4yrs) covid vaccine but was accidentally given the Pfizer Bivalent (6ms-4yrs) vaccine.  Pt. did not  experience an adverse event from the vaccine.
Within 3- to 6 months acute wandering joint pain and swelling later to be addressed as auto-immune in nature. Now chronic multi joint swelling.
Patient's wife arrived at pharmacy 9/15/21 the day after vaccine #3 was given 9/14/21.  She stated that he had several side effects including headache and palpitations.  He had a pacemaker/defibrillator installed 9 months ago and has had no issues with it.  She said the defibrillator did not activate but the pacemaker did something to help the palpitations.  I asked her to contact his primary doctor and then called the doctors office (listed earlier) to inform them about side effects from covid moderna vaccine and to followup with patient.  She said he had no side effects out of the ordinary from vaccine part 1 and 2. (given 1/13/21 and 2/10/21)
was given expired vaccine. pharmacy received short dated product and at that time the expiration lookup site was not working and we had the bud date of 10/2022. exp should have been 9/30/22 and was given on 10/3/22. had a recall on 10/12/22 alerting pharmacies of this issue
inadvertently received an additional dose of Fluzone quadrivalent today, with no ae; Initial information received on 22-Dec-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 2 years old female patient who inadvertently received an additional dose of fluzone quadrivalent today (extra dose administered), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patients past medical history, concomitant medication, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Dec-2020, the patient was vaccinated with 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE (lot: UT7102JA; expiration date: 30-Jun-2021) via intramuscular route in the left deltoid.   On 22-Dec-2020, 6 days after patient received the vaccine, patient inadvertently received an additional dose of Fluzone quadrivalent (extra dose administered).  No adverse event reported at the time of reporting.  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.
first dose of Shingrix 18 months ago and has not received a second dose yet.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date 18 months prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that the patient did not received 1st dose at this pharmacy but may receive 2nd dose there. The reporter consented to follow up via email.
Patient came in 6/11/07 complaining of pain right wrist going to antebrachial area, then left wrist join antebrachial area, start in 6/10/07 pain and swelling right and left wrist, tenderness muscle of bottom arms join to the shoulder small redness on right wrist looks mosquito or insect bite.
Extremely stiff arm, burning / stabbing pain in arm (still present after 3 weeks), grapefruit size red blistering rash staring approx 10 days post injection, broken blood vessels about 1- 1.5in diameter surrounding injection site starting approx 10 days post injection.  Swelling in arm starting immediately, quite visible.  Greenish bruise about 1" diameter at site of injection.  Fever for 2 days upon wakingm (subsided within 2 hrs).  Very susceptible to rashes, very concerned about 2nd dose.  Penicillin skin rash allergic reaction took over 6 months to clear.
12 HOURS AFTER VACCINATION EXPERIENCED HOT FLASH LASTING OVER 15 MINUTES WITH DRYNESS OF MOUTH
Information has been received from a health professional concerning her aunt who was vaccinated with a dose of Zostavax. It was reported that the patient experienced a reaction and went to the ER. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
There was 10 days of soreness in my right shoulder region followed by a palpation of a mobile swollen, slightly tender lymph node palpated in my right supraclavicular fossa.
This spontaneous report as received from a physician's assistant refers to a female patient of unknown age. The patient's concurrent conditions and pertinent medical history were not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose and lot # not reported) intramuscularly. The physician's assistant reported that on an unknown date, the patient experienced Guillain-Barre syndrome after she received GARDASIL. The patient sought medical attention, called the physician assistant office. At the time of the report, the patient's outcome was unknown. Upon internal review Guillain-Barre syndrome was considered to be medically significant. Additional information has been requested.
Sweaty, pale, shaking, couldn't focus, breathing Rx, couldn't concentrate, developed asthma.  60 day follow up on 10/27/2003: "Vaccine recipient did not recover from the adverse event.  Has migraines, heart palpatations, sick and queezy feeling, faint feeling and just as never fully recovered to her usual self."
Heart rate became elevated from 7pm to 12:30am. Averaging around 100bpm. Had the chills during this time period with temperatures of 95.5 and 97. I feel asleep and woke up around 3:30am and deltas if I broke through.
This case was reported by a physician via sales rep and described the occurrence of injection site lymphadenopathy in a 18-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO .5 ml. On an unknown date, 5 days after receiving BEXSERO, the patient experienced injection site lymphadenopathy. On an unknown date, the outcome of the injection site lymphadenopathy was unchanged. It was unknown if the reporter considered the injection site lymphadenopathy to be related to BEXSERO. Additional details were provided as follows: The exact age at vaccination was not reported. The patient experienced 3 much enlarged lymph nodes at site of injection of BEXSERO vaccine. It was reported that the administration was concluded by a different pediatrician. The date of birth of the patient was wrongly reported. However, no clarification could be obtained. The batch number of BEXSERO was wrongly reported as 0000 with expiry date (same as that of the date of birth of the patient). However, no clarification could be obtained. Follow up information was received from physician on 21st October 2016: The reporter was the patient's aunt. The reporter type was wrongly captured in previous report, the reporter was physician and not consumer. This was also reported by the Medical Science Liaison (MSL).
A day after the vaccine, the patient experienced joint pain and muscle aches, and both eyes started to swell with redness in both eyes.  This continued for 5 days post-vaccination.  Eyes were not dry, but just swollen.  Pt took Tylenol and put compresses on her eyes at home.  Symptoms are now resolving.  Patient instructed to follow up with her PCP should symptoms continue or worsen.  Patient said she was just reporting so we'd be aware but felt she was getting better.
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's historical and concurrent conditions, drug reactions and allergies, and concomitant medications were not reported. On 22-SEP-2017, the patient was vaccinated with VARIVAX, subcutaneously, lot # N012487 and expiration date 20-APR-2017 (dose was not reported), and during the same office visit received 1 separate dose of PROQUAD) (albumin status of rHA (recombinant human albumin)) lot # N009775 and expiration date 20-SEP-2018 (dose and route of administration were not reported), both reconstituted with MERCK STERILE DILUENT (dose, frequency, route of administration, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date of vial placed in refrigerator was on 21-OCT-2021 and vaccine did not undergone any temperature excursion. Patient did not experience ant adverse event. No concomitant were reported. No treatment were reported.
Pt reported dizziness, light-headedness and sweatiness upon injection, which improved over the course of 10-minutes while pt sat and drank water. Pt declined any additional medical attention when RPh offered to call 911. Pt reported similar experience with previous vaccines received at drive-thru COVID-19 vaccination clinic.
Red swollen and itchy surface 6 inches up and down thigh 3 inches side to side.
Fever 103-104 vomiting, sugar increased to 400, all symptoms with in 4 hours time span after receiving vaccine.
Patient received her 2nd SHINGRIX shot on 8/26 at 4:08 pm. On 8/27 she woke to swollen face with redness on cheeks. By 8/29 she had a swollen puffy right eye. She went in to see MD on 8/29. Patient cannot relate this incident to any new food/insect bite/other med and so suspects SHINGRIX could have caused the reaction.
In 2003 right shoulder pain (severe at times) treated for Tendonitis (cortisone shot). In summer of 2004 pain returned in right shoulder (Constart). MRI shoed joint being totally gone due to arthritis ( no injuries ever to said joint). Need surgery now and probable replacement in 5 years.
Sunburn feeling on top of head; Dark urine; Fatigue; Joint aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SUNBURN (Sunburn feeling on top of head), CHROMATURIA (Dark urine), FATIGUE (Fatigue) and ARTHRALGIA (Joint aches) 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.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUNBURN (Sunburn feeling on top of head), CHROMATURIA (Dark urine), FATIGUE (Fatigue) and ARTHRALGIA (Joint aches). At the time of the report, SUNBURN (Sunburn feeling on top of head), CHROMATURIA (Dark urine), FATIGUE (Fatigue) and ARTHRALGIA (Joint aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information were not reported Treatment medication information were not reported
Client states that on the evening of 11/14/00, around 17:30, she "felt sick"; about midnight she complained of backache, neck and arm aching. Called nurse "hotline" and was advised to take Tylenol, which she did. On 11/16/00, client states she felt light-headed and called her doctor, who was not in. She returned to the health dept where she got her shot. Examination of the right arm, indicated swelling, redness and warm to the touch from the middle of the upper arm to the elbow; and a small raised blister on the anterior right arm about 2" above the elbow which appeared to be an insect bite. IZ records indicate pneumococcal vaccine was administered in right deltoid. Health dept placed a call to client's doctor who was on vacation and was advised by their office to send client to walk-in clinic or the ER for follow-up. Client chose to go to walk-in clinic and was dx'd with "cellulitis". On 11/20/00, client reports she received antibiotic shot on 11/16 and 11/17 and her arm is better although her right arm to the middle of her chest is "still sensitive to touch".
no other AE occurred; VARlVAX was administered after a temperature excursion; This spontaneous report has been received from a pharmacist referring to a patient of unknown age and unknown gender. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On 07-DEC-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 1 dose after a temperature excursion for prophylaxis (lot # U019904, expiration date 24-JUN-2023; strength and route were not reported). Vaccine was stored at 36 F for 46 hours (product storage error). There was no previous temperature excursion. It was confirmed that no other adverse event (AE) occurred.
Severe headache, tired, achy, nausea, feverish, slightly dizzy, and generally weak feeling.
Information has been received from a consumer who reported that on 18-MAY-2007 she was vaccinated with the first dose of GARDASIL (lot #, and route not reported).  The consumer reported that on 22-OCT-2007 she was vaccinated with the second dose of GARDASIL (lot #, and route not reported).  She noted that she did not receive the third dose of GARDASIL in January, because she had the flu.  No further information was provided.  Additional information is not expected.
started getting hissing sound in bilateral ears. Went to my ENT doctor & he diagnosed it as bilateral tinnitus. I took Lipoflavinoid with no relief. hearing loss, mixed bilateral. Hearing loss unspecified hearing loss; constant tinnitus; chroni micrvascular ischemic changes
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 2:Pfizer / Dose Number: 1:Janssen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 27Nov2021 as dose 2 (booster), single (Lot number: Fj8757) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 02Apr2021 as dose 1, single (Lot number: 043 A21A), in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose Number: 2:Pfizer / Dose Number: 1:Janssen". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: testing negative two consecutive days; (unspecified date) Negative, notes: testing negative two consecutive days; (Oct2022) Positive, notes: COVID returned 7-8 days after finishing my last dose of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: COVID returned 7-8 days after finishing my last dose of Paxlovid and testing negative two consecutive days. Patient received Paxlovid  as COVID 19 Treatment.