chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen mouth and throat after 1st dose; Swollen mouth and throat after 1st dose; not receive the 2nd dose, thus, leaving the vaccination scheme incomplete; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of throat swelling in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced throat swelling (Verbatim: Swollen mouth and throat after 1st dose), swollen mouth (Verbatim: Swollen mouth and throat after 1st dose) and incomplete course of vaccination (Verbatim: not receive the 2nd dose, thus, leaving the vaccination scheme incomplete). The outcome of the throat swelling, swollen mouth and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the throat swelling and swollen mouth to be related to Shingrix.     It was unknown if the company considered the throat swelling and swollen mouth to be related to Shingrix.   Additional Information: GSK receipt date: 7-Nov-2023 A pharmacist called to inform that a patient got their mouth and throat swollen after getting the 1st dose of Shingrix.  After this, the patient's doctor told the patient that he should not receive the 2nd dose, thus, leaving the vaccination scheme incomplete. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not provide any dates or lot number, since the product had been administered at an unknown facility. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient received her vaccine about 11:50 AM and waited in the parking lot (because she is under quarantine and not allowed to enter the facility) for the appropriate 15 minutes. Within about 10 minutes she began experiencing shortness of breath, throat felt restricted and severe nausea. Myself, another pharmacist, and several members of the staff met them in the parking lot and assessed her condition. Because of her symptoms, we determined it was appropriate to go ahead and administer the EpiPen 0.3mg and call 911 at that time. About 10 minutes later we gave her a 25mg oral dose of Benadryl while we waited on the ambulance to arrive. The ambulance arrived within the next 10 minutes and by then the patient stated she was feeling much better. The EMT examined her and declined any further medical assistance. I called the patient at her home 2 hours later and she said she had some light itching and dizziness. I told her the dizziness could be due to the after-effects of the EpiPen but if it worsened or there were any other signs of an allergic reaction to report to the ER immediately or call 911. This may have been more of an anxiety related reaction due to there being no signs of swelling around the lips or mouth, but we decided it would be best to be overly cautious in this situation.
After receiving the vaccine, patient and her mother walked out to the car and she began vomiting and was less responsive. She returned to the office where her BP was initially 84/40 and then dropped to 70/30 and she continued to be poorly responsive. She was given 0.15 mg epinephrine from Epi-pen, and HR and BP improved. 911 was called for paramedic transport to hospital. She did not require second Epi injection. She was transported to ED where she was given Benadryl 13 mg iV, Zofran 2 mg PO, Solu-Medrol 26 mg injection IV and a bolus of normal saline. She was much more responsive after about an hour, was observed in the ED for 4 hours and was back to normal state and behavior when discharged.
Immediately following Tdap vaccination, pt lost consciousness and experienced jerking/ seizure like movements. Pt hit head on vaccine refrigerator. Laceration noted above right eyebrow. Ammonia Inhalant used, consciousness regained. While transferring from chair to exam table consciousness lost again. Pt lowered to floor, ammonia inhalant used, consciousness regained. B/P- 76/48. Head elevated, water and gingerale given and tolerated. Denies N/V, head pain. Dizziness present Transferred to ER for laceration.
pt recv vax 23NOV94 & MD advised was allergy; had rash @ site on chest, mostly upper lt arm leaving red spot size of nickel on lower arm; rash subsided but spot present x 1month;
Diffuse skin itching. Unsure if this is related to vaccine. Symptoms improved w benadryl.
Left thigh with 1.5x1cm redness, extreme leg soreness (cried with light touch to leg).
No additional AE; Improperly stored vaccine was administered after temperature excursion; This spontaneous report was received from a nurse and refers to a 17-months-old female patient. The patient's pertinent medical history, concomitant medications and drug reactions and allergies were not reported. Her historical vaccines included influenza vaccine, hepatitis B vaccine (manufacturer unknown), measles vaccine (+) mumps vaccine (+) rubella vaccine (MMR) (manufacturer unknown), diphtheria vaccine toxoid (+) HIB vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3V (MRC 5) (+) tetanus vaccine toxoid (PENTACEL), pneumococcal vaccine conj 13V (CRM197) (PREVENAR 13), rotavirus vaccine live reassort oral 5V (ROTATEQ), and varicella vaccine (unknown manufacturer).  On 06-JUN-2023, the patient was vaccinated with Hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, administered in the left arm as prophylaxis (Lot number X003791 has been verified to be a valid lot number for vial formulation, expiration date reported as 01-JUL-2024, but upon internal validation established as 01-JUN-2024) (strength, dose, route of administration, and vaccination scheme were not reported) after temperature excursion (Product storage error). No side effects or symptoms were reported (No adverse event).  This one of several reports received from the same reporter.
first dose was Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dose was Pfizer) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 18-Apr-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 26-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose was Pfizer). On 18-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (first dose was Pfizer) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided Treatment medication was not provided
Not long after the lst vaccine I developed a very sore arm that has not gone away a year and a half later. I also noticed severe ringing in both ears a month or so after the first vaccination and even worse each vaccination following. The ringing in my ears still persists to this day!
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck). After receiving ZOSTAVAX (Merck), "a year or 2 ago", in approximately 2008 the patient did come down with shingles, although the patient presented with limited symptomatology. It was unspecified how long after getting the "shot" the patient developed shingles. The vaccine was administered at an unspecified pharmacy. It was reported that the shingle improved after stopping therapy. The patient sought unspecified medical attention. Additional information has been requested.
2th dose was rescheduled for 3/5/21 which is going to be 44 days; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and due to storm 2nd dose was rescheduled for 3/5/21 which is going to be 44 days after the 1 shot/inappropriate schedule of product administration.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient received 1st dose of Moderna covid vaccine and due to storm 2nd dose was rescheduled for 5 Mar 2021 which was going to be 44 years days after the 1st shot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, due to storm 2nd dose was rescheduled for 3/5/21 which is going to be 44 days after the 1 shot was considered resolved.; Sender's Comments: This report refers to a case of a male patient who experienced Inappropriate schedule of vaccine administered for mRNA-1273, (Batch number unknown) with no associated AEs. His second dose was rescheduled for administration 44 days after the first dose which is beyond the recommended window period.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: FL6304), on 03Mar2021 as dose 2, single (Lot number: FL9236) and on 18Nov2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Mild MS" (unspecified if ongoing), notes: Other medical history: Mild MS,; "diabetes" (unspecified if ongoing), notes: Other medical history: diabetes,; "hyperlipidemia" (unspecified if ongoing), notes: Other medical history:  hyperlipidemia,; "rosacea" (unspecified if ongoing), notes: Other medical history:  rosacea,; "fibromyalgia" (unspecified if ongoing), notes: Other medical history: fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19.
Water balloon consistency swelling ipsilateral mid axillary line, 3rd-4th rib. Tender with pulling sensation elbow to inferior costal margin.  Narrative:  2nd lymph node size of tennis ball. Pulling from  elbow down to rib cage. Taking ibu and acetaminophen both 6/10
The muscle where the vaccine was injected swelled quite a bit and is still swollen.; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8734) via an unspecified route of administration in the arm right on 06Apr2021 at 15:30(at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included ibuprofen (MOTRIN) from unknown for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration on 07Mar2021 at 15:45 as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 the patient experienced muscle where the vaccine was injected swelled quite a bit and is still swollen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event muscle where the vaccine was injected swelled quite a bit and is still swollen. was recovering.   No follow-up attempts are needed. No further information is expected.
Information has been received from a physician who reported that an extra dose of ROTATEQ (lot not reported) may have been given at the same visit when a child spit up the initial dose.  Additional information is not expected.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with MMR II (lot # H018949, expiry date: 18-OCT-2014, therapy type, dose, route were unknown), which was improperly stored vaccine. The outcome of the event was unknown. This is one of several reports that received from the same source. Additional information is not expected.
swirl patterns of raised smooth areas all over the tongue (no pain) for 3 days which then turned to large oval raised smooth patches; loss of taste; lasting debilitating headache for over 5 days; unable to stand; nausea; vomiting; stomach pain; Sustained fever of 103/ fever at 101 and 99; uncontrollable chills and shivers; sweats; This is a spontaneous report from a contactable consumer or other non hcp. A 41-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation:Solution for injection, Lot Number: Ew0171), via an unspecified route of administration on 20Apr2021 13:15 (at the age of 41-year-old) as Dose 2, single for covid-19 immunization. Historical vaccination included the patient received first dose of BNT162B2 on 30Mar2021 13:15 (Lot number= Ep7533) on right arm as Dose 1,Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination the patient was not diagnosed with COVID-19 nor been tested for COVID-19 post vaccination. The patient had no Known allergies. The patients current age was reported as 42 years. On 20Apr2021 12:00, the patient experienced sustained fever of 103 via oral and temple monitoring for over 3 days, uncontrollable chills and shivers for 2 days straight, followed by 2 days of sweats with fever at 101 and 99, swirl patterns of raised smooth areas all over the tongue (no pain) for 3 days which then turned to large oval raised smooth patches and loss of taste (still occurring), lasting debilitating headache for over 5 days unable to stand, nausea, vomiting and stomach pains for over days (still occurring). Patient received Advil pepto as therapy for the events. The patient underwent lab tests and procedures which included body temperature of 103 in Apr2021 (sustained fever of 103 for over 3 days), body temperature of 101 in Apr2021 and body temperature of 99 in Apr2021. On 22Apr2021, the patient had recovered from the event uncontrollable chills and shivers while in Apr2021, the patient was recovered from the event sweats while the patient was not recovered from all other events.  No follow-up attempts were needed. No further information was expected.
SUN REACTIVE; HIVES ON FACE, NECK  AND CHEST; SWELLING OF THE FACE; SKIN ISSUES DOWN ARMS; This spontaneous report received from a patient concerned a 46 year old female. The patient's weight was 260 pounds, and height was 62 inches. The patient's concurrent conditions included heavy plegic migraine, rheumatoid arthritis, and non smoker.  The patient experienced drug allergy when treated with amoxicillin/clavulanic acid, moxifloxacin hydrochloride, and oseltamivir phosphate. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: 07-AUG-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included adalimumab for rheumatoid arthritis.  On 15-APR-2021, the subject experienced swelling of the face. On 15-APR-2021, the subject experienced skin issues down arms. On 15-APR-2021, the subject experienced hives on face, neck and chest. On an unspecified date, the subject experienced sun reactive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swelling of the face, hives on face, neck and chest, and skin issues down arms, and the outcome of sun reactive was not reported. This report was non-serious.
Patient developed hives on the day after his vaccine, was given Benadryl - did also have hives on the following day.  Mother also reports that patient was on a bean bag chair that had been washed in a new detergent - so may have also been caused by new soap.
pt recv vax 17MAY96 & 15JUN96 pt devel a gen rash w/papules, blisters & itch which was dx as varicella;there was no assoc  fever;pt recovered;
I do not have the vaccine lot number; was given outside our institution She was diagnosed with venous sinus thrombosis
Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 at 10:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 19Apr2021 at 16:45 as dose 1, single (Lot number: 032L20A), in left arm, on 23Feb2021 as dose 2, single (Lot number: 022M20A), in left arm, on 13Nov2021 as dose 3 (booster), single (Lot number: 033F21A), in left arm and on 11May2022 at 16:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunization. The patient's relevant medical history included: "Pacemaker for sick sinus syndrome due to undiagnosed and untreated Lyme disease." (unspecified if ongoing), notes: Pacemaker for sick sinus syndrome due to undiagnosed and untreated Lyme disease.; "sick sinus syndrome" (unspecified if ongoing), notes: Pacemaker for sick sinus syndrome due to undiagnosed and untreated Lyme disease.; "Lyme disease" (unspecified if ongoing), notes: Pacemaker for sick sinus syndrome due to undiagnosed and untreated Lyme disease.; "known allergies: wheat allergies" (unspecified if ongoing), notes: known allergies: wheat allergies; "Known allergies: nickel" (unspecified if ongoing), notes: Known allergies: nickel. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Known allergies: Keflex", notes: Known allergies: Keflex. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 11May2022, outcome "unknown", described as "vaccine brand other=Moderna/vaccine brand=Pfizer / BioNTech"; COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Muscle weakness with dysphagia and dysarthria leading to a diagnosis of myasthenia
PAIN AS FEELING LIKE A BUBBLE OF FLUID; PAIN FEELS LIKE A DEEP, SOFT TISSUE INJURY; INJECTION SITE SWOLLEN; PRESSURE UNDER THE MUSCLE; INJECTION SITE ARM PAIN AND TENDER; SPACEY; This spontaneous report received from a patient concerned a 37 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: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 01-JUL-2021, the subject experienced spacey. On 01-JUL-2021, the subject experienced injection site arm pain and tender. On 16-JUL-2021, the subject experienced pain as feeling like a bubble of fluid. On 16-JUL-2021, the subject experienced pain feels like a deep, soft tissue injury. On 16-JUL-2021, the subject experienced injection site swollen. On 16-JUL-2021, the subject experienced pressure under the muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacey on 01-JUL-2021, and had not recovered from injection site arm pain and tender, pain as feeling like a bubble of fluid, injection site swollen, pressure under the muscle, and pain feels like a deep, soft tissue injury. This report was non-serious.
Pt developed mild Shingles rash lower back that developed into blisters over the following week - she was on a cruise.
Patient who is 7 years-old presented to be vaccinated by one of our occupational health nurses.  The nurse selected a labeled syringe from the vaccine container supplied to her.  She then checked the contents, labeling, and placed the vaccine in her pocket.  She knelt next to the child who was seated, retrieved the vaccine from her pocket, and inserted the needle in the child?s deltoid.  She worked to use the plunger of the syringe but found that it had been discharged, likely into her pocket.  The grandmother of the child was informed, and she was re-vaccinated, after speaking with with an appropriately filled syringe.  I subsequently spoke to the grandmother as well, providing her my contact information if any additional questions should arise.