chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; inadvertently received an expired dose of MMRII; This spontaneous report as received from a medical assistant (also reported as administrator) refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided.   On 22-APR-2019, the patient inadvertently received an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (exact dose, anatomical location and route of administration were not provided, lot # N025889 with expiration date of 18-APR-2019) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # N023306, expiration date: 20-JAN-2020). No adverse effects were reported.
Engerix-B second dose pediatric formulation instead of the adult; Engerix-B second dose pediatric formulation instead of the adult; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 50-year-old male patient who received HBV (Engerix B 10 mcg) (batch number 25N39, expiry date 16-MAR-2024) for prophylaxis.   Previously administered products included Engerix-B (1st dose received on an unknown date).   On 09-JUN-2023, the patient received the 2nd dose of Engerix B 10 mcg. On 09-JUN-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: Engerix-B second dose pediatric formulation instead of the adult) and adult use of a child product (Verbatim: Engerix-B second dose pediatric formulation instead of the adult). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 15-JUN-2023 The Engerix-B first dose was administered on another pharmacy and that is why there were no details available about that dose. Follow-up declined. The reporter did not consent to follow-up. An adult patient received Engerix-B dose pediatric formulation instead of the adult, which led to underdose and adult use of a child product.
charlie horse leg cramps; leg cramps; some side effects; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (charlie horse leg cramps), MUSCLE SPASMS (leg cramps) and VACCINATION COMPLICATION (some side effects) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (charlie horse leg cramps), MUSCLE SPASMS (leg cramps) and VACCINATION COMPLICATION (some side effects). At the time of the report, MUSCLE SPASMS (charlie horse leg cramps), MUSCLE SPASMS (leg cramps) and VACCINATION COMPLICATION (some side effects) outcome was unknown.        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.   No Concomitant medication was reported.     No treatment medications were reported.
Nasal and chest congestion followed by, eye swelling and high fever of 101 degree F starting at 11:00 PM on 10/25/16 and still continuing currently on 10/28/16. Baby seems to be aching and is fussy.
Amenorrhea - no period until January 2022 following second of the 2-shot vaccination on September 21st, 2021 (missed 4 periods). New repeated hot flashes (no prior experience of hot flashes), night sweats, irregular period since vaccination, even a year later (September 2022). No prior experience of months of missed, irregular periods. Menstruation still has not returned to normal, periods are months between and sporadic. Still experiencing hot flashes and night sweats. Period was normal and regular prior to covid vaccination, no hot flashes or night sweats prior to Covid vaccination.
I have 99 fever; My arm is sore; Cold; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/lot number, NDC and UPC number and expiry Date: unknown), via an unspecified route of administration in Dec2020 (at the age of 67-year-old) as a single dose for COVID-19 vaccination. The patient had no relevant medical history. The patient's concomitant medications were not reported. In Dec2020, the patient woke up with a 99 fever that went to 98.4, arm was sore and didn't know if it was a cold. The patient was treated with ibuprofen for sore arm. The clinical outcome of 99 fever, arm was sore and cold was unknown.    No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
28 yo vaccinated 3/26 and on 4/2 noted that the skin underneath the opsite was very red and had some small pimples develop. It became very painful and the redness then began to spread circumferentially around the arm. The pimples began to have some clear fluid underneath but did not look exactly like the vaccination site (which was big and about to scab already). He felt like he had fevers at night and came in to ER on Sat. (4/5) Temp was 100.4, he was talking, nontoxic. He was admitted and placed on unasysn for one dose and then switched to oxacillin with some improvement over the next 2 days. No cultures were sent as there was no drainage to culture. He was discharged on 4/7.  The presumptive discharge diagnosis was reaction to the adhesive (opsite) with ? mild cellulitis.
Low grade fever for 24 hours. Muscle pain for 24 hours. Soreness at injection site for 5 days. Rash on right leg starting on second day after injection. Initial rash subsided after 4 days. New larger rash on left leg and new rash on right leg starting 4 days after injection. Rash is still spreading at this time on both legs. No treatments.
This case was reported by a other health professional and described the occurrence of shoulder pain in a adult unk patient who received FLUARIX Quadrivalent. On 4th September 2014, the patient received FLUARIX Quadrivalent (unknown). On an unknown date, an unkown time after receiving FLUARIX Quadrivalent, the patient experienced shoulder pain, pain in arm, back pain, neck pain and stiffness. On an unknown date, the outcome of the shoulder pain, pain in arm, back pain, neck pain and stiffness were unknown. It was unknown if the reporter considered the shoulder pain, pain in arm, back pain, neck pain and stiffness to be related to FLUARIX Quadrivalent. Additional information received: This case was one of the 8 cases reported after vaccination with FLUARIX Quadrivalent (see case US2014GSK005295).
On Monday 3/8 I started feeling numbness, pain, and tightness in my left hand and elbow. During the next 24 hours my hand started to become very weak and my fingers began curling over each other. I had a video call with the doctor from family medicine and he referred me to OT for a check. I went to physical therapy and hand therapy on Thursday 3/11 and they evaluated and created a device to allow my fingers to still move, but prevent them from curling. Pain and weakness in the hand have continued.
On 9/27/16 patient received 5 vaccines listed in 13. Two doses of MMR were administered due to the needle separating from syringe and complete dose clearly not given. Patient had some urticaria - felt to be due to emotional upset, (6 needles). Later urticaria persisted and she developed nausea. She proceeded to ED for anaphylaxis treatment.
Patient received dose #1 of the Moderna mRNA vaccine at 8:45 AM. MST. No reaction occurred immediately after injection. At 12:45 PM MST patient while driving and eating a sandwich patient suddenly dropped his sandwich and his wife noted new slurred speech and drooping of the lower right side of his face. They drove to the hospital. Patient was evaluated in the ER and was found to have a normal EKG,  CT of the head and troponin which were normal. Facial drooping resolved prior to ER arrival but mild slurred speech persisted for 36 hours and then spontaneously resolved. MRI brain was done on 2/8/21 and was unremarkable.
This case was reported by a other health professional via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 56-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020). On 10th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 11th May 2018, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb and injection site erythema. SHINGRIX was discontinued. On an unknown date, the outcome of the extensive swelling of vaccinated limb and injection site erythema were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb and injection site erythema to be related to SHINGRIX. Additional information was reported as follows: The medical assistant reported that the patient was seen at the office for follow-up on 14th May 2018. The medical assistant reported that the patient experienced extreme redness at the injection site from her deltoid to her elbow including swelling. The patient required emergency room visit. The medical assistant has denied permission to contact their office.
Menstrual cycle change beginning 6 weeks after first dose and has continued every month to present. Beginning  6/3/21 length has been at least 7 days with very heavy flow (previously since I was 12 years old flow was light and maximum of 3-4 days). Cycle has always been 28 days since I was 12 years old, never have had irregularities in my cycle.  Beginning  October 2021 I had 2 cycles two weeks apart, this has never happened before. This again happened this month beginning 11/3 lasting one week until 11/10 then again  another cycle starting 11/15.  I have had no changes to my diet, exercise or medications. I began researching possible causes and saw various online articles about other women reporting changes to menstrual cycles after the Covid vaccine and possible research being done on this topic. I was very concerned because in 33 years I have never had any changes in my menstrual cycle and it has always been  regular, every 28 days and a short duration. Beginning 6 weeks after the Covid vaccine it has been longer, heavier and now occurring twice per month the last two months.
Instant pain in neck and ear at time of injection. Has had mild headache since then. No treatment sought.
Large 9 cm red area with 3x4 cm raised x 6cm area. No drainage - warm to touch. Doctor advised Benadryl cream to area with ice packs. If no better in 2 days return to office. Pt reported to office 6/9/09.
Migraine headaches, fever of 100.8, severe body aches, severe body chills, left upper arm swollen and major pain in whole arm, sneezing and severe running nose and nauseated really bad
Swollen arm for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm for 2 days) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B12A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), ARIPIPRAZOLE (ABILIFY), METOPROLOL, LEVOTHYROXINE and BUSPIRONE for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm for 2 days). On 12-Apr-2021, PERIPHERAL SWELLING (Swollen arm for 2 days) had resolved. Not Provided      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.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 14-JUL-2015, the patient was vaccinated with expired dose of MMR II lot # J0101577/0457AE and expiry date of 11-JUL-2015 (unknown strength, route and dose). Concomitant medications were not reported. No adverse effects were reported. The outcome of expired product administered was unknown. There was no product quality complaint involved. Additional information is not expected as reporter denied further contact.
Breakthrough case admission after 2 vaccines Pfizer 4/9/21 no lot#;  Pfizer 4/30/21 no lot#
No adverse event occured.  I administer a high dose quadravalent flu vaccine to a 57 year old that should have received the standard quadravalent vaccine.  The patient is aware of the mistake and not upset.  I monitored him on and off for two hours as I completed my facility review.  I will notify his physician also.
cough and dyspnea starting on 1/11/22.  Hypoxic.    TX includes: Oxygen, remdesivir, corticosteroidsprophylactic anticoagulation, pantoprazole
12/29: severe joint pain which prevented me from working (used OTC ibuprofen to help manage symptoms), moderate sore arm, mild headache, mild nausea 12/30: severe facial nerve pain onset in evening while I was laying in bed, followed by pins and needles tingling feeling. Went to clinic on morning of 12/31 due to symptoms and lingering facial Paresthesia. Doctor recommended I not receive second dose of vaccine and tentatively diagnosed me with a mild/incomplete Bell?s Palsy or trigeminal neuralgia. Important to note that I did NOT experience any facial weakness or drooping. Did not receive any prescription medications. Paresthesia resolved within 2 days.
Full body hives beginning 48 hours after receipt of second dose. Symptoms include, itchy burning skin, rash, hives, sensitivity to sunlight on exposed skin, lethargic lasting at least 5 days.  Treatment: oral steroids, steroid cream, over the counter allergy relief medicine, Benadryl and Hyrdoxyzine (as an anti-histamine and sleep aid)
This case involves an unknown age female patient who experienced couldn't walk (gait disturbance) and body hurt so bad (pain) after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site prophylactic vaccination. On an unknown date the patient developed a non-serious events couldn't walk (gait disturbance) and body hurt so bad (pain) (unknown latency) following the administration of INFLUENZA VACCINE. No laboratory data reported. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of the events was reported as unknown.
Pt c/o shortness of breath 2.5 hours after vaccine. Also reports hives, headache, dizziness and nausea since last night.
Per mom after having immunization five days later hive tye rash appeared. Child was seen at ER and told she was having a reaction to one of the immunizations and given Keflex. Was seen by her doctor next day. Rx fill for Keflex and started at approx 3 mos meds given on 3 mo later original rash began to look diffused. Mom was also told she had a cellulitis and tenderness was noted.
wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) 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 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) 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 (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml).    No concomitant product reported by reporter.  Physician reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So, they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. Patient received under dose of 0.25 ml of Moderna Bivalent Booster.  It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master Case
Information has been received from a registered nurse concerning a 5 year old health female with no allergies and no medical history who on 08NOV1999 was vaccinated with a dose of varicella virus vaccine live. On 11JAN2004 the pt developed chicken pox. The pt had spots on her back and multiple crusted area on her chest and back. There were less than 50 lesions . There was no fever . Unspecified medical attention ws sough and no treatment was required. It was noted that the pt had been exposed to her grandmother who had shingles. No product quality complaint was involved. I was also reported that the pt's brother was vaccinated with a dose of varicella virus vaccine live and developed chickenpox. Additional information has been requested.
Patient's arm swelled up, was red, warm to touch & itchy. This started approximately 24 hours after the flu vaccine. Patient saw his doctor on the next day, was diagnosed with cellulitis and given KEFLEX for 10 days. Swelling down as of 12-8-10. Getting much better.
I started to have feelings of dizziness two days after the vaccine. I developed a rash under my right breast for two weeks which scarred. The rash started four weeks after the first dose. It came and went during the day. I felt very weak and a little weird. It kept repeating over the next three weeks. It got worse one day and I had a burning feeling and it felt like a wave that went through my body. I went to the ER because it did not go away all day. I felt very weak. It slowly subsided after three weeks and I got the second dose eight weeks after the first. I feel better now, and it is only happening every few days. I have seen a Neurologist twice.
Shortness of breath, DOE, worsening daily from time of shot to now. PCP on 4/13, CXRAY 4/16, Pulmonology 4/26/21, ER 5/3/21 and admitted.
This spontaneous report as received from a physician refers to a multiple, unspecified patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients "might had been administered" an improperly stored doses of VAQTA (strength, dose, frequency, route of administration, lot # and expiration date were not reported). The storage temperature was 30 Fahrenheit degree for a 84 hours (7 cycles of 12 hours each cycle). There was an data logger. The products were back to range. No adverse effects were reported. Additional information has been requested.
Pt recv vax on 4/10/99; on 4/11/99 pt exp chills, fever, joint pain, headache, painful swallowing, vax site red/ swollen/warm/ pain; tx=warm compresses, Motrin
sore arm; pain; chills; lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (sore arm), PAIN (pain), CHILLS (chills) and DIZZINESS (lightheaded) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030120A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced LIMB DISCOMFORT (sore arm), PAIN (pain), CHILLS (chills) and DIZZINESS (lightheaded). At the time of the report, LIMB DISCOMFORT (sore arm), PAIN (pain), CHILLS (chills) and DIZZINESS (lightheaded) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Shoulder and neck pain, dizziness and diarrhea, loss of appetite, vomiting
adverse events: 20 hours after 2nd dose:  1.classic drug rash across torso and abdomen (small red dots that itched some all over the areas involved) 2. Pain like fire in all joints 3. unable to walk on feet without pain and fire shooting out form inside 4. unable to touch many spots on body; slightest pressure felt as respiration-changing pain 5. muscle groups muscles firm/ hard/tight (confirmed by physician at appt on monday 5/3), 4 days later  treatments: day 1 of symptoms: toradol. numbed pain for a few hours for each dose. Pain did not recede day 4 of symptoms: dr. prescribed course of prednisone. Pain improved slightly but still not able to walk on feet day 10 of symptoms: dr prescribed 2nd course of prednisone; pain continues to improve but still unable to walk on feet in am and last pm, and continuing pain in right achilles area and left outside midsole as well, altering ability to wear socks touching or shoes touching the areas. day 20 of symptoms; Both prednisone courses complete:  joints pain and pressure points move from joint to joint; unable to walk on feet in am and if ieated at table or driving for more than 60 minutes.  continuing pain in right achilles area and left outside midsole as well, altering ability to wear socks touching or shoes touching the areas. day 30 of symptoms:: there is a palpable hard area on outside of left midsole day 36 of symptoms : making another dr. appointmento follow up on footman, ability to walk, joint pain, and palpable hard area on left foot.  no fever, no hot areas;
Client started to have throat swelling, burning eyes. As the day went on continued to get worse.  Drove self to Immediate Care at 02:30 PM. Client found it hard to speak because of swelling in the throat. Client told it was an allergic reaction to the High Dose flu vaccine.  Benadryl IM given and Solu Medrol given.  Client improved and was sent home.
The first day was kind of weird, I had felt fine and I was running a 101 temperature. I went to a facility to get tested because, I had been exposed the week before. I was heavy, tired and bad body aches. I was kind of wheezy. I took Tylenol. Lots of water and sleep. I remember sleeping a lot. I was only down for 2-3 days like that.