chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of Moderna COVID-19 vaccine 12 hours after the initial vial puncture, and not after the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of Moderna COVID-19 vaccine 12 hours after the initial vial puncture, and not after the published expiration date) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 045L21A, 040A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of Moderna COVID-19 vaccine 12 hours after the initial vial puncture, and not after the published expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of Moderna COVID-19 vaccine 12 hours after the initial vial puncture, and not after the published expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  This patient had not reported symptoms.  No additional doses and medications have been administered in response.  Upon follow up, reportedly, agent clarified that patient's concerns were regarding the administration of Moderna COVID-19 vaccine 12 hours after the initial vial puncture, and not after the published expiration date.  No additional treatments have been administered in response.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2022: Live significant follow up information received: Event verbatim and narrative updated.
had Shingrix 4 yrs ago, scheduled for another; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 years ago from reporting).   On an unknown date, the patient did not 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 Information: GSK Receipt Date: 13th July 2022 Reporter's Comments: The patient self-reported this case. The patient's doctor's office could not get more (2nd dose) in the next 6 months. Now she was scheduled for another Shingrix vaccine. The patient asked did she need to start over and get two doses or just get one. The patient's physician said 1 dose and the pharmacist said to start again and have 2 doses and patient stated she would go with physician and the disease control and ignore the pharmacist even though she know him and he's going to be not nice about this. Reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive second dose, which led to incomplete course of vaccination.
This medically confirmed spontaneous report (initial receipt 22-Jul-2015) concerns a patient (demography not reported). On an unspecified date, the patient received unspecified flu vaccination (manufacturer and batch number not reported) and ZOSTAVAX (batch number not reported) concomitantly. ZOSTAVAX was given to prevent shingles. On an unspecified date, the patient developed pruritus that lasted between 2 and 3 months. No further information was provided. The outcome was not reported.
Pt became limp and fell off the chair he was sitting in. Pt struck his left forehead on the floor. Pt complained of inability to control his muscles and felt limp. Pt was lifted to stretcher. Pt vitals were evaluated and found to have hypotension (81/67). Pt was also found to have significant left sided weakness and Pt stated it was a struggle to control his movements. Pt was transferred to Fire/Rescue for transport to ED.
Mother states the patient was vaccinated on Dec-7-2015 at 8:34 AM with KINRIX Rt arm. MMR in the left arm, Varicella Left arm. Today, Dec-8-2015 presents with redness, swelling on Rt arm.
Client (per mother) developed hives under arm (same arm where vaccine given) and some hives on back.  Mother states this began to occur late on 05/24/2003.  As of 05/29/2003 hives are still present but less itchy.
Arm pain; Fatigue; Muscle ache; Leg pain; Dizziness; Headache; Nausea; Vomiting; Diarrhea.
I started wheezing and felt short of breath like someone was sitting on my chest. When I took a breath in I started coughing. Later my eyes, neck, throat and face were swollen and itchy.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. At the time of patient's vaccination, patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effects, which induced patient to be vaccinated.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare for shingles. And on an unknown date the patient was hospitalized. As a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, patient has and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The outcome of the event of shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
fainted and woke up on floor; sweating thru pajamas; throwing up; sore arm; A spontaneous report was received from a consumer concerning a 70-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm,, fainted and woke up on floor, sweating through pajamas and throwing up.  The patient's medical history was not provided. Concomitant medications reported were unspecified statin, blood pressure medication, antiviral medication.  On 02 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 007M20H) intramuscularly for prophylaxis of COVID-19 infection.  On 02 Mar 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012A21A) intramuscularly for prophylaxis of COVID-19 infection.  On 02 Feb 2021, the patient experienced the event, sore arm.   On 03 Mar 2021, the patient fainted in the kitchen and woke up on floor. The patient reported sweating through pajamas and started throwing up.  Patient did not take any treatment for second dose events.  Action taken with mRNA-1273 in response to the events was not applicable   The event, fainted, was considered resolved on 03 Mar 2021.  The outcome of events sore arm, sweating and throwing up were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Drowsiness (may not be related), migraine-like headache, slight dizziness.
Patient got his first COVID shot on April 3rd, had a HA for a few days after the shot. Then fine. Had his second shot on April 25th, had a HA for a few days gradually improving. Then on the 28th went for a run and  after 3 miles had bad HA so had to stop. Went home and slept. Since then has tried to work out and feels fatigued w/ worse HA.         No Hx HA's. Still has a HA, pain on top of head, feels hungover, denies vision changes or photophobia, no nausea. Pain not too bad but cannot work or do anything physical. No other areas of discomfort.         Pfizer. Did not report to Vaers.
Severe joint pain for 2 days- between each bone in every toe, ankles, spine, fingers, neck. Headaches. Intermittent joint pain still to this day with increased bruising without known cause all over legs. Headaches still.
Chills, fever, rash, heart racing for hours, headache, neck ache, joint ache
Patients delayed in getting the other twinrix doses; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in an unspecified number of patients who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient did not  receive Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-Feb-2023 Reporter's comment:  The case was reported by the nurse. The nurse reported that they had patients that came in off schedule. In a case where a patient was delayed in getting the other Twinrix vaccines, the nurse asked if they have to start over, or was there a max time where the patient could be delayed between all doses. Additional supportive information: As patient did not received their next dose of twinrix which led to incomplete course of vaccination. Reporter consented to follow up.
5 days after 1st dose mildly sick for 1 day. 11 days after 1st dose severe attack of arthritis in my right hand only for a day. 18 days after 1st dose an attack of Bells Palsy on left side of face with a severe headache for several hours.  These symptoms were similar to but more severe than those that were experienced prior to treatment of chronic Lyme Disease.  1 day after 2nd dose extreme arm and upper body pain. Day 2 after 2nd dose extremely ill. Day 3 after 2nd dose extremely ill with difficulty breathing.  Almost wentto ER but the next day I was fine.
About 1000 am and about 2-3 minutes after pfizer and flu vaccinations were administered, a screener relayed information to the Agency, the  Patient reports lightheadedness. The writer(Nurse) who administered  the vaccinations checked on the patient while a Second nurse was enroute with the vital sign machine who then obtained vitals and monitored the patient until  the rapid response team arrived.1000 am the writer (Nurse)observed patient to be  ill-looking,upper torso flaccid, position in the bus seat, arms at his side,  facial flushing,head turned to right. The patient observed as mouth  breathing,tachypnea,and in respiratory distress. 1001 the Agency called the Rapid  Response team. The patient is alert to name and oriented to situation. Patient  verbalized complaining of "lightheadedness". At 1002, the patient verbalized to  the second nurse that he had tingling feeling in lips and mouth, chest heaviness  and verbalized SOB during the course of examination, but with distraction failed  to respond to further questioning. Additional reports tingling in hands  progressing to numbness on left arm during course of examination.  Second Nurse at 1002 observed patient in sitting position, grimacing  and in apparent  distress, responsive to voice and speaks with short phrases.  Initial VS:BP 168/109,HR 100, SpO2 91% in RA,tympanic temp 97.6 fareinheit.  Respirations labored evidenced by intercostal retractions.1008 the rapid response  team at the patients side.  B: the patient arrived with a group in a van to receive vaccinations.  A: No oral or subcutaneous injections given prior to arrival of rapid response  team. It appeared the patient expeienced either an allergic reaction secondary to  two vaccines or in acute anxiety.    R: About 1015, the patient was transported to the ER via company van for further  monitoring and complete assessment due to potential respiratory compromise.
loose cough; chills; slight increase in temp (no higher than 100.8) for 24 hours; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the arm left on 24Apr2021 at 11:30 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included environmental allergy, sinus infection (Chronic sinus infections) and upper respiratory disorder (chronic upper respiratory issues). Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), acetylsalicylic acid, caffeine (BAYER BACK & BODY PAIN) and acetylsalicylic acid (ASPRIN) from unknown dates taken for unknown indications. The patient previously took erythromycin (MANUFACTURER UNKNOWN) for unknown indication on unknown date. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 03Apr2021 at 13:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Prior to the 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 COVID vaccine. On 25Apr2021 at 07:30, the patient experienced incredible chills, slight increase in temp (no higher than 100.8) for 24 hours, and a cough. It had been 5 days and the patient still had a loose cough that the patient was concerned about and the patient would like to talk to someone before making an appointment with her physician to discuss a course of treatment and need to know about medications that her physician normally prescribes for upper respiratory problems vs. vaccine ingredients. The clinical outcome of the event loose cough was not recovered at the time of this report.  The clinical outcome of the event slight increase in temp (no higher than 100.8) for 24 hours and chills was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient developed a 6 cm diameter red, swollen area around site of vaccination. It was also warm to the touch. He also suffered fatigue and malaise for approximately 36 hours following the injection. He spent that 36 hours in bed, unable to get up and function normally. On 03/26/19 he was seen in our office and still had a 3-4 cm red, slightly raised area around the site of the injection. The fatigue and malaise were gone.
Crops of papules and vesicles on legs, trunk, face. No fever, pruritic lesions. Mild case of varicella.
She got the vaccine and that evening she hurt so bad.  The right arm pain was really bad, she also has osteoarthritis on her shoulder and her neck.  She ended up with a headache.   She has had several injuries and these areas were accentuated x3 since the vaccine.  She has a history of shingles and it felt like shingles pain.   Due to the pain she did not sleep Saturday or Sunday 2/7 and 2/8 and was in the bed for most of these days.   She has stomach problems, and this was not good either.  She still can feel in the right arm where she received the vaccine and  not unless she presses on it.  Everything quieted down on 2/8/21, and back to her usual self.  She did not take anything for relieve of the pain.   She also had fever of 99.6 with this.
Received flu shot 8-31-2011. Sore throat and weakness by 6 pm 8-31-2011. Still weak and sick 9-1-2011. Developed into severe muscle pain, aches and severe chills and weakness by evening. Improving 9-2-2011, but still somewhat sore and weak.
Patient was given Covid Booster as he was alerting due in our vaccination  charting system. I asked pt. if he was interested in getting his 2nd  booster. He stated he was and would like this today. He was unable to find his  vaccine card at this time, I proceeded to give him his booster as requested.  After giving booster, pt found card and it showed that he did in fact get a  second booster at a pharmacy in March 2022.
Moderna COVID-19 Vaccine EUA.  One week after vaccination (Feb 9), area around site became red and itchy.  By next day area was swollen, tender, very itchy and still red.  Sept. 11 symptoms were easing.  Saturday , Feb 13  itching  & soreness are back.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-DEC-2015 at 14:51 the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L025738, expiry date: unspecified (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high and low temperature were 6.2 and 4.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
soreness in arm; Rash all over body; swollen bumps all over their body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), RASH (Rash all over body) and SWELLING (swollen bumps all over their body) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH (Rash all over body) and SWELLING (swollen bumps all over their body). On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm), RASH (Rash all over body) and SWELLING (swollen bumps all over their body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
ONE WEEK AFTER SHINGLES VACCINE CLIENT HAD DEVELOPED RASH ON ENTIRE BODY AND IT LASTED FOR ONE MONTH. NO FEVER NOR ITCHING ACCOMPANIED.  IT RESOLVED BY ITSELF.
received dose 1 / on :8 march 2019 dint get 2nd dose / Hcp also believes the wife may have also but unsure; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   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 information was provided as follows: The age at vaccination was not applicable for this report. The reporter believed that the patient might had not received 2nd dose of Shingrix but was unsure.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details were reported for 1st dose. The reporter consented to follow up. This case had been linked with US2021153984, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021153984:Same reporter
In about 1.5 hours after the shot my throat started swelling up and making it very difficult to swallow but my airway was fine so i didnt get any treatment . This swallowing issue lasted about 4-5 hours then went away . After the swallowing issue i was getting dizzy for 3-4 hours randomly and that started about 4 hours after the shot and went away the same night and no treatment was sought .
injecion site swollen; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injecion site swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced INJECTION SITE SWELLING (injecion site swollen). At the time of the report, INJECTION SITE SWELLING (injecion site swollen) outcome was unknown. Not Provided          No concomitant medications were provided.  Treatment with ice packs pertained to the events, was provided by the patient.
The day of Sunday 8/19/18, Patient felt very tired. After dinner he wen to play video games (as he often does). His sister checked on him about 8:30pm and found him slumped over his computer, unresponsive. 911 called. No abnl movements or sounds heard. Had bit tongue on (R) but no incontinence. Took 30+ min to "come-to". Also found to have an impaction Fx of his (R) Prox humerus - Hill sachs" deformity may need surgery on shoulder.
Hives noticed first on stomach, then thighs and armpits, then spread to chin, chest, and legs.  Tactile fevers during first few hours.  Mother of patient states hives lasted ~5-6 hours, during which time patient was seen by a pediatrician who prescribed Zyrtec.  Zyrtec given, although hives had already began to resolve.
This is a spontaneous report from a contactable physician. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. The patient experienced bronchospasm on an unspecified date with outcome of unknown. Follow-up (26JUN2015): Follow-up attempts completed. No further information expected.
Baby was given pneumococcal polysaccharide vaccine (adult dose) instead of Hepatitis B vaccine.