chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swallowed some fluid while he was coming out; baby was in NICU for 3 days for respiratory issue; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER NEONATAL (baby was in NICU for 3 days for respiratory issue) and NEONATAL ASPIRATION (swallowed some fluid while he was coming out) in a 6-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Maternal exposure during pregnancy on 30-Dec-2020.    No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) 1 dosage form. On 15-Jan-2021, the patient experienced NEONATAL ASPIRATION (swallowed some fluid while he was coming out) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY DISORDER NEONATAL (baby was in NICU for 3 days for respiratory issue) (seriousness criterion hospitalization). The patient was hospitalized for 3 days due to NEONATAL ASPIRATION and RESPIRATORY DISORDER NEONATAL. At the time of the report, RESPIRATORY DISORDER NEONATAL (baby was in NICU for 3 days for respiratory issue) and NEONATAL ASPIRATION (swallowed some fluid while he was coming out) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Transplacental) was unknown.       The mother was at 36 weeks of gestational age when she received the first Moderna COVID-19 vaccine (025L20A) on 30 Dec 2020. She was taking prenatal vitamins and had been on progesterone suppository to prevent shortening of cervix, but she stopped it at 32 weeks of gestation. Her estimated due date was 26 Jan 2021, but she gave birth to 1 baby. There were no complications, except the baby was in the neonatal intensive care unit for 3 days for respiratory issue because he swallowed some fluid while he was coming out.   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.   This case was linked to MOD-2021-200573, MOD-2021-200726 (Parent-Child Link).   See case MOD-2021-200573,MOD-2021-200726 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: No new information; Sender'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.
This spontaneous report has been received from a registered nurse referring to a 32 year old female patient with multiple sclerosis. The patient had mental health issues including major depression and anxiety. The patient was allergic to fluoxetine. On 03-AUG-2017, the patient was vaccinated with a dose of PNEUMOVAX23 (intramuscular left deltoid, lot # M042324 and expiration date 10-JUN-2018) for vaccination (prophylaxis). On an unspecified date in August 2017, within hours of receiving PNEUMOVAX23, the patient felt a fever, body aches, and nausea and began to vomit which prompted to the emergency room. While in the hospital (in August 2017), the patient began to have warmth and redness near the injection site and was diagnosed with cellulitis. The patient had been receiving intravenous (IV) vancomycin as treatment. As of 07-AUG-2017, the patient was still in the hospital and she felt that her arm was still sore and red and she felt the treatment had not yet kicked in.  At the reporting time, the patient did not recover from the events. The causality between the events and PNEUMOVAX23 was not reported. Upon internal review, cellulitis was determined to be medically significant.
On 2/7/2021 he suffered a myocardial infarction with permanent reduction in ejection fraction and requiring placement of a cardiac stent
COVID symptoms started on 9/7/21, tested covid+ on 9/8/21, scheduled to receive regeneron infusion but developed shortness of breath and oxygen saturations fell to 81 and 82% on room air, sent to ER for hospitalization
Muscle pain everywhere; Fever; Fatigue; Big headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration on 07Apr2021 at 14:15 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included progesterone (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and estradiol gel (ESTROGEN) from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient previously took erythromycin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. 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 vaccination. On 08Apr2021 at 07:00, the patient experienced fever, big headache, muscle pain everywhere and fatigue for 2 and a half days. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, big headache and muscle pain everywhere were resolved on an unknown date in Apr2021 and the clinical outcome of fatigue was resolved on 10Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Arm got sore and soreness moved to clavicle area in about 2-3 days. Then, lymph nodes around clavical area  became swollen and stayed swollen for  about  2 weeks but are getting better now. No treatment needed and did not go to MD. Note: vaccine could be lot EU6200 because not sure of writing.
PT EXPERIENCED SIGNIFICANT INJECTION SITE REDNESS AND PAIN (UNABLE TO LIFT ARM THE FIRST 24 HOURS AFTER. HE EXPERIENCED CHILLS AND FEVER UP TO 103 DEGREES.
KINRIX dose was given before age 4-6 yrs. Client called on 01/03/12 no adverse reactions noted.
Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; Soreness on day 2 Day 3- site of injection was swollen, painful, and itched; This is a spontaneous report from a non-contactable Other healthcare professional (HCP) (patient). A 31-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: E4284), via an unspecified route of administration on 22Dec2020 11:30 at a single dose in left arm for COVID-19 immunization. Medical history included asthma, known allergies: dust mites. The patient experienced soreness on day 2 (24Dec2020) and day 3 (25Dec2020), site of injection was swollen, painful, and itched on 24Dec2020. No other vaccine in four weeks received. No treatment received for these events. The patient had no COVID prior vaccination or no COVID tested post vaccination. This is a non-serious report. The outcome of events was not recovered.   No follow-up attempts are possible. No further information is expected.
The same day I had fatigue and joints in my body hurt; my doctor ran a couple of test and all of them were negative. I ended up having high blood pressure and shortness of breath and my doctor put me on blood pressure medicine.
Patient had a positive covid test 12/4/2021. The patient has had symptoms for 3 weeks of cough and not feeling well.
Erythema right arm - site increase in temp (most of upper arm involved), ROM WNL, neurovascular exam intact.
Patient chose to not wait near the pharmacy and go shopping in the store.  Patient felt faint, so she went to a bench located in the front of the store where she sat down, then laid down. She felt like she passed out for a couple seconds.  Her significant other called 911.  A customer service manager came and contacted me to let me know of the situation.  I had the patient drink some water and stay lying down.  The  paramedics showed up.  I told them about the immunization, and instructed them that she should drink water and remain lying down, and that the dizziness should pass in about 20 minutes.  They watched her for the 20 minutes, then escorted her out to her car.
COVID-19 viral infection:  -patient is not currently hypoxic and denies any significant symptoms.   -not meeting indication for him to severe or dexamethasone.      10/22/2021 VACCINE DOSE 3 3/15/2021    2 2/22/2021   1
I experienced some discomfort immediately after the vaccine. I felt like I had a band of tight ness around my chest. I ended up need IV fluids and a severe immune response and rigors. The chest tightness and chest pain persisted intermittently for two to three weeks after the vaccine. I had some shortness of breath in the first few days.
Vaccine was administered from a vial that had been left at room temperature since 10:15am the previous day (29 hours since first puncture).
Severe headache; Chills; This is a spontaneous report from a non-contactable consumer, the patient. A female patient of unknown age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via unspecified route of administration in left arm on 17Mar2021 at 09:30 AM (age at vaccination unknown) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration on unknown date for COVID-19 immunisation. On 18Mar2021, the patient experienced severe headache and chills but no fever. The patient did not receive any treatment for events. The clinical outcome of severe headache and chills was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Protect Confidentiality" checked for reporter since reported for self, for all events: "Treatment Received?" captured as "No" per source reported "if treatment ae: No" and Final sentence updated from "Information about lot/batch number cannot be obtained. No further information is expected." to "No follow-up attempts are possible; information about lot/batch number cannot be obtained."
injection site pain; sore throat; cough; mild headache; muscle pain; This is a spontaneous report from a contactable other healthcare professional.  A female patient of an unspecified age (Age: 54: unit: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 18Dec2020 to 18Dec2020 as single dose for Covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The reported explained that the patient received the COVID-19 vaccine on 18Dec2020, after which she experienced: " injection site pain, sore throat, cough, very mild headache and muscle pain". She then asked if her symptoms were part of the commonly reported side effects, and if she should take a COVID test. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
The caller said the patient's first dose of GARDASIL 9 was administered on 12/29/2022 (lot and expiration date unknown).; no other AE; Customer called to report an AE for GARDASIL 9. The caller said that a pregnant patient received GARDASIL 9 on 8/1/2023. The caller said this was the patient's second dose of GARDASIL 9. The caller said the patient's first dose of GARDASIL 9 was ad; This spontaneous report was received from Other and refers to a 35-year-old female patient (pregnant, LMP 10-JUL-2023).  The patient's medical history included  human papillomavirus infection, and rhinitis allergic. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-DEC-2022, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, unk, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 01-AUG-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 2nd dose, lot #w014479, expiration date: 16-DEC-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, customer called to report an AE for GARDASIL 9. The caller said that a pregnant patient received GARDASIL 9 on 8/1/2023. The caller said this was the patient's second dose of GARDASIL 9. The caller said the patient's first dose of GARDASIL 9 was administered on 12/29/2022 (lot and expiration date unknown). Confirmed with caller no other AE occurred. Case number provided. (Vaccine exposure during pregnancy, Vaccine exposure before pregnancy). AE letter sent to prescriber. No other AE. No PQC. At the time of reporting, the outcome of the events was not known. The action taken with GARDASIL 9 regarding events was reported as Not Applicable.
Pt reported Neuropathy (pain) w/ Moderna Covid Vaccination. during December admission for unrelated reasons.  Unknown time course or which dose resulted in reaction.
Massive headache every morning. Then moves towards fever, sore throat, and loose stool.
Client presented for covid vaccination.  0.5 Moderna drawn up. Site injected and very tiny drop of vaccine ran out of the syringe as injection was completed. Drop loss at hub of syringe. Loss amount was much less than half a dose so client was not revaccinated per CDC.  Syringe used was Eclipse 23G x 1: syringe
Initial report was received from a healthcare professional on 07 December 2012. A nine-year-old female patient had received an injection in the left deltoid of FLUZONE, lot number UH734AD, on 04 December 2012. The day after vaccination on 05 December 2012, the patient began having symptoms of redness, swelling and the area felt firm at the left deltoid area. The physician stated that the vaccine may have been given lower than the deltoid muscle and possibly not into the muscle. The redness has lightened, but continues to increase in size and swelling has increased. The physician stated it may be cellulitis. The patient is able to move her arm without discomfort or restrictions. Treatment included OMNICEF, ORAPRED and BENADRYL. The patient had no illness at the time of vaccination and no past medical history. No laboratory or diagnostic testing was provided. Outcome was not recovered. Documents held by sender: None.
Aside from the ongoing heart palpitation and headache and high blood pressure from the 2nd dose adverse event  -- 3 days after my booster shot I experienced pain in my Right side hip area. I couldn't walk, and I had to wear a back brace. I went to the doctor and they did an X-Ray and was prescribed with Meloxicam (5mg). Up to this day I am still experiencing  the same symptoms such as heart palpitations, tolerable headache and the lower back pain which transferred towards my stomach.
vesicular rash; This case was reported by a physician via sales rep and described the occurrence of vesicular rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 21 days after receiving Shingrix, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the vesicular rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed vesicular rash which looked like herpes type rash but more scattered presentation. Developed 3 weeks post shingrix dose.  The reporter was unsure if related.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 16-JAN-2012 at 07:30 and on 17-JAN-2012 at 7:30, ZOSTAVAX (Lot # reported as 0869AA) (Lot # 0869AA is an invalid lot for ZOSTAVAX) was exposed to -8 degrees C for an estimated total time out of range of 14 hours. On 01-MAR-2012 at 7:30, ZOSTAVAX (Lot # reported as 0869AA) was exposed to -14 degrees C for an estimated total time out of range of 10.5 hours and on 03-MAR-2012 at 11:30 it was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 07-MAR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (Lot # reported as 0869AA) (dose and route of administration were not provided). No adverse experience was reported. This is one of 182 reports from the same source. Additional information has been requested.
Patient with persistent numbness to the contralateral thumb from the injection site 2 days after the injection and persisting for at least 3 days from the onset
Still having migraines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 42 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) as dose 1, single and administration date 30May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; botulinum toxin type a (BOTOX) (ongoing) (Batch/Lot number: unknown) for migraine. Relevant medical history included: "Migraines" (ongoing), notes: Migraines. The patient's concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "Still having migraines". Therapeutic measures were taken as a result of migraine.  Additional information: The patient received Qulipta as treatment for the adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Information has been received from a physician via company representative referring to a female patient of unknown age. In 2013 and in 2014, the patient was vaccinated with a dose of GARDASIL (dose, route and lot number not provided) respectively. On an unknown date, the patient experienced dizziness, stomach pain, headache, episodes of nearly passing out (causing the patient to need to pull over while driving), tingling in extremities, weakness and fatigue. The outcome of events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
3 cm round and slightly raised erythematous, tender and warm over injection site. Treated with ibuprofen q4h with food and icing the area 3 x per day.
Hives all over body/huge welts everywhere; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over body/huge welts everywhere) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SERTRALINE, ATORVASTATIN and PANTOPRAZOLE for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (Hives all over body/huge welts everywhere). At the time of the report, URTICARIA (Hives all over body/huge welts everywhere) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Report cross-linked to MOD-2021-021974.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 27-Apr-2021 included no new information.
Approximately 2 hours after receiving the MMR vaccine, my lips started to tingle. My tongue felt weird.   I went to the ED.  Labwork was completed.  Received benadryl, pepcid and solu-medrol.
This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy arm after the shot) in a 100-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Nov-2021, the patient received third 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PRURITUS (itchy arm after the shot). At the time of the report, PRURITUS (itchy arm after the shot) outcome was unknown. Not Provided          Treatment information was not provided. List of concomitant medication were not given.   This case was linked to MOD-2021-405414 (Patient Link).
I did not have any adverse reactions to the vaccine. However, sixteen days later (on 21 May 2022) I started experiencing mild "cold like" symptoms (cough, runny nose, sneezing) and self tested for COVID-19 using the OTC at home kit and tested POSITIVE. I tested twice on 21 May to confirm.  Checked with my Physicians' office on 21 May  via tele-health call, they recommended self-isolation and Tylenol. From 21 May I have checked my temperature and blood/oxygen levels twice daily,  no fever, and I have normal (97~100) blood/oxygen levels. My symptoms diminished starting on day seven. I  self tested again on day five, and was still positive; tested again on day ten, was still positive; tested again on day twelve, am NEGATIVE.
Patient developed redness same day of getting shots, and itching.  Mom was using ice to arm.