chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NAUSEA, VOMITING, FEVER, BONE PAIN IN LEGS. ENLARGED AND PAINFUL LYMPHNODES UNDER BOTH ARM PITS. I GOT THE BOOSTER IN WHICH MY WORKPLOACE SAID YOU COULD GET THE BOOSTER AFTER JUST HAVING COVID.  EN D OF DECEMBER I WAS VERY SICK WITH COVID AND STILL MANDATED THE BOOSTER.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On 02-NOV-2016, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (dose unknown) intramuscularly (Drug use via unapproved administration route). No adverse symptoms were reported. Additional information has been requested.
Phone call received from Mom 07/20/2010: Stated infant "cried for 5 hours following shots". When asked if crying was high-pitched, stated "I don't know". When asked if infant also ran a fever, stated, "I don't know; I didn't take it". Referred to pediatrician to report above reaction before next set of immunizations due. Phone call received from mom 07/23/2010: Stated she talked with pediatrician and he said not to give pertussis with next shots.
Patient claimed she had itching in site of injection and her back, chest and then she said she has diffuclty breathing and tightness in her chest and throat heavy tongue.
Presented to ED @ 0815 (approx 45 mins after 2nd Moderna vaccine) c.o. dizziness, N/V, chest pain.  Patient reports throat swelling although no obvious facial/throat swelling on exam, no wheezing.  Treated as anaphylaxis. Temp 36.2, BP 186/103, HR 70, RR 24, O2 sat 99.  Benadryl 50mg IV, Epinephrine 0.5mg IM, Pepcid 20mg IV, Zofran 4mg IV, Solu-Medrol 125mg IV, Tylenol 1000mg po, 1L NS IV bolus.  H/o covid infection ~ 3 months ago, now recovered from COVID PNA as well.
Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's sister. Additional information was not available. For tolerances of 2nd dose, refer case US2019AMR142256. The reporter did not consent to follow up.
Patient developed an episode of depressed BP and elevated heart rate the morning of March 10 2021. Felt light-headed and sought medical help at PCP office. referred to ER, where diagnosis of Afib was given, and appropriate medication was administered. Patient had no prior history of Afib, or any other arrhythmias. Followup care of cardioversion.
After the 2nd of 5 shots (MMR broken up into 5 shots by allergist) skin developed large bump and redness that started spreading. Given Zyrtec.
second dose of Moderna given at 4:00 pm.  The next day around 12:30 pm I started to feel fatigue and feverish.  I went to bed and continued to feel tired, lethargic, headache and fever.  My temperature went to 102 and I took Tylenol.  By 8 pm I was feeling better and able to eat a small dinner,  but still tired.  Sunday I did not have a fever and felt a bit tired but nothing  sever and able to function all day and be out.  Monday morning I had an outbreak of Cold Sores- the worst ever, I have 4 blisters one on each corner of my lips.  I took Valtrex and have had a head ache for 2 days, which is not unusual if I take a Valtrex.   I will note that I also gave myself my Duplexent injection on Sunday- cold sore can be a side effect- although I have not had one in 2 years.
9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. As1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended).    Patient age was reported as 2 years and 10 months.  Concomitant product use was not provided by the reporter.  HCP stated that the temperature happened on 18-Jul-2022. The duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were at the time of report frozen after the excursion.   No symptoms were reported after the administration of the vaccine.  Treatment information was not provided.
Pt received flushot on left arm. status normal. then pt received covid vaccine in right arm. immediately after the injection, pt became unconscious for ~ 5 seconds, and became very hypotensive. pt awoke and stated she has spells of fainting before and seemed very tired and unable to walk. pt was giving water and a snack and after 30 mins was able to walk.
wound up with  COVID 19; Missed the 2nd shot; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (wound up with  COVID 19) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot) 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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (wound up with  COVID 19) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot). At the time of the report, COVID-19 (wound up with  COVID 19) and PRODUCT DOSE OMISSION ISSUE (Missed the 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive for COVID 19 on an Unknown date.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided. Treatment information was unknown.
Fever of 103.1, gave Tylenol, had fever until 12/29/11, rash developed on chest and neck 12/30/11.
This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (very itchy), SWELLING, VACCINATION SITE WARMTH, FEELING ABNORMAL, and DIZZINESS in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Stroke. Concomitant products included ATORVASTATIN, ASPIRIN, VITAMINS, and CLARITIN for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced RASH PRURITIC (very itchy), SWELLING, VACCINATION SITE WARMTH, FEELING ABNORMAL, DIZZINESS, and VACCINATION SITE RASH. On an unknown date, the patient experienced RASH. The patient was treated with HYDROCORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (very itchy), SWELLING, VACCINATION SITE WARMTH, FEELING ABNORMAL, DIZZINESS, RASH and VACCINATION SITE RASH outcome was unknown.        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.
Pt vaccinated with MMR developed low grade fever, mild parotid swelling of lids& anterior cervical adenopathy 5 days after MMR given.
Left-sided tinnitus, significant dampening of sound along with the ringing, 6 hours following the vaccination. Still happening (15 minutes later)
One week after receiving my first does I started feeling sick, almost feverish, I woke up in a sweat with my arm hot, itchy & a big red rash & a lump in the same spot as the injection shot. 3 days later the rash/lump is still present & it is itchy as well as very painful & sensitive. Also experiencing on/off fevers, cold sweats & shortness of breath. Unable to visit doctor since it is the weekend & hospitalization doesn?t seem to be needed at this moment.
Td given Ld, MMR RA-5 mins later c/o feeling sick-slumped in chair, had petit mal seizure (3-4 sec) then to floor-unresponsive-O2 started at 2/L min mask Epi given SQ RA 103/60-60-28-ambulance arrived 10 min later-saw ER MD-stable. DG: vasal vagal response.
75 Y/O male fully vaccinated against COVID came to ER approx 10 days ago and tested + for covid. He was discharged home with symptomatic treatment. He returned to ER with C/O weakness, Diarrhea, and SOB, He was noted to have AKI with creatinine 3.4, Patient seen by ID and started on IV decadron and remdesvir.  Tested positive on 9/8/2021  62-year-old male with PMH of COPD, chronic hypoxic respiratory failure on home O2 at 3 L,  atrial fibrillation, insulin-dependent diabetes, carotid artery disease, HTN, OSA, HLD and morbid obesity presented to the hospital today after having increased work of breathing, hypoxia with minimal exertion, right-sided chest pain and palpitations.  Patient has been suffering with positive at home coronavirus testing since August 7th.  Patient has been managing at home with oxygen and oral steroid treatment per his primary care doctor.  Over the last 3-4 days his work of breathing has increased.  Patient states that his oxygen saturation is as low as 84% when ambulating short distance.  He usually does not have to wear his oxygen all the time, only at night but over the last month he has required 3 L continuously.  He has required 4 L over the last 4 days to maintain O2 sat greater than 90.  Patient has had a few episodes of nausea vomiting several days ago, denies diarrhea.  Laboratory evaluation is significant for lactic acidosis, hyperglycemia, hypo magnesemia.  COVID swab is positive.  Chest CT was obtained which revealed multifocal pneumonia, No evidence of central pulmonary emboli.  Sepsis is present on admission, weight based IV fluid resuscitation and antibiotics were initiated.            Otherwise, patient denies any recent fevers/chills/sweats/nausea/vomiting/productive cough/chest pain/chest pressure/palpitations/abdominal pain/diarrhea/constipation/frequency/urgency/dysuria/hematuria/hematemesis/melena.
2 days after my second dose of the Moderna vaccine, my legs and ankles were throbbing. My legs did not have swelling but my ankles did. Ever since March my ankle swelling has not went away, previously i had ankle swelling or achy feet or ankles ocassionally, but it would go away. Since the second dose the swelling and pain has not went away I have been going to see doctors ever since. I have done physical therapy, which didnt help much. Rhematologist, who thinks maybe i have Rhematoid Arthritis, but not a definite diagnosis. I definelty developed Arthritis in my whole body by April/ May. My ankle swelling is constant even when i am laying down, standing, sitting etc. It has affected me by being in pain all the time, when previous to the vaccine I did not have this swelling, I also did not have consistent Joint pain.
I started having congestion, fatigue, fever, sore throat, drainage down the back of my throat, I actually felt very exhausted. I took a home COVID-19 test that came back positive, called our COVID-19 hotline to discuss my positive test and symptoms. I was prescribed the Paxlovid and was able to start the medication that evening. I started to feel better in two days. I tested negative in five days, then two later I tested positive again. This time it took a bit longer for me to test negative, but I have recovered from the rebound COVID-19.
Within 2 minutes of injection, I became tachycardic; shaky; a bit dizzy; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 18Dec2020 07:15 AM at right arm, at SINGLE DOSE for covid-19 immunization. Medical history included anxiety and depression, allergies to IV dye, Bee stings. Concomitant medication included famotidine (PEPCID), diphenhydramine hydrochloride (BENADRYL), ergocalciferol (VIT D), acetylsalicylic acid (BABY ASPIRIN). The patient previously took levofloxacin (LEVAQUIN) and experienced allergy, ceftriaxone sodium (ROCEPHIN) and experienced allergy. The patient was not pregnant at the time of vaccination. Within 2 minutes of injection, the patient became tachycardic, shaky and a bit dizzy from 18Dec2020 07:15AM. These events resulted in Emergency room/department. No treatment was received for these events. 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 4 weeks prior to the COVID vaccine. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was recovered in Dec2020. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Systemic: Allergic: Rash Generalized-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild
Husband stated that she died of an aneurysm on March 28, 2021. He will provide details later.
Myalgia, Fever, swelling to left arm and left side of face Narrative:
Four hours after first vaccine I got a rash of bumps on my right hand and right forearm. Extremely itchy.  The rash has subsided for the most part, after 4 months, but still itches at times.   After the second dose, the skin on my right forearm and hand became very thick. On my fingers it was primarily my thumb, index and middle finger that turned dark and hard. The index finger is still healing; but, it is still hard and itches.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history, drug reactions or allergies were not reported. On 18-JAN-2016, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and albumin status therapy type as rHA (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccine were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
The patient reports headache, chills, congestion, cough, fatigue, nausea, and sore throat starting Monday 11/29. The patient received her Pfizer booster on 11/23. The patient's daughter is confirmed positive COVID-19 and she had exposure to her daughter. The patient tested positive for COVID-19 during encounter. The patient was discharged home in stable condition.
Nausea (began on 11/28/2021) and general fatigue for several days. Then an extreme headache developed, especially after waking to the point where my eyes would water. Headaches started approximately 2-3 days after receiving the booster. Headaches were most severe within an hour or so after waking. December 2 was one of the most severe headaches, where functioning in the morning was distorted due to severe pain. Tylenol/ibuprofen did not help. Headaches subsided for the most part after the morning of 12/2/2021.
Had my shots on Thurs., Aug 26 AM. The following day, Aug 27, I passed out while having lunch. I was brought to the emergency room. My eyes rolled up and lethargic. I was released the following day. Have been having diarrhea and don't feel well for several days now.
pt recv vax 3APR97 & devel macular-papular light pink rash from 2-3cm, flat to sl raised, otherwise no sx;rash appeared in groin area on 13APR97 spread to trunk & a little on face on 14APR97;
Patient had COVID-19 vaccine at our onsite clinic on 07MAR21 at 0710.  She was complaining of abdominal pain and nausea.  She was given Benadryl 25 mg po and monitored an additional 30 minutes by a registered nurse.
On 10MAR2023 my toe on my left foot toe number three on my left foot started to feel kind numb. I removed my sock and the toe was white, after one half hour the color returned and the numbness went away, I was outside later that evening with no gloves so later that evening 11MAR2023 I experienced pain in my right hand, fingers and foot. The next morning my fingers two and three were swollen and cracked. On my right hand my middle finger had turned white towards the top and became progressively worse over the next few days.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided. Reporter stated that Moderna vaccine (Lot number 026C21A) was pulled from the freezer on 13-Oct-2021 with a use by date of 12-Nov-2021 (30 days storage viability in the fridge).21 doses administered 26Oct2021 and 13 doses administered 25Oct2021.   This case was linked to MOD-2021-367076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains no new information.
Onset of malaise and low grade fever early am 5-10-12 with increase of fever to 101.9 by midday. Also reports sore throat. Responded to TYLENOL - still has low grade fever & malaise on 5-11-12.
Information was received from a registered nurse referring to multiple unknown patients of unknown age and gender. Patients' current condition, concomitant medication and medical history were not provided. On 8 and 15-AUG-2016, for prophylaxis, multiple unknown patients were each administered with a dose of improperly stored ROTATEQ (lot # L037924, expired date 22-JUN-2017, oral, dose was unknown) after 78 and 246 hours of exposure to 53 Fahrenheit, respectively. On 10, 11 12 and 15-AUG-2016, for prophylaxis, multiple unknown patients were each administered with a dose of improperly stored ROTATEQ  (lot # L037574, expired date 1-JUL-2017, oral, dose was unknown) after 48,72,96 and 168 hours of exposure to 53 Fahrenheit, respectively. The data logger was involved, and there was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter.   Additional information has been requested.; Sender's Comments:  US-009507513-1612USA014271:
Patient experienced swelling, redness, pain in right arm. It looks like a bruise. Warm to the touch. Patient has had a doctor look at it.
Red spot; it itched alot; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH MACULAR (Red spot) and PRURITUS (it itched alot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced RASH MACULAR (Red spot) and PRURITUS (it itched alot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 07-Jan-2021 for Vaccination site reaction, at an unspecified dose and frequency. At the time of the report, RASH MACULAR (Red spot) and PRURITUS (it itched alot) outcome was unknown.        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.   Concomitant medications were not provided by reporter.
Four hours after first dose, headache and fatigue. Ten hours after first dose (around 12am same day), splotchy red and slightly itchy rash on right leg, partly on left. Diminished in severity over two days' time.
Immunized 4/8/09, The following day in the afternoon the client came to office w/his father and an examination of the arm was made.  Red circular area on his left arm at the sites of the immunizations, the area was warm to touch, area reddened: 1 1/4 x 3/3/4.  With a palable firmess to area that was reddened.  Noted the client with sinus drainage.  The father of client advised the client had the symptom (nasal drainage) before the immunization. No other symptoms noted (ie:  fever, nausea, shortness of breathe or pain). Symptoms resolved with 2 days of oral Benadryl.  As suggested by personal physician.
This spontaneous report was received from a medical student and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-DEC-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX 0.65 ml, subcutaneously, lot # L035504, expiration date 16-DEC-2016. No adverse effects were reported. Additional information has been requested.