chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain in the arm; Rumbling of stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the arm) and ABDOMINAL DISCOMFORT (Rumbling of stomach) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm) and ABDOMINAL DISCOMFORT (Rumbling of stomach). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in the arm) and ABDOMINAL DISCOMFORT (Rumbling of stomach) outcome was unknown.            Concomitant medications details were not reported by the reporter.
No adverse reactions noted. Patient has a follow-up OB appointment for an ultrasound. She is currently 12 weeks pregnant.
Upper arm under flu shot site is red and warm to the touch. Spot is large, roughly 4-5inches in length, and spans the width of arm
patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 14-Sep-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-364770, MOD-2021-363753 (Patient Link).
Day 1 post vaccination: vomiting, fever, pain and inflammation at injection sites. Day 3 post: warm and inflammation at injection sites. Tender to the touch.
Approximately 5-6 days after my vaccination I began to experience blurred vision.  There was a feellng of pressure coming from my eyes.  When both eyes were open I had double vision.  If one eye was closed vision was more normal.  Overall, vision was blurred and there was pain/discomfort in the eyes. On March 27 I went to the eye doctor  After examining me he concluded I had experienced cranial nerve palsy in the sixth abducent nerve. It was my left eye that was affected.  In my past, i have had two incidences of bells palsy and one incident of an eye stroke'.  I am not diabetic. My bp and cholesterol are good. I tested negative for Lymes disease 2 years ago.
On the morning of he 9th day after my first vaccine dose, my palms got intensely itchy. Over the course of the day, my body broke out in the worst hives of my life (including the palms of my hands and the soles of my feet). I had a blood test through a clinic which ruled out other possible diagnoses. Hives lasted approximately one week. It was terrible. But I still plan to get my second dose.
Fatigue after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue after 2nd shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Fatigue after 2nd shot). On 21-May-2021, FATIGUE (Fatigue after 2nd shot) had resolved.            No concomitant product use was provided. No treatment medication was provided.   This case was linked to MOD-2022-473936, MOD-2022-473947 (Patient Link).
Patient reported experiencing swelling on the upper left arm on Saturday. On Sunday, he started seeing the injection site turning blue. On Tuesday, he called back and reported the entire upper arm is purplish blue. I recommended him to call his PCP on Wednesday and apply ice pack to the upper arm. When following up with him on Wednesday (2/3/21), he reported the PCP stated that he has hematoma. No treatment necessary, but to continue the ice pack method.
Form provided  by patient at 6-20-17 Nurse visit appointment. She reports swelling around injection site and left upper arm x 1 week. She did not seek medical advice. X-strength Acetaminophen 500 mg for pain and local fever in arm area.
Pt noticed itching the evening of vaccine. The next AM with left arm swelling and induration.
Local rash erythematous maculopapular on R deltoid near and around Pneumovax site which erupted immediately after shot was given and responded well to Zyrtex 10mg and singular 5mg, benadryl.
No adverse event; They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 201L22A) for COVID-19 prophylaxis.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 06-Jul-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 06-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2mL dose from the vial with the pink cap. They were supposed to receive the blue cap at a 0.25mL dose.).    No concomitant information was reported. It was reported that patient had no reported symptoms. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-732503 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732503:Linked to Master case MOD-2023-732484, same reporter
A non-serious spontaneous report of blisters on mouth was received from a physician's office concerning a three-year-old subsequent to FLUMIST.  This case is submitted in accordance with manufacturer's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.  Neither relevant medical history nor concomitant medications was reported for this patient.  The patient received FLUMIST for the first time and Hep A for the second time.  Twenty-four hours after receiving FLUMIST and Hep A, the patient developed blisters on mouth.  After the office had further discussion with the toddler's mother, it was discovered that the child has had blisters around the mouth on several different occasions and it was probably no related to vaccines.  The outcome of the adverse events was not reported.  Additional dosing with FLUMIST was not reported.  The adverse event of blisters on mouth was reported as probably not related to FLUMIST.
Patient expired 7/27/23 Pt sen to ER today for sepsis with covid
5-10 mins after giving the moderna covid vaccine, pt had a hypotension followed by chest tightness and difficulty of breathing. Benadryl, Epi IM and Solumedrol given. Pt awake, alert and oriented all the time. Did not lead to cardiac arrest but pt stated he was not feeling better and pt ended up going to the hospital. pt was on the dialysis machine with his treatment when the vaccine was given.
Initial report was received from a health care professional on 20 November 2012. "Between 10.20.12 and 11.18.12, 13 pediatric patients under age 21 were tested positive for flu A and 15 who were not vaccinated were tested positive for flu A. 8 vaccinated FLUZONE (lot number not reported) were tested positive for flu B and 10 not vaccinated were tested positive for flu B. Several staff member have also been positive after vaccination." The date of vaccination for these "multiple patients" was also reported as "10/12" and the adverse event onset was reported as "10/12." No further information was available at the time of the report. The outcome of the patients were not reported. Documents held by sender: None.
Information regarding Flu Mist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a parent regarding her 5-year-old son who experienced vomiting. At 5 years of age, the patient received a dose on 25-Nov-2003. Medical History: Relevant medical history was not provided. Product Details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 25-Nov-2003. Concomitant Therapy: Concomitant medications were not reported. Event Details: The patient experienced vomiting (vomiting) on 26-Nov-2003 at 2:00 AM. At the date of the report, the mother indicated that she had not notified the physician. No additional information was available at the time of this report.
COVID; COVID; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported that a patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 20Jan2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. This Pharmacist reported that she has an employee who was administered their first dose of Pfizer COVID Vaccine on 20Jan2021 and was then diagnosed with COVID last week in Jan2021. She called to ask what is the appropriate timeline for the employee to get the second dose of Pfizer COVID Vaccine. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity after the first vaccine dose administration.
Symptoms began 6 or 7 days after injection and lasted until mid-March. Redness & swelling to site lasted couple days. Pt used ICY HOT patch then began swelling under arm (armpit area) and arm would go numb in certain positions. This lasted until March.
No additional adverse events.; an improperly stored VARIVAX was administered to a patient.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.   On 27-APR-2020, the patient was administered with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot#S025913 with expiration date: 20-AUG-2021; dose, route and strength were unknown) for prophylaxis (incorrect product storage). The sterile diluent that was used to reconstitute the vaccine was properly stored. No additional adverse events.  Administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced the temperature excursion under -14 degrees Celsius (C) to -10 degrees Celsius (-11.2C) for 9 hours and 58 minutes and -9 degrees Celsius to 8 degrees Celsius (3C) for 13 hours and 35 minutes. There was no previous temperature excursion.
Pt admitted for fluid in peritoneum and an 8x10 cm adnexal mass.  Prior to surgery COVID swab was positive, but pt did state that she had been coughing for about a week.
Second shot received at 4pm on Thursday. At approximately 2am on Friday, fever of 103.5 unresponsive to APAP or Ibuprofen for approximately 18 hours, severe body aches especially in both shoulders and hips, extreme fatigue, and headache.  After 18 hours, fever was responsive to Ibuprofen but headache, aches, and fatigue still present with general malaise. Then, fever of 101.5 returned about 1am on Sunday and resolved in the morning following another dose of Ibuprofen. Headache and general malaise finally resolved on Monday.  The post COVID second vaccination reactions appear to be under-reported and occurring at a greater percent than currently being relayed to the public.
pt recv vax 25SEP95 & pt devel shingles w/papular lesions;lab eval revealed a positive test for varicella antibodies;however a cult was neg;PCR revealed wild type virus;pt recovered;
Acute Immune Demyelinating Polyneuropathy; symptoms of distal paresthesias started the evening after vaccine administration, eventually developed distal weakness and facial diplegia with cytoalbuminologic dissociation. He was admitted to Hospital for IVIG therapy then discharged to acute rehab.
sore throat, pain at injection site. Started having intermittent hives and generalized pruritus 1.5 days after getting vaccine.
4 year old female had redness, swelling, warmth small blisters at site of left leg after receiving DTaP #5 & IPV #4.
Erythema with streaking from deltoid to (R) axilla with moderate alignment of (R) axillary lymph node (+) tenderness & warmth.
Information has been received from a registered nurse regarding a 15 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013248: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013253: US-009507513-1710USA001718.
On 04/09/2021 I went and got my 2nd dose about 8 hours later I noticed, I had a hard knot in my left arm, So on 04/10/2021 I called to the doctor office to tell them what was going on and the Dr advised me to go to the ER if the pain worsens but I just decided to wait since she had scheduled me an appointment to come in that Monday on 04/12/2021. It was so painful that I could not exercise. I lost mobility in my arm. When I got to the doctor, she looked at my arm and said it was an adverse event from the covid19 vaccine  to go home and put ice on it, which the pain  lasted about 5 days before going away
Seizure outbreak of 15 seizures within a week of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 16:30 (Lot number: Fk5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "Adhd" (unspecified if ongoing). Concomitant medication(s) included: ONFI; INTUNIV; LACTOSE. The following information was reported: SEIZURE (medically significant, life threatening) with onset 05Dec2021 22:00, outcome "not recovered", described as "Seizure outbreak of 15 seizures within a week of the vaccine". The event "seizure outbreak of 15 seizures within a week of the vaccine" was evaluated at the physician office visit. Therapeutic measures were taken as a result of seizure.  Additional information: Seizure was life-threatening and medically significant. It did not result to death, no hospitalization, not disabling/incapacitating, not congenital anomaly/birth defect. No other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No known allergies. AE treatment: Increase in seizure medication and reduce meds. AE resulted in: Doctor or other healthcare professional office/clinic visit. Life threatening illness (immediate risk of death from the event).  No follow-up attempts are possible. No further information is expected.
Is rash and hives abreported side effect to the booster shot; Is rash and hives abreported side effect to the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Is rash and hives abreported side effect to the booster shot) and URTICARIA (Is rash and hives abreported side effect to the booster shot) 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 RASH (Is rash and hives abreported side effect to the booster shot) and URTICARIA (Is rash and hives abreported side effect to the booster shot). At the time of the report, RASH (Is rash and hives abreported side effect to the booster shot) and URTICARIA (Is rash and hives abreported side effect to the booster shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
p/vax pt had h/a; vomited; nausea; sweating; red pink circle at inj site; still recovering
Had 2 brief episodes - body stiffened, clenched arms, some shaking. Lasted about 2-3 seconds. Was tired afterwards. BP lower than normal. Felt dizzy. Was monitored laying down for 30 min., then sitting for 20 min. Vital were taken every 30 min. During episodes, she was not responsive to name, or communication. Brief altered level of consciousness.
Initial unsolicited case received from a nurse on 05 Jun 2018. This case involves a patient (age and gender not reported) who was vaccinated expired dose of PENTACEL (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unspecified date. Patient's medical history and concomitant medications were not reported. It was an actual medication error case due to Expired vaccine used. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Lower back pain onset around 5pm on 3/10/2021. Took acetaminophen and applied ice which relieved the discomfort.  Awoke around 5a.m. on 3/12/2021 with more severe lower back pain. Applied Acetaminophen and ice which has reduced the discomfort as of 9:45a.m. on 3/12/2021
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an elderly, currently 69 years old female patient. Information regarding medical history, concurrent conditions, or concomitant medications was not provided. In 2017, 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.  On an unknown date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
I experienced head congestion and a cough. I felt pressure in my head and I had nausea and a sore throat around my right eye; it was swollen and it had a slight discharge. I went to the doctor due to thinking it was sinus congestion. I was told by urgent care that it was a reaction to the vaccine. I had to sleep about 20 hours from being fatigued. My eye appeared to be a stye. That's still there. My lower eyelid is turned over due to this.
10 X 10 cm redness & swelling right deltoid reaction for 5 days.
The next morning I had a low grade fever with some fatigue that subsided by the evening.  Next morning I was completely fine. But approximately one week later I developed rashes on the back on my neck and both wrists. They aren't conspicuous, but they do itch. I've had them for about two - three days. The rashes are slowly subsiding.
A FEW MINUTES AFTER VACCINE ADMINISTERED HE REPORTED HE FELT DIZZY AND WAS SWEATING PROFUSELY.  HE STATED HE HAD NOT EATEN YET AND WAS VERY NERVOUS TO GET THE VACCINE.  HE WAS SEATED,  GIVEN WATER AND CRACKERS AND MONITORED FOR 20-30 MINUTES.  HE FELT MUCH BETTER AND DECLINED ANY HELP BY EMT, STAFF OR CALLING FAMILY.  HE FINISHED HIS GROCERY SHOPPING, CHECKED BACK IN WITH THE PHARMACY AND WAS DOING FINE.
The next day I started having a headache and feeling foggy. I woke up that night with a pounding headache and chills. I have continued to have headaches and dry mouth.  Yesterday I developed canker sores around my mouth
Awoke in AM with headache, severe nausea, severe chest pressure, SOB. Went to urgent care. Received ZOFRAN for nausea. Took TYLENOL at home Dx-Rxn. to Influenza Immunization.
2 wks after immunizations - client c/o abdominal cramping. Today client reports 1 boil on her (R) knee and approx 5 smaller boils on her abd - around her panty-line. Red, raised ,hard bumps that are tender.  11/14/08 Reviewed PCP medical record of 8/21/2008. FINAL DX: boils Record reveals that patient started developing boils all over after started DepoProvera for birth control.  Tx w/antibiotic.  Plan to refer to dermatology if treatment not successful.