chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (4 drinks/week) from 2010 to 20-Aug-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Aug-2020 and the estimated date of delivery was 11-May-2021. On 19-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy. The delivery occurred  on 22-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 3380 grams (7lbs 7oz). The outcome was reported as Term Birth NOS. Live, full-term birth Male baby. Fetus/Infant length: 51 cm, Head circumference: 15 cm. No perinatal complications observed in the infant. No fetal/infant abnormalities identified on delivery. Baby's APGAR score was not known but baby was normal. On 19-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Aug-2020, Pregnancy test: positive (Positive) positive. On 14-Dec-2020, Ultrasound scan: normal (normal) Normal. On 20-Mar-2021, Blood glucose: negative (Negative) Negative. On 10-Apr-2021, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.    Patient (mother) did not have a history of subfertility. There were no pregnancy-related complications or other acute illnesses. Patient (mother) did not have any problems during a delivery.   This case was linked to MOD-2021-272297 (Parent-Child Link).   See case MOD-2021-272297 for details regarding the child case.  Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Pregnancy Information , Medical history and Lab data updated. Vaccine dose details and action taken with drug updated.
Flu shot reaction (L) shoulder cellulitis KEFLEX 500 mg 3x/day #30.
INFLAMMATION IN THE RIGHT EYE; BROWN SPOTS AT THE INJECTION SITE; ITCHINESS AT THE INJECTION SITE; BUMP AT THE INJECTION SITE; INJECTION SITE PAPULE; WEAKNESS IN BOTH LEGS; SWELLING AT THE INJECTION SITE; REDNESS AT THE INJECTION SITE; INJECTION SITE RASH; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for non-infectious intermediate, posterior and panuveitis, and moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the subject experienced inflammation in the right eye, brown spots at the injection site, itchiness at the injection site, bump at the injection site, injection site papule, weakness in both legs, swelling at the injection site, redness at the injection site, and injection site rash. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from brown spots at the injection site, redness at the injection site, swelling at the injection site, weakness in both legs, and injection site rash, and the outcome of inflammation in the right eye, itchiness at the injection site, bump at the injection site and injection site papule was not reported. This report was non-serious.
Pt. received HPV vaccine approx. 5 PM 4/11/12. Awoke early morning hours of 4/12/12 with nausea/dry-heaving followed by spitting up scant amount of blood x 1. Temp approx 100-101 degrees. Pt. given aspirin x 1 by father. Decreased energy and appetite as of 9:15 AM 4/12/12.
Muscle spasm/pain started in my left upper back/shoulder two days after the vaccine. Over the course of the following two days the pain/spasm spread across my entire upper back/neck/shoulders until I couldn?t move at all and was in tears from the pain. I took 5 ibuprofens in the afternoon and rested on a heating pad until roughly 10:00. Then I took 5 more ibuprofens and went to bed. Woke up (Sunday) still very tight and sore but at least I could move my arms. That afternoon a severe sore throat developed. Can hardly swallow now.
Approximately 20 minutes after receiving the vaccine (which was dose #2) I felt radiate down my arm. I went back to the pharmacy and advised the pharmacist. She advised me that other women have had the same effect, for unknown reasons. She advised me to go home and rest and go to the ER if I experience further problems over the next few days.  A few weeks later, I began feeling strong heart palpitations in the evening when at rest. I am still experiencing them now.
When administering the Pfizer vaccine, the needle retracted into the syringe causing the vaccine to run down the patient's arm. Syringe used was a Vanish Point syringe, lot # G201122, exp date: 10-28-2025.  The patient did not have an adverse event or reaction.  The vaccine dose was wasted.
Past the 42 day mark; really bad body pain/aches from head to toe; bad headache; vomiting at least 3 times; bad swelling in lymph nodes under left arm/little swelling in lymph nodes under right arm; slept 2-3 hours at a time all day; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept 2-3 hours at a time all day), PAIN IN EXTREMITY (sore arm), PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark), MYALGIA (really bad body pain/aches from head to toe) and HEADACHE (bad headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, ANASTROZOLE (ARIMIDEX), PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), LISINOPRIL, VITAMINS NOS and PROBIOTICS NOS for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced SOMNOLENCE (slept 2-3 hours at a time all day), MYALGIA (really bad body pain/aches from head to toe), HEADACHE (bad headache), VOMITING (vomiting at least 3 times) and LYMPHADENOPATHY (bad swelling in lymph nodes under left arm/little swelling in lymph nodes under right arm). In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) in April 2021 for Adverse event, at an unspecified dose and frequency. In April 2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, SOMNOLENCE (slept 2-3 hours at a time all day), PRODUCT DOSE OMISSION ISSUE (Past the 42 day mark), MYALGIA (really bad body pain/aches from head to toe), HEADACHE (bad headache), VOMITING (vomiting at least 3 times) and LYMPHADENOPATHY (bad swelling in lymph nodes under left arm/little swelling in lymph nodes under right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment included Advil.
fever 104 x 3 days, chills, myalgias and sterile exudative pharyngitis
I was just in the shower and washing my face and neck. My fingers went down to lower left jaw, I felt a lump. That was in August. It wasn't painful and I had no other symptoms. I went to see my primary care doctor on October 3rd, 2022 before I was leaving to go on a trip. He referred me to head and neck physician. I went on vacation and when I returned I saw Dr. October 27th, 2022. I had an MRI on November 9th and they noted that I had a total of 3 enlarge lymph nodes. On November 29th, 2022 I went for a biopsy at a health care facility. The concern was my Lymphoma may be coming back so they were supposed to do a test for Lymphoma which they didn't do. I had to do a second biopsy on December 13th, 2022. That came back inconclusive because doctor did not get into the right area of the lymph node. I will be having an ultrasound on the lymph nodes on January 21st, 2023.
patient came in with her family to receive her second dose covid pfizer pediatric vaccine.  Patient received her vaccine around 12:10 pm. She stood up and moved towards wall to stand with mom and sister, so her dad could sit to get his pfizer booster vaccine.  around 12:15, there was a bang/thud and patient slumped to the floor.  The mom picked her up and put her on dad's lap, and found she had passed out and hit the back of her head against the wall.  The patient came to on her own and started crying.   She was scared, complained back of her head hurt and that her tongue was numb.  She was given an ice pack for her head and a bottle of water.  Patient was able to take sips of water.  we offered to call ambulance, family declined.  Patient stayed in our immunization room for observation for 30 minutes.  Patient had no issues breathing/swallowing.  we suggested that she be seen by a medical professional, the mom said they would watch her.  We then suggested at least contacting family doctor.  The family then went to the food court to get some food.  Checked on the patient, she was no longer crying, she was sitting on her own and eating.  Again had no complaints of breathing or swallowing issues.  Called mom around 5:50 pm, no answer, left a message checking up on patient.  It is unknown as of today if patient seeked medical care.
Patient reported localized hives and itching to the left arm about 30 minutes after receiving vaccine. Paramedic on-duty immediatley brought equipment to patient to render care. Patient was given 50mg of benadryl IM and monitored for an additional twenty minutes. Patient's symptoms resolved and she expressed that she did not feel ambulance transport to hospital was necessary. Paramedic obtained an Against Medical Advice from medical control and patient was released into her mother's care with advice to activate 911 should symptoms return.
Information has been received from a registered pharmacist and a woman from a physician's office concerning a 64 year old female who on 16Sep03 was vaccinated IM in the left deltoid with a first 0.5ml dose of pneumococcal 23v polysaccharide vaccine. On 18Sep03 at 1517, shortly after vaccination, the pt complained of his left upper arm as pink and warm to the touch. It was also reported that the pt had redness throughout the vaccinated arm which was also painful to the touch. The pt also had numbness down to the fingers. The reaction began to subside in an hour. Unspecified medical attention was sought and the pt was informed to use ice to the upper extremity and diphenhydramine (Benadryl) prn. It was reported that the pt agreed to this. No prescription drug was required. Subsequently, the pt recovered. The date of recovery was unknown because the pt never called back the physician's office. No product quality complaint was involved. It was also reported that another pt was vaccinated IM with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine and developed redness, pain, numbness and an elevated temperature. No further information is expected.
Right after getting the vaccine, in the evening, I felt achy and uncomfortable the rest of the night. The next day, everything felt better, except for my neck. I was in severe neck pain for many weeks, even unable to work for around 2 weeks and struggling to work after that.  I received 2 different sets of trigger joint injections to ease the pain. While I cannot know what caused it, it may have been an inflammatory response to the vaccine.
13Jun96 pt recv 1 dose vax. 11Feb98  pt exp "multiple lesions in her mouth, throat,trunk & vaginal area". Pt had fever.
ALLERGIC REACTION TO VACCINE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2020, treatment medications included: prednisone. On MAR-2021, treatment medications included: cetirizine hydrochloride. On 09-MAR-2021, the subject experienced allergic reaction to vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from allergic reaction to vaccine. This report was non-serious.
No additional AE; Medical assistant reports one dose of improperly stored VARIVAX was administered to one patient.         ?     ?; This spontaneous report has been received from a medical assistant, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 21-NOV-2022, the patient was vaccinated with an improperly stored dose of with improperly storage dose of varicella virus vaccine live (Oka/Merck) (VARIVAX)injection, for prophylaxis (lot number: U033046, which was determined to be valid, with an expiration date on 21-OCT-2023) plus an sterile diluent (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 14 degrees Fahrenheit (F) up to 46 degrees Fahrenheit, during a time frame of 5 hours and 20 minutes (product storage error). There was no previous temperature excursion.   No additional adverse events were reported in the patient.
the patients family has not called in or reported any issues/specific adverse events; diluent from HAVRIX vaccine (0.4 % Sodium Chloride) was used to reconstitute MMRII; This spontaneous report was received from a nurse and refers to a 12-month-old female patient.  The patient's medical history was not reported. The patient's concurrent conditions included cat allergies. Concomitant therapies were not reported.   On 15-FEB-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #W009105, expiration date: 04-DEC-2023 (strength, route of administration, and indication were not provided) diluted on 0.4 percent sodium chloride (HAVRIX DILUENT) lot #EE542, expiration date: 23-FEB-2024 as vaccine diluent (route of administration was not provided) (Wrong solution used in drug reconstitution). No additional adverse event was reported.
20 minutes after receiving Covid 19 Vaccine /Pfizer, employee complaints of shortness of breath, chest tightness, pulse = 100.  Medical team was called and Employee was taken to the ER.
Flu like symptoms chills muscle soreness pains all over body.  The worst most debilitating symptom was the head pain which was not a headache.  It was sharp shooting nerve pain ever thirty seconds above ears in ears side of head back of ears.  The pain was so severe I could not help but gasp constantly with every shocking pain.  It lasted until the next day then started to diminish.  Nothing helped  however as it was diminishing Tylenol helped
Patient began experiencing back pain and numbness starting on 12/22/21 about 2 hour after receiving vaccines. She used Tylenol and motrin to help with pain.  Pain has continued and she began to use icy hot patches. Patient developed rash this morning and called pharmacy to ask what they should do. Patient believes that they may have shingles and is going to be checked out by a doctor.
Fever, swollen arm, abnormal range of motion, severe pain. Swelling going down-Pain improving. Revised form Pt said swelling going down and pain improving.
Severe inflammation in my neck, spine, shoulders, elbow, wrist, fingers, knees, ankles.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 33-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: Ew0161, Expiry date : not reported), via an unspecified route of administration, in the Arm Right on 23Apr2021 15:00 (at the age of 33-years) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included ankylosing spondylitis. Patient previously took Vancomyosin, Rocephen and experienced allergy and latex allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccine, the patient was not diagnosed to COVID-19, since the vaccination the patient has not been tested for COVID-19. Concomitant medication(s) included diazepam (VALIUM), naproxen taken for an unspecified indication, start and stop date were not reported.  The patient previously took vancomycin, rocephin [ceftriaxone] and experienced allergy. The patient has received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: Ew0177, Expiry date : not reported), via an unspecified route of administration, in the Arm Right on 14May2021 16:00 as DOSE 2, SINGLE for covid-19 immunisation.  Facility type vaccine was workplace Pharmacy or drug store. On 24Apr2021 09:00, the patient experienced severe inflammation in his neck, spine, shoulders, elbow, wrist, fingers, knees, ankles. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of severe inflammation in my neck, spine, shoulders, elbow, wrist, fingers, knees, ankles (prednisone). The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Night sweat; Soreness of the thighs; This is a spontaneous report from a contactable Nurse (patient). A 47-years-old female patient received bnt162b2 (Batch/lot number: EJ1685), via an unspecified route of administration on 22Dec2020 16:30 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient experienced night sweat on 22Dec2020 with outcome of unknown, soreness of the thighs on 22Dec2020, which was ok with outcome of recovered on Dec2020.
Throbbing headache 9/5/12 AM, EXCEDRIN migraine. Rash at injection site left deltoid 9/6/12 AM 9/6/12 fever.
Children accidentally given Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's comments; This case was reported by consumer via interactive digital media. The patients (children) accidentally administered with Shingrix. Additional supportive information: The patients were children accidentally administered with Shingrix which led inappropriate age at vaccine administration. Follow-up would not possible as no contact details were available.
Redness around the injection site on both thighs. Uncontrollable crying for 3 consecutive nights after injections.
This case was reported by a physician via a sales representative and described the occurrence of swelling and redness at the injection site in a pt who received Infanrix. The physician reported "several patients" had experienced swelling and redness at the injection site; however no pt identifiers were provided. On an unspecified date in 2003, the pt received Infanrix. At an unknown time later in 2003, the pt experienced localized swelling and redness at the injection site. The physician stated they had used "a 7/8 inch needle to administer the injections". At the time of reporting, the events had resolved.
pt recvd Norplant system in 1991 & exp cramping, spotting, bloating & weight gain every 2 weeks; Pt received vax and exp some of the same symptoms weekly;
Redness and swelling at site of injection - about 4 inches wide and 2 inches across. This is day 3 (6-17-17).
Information has been received from a health professional concerning a female patient who was vaccinated with a first dose of Gardasil vaccine (yeast). Subsequently as the patient was leaving the examination room, the patient fainted. Unspecified medical attention was sought. The patient recovered shortly after fainting. No product quality complaint was involved. Additional information has been requested.
Dx with phlebitis of the right arm, starting on morning 10/13, starting with dark line and pulling sensation in ventral right arm. 10/14 noted tenderness at elbow, then progression of lines past elbow to forearm that eve. Sought virtual care on 10/14 AM. Started on 325mg aspirin and 400mg ibuprofen TID, heat, and compression as helpful. No hand or arm edema noted. Follow up on 10/18, bruising resolving, more on forearm, mild localized swelling near ecchymosis. Subjective arm fatigue. Normal radial pulses and cap refill. Plan to continue aspirin for full 7 days, monitor for resolution as symptoms seem to be improving. Continue to keep differential open if other sx occur. Did have stomach pain and 1 episode of diarrhea 10/14- assume food related d/t also in family member. Also stomach pain only 10/16- suspect NSAID related. d/c ibuprofen 10/17. None since. Context -2nd Moderna on 10/4 and flu shot on 9/29 in the right arm. No hx of prior DVT, prior clotting event, or phlebitis.
CHILD AGED 11 RECEIVED PFIZER FIRST DOSE ADULT LOT# AND DOSE
Patient developed severe gout in L foot 3 days post vaccine. Seen in office and treated. Hadn't had episode for 30 years. Was not on chronic gout medication. No other precipitating events. No change in foods or meds.
Information has been received from a nurse practitioner (NP) concerning a 28 year old female w/NKDA who in 1997 was vaccinated (first dose) with varicella virus vaccine live (dosages, route and lot number not provided. Concomitant therapy included hormonal contraceptives (unspecified date in1997, the patient developed a "site reaction". It was indicated that at that time, the patient had sought medical attention. No further information is available.
Injection site below the deltoid muscle, caused a reaction and patient saw her doctor who prescribed KEFLEX 50 mg for 7 days.
Documentation shows patient was administered Covid 12+ vaccine instead of the age appropriate 5-11 dosing. Staff no longer here to verify accuracy.
APAP given prophylactically upon arrival @ home; father states pt began shaking parents covered for warmth; shaking cont to intensify followed by eyes rolling, spittling parent unsure of loss of consciousness;