chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Maternal exposure during breast feeding; Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 38-year-old female patient (gravida 1, para 0) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031l20a and 012l20a) for COVID-19 vaccination.     The patient's past medical history included Alcoholic. Family history included Hirschsprung's disease (Patient's brother had Hirschsprung's disease history was reported.). Concurrent medical conditions included Sulfonamide allergy and Hypothyroidism since 17-Dec-2020. Concomitant products included LEVOTHYROXINE from 17-Dec-2020 to an unknown date for Hypothyroidism.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-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 27-Aug-2020 and the estimated date of delivery was 22-May-2021. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-ninth week of the pregnancy. The vaginal delivery occurred on 24-May-2021, which was reported as Full-term. For neonate 1, the birth weight was 3350 grams (7lbs 6oz) with an APGAR score of 8 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. fetus height 53.34 cm and 39 weeks of gestation was reported. On 08-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2020, Pregnancy test: Positive.         Concomitant product used included prenatal gummy medications which is taking orally from 01 Oct 2020 for pregnancy.Fetus detail includes identified infant abnormalities at 1 month post-partum  laryngeal malacia was reported.Pregnancy related complications included hypothyroidism. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Significant Follow-up contains pregnancy information,allergy,Pregnancy test,LMP date,height and weight race of the patient,fetus details, family history and best doctor information and concomitant products.
Elevated resting heart rate over 100 beats per minute  over the course of a few hours. Starting around 24 hours after 2nd dose of vaccine.
Flu shot given 11/16/16 on the (L) upper arm. She states she start feeling the pain over hr. later. The pain did not go away after a week. Took pain meds/warm compression on the site no relief. 2 wks past by no relief - she feels a knot on the (L) arm C/O muscles like being pull. Pain 7/10.
Waves of weakness; Waves of dizziness; in bed all day; Tired; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (in bed all day), FATIGUE (Tired), HEADACHE (Headache), DIZZINESS (Waves of light headiness) and ASTHENIA (Waves of weakness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced SOMNOLENCE (in bed all day), FATIGUE (Tired) and HEADACHE (Headache). On 07-Mar-2021, the patient experienced DIZZINESS (Waves of light headiness), ASTHENIA (Waves of weakness) and DIZZINESS (Waves of dizziness). At the time of the report, SOMNOLENCE (in bed all day), FATIGUE (Tired), HEADACHE (Headache), DIZZINESS (Waves of light headiness), ASTHENIA (Waves of weakness) and DIZZINESS (Waves of dizziness) outcome was unknown.
slight soreness at the injection sight for both shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: ER8734) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergy to Sunflower seed" (unspecified if ongoing), notes: allergy to Sunflower seed; "Allergy: Menthol" (unspecified if ongoing), notes: Allergy: Menthol. Concomitant medication(s) included: SERTRALINE; NUVARING. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03May2021, outcome "recovering", described as "slight soreness at the injection sight for both shots". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Patient received other medications (Sertraline 100mg daily and Nuvaring) within 2 weeks of vaccination.  No follow-up attempts are possible. No further information is expected.
Breakthrough COVID infection in fully vaccinated patient. Positive date 07/07/2021.
Pt. experienced itch approx. 24 hours after vaccination. Red raised rash, hot to touch. No fever/pain. Pt. was told PREVNAR given in the affected arm. Vaccine screening form showed ZOSTAVAX given in this arm.
sore right arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore right arm) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L204) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Cholesterol. Concomitant products included BUPROPION, GABAPENTIN, LEVOTHYROXINE SODIUM (OROXINE), FAMOTIDINE and OLMESARTAN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore right arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore right arm) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported.   This case was linked to MOD-2021-247917, MOD-2021-247917 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: TCR - NNI about case.
incorrect vaccine dose administration. Adult dose w/ above lot was administered to 10 year old patient.
Patient lost consciousness after receiving immunizations.  Patient fell off exam table and hit her head/face on nurses foot when she hit the floor.  Patient had  a abrasion  and small cut to bottom lip.  Patient regained conscious in about 1 minute. Patient was provided first aid at the site and when stable was transferred by parents private car  to local ED for evaluation of loss of consciousness, dizziness and headache.
This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 66-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included pneumonitis hypersensitivity (diagnosed in 2014). In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant), injection site pain, injection site swelling, injection site erythema, general body pain, injected limb mobility decreased and joint range of motion decreased. The patient was treated with prednisone. On an unknown date, the outcome of the polymyalgia rheumatica, injected limb mobility decreased and joint range of motion decreased were not recovered/not resolved and the outcome of the injection site pain, injection site swelling and injection site erythema were recovered/resolved and the outcome of the general body pain was unknown. It was unknown if the reporter considered the polymyalgia rheumatica, injection site pain, injection site swelling, injection site erythema, general body pain, injected limb mobility decreased and joint range of motion decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on an unknown arm. It was hurt during injection. After the vaccination, the patient experienced the injection site was swollen and became red. These symptoms were resolved after several days. Since the vaccination, the patient was not able to straighten her left, could not raise her arm and was achy all over. The patient went to her general practice physician and her chiropractor. The patient recently went to a rheumatologist and was diagnosed with polymyalgia rheumatica. The patient's prescribed a Prednisone and was told that would need to take it for one year. The patient's physician told that did not receive the 2nd dose of the product. The reporter was considering filing a lawsuit. The reporter did not consent to follow-up. This case has been linked with case US2019GSK070689, reported by the same reporter.
pt recvd vax 21APR93 & pt was nervous about the inject & w/in 1/2 hr of inject, pt exp flushing, perspiration & had a pulse of 100 beats per minute; had no rash or dyspnea & soon returned to nl; No further details were provided;
About an hour and a half after I got the shot my throat started to get tight and I started wheezing. I was dizzy. My heart felt tight and fluttery. Fever of 99.3 (It's ususally about 97.7).  I had coughing fits (unproductive). Rash over my chest and neck. My skin was incredibly itchy everywhere. It felt like every cell in my body was angry. My brain felt weird and throbbing. This stopped after about an hour or two. I get similar events in waves of lesser intensity still.  Nausea and tummy pain too.
Sharp pain in left arm. Not at injection site.  Following a nerve path. Pain has lessened by still present today.
Subsequent to second dose in vax series, pt previous symptoms form first vax worsened - flu-like symptoms without vomiting, extreme exhaustion, loss of weight, joint and muscle pain, headache, fever, muscle spasms, weakness, and elevated liver enzymes. Pt was see by physician and treated with Robaxin, Piorinal Clisoril, Klonopin, and Tylenol with codeine. Physician's reports on 05/30 indicate she reported at visit that she 'felt poorly' for 3 weeks. She had increased fever, but no temperature given by pt,chills, fatigue, and no appetite. She was diagnosed otitis media. She received vax in series at this time. 06/06 pt complained of persistent fatigue and chest congestion with cough, chest pain with deep inspiration. Ausoulaton: clear chest. 06/17 slipped on water and fell, pain in back and hips. 08/17 complained of fatigue, one reported, 'she can go to sleep at any time .' 09/19 ER reported mid-back pain. Referred to pain clinic. 09/25 complained right upper pain intermittently for several months. Discomfort can be relieved by stretching. The pain radiated to back. 05/25/1997 reported acute onset of severe right upper quadrant and epigastric pain which awoke her from sleep. Nml liver function noted. Dx not provided. 12/04/1997 swollen lymph nodes noted. 01/19/1998 progress notes document patient. 08/28/1999 Atypical chest pain and multiple body aches. Essentially nml stress. 10/07/98 Physicians records indicate pt stated she was 'sick for two and 1/2 years'. She reported feeling extremely fatigues/exhausted and spending days in be post physical activity. After review of labs, the physicians assessment was chronic fatigue syndrome with fibromyalgia. 10/15/98 Generalized malaise, fatigue, off and on muscular aches and pains, and foot swellings. 01/13/99 general joint achiness in feet. 11/07/99 Fibromyalgia flare-up with ataxia and weakness. 11/23/99 lumbar pain related to fibromyalgia syndrome. 01/06 chest pain radiated to back. Was seen in ER on 01/03/00 having increased muscle cramps and spasms. Was given Vicodin and was taking Baclofen and Motrin. Mostly localized to the left side. Was noted difficulty in moving left arm and hand. chronic pain. Noted trigger points being painful. Pain medications alleviate pain only partially. 03/27/00 noted some improvement, on cataflam, in easing up right-sided abdominal pain. Noted crepitus in joints. Had episodes of losing balance: fell down stairs once. Noted ataxia with difficult concentration. Had tremors and left-sided discomfort with paresthesia/dysesthesia. Apraxia at times. This case has been made medically serious as the pt indicated she was incapacitated as she was unable to work.
11 YEAR OLD CHILD WITH DATE OF BIRTH WRITTEN INCORRECTLY ON CONSENT BUT AGE WRITTEN AS "12". CHILD ACCOMPANIED BY INDIVIDUAL PRESENTING AS MOTHER. CHILD WAS UNDERAGED AT TIME OF VACCINE ADMINISTRATION. RECEIVED UNAUTHORIZED DOSE.
Hypoglycemic event/blood sugar dropped a bit/sweaty/clammy/hands start to shake when blood sugar is low; This is a spontaneous report from a contactable pharmacist (patient). A 43-years-old female patient receive the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 13Jan2021 at 12:30 at a single dose for COVID-19 immunization. Medical history included Type 2 Diabetic-diabetic for six to seven years and have had no hypoglycemic events. There were no concomitant medications. No additional vaccines administered on the same day of the second dose of BNT162B2. Prior vaccination within 4 weeks included the first dose of bnt162b2 on 23Dec2020 at 12:30 (lot number: EH9899). The patient also experienced arm soreness with prior vaccinations (did not provide product names). The patient is a healthcare worker, diabetic and on insulin only. The patient received the second dose of BNT162B2 on 13Jan2021, and in the last two mornings, she had hypoglycemic events. Nothing in her diet or routine has changed. In the morning of 14Jan2021, she was at work in the clinic and her blood sugar dropped but she doesn't know how low she dropped. She ate a chocolate chip cookie to correct her blood sugar. It was corrected to 91; she didn't have her machine with her. On 15Jan2021 at 1030, the patient was sweaty, clammy, and her hands start to shake when her blood sugar gets low. She had three 15gram fruit bars and two sips of Coke before she passed out. The nurses around her were doing blood pressure checks and a STAT blood sugar check. About five to ten minutes after that, her blood sugar was 93. Her blood sugar was checked again, and it was 198. She stated this is not surprising because she overcorrected her blood sugar. The events required a visit to the physician office that day. The patient clarified that she was diagnosed with type 2 diabetes, takes Lantus - dose changes; normal dose is between 40-45 units once a day with the Solostar pen. That morning, the patient was given a dose of 45 units. Humalog with pen for administration (dose: administered 2 units that morning). The patient uses Humalog only as needed. The patient had undergone blood tests and procedures which included blood sugar tests where blood work was drawn at the endocrinologist's office. The tests included A1C, C-peptide, blood sugar, and to verify which kind of diabetes she has; no results to report.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed the varicella virus with approximately 30-40 macular and vesicular lesions on day one accompanied by a slight fever.
brainfuzz headache; Aches; woke up nauseous; wobbly Almost fell over twice. Had to steady self; This is a spontaneous report from a contactable consumer, the patient.  A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 19Jan2021 at 11:15 (at the age of 78-years-old) as a single dose for COVID-19 immunization.  Medical history included prostatitis, high blood pressure, and high cholesterol, all from unknown dates and unknown if ongoing. The patient previously had COVID-19 prior to the vaccination on an unknown date to an unknown date (not ongoing).  The patient did not have any allergies to medications, food, or other products.  Since the vaccination, the patient had not been tested for COVID-19. The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Jan2021 at 07:45, the patient experienced brainfuzz headache, aches, woke up nauseous, and wobbly (almost fell over twice and had to steady himself). The patient did not receive any treatment for the events. The clinical outcomes of brainfuzz headache, aches, nausea, and wobbly, were recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Pt recvd DTP/OPV 6NOV91 & devel low grade fever, was limp & still most of day; very little redness or swelling @ site today 7NOV91; no fever;
One week after shot experiencing chronic inflammatory demyelinating polyneuropathy nerve damage in legs, arms, feet, fingers, and burning and left eye blurry vision. Treatment at this point is unknown. I am still undergoing care from a neurologist. I seem to be having weakness, pain, burning in my nerves that are found in my legs, hands, feet, back, and my left vision is blurry. It has only been 5 weeks with these symptoms. I have had blood work which has come back normal. We are waiting to see from other test, we are trying to come up with a treatment but first we need to be diagnosed properly. Guillain Barre, CIDP, and auto immune polyneuropathy are all things we are checking into.
Dizziness and LOC x 30 sec, about 10 min after vaccination.
I was out of town but was tired with sore throat and blurry vision on 12/28. The next day I went to a nearby Urgent Care and was feeling fatigued with flu-like symptoms. COVID test first and it was positive on the PCR test. Was told to quarantine for 10 days even though the quarantine guideline at the time was 5 days. Was given prescription cough medicine, Albuterol, and nausea medicine. Is still under quarantine. Not yet recovered.
have not received second dose of Shingrix vaccine within the 6 month; This case was reported by a nurse via and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patients received 1st dose of Shingrix at primary reporter's facility. The nurse reported that approximately 50 patients in their practice had not received second dose of Shingrix vaccine within the 6 month window for various reasons, and many were now approaching 12 months.   The nurse did not have specific patient identifiers or lot numbers at time of reporting. The reporter consented to follow up.
Shingles; Vaccination failure; Information has been received regarding a case in litigation, referring to a male pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided.     In 2016, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) for the long-term prevention of shingles and/or zoster-related conditions.         On an unknown date, the pt experienced shingles (herpes zoster). The pt healthcare provided, believed that it was effective in preventing shingles on a long-term or permanent basis that it did not carry any significant risks of adverse effects (vaccination failure). Pt was treated at a physician office an hospitalized on an unspecified date.   As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, included but not limited to medical losses and costs which included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.         At the time of the report, the outcome of herpes zoster was reported as not recovered. The outcome of vaccination failure was unknown. The lawyer considered herpes zoster and vaccination failure to be related to zoster vaccine live (ZOSTAVAX).
Anaphylaxis Initial symptoms were hypersalivation and metallic taste in mouth. Then developed shortness of breath, tight chest and tongue swelling
Vaccine given 10/8. 24 hours later child had re, hot, swollen itch skin at injection site. Area of reaction 2x3 inches.
pt recvd vax 22FEB93 & inadvertently administered 0.5ml instead of the regular 1ml dose & 15 mins following vax pt exp dizziness, lightheadedness, nausea & was pale; pt had an inc pulse rate & felt flushed; sx lasted for 2 hrs;
4cm round reddened area to left upper thigh. Treated with Keflex antibiotic 250/5 1/2 tsp TID x 10 days.
Caller reported that VARIVAX that underwent a temperature excursion was administered.; No adverse effect reported; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies, and concomitant medications were not provided.  On an unspecified date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, route of administration, anatomical site of vaccination and vaccine scheme were not reported; lot number T022312 has been verified to be a valid lot number, expiration date reported and established as 30-JUN-2022) as prophylaxis.   The vaccine was improperly stored at 14 Fahrenheit degrees to 46 Fahrenheit degrees (20.84 Fahrenheit degrees) for 1 hour, 20 minutes (product storage error), which was detected by digital data logger. There was no previous temperature excursion. No adverse events were reported.
Itching to face; rash, trouble breathing, swelling to face, swelling to throat. Seen at ER and was treated for allergic reaction.