chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 29-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included Obesity in 2012 and Alcohol use from 2011 to May 2020. Concurrent medical conditions included Sulfonamide allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Nutritional supplement, VITAMIN D2 for Prophylaxis against vitamin deficiency.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Jun-2020 and the estimated date of delivery was 21-Mar-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Glucose tolerance test: normal (normal) normal. On an unknown date, Ultrasound scan: normal (normal) normal at 8, 12, and 20 weeks..     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 product use was not provided by the reporter. Treatment information was not provided.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Initially bumps 3 to 4 bumps on lower left arm then spread to lower left leg & foot.  Eventually it spread to lower right leg & foot (never on thighs), left hand, right arm, shoulder & back.
Reported symptom onset 11:09 of tingling outer lip area and tip of tongue. VS: BP 146/82, pulse 57, Resp 16 at 11:09. Administered 20ml Diphenhydramine Elixer by mouth at 11:16. Reports tingling resolved on tongue and "mostly gone" from lips. Alert after incident, accompanied home by husband.
myalgias,  sore throat, congestion, cough x24 hours; ibuprofen and tylenol for symptomatic relief; resolved
Pain, swelling, redness at inject iste.  Atarax, Vicodin used for treatment. Treated at an urgent care facility. Symptoms subsided after treatment.
Initial report received from a healthcare professional on 12 December 2012. A 28-year-old female patient had received an intramuscular first dose of ADACEL (Lot number U4421AA, anatomical site of vaccination was not reported) on 11 December 2012. The patient was pregnant at the time of vaccination. The last menstrual period date was 09 May 2012 and the expected date of delivery is 13 February 2013. The patient's health during pregnancy, risk factors, medical history and concomitant medications were not reported. As of 11 December 2012, the patient did not experience any adverse event. Follow-up information received from a health care professional on 03 September 2013. The patient's maternal age was 26 years old. The last menstrual period was 05 September 2012. The patient experienced hypothyroidism and Crohn's on unreported dates during pregnancy. The patient was administered Tdap and SYNTHROID during pregnancy on unreported dates. The patient did not experience any adverse events following vaccination. The number of pregnancies for the mother was one with a normal outcome. The patient experienced a premature rupture of membranes at 33 weeks. The end of pregnancy was 26 December 2012 and the birth outcome was infant normal. List of documents held by the sender: None.
From the point of injection in the left deltoid down to the elbow the arm was red, hot, stiff, and swollen. Patient reported pain as well as itching in the swollen part. Arm was also bruised the size of a half dollar at the injection site. Dr. diagnosed her with cellulitis after immunization and prescribed her amoxicillin 875mg twice daily for 10 days.
It was reported that a pt (6 of 10) received a Fluzone SV '00-'01 on 10/9/00. Reportedly, within 48-72 hours, post vax, the pt complained of pain, redness, swelling and induration at the injection site. No specifics provided; further information requested.
Patient c/o of pain at injection site 12(8)08 at 0130. Dr notified, Tylenol given and cold pack applied. Tylenol was given again at 0630. Patient continued to complain of pain, nurse noted tenderness, redness and swelling to (L) upper arm. Site was noted to be red and warm to touch by Doctor. Benadryl and Vicodin given 12/08/08 at 1005. Symptoms improved.
Expired dose was administered; One of our staff members gave a Moderna vaccine from a vial that was kept in the fridge for 12 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose was administered) and PRODUCT STORAGE ERROR (One of our staff members gave a Moderna vaccine from a vial that was kept in the fridge for 12 hours) 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 EXPIRED PRODUCT ADMINISTERED (Expired dose was administered) and PRODUCT STORAGE ERROR (One of our staff members gave a Moderna vaccine from a vial that was kept in the fridge for 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered) and PRODUCT STORAGE ERROR (One of our staff members gave a Moderna vaccine from a vial that was kept in the fridge for 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Headache, Myalgia, Diarrhea, chills Narrative:  Other Relevant History:
This is a spontaneous report from a contactable other HCP (Patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 12May2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included she had an issue with red dye in the past and states her 'throat started closing up' from it. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unknown date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient stated she had her second Pfizer Covid vaccine dose on Wednesday 12May2021. On Sunday 16May2021 she developed hives and a rash that has gotten progressively worse. She was taking prednisone and Benadryl to help treat it. She wanted to know if this has been reported before and how long it could potentially last. The outcome of event was unknown.  Information about Lot/Batch number has been requested.
After receiving first dose of Hep B vaccination series in her Right arm intramuscular patient reported her entire arm feeling heavy and numb, "like it was asleep," for about 5 hours after injection. She also had trouble writing with her right hand and had to use her left hand to support her right wrist when she was writing.
The pt experienced convulsions, loss of consciousness, pain in the left arm, blood pressure of 80/40, and an irregular pulse rate (48). Causality is stated to be unrelated. The most likely cause is a circulatory reaction due to the injection rather than the vaccine.
Uveitis; Arthritis flare up/  Pain aggravated/ Occasional flare up in right arm of pain; interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of UVEITIS (Uveitis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    Concomitant products included COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 vaccination.   On 20-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen, citrate free. On an unknown date, the patient experienced UVEITIS (Uveitis) (seriousness criterion medically significant), ARTHRITIS (Arthritis flare up/  Pain aggravated/ Occasional flare up in right arm of pain) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, UVEITIS (Uveitis) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown and ARTHRITIS (Arthritis flare up/  Pain aggravated/ Occasional flare up in right arm of pain) had not resolved.            No medical history was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 63-years-old, female patient with medical history of ANKYLOSING SPONDYLITIS, who experienced the unexpected non serious AESI event of arthritis (reported as Arthritis flare up) and unexpected serious (medically significant) event of uveitis, which occurred unspecified day after third dose of mRNA-1273 vaccine. In addition, the patient previously received a different Covid-19 vaccine JANSSEN COVID-19 VACCINE (interchange of vaccine products) 2 doses prior to mRNA-1273 vaccine. Medical history of ANKYLOSING SPONDYLITIS is confounding for the event arthritis (reported as Arthritis flare up). The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 63-years-old, female patient with medical history of ANKYLOSING SPONDYLITIS, who experienced the unexpected non serious AESI event of arthritis (reported as Arthritis flare up) and unexpected serious (medically significant) event of uveitis, which occurred unspecified day after third dose of mRNA-1273 vaccine. In addition, the patient previously received a different Covid-19 vaccine JANSSEN COVID-19 VACCINE (interchange of vaccine products) 2 doses prior to mRNA-1273 vaccine. Medical history of ANKYLOSING SPONDYLITIS is confounding for the event arthritis (reported as Arthritis flare up). The benefit-risk relationship of mRNA-1273 is not affected by this report.
Nausea; no appetite; felt woozy; Low grade fever; felt crummy and spent the day in bed /She is not feeling too good; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 04Feb2021 14:00 (at the age of 62-years-old) (Batch/Lot Number: EL9269) as single dose for COVID-19 immunisation. Medical history included hypothyroidism from 2015 and ongoing, hyperthyroidism, cholesterol, bipolar ii disorder. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for hyperthyroidism from 2012 and ongoing; simvastatin (SIMVASTATIN) taken for blood cholesterol abnormal from 2010 and ongoing; lamotrigine (LAMICTAL) taken for bipolar ii disorder from 2003 and ongoing; venlafaxine (VENLAFAXINE) taken for bipolar ii disorder from 2000 and ongoing. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. The patient no Prior Vaccinations (within 4 weeks). The patient previously first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 14Jan2021 (at the age of 62-years-old) (Batch/Lot Number: EL3246) for COVID-19 immunisation. Since 05Feb2021, the patient experienced low grade fever, no appetite and felt woozy. Since 06Feb2021, the patient had nausea. That was day four since she received the second dose of the Covid-19 vaccine. She was not feeling too good. She has had a low grade fever and nausea. She has not had anything weird or unusual. She was still drinking liquids but had no appetite. She still felt woozy. still felt woozy. Her temperature was 100.2 degrees. She felt crummy and spent the day in bed. When asked about concomitant medications, patient asked if there would be a difference in taking these medications verses not taking the vaccination. She had a medical background and didn't go seek treatment. She wanted to know when she would feel better, there was anything that anyone could do. This had knocked her for a loop. The event did not require visit to Emergency Room/ Physician Office. The patient had no relevant tests done. Outcome of the events low grade fever was recovered on 06Feb2021; nausea, felt woozy was recovering; no appetite was not recovered; felt crummy and spent the day in bed /she is not feeling too good was unknown.  Follow-up attempts completed. No further information expected.
Infection control nurse from hosp reported child admitted 10/22/09 temp 99.6, unable to walk, CPK - 3362. Reports 10/23 temp 99.3, CPK - 1165, moving all extremities (states she is unaware of ambulatory status).  10/26/09 Hospital / ED records received service dates 10/22/09 to 10/23/09. Assessment: Rhabdomyolysis. Patient presents with muscle pain lower extremities bilateral. Fever of 104. Ambulatory with limp. 10/29/09 Medical records received for DOS 10/22/09-10/23/09. FInal DX: Rhabdomyolysis.  Progress note: Heart rate approx 50 overnight. CPK decreasing but CMBK 18.8.  ICD9 codes: 728.88
Lost patches of hair on his head. Took months to grow back. 6 months later he lost more patches of hair.
I have a rash or hives all over my hands, my knees, my feet, and it's spreading everywhere. Please help me. I'm in so much distress
leg (thigh) swollen-red, tender, general body for approx 10-15min-occurred x2 few hr p/vax;? allerg rxn;
We noticed him spinning around, pacing back and forth and banging his head. There was no treatment given. It was recommended that he continue to receive vaccines (that contain thimerosal); (He now has autism). He is dx'd with mercury poisoning. Annual follow up states pt has not recovered. he still has autism and high mercury levels in his system.
The day after my vaccine a rash the size of a baseball developed on my left arm. It was red swollen and itchy. I called the doctor. It was virtual and they mentioned to put ice and heat on it for a week or two. It resolved after four days or so. I feel fine now it's completely gone.
Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 18-NOV-2014 at the health department as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 11-OCT-2016, the patient was treated by a nurse practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed acyclovir (ZORIVAX), and gabapentin for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Fainting - I fainted twice the morning after the vaccine. Also had headache, body ache, fever, chills and loss of appetite
Received varicella vaccine and developed a rash all over scalp and back area. It is not reported that it is even possible to get the chickenpox after receiving the vaccine. I work in the healthcare field and am having to stay home due to this rash. Healthcare providers are not informed also of the risk of developing chickenpox after the vaccine.
COVID Arm; Caused skin to droop under arm; Had sores in it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID Arm), SKIN ATROPHY (Caused skin to droop under arm) and PAIN OF SKIN (Had sores in it) 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 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 VACCINATION SITE REACTION (COVID Arm), SKIN ATROPHY (Caused skin to droop under arm) and PAIN OF SKIN (Had sores in it). At the time of the report, VACCINATION SITE REACTION (COVID Arm), SKIN ATROPHY (Caused skin to droop under arm) and PAIN OF SKIN (Had sores in it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.  Caller also reported she heard of seeing more of "COVID Arm" after people have  Moderna COVID-19 vaccine.   This case was linked to MOD-2021-419549, MOD-2021-419641 (Patient Link).   Reporter did not allow further contact
This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions, or drug allergies/drug reaction described. On 27-OCT-2015, the patient was vaccinated with improperly stored VARIVAX (Merck) (lot # L006386 with expiration date 25-FEB-2017; dose and route were not reported). No adverse symptoms were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
I felt tired, sore and overall a bit lethargic the day after but nothing terrible. I started feeling better after 3:00 pm, the day after the 2nd vaccine. I didn't realize I had such a bad rash until I was getting ready for bed late last evening (around midnight) and saw my left arm/shoulder was swollen and had a large rash that seemed to extend to my chest and face. My face was very flush too. It went away by morning and did not hurt. I always look very red when I have any kind of rash due to my fair skin. I get red easily but it was definitely swollen and not a normal redness event. My arm is still a bit swollen and red toward the injection site but seems to be subsiding. I feel okay. I had a little bit of dizziness today (the second day after the vaccine) but nothing major.
This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (a metallic taste in my mouth) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (a metallic taste in my mouth). At the time of the report, DYSGEUSIA (a metallic taste in my mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information for the event was provided.
within 10 hours of vaccine given on 12/18/2020 pt reports she had chills, fever to 100F, back pain, dysuria, diarrhea with reported blood in urine and /or stool all of which worsened by 24 hours, pt advised to seek ER evaluation by on call doctor on 12/19/2020 but did not, was seen 5 days later and evaluated
Information has been received from a physician's assistant concerning a 16 year old female who in November 2006, was vaccinated intramuscularly with GARDASIL (lot # not reported).  Concomitant therapy included tetanus toxoid and meningococcal vaccine (unspecified) given "on the same day" in November 2006.  In approximately January 2007, "two to three months later", the patient developed a wart on her forehead.  The patient sought medical attention for treatment of the wart.  The wart was surgically removed on an unspecified date.  The patient was not hospitalized for the procedure.  It was reported that the removed wart tested positive for HPV.  Therapy with human papillomavirus vaccine was discontinued.  Subsequently, on an unspecified date, the patient recovered from the wart on her forehead.  Additional information has been requested.
Extreme pain in right arm. Patient called doctor but has not seen doctor. Patient is not taking any medications. States R-arm is little sore as the day goes on she uses R-arm the pain worsens. Eval 11/5/09 Tx ibuprofen and heat.
Dizziness, Myalgia, Fever, FATIGUE/CHILLS/LIGHT HEADED/GI UPSET (NOT SPECIFIED)/ARM PAIN Narrative:  Other Relevant History:
Pt developed hives, increased rhinitis, SOB. Treated with Benadryl 25mg PO and several vital signs.
Swollen arms, tender to the touch with left armpit pain.  Erythema over left deltoid4.5 cm X 8 cm, warm , tender non indurated, mild erythema over righty deltoid 3cm x 4 cm, minimally tender, non indurated.
fainted; This spontaneous report was received from a pharmacist via a company represent referring to the pharmacist's son of unknown age. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown.  On an unknown date, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose detail, route, lot # and expiration date were unknown) in the doctor's office for prophylaxis.         On the same date, after receiving the vaccine, the patient fainted. It was unknown if the patient had sought medical attention, laboratory diagnostic studies were performed or if the patient received any treatment. The outcome of the event was unknown. The causality assessment between the patient fainted and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.  Upon internal review, the patient fainted was determined to be medically significant.
First dose:  soreness in left arm for 1 day.    Second dose: Day 1 and 2:   Heat sensations from the inside of my body.   Opposite of a flu like feeling.    Day 1 thru 4:  Insomnia