chrisvoncsefalvay/vaers-outcomes huggingface dataset:
VITAMIN B12 DECREASED/LOW B12; VITAMIN D DECREASED/LOW D; IRON LOW; POTASSIUM LOW; VACCINATION SITE PAIN/COVID19 VACCINATION HURT; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe adult crohn's disease, and non-infectious intermediate posterior and panuveitis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult crohn's disease, and non-infectious intermediate posterior and panuveitis. No concomitant medications were reported. On an unspecified date, the patient experienced vitamin b12 decreased/low b12, vitamin d decreased/low d, iron low, potassium low, and vaccination site pain/covid19 vaccination hurt. Laboratory data (dates unspecified) included: Iron Low, Potassium Low, Vitamin B12 Low, and Vitamin D Low. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of the vitamin b12 decreased/low b12, vaccination site pain/covid19 vaccination hurt, vitamin d decreased/low d, iron low and potassium low was not reported. This report was non-serious.
Sore arm, injection area. At about 40-60% use of arm. Slowly getting better.
Patient received Shingrix vaccine on 9/12/23 approximately 3:30 pm. She reports went home and noticed some left facial swelling. Her son thought it may have been due to her concurrent toothache (broken tooth), which she had a dental appointment for the next day. During her dental appointment on 9/13/23, the dentist confirmed via x-ray that the facial swelling was not caused by her broken tooth. Patient went home on antibiotics: cleocin 300 mg, and meloxicam 7.5 mg post tooth extraction. On 9/18/23, the patient's son contacted the clinic and informed triaged nurse that patient has left painful facial rash, swollen tongue and nose, and headache. Rash reaches left side of nose, including nostril and up to the left eye with conjunctivitis. It was reported swelling began on 9/15/23 an worsening. Patient confirmed no difficulty in breathing or swallowing. Patient was seen in the clinic or concerns for reactivation of shingles possibly with secondary skin infection and involvement of left eye. Patient was given acetaminophen 650 mg x 1 dose for headache and was sent to ER. Upon presentation in the ER, patient reported left eye swelling, pain. and blurry vision x 3 days. On physical exam, patient was positive for erythematous rash to the left cheek that extends from the bottom of her face up to the eye. There was overlying bulla/papules in various stages of healing and was very tender to the touch. Her (L) eye has conjunctival erythema, hutchinson sign positive, and V2 distribution of zoster. ER provider documents vesicles and distribution are consistent with herpes zoster. Patient was diagnosed with herpes zoster of the face (trigeminal nerve) and started on anti-viral therapy: valacyclovir 500 mg tabs: take 2 tablets three times a day for seven days. Patient was also prescribed a Medrol Dosepak.
the pain travels from the top of her arm to her elbow anytime she moves it; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 05Oct2021 16:30 (Lot number: EW0185) at the age of 35 years as dose 2, single for covid-19 immunisation. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, 1st dose received on: 14Sep2021, Age at Immunization if date not available: 35, Lot Number / Expiry Date: EW0191, the expiry date is unknown to the caller., Route, Anatomical Location: Injection in the left arm, Vaccine Lot Expire Date: Unknown to the caller., Time the Vaccination Was Given: 16:30 for both doses.), administration date: 14Sep2021, when the patient was 35 years old, for Covid-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 05Oct2021, outcome "not recovered", described as "sore arm"; ARTHRALGIA (non-serious), outcome "unknown", described as "the pain travels from the top of her arm to her elbow anytime she moves it". Therapeutic measures were taken as a result of pain in extremity. Prior to vaccination, patient did not received any other vaccine.   Clinical information:  Description of complaint: The caller took Tylenol for the soreness in her arm after receiving the COVID vaccine, but continues to have worsening pain in her left arm. She took Tylenol for the pain for one day. She doesn't like taking pills. She figured it would go away. She doesn't remember the strength. It was oral Tylenol. She does not have an NDC, LOT, or expiry date to provide for the Tylenol.  Follow-Up (17Dec2021): Follow-up attempts are completed. No further information is expected
hot to touch left arm; hardness left arm; red welt 2-3 inches in size left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot to touch left arm), VACCINATION SITE INDURATION (hardness left arm) and VACCINATION SITE ERYTHEMA (red welt 2-3 inches in size left arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 048AZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (hot to touch left arm), VACCINATION SITE INDURATION (hardness left arm) and VACCINATION SITE ERYTHEMA (red welt 2-3 inches in size left arm). On 18-Mar-2021, VACCINATION SITE WARMTH (hot to touch left arm), VACCINATION SITE INDURATION (hardness left arm) and VACCINATION SITE ERYTHEMA (red welt 2-3 inches in size left arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment medication included topical steroid.
This case was reported by a sales representative and described the occurrence of an injection site reaction in a subject of unspecified age and gender who was vaccinated with hepatitis B vaccine, manufacturer unknown, for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date in 1997 the subject received a dose of hepatitis B vaccine (dose number not provided). At an unspecified time after vaccination with hepatitis B vaccine, on an unspecified date in 1997, the subject experienced an injection site reaction characterized as rash and itching. The injection site reaction resolved on an unspecified date on or before May 17 2005.
c/o nausea several hours following vaccine administration. Rest, sips of water, gradually resolved.
Systemic: Body Aches Generalized-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Joint Pain-Severe, Additional Details: patient received flu and covid booster at same time differing arms. pt reports severe muscle spasms and inability to move the next day
Rash at injection site, fever 100.4, body aches, chills about 16 hours after injection
Vertigo, Extreme dizziness 6 days so far, nausea,headaches
initially next day had redness and swelling at site >3 inches around site, still red when speaking today, but dizziness onset 1/28/2021 in the morning. Drinking plenty of fluids
Within 45 minutes to hour of taking vaccine my right knee locked up; I could barely walk or barely put pressure on it/I cannot get out of the bed or go to the bathroom; wet my pants; This spontaneous case was reported by a consumer and describes the occurrence of JOINT LOCK (Within 45 minutes to hour of taking vaccine my right knee locked up), GAIT DISTURBANCE (I could barely walk or barely put pressure on it/I cannot get out of the bed or go to the bathroom) and ENURESIS (wet my pants) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS and VITAMIN D3 for an unknown indication.    On 27-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced JOINT LOCK (Within 45 minutes to hour of taking vaccine my right knee locked up), GAIT DISTURBANCE (I could barely walk or barely put pressure on it/I cannot get out of the bed or go to the bathroom) and ENURESIS (wet my pants). The patient was treated with ACETAMINOPHEN at a dose of 500 mg. At the time of the report, JOINT LOCK (Within 45 minutes to hour of taking vaccine my right knee locked up), GAIT DISTURBANCE (I could barely walk or barely put pressure on it/I cannot get out of the bed or go to the bathroom) and ENURESIS (wet my pants) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-062826 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-062826:Patient case
Extreme chills; Vomiting; No energy/had very little energy; Confined to bed and only slept; Eat very lightly (crackers, water, ginger ale); Still very tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Extreme chills"; VOMITING (non-serious), outcome "unknown"; ASTHENIA (non-serious), outcome "unknown", described as "No energy/had very little energy"; BED REST (non-serious), outcome "unknown", described as "Confined to bed and only slept"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Eat very lightly (crackers, water, ginger ale)"; FATIGUE (non-serious), outcome "unknown", described as "Still very tired".  Additional information: Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused prolonged hospitalization: No. Seriousness criteria-Disabling Incapacitating: No. Seriousness criteria-Congenital anomaly birth defect: No. No other vaccine in four weeks. Other medications in two weeks:  55+ multivitamin. Adverse event: About 15 hours after the shot I had extreme chills for about 2 hours, starting adverse event extreme chills for about 2 hours, starting at 4 a.m. Beginning at about 9:00 vomiting began. I could not even take a sip of water without vomiting for the next 36 hours. During this time I had no energy and was confined to bed and only slept. Beginning about 48 hours after the shot I could eat very lightly (crackers, water, ginger ale) and still had very little energy. I was feeling more normal about 4 days after the shot, but still very tired. This was my 5th Pfizer shot, and I had the exact same reaction after all 5 doses. The patient had no covid prior to vaccination. Known allergies: No.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Child came in complaining a rash on right thigh ? where the Varivax was administered (on 1-29-02), about size of nickle / red with several small bumps around nickle rash raised, little diarrhea on day came in for rash on leg and little congestion. diagnosed ROM and rash/ reaction vaccine
Case number PHEH2013US006963 is an initial spontaneous report received from a pharmacist on 22 Mar 2013. This report refers to a female patient whose age was not reported. She was vaccinated intramuscularly with a dose of MenA lyophilized conjugate of MENVEO, (batch number: not reported) which was reconstituted with sterile water instead of liquid component on 11 Mar 2013. No adverse events were reported following the maladministration.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Counseled patient. She said she ate very little before the vaccination. She fainted for a couple minutes and had to lie down. She informed pharmacy staff. I went over to her and offered her a bottle of water and stayed with her for approximately 10 minutes until she felt fine. She said after a couple minutes and drinking some water she felt fine. She stayed sitting in the vaccination/observation area for 10 more minutes. She was at the store for approximately 45 mins and waited 30 min after shot
Death 7 days later 4/20/-09-autopsy report received-Final diagnoses:straw colored pericardial effusion and ascites. No antemortem trauma.
Erythema induration at left thigh elevated white blood cell count to 13.7 K Fever to 100.5
All joints swollen and hurting, vomiting, lethargy, charley horse in left arm and leg, dizziness, headaches, sensitive to light and tv screen or phone screen. Left toes swollen, bottom of feet sensitive and hurting.
chills/ nausea / vomiting/ fever uncontrolled convulsions lasting 30 min. aching body 3 days
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 12Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 13Oct2023 to 17Oct2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
******************COVID BREAKTHOUGH CASE*********************  I had bronchitis that started before I got vaccinate around May 1 and on the 9th flu like symptoms. Did a home test neg  My husband had severe symptoms and mine started to intensify Wednesday did a test and it was positive PCI Thursday I received a script Paxlovid 10 dose 2 per lasting five days in total.    I did another home test yesterday and it was positive but it was a faint line.
Injection was given with some force, arm bleed at injection site, arm started hurting immediately and continued for 2 day. Two days after injection left pectoral muscle and left anterior rotator cuff became achy. Six days post injection moderate to severe pain with burning sensation occurred in left pectoral muscle, around left clavicle, and left anterior rotator cuff. Pain continued for 5 days. I placed arm in sling to reduce movement and took anti-inflammatory meds with Tylenol for the pain. 13 days post injection, pain subsided. I am currently able to move arm without pain, only tenderness around anterior rotator cuff remains. No accidents occurred.
Left arm had swelling the size of an orange (at site of subq injection) by evening went to ER when tongue and eyelids felt swollen and tingly. Arm became progressively more swollen over next 2 days despite having received a cortisone shot and tapering Prednisone dose as well as liquid Benadryl. Swelling gradually resolved.
bradycardia, hypotension near syncopal episode shortly p/vax given; 0.3cc epinephrine 1,000 given; much improvement; d/c in satisfactory condition;
I got the shot . But still ended up in the hospital with the flu; Initial information received on 25-Dec-2022 regarding an unsolicited valid social media serious case received from a patient   This case involves an unknown age and unknown gender patient who experienced 'i got the shot . but still ended up in the hospital with the flu' after receiving vaccine Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is unknown if the patient experienced any additional symptoms/events   It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a  dose of suspect Influenza vaccine produced by unknown manufacturer (strength , dose, formulation, frequency, lot number, route,  administration site and expiry date: not reported) for Flu    On an unknown date the patient developed a serious event i got the shot but still ended up in the hospital with the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  It is unknown if there were lab data/results available.   Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event (I got the shot . But still ended up in the hospital with the flu).  At time of reporting, the outcome was Unknown for the event i got the shot . but still ended up in the hospital with the flu.  Seriousness Criteria: Event leading to hospitalization; Sender's Comments: Sanofi Company Comment dated 25-Dec-2022: This case involves an unknown age and unknown gender patient who experienced 'i got the shot but still ended up in the hospital with the flu' after receiving vaccine Influenza vaccine. The time to onset is compatible with the role of the product. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the individual role of the suspect vaccine cannot be assessed.
Immunization given 3/5/03, pt awakes 3/6/03 with right arm swollen, red and warm to touch - started on Keflex (250/5) susp & Motrin. PT will RTC 3/10 for follow up.
Background: On 8/11/23 I had a gender affirming double mastectomy. Within four hours of getting my COVID booster on 9/24/23 my surgical scars began to ache and itch, which got progressively worse as time went on. I attempted to treat this with Benadryl and Advil without luck. On 9/25/23 the sensation in my surgical scars switched to a burning/scalding sensation that was not manageable with Benadryl/advil. The impacted area for the sensation was essentially a 4" band running from armpit to armpit across my chest. It was impossible to focus during the day due to the pain and very difficult to sleep. On 9/26/23 I went to a urgent care facility, where the provider noted that my COVID booster injection site was hot to the touch, as were my surgical scars/sites. I was prescribed a pulse of prednisone and 5% lidocaine patches.  Prednisone dosing was set at 60mg day 1, 40mg for days 2-4, and 20mg for days 5-10.  Lidocaine patches were allowed for 12 hours on, 12 hours off, and I utilized them at night on 9/26 and 9/27 to reduce the remaining sensation in my surgical scar sites to sleep. Prednisone pulse dramatically improved the inflammation and pain in my surgical sites to a tolerable level, and the lidocaine patches further reduced the pain/sensation so I was able to sleep.  I'm not sure which influenza vaccine I received, I was not provided documentation or information by the pharmacy I visited on either vaccine I received, and only know I got the Pfizer COVID shot as it was noted on my appointment.  I believe I have had a reaction similar to what is described in article.
mild injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown Manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKNOWN (BOOSTER); Unknown Manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "mild injection site pain".  Additional information: The reporter wanted to know if it is okay for him to take Tylenol for mild injection site pain. It was nothing serious. She did not want to do a report.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200966592 same reporter/drug/event; different patient.;
Information has been received via the Merck Pregnancy registry, from a registered nurse, concerning a female patient (age not specified) who on 05-JUL-2007 was vaccinated with a dose of Gardasil (lot # not provided). Concomitant therapy included ethinyl estradiol/noregestimate (ORTHO TRI-CYCLEN LO). On an unknown date, the patient became pregnant (gestation details not provided), and on 23-OCT-2007 she had miscarriage. She was treated in the physician's office (details not provided). At the time of this report, the patient was recovering from the miscarriage. Upon internal review, the event of miscarriage was considered to be an other important medical event. Additional information has been requested.
Itching to left arm, not at injection site. Continues to scratch arm. Remind pt to stop. Gave 25mg PO BENADRYL & sent to school nurse. Home with parent, c/o HA, nausea with eating, rested 3 hrs, awoke with no further reaction. Back to school 2/3/10.
Unsure if this is reportable. Received ROTATEQ 12-17-08. Vomiting and diarrhea began on 12-20-08. To hosp. 12-20-21-08. 1/7/09-records received for DOS 12/19/-12/20/08-DX: acute gastroenteritis. Dehydration. Acidosis. prematurity. Gastroesophageal reflux. presented with C/O vomiting, diarrhea, began 3 days ago.
The cases were received on 21 March 2014 at agency. Initial misuse report received from a healthcare professional on 24 January 2014. A '9-month-old' patient (no information was provided regarding the patient) had received first dose of FLUZONE 0.5 ml on an unspecified date. I.E. overdose. No adverse event was reported. List of documents held by sender: none. This case is linked with case number 2014SA046384.
Patient started feeling light headed and dizzy about 15 minutes after her vaccination. She was flushed and saying she was going to pass out. I helped the patient lie down and put her feet on a chair. I fanned her. My technician called 911. She never lost consciousness. The fire department arrived about 10 minutes later and took her vitals. She had an elevated BP, normal glucose, normal O2 sat. She had rapid and shallow breaths. The patient began to fell somewhat better when EMS arrived. They put her on a stretcher and brought her to an ambulance for further evaluation.
redness for 4 days size pie plate-redness went away-soreness, pain stayed;16DEC98 soreness;cant lift arm too high;seems to be in the muscle;
The child developed a red, swollen area at the injection site, approximately 2 1/2 - 4 inches around (per patients mother's report). Denies pain or discomfort. Lasted 3-4 days.