chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown.            No relevant concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-258737.
100F fever, chills, nausea, dizziness, full-body weakness, and headache in the morning. Took Tylenol and all but the headache went away. At night starting around 8pm EVERY joint in the body hurt down to each finger and hip. Applied warm compresses over the body and it eased the pain.  Sore arm.
headache; fatigue; This case was reported by a physician via sales rep and described the occurrence of headache in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced headache and fatigue. On an unknown date, the outcome of the headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache and fatigue to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Age at vaccination was not reported. Physician stated she seen a patient today, on the day of reporting she experienced fatigue and headache for 4 consecutive days and went to the urgent care after received Bexsero. Patient was fine at the time of reporting.  Physician stated that the patient had not received any other vaccines. The reporter did not agree to follow up.
Arm got very itchy, swelling and redness about the size of a baseball, and a severe bruise
Diffuse bruising on back, arms and legs No known injury or trauma  New onset fever 8/1/22 up 101
Sore arm; Redness around the Injection site; Swollen axillary lymph nodes; Joint pain; Chills; Fatigue and Tiredness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the Injection site), LYMPHADENOPATHY (Swollen axillary lymph nodes), ARTHRALGIA (Joint pain) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE ERYTHEMA (Redness around the Injection site), LYMPHADENOPATHY (Swollen axillary lymph nodes), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue and Tiredness) and HEADACHE (Headache). On 10-Mar-2021, VACCINATION SITE ERYTHEMA (Redness around the Injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), LYMPHADENOPATHY (Swollen axillary lymph nodes), ARTHRALGIA (Joint pain), CHILLS (Chills), FATIGUE (Fatigue and Tiredness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Side effects; This case was reported by a nurse via call center representative and described the occurrence of adverse event in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had side effects. The patient gave blood every 2 months and just gave blood day before reporting.  The patient had one month before the 6 month period was up.
Patient called complained of bleeding from site of vaccination - several hours after placement. Seen in office, positive swelling, positive pain, site reddened and warm to touch. 6-8cm induration. Advised cool compresses, Tylenol Q 6H.
Noticed bruising after scratching the itchy area on the body. The body itch occurred in early March but no bruising from scratching. The bruising started after the vaccination on April 16, 2021.
Tingling in hands and feet; numbness in toes , lose control of legs and arms not being able to walk and a lot of pain.  I was treated with plasma IVIG , and steroids. Still in rehab
Immediate swelling and discoloring at the injection site. Swelling continued for about 40 minutes. Entire upper arm from shoulder to elbow swollen. Face and neck flushed bright red. Tingling sensation of arm and fingers. Patient felt light-headed. All symptoms resolved within 90 minutes.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2014, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
numb sensation in the left side of her tongue after three shots; numb sensation in the throat after three shots; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numb sensation in the left side of her tongue after three shots) and PHARYNGEAL HYPOAESTHESIA (numb sensation in the throat after three shots) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included TIA (the left side of face and arm got numb, she does not know if this can be related). Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced HYPOAESTHESIA ORAL (numb sensation in the left side of her tongue after three shots) and PHARYNGEAL HYPOAESTHESIA (numb sensation in the throat after three shots). On 22-Oct-2021, HYPOAESTHESIA ORAL (numb sensation in the left side of her tongue after three shots) and PHARYNGEAL HYPOAESTHESIA (numb sensation in the throat after three shots) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that after the first and second dose, and now after the booster, she got a numb sensation in the left side of her tongue and in her throat. It started about 25 minutes after the shot and lasted for about 1-2 hours.  Myo or pericarditis when she was 2 years of age.   This case was linked to MOD-2021-361901, MOD-2021-361778 (Patient Link).
This spontaneous report as received from a Certified Pharmacy Tech refers to a 45 years old female patient. On an unknown date, the patient was inadvertently vaccinated with ZOSTAVAX instead of VARIVAX (Merck). No lot# and route reported. No adverse effect reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Initial information received on 26-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 77 years old unknown gender patient who received a dose of MENACTRA (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medications included was PREVNAR 13. It was a case of actual medication error due to inappropriate route of vaccination. Patient received MENACTRA subcutaneously instead of intramuscular.  It was not reported that if any adverse reaction was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
24 hours after Dose given at Pharmacy she started to have symptoms.  Injection site pain, H/A , Joint pain, slight swelling at injection site.  48 hours after Dose Dizzyness started and she is still having it. However it is subsiding. She still remains with original symptoms she had  at 24 hours post vaccination, and in general she states she is still feeling unwell. She is being Covid-19 tested today. If her dizziness or any symptoms increase she will go to Urgent care.
Erythema and swelling around left deltoid with induration. Mild warmth and No fevers /chills. Suggested heat alternated with ice. No abx.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 69 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". She is currently in quarantine and does not know when she has to take the booster dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
10 minutes after having vaccine, pt had syncope. Patient was monitored in office x 1 hour after incident and pt was stable and discharged home.
small rash at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 24th May 2019, the patient received the 1st dose of Shingrix. On 25th May 2019, 1 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received Shingrix and One day after, the patient had a small rash at the injection site, which resolved after a few days without any treatment. The reporter had consented to follow up. The case has been linked to the case US2019137612 reported by same reporter. There was discrepancy between the outcome reported in the structured field (recovered/ resolved) and the outcome reported in the source document (recovered/resolved with sequel).
ONCOLOGY/HEMATOLOGY SUMMARY: -4/7/2021.  Patient received COVID-19 vaccine Johnson & Johnson.  A week later he developed an eruption on his trunk which resolved followed by extensive bruising and asymptomatic mucosal bleeding. -5/4/2021.  Leukocytes 7.4, hemoglobin 14.9, platelets less than 5K, creatinine 1.02, liver function within normal range.  Initiated dexamethasone 40 mg daily x4. -5/7/2021.  Platelets improved to 31K, leukocytes 16.6, hemoglobin 14.5, CRP 3.6, ESR 4. Negative serology for HIV, Hep B, C, tick borne disease. Normal ANA. Normal b12, folate levels, low TSH but normal freeT4. -5/10/21. Platelets decreased to <5K. Started prednisone 1mg/kg at 80mg daily with poor response, thus tapered off in 15-20 days. -5/17/21. Bone marrow biopsy. Results pending. -5/18/21-5/20/21. IVIG 1gm/kg x 2. - 5/24/21. Improved platelet count to 133K/uL
C/o fever 100.8 x2 days. Pain,Redness and swelling at injection site "the size of a Baseball".
Onset of full blown Tourette's Syndrome (movement disorder) and comorbid Attention Deficit Hyperactivity Disorder. The onset of these symptoms occurred approximately one to two months after vaccinations. Symptoms worsened greatly and very noticeable by March 19, 2008. 6/3/08-records received -consult 4/14/08-Diagnosed 2 years ago with Tourette's syndrome of mild severity and attention deficit disorder. Tics, eye twitching and mouth opening. Well until end of last month exhibited restlessness, pacing back and forth, hand tremors, occasional disfluency. Teeth grinding and feet tapping. Assessment-Touorette like symptoms reappeared with some OCD like features. 1/21/2010 Continued Obssessive Compulsive Disorder and tourette symptoms and ADHD.
Post/vax, pt walked to classroom. Within 10 min, she became limp, "eyes rolled back" & began to jerk all over body, as in a seizure, lasting approx 30 sec. Her color was pale, B/p 124/60 & P-84. At 1:40, B/P 108/44 & P-80.
Vaccines went into 2-8 C thaw state on or about 20-Dec-2021; Patient Received vaccine beyond Expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 1:49 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 1:49 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient Received vaccine beyond Expiry date) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The Ethnicity was reported as White. No treatment medications were reported.
Pt had a nose bleed, short duration but lots of blood. lasted about 5 minutes.
Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) 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 vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Expired vaccine was administered to total of 24 patients including 15 males and 9 females. It was reported administrations were mostly for booster shots. No side effects were reported.  No treatment information was provided.
Full body hives, facial swelling and body itching Needed to take 2 weeks of oral high dose steriods. 50mg oral benadryl Q6 hours for 48 hours.  Oral zyrtec for 4 weeks switched to 30 day course of oral Singulair. switched to oral claritin daily and pepcid daily Unable to wean off Claritin, singulair and pepcid. full body hives and itching returned after 48 hours of stopping oral meds.
4 or 5 days later I went to urgent care and took a covid test and tested positive, I took alegra D and tylenol to cover the symptoms and was better after 3 days
inflamed; red almost to above, inside her arm, almost cover her arm; itchy; red arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red arm), VACCINATION SITE PRURITUS (itchy), INFLAMMATION (inflamed) and VACCINATION SITE ERYTHEMA (red almost to above, inside her arm, almost cover her arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CALCIUM and FISH OIL for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red arm). On 28-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (red almost to above, inside her arm, almost cover her arm). On an unknown date, the patient experienced INFLAMMATION (inflamed). At the time of the report, VACCINATION SITE ERYTHEMA (red arm), VACCINATION SITE PRURITUS (itchy), INFLAMMATION (inflamed) and VACCINATION SITE ERYTHEMA (red almost to above, inside her arm, almost cover her arm) outcome was unknown.            Patient was taking blood pressure medication, Hormones treatment. Action taken with mRNA-1273 in response to the event was not applicable.
Narrative:  COVID infection following COVID vaccine series, 01/21 Pfizer, dose #1 (private) 02/11 Pfizer, dose #2 (private) 07/23 pt cc: cough, fatigue, congestion, rhinorrhea, chills, dyspnea, myalgias, sore throat 08/03 COVID swab, result: detected 08/18 clinically resolved
acthib that was administered a week after the expiration date with no reported adverse event; Initial information received on 17-Aug-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 1 years old female patient to whom HIB (PRP/T) vaccine [ACT-HIB] that was administered a week after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic vaccination.  On 17-Aug-2023, the patient received 0.5 mL dose 4 of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (Frequency: once; Strength: standard) (batch number: UJ739AAA; expiry date: 10-Aug-2023) via intramuscular route in the right thigh for Immunization a week after the expiration date with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event acthib that was administered a week after the expiration date with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Initial and follow-up information has been received from a healthcare worker concerning a 9 year old female with no known allergies who on 17-OCT-2000 was vaccinated with the first dose of VARIVAX (Oka/Merck). On 16-JUN-2008 at 11:00 AM the patient was vaccinated subcutaneously into the right leg with the second 0.5 ml dose of VARIVAX (Oka/Merck) (lot no. 659434/1911U). There was no concomitant medication. On an unspecified date the patient developed local reaction with erythematic, swelling and pain at the injection site. And the patient complained of fever. The local reaction progressed over 48 hours to induration. The patient was treated with antibiotics for a cellulitis. At the time of report, the patient was not recovered. This is one of several reports received from the same source. Additional information is not expected.
Red and swollen at injection site of golf ball, hot to touch, itching - treated with Benadryl and cool compress.