chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 12 year old female patient who on 21-JUL-2010 was vaccinated SC with a second dose of VARIVAX (Merck) (lot# 666821/0223Z). That same day the patient experienced a large red knot at the injection site. The patient did not seek medical attention. On an unknown date the patient recovered. This is one of several reports received from the same source. The physician expressed concern for this lot. A lot check has been requested. A preliminary lot check investigation was performed. To date our investigation has found that this lot (666821/0223Z) conformed to quality release parameters and the manufacturing was typical of a lot of VARIVAX. Additional information will be provided upon finalization of this manufacturing investigation. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information was received from the physician concerning a 12 year old female patient with no illness at time of vaccination, no preexisting allergies, birth defects and medical conditions, and no adverse event following prior vaccinations, who at 11:00 am on 20-JUL-2010 (previous reported as 21-JUL-2010) was vaccinated SC with a second dose of VARIVAX (Merck) (lot# 666821/0223Z) in the right arm. On 21-JUL-2010 the patient experienced arm swollen, red, hot, and painful at shot site. On an unknown date the patient recovered. No further information is available.
Redness, swelling, pain, lasted 2 days. Benadryl was given by her daughter. Pt reported 2wks after the vaccine date. Upon exam on 1/22/16, no redness or swelling. Somewhat uncomfortable when lifting the left arm.
no adverse reaction, vaccine ordered, and vaccine given have the same generic name Bexsero, education given to staff and immunization schedule reviewed.
I had a sore throat, achiness, chills but no fever, congestion bad cough that started May 14, 2022. These symptoms were mild and progressively got worse for three days. On day five or six the coughing got worse to the point that I called the doctor. It sounded a lot like bronchitis and I was advised to stay with taking the over the counter cough and cold medications Nyquil and Mucinex. I started to fell better the Friday before the May holiday.
Patient complains of body aches, joints, neck px. since 20:00 on 11th Aug 2015.
patient received the fluzone quadrivalent np instead of the fluzone high-dose quadrivalent with no reported adverse event; Initial information received on 28-Sep-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves an unknown age and unknown gender patient patient received the influenza quadrival A-B vaccine [Fluzone Quadrivalent] np instead of the influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] With No Reported Adverse Event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On an unknown date, the suspect influenza quadrival A-B vaccine suspension for injection and influenza quadrival A-B high dose HV vaccine (strength, lot number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) and patient received the fluzone quadrivalent np instead of the fluzone high-dose quadrivalent with no reported adverse event (wrong product administered) (latency: same day). Information on batch number was requested.  It was unknown if any lab data/test results available  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) and quadrivalent influenza vaccine (Fluzone Quadrivalent) was not applicable.  Outcome: unknown.    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.
COVID-19,Sickness; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19,Sickness) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (COVID-19,Sickness). At the time of the report, COVID-19 (COVID-19,Sickness) outcome was unknown.            The co-suspect drug Humira was used for moderate to severe ulcerative colitis.  No concomitant medication was provided by the reporter.  It was unknown if patient was enrolled in COVID-19 vaccine trial.  No treatment medication was provided by the reporter.  Company Comment: This spontaneous case concerns an adult female patient (with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19  unspecified day after receiving a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed per medical judgement.; Sender's Comments: This spontaneous case concerns an adult female patient (with no relevant medical history reported, who experienced the unexpected non serious AESI of COVID-19  unspecified day after receiving a dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed per medical judgement.
Local reaction at injection site 8-9 inches long oval rash w/ darker 2-3 inches long oval center - warm to touch. Treatment w/ cool compress and BENADRYL - observation.
Participant felt dizziness, hot and sweaty after vaccinated/EPI administered/ 911 called, EMS arrived, participant transported to local ER for further evaluation.
Systemic: Fainting / Unresponsive-Mild, Systemic: Patient passed out and recovery after 40 seconds of chest compression-Mild, Additional Details: Patient was seen rocking back and forth in his chair according to 3 observers in the room, then fell back hit his head after observed his face turned pale. 3 Observers rushed over to him, patient was not breathing, unconscious and not responsive, eye ball stiff, sweating but cold. Eyelid peeled back and the eye is responsive to light. Started chest compression immediately and after 40 seconds of chest compression at third round, patient came back. no hx of preexisting condition or allergies note
body aches; nausea; chills; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LENVIMA. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body aches"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; CHILLS (non-serious), outcome "unknown", described as "chills"; ASTHENIA (non-serious), outcome "unknown", described as "weakness". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mild DRESS syndrome, rash, blood in urine. note it may have bene the doycycline, as simialr symptoms recurred later with a dose of doxy on jan 2nd, not hospitalized.  pt is a MD
Loss of voice; Swollen eyes; Fatigue extreme; Hair loss; 1st Dose on 13-Aug-2021 and 2nd Dose on 13-Oct-2021; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Loss of voice), EYE SWELLING (Swollen eyes), ALOPECIA (Hair loss), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 13-Aug-2021 and 2nd Dose on 13-Oct-2021) and FATIGUE (Fatigue extreme) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2022, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 13-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 13-Aug-2021 and 2nd Dose on 13-Oct-2021). In June 2022, the patient experienced ALOPECIA (Hair loss). On an unknown date, the patient experienced APHONIA (Loss of voice), EYE SWELLING (Swollen eyes) and FATIGUE (Fatigue extreme). At the time of the report, APHONIA (Loss of voice), EYE SWELLING (Swollen eyes) and ALOPECIA (Hair loss) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose on 13-Aug-2021 and 2nd Dose on 13-Oct-2021) and FATIGUE (Fatigue extreme) outcome was unknown. Not Provided          No concomitant medication was reported.  It was reported that patient experienced lost voice, very tired, swollen eyes or puffy eyes and hair loss with HUMIRA adalimumab Solution for injection in pre-filled pen.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the events of lost voice, swollen eyes or puffy eyes and hair loss with  humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of very tired was not provided.  No treatment medication was reported.
Lightheaded , dry mouth, feeling sick to stomach , difficult to breath within first few minutes of administration. Contacted Fire Rescue. Upon exam  confirmed reaction to vaccine and transported to hospital.
On 10/29/09, developed fever of 100 F. Felt very tired. 10/30/09, fever 99.2 and tired. 10/31 and 11/1 had no fever but was tired and lightheaded. Stayed in bed 11/1. 11/2 lightheaded, no fever.
Heart attack; Short breath; Headache; Chills; A spontaneous report  was received from a 37 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced heart attack, headache, chills, and short breath.    There was no medical history provided. Concomitant medications included colecalciferol and metoprolol both for unknown indications.   On 13 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Batch # 02L20A), in in his left arm, for prophylaxis of COVID-19 infection.   On 14 Jan 2021, the day after vaccination, the patient experienced the non-serious events of headache, chills, arm pain, and short breath. On 19 Jan 2021, six days after receiving the vaccine, the patient experienced the serious event of heart attack. Treatment included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events heart attack, headache, chills and short breath  was unknown at the time of this report.; Reporter's Comments: This case concerns a 37-year-old, male patient. The patient's medical history was not provided. The patient experienced a serious, unexpected event of myocardial infarction 7days after the first dose of mRNA-1273 (Batch # 02L20A). The patient also had non serious event of headache, chills and dyspnea the day after the first dose of mRNA-1273 (Batch # 02L20A). Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Fever of 104 started on day 5 lasted 4 days. Rash started day 7, diarrhea started day 9, inconsolable crying started day 10 5 lsted for 4 days.
ACUTE NON ST ELEVATION MI 8/2/2021 ACUTE NON ST ELEVATION MI HYPOTENSION 1/14/2022 ACUTE NON ST ELEVATION MI ACUTE NON ST ELEVATION MI 8/2/2021 AT RISK FOR CARDIOVASCULAR DISEASE HYPOTENSION 1/14/2022 AT RISK FOR CARDIOVASCULAR DISEASE
This spontaneous report was received from a 61 year old female patient. The patient's concurrent conditions included high blood pressure and allergy to latex and penicillin. The patient's medical history and concomitant medications were not provided. On 18-MAR-2016, the patient was vaccinated with ZOSTAVAX 1 shot (lot number, expiry date, route, dose and frequency were not reported) for shingles prevention. On 18-MAR-2016, after vaccination, the patient experienced injection site swelling about the size of a quarter, that increased to the size of a silver dollar. On 19-MAR-2016 (reported as on the next day), it was reported that the injection site was itchy and had a rash. The patient sought medical attention on 20-MAR-2016, when the swelling reached her shoulder area. The area was hot. The patient received a treatment with BENADRYL and camphor, methol, SARNA CREAM for the reported adverse events. No product quality complaint (PQC) was involved. At the time of this report, the outcome of injection site swelling, peripheral swelling, feeling hot, rash pruritic and Injection site pain was reported as not recovered. The reporter did not provide causality assessment between the reported events and the ZOSTAVAX. Additional information has been requested.
Patients received 0.25ml of Moderna bivalent vaccine; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patients received 0.25ml of Moderna bivalent vaccine).    No concomitant drug information was provided. It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. No treatment drug information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: follow-up received, updated I narrative.
Bladder spasms , urgency and increased frequency of urination. This lasted several days but was very intense the evening of the injection.  The above is a chronic condition following cancer treatment (hysterectomy,  pelvic radiation), however is controlled with medication.  Medication had been taken appropriately in the days prior to and after the vaccine. This could be  explained day two, as there was an increase in water intake due to severe thirst, however no significant increase in water intake the day of the vaccine.  Between 11 pm and 3 am urinated 8 times (typically urinate 0-1x/evening). After 3 am, experienced insomnia the rest of the evening  (awake and alert) Odd taste in mouth (occurred immediately with injection and lasted about 20 min) Dizziness (started within min of receiving vaccine and lasted 2 days) Poor temperature regulation (started within 1-2 hours following vaccine was severe hot/cold with severe sweating for 3 days.  Currently continues 1.5 weeks following injection, however at a lesser extent. Currently , I over-heat with minimal exertion.) Extreme fatigue -slept for 1.5 days following  vaccine.  Notable fatigue  persists  currently, which is 1.5 weeks following vaccine. Fatigue with work-related tasks extremely easily and  with  working out (lifting weights, unable to jog due to fatigue)
Patient received incorrect vaccine, should have received DTaP, not Tdap, and received Meningococcal vaccine prior to required childhood vaccine schedule.  No adverse events occurred.
15 days after vaccine, pt developed fever of 105F + for 5 days and then tell-tale rash of Roseola on 6/26/01.
BRIGHT RED AREA MEASURES 5.5CM X 2CM; PINK AREA MEASURES 14CM X 7.5CM; VERY ITCHY. TX: CLARITIN; WILL START THIS EVENING (5/22): ZYRTEC; TRIAMCINOLONE CREAM 0.1% TWICE DAILY; ZANTAC 150MG.
Patient described her tongue swelling up about 5 minutes after receiving the Moderna vaccine. This lasted for about 24-48 hours.
Patient came into pharmacy on 5/24/22 saying he has very intense itching but no signs of a rash. He is convinced it is from the Moderna vaccine because he got the itching after his second dose and he said it got worse after each booster.
Patient received Pfizer COVID vaccine on 3/25/21 (lot # EP7533), 4/17/21 (lot # ER8731), and 11/11/21 (lot # FH8028). On 1/12/22, patient tested positive for COVID. On 1/24/22, patient admitted to our inpatient facility med/surg unit with acute hypoxic respiratory failure due to COVID19 pneumonia and volume overload. On 1/25/22, patient was discharged home in good condition.
Injection at 4pm; started having chills/fever(104) /body aches 2-3pm next day then threw up dark tarry blood 11pm
memory problems; speech was garbled; He wanted to use a magnifying glass as a fork to eat; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (memory problems), DYSARTHRIA (speech was garbled) and CONFUSIONAL STATE (He wanted to use a magnifying glass as a fork to eat) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included Neuropathy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for Anticoagulant therapy, DOCUSATE SODIUM for Bowel movement irregularity, SIMVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVETIRACETAM (KEPPRA) for Seizures, CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced MEMORY IMPAIRMENT (memory problems), DYSARTHRIA (speech was garbled) and CONFUSIONAL STATE (He wanted to use a magnifying glass as a fork to eat). At the time of the report, MEMORY IMPAIRMENT (memory problems), DYSARTHRIA (speech was garbled) and CONFUSIONAL STATE (He wanted to use a magnifying glass as a fork to eat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
received her first Shingrix shot on 05-Nov-2020 / second Shingrix shot on 13-May-2021.; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 5th November 2020). Concomitant products included covid 19 vaccine pfizer.   On 13th May 2021, the patient received the 2nd dose of Shingrix. On 13th May 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The case was reported by the patient for herself. The age at vaccination was not reported. The patient received her second Shingrix shot later than the recommended interval, which led to lengthening of vaccination schedule. The patient also received a Pfizer Covid-19 shot on 18th March 2021. No further information was reported. The patient consent to follow up was unknown.
Approximately 10 hours after injection (injection at 5pm on 4/21), the first symptoms came on suddenly and lasted for about 7 hours (3am-10am on 4/22). These symptoms included severe nausea, headache, weak/rapid heart rate, chills, muscle aches, and a fever of 101 degrees F.  Lymph nodes in the left armpit were also swollen and painful to the touch. After 10am, the chills and fever subsided, but the headache, general muscle aches, swollen lymph nodes, and bouts of nausea persisted (these lasted the entire day). The following day (4/23),  nausea and muscle aches subsided but the headache remained. The headache only came on whenever changing elevation of the head (standing up, sitting down, bending over), at which point it would be painful for a few minutes after moving. An extremely stiff, painful neck also began the same day (4/23) and persisted for approximately 2 days after injection (accompanied by the headache). Lymph nodes under the collar bone on the left side of the body also became swollen (4/23). Lymph nodes in armpit and under collarbone are still swollen 6 days after injection, although not painful.
44 y F referred to clinic after allergic response to COVID vaccine this afternoon. Pt received dose of covid vaccine at 1713.  at 1723 pt c/o itching R wrist and neck.  3 small reddened areas noted.  Vaccine hypersensitivity protocol initiated; RRT initiated.  Allergic reaction to COVID vaccine-pruritic hives without angioedema-resolved with Benadryl
No other adverse events reported.; Caller reports that improperly stored vaccines were administered.; This spontaneous report has been received form an administrator, concerning a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history and concomitant therapies was not reported.  On 30-MAR-2023, the patient was vaccinated with an improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), 1 time dose, lot #U031056, expiration date: 16-JUN-2024, administered for prophylaxis (strength, and route of administration were not provided).  The administered dose underwent a temperature excursion of -40 degrees Fahrenheit (F), for 70 hours and 5 minutes. No previous temperature excursion was reported. No additional adverse event was reported.
Erythema multiforme-Truncal distribution with macular papular patter-pruritic
Child developed diffuse urticarial and macular rash 6 hours after receiving MMR #1, Varicella #1, Influenza, and DTaP. Resolved in 3-4 days with BENADRYL. Then 7 days post vaccination developed worsening urticarial and macular rash, with temp to 104 on day 9 post-vaccination. IV steroids given in ER. Rash and fever resolved 3-4 days later. Unclear if allergic reaction to vaccines vs viral infection.