chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented to COVID vaccine clinic today and developed a mild reaction after receiving the second Pfizer vaccination.  Pt reported a blister like rash on her chest after receiving the first dose. Hx of hives with adhesives and latex, occasional rash with tylenol.  Pt reported a flushing sensation and swollen lymph nodes in neck 30 minutes after administration. Pt reported tingling in her hands shortly after. BP: 135/73 HR: 72 O2: 100% Pt denied SOB, swelling of face/tongue/throat, difficulty swallowing, nausea, itchiness, dizziness. No visible swelling.  Paged Allergy (Itchy). Advised to give Zyrtec 10 mg and observe to see if there is any improvement. Symptoms improved 15 minutes after administration of Zyrtec 10 mg. Pt sent home and advised to continue to take antihistamines as needed
Patient broke out in hives day after shot, also ran slight fever and complained of some dizziness.
Aunt developed Heart arrhythmia after Moderna; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Aunt developed Heart arrhythmia after Moderna) in a female patient of an unknown age 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) 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Aunt developed Heart arrhythmia after Moderna) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Aunt developed Heart arrhythmia after Moderna) outcome was unknown.            No Concomitant and Treatment Drug was provided by reporter.  Company comment: This Spontaneous case concerns a female patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of Arrhythmia. The event occurred on an unknown date after the a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5). No information about dose number or vaccination schedule was provided. No diagnostic or laboratory findings or information about clinical course of event was provided. The benefit-risk relationship of  Spikevax Bivalent .222 (Original/Omicron BA.4/5) is not affected by this report.; Sender's Comments: This Spontaneous case concerns a female patient of unknown age, with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of Arrhythmia. The event occurred on an unknown date after the a dose of Spikevax Bivalent .222 (Original/Omicron BA.4/5). No information about dose number or vaccination schedule was provided. No diagnostic or laboratory findings or information about clinical course of event was provided. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) is not affected by this report.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 47 year old male patient who received 0.5 ml dose of FLUZONE QUADRIVALENT (batch number UI997AA, expiry date 30 June 2019, route of administration were not reported) in right deltoid on 10 Oct 2018. It was a case of potential medication error due to Incorrect product storage as FLUZONE QUADRIVALENT, stored in temperature of (-4) C. No known reported symptoms. 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.
Left UE neuralgia: pain, tingling, numbness fingers to arm. Pain to active motion. Referred to ped. neurology 8/8/07-records received for DOS 7/31/07-Assessment:left upper extremity neuralgia associated with human papilloma virus vaccine number two. C/O pain in left arm, numbness and tingling started in fingers and progessed to hand. PE: significant decreased feeling to light touch on third, fourth and fifth fingers but less so on the first and second fingers on the dorsal hand but uniformly decreased to light touch on palmar aspect. Decreased feeling to light touch lessened towards the elbow. Pain to palpation of her arm in anterior and lateral aspects, pain to active motion. To see neurologist on 8/10/07 10/9/07-records received from neurologist for DOS 8/10/07-Impression: history of transient arm numbness and possible weakness status post human papillomavirus immunization. Normal neurological examination presently with no symptomatology and no weakness or peripheral sensory deficit. Overall presentation suggest an acute brachial neuritis possibly immunization induced. Recommend no further similar immunization. No additional diagnostic or laboratory tests ordered.
9/17/2020 + COVID with PCR Test. 1/29/2021 1st Moderna COVID vaccine 042L20A 4 pm, left arm. 2/26/2021 2nd Moderna COVID vaccine 010A21A 4 pm left arm. 4/11/2021 became ill. 4/14 + COVID with PCR test.
itching every where like chest back and arms; Itchy at the injection site; slight fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching every where like chest back and arms), VACCINATION SITE PRURITUS (Itchy at the injection site) and PYREXIA (slight fever) in an 88-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching every where like chest back and arms), VACCINATION SITE PRURITUS (Itchy at the injection site) and PYREXIA (slight fever). At the time of the report, PRURITUS (itching every where like chest back and arms), VACCINATION SITE PRURITUS (Itchy at the injection site) and PYREXIA (slight fever) outcome was unknown.        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.   No relevant concomitant medications were provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Reporter details, patient details and events were added.
I had 2 vaccines in 4/2021 and a Booster in 12/21.  I did test positive for Covid in 7/2022.  I am having pain in all my joints.  I can barely get out of bed in the morning and get going.  I have a lot of pain when I am sleeping.  The more I move the better I feel.  If I sit even for 5 minutes it hurts to get up.  I am currently being treated for lymes disease because I have dogs and live in the woods.  I do no recall getting bit by a tick but it could be possible.  All my blood work came back normal except for my ANA test which was 1:80.  I did test negative for lymes.  I have been referred to a rheumatologist, but they can not see me until August.
On 09/27/2021, pt entered our facility and reported receiving unknown COVID vaccine. Per P&P, Intake RN placed an order to "review for COVID 19 Vaccination." On 10/16/2021, staff RN completed the order prior to confirming vaccination information.  On 01/28/2022, pt. placed a sick call slip "requesting to get a COVID shot."  Staff RN placed an order to "Administer COVID 19 Vaccine Order" per our P&P.  On 02/02/2022, pt received Moderna 0.5 dose to left arm, monitored for 15 minutes with no adverse reaction.  It was later identified that the patient had already received 1st and 2nd doses of vaccines while in the process of inputting COVID-19 vaccination information in the system.  Immediately,  pt. was re-evaluated with no s/s of adverse effects r/t to the vaccine and confirmation received that his intention was to receive a booster. Action Plan:  To review all patients COVID vaccination history/status in the system prior to placing order/administering COVID-19 vaccines. We will update our current COVID-19 vaccination consent to include the question, "Have you received a COVID-19 vaccination."
extreme fatigue; body aches; very sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Unknown and Expiration date: Unknown), via an unspecified route of administration in Left arm on 29Jan2021, 09:15 AM (at the age of 68-year-old) as a single dose for COVID-19 immunisation in Public Health Clinic/facility. The patient's medical history included Type 2 Diabetes, High BP (blood pressure), High Cholesterol, Asthma. List of any other medications the patient received within 2 weeks of vaccination: Yes (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. About 48 hours after injection, on 31Jan2021 09:00 am, the patient experienced extreme fatigue, body aches, very sore arm. The reporter assessed the events as non serious. The patient did not receive any treatment for the adverse events. The outcome of the events was recovered in 2021.  Information on the lot/batch number has been requested.
Extreme shaking from chills, temperature of 104, entire body broke out in hives, and headache
Arm swelling/ swelling in my arm; Arm pain; The vaccine knocked me on my butt every single time; High fever/ fever; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (Arm swelling/ swelling in my arm), PAIN IN EXTREMITY (Arm pain), VACCINATION COMPLICATION (The vaccine knocked me on my butt every single time) and PYREXIA (High fever/ fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066K21A, 026021A, 014M20A and 007M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling/ swelling in my arm), PAIN IN EXTREMITY (Arm pain), VACCINATION COMPLICATION (The vaccine knocked me on my butt every single time) and PYREXIA (High fever/ fever). At the time of the report, PERIPHERAL SWELLING (Arm swelling/ swelling in my arm), PAIN IN EXTREMITY (Arm pain), VACCINATION COMPLICATION (The vaccine knocked me on my butt every single time) and PYREXIA (High fever/ fever) outcome was unknown.            Concomitant medications included unspecified high blood pressure medication. Patient does not remember arm of administration for dose 1 and 2. No treatment medications were reported.   o
Beginning 27 hours after vaccination, Chills and fever of 101* even while taking acetaminophen . Headache and sore neck. Golf ball sized welt at vaccination site
Patient presented localized redness on her right bicep area. She described soreness and itching in the area but also stated that the itching had resolved.
15 mm hard ball shaped bump at TDAP injection site with erythema, warmth, pain. Client notes s/s started 72 hrs after TDAP received and the bump has gotten smaller, but still present.
unable to get the second shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2021, received first dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: unable to get the second shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 30-OCT-2023 The case was received from the patient via interactive digital media. The patient received a Shingrix shot during the COVID pandemic (in 2021) but was unable to get the second shot. The reporter asked if he should start over now and get two shots (as though he never received any shots), or do he get his second and final shot now. The follow-up could not be possible as no contact details were available. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Vaccine given Monday01/10/2005, mo called 01/12/05. 5 areas poss. chicken pox abd and by L arm pit area.
At the injection site, the skin became red and spread out across upper arm. It was warm and tender to the touch. There is still a pink circle approximately 2 inches across at the injection site. No longer tender to touch or warm. Two days later, on the inside of the arm down by the elbow, another reaction appeared. It was red and circular in shape. This was also visibly raised as if swollen and hurt when touched. Once the swelling and pinkness subsided, a visible bruise appeared. Was concerned when the second reaction appeared. Went to a clinic. Doctor determined it was a reaction to the shot. Prescribed prednisone and antibiotic.
Patient is 29 weeks pregnant and received COVID-19 vaccine (booster dose); This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Patient is 29 weeks pregnant and received COVID-19 vaccine (booster dose)) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is 29 weeks pregnant and received COVID-19 vaccine (booster dose)). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Patient is 29 weeks pregnant and received COVID-19 vaccine (booster dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Right upper arm with localized swelling and redness and warmth to the area. Oral temperature was 98.7F. Also, had an achy arm.
Information has been received from a physician concerning a 60 year old female who on 28-SEP-2010 was vaccinated with PNEUMOVAX 23 (Lot # not reported, route and injection site not reported). After administration of the vaccine, the patient experienced redness, pain and swelling at the injection site. The patient also experienced swelling of the arm. Outcome of the events were not reported. Follow-up information has been received from a medical assistant concerning the patient who had injection site reactions after vaccination with the same lot number (Lot # 667274/0883Z) of PNEUMOVAX 23. The patient had "severe" reactions consisting of red, hot, painful and swollen arms with the reaction extending from the injection site to elbow. Outcome of the events were not reported. This is one of several reports received from a same source. Additional information has been requested.
Signs/Symptoms: Patient experienced sweatiness, dizziness, fatigue 5 minutes post-vaccination Treatment: Laid patient down on gurney, elevated legs, cold compress to neck, provided sips of water. Monitored HR, BP, and O2 levels- all WNL. Outcome: Patient relieved of symptoms after interventions. Advised to tell vaccinator of AE for 2nd dose.
Patient was given 0.25mL of the dark blue and purple Moderna COVID booster instead of 0.5mL
fever 103-104 w/in 12hr;erythema, swelling site rt thigh, marginated 6x10cm w/in 24hr;fever resolved
Heart palpitations of flutters; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) on 04Apr2021 at 17:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021, after the vaccination, the patient experienced heart palpitations of flutters. They were still occurring as of 09Apr2021 (Friday). The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event heart palpitations of flutters was not resolved at the time of this report.   No follow-up attempts are needed, information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a 67 year old female with hypertension and hypothyroidism who on 29-SEP-2006 was vaccinated with a first dose of Pnemovax 23 (Lot# not reported). Concomitant therapy included LEXAPRO. The nurse reported that on 29-SEP-2006, after receiving the vaccination, the patient developed  severe pain in the arm persisting for 2 days. The patient also reporting having "cold sweats" with her chills. The patient was reported to be recovering but her arm was still tender today. The patient sought unspecified medical attention. There was no product quality complaint involved. Additional information has been requested.
pt brought to clinic, pale, lethargic, but arousable noted to be tachycardic, but afebrile; good BP adm to hosp for observation; w/in 24 hrs pt more active feeding well; diagnostic work-up completed to r/o any other illness all neg;
Abdominal pain for a few hours. Diarreah and stomach pain. Lasted a couple of hours.
And now her and her husband have COVID; And now her and her husband have COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (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) all with onset 08Jan2022, outcome "unknown" and all described as "And now her and her husband have COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: her and her husband have COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. The doctor prescribed paxlovid and patient did not get it till around 13th or 14th and took it for 5 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
szs x 1min-1 day post vax & 2 1/2 wks p/vax; CAT seen 19NOV neg; fam hx pos for szs (father) EEG suggest epileptic disturb-tx Phenarbarb
Chills, body aches, headache, nausea. Started about 12 hours after receiving the vaccine, have not subsided as of 10am the next day.
swelling at site, arm pain whole arm, fever, swollen lymph nodes in neck, fatigue, vomiting, muscles pains whole body
No side effects reported other than fever, but vaccine was given past the 30-day thaw period in the refrigerator. (thawed 1/30, given on 3/24). Moderna was reached out to - they did stability testing on the lot number and found the vaccine maintained the activity required to protect against COVID-19.
Pain at injection site, swelling at injection site, lethargic, nausea, dry heaving, body aches, sore throat
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 54-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment details were provided. Time from first puncture was 3 days. The Moderna vaccine was used as though it had preservative, just like flu multi-dose vials.   This case was linked to MOD-2021-333941 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains no significant information
Moderna COVID-19 Vaccine EUA - 2nd shot - Pain in L Arm at injection siterna COVID-19 Vaccine EUA - General weakness, flu-like symptoms
Menveo given in error in place of Hiberix. Not off label for age, to call mother in two weeks to give the Hiberix needed.
Injection site hurt so much I couldn't lift my arm over my head, chest burned, muscles ached, sore throat and headache, elevated temperature of 99° when checked, chilling followed by sweating all night long in my sleep. Symptoms began appearing around noon the day after my vaccine and dissipated overnight while I slept.
Initial report received from a healthcare professional on 20 March 2013. A 37-year-old pregnant female patient had received first intramuscular dose of ADACEL vaccine (Lot number U4586AA, anatomical site of vaccination was not reported) on 20 March 2013. The last menstrual period date was 21 June 2012 and the expected date of delivery was 28 March 2013. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as "not applicable". As per reporter, the patient did not experience any adverse event. List of documents held by the sender: None.