chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 4 (booster), single (Batch/Lot number: unknown) and on 28Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "prediabetic" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "lung scarring from pneumonia" (unspecified if ongoing); "pleurisy", start date: 2019 (unspecified if ongoing); "pneumonia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 from 09Feb2023 to 14Feb2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First shot was in my right arm on 12/30/2020, I only experienced minor pain in my right arm the next day around the injection site.   Second shot was in my right arm on 01/20/2021, the next day I experienced a minor fever, minor body aches, a headache, and tiredness. These symptoms lasted approximately 12 hours. These symptoms matched what co-workers and friends had also experienced.
I had adverse affects after my booster on December 2nd 2021. I am 24, and I workout around 5-6 times a week. I went to work out the morning after the booster and all of a sudden well into my workout I couldn't breathe, my heart was pounding, and my chest hurt. This proceeded to happen on Saturday, and Sunday. Sunday's episode was so bad I almost passed out, I found myself not being able to run over 15 minutes which was uncharacteristic for me in usual course, and my chest pain had became more apparent. I consulted with a doctor on demand after i couldn't sleep, and I went to the ER Sunday evening. They checked my blood, blood pressure, chest xray, etc..it all came back normal. However, I indicated that things had only changed after the booster, but this was disregarded by the hospital staff. Luckily, after about a week my pain subsided to a more normal level and I have returned to mostly normal exercise. However, I am worried this may come back, and or I have  damage. After researching side effects of the booster, it seems as though myrocarditis seemed to be the reasoning.
mom called 1145AM pt eyes puffy told to go to ER;tx @ ER w/DPH & steroids;mom called back 4PM hives around mouth, eyes getting puffy;told by MD to give DPH;
Information has been received from a medical coordinator concerning an 18 year old female  who on 25-MAR-2009 was vaccinated with the first dose of GARDASIL (lot no. 661952/1129X) (route not reported).  On 25-MAR-2009, five minutes after the shot, the patient passed out and hit her head.  The medical coordinator heard the bang and treated the patient immediately.  The patient administered smelling salts, the doctor examined the patient, but the patient complained of a headache so the patient was taken to the hospital via ambulance.  The patient was kept in the hospital for a few hours for observation but discharged her the same day.  The patient was not admitted.  The medical coordinator reported the patient's status was 'recovered' but this is only an assumption because they had not heard back from the patient's family.  Additional information has been requested.
Patient stopped by pharmacy to show red (flat, not raised) circle around injection site that had not disappeared nearly a month after vaccine.
red circle was drawn around the area of swelling; pain; redness; This case was reported by a other health professional via call center representative and described the occurrence of swelling in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th February 2020, the patient received the 1st dose of Shingrix. On 20th February 2020, 3 days after receiving Shingrix, the patient experienced swelling, pain and erythema. On an unknown date, the outcome of the swelling was recovering/resolving and the outcome of the pain was not recovered/not resolved and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the swelling, pain and erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix red circle was drawn around the area of swelling.  The patient saw the physician again and the swelling had reduced and the redness resolved but the pain was still present. The reporter consented to follow up.
no additional adverse events reported; administration of expired MMR II; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 10-DEC-2021, the patient was administered expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (expired product administered) lot # S035356, expiration date 05-NOV-2021 (formulation, dose number, dose, site and route of administration not reported) for prophylaxis. No additional adverse events were reported.
Tested positive for COVID-19 after being fully vaccinated; Tested positive for COVID-19 after being fully vaccinated; This is a spontaneous report from a Pfizer-sponsored program from a contactable nurse. A male patient of an unspecified age received 1st and 2nd doses of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), both on unspecified route of administration, on unspecified date, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID-19 after being fully vaccinated on unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date.  The information on the lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (COVID-19) with BNT162b2 can not be fully excluded.
Neutropenia 2/2/02 chance discovery. Slight rash per phone report on 2/1/02. Temperature of 103F on 1/31/01 per phone report.
dose given after vials stored in dry ice box ran out of batteries.temperature therefore unable to be monitored, thus deemed compromised by CDC
Patient experienced a hive under her right eye and said her throat felt a little tight but had no difficulty with breathing. two doses of 25mg liquid diphenhydramine was administered at 11:40 am and 11:50 am
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 18-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml VIs 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 1188 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Mar2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) 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 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 11/19/15, 49 yo F presented to clinic for scheduled appointment. During visit, pt was ordered to receive Flu vaccine (QUADRIVALENT) and Pneumococcal polysaccharide vaccine 23-valent (PNEUMOVAX-23). Per immunization records, both injections were administered into pt's left deltoid. The influenza vaccine was Lot #UI505AA, exp: 6/30/2016). The pneumococcal vaccine was Lot #L019835, exp: 3/23/2017). On 11/20, pt called clinic and reported that she had developed a fever and the injection site was erythemic and painful. Pt was advised to hydrate and "control her fever with alternating Tylenol 500 mg and Ibuprofen 400 mg (every 6 hours)". On 11/22, pt called and reported increased pain and erythema. Pt then went to ED for evaluation. Pt was diagnosed with cellulitis and prescribed treatment with cephalexin. On 11/23, pt returned to clinic for evaluation, as the area of erythema had expanded beyond the originally demarcated borders. On exam, pt was afebrile with erythema and warmth of left upper arm. Pt was advised to continue cephalexin, monitor site and notify MD if there is no improvement over next 24-48 hours. Pt was then discharged in stable condition. NOTE: Pt has a history of mixed connective tissue disease for which she takes methotrexate 20 mg PO once weekly. This therapy was held during time of event.
Patient c/o itchy throat, mild chest discomfort. Skin of upper chest was slightly reddened. Pt is asthmatic and stated she did not take her inhalers this  morning. Vital signs at 03:05 - Bp 160/90, p 78 , O2 % 98%. At 3:11 Benadryl 25 mg po was administered. Some relief noted, but a 3: 40 pt stated the symptoms were returning  with lip numbness, and another Benadryl 25 administered. At 3:55 throat feels better lip numbness has subsided. A 4:oo pm family member arrived with asthma inhalers and pt took them. At 4:15 patient was released to care of family. Last vitals at 4:10 : BP 154/80, p 74, )2 99%.
Vaccine dose number: 6; Vaccine dose number: 6; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Jun2023 at 14:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CRESTOR and Novadoz, stop date: 17Jun2023. Vaccination history included: Covid-19 vaccine (Dose 5), for COVID-19 immunization; Covid-19 vaccine (Dose 4), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 1), for COVID-19 immunization. The following information was reported: COVID-19 (non-serious) with onset Jun2023, outcome "unknown", described as "COVID 19 Treatment"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset Jun2023, outcome "unknown" and all described as "Vaccine dose number: 6". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Anaphylatic reaction. Epipen, Benadryl and steroids. Pt was admitted to the hospital.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lymphoma" (unspecified if ongoing), notes: Past: Lymphoma.; "anxiety" (ongoing), notes: Current: Anxiety; "Asthma" (ongoing), notes: Current: Asthma. Concomitant medication(s) included: PROZAC, start date: Dec2017; ALBUTEROL SULFATE HFA, start date: Sep2019. Past drug history included: Amoxicillin, reaction(s): "Allergy", notes: known allergies:Amoxicillin, Regalin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Re-tested positive after testing negative; (2022) Negative, notes: Re-tested positive after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe chills, body aches, low grade fever, slight shortness of breath, mild burning sensation on skin. Lasted for around 3 hours.
This spontaneous report as received from a physician refers to multiple unspecified patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates the multiple patients were vaccinated with improperly stored VARIVAX (Merck) (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse effects reported. Additional information has been requested.
Information has been received from a registered nurse concerning a 22 years old female with unknown medical history and unknown drug allergies who on 16-JUN-2009 was vaccinated with the first dose of GARDASIL at 4:00pm.  Concomitant therapy included MUCINEX.  "Starting at 10:30pm the patient started having episodes of weakness, burning, tingling pain and a metallic taste from her tongue to her toes."  "She had these episodes 15-20 times before going to the hospital."  At 12:23am on 17-JUN-2009 the patient went to the ER Room but was not admitted.  She underwent unspecified blood work (results not reported).  She was released at 3:45am that same day.  When the patient got vaccinated her blood pressure was 125/72.  At the hospital it was 156/94.  The patient had recovered on 17-JUN-2009.  Additional information has been requested.
patient received expired Daptacel/no AE; Initial information received on 04-Feb-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a patient ( unknown demographics) who received expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]/no AE(expired product administered) for prophylactic vaccination [batch number, dosing details, route and site of administration not reported].  Medical history, concomitant therapy, medical treatment, vaccination and family history were not provided.  It was of actual medication error case due to expired vaccine used.  At the time of reporting, adverse event was not reported.  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 and Module VI of the 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.  Information on the batch number was requested.
Patient came to the pharmacy on Monday 10/15/18 at 9:30 AM. Both arms were red and warm where she received her Flu and PREVNAR injections. Both injection sites were too low on the arms and not in the Deltoid muscle area. I informed patient that both injections were given too low and suggest she see her doctor.
Initial and follow up information received on 05-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse with live follow-up on same date. This case involves an eight years old female patient who received a 0.5 ml dose of MENACTRA, (lot number, expiry date, dose in series, route and site of administration was not reported) on 27-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. Patient received no other vaccines concomitantly. It was a case of actual medication error due to inappropriate age at vaccine administration. 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. List of documents held by sender: none.
mom reported swelling & redness @ rt thigh 2-3 hrs p/inject of vax; mom also reported smaller amt of redness & swelling in lt thigh; mom stated had a fever but did not know what pt's temp was; seen in ER & was instructed to use Pediaprofen;
Initial misuse report received from a healthcare professional (nurse) on 20 January 2014 and the case was received on 21 March 2014. A female patient (date of birth was not reported) had received a dose of FLUZONE HD vaccine (batch number, route and site of administration was not reported) on an unspecified date. The patient had received a dose of FLUZONE HD vaccine on an unspecified date in October 2013. No adverse event was reported. List of documents held by sender: none.
Pt recvd vax & devel rash between fingers, blistery onto palm of hands & behind knees;
Site: Pain at Injection Site-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Joint Pain-Medium, Additional Details: started 10 days after getting shot, has very significant body and joint pain
A nurse reported that several pts exp a sore arm & generalized achiness following vax; No further details were provided;
The muscle in my left arm has been stiff and sore since I received the vaccine.  I am an active person and this stiffness has been a bother to me.
Patient experienced swelling/ SOB, urticaria after Varivax vaccine. Patient was giving Benadryl 25mg PO and Nebulizer treatment with Albuterol for wheezing. Vitals stable.
SMALL BUMP / HARD, LUMP AT INJECTION SITE UPON REMOVAL OF NEEDLE.  REDNESS AROUND BUMP THAT EXTENDED OUT ABOUT 1 INCH, PT FELT BURNING AT SITE AND UP TO SHOULDER.
This spontaneous report as received from a register nurse refers to a 4 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 07-MAR-2014, the patient was vaccinated with first dose of ROTATEQ oral, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Patient stated she went to the ER about 4-5 days after she got the vaccine.  She said her arm was red, swollen, hot to the touch.  She said the ER said she had a staph infection and they placed her on antibiotics.  She went to other pharmacy today (8/26/15) and got her second Varivax dose in the other arm.
Left shoulder pain which radiates to left arm elbow and hand with decrease range of motion of left shoulder.
Vaccine given on 9/27/11. Swelling (L) arm ensued - 9/29/11 measured 1x8cm.
Redness at injection site.  Given Bactrim DS 1 tablet twice daily for 10 days.
This spontaneous report as received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not provided. In November 2015, the patient was vaccinated with the first dose of GARDASIL 9 for prophylaxis (route of administration, lot# and expiration date were not reported). In November 2017, the patient was vaccinated with the second dose of GARDASIL 9 for prophylaxis (route of administration, lot# and expiration date were not reported). No adverse effects were reported. Follow-up information was received from the reporter on 01-FEB-2018. She confirmed the requested information. She also stated that this information guided the office to revise their policy/procedure addressing inappropriate schedule dose. She was thankful for the "preferred "administration recommendations. She provided the following additional information regarding the case at the time of call: She declined to give patient specific information, such as name or date of birth. She only stated that patient was a female. Firstly, she corrected that the first dose administered on 23-NOV-2015 was GARDASIL (Lot number K016966, expiration date: 10-MAY-2017). This was incorrectly recorded originally as GARDASIL 9. The dose was given by another specified provider. On 15-NOV-2017, patient presented to office as a new patient. She was administered GARDASIL 9 (lot number N009801, expiration date: 20-NOV-2019). Lastly, she shared that patient is scheduled to return to office for another dose in the near future. No additional information was provided at time of call.