chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid; Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 76 years, in right arm 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), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of covid-19, drug ineffective included paxlovid therapy.  Clinical course: The known allergies were reported as no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Painful and extremely swollen lymph node in the neck/collarbone area on the same side as the shot was received.  Pain was so bad that any physical contact at all was excruciating.
Blurry vision and headaches approximately two weeks after GARDASIL injection. Now diagnosed with MS.
When I took my 1st Pfizer dose on 6/2/21, I suffered an allergic reaction (lymph glands swelled & my throat closed, making it difficult to swallow). This made it very difficult to use my CPAP, which my job requires me to use for my sleep apnea.  The CDC website recommends not taking Pfizer or Moderna for the 2nd dose if you had an allergic reaction to the 1st dose. So, I delayed receiving another dose. However now, as a federal employee, I am required to become fully vaccinated. I have a family history of blood clotting (my mother suffered a massive stroke as a result), so the J&J vaccine is not a viable option due to the multitude of reports of blood clotting as a side effect. I consulted with my FAA medical examiner who I go to for my annual physical (for my job) and he recommended taking the 2nd Pfizer dose, but to also take 50mg of Benadryl before and after, which I did. I took the 2nd dose two days ago and had an even worse allergic reaction. In addition to my lymph glands swelling and throat closing, my left eyelid is swollen and drooping. I went to the doctor yesterday for a diagnosis, which is outlined in Item 19.
Itchy bump or bumps reoccurrence on right arm in upper tricep area and sore joints, occasional headaches.
allergy on the forehead, on the left side and in both eyes; allergy on the forehead, on the left side and in both eyes; This spontaneous case was reported by a physician and describes the occurrence of EYE ALLERGY (allergy on the forehead, on the left side and in both eyes) and HYPERSENSITIVITY (allergy on the forehead, on the left side and in both eyes) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LOSARTAN POTASSIUM, CLONIDINE HCL, HYDROXYZINE, CARBINOXAMINE MALEATE (OMEGA 100), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN, PENTOXIFYLLINE, CHOLECALCIFEROL, ESCITALOPRAM, CLONAZEPAM, HYDROCHLOROTHIAZIDE (HYDRODIURIL), DICYCLOVERINE HYDROCHLORIDE (BENTYL), PANTOPRAZOLE, CEFIXIME (FLEXERIL [CEFIXIME]) and COLECALCIFEROL (VITAMIN D 3) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced EYE ALLERGY (allergy on the forehead, on the left side and in both eyes) and HYPERSENSITIVITY (allergy on the forehead, on the left side and in both eyes). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, EYE ALLERGY (allergy on the forehead, on the left side and in both eyes) and HYPERSENSITIVITY (allergy on the forehead, on the left side and in both eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 at 16:00 as dose 2 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Auto immune disease" (unspecified if ongoing), notes: other medical history: Auto immune disease; "Allergy" (unspecified if ongoing), notes: known allergies: Yes. Concomitant medication(s) included: VYVANSE, start date: 01Oct2008; TRAZODONE HCL, start date: 01Oct2001; PAXIL CR, start date: 01Oct2001. Vaccination history included: j&j (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Left, Vaccine Administration Time: 14:00), administration date: 11Mar2021, when the patient was 53-year-old, for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. the patient had known allergies.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the event Drug ineffective, COVID-19 and the administration of the vaccine cannot be excluded.
13 hours post vaccination felt absolutely freezing with chills although 2 heavy blankets were on me. Cheeks were hot. Could not sleep. Fever persisted through 24 hours post vaccination.  Severe Throbbing piercing headache also began about 14 hours post vaccination. Headache is much worse upon standing. Headache still persisting 32 hours post vaccination.
Drug administered to patient of inappropriate age. A consumer report had been received. The report concerns a 61 year old, female consumer, who had been receiving FLUMIST (Intranasal). FLUMIST (Intranasal) started on 17-Oct-2013. The patient experienced very tired, headaches, muscle aches, cough, and diarrhea which started on 19-Oct-2013 and 61 year old patient was administered FLUMIST which started on 17-Oct-2013. The outcome of the event of 61 year old patient was administered FLUMIST very tired, headaches, muscle aches, cough and diarrhea is unknown. The report was considered to be non-serious.
Rash (raise bumps) to both lower arms (took over-the-counter Benadryl rash disappear: time 8am), had severe Headaches (took Tylenol: extra strength: time 8am) headache disappeared in about 1 1/2 hours.
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. On 12-JAN-2016 the patients were vaccinated with improperly-stored doses of VAQTA lot # L023936, expiration date 15-MAR-2017; lot # L015460, expiration date 20-JUL-2017, (dose, dose #, route and application site were not reported). The reported was not aware of any adverse effects. This is one of several reports received from the same source. Additional information has been requested.
Single hive that appeared at 1"x0.5" and irregular shape on upper left arm near to injection site. Despite regular dosing of 10mg Cetirizine and application of 1% Hydrocortisone cream grew over the next 3 days to a diameter of roughly 3"x2". Intense itching, swelling at the hive site and moderate heat from the hive. Resolved slowly over the next several days. 98% gone by day 7.
I got a flu shot midday Friday 9/18/21 and within an hour or two I started feeling very bad (headache, generalized aching, severe fatigue) which left me bedridden until Monday when I felt a little better and could do a few chores but I am still sick with pain control requiring Tylenol in am, Lyrica in afternoon and morphine in evening.   No respiratory symptoms, vital signs normal, lab (ordered by Dr) shows CBC chemistry panel TSH and sed rate all normal.  Vital signs all normal. I have had flu shots every year for many years with no reaction; I doubt it is   an infectious disease? I have no fever or respiratory symptoms and have been away from home very little and then always masked.  A flare of my neuropathy?  I have an autonomic neuropathy which has been very stable.    I am a retired physician.
Narrative:  1025: Patient c/o heart fluttering intermittently. Hx of afib w/ cardioversion (stated by patient). No other symptoms. BPL 111/68 HR 72. Difficult to find radial pulse, irregular pulse. Tremor, unable to use pulse ox for HR. Auscultated heart, no irregular beat heard. 1040: BP 116/58 no other complaints other than intermittent flutter. HR 68. 1055: HR 70 BP 106/71 11:00: states fluttering feeling is resolving, no other symptoms. States he feels just like he felt when he arrived at the clinic.
After being vaccinated felt headache, dizzy and nauseous. Notified medical observation staff after his initial 15 minute observation period was over. Vitals obtained, patient assessment performed, give water and observed for an additional 15 minutes. Released after this additional time period.
Shingles; She can't even use one of her arms; Muscle aches; Nerve pain; Pain; Swollen; Low platelets; Body aches; Chills; Got the second dose 2 weeks after the first dose; Could not function correctly; Headache; This is a spontaneous report from a contactable consumer. A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, in Left Arm on 03May2021 at 11:30 (at the age of 44-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown, Expiration date: unknown), via an unspecified route of administration, administered in Left Arm on 19APr2021 at 11:30 as dose 1, single dose for COVID-19 immunization and experienced Could not function correctly, Headaches, Body aches, and chills. On 03May2021, the patient got the second dose 2 weeks after the first dose and experienced Could not function correctly pain , muscle aches, Body aches, swelling, Chills, Pain was all over the body on the right side. on 13May21 patient experienced Shingles, pain, Swollen, Low platelets caller stated that now she can't even use one of her arms. She had muscle aches and her nerves are acting up. She had nerve pain. patient visited physician office for adverse event. The patient underwent lab tests and procedures which included blood test: positive on 23May2021 Positive for shingles, blood test: decreased on 23May2021 low platelets. Therapeutic measures were taken as a result of all the events where she was given an antibiotic and nerve pain medicine. These were Diclofenac 75 mg, Prednisone 20mg, Valacyclovir 1gm and Gabapentin 300mg. The outcome for the events was not recovered.  Information on the lot/batch number has been requested.  Amendment: (06Jun2021) This follow-up report is being submitted to amend previously reported information: To recode LLT from Loss of personal independence in daily activities to LLT General malaise, to delete LLT off label use.  Follow-up (21JUL2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
the patient has been waking up with a stiff neck which was worse at night; This is a spontaneous report from a medical team. A contactable consumer (patient himself) reported that a male patient of an unspecified age (Age:70; Unit: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE (first dose) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Over the past two days (unspecified dates), the patient has been waking up with a stiff neck which was worse at night. The outcome of event was unknown.  Follow-up attempts are completed. The following information on the batch number has been requested.
First shot issued 9/14/2021 Pregnancy: Estimated delivery date 24 May 2022, miscarriage diagnosed 20 Sep 2021 Second shot issued 10/05/2021 Symptoms: Headache, nausea, swollen lymph node under injected arm's armpit, low grade fever, chills, excessive sweating, gastrointestinal issues including diarrhea, increased urination, muscle soreness/aches, chest pain.
RECEIVED 2.5ML OF THE JANSSEN COVID-19 VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 30 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: 14-DEC-2021) 2.5 ml, administered on 14-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-NOV-2021, the patient experienced received 2.5ml of the janssen covid-19 vaccine. On 14-NOV-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the received 2.5ml of the janssen covid-19 vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211219731, 20211219686, 20211220537, 20211220233, 20211219807, 20211220948, 20211221158 and 20211221439.
Information has been received from a physician concerning a female who on 21-FEB-2008 was vaccinated with Gardasil (lot numbers not reported). Concomitant therapy included Varivax (duration and dose not reported). Other concomitant therapy included MENACTRA (Sanofi Pasteur) and DTAP-IPV (GSK). On 22-FEB-2008 the patient experienced fainted, developed redness at injection site and low grade fever 100.4F). The patient was reported to be recovering. No further information is available. Additional information is not expected.
Bloodshot eye; Pain in arm; Pain localised; Shoulder pain; Muscle tension; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (Bloodshot eye), PAIN IN EXTREMITY (Pain in arm), PAIN (Pain localised), ARTHRALGIA (Shoulder pain) and MUSCLE TIGHTNESS (Muscle tension) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced OCULAR HYPERAEMIA (Bloodshot eye), PAIN IN EXTREMITY (Pain in arm), PAIN (Pain localised), ARTHRALGIA (Shoulder pain) and MUSCLE TIGHTNESS (Muscle tension). At the time of the report, OCULAR HYPERAEMIA (Bloodshot eye), PAIN IN EXTREMITY (Pain in arm), PAIN (Pain localised), ARTHRALGIA (Shoulder pain) and MUSCLE TIGHTNESS (Muscle tension) 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 concomitant medication was reported.  No treatment medication use was reported.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (sore arm). On 09-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
My COVID-19 symptoms started on 11/20/2022 around 4:00PM. I had a sore throat. I thought it was  due to allergies or may be sinus. On 11/22/2022 I had a headache, cough, fever, chills, congested, sore throat. On 11/23/2022 all my symptoms got worse from the previous day. It was so bad that I took a home COVID-19 test which was positive. I also called the pharmacy tele doc help line since my symptoms got worse. They prescribed me with LAGEVRIO (molnupiravir) for 5 days and benzonatate (cough) as per needed. I was down with COVID-19 infection for 2 weeks.
Information has been received from a Pharm D healthcare student concerning a female (age not reported) who on an unspecified date was vaccinated with her first dose of Gardasil (yeast). Two weeks post vaccination, the patient developed a full body rash with tiny, erythematous papules. The patient sought unspecified medical attention. The pharmacist stated that the he has no other information, as the nurse had the chart. At the time of this report, the outcome of the event was unknown. Additional information is not expected.
Case number PHEH2014US024983, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 48-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 24 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Left arm, and left leg vein jumping, accelerated heart and twitching with chest tightening
This spontaneous prospective pregnancy report as received from a nurse refers to a 25 year old female patient. Patient had no pertinent medical history. On 10-FEB-2014 the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. Patient did not use concomitant medications. Patient was subsequently determined to be pregnant. The patient contacted the nurse on 13-FEB-2014 to report she had a positive pregnancy test. The nurse has referred to an unspecified obstetrical practice for evaluation. No further information provided. No treatment was given for the event. Outcome of pregnancy and the LMP and EDD were not known. Outcome of the event was unknown. Additional information has been requested.
Started with lesions 10/28/06-still breaking out 10/30/06.
after Easter, my tongue felt tingly for a day and I had heightened allergies.  My kids had allergy overload at the same time, and my husband felt the same.
About 2 inch area of redness, swelling and itching . Some warmth to touch and hardness
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 08-JUL-2015, the patient was vaccinated with an improperly stored PEDVAXHIB Single Dose Vaccine, 10-pack, lot number K004541, expiration date 04-DEC-2016, (dose, route and anatomical location were not reported). The improperly stored PEDVAXHIB was in a Refrigerator, and, the highest temperature of excursion was 47 Fahrenheit degrees (8.33 Celsius degrees) with a sum of 24 hours of excursion. No adverse effects were reported and no product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a female patient (elderly) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccine was administered.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC 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.  Documents held by sender: none.
Pt recv vax on 1/25/99; on 1/26/99 pt exp itchy skin, left side leg pain & stomach ache
At about midnight on the day I got the shot I started feeling feverish and ill. My body kept trembling and I felt extremely cold. Even covering myself up with 5 blankets couldn't stop the feeling of trembling with cold. My body started aching, especially my entire right arm (in which the shot was administered). My right wrist hurt and  felt like it was sprained (even thought it was not). I could not sleep because of the discomfort. I have had a terrible headache ever since then which has not gone away 35 hours later, in spite of taking 1 Acetaminophen tablet (325mg.) every 12 hours.  I also started feeling slightly nauseous about 24 hours after the vaccination was administered. The nauseous feeling comes and goes since then, but I have not vomited.  It is now 50 hours since I was vaccinated, and I still feel unwell with the headache, right arm ache, fatigue and chills.