chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered pharmacist concerning a 56 year old female patient with no drug reaction or allergies, who on 17-FEB-2011 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665904/0866Z EXP 04-JUL-2011) IM.  On 17-FEB-2011, within 2 hours post vaccination, the patient developed reddness and swelling at the site of injection.  On 18-FEB-2011, "within 24 hours", she had a 4 inch band of swelling around the circumference of the arm.  She also had difficulty in range of motion in the arm and difficulty lifting the arm.  The patient went to an immediate care center and was told to use ice and BENADRYL.  The patient recovered on 20-FEB-2011.  There were no diagnostic laboratories studies performed.  Reddness and swelling at the site of injection, difficulty in range of motion in the arm and difficulty lifting the arm were considered to be disabling by the pharmacist.  Additional information has been requested.
Patient presented to COVID-19 vaccination clinic with mother for first COVID-19 vaccine dose. Patient c/o feeling dizzy post vaccine and vomited x 1. Mother of patient stated that patient always feels anxious and blood pressure increases whenever she is in a medical setting.
pt recv 1st dose varivax 7/19/95 & 4/98 pt devel a mild case of chicken pox, no fever/itching noted.
weak, loss of Appetite called 911 transported to Hospital 4/21-patient still having issues with eating , patient was dehydrated . went to hospital , got out now
Fever, chills, vomiting, headache, I did not think that I was going to make it, hives & rash from medical
Pt recvd vax & 1 to 2 mins p/vax c/o dizziness & feeling like was going to pass out; VS 118/68, P100, skin hot, diaphoric denied difficulty breathing w/lungs clear auscultation, cyanosis noted around mouth & pt c/o throat swelling;
Lower than authorized dose volume administered. As the vaccine was being administered, less than half of the dose leaked out. Per CDC, as more than half of the dose was administered, a repeat dose was not given.
Nauseous most of 2nd day;  Took Tylenol at onset of symptoms which resolved most nausea
After the second booster, 4th vaccine the first week brought on shingles on both sides of lower back.  Second week started with perineal lump that after few months turned into anal cancer from HPV.  Seems like this vaccine wiped out immune system.
Erythematous macular rash noted to BUE and BLE occurring approx 24 hrs after administration. Treated with 10 day tapered course prednisone and antihistamines/calamine lotion PRN.
Injection site swelling, stiff neck/back/left arm, pain under armpit, feeling of coming down with a cold
administered expired typhim to a patient, no adverse event; Initial information received on 19-Nov-2019 and follow up information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown patient who was administered expired TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Nov-2019, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot number not reported expiration date: 27-Oct-2019 via unknown route in unknown administration site.  It was a case of actual medication error due to expired product administered.   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 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.  There will be no information available on the batch number for this case.
Pt had an enlarged erythematous wheal around injection site on right thigh. Pt also has a temperature of 101 F and vomiting and dizziness.
Local reaction to immunization. Swollen from left groin to ankle. No heat, no fever, no discharge.
daily recurring headache; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Lot number: ENS318, Expiration date was not reported) via unspecified route of administration 28Jan2021 10:45 right arm as single dose for covid-19 immunisation. The patient medical history included CAD, asthma, high blood pressure and high cholesterol. The patient concomitant medication included valsartan (VALSAR) at 160 mg, atorvastatin at 40 mg and metoprolol at 75 mg. Patient did not have Covid prior vaccination. Patient did not test Covid post vaccination. The patient experienced daily recurring headache on 28Jan2021. Patient did not receive any treatment for adverse event. The outcome of the event was not recovered.
Hypertension stage 4, fast heart beat, shortness of breath after a few steps. I couldn't finish testing cause of not having medical insurance & losing my job.
Insomnia; muscle aches; joint pain; cold extremities; fatigue; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07May2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. The patient previously had peanuts and experienced peanut allergy. Concomitant medication received within two weeks of vaccination 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 07May2021, the patient experienced insomnia, muscle aches, joint pain, cold extremities, fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events insomnia, muscle aches, joint pain, cold extremities, fatigue was resolved on an unknown date in May2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Severe daily persistent headaches since the vaccine .  3 wks so far .  Treatments so far : NSAIDS ( Aleave, Tylenol, excedrin , nabumetone) Fiorcet  Tizanidine hcl None have taken headache away - just helped decrease pain slightly  Patient will try Toradol injection and acupuncture this week  Dose 2 Moderna is scheduled for 4/2
Redness in the area where the vaccine was given on the right arm, swelling, and sporadic itching. After 8 days it still persists
Patient stated he had not received a COVID vaccine previously. Administered Pfizer COVID vaccine to the patient on 8/30/21. Upon logging into state immunization registry after administration, it was discovered he had actually received an initial dose of Moderna COVID vaccine on 5/20/21 at another healthcare facility. Called patient to discuss, and patient admitted that a family member told the patient his vaccine was "invalid" and to get the new series at facility. Told the patient we would be contacting the manufacturer for further guidance and to call us with concerns or adverse events experienced.
Development of raised, red, itchy rash on face, neck, arms and back. Visited primary care provider.  Treated with Benadryl and Pepcid.
On Monday, Nov. 19, 2007, between 3 & 4 PM I received a PPV shot at the health facility.  The shot was drawn from two different multi dose vials with lot no's. Unknown.  The injection was placed in the upper right arm.  A copy of Pneumococcal-7/29/97 Vaccine Information Sheet was given to me for my information.  On Tuesday my right arm increased in redness and started to swell, I also developed a fever, muscle aches and loss of appetite.  I was not overly concerned because Section 6 of the handout suggested the reactions are rare but normal.  By Wednesday, I decided it was time to have the arm checked so I went to the medical center.  I was examined by a doctor who diagnosed cellulitis.
Administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) in an 84-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator reported as unknown and the vial did not undergo any temperature excursions. The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Non significant follow up received.
great than 42 days since the first vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (great than 42 days since the first vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (great than 42 days since the first vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (great than 42 days since the first vaccine) outcome was unknown. Not Provided      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.Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Chest tightness, shakiness, OFF balance (almost fell when trying to go to bathroom), Fever <100F,.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Pertinent medical history was unknown. On an unknown date, unspecified number of patients were vaccinated with doses of VAQTA (dose, route of administration, anatomical location and lot# was unknown) which were improperly stored. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. This is one of several reports received from the same reporter. Additional information is not expected as reported is not willing to be contacted.
Covid Arm - onset on day 8 after vaccine. Large red area - approximately 6"x3 Warm, intense itching and sore to touch Lasted approximate 6 days - less reddening and itching as each day passed
COVID-19 vaccine booster clinic at nursing facility. Resident reported as needing Pfizer booster, 2nd dose received 2/16/2021 per PRIVATE database. Booster dose given 1/19/2022. Resident's family provides vaccine card after injection given that resident has received booster dose in 12/2021. No record of dose being given in PRIVATE in December. Resident potentially received 4 doses total.
This patient arrived at the vaccination clinic requesting the Janssen vaccine but mistakenly was administered Pfizer.
On 4/12/10, pt. felt nausea, achiness, diarrhea, vomited.  On 4/17/10, began having joint and muscle pain.  Main event: severe joint and muscle pain, CRP and ESR elevated.  Currently on steroids for pain relief.
about 45 mins after vaccine administration patient began to experience itching in hands.  No fever, chills, headaches, visual changes, lightheadness, or dizziness.  No nasal discharge or sore throat.  No neck or back pain.  No difficulty breathing or swallowing.  No throat swelling.  No chest pain, shortness of breath, abdominal pain, nausea, vomiting or diarrhea.  No numbness or tingling.
Have pain at the site; Slight headache; Muscle pain; Chills; Have severe itching all over my body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiry date was not reported) via intramuscular route of administration, administered in Arm Left on 17Mar2021 (at the age of 68 years old) as DOSE 2, SINGLE for covid-19 immunisation. Also, the patient has received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: GL9266, Expiry date was not reported) via intramuscular route of administration, administered on 24Feb2021 as DOSE 1, SINGLE for covid-19 immunisation which leads to pain at the site. The patient medical history included cholesterol and acid reflux from an unknown date and unknown if ongoing. The reporter stated that, I do not know what I wanted to tell you about myself as far as medical conditions. I do not have anything that should affect this, I normally every year get the flu shot for instance, I have Pneumonia shot, I have Shingles shot, so I get all my inoculations as far as others. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastroesophageal reflux disease, start and stop date were not reported, saccharomyces boulardii (FLORASTOR SACCHAROMYCES BOULARDII) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 the patient experienced have severe itching all over my body. On an unspecified date the reporter stated that, he has pain at the site from both shots (COVID Shot), the second was worse than the first, he did have the second time slight headache and muscle pain for about a day. He also has chills but that was only for an hour. The patient underwent lab tests and procedures which included blood test with results as normal on unspecified date, electrocardiogram with results as normal on unspecified date, weight 200, actually it is 199 I was rounding it up on unspecified date. The outcome for the event, have severe itching all over my body was not recovered and the outcome for the events have pain at the site, slight headache, muscle pain, chills was recovered.  No follow-up attempts are possible. No further information is expected.
Headache, Sedation, Myalgia, Arthralgia, fatigue Narrative:  Other Relevant History:
Pt was given Moderna 2nd dose 21 days from first dose. Pt states that she had heart pain and went to the ED for evaluation. Pt was also initially misunderstood that she was receiving a booster and was given 0.25mL x2.
I only had a slightly sore arm after dose; This is a spontaneous report from a two contactable consumer. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, administered in Arm Right, on 09Mar2021 (at the age of 60-year-old), as dose 1, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced slightly sore arm after first dose in Mar2021 and it was reported that it did not last long. No treatment received for the event. The patient recovered from the event in Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11 days post vac, heavy period, had heavy periods already 'covid changes my period"
Starting approximately 8pm full body aches. By midnight headache worse than any have ever had. Spent next day in bed & most of today
BP 159/77 SP02 100% RA HR 66 BG 84
started to feel sick; diarrhea; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started to feel sick), DIARRHOEA (diarrhea) and VOMITING (throwing up) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced MALAISE (started to feel sick), DIARRHOEA (diarrhea) and VOMITING (throwing up). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Adverse event, at an unspecified dose and frequency. On 10-Mar-2021, MALAISE (started to feel sick), DIARRHOEA (diarrhea) and VOMITING (throwing up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was reported to take Pepcid and Imodium for the events.  No concomitant medications were reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Red, warm skin, painful to touch at injection site.  Tx: cold compress, NSAD's
site was red, it was painful, it hurt across her shoulder and up her neck; site was red, it was painful, it hurt across her shoulder and up her neck; Headache; Diarrhea; it hurt across her shoulder and up her neck; it hurt across her shoulder and up her neck; This is a spontaneous report from a contactable Nurse(patient). A 65-year-old female patient received BNT162B2( lot number EH9899) via an unspecified route of administration at arm on 17Dec2020 at single dose for the vaccine for COVID. The patient medical history included Blood pressure high and Low thyroid. The concomitant products included losartan for Blood pressure high, levothyroxine sodium(SYNTHROID) for Low thyroid.  The patient got the BNT162B2yesterday afternoon on 17Dec2020 and her site was red and she had got a headache and stuff and she was supposed to report the adverse reactions on 18Dec2020. Her site was red, it was painful, it hurt across her shoulder and up her neck and she had got a headache and diarrhea on 18Dec2020. The patient stated she didn't have it before. The patient got it for work, she didn't have a doctor prescribed it. The patient took some Advil yesterday it helped a little bit but she haven't taken anything today. For the vaccine for COVID because the patient work in ICU. The patient was given the product in her arm. The reporter consider the events "site was red, it was painful, it hurt across her shoulder and up her neck , headache and diarrhea" were related to BNT162B2. The outcome of the events was not recovered.
Very sore arm for 2 days, then  gradual improvement over days 3 and 4
Employee's arm is sore 3 days after vaccine. Arm is red with a bruise that is black/bluish, with evolving cellulitis. Provider prescribed Keflex 500 mg PO Q8hr x 10 days. Had a temperature of 103 on 1/4 but resolved on 1/8.
Interchange of vaccine products; anxious; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and ANXIETY (anxious) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and ANXIETY (anxious). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved and ANXIETY (anxious) 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.   No treatment medication was reported. No concomitant medication was reported.  The patient received the first dose of the moderna covid-19 vaccine on 09APR2021, and he did not come back to get the second dose of the vaccine because he was anxious and he was not sure that he would receive the second dose. He came in yesterday and verbalized to the staff that he received the first dose as Pfizer and he did not have his vaccination card on him, so the Pfizer covid-19 vaccine was administered to him as the second dose. Patient did receive the moderna covid-19 vaccine as the first dose.
Nausea, headache, muscle spasms all over, and pain from fingers, shoulders down to heels.
Patient has redness at injection site approximately 3 inches in diameter. It is raised and warm to the touch. He was advised to take Tylenol or Ibuprofen for pain and use a cold compress as needed
Redness and swelling at injection site on day 8, with worsening spread of redness and induration on day 9
LINGERING PAIN INSIDE MY SHOULDER AREA, RADIATING OUTWARD; FEVERISH; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lingering pain inside my shoulder area, radiating outward, and feverish. Treatment medications (dates unspecified) included: origanum minutiflorum oil. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lingering pain inside my shoulder area, radiating outward, and the outcome of feverish was not reported. This report was non-serious.