chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports tingling in knees and restlessness that started on day of vaccination and has continued since. Patient has been asked to continue following up/reporting with status of the adverse event to healthcare provider.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On 24-SEP-2015 the patient inadvertently received an expired dose of PNEUMOVAX23 (lot # K004281 with expiration date of 22-MAR-2015, 0.5 ml, once, intramuscular) (expired product administered). No adverse effects were reported. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE PERIPHERAL NEUROPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
I had sore throat and conjunctivitis in right eye. And day after (11/21) developed a cough with severe congestion in nose and throat. Contacted doctor thru telehealth (11/24) and was given prescription for albuterol inhaler, prednisone, and benzonatate. Was also suggested to take Mucinex.
Nausea; Headache; Fatigue; Sore arm; This is a spontaneous report from a contactable nurse. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733) via an unspecified route of administration in the left arm on 25Mar2021 at 09:00 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and flu vaccine allergy. Concomitant medication included levothyroxine sodium (EUTHYROX) taken from an unknown date for an unknown indication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 13:00, the patient experienced nausea, headache, fatigue and sore arm(pain in arm). The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other health care professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events nausea, headache, fatigue and sore arm was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Overall Muscle Soreness and Weakness Chills Sore Arm - Location of Shot Runny Nose Light Headed
No adverse effects reported. No additional AE.; HCP calling to report patient received supported TE VARIVAX vaccine.; This spontaneous report was received from a nurse and referred to a 12-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-NOV-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, single dose, (lot number X017489 has been verified to be a valid lot number, expiration date reported and validated as 25-JUN-2025 [expiration date also reported as 14-JAN-2025, discrepant information) administered for prophylaxis (strength, vaccination scheme, anatomical location and route of administration were not provided) after a temperature excursion of 29.8 Fahrenheit (F) degrees during a time frame of 2 hours and 18 minutes (product storage error). No adverse effects were reported.
Allergies in my whole body; Hives; Rashes; This is a spontaneous report from a contactable consumer. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 08Mar2021 at 11:00 (at the age of 33-year-old), as a single dose for COVID-19 immunisation. The patients medical history was not reported. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN) for unknown indication from unknown date. 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. On 10Mar2021 at 00:15, the patient experienced allergies in her whole body, hives and rashes. The patient received different types of treatment for these events but nothing was working. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events allergy, rash and hives were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Information has been received from a consumer for VARIVAX (Merck), a Pregnancy Registry product, concerning her 17 year old son's girlfriend with no known allergies who on 14-MAY-2010 was vaccinated with a first dose of VARIVAX (Merck) (lot number not provided). There was no concomitant medication. On 19-MAY-2010 the patient developed a fever of 104 degrees Fahrenheit and she was taken to the emergency room. On 19-MAY-2010, she received TYLENOL for the fever and she had a positive pregnancy test which showed she was currently four weeks pregnant. Last menstrual period was approximately on 10-SEP-1992. On 12-JUL-2010, the girl's mother took her to the clinic for her second dose of VARIVAX (Merck). On 12-JUL-2010, the person administering the injection did not ask if she was pregnant and the patient received the second dose of VARIVAX (Merck) (lot number not provided). No other relevant laboratory testing was performed. The consumer reported that on 12-JUL-2010 the patient would not be receiving any more doses of VARIVAX (Merck). Estimated delivery date is approximately on 26-JAN-2011. At the time of the report the patient was currently "feeling fine". It was unspecified if the patient sought medical attention. Additional information has been requested.
Pt developed chills, nausea, body aches, itchy arm hours after receiving vaccine. The next day the arm was swollen, red and itchy and warm to touch..
Sore left arm at injection site; Intense chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 25Apr2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 03Apr2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 05:00, the patient experienced sore left arm at injection site, intense chills, headache and fatigue. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore left arm at injection site, intense chills, headache and fatigue was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Nausea causing patient to be bed ridden. Rash down arm. fever. Headache.
under her chin, a lump about the size of a golf ball; face really swollen; Huge painful; This is a spontaneous report from a contactable consumer (patient's husband) and contactable nurse (patient herself). A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jul2021 (Batch/Lot number was not reported) at the age of 66 years old as dose 1, single for COVID-19 immunization. Medical history included Blood pressure high, Heart disease, Diabetes, Thyroid diseases, Crohn's disease and swollen lymph nodes, all from unknown dates and unknown if ongoing.  Concomitant medications included taking medicine for high blood pressure, heart, thyroid and diabetes and has Crohn's diseases. No prior vaccination (within 4 weeks). As reported, patient received vaccine 5 days ago (Jul2021) and on 07Jul2021 ("this morning"), she got up with her face really swollen and right under her chin, a lump about the size of a golf ball. Further stated that she's had swollen lymph nodes before but nothing like this. It's huge. None of her other lymph nodes seems to be tendered and nowhere under her arm so it's just a lump under a chin. Further stated that, patient woke up and there was a huge painful (incomplete sentence) on Jul2021. Outcome of events were unknown.  Information on the lot/batch number has been requested.
Patient had swelling, redness, and a knot on the back of left arm where ZOSTAVAX was given. Went to doctor the next day was given antibiotics for cellulitis. Doctor suspected patient may have latex allergy.
Initial information received on 05-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 27-years-old male patient who was vaccinated with 0.5 ml first dose of MENACTRA, lot U6179AA (Expiry date 29-Mar-2020 ) via subcutaneous route in the left arm on 05-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Hepatitis A Vaccine intramuscularly in right arm. It was an actual medication error due to inappropriate route of vaccination (MENACTRA was given subcutaneously). It was unknown whether patient experienced any adverse event following vaccination. 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. List of documents held by sender: none.
severe stiffness & aching plus cold sx; could barely move arms & shoulders due to severe pain lasted over a wk;
This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not reported. On unspecified dates between 03-NOV-2017 and 02-JAN-2018, the patients were vaccinated with VARIVAX lot # N019127, expiration date 22-JUN-2019 and with PROQUAD (albumin status: rHA) Lot# N014950, expiration date 11-NOV-2018, (route, dose and frequency were unknown) both for prophylaxis, which had a temperature excursion of 6F to 14F for 13 hours on an unspecified date. It was reported that the vaccines did not have previous temperature excursion and it was detected by a data logger. Concomitant therapies included sterile diluent (manufacturer unknown).
This case was reported by a physician and described a 31 yr old male pt who did not respond to the hep B vaccine recombinant (Engerix B) immunization series. The pt received  doses of Engerix B on 15May1998, 15Jun1998, and 14Dec1998. The physician stated that he did not know if he took a titer after the first series, but a hep B surface antibody titre in May 2003 was negative. The pt then received booster doses of Engerix B on 29May03, 07Jul03 and 09Oct03. Repeat hep B surface antibody titers performed in Nov 2003 and Dec 2003 were both negative.
Patient developed a soreness and then itching developed.  She then noticed a knot to the left of the injection site.  She has now developed approximately 2 inch long area of redness across her deltoid.
Pt here with c/o possible vaccine reaction, redness, swelling & heat to area. Patient is a 5 y.o. female. She presents to the office today with complaints of redness, swelling on Lt arm 6cm induration the next day, larger and also on Rt arm 3cm induration the second day that have been ongoing since her vaccinations in office.
First Shot 1 month later hands were stiffening during needle point, crocheting and knitting.  4th Shot, my elbows and hands were aching 1 week after shot.  5th shot 4Jun04 6 weeks later had lump on baby finger. Ached all over body and I still do I am seeing a Rheumatologist now.  06 Got a lump on knee and they don't know what's causing this.  Also in 99 I had a lump in my breast removed.  00, had another lump in breast removed and 04 had a lump on side of chest removed.  All were noncancerous, but I never had any of this before.  I ached constantly and am taking medicines for inflammation.
I had a Lacunar infarction------a stroke!  I have low BP, low cholesterol, no diabetes, and no family history of stroke
pt began running high fever & crying inconsolably @ around MN on 31DEC97;this persisted all noc despite APAP & usual comfort measures MD adm to hosp 31DEC97 fever reached >105 w/OM & discharged home on 1JAN98;
Vaccine administered 8/31/11. The following 2 days with extreme fatigue and then developed redness, warmth and swelling at site.
This spontaneous report as received from a Doctor of pharmacy refers to an adolescent male patient of unknown age. The patient was vaccinated with an expired 0.5 ml dose of RECOMBIVAX HB (Lot # not reported, expiration date 09-OCT-2012) SQ on 10-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information is not expected.
Patient did not take doses as scheduled. Was supposed to take 1 capsule by mouth every other day. Patient took 1 capsule by mouth daily.
Approximately, on day 6-7, left antecubital swelling and tenderness. Over next few days, gradual worsening pain and edema of the area and inner aspect of left upper extremity. Pain felt into the left axilla, Focal redness over ventral aspect of elbow. First, I did not relate it to vaccine and was not sure of etiology. Day 13: linear red indurated/ palpable ropy area , markedly tender in proximal forearm. Worse swelling and pain. Day 14: red Line extends upward towards axilla Day 15: Saw primary care physician Recommended antibiotics and Aspirin, warm compresses and ordered ultrasound. Findings were consistent with lymphadenitis and lymhpangitis
weakness, fatigue, afib with RVR treated with amiodarone gtt, pt converted and PO amiodarone was started. lasix was also given for overload, transitioned to PO.
On the next day exp fatigue last mostly that day. I woke up on Thursday no issues at all. The following Sat on 12/19 exp coughing and that was it. I stay home one day to rest but dint miss work.
Fever; cough; Positive COVID-19 Test; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever), COUGH (cough) and COVID-19 (Positive COVID-19 Test) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concomitant products included IRBESARTAN and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced COVID-19 (Positive COVID-19 Test). On an unknown date, the patient experienced PYREXIA (Fever) and COUGH (cough). At the time of the report, PYREXIA (Fever), COUGH (cough) and COVID-19 (Positive COVID-19 Test) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Nausea; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (051529).  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 13Sep2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Diarrhea".  Additional information: Verbatim and Event Description: Patient held Xeljanz doses for 2 months to get her COVID-19 vaccines and her flu shot. Just started taking the medication again on 12Jun2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; 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 61-year-old male patient received BNT162b2 (BNT162B2), on 04Dec2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Negative; (06Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received other medication in 2 weeks. Patient received Paxlovid (anti viral) from 24May2022 to 29May2022 for COVID-19 treatment. Paxlovid rebound - after testing negative on 29May2022, symptomatic on 04Jun2022 and tested positive again on 06Jun2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I received a pneumonia shot on Wednesday morning from pharmacy. On Wednesday evening, I started developing coldness and shakiness, starting to vomit, tired, weak, headache, sore, muscle pain underneath my right arm, where I received the shot.
photo sensitivity to left eye odd numbnes/pain in cheek bone below left eye.  Now blind in left eye with drooping eyelid.
Vaccine's Max/low Temperature: 34.3 F and 49.1 F TOTAL Time of excursion: 24 hours and 19 minutes with no reported adverse event; 1 vaccine was administered after 5th excursion with no reported adverse event; Initial information received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 64 years old male patient where reporter reported diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] max/low temperature: 34.3 f and 49.1 f total time of excursion: 24 hours and 19 minutes with no reported adverse event and 1vaccine was administered after 5th excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Sep-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult (lot- C5965AA and expiration date- 02-Mar-2024) via intramuscular route in the right deltoid (left arm) (dose, formulation, strength: not provided) for Immunisation (product storage error) (latency- same day).  On an unknown date in 2023, 1 vaccine was administered after 5th excursion with no reported adverse event (poor quality product administered) (unknown latency) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  there were 5 temperature excursions: On 11Sep2023 for 8 hours and 38 minutes and temperature was 49.1 F (9.5 C). On 12Sep2023 for 7 hours and 43 minutes and temperature was 48.4 F. On 20Sep2023 for 1 hour and temperature was 48.9 F. On 21Sep2023 for 1 hour and 59 minutes and temperature was 34.9 F. On 22Sep2023 for 4 hours and 15 minutes and temperature was 34.3 F (1.3 C). Unopen Products: TENIVAC Reason: unknown to the reporter, doctor is not sure about what happened, doctor thinks it might be power outage or the refrigerator had malfunction Max/low Temperature: 34.3 F and 49.1 F TOTAL Time of excursion: 24 hours and 19 minutes Human error? Unknown   Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
About a week after receiving my first dose, I started to feel winded. I was also experiencing pain in my upper back. I went to Hospital ER. When I got there, they thought I may have had COVID-19. I had a slight fever at night, but that was the only time. I had blood work and a CAT scan that revealed I had a blood clot in my right lung. I was put on blood thinners and referred to a Hematologist. I was taken off blood thinners a couple of weeks ago. I told my doctor that I am still a bit winded at times, so he put me back on the blood thinners for another three months.
After receiving my 5th dose on 04/19/2023 in the  late morning I  was having problem with balance issues and it continued through out. Within the end of the week I went to see my doctor. My doctor did prescribed me medications but  it didn't help. I went back again and this time he ordered an MRI. The MRI came out normal. He scheduled physical therapy for the balance issue but I haven't started  that yet. Am not sure if its vaccine related  but it happened right after the vaccine.
Extreme shortness of breath that lasted overnight and resulted in trip to ER, diarrhea the night of injection
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On 26-FEB-2015, the patient received a dose of GARDASIL (0.5 ml, intramuscularly; lot#, exp. date and anatomical location were not reported) that was improperly stored. It was not specified which dose in GARDASIL series this was . No adverse experience was reported. Additional information has been requested.
genl weakness local erythema soreness/swelling & lightheadedness reported in a pt receiving 1 dose of vax  9NOV93; pt c/o burning pain immed following vax; pt exp erythema the size of baseball & swelling size of a quarter @ inject site;