chrisvoncsefalvay/vaers-outcomes huggingface dataset:
terrible joint pain; muscle aches; headaches; naseaua; terrible fatigus; reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 2, single (Lot number: ER8732) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Prev dose lot number=EN6201, Prev dose vaccine location=Left arm), administration date: 10Mar2021, when the patient was 70-year-old, for COVID-19 IMMUNIZATION, reaction(s): "terrible joint pain", "muscle aches", "headaches", "naseaua", "terrible fatigus". The following information was reported: HEADACHE (non-serious) with onset 31Mar2021 at 14:30, outcome "recovered" (2021), described as "headaches"; MYALGIA (non-serious) with onset 31Mar2021 at 14:30, outcome "recovered" (2021), described as "muscle aches"; NAUSEA (non-serious) with onset 31Mar2021 at 14:30, outcome "recovered" (2021), described as "naseaua"; FATIGUE (non-serious) with onset 31Mar2021 at 14:30, outcome "recovered" (2021), described as "terrible fatigus"; ARTHRALGIA (non-serious) with onset 31Mar2021 at 14:30, outcome "recovered" (2021), described as "terrible joint pain". The events "terrible joint pain", "muscle aches", "headaches", "naseaua" and "terrible fatigus" required physician office visit. Therapeutic measures were not taken as a result of arthralgia, myalgia, headache, nausea, fatigue.  Additional information: Patient had the same types of reaction for the 2nd dose, but the issues lasted about 6 weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258400 same patient/event, diffrent drug dose;
Normal labor and delivery on 12/2/2021. Hospital admission within 6 weeks of receiving the COVID vaccine.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 07-DEC-2015 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) (lot # L010596, expiration date 06-APR-2017; dose and route were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion five times. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for each time were 24, 8.4 and R; 24, 8.5 and R; 24, 9 and R; 24, 8.3 and R; 24, 8.1 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
woke Up this morning with a tenderness behind my ear; morning with a tenderness behind my ear that radiates down my neck; lymph node that's a little swollen/I pressed behind my ear and it seems like it's a lymph node; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (woke Up this morning with a tenderness behind my ear), PAIN (morning with a tenderness behind my ear that radiates down my neck) and LYMPHADENOPATHY (lymph node that's a little swollen/I pressed behind my ear and it seems like it's a lymph node) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced TENDERNESS (woke Up this morning with a tenderness behind my ear), PAIN (morning with a tenderness behind my ear that radiates down my neck) and LYMPHADENOPATHY (lymph node that's a little swollen/I pressed behind my ear and it seems like it's a lymph node). At the time of the report, TENDERNESS (woke Up this morning with a tenderness behind my ear), PAIN (morning with a tenderness behind my ear that radiates down my neck) and LYMPHADENOPATHY (lymph node that's a little swollen/I pressed behind my ear and it seems like it's a lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
Sore arm, chills & shivering at first, then overheating in bed, low grade headache, low grade muscle aches throughout body, mouth dryness, lack of energy; feels like onset on mild flu.
This spontaneous report has been received from a consumer concerning 140 anonymous female patients of unknown age. On an unknown date patients were vaccinated with GARDASIL injection (dose/ dose in series/ route unknown). The reporter indicated that on an unspecified date, 140 anonymous women died after receiving GARDASIL. Cause of death was not reported. The reporter stated 'how many reported fatalities were needed for a product to be pulled from the market'. She further stated, 'with all of the side effects women experienced after receiving GARDASIL, Merck should not still be pushing the product and the product's prescribing information needed to be updated'. The reporter indicated that she was seeking an attorney because 'Merck needs to update the GARDASIL prescribing information to include the 140 who have died because they received GARDASIL'. She enquired about the address for the Office of General Counsel. This is one of several reports received from the same reporter. Additional information has been requested.
*  All of skin feels warm sensation to burning in left arm; sensation not crawling, not tingling, not numb, not shooting pain, not pricking of pins and needles.  * Upper body muscles tingling.  * Muscles relaxed to weakness or numbness.  * Feeling tired, sleepy, fatigue.  * Forehead pressure; not congestion, headache, or fever.  * Eyes tired and burning.
The morning of the day after vaccination, developed what looked/felt like a heat rash on neck, extending to throat, beneath chin. Included redness, and with small hive-looking to small blister-like bumps that itch. Worsened when outdoors (90 degrees F) in direct sun OR in shade. Three days ago, spread to chin and around mouth. Accompanied by headache the first morning rash occurred. It's now been two weeks, and persists. Took a BENADRYL (antihistamine), with no change or effect. Applied CORTIZONE ointment, with no effect. Visited dermatologist today, 5/31/2018, who, honestly, was no help. Wasn't familiar with SHINGRIX, so couldn't offer opinion whether or not the cause. I believe it's related to vaccine due to timing and after reading "side effects" on manufacturer's website.
Day of test Friday: nausea Day 0 Friday night: Fever +3 from baseline, vomiting, chills, aching bones Day 1 Saturday: Fever +3 from baseline, aching, fatigue, diarrhea Day 2 Sunday: Fever, bones aching, muscles in legs feel like contracting involuntarily, woke up with  big fat swollen lips, swollen throat, could barely talk, throat clearing, hard to swallow Day 3
Rash starting 15 days after vaccine. Rash is raise, red and itching more consistent with contact dermatitis. It's all over body, arms, legs, chest and abdomen.  Seen at walk in clinic 07/08/2006, healthcare provider 07/11/2006 for follow up.
presenting with chest pain for 4 hours.  Pain started gradually.   It is described as dull and aching, radiating into nowhere.   Pain is described as moderate upon onset and is currently mild.  No history of the same.   Pain is not worse with exercise. Patient has no decrease in exercise tolerance recently.  Patient stated his chest pain starts on his right side and radiates to the middle of his chest and up to the right side of his neck.  Patient denies any injury to his chest.  Patient's mother stated he was given Tylenol.   Patient's mother states that symptoms began on Friday after
Within a week popped rash face, temples and forehead and my back. Spots on my neck. Dermotoligt Prescribed - Clindamycin Phots 1%, Clobetasol Propionate Cream USP .05%, Visited Allergist Triamcinolone Acetonide Cream USP 0.1 % , Hydrocortisone Ointment .25% Tacrolimus.
Injection site turned bright red swelled up and was hot...about the size of a apple. Eight days after first shot.
This spontaneous report as received from a healthcare worker refers to a 64 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2015, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (0.5 ml, intramuscular, lot # K004281, expiration date 22-MAR-2015). No adverse effect was reported. Additional information has been requested.
Pain and swelling at the site of injection; Pain and swelling at the site of injection; This spontaneous report was received from a nurse referring to a 41-year-old female patient. The patient's concurrent conditions were not reported. The patient's medical history included herpes virus infection. Concomitant therapies included ethinyl estradiol, norgestimate (TRI-SPRINTEC) and valacyclovir hydrochloride. On 22-OCT-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular (dose 1, lot# R024259, expiry date: 30-MAY-2021) for prophylaxis. On 09-JAN-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) intramuscular (dose 2, lot # S026372, expiry date: 01-APR-2020) for prophylaxis. On 25-JAN-2020, the patient developed pain (injection site pain) and swelling at the site of injection (injection site swelling). The patient did not receive any treatment for the event but called the nurse and sought medical attention. The outcome of injection site pain and injection site swelling was not recovered. The causality of the events was not reported with respect to suspect therapy hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).
SECOND DOSE IS MORE THAN 42 DAYS FROM FIRST DOSE WHICH IS 12/22/21
Around 4pm at work and noted "scratchy throat", Took Benadryl 25mg and went home.  Around 5:30pm felt like throat was swelling. Took 2nd Benadryl 25mg.  That night noted rash on face and chest. Took Benadryl 50mg and rash subsided.  On Sunday 9/26/21 vomiting x 2hrs then that evening noted rash on chest. Took Benadryl 50mg and used Benadryl cream.  Rash subsided. Still feels "off kilter".
Headache, Myalgia, chills, labored breathing, body is heavy Narrative:
Headaches/chronic headaches; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A patient of an unspecified age(reported as 18-19 years old) and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date in 2018 at single dose for immunization. The patient medical history and concomitant medications were not reported. It was reported that a patient received her first dose of meningococcal group b rlp2086 about 1 year ago at a pharmacy, was not sure which pharmacy. The patient experienced headaches after the first dose in 2018, and those headaches did not go away. The patient had to see a Neurologist for treatment of the chronic headaches. The outcome of the event was unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
Pt reports having her 2nd covid vaccine on 3/5, and on 3/17 began to have significant lower leg pain, tenderness, and purpura.  Pt was diagnosed with erythema nodosum.
bleeding; This is a spontaneous report from a contactable consumer (patient). A 42-year-old not pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 06Apr2021 10:30 (Batch/Lot Number: ER8734) as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included allergies to Penicillin, turkey, chicken. Patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had vaccine on 06Apr2021 and that evening about 22:00 started bleeding very heavy. She bled for 2 1/2 weeks changing overnight pads ever 45-60 minutes. On 21Apr21 was bleeding so bad. Changing pads every 10 minutes. Patient went to the emergency room and was gave a very heavy dose of hormones to stop the bleeding. She went to see gynaecologist on 23Apr21 and was scheduled for a hysterectomy due to all the bleeding. The event outcome was not recovered. The patient was hospitalized for bleeding (haemorrhage) for 1 day. The patient underwent lab tests and procedures which included Nasal Swab covid test: negative on 10May2021.
p/vax pt devel fever & red @ inj site lt deltoid;lt arm cellulitis;cellulitis resolved but cont w/mild intermittent myalgia & intermittent sweats;probable serum sickness;
Patient had some chest tightness about 10 minutes after vaccine administration (about 11:20am).  I Considered the use of epipen, but she had no complaints of difficulty breathing or throat symptoms.  She is an asthmatic, I called her MD, obtained a Proair inhaler and gave it to her since she did not have her inhaler with her.   About 15 to 20 minutes after, she was feeling better.  I had her wait until 12:28pm before I gave her the ok to leave
No additional AE reported, and no further information provided/ Patient did not have any known adverse reaction; was inadvertently administered after its labeled expiry date; This spontaneous report was received from a nurse and a licensed practical nurse and refers to a 12-month-old female patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies was provided. Her historical vaccine included hib conj vaccine (tet toxoid)(ACTHIB). Her concomitant vaccines included varicella virus vaccine live (oka/merck)(VARIVAX) and hib conj vaccine (tet toxoid)(ACTHIB).  On 11-JAN-2021, the patient was inadvertently vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA) injection, first dose, 25U/0.5ML, 1 dose, intramuscularly in the right thigh, lot # T008149 (lot number T008149 has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) formulation vial), expiration date: 06-JAN-2021 for prophylaxis.  The patient did not have any known adverse reaction. No treatment was prescribed. There were no known temperature excursions involved. The licensed practical nurse reported that the patient was not going to be revaccinated.
Treatment of COVID-19, Date of start of drug: 23Oct2023; Pfizer / BioNTech, Date: 20Oct2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 16:00 as dose 1, single (Lot number: HG2282) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative/Ulcerative Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset Oct2023, outcome "unknown", described as "Treatment of COVID-19, Date of start of drug: 23Oct2023; Pfizer / BioNTech, Date: 20Oct2023". Therapeutic measures were taken as a result of covid-19.  Additional information: Patient also received treatment with Paxlovid from 23Oct2023 to 27Oct2023 for Covid-19. Patient had no known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360488 same reporter/patient, different product/AE;
After 20 hours pt. felt fatigue nausea. After 1 week arm was swollen, red, pt. was fatigued and nausea.
Patient called today (Sun) after receiving vaccine on Friday - experiencing redness, swelling, pain, and a rash around injection site - patient will be seeing PCP to have it checked tomorrow (Mon).
Received dose 1 3/17. Felt normal 3/18. 3/19 pm, started experiencing myalgias, chills, fever 100*. Fully recovered 3/20pm, felt well through 3/21. 3/22pm through 3/25 experienced fever, myalgias, chills worse than before. Received second dose in series 4/7/21, ADE currently unknown.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 18-MAR-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster also known as shingles and other complications. On or about 30-SEP-2015, for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Started with fever, headache, and joint pain. Those subsided and I immediately started having severe abdomen pain that started on the left side, went across my abdomen at the naval level, and around my back to the right side. Currently still having pain.
3:45 AM awoke with dizziness and loss of balance. 4:57AM  awoke again with more intense dizziness and loss of balance; stubbled, fell  in bathroom. Symptoms have persisted of state of drunkenness'  when walking and head is feeling "weird".
10-5-10 fever 102, redness, swelling rash at injection site. Oct 7 - to MD - ibuprofen 100+ 102 - Dx. cellulitis - antibiotic, localized to arm. No f/u MD visit required symptoms, fever subsided - 10-10-10. Completed antibiotic required - states has pneumonia q 10 years.
This spontaneous prospective pregnancy report as received from a physician for VARIVAX (Merck), a Pregnancy Registry product, concerning an approximately 36 year old female. The patient has a history of 1 previous pregnancy, it was unknown if a birth defect or stillbirth or miscarriage occur in any previous pregnancy. On 14-MAY-2012, the patient was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot number not reported). No other co-suspects were reported. It was noted that the patient did not experienced local reaction at the vaccination site, varicella (chickenpox) symptoms or Herpes Zoster (shingles) symptoms post vaccination. Subsequently, the patient became pregnant with a last menstrual period (LMP) of 11-MAY-2012 and an estimated delivery date (EDD) of 15-FEB-12. On an unspecified date the patient experienced urinary tract infection treated with MACROBID and reflux treated with PROTONIX. It was also reported that the patient was tested for varicella antibodies before vaccination with VARIVAX (Merck) (in an approximately 2012) with result reported as "negative". At the time of report, the patient's outcome was unknown. Additional information has been requested.
Headache, chills, felt feverish, sore throat, runny nose, sinus pressure, congestion, loss of smell, fatigue
It started with diarrhea, headache, dry cough, fever of 100.4, body aches. The stomach issues have turned into a bacterial infection. I have fluid in my ears. My doctor decided to put me on an antibiotic. The fever had gone away after 10 days however the stomach cramping and diarrhea lasted for around 12 days. I tested positive for COVID. I am on the mend now but my left ear still hurts quite a bit.
Incorrect diluent was used to reconstitute the SHINGRIX vaccine. Instead of using the adjuvant suspension component on the package, the sterile diluent for ZOSTAVAX vaccine was used instead. The CDC recommends redoing the first dose of the vaccine to the customer after 4 weeks. The patient and her primary care doctor's office was informed of the this incident and to come back sometimes after February 21st 2018 to redo the first dose. Patient had no adverse reaction to this error.
Redness at sight of injection the day after vaccines. Redness increased and swelling began at site of injection by the end of that day. Swelling is still bigger than half dollars size and very warm to touch.  Mom is tx with ice and Tylenol.
10/06/2010: FEVER, ACHES, HOARSENESS,SORE THROAT, SWOLLEN RED EYES, AND ACHES IN VARIOUS JOINTS. 10/07/2010: INADDITION TO THE ABOVE - BEGAN COUGHING. COUGHING UNTIL VOMITING OCCURRED. NOT VOMITING ANY OTHER TIME THROUGHOUT THE DAY. ALSO EXPERIENCED WHEEZING AND BEING TIRED MORE THAN USUAL FROM FIBROMYALGIA. STARTED SNEEZING. 10/08/2010: ALL SYMPTOMS CONTINUED WITH COUGHING INCREASING.  EXPERIENCED A RUNNY NOSE. OCCASIONALLY EXPERIENCED SHORTNESS OF BREATH. 10/09/2010:  FEVER, RED EYES, AND SORE THROAT SUBSIDED. ALL OTHER CONDITIONS CONTINUED.  10/10/2010: HOARSENESS BEGINS TO DIMINISH. CONTINUED TO EXPERIENCE COUGHING, RUNNY NOSE, TIREDNESS, WHEEZING. 10/11/2010: HOARSENESS IS GONE, ALL OTHER CONDITIONS CONTINUE.
This spontaneous case, initially received on 11-Jul-2016, was reported by a health professional and concerns a female patient. Weight: 62.58 kg; Height: not provided. Administration of company suspect drug(s): On an unknown date, the patient received Influenza Virus Vaccine (INN). Dose regimen: Not reported, Route of administration: Not reported. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date following vaccination, the patient experienced allergies (outcome: not reported). Linked Case ID(s): US-BEH-2016071024 (same patient).
11 days p/immun pt had a cont. cry all night long; c/o hurting all over & fussy; sx lasted 18 hrs; Also had vomiting, rash & "low" grade temp; Initially mom reported temp as >104
Fever, chills, body aches (back), and one enlarged supraclavicular lymph node on same side of vaccine appeared 6 days after vaccination and is still present 9 days later. Initially painful. Pain subsided after 24 hours.  Painful left armpit night after vaccine and morning after.
Patient presented to emergency department on 9/5/2021. She was recently admitted and discharged from a different hospital from 8/30/21 to 8/31/21 with COVID-19 infection. She was found to by hypoxic at admission and started on supplemental oxygen. She was treated with remdesivir and dexamethasone during admission. Patient was discharged on 9/20/2021 to skilled nursing facility still requiring supplemental oxygen.