chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is in follow-up to report (s) previously submitted on 1/16/2009. Information has been received from a pharmacist, concerning a female patient with hyperlipidaemia and no known drug reactions or allergies, who on 11-SEP-2008 was vaccinated with the first dose of GARDASIL, 0.5ml, intramuscularly and on 21-NOV-2008 was vaccinated with the second dose of the HPV vaccine (Lot # 655165/0137U), 0.5ml, intramuscularly.  Concomitant therapy included LIPITOR and clobetasol propionate cream. The pharmacist reported the patient developed arm apin 3 weeks after the second dose of vaccination date. At the time of ther report, the pain has not resolved. Follow-up information received from pharmacist indicated that the patient had no known drug reaction/allergies or any medical condition, who on 21-NOV-2000 at 15:30 pm, the patient was vaccinated with the second dose of GARDASIL in the left deltoid. On 15-DEC-2008, the patient developed arm pain, most on deltoid area and traveled down her arm. A neurology exam was performed resulting negative per patient. At the time of the report, the patient had recovered. No further information is available.
This spontaneous report was received from a nurse practitioner refers to an elderly female patient of unknown age. The patient was vaccinated with PNEUMOVAX23 (lot # reported H009826, expiration date 11-FEB-2014) intramuscularly in the arm on 24-SEP-2012. Other suspect therapies included FLUZONE (manufacturer unspecified) on the opposite arm on 24-SEP-2012. No concomitant medications were reported. Sometime between 24-SEP-2012 and 26-SEP-2012 the patient developed redness and swelling at the site of PNEUMOVAX23 injection. She went to see an unspecified physician who diagnosed her with cellulitis at the site of PNEUMOVAX23 injection. The physician prescribed KEFLEX to the patient. She was recovering. A lot check was requested. The patient sought medical attention for the event by going to a physician. This is one of the several reports from the same reporter. Additional information has been requested.
PATIENT RECEIVED VACCINE, AFTER 3-5 MINUTES PATIENT FELT HOT, WAS GIVEN WATER TO DRINK. PATIENT FELT SWEATY. ASKED IF PATIENT HAD OTHER SYMPTOMS. MONITORED PATIENT FOR A FEW MORE MINUTES. WHEN I WAS MONITORING HER SHE NOTIFIED US THAT SHE WAS HAVING TROUBLE SWALLOWING AND STILL FELT HOT. I THEN ADMINISTERED AN EPINEPHERINE INJECTION0.3MG DOSE INTO THE LEFT QUAD AND HAD MY TECH CALL 911. PARAMEDICS CAME AFTER 10-15 MIN. PATIENT WAS OK BUT STILL FELT AS THOUGH SHE WAS HAVING TROUBLE SWALLOWING. THE PARAMEDICS TOOK THE PATIENT TO THE HOSPITAL FOR OBSERVATION.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  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: 207A21A, and expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
29MAR used sunscreen 15 (has used it before);went skiing;got sunburn to face;skin peeled for 1wk;since 4APR has had intermittent episodes of facial flushing;referred to MD;
Sore arm; Nerve pain downarm into wrist.; Brain fog; Clammy hands; tired clammy hands; Stomach upset; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Ep7534) via an unspecified route of administration in the left arm on 15Mar2021 at 10:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included Reynaud's, osteoarthritis, irritable bowel syndrome. Allergies to medications included penicillin, ampicillin, clindamycin and erythromycin. Concomitant medications received within 2 weeks of vaccination included vitamin (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), omega (MANUFACTURER UNKNOWN), turmeric (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 15Mar2021 at 10:15, the patient experienced sore arm, nerve pain down arm into wrist, days after and continuing over two weeks brain fog, tired, clammy hands and upset stomach. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse events was reported as no. The clinical outcome of the events sore arm, nerve pain down arm into wrist, days after and continuing over two weeks brain fog, tired, clammy hands and upset stomach were resolved with lasting effects.  No follow-ups attempts are needed. No further information is expected.
A report was received from a healthcare professional on 10/15/2003 concerning a group of approximately 15 vaccinees who experienced injection site reaction, with redness, swelling and itching a few minutes after receiving Fluvirin on an unspecified date. On an unspecified date the vaccinees experienced injection site reactions with redness, swelling, and itching.  The vaccinees recovered on an unspecified date without treatment. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1, 22 December 2003. A follow up report was received from a healthcare professional concerning a 27 year old female vaccinee who experienced redness, swelling and severe itching at the injection site on the same day as  receiving Fluvirin on 10/10/2003. On 10/10/2003, the vaccinee experienced redness, swelling and severe itching at the injection site after receiving Fluvirin 0.5ml.  The symptoms lasted for a duration of 24 hours, and had resolved at the time of follow up report. No follow up pending.
Weak; Hot; Sweat sweat sweat; Exhausted; Fever just a little north of 102 degrees; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), FEELING HOT (Hot), HYPERHIDROSIS (Sweat sweat sweat), FATIGUE (Exhausted) and PYREXIA (Fever just a little north of 102 degrees) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (Medical history not reported.). Concomitant products included LEVOTHYROXINE for Disorder thyroid, VITAMINS NOS for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced ASTHENIA (Weak), FEELING HOT (Hot), HYPERHIDROSIS (Sweat sweat sweat), FATIGUE (Exhausted), PYREXIA (Fever just a little north of 102 degrees) and FATIGUE (Fatigue). On 11-Apr-2021, ASTHENIA (Weak), FEELING HOT (Hot), HYPERHIDROSIS (Sweat sweat sweat), FATIGUE (Exhausted), PYREXIA (Fever just a little north of 102 degrees) and FATIGUE (Fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 102 (High) fever ranged between 100 to 102.8 and settled around 101.5,then down to 99.2.         Concomitant medications included unspecified statin for cholesterol.  Treatment medications included Tylenol (acetaminophen.
Awakened to sore arm at around 3A.M.and decided to take an Aleve.  Walked to the kitchen and proceeded to get the medication when I started to feel very light headed.  I was feeling very strange so I tried to squat down to the ground when I must have blacked out for my husband came out to the kitchen and found me lying on the floor and was unresponsive for a few seconds.  I came to and remained on the floor where I was soaking wet ( as though  I had exercised for an hour on my treadmill).  After a few minutes resting, I felt fine.  I had some water with 1 Aleve and went to change my clothes and went back to bed.  It wasn't until around 7 o'clock that I realized that my head was hurting.  I felt my scalp and it was extremely sore and I had a slight headache.  It was at this time I realized that I had hit my head on the island cabinet and actually cracked the wood.  The headache remained all day for I was afraid to take any further meds in case I had a slight concussion.  Other than the soreness of my scalp and slight headache, I felt fine.  The next day I felt great, except for the tenderness to my head.
Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; Diarrhea; Abdominal pain; Joint/muscle pain; Joint/muscle pain; Nausea; Fatigue; Severe headache; Sore arm; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration in the right arm on 15Jan2021 13:00 at SINGLE DOSE (first dose) for COVID-19 immunization. Medical history included systemic lupus, "hypothyroid", Leiden Factor V. Patient's known allergies: penicillin, erythromycin and tetracycline. 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 hasn't been tested for COVID-19. Concomitant medications included hydroxychloroquine, clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity, tetracycline and experienced drug hypersensitivity.  On 15Jan2021 16:00, the patient experienced fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm. Outcome of events was fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm not recovered. Outcome of the other events was unknown. Patient did not receive any treatment for the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
ACHING ALL OVER/GENERAL PAIN; LOST TIME; PRESSURE IN MIDDLE OF BACK; VOMITING; FEVER; HEADACHE; NAUSEA; DIARRHEA; CHILLS; EXTREMELY WEAK; PAIN IN BACK; NO APPETITE; This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, lost taste, and lost smell, and other pre-existing medical conditions included: Patient was on blood thinner for less than one day and her primary care physician (PCP) discontinued the blood thinner. Patient had family history of blood clot. The patient was previously treated with apixaban for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. On APR-2021, Laboratory data included: Fibrin D dimer high (NR: not provided) not reported. On JUL-2021, Laboratory data included: Fibrin D dimer high (NR: not provided) 617, 0.50 (unit not reported). On SEP-2021, the patient experienced pain in back. On SEP-2021, the patient experienced no appetite. On SEP-2021, the patient experienced chills. On SEP-2021, the patient experienced extremely weak. On 02-SEP-2021, the patient experienced aching all over/general pain. On 02-SEP-2021, the patient experienced lost time. On 02-SEP-2021, the patient experienced pressure in middle of back. On 02-SEP-2021, the patient experienced diarrhea. On 02-SEP-2021, the patient experienced vomiting. On 02-SEP-2021, the patient experienced fever. On 02-SEP-2021, the patient experienced headache. On 02-SEP-2021, the patient experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.1 (average). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost time, and chills on SEP-2021, was recovering from fever, vomiting, and headache, had not recovered from diarrhea, aching all over/general pain, pressure in middle of back, nausea, pain in back, and extremely weak, and the outcome of no appetite was not reported. This report was non-serious.
pt recvd series of Hep B (recomb); 2nd series was administered on following dates 10JUN91, 10JUL91 & 17DEC91; lab eval revealed pos Hep B surface antigen on 22FEB92;
Warm feeling in back of throat that started about 10 minutes after the shot, then immediate dizziness and I went out for help from a physician in hallway. Next thing I remember I was on an exam table and I had not strength in my limbs and core. I had a rash on neck and chest. They monitored my vitals and decided I needed to go to urgent care or ER. Since the urgent care was on the way to the ER they took me there. They moved me from wheel chair to ecam table. Gave me epi and Benadryl injections, prednisone by mouth and started an IV. They monitored my vitals and said if I worsened are didn't respond then they would send me to ER. They gave me some Pepcid and eventually over the 3 hours I was able to stand on my own and they decided to discharge me around 14:00, making sure that I had someone who could stay with me at home.
p/ recv vax approx 3 yrs later pt devel mild breakthrough case of chickenpox w/approx 50 spots, exp runny nose
very pal; I had breathing problems/short of breath; heartbeat was fast.; This is a spontaneous report from a contactable consumer. This female consumer reported.  A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, batch/lot number and Expiration date was not reported), via an unspecified route of administration, on 23Jan2021, as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On 23Jan2021, 10 min after getting the vaccine she was very pal, she had breathing problems, short of breath and heartbeat was fast. They took her to the ER and was given steroids. She didn't stay long. No one called her for the second shot. The patient think it's supposed to be today or tomorrow. Is it 2 weeks or 3 weeks. The patient underwent lab tests and procedure which includes heart rate with a result of fast on 23Jan2021. The outcome of the events were unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a consumer refers to her sister in law of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot number not provided). On an unknown date the patient developed shingles. The outcome of shingles was unknown. Additional information is not expected.
felt like had the flu; nausea; abdominal cramps; weak; low grade fever; shaking; shivering; could not go to work the day after receiving the vaccine; This case was reported by a consumer and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th September 2020, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, nausea, abdominal cramp, weakness, fever, tremor, shivering and malaise. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the influenza-like symptoms, nausea, abdominal cramp, weakness, fever, tremor, shivering and malaise were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, nausea, abdominal cramp, weakness, fever, tremor, shivering and malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and at the same night experienced shivering, chills, tremor, fever, abdominal cramps, felt weak, nausea and had flu like symptoms. The reporter stated that, events lasted for about 12 hours and were resolved. The patient was treated with tyenelol for the eventsand was not able to go to work on the day after receiving vaccine. The reporter consent to follow up.
Eleven or 12 days after my 2nd booster with the Moderna COVID-19 vaccine (I had got all my prior 3 COVID-19 vaccines with Moderna as well) I developed red, VERY itchy and uncomfortable  rashes all over my hands and feet.  They changed location and as the day progressed, I got rashes in my neck, my back, my tummy, my thighs.  In the days that followed, I got them even on my thighs, loin area.  They were really uncomfortable and VERY itchy. I have now learned (from a dermatologist I saw today) that these are hives or urticaria.... I tried Benadryl and that helped.  I thought the rashes would go away in a few days, like the "COVID arm" rashes I got on my arm after the 1st & 2nd COVID vaccine injections, which were delimited to the injected site...  But no...  this rash arrived to stay.  I still have them, now almost for 2 months since they began in mid-August.  Thankfully, my PCP suggested Zyrtec, which works well (as Benadryl), but both are sedating for me.  And I don't want to take these for weeks as I fear that when I stop them my anxiety/ insomnia may return more vividly as my body gets used to feeling sleepy with these meds.  Claritin does NOT work for me.  Aside from the urticaria concern, what happened to my body? What hacked my immune system? When will this mast cell/hyper histaminergic state craziness subside?   Can I have my annual flu shot?  I am afraid of taking even the flu shot, knowing my immune system is in overdrive.  I am totally scared of taking another COVID-19 booster shot ANYTIME in the future.  What is this side effect?  What caused it? How can this be re-set to my normal levels?  Should I just refuse any future COVID shots?  And the flu shot?
Luer lock leaked out vaccine. Patient didn't get a full dose. Less than half dose estimated to be given. Patient was given another dose full  dose of vaccine.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient reported feeling fine when she came to get vaccine but was nervous. While waiting for 15 mins post vaccination she started to feel nauseaus and shortly after vomited. She was given some water and she felt fine. Followed up with patient on 02/12/22 and spoke with patient in presense of dad and she is doing fine. Not experiencing any other symtoms
This spontaneous report as received from a medical assistant refers to an unspecified patient of unknown age and gender. On 30-OCT-2014 the patient received an expired dose of M-M-R II (route, dose and frequency not reported, lot # H012571, expiration date 29-JUN-2014). No adverse effects reported. Additional information has been requested.
about 1 minute after receiving flu vaccination, the patient appeared to be flushed with red blotches on her face. she was having trouble speaking and stated that she was short of breath. vitals taken, notable for tachycardia but no hypotension or hypoxemia. auscultation notable for sinus tachycardia, lungs clear but tachypneic, no wheezing or rales. epinephrine auto-injector 0.3 mg dose administered on  the right lateral thigh. flushing and rash improved after epinephrine. patient appeared anxious but breathing started to calm down. she remained hemodynamically stable. taken to ER and released after several hours of continued stability. the patient has had flu vaccine in the past without any problems.
Worsening soreness (R) shoulder. Difficulty moving shoulder/sleeping secondary to pain.
Medication Error:  Patient received Pfizer COVID-19 vaccine as second dose in series after receiving Moderna as her first dose.  (Moderna 1st dose 6/22/21 date of administration, lot# 017B21A).  No adverse event, signs or symptoms noted after vaccination administration.
Upon presentation for Dose #2 in Moderna series, patient had noticeable bruising at the injection site of Dose #1 (left arm). Patient reports soreness, limited range of motion in left arm, and injection site was tender to the touch. Gentle pressure was applied to the injection site and surrounding area to assess their pain. Patient reported a pain score of "6 or 7" on a scale of 1-10. Per patient, they have had these symptoms since 3/10/22 when they were given their first dose. Per patient and their son who was present at the time, they experienced "lots of bleeding" at the time of administration of Dose #1. Patient states they recently started taking Tylenol for the pain in their left arm. In addition to Tylenol, I suggested a cold compress for further symptom management.
Given vaccine approximately 03:15PM. About an hour later, I began to feel weak and tired, developed a headache, the muscle aches in neck and body; got very tired and slept most of the next day and a half.
A non-serious spontaneous report of inadvertent administration of expired FLUMIST was received from a health professional concerning a five-year-old female patient. The product expired on 07-Feb-2010 and on 16-Feb-2010 the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
periodic sinus infections; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SINUSITIS (periodic sinus infections) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On an unknown date, the patient experienced SINUSITIS (periodic sinus infections). At the time of the report, PAIN IN EXTREMITY (sore arm) and SINUSITIS (periodic sinus infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.