chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Quite a bit of Swelling, red skin color, itchy.  Seems to worsen by the day.
This spontaneous prospective pregnancy report was received from a registered nurse and refers to a currently 25 years old female patient. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 16-DEC-1993, the patient was vaccinated with the first dose of M-M-R II, (dose, frequency, route, lot number and expiration date were not provided), for prophylaxis. Subsequently on 13-DEC-1996, the patient was vaccinated with the second dose of M-M-R II, (dose, frequency, route, lot number and expiration date were not provided), for prophylaxis. Then, on approximately 20-JAN-2018, the patient became pregnant with an approximately last menstrual period (LMP) of 06-JAN-2018 and an estimated delivery date (EDD) of 13-OCT-2018. On an unknown date in 2018 (reported as"while pregnant"), the patient had an "MMR titer" drawn and the results of the "MMR titer" showed that the patient "did not have immunity" (antibody test negative). Primary reporter reports the patient has not received any additional doses of M-M-R II since becoming pregnant. At the time of reporting, the pregnancy outcome was pending. The outcome of antibody test negative was unknown. The causal relationship between antibody test negative and M-M-R II was not provided.
DAPTACEL was given to a 12 year old with no reported adverse event; Initial information received on 31-Aug-2022 regarding an unsolicited valid non-serious case received from a consumer/non-HCP.  This case involves a 12 years old female patient who was given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] to a 12 year old with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccines included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Immunisation; and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Immunisation.  On 12-Aug-2022, the patient received a 0.5 ml once, 6th dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (formulation, strength: unknown), (lot C828AA, exp date: 30-Mar-2023) via intramuscular route in the right deltoid as immunization.  On 12-Aug-2022 (latency: same day),  the patient developed a non-serious event of "Daptacel was given to a 12 year old with no reported adverse event" (product administered to patient of inappropriate age) following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE.  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 guidelines. 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.
Significant painful lymphadenopathy in the R axilla; This is a spontaneous report from a contactable physician. A 27-year-old female patient received the the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL3248), intramuscularly in the right arm, on 06Jan2021 at a single dose for covid-19 immunization. The patient has no medical history. The patient has no known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and OCP.  The patient experienced significant painful lymphadenopathy in the right axilla on 07Jan2021 20:00 with outcome of not recovered. The outcome of the event was not recovered. The patient did not receive treatment for the event. The patient did not have Covid prior to vaccination. The patient has not been tested for Covid post-vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Sometime in 2010 the patient was vaccinated with the first dose of GARDASIL. On 26-AUG-2013 the patient was in the office to receive second dose of GARDASIL, which will be late. No symptoms were reported. Additional information has been requested.
8/3/09 Mother phoned at approx. 3:50 PM - States that after arriving home, patient was pale - "White as a ghost" & clammy.  No hives, no problems breathing.  States also when patient was walking to car, had complained of burning at injection sites & blurred vision.  Reports that patient was anxious about injections.  Phone call to mother at 4:05 PM - Vision clearing.  Phone call at 4:25 PM patient tired, cold.  Phone at 5:10 PM tired but no further problems - & same on 8/4/09 - per phone call to mother.
The pt received Varivax vaccination on 02/07/2002. She started with papules on legs on 02/28/2002 (phone conversation) did not set blisters or scabs. Multiple raised erythematous plaques, papules.
Received vaccinations on 1-17-11 came in for office visit. 1-19-11 rash with multiple blisters around vaccination site, erythema over left deltoid. Patient did come back in the office. 1-20-11 rash worse about 30 blisters on left arm patient started on medication.
achy; Swollen; ifts her arm it is very achy; warm to the touch; injection arm sore/hurt; sore arm for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a day or two), PAIN (achy), SWELLING (Swollen), PAIN (ifts her arm it is very achy) and INJECTION SITE WARMTH (warm to the touch) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm for a day or two). On 02-Apr-2021, the patient experienced PAIN (achy), SWELLING (Swollen), PAIN (ifts her arm it is very achy), INJECTION SITE WARMTH (warm to the touch) and INJECTION SITE PAIN (injection arm sore/hurt). At the time of the report, PAIN IN EXTREMITY (sore arm for a day or two), PAIN (achy), SWELLING (Swollen), PAIN (ifts her arm it is very achy), INJECTION SITE WARMTH (warm to the touch) and INJECTION SITE PAIN (injection arm sore/hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided
Immediately upon receiving the first injection of the two part series, I felt coldness running down my left arm as if I was getting an IV and then tingling and numbness in my left thumb. The numbness and tingling remained for approximately 5 to 8 hours that day.  Additionally immediately upon receiving my second dose in the series on April 26, 2011 at 9:20 AM I felt both my left and right arms and hands go numb after approximately 45 minutes I felt numbness in my left cheek and upper left and lower lips. The numbness remain for approximately four hours with full resolution by eight hours later.
he felt lethargic; headache; low grade fever; lymph nodes under his left arm was very sore; soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (he felt lethargic), HEADACHE (headache), PYREXIA (low grade fever), LYMPH NODE PAIN (lymph nodes under his left arm was very sore) and VACCINATION SITE PAIN (soreness at injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K202A and 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ), ACETYLSALICYLIC ACID (ASPIRIN 81), UBIDECARENONE (COQ10 [UBIDECARENONE]) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LETHARGY (he felt lethargic), HEADACHE (headache), PYREXIA (low grade fever), LYMPH NODE PAIN (lymph nodes under his left arm was very sore) and VACCINATION SITE PAIN (soreness at injection site). At the time of the report, LETHARGY (he felt lethargic), HEADACHE (headache), PYREXIA (low grade fever), LYMPH NODE PAIN (lymph nodes under his left arm was very sore) and VACCINATION SITE PAIN (soreness at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, White blood cell count: low (Low) Low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30-JUN-2021. contains no new information.
This case was reported by a physician via interactive digital media and described the occurrence of pain in arm in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received on unknown date). On 1st July 2018, the patient received the 2nd dose of SHINGRIX. On 1st July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient stated that, the vaccine was reactogenic in terms of arm soreness for him presumably from the AS01 adjuvant containing MPL and QS21. As someone who also developed recombinant protein vaccines the reporter understand the need for such adjuvants.
Patient experienced redness, swelling, pain and heat away from the injection site lower on the bicep/tricep area. After increased discomfort for about 3 days sought medical attention and was diagnosed as cellulitis. Treated with antibiotics, however experienced some blistering and peeling at site of redness.
CHEST TIGHTNESS; FEVER; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: None, No known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: 21-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-SEP-2021, the patient experienced chest tightness. On 02-SEP-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, and fever on 03-SEP-2021. This report was non-serious.
12 hours after 2nd Vac. Had a temp that reached 103.0 degrees. High temp for 24 hours. Then a low grade fever of 100.4 or less, for the next 48 hours. Total of 72 hours with a fever.  Had a sore left arm, with  blotchy red  patches of area for the next 5 days following the Vac.
On February 23, 2023, she had fever symptoms and fever of about 100.  On Friday she tested positive for COVID-19.  She was tired, achy, cough and a runny nose.  Her cough became quite significant.  She coughed so hard her ribs hurt.  She contacted the doctor and was given steroids and Paxlovid.  She gradually got better.  She was off work for over a week.  She tested negative about March 1, 2023.  As of today, she complains of being more tired than usual.
Information has been received from a health professional concerning a 69 year old male with an allergy to lisinopril (manufacturer unknown) (WAES # 0705USA02755) and no pertinent medical history who on 24-APR-2007 was vaccinated with a dose of Zostavax (lot # 656394/0162U). There was no concomitant medication. On 27-APR-2007 the patient developed severe right leg pain. Unspecified medical attention was sought. No treatment was recommended, but the patient was taking his wife's NEURONTIN. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 06/14/2007. The health care professional reported that on 27-APR-2007 the patient developed severe right leg pain. Additional information has been requested.
Syncope I was treated for a split lip, severe neck pain, pinched nerve resulting in L arm paralysis  Muscle relaxers and pain killers were prescribed  Arm movement returned after about  3 weeks
very bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very bad reaction) 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 30-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced VACCINATION COMPLICATION (very bad reaction). At the time of the report, VACCINATION COMPLICATION (very bad reaction) outcome was unknown.            It was reported that patient had received a 2nd booster Moderna Covid-19 vaccine on 30Mar2022 and had "very bad reactions" that started on 31Mar2022 at morning. No concomitant medication was reported. No treatment information were reported.
paresthesia; paralysis; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (paresthesia) and PARALYSIS (paralysis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PARAESTHESIA (paresthesia) (seriousness criterion hospitalization) and PARALYSIS (paralysis) (seriousness criteria hospitalization and medically significant). At the time of the report, PARAESTHESIA (paresthesia) and PARALYSIS (paralysis) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Patient was hospitalized for a month and had weeks of physical therapy. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company comment: This is a spontaneous case reported by a consumer. A female patient of an unknown age, with no reported medical history, received 2 doses of mRNA-1273 vaccine in March 2021 and experienced serious events of paraesthesia and paralysis from the chest  down in April 2021 which lead to a month-long hospital stay and weeks of physical therapy. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case reported by a consumer. A female patient of an unknown age, with no reported medical history, received 2 doses of mRNA-1273 vaccine in March 2021 and experienced serious events of paraesthesia and paralysis from the chest  down in April 2021 which lead t a month-long hospital stay and weeks of physical therapy. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Palpitations and flushing of face. Tachycardia upto 119 bpm
Huge red mark around where got the shot; Itchiness everywhere beginning 30 minutes after vaccination; Rashes appearing on thighs and stomach within 24 hours and worsening around 30 hours; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07May2021 at 12:00 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to latex and gluten. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Apr2021 at 12:30 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. On 07May2021 at 12:30, 30 minutes after vaccination, the patient experienced itchiness everywhere. On 07May2021, within 24 hours, she experienced rashes appearing on thighs and stomach and worsening around 30 hours. On 07May2021 at 13:30, the patient had huge red mark around where she got the shot. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchiness everywhere, rashes appearing on thighs and stomach and huge red mark around where she got the shot was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sat. morning (Left arm) arm swelled red and hot. Bowels let loose all over couldn't get to bathroom exploded. Contact clinic Nurse Practitioner, went back and showed her red hot swollen said to put ice on it and take BENADRYL. Went back Oct 9 2017 I don't own a computer. My arm is discolored yet where had shot all around top.
Headache X 4 days with fever to 101: Rash on chest and face.
Pain at vaccination site; Pain radiates down to pinky and up through next shoulder, and upper back; Pain radiates down to pinky and up through next, shoulder, and upper back; Pain radiates down to pinky and up through next, shoulder, and upper back; Pain radiates down to pinky and up through next, shoulder, and upper back; Interferes with activity 5-6 times a day; Waking me up 2 -3 times a night; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 09Mar2021 (at the age of 53-years old) as a single dose for COVID-19 immunisation. Medical history included Non-Alcoholic Steatohepatitis (NASH), hay fever, Selective IgM deficiency (SIgMD) and fibromyalgia. The patient was allergic to narcotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 16Feb2021 (at the age of 53-years old) at as a single dose for COVID-19 immunisation. On 09Mar2021, the patient experienced pain at vaccination site which was ongoing 2 months after shot. The pain radiated down to pinky and up through next, shoulder and upper back. The pain interfered with activity 5-6 times a day in addition to waking up 2 -3 times a night. Since the vaccination, the patient had been tested for COVID-19. On 28Apr2021, the patient underwent COVID-19 test (nasal swab) and the result was negative. The events resulted in doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included treatment with unspecified muscle relaxants, chiropractic, massage and Nerve cal. The clinical outcome of the events pain at vaccination site, pain radiated down to pinky and up through next, shoulder and upper back, interfered with activity 5-6 times a day and waking up 2 -3 times a night  was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
SWELLING UNDER ARM PIT, TENDERNESS UNDER RIGHT ARM, PAINFUL TO PUT ARM DOWN.  WK BEFORE REC'G VACCINE HAD FLU/DIA, ACHES, CHEST TIGHTNESS, TAMIFLU REC'D TAKEN FOR 3 DAYS.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer-sponsored program Covax US Support. A contactable consumer (patient herself) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unknown date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was  due to have 2nd dose on Sunday (14Mar2021) but tested positive (05Mar2021). She wanted to know when she can take the 2nd dose.  The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 05Mar2021. The event outcome was unknown.  Information on the lot/batch number has been requested.
fats in her stomach; cyst in her pancreas; gastritis; she is not feeling well; sick last night because of stomach issue,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTRITIS (non-serious) with onset Mar2021, outcome "unknown", described as "gastritis"; MALAISE (non-serious) with onset Mar2021, outcome "unknown", described as "she is not feeling well"; ILLNESS (non-serious) with onset Mar2021, outcome "unknown", described as "sick last night because of stomach issue,"; ABDOMINAL MASS (non-serious), outcome "unknown", described as "fats in her stomach"; PANCREATIC CYST (non-serious), outcome "unknown", described as "cyst in her pancreas".   Follow-up attempts completed. No further information expected.
Flu like symptoms, chills. Per patient, his doctor told him he could take pain relief (TYLENOL or Ibuprofen) and that the symptoms would pass.
Spiked the temperature during the night; Body ache; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. There were no medical history and no concomitant medications. The patient was not having any serious side effects but she was having like probably spiked temperature during the night, body ache, and fatigue on 22Dec2020. The patient want to make sure if it is okay to take paracetamol (TYLENOL) or ibuprofen (MOTRIN) generally. Outcome of the events was unknown. The reporter assessed that the events were related to the suspect drug.
3 weeks post vaccination, developed swelling in the lymph nodes left axilla, swelling at injection site-minimal. Vesicular lesions erupted on 11/13/22 Shingles left chest and left side, does not cross the midline, along the dermatome.
Vomiting X 1, Fever of 102 on 8/25/10. Vomiting X 1, on 8/26/10 (in AM).