chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an initial report of an Adverse Event, received on 15Sep2015, for Protein Sciences FLUBLOK. The female subject, received FLUBLOK Intramuscular on an unknown date. On 15Sep2015, the subject called to report pain on site injection. At the time of the report, the outcome of the event was not reported. Concomitant medications were not reported. The company's assessment of the causal relationship between pain on site injection and FLUBLOK is a possible relationship in light of the safety profile information injection site pain is an expected event. In summary, this case report does not change the known safety profile of FLUBLOK.
Has bad body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Has bad body aches"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Additional information: Patient has no health issues.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain at site immediately -it stayed swollen and hard the size of my hand for 6 days very painful - swollen site very pronounced chattering teeth from  chills and myalgia the next day i sweat . i had to go home early from work  long lasting headaches- from first and second- lingering migraine
bad headache; soreness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received Shingrix. On 26th November 2019, less than a day after receiving Shingrix, the patient experienced pain. On 27th November 2019, the patient experienced headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache and pain were unknown.   It was unknown if the reporter considered the headache and pain to be related to Shingrix.  Additional case details were reported as follows: The nurse suggested the patient to take Tylenol for the soreness.  It did not help.  One day after receiving Shingrix, the patient woke up with a bad headache.  The patient asked if he or she should take Tylenol or Motrin. The patient would contact to nurse at the doctor's office.
93-year-old male with a past medical history of systolic CHF ASHD. The patient came to the emergency department because of shortness of breath, elevated blood pressure. He was also found to be COVID positive in the emergency department. He was immediately started on Remdesivir, decadron, supplemental oxygen; Rocephin and Monodox for possible superinfection. His troponin was also elevated, cardiology consult was placed and the patient was started on heparin drip, aspirin, statin and beta blockers. His amlodipine was increased to 10 mg. He was also put on Lasix, his input and output monitored and daily weights. Cardiology determined that the patient did not need any cardiac procedures at this time. During admission his breathing continued to improve, he has been weaned off supplemental oxygen. He had episodes of elevated blood pressure which were controlled with medication. At this time he is back to his baseline uncomfortable; he denies chest pain, palpitation, shortness, GI/GU symptoms. He will be discharged home with home health and advised to follow-up with his PCP within 3-5 days. He will also be discharged with his remaining dose of antibiotics and steroids. His lisinopril has been held due to acute kidney injury, this should be re-evaluated by his PCP during his next visit.
Information has been received from a consumer concerning her daughter (age not reported) with no pertinent medical history, drug reactions/allergies or concomitant medication usage who on 18-JUN-2007 and 15-Aug-2007 was vaccinated (route and site not reported) with the 1st and 2nd dose of the Gardasil (lot # not reported). The patient's mother stated that she picked up the 1st dose of Gardasil from the pharmacy and drove it to the doctor's office in 90F temperature with the air conditioning on and waited for about 1 hour at room temp at the doctor's office for the vaccine to be administered. On 18-JUN-2007, post vaccination, the patient experienced pain immediately after vaccination that lasted up to 2 weeks. The patient was unable to exercise for 1 week post vaccination. The patient stated that the pain was so intense that she felt like crying. The patient developed swelling near injection site, dry skin, dry hair after the 1st dose was administered. The patient also felt very hungry for 1 week after the 1st dose and believed she gained 5 lbs. The patient's mother stated that she picked up the 2nd dose of Gardasil from the pharmacy and stored it in her refrigerator (temp unknown) for 2 days before taking it to the doctor's office. On 15-AUG-2007, post vaccination for the 2nd dose, the patient experienced pain after vaccination that lasted up to 2 weeks. The patient received unspecified medical attention, no diagnostic test were performed. The patient recovered 2 weeks after each vaccination. In follow-up, the vaccination nurse was unable provide no additional information. This is one of several reports from the same source. The reporter stated that the patient had a few friends (number not specified) who received Gardasil and they all complained of pain on the injection arm. One friend still has pain when she gets tapped around the injection area. The friend was injected in June 2007. No additional information is expected.
Site: Bruising at Injection Site-Mild, Additional Details: Pt reports a bruise the size of a quarter on the injection site. No other symptoms, but concern that the discoloration has not gone away for a week.
felt weak; felt hot; her throat went shut; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak), FEELING HOT, OROPHARYNGEAL DISCOMFORT (her throat went shut), MYALGIA (body ache), and HEADACHE in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced ASTHENIA (felt weak), FEELING HOT, OROPHARYNGEAL DISCOMFORT (her throat went shut), MYALGIA (body ache), and HEADACHE. At the time of the report, ASTHENIA (felt weak), FEELING HOT, OROPHARYNGEAL DISCOMFORT (her throat went shut), MYALGIA, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Blood pressure increased: high.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported. Treatment medication include strong antibiotic.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 17 month old female patient. On 13-MAY-2014 the patient was vaccinated with VARIVAX (dose, route not reported) lot # J009987 and expiration date 12-AUG-2015. On 19-JUN-2014, the patient developed a rash. The patient sought medical attention by office visit. At the time of the report the outcome of the event was reported as not recovered. Additional information has been requested.
swelling in her epiglottis; swelling in the larynx; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EPIGLOTTIC OEDEMA (medically significant), outcome "unknown", described as "swelling in her epiglottis"; LARYNGEAL OEDEMA (medically significant), outcome "unknown", described as "swelling in the larynx". The events "swelling in her epiglottis" and "swelling in the larynx" required physician office visit.  Additional information reported that patient's parent wondering if there were any reported side effects from the COVID vaccine regarding swelling in the larynx, specifically the epiglottis. Patient who is 15-year-old, received 2 doses of the Pfizer COVID vaccine and then developed swelling in her epiglottis. She is currently seeing a doctor for this condition but they have not been able to give her a diagnosis as to what caused it.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
alopecia; This case was reported by a other health professional via call center representative and described the occurrence of alopecia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced alopecia. On an unknown date, the outcome of the alopecia was not recovered/not resolved.   It was unknown if the reporter considered the alopecia to be related to Shingrix.     Additional Information: GSK receipt date: 15-OCT-2022 Reporters comment: The reporter reported that the patient received the both doses of the shingrix vaccine experienced alopecia after the first dose and it continued after the second dose. Additional Supportive information: in narrative it was the alopecia started after the first dose, no resolution date was provided and on the contrary he stated that the event continued after the 2nd only one case was created for the 1st dose, no further details were provided
No additional AEs were reported; patients received improperly stored vaccines/temperature: 34.3 F; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.  On 28-MAR-2022, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) route of administration defaulted to oral, lot # U026664, expiration date: 24-FEB-2023 or lot# 1741817, expiration date: 30-JUL-2022 (the nurse did not know which specific lot of vaccines were administered to specific patients) (strength and exact route of administration were not provided) for prophylaxis and improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #U026217, expiration date: 02-NOV-2023 (strength and exact route of administration were not provided) for prophylaxis (product storage error). The vaccines had been improperly stored in the temperature of 34.3 Fahrenheit degrees (F) for 55 minutes with no previous temperature excursion. It was unknown if digital data logger was involved. No additional adverse events were reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA001621: US-009507513-2204USA001657: US-009507513-2204USA001730: US-009507513-2204USA001748: US-009507513-2204USA001791: US-009507513-2204USA001794: US-009507513-2204USA001805: US-009507513-2204USA001806: US-009507513-2204USA001814: US-009507513-2204USA001839: US-009507513-2204USA001848: US-009507513-2204USA001849: US-009507513-2204USA001865: US-009507513-2204USA001888: US-009507513-2204USA001926: US-009507513-2204USA001952: US-009507513-2204USA001980: US-009507513-2204USA001994: US-009507513-2204USA001998: US-009507513-2204USA002003: US-009507513-2204USA002007: US-009507513-2204USA002009: US-009507513-2204USA002019: US-009507513-2204USA002052: US-009507513-2204USA002055: US-009507513-2204USA002072: US-009507513-2204USA002073: US-009507513-2204USA002074: US-009507513-2204USA002075:
No adverse reaction - third dose (full dose of 0.5ml) was administered without proper implications (only risk factor was age above >65).
chills; muscle pain; fever (103 F); This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever (103 F)), CHILLS (chills) and MYALGIA (muscle pain) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever (103 F)), CHILLS (chills) and MYALGIA (muscle pain). At the time of the report, PYREXIA (fever (103 F)), CHILLS (chills) and MYALGIA (muscle pain) outcome was unknown.            Treatment information was not provided.  Concomitant product used was not provided by the reporter.   This case was linked to MOD-2021-072148 (E2B Linked Report). This case was linked to MOD-2021-025595 (Patient Link).; Sender's Comments:  MOD-2021-072148:Husband's Second Vaccine
PT RECEIVED INJECTION IN AM AND BROKE OUT IN HIVES LATER THAT EVENING. HIVES VARIED IN SIZE FROM LARGE (HALF-DOLLAR) TO SMALL (DIME) AND ONLY APPEARED ON THE LEFT ARM BELOW THE INJECTION SITE. PT APPLIED A COLD PACK TO THE ARM WHICH HELPED DECREASE THE SWELLING. SHE REPORTED THE HIVES WERE MILDLY ITCHY BUT TOLERABLE, NOT PAINFUL, BUT TYPICAL ACHEY ARM AS EXPERIENCED WITH ALL PREVIOUS INFLUENZA VACCINATIONS.
Approximately 20 minutes after receiving the vaccinations patient developed swelling of the eyes and hives.  The doctor administered Benadryl and called 911.  Patient was transported to an ED (unknown which hospital or what treatment was performed).
Pain and swelling 24 hrs post injection, developed redness, itchyness and warm to the touch on day 3. Its day 9 and the redness and swelling seems to become bigger and bigger with each passing day. I have been documenting the growth.
Local erythema and induration right upper lateral thigh. Treated with Benadryl and Tylenol.
Generalized hives and whelps - Urticarial allergy reaction plus eyelid swelling, writs/ankle swelling, intense pruritus.
Rash at injection site, applied Neosporin topical ointment. Has not completely healed after 6 weeks.
BMI >54, SOB and productive cough associated with COPD with acute exacerbation, pH 7.29, PCO2 56, PO2 62 on 3L via NC. Wheezing present no rales, chest xray results show no segmental consolidation.
Fever, chills, lethargy. No relief from tylenol. All symptoms within 24 hours of vaccine
Narrative: Patient, died 12/14/2022 at hospital after presentation to ER on 12/9/2022 with Admitting Diagnosis: Respiratory failure Pt had received a covid vaccine EUA (J&J) on 5/3/2021. This death does not appear to be related to the covid vaccine. Reporting since vaccine is EUA status.
Pt recv vax on unknown day;  post vax pt exp deep/ hot vax site rxn
Got Johnson and Johnson shot 4/10/2021:   4/11/21-4/12/21  headache, hot and cold chills  4/13/21- abdominal pain and  shortness of breath 4/14/21- shortness of breath (sob) 4/15/21- headache, pain right side chest 4/16/21- fatigue, pain left side chest 4/17/21- sob (bad) 4/18/21- 4/21/21 sob 4/22/21 -woke up struggling to breath. Family Physician sent me to hospital. She was thinking blood clot lungs 4/23/21-current sob
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Tingling of center part of tongue. No swelling.
Room spinning out of control, dizziness, lightheadness,  naseau,  vomiting,  vertigo, unsteady on feet
09/11/22 presents to ED for "fall". PMHx of "SIADH, HTN, and CAD (on Plavix)"
A 40 year old female who received FluMist on 01/06/2006 with family reported a stuffy nose, achiness, cough and a fever.  No history of close contact with anyone with flu or a cold.  The physician did not treat symptoms and the symptoms are ongoing.
6yo male patient here with mother and brother to check reaction to influenza vaccination. Patient received influenza vaccine on 9/18/23 in the left deltoid and now has a 17cm wide inflammatory reaction at the site. Patient is afebrile and has a little itching at site.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 12:00 (Batch/Lot number: unknown) at the age of 23 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "known allergy: Moderate-Egg white" (unspecified if ongoing); "known allergy: Mild-dairy" (unspecified if ongoing); "known allergy: gluten" (unspecified if ongoing); "known allergy: egg yolk" (unspecified if ongoing); "known allergy: oats" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COUGH (non-serious) with onset 03Aug2021 17:00, outcome "recovered" (2021), described as "Slight cough"; FEELING COLD (non-serious), CHILLS (non-serious) all with onset 03Aug2021 17:00, outcome "recovered" (2021) and all described as "Chills very very cold"; PAIN IN EXTREMITY (non-serious) with onset 03Aug2021 17:00, outcome "recovered" (2021), described as "Very sore arm"; PYREXIA (non-serious) with onset 03Aug2021 17:00, outcome "recovered" (2021), described as "Fever of 101.2 F. Lasting roughly one evening". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, feeling cold, chills, pain in extremity, pyrexia. Additional information: The patient had no Covid-19 prior vaccination and had not tested Covid-19 post vaccination. The patient had no other vaccine in four weeks and no other medications in two weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax & devel fever of 102 2hrs post vax which lasted 48hrs & didn't respond to anti-pyretics;pt also devel a red rim around inj site & a large amount of edema in the thigh;mom reported thigh was twice the nl size & painful to touch
Lymph node swelling on day 7. Lasting to day 14; Back ache; fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A 41-year-old non-pregnant female patient received  first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 16Jan2021 12:45 (Batch/Lot number was not reported) as 1ST DOSE,SINGLE for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient had no known allergies. The patient had no other vaccine within 2 to 4 weeks. The patient was not diagnosed with COVID-19 prior to vaccination and since vaccination. The patient experienced lymph node swelling on day 7. lasting to day 14, back ache and fatigue on 23Jan2021. The patient did not received any treatment. The outcome of the events was recovering.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
left side neck pain; numbness and tingling on the left side of my body; tingling in my fingertips (both hands); very tired; muscle aches; low grade fever; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events( hemidysaesthesia, paraesthesia, neck pain, fatigue, myalgia, pyrexia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On jan142021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Lot/batch: unknown) intramuscularly in the anatomical location for the prophylaxis of COVID-19 infection.  On 21jan2021 the patient experienced the event hemidysaesthesia with medically significant seriousness criteria.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was unknown.; Reporter's Comments: This case concerns a female of unknown age who experienced medically significant and serious unexpected event of hemidysaesthesia along with a NS unexpected neck pain, paraesthesia and NS expected pyrexia, fatigue, myalgia. The events occurred 8 days after the first dose of mRNA-1273. Treatment and event resolution not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Within three minutes of 2nd dose of vaccine, my lips  began tingling.; Soon roof of mouth, lips and tongue went numb; This is a spontaneous report from a contactable consumer, the patient. A 39-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 28Apr2021 at 13:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported.  Concomitant medications were not reported. The patient previously took cefalexin (KEFLEX) on an unknown date and experienced drug allergy. The patient previously 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 07Apr2021 at 09:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. 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. On 28Apr2021 at 13:03, within three minutes of second dose of vaccine, the patient experienced lips and tongue tingling. Soon roof of mouth, lips and tongue went numb, which lasted for an hour or so. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tingling in lips and tongue, numbness in roof of mouth, lips and tongue was recovered on 28Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Immediate pain in right upper arm following vaccine administration. Patient reports persistent symptoms of right upper arm and shoulder pain with movement at 4 weeks post-vaccination