chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ache in the arm; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (ache in the arm), CHILLS (chills) and HEADACHE (headache) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050D22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE for an unknown indication.    Interstial Lung disease related to Rheumatoid Arthritis Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 14-Jan-2022. Previously administered products included for COVID-19 vaccination: COVID-19 vaccine (1st dose) and COVID-19 vaccine (2nd dose). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine and COVID-19 vaccine. Concurrent medical conditions included Rheumatoid arthritis-associated interstitial lung disease and Interstitial lung disease.   On 07-Dec-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient received dose of COVID-19 VACCINE (unknown route) 1 dosage form. On 11-Dec-2022, the patient experienced MYALGIA (ache in the arm), CHILLS (chills) and HEADACHE (headache). At the time of the report, MYALGIA (ache in the arm), CHILLS (chills) and HEADACHE (headache) was resolving.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Patient received  two COVID vaccines previously. On 12-Dec-22, five days later, patient woke up to extreme chills and had to put on extra layers to warm up. That day had an extreme headache, diminished after 7 hours. Patient had the same chill before but they were within 24 hours of injection. The patient did not experience any additional symptoms/events. No treatment medications were reported.
had interrupted sleep the entire time; got a sore throat; bad cold; congestion; Initial information received on 03-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional via social media.  This case involves patient (Adult and unknown gender) who had interrupted sleep the entire time (sleep disorder), got a sore throat (oropharyngeal pain), bad cold(nasopharyngitis) and congestion (nasal congestion) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   Concomitant medications included COVID-19 VACCINE for Immunisation.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not provided) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "had interrupted sleep the entire time" (sleep disorder), got a sore throat (oropharyngeal pain), bad cold(nasopharyngitis) and congestion (nasal congestion) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "Got my flu shot September 22, got a sore throat the following Friday which turned into a bad cold & congestion which i still have to this day. I've had interrupted sleep the entire time. I had flu shots for 25 years & never had this problem. Yes, I've had both Covid shots earlier this year."  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported events.  There will be no information on the batch number for this case.
Shingles; Information has been received regarding a case in litigation from an attorney reporting on a patient (pt) of unknown age and gender. There was no information about the pt's concurrent conditions, medical history or concomitant medication.  In 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) as prescribed and/or administered by a healthcare provider at the office of a physician for the long-term prevention of shingles and/or zoster-related conditions (dose, route of administration, lot number and expiration date were not reported).  Subsequently to the pt vaccination with zoster vaccine live (ZOSTAVAX), on an unknown date, the pt was treated by a healthcare provider (HCP) for shingles. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome shingles was not provided.
Adverse event: Vaccine administered 6 days after beyond use date and less effective. Treatment: Pt is receiving another dose in office as recommended by Pfizer and the state.
after sitting him to wait 15 min he passed out and fell out of his chair.  Pale, sweaty and nauseated but did not throw up.  Said it was his needle phobia.  Called later after the episode was over and he drove home to tell me his head hurt when he chewed so he would assume his head hit the floor.
Redness, warmth and pain in right arm, noted on 12/16/00. Pt applied ice and took Tylenol on 12/16/00. Reaction lasted approx. 3 days. Required no medical attention. Follow-up call on 12/19/00, pt states fully recovered.
This patient presented to the Emergency Department accompanied by her significant other, from urgent care, via private vehicle with a complaint of abdominal pain and bloating, nausea and vomiting. The patient stated symptom for past 3 days.  She denied shortness of breath per se, but stated that when she took a deep breath, it felt limited due to the abdominal distention. She denied dysuria, hematuria, black or bloody stool. She stated last night, she began having some left low back pain and left posterior shoulder pain. Denied fevers. Patient stated a s light sore throat. Patient was positive for COVID-19 FULLY VACCINATED AND BOOSTERED last Pfizer booster was 7/30/2022.The patient was admitted to the hospital for further evaluation and management of Type 1 Diabetes, Diabetic Keto Acidosis and suspected Acute Kidney Injury and COVID-19 infection. FOR ANY FURHTER INFORMATION, CONTACT PROVIDER. PUBLIC HEALTH DEPARTMENT DOES HAVE ANY ADDITIONAL INFORMATION ON PATIENT OUTCOME.
The next day after the vaccine, I had a rash on the injection site that lasted 24 hours. This has happened on the first dose that was reported as well but was much worse. I put cortisone cream on the site which did help the itching.
pt recv vax 4SEP96 & devel fever 101-103 12SEP, 13SEP, 14SEP, 15SEP;pt was brought to ER on 15SEP96 & was noted to have gen fine rashes on body & extremities & also was dx w/OM;ATB & DPH prescribed;
Swelling around injection site - size of golf ball and warm to the touch, concerned it may not have been injected deep enough
Patient reported a racing heart, pounding heart, and chest ache. It was suggested the patient see his MD immediately, and get back to us. Patient has not returned out call to let us know what tests, treatments, or outcomes he received.
THE PATIENT STATED THAT HER ARM WAS VERY SORE AND WARM TO THE TOUCH AND DIFFICULT TO RAISE HER ARM.
Pain at injection site; This is a spontaneous report from a contactable consumer (patient herself). A 32-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 26Jan2021 at 11:45 as a single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was not pregnant at the time of vaccination. Concomitant medications included ibuprofen (ADVIL), paracetamol (TYLENOL), and multivitamins (unspecified); also reported as medications that the patient received within two weeks of vaccination. The patient previously took amoxicillin and Cefzil and experienced drug hypersensitivity. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination. The patient experienced pain at injection site on 27Jan2021. The patient has not tested positive for COVID-19 since the vaccination. The patient did not receive any treatment for the event. Outcome of the event was recovered. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).
Patient received vaccine on 09/08/2017 and woke up the next morning 09/09/2017 with a rash at site of infection. Several hours later that rash progressed to swelling of the right arm. Following the swelling of the arm patient began to develop pruritus in abdominal region.
Coughing up blood; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the right arm on 20Mar2021 at 13:00 (at the age of 70-years-old), as a single dose for COVID-19 immunisation. Medical history included Hepatitis C, emphysema and penicillin allergy. Concomitant medications included calcium (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN) and vitamin b12 (MANUFACTURER UNKNOWN); all for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 06:00, the patient was coughing up blood when she woke up. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the event. The clinical outcome of the event coughing up blood was recovered on 22Mar2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant medications was not provided. It was reported that on 29-OCT-2015, the patient was administered (Merck) VARIVAX (lot # K011082, expiration date: 08-AUG-2016, dose and route were not provided), that was improperly stored (temperature: 24.3 F, time frame: 57 hours; there was no previous temperature excursion). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given second dose 5 days early. First shot was on 4/22/2021 and second shot was given 5/8/2021. Patient did not experience any adverse effects
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unknown age and gender. No information on the patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23, lot # M037533 with expiry date on 07-MAY-2018, and lot # N010109 with expiry date on 20-NOV-2018 (dose and route of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 35.2 degrees Fahrenheit for 15 days. Data logger was involved in recording the excursion details. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007335: US-009507513-1709USA004696.
Thinks she had night sweats after 1st dose; she is so sick after the 1st dose; Threw up all night long after 1st dose/Throwing up everything after 1st dose; Thinks she had fever after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Thinks she had night sweats after 1st dose), ILLNESS (she is so sick after the 1st dose), VOMITING (Threw up all night long after 1st dose/Throwing up everything after 1st dose) and PYREXIA (Thinks she had fever after 1st dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (Thinks she had night sweats after 1st dose), ILLNESS (she is so sick after the 1st dose), VOMITING (Threw up all night long after 1st dose/Throwing up everything after 1st dose) and PYREXIA (Thinks she had fever after 1st dose). At the time of the report, NIGHT SWEATS (Thinks she had night sweats after 1st dose), ILLNESS (she is so sick after the 1st dose), VOMITING (Threw up all night long after 1st dose/Throwing up everything after 1st dose) and PYREXIA (Thinks she had fever after 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she thought she received Johnson and Johnson but later she was informed that she received Moderna COVID 19 vaccine.  No concomitant medications were reported. No treatment details were reported.
4inx6in area (L) deltoid/arm redness, warmth around vaccination site. Symptomatic care. No systemic signs or symptoms.
This is a spontaneous report from a contactable physician who reported for himself. This 71-year-old male patient received PREVNAR 13 via intramuscular route of administration, in left deltoid, at the age of 70 years, on 19Oct2015, at 15:00, at 0.5 ml single. It was given 9 days too early. Medical history was not reported. No vaccines were given on same date along with suspect vaccine. Vaccination given within four weeks included influenza vaccine. He concomitantly received a lot of medications and took cardiac stuff like a beta blocker. The patient received PNEUMOVAX 23 after the age of 65-years, but prior to receiving PREVNAR 13. The patient experienced early pneumonia in Feb2016 with outcome of resolved in Mar2016. The primary infection site was in lungs. Clinical course was reported as follows: The patient stated that he received PREVNAR 13 and he became severely ill several months after the vaccine. No cultures were done but it might have been early pneumonia. He was given 10 days of LEVAQUIN as treatment. The patient was diagnosed with early pneumonia in early Feb2016. He was treated by a physician at an emergency care center. No admission to hospital was involved. A chest X-ray done at the emergency care center in Feb2016 showed either atelectasis or a little pneumonia. The patient had no fever, just had terrible cough and phlegm that would not stop. Phlegm was always clear. He had symptoms for 10 days before seeing the doctor. The cough lasted a month. After two weeks, he started to feel better and his symptoms gradually reduced. The physician did not feel the early pneumonia was related to PREVNAR 13. Follow up (23Jun2016): New information from the same contactable physician includes: vaccination time, route of administration, details about treatment received and lab data details. Follow-up attempts completed. No further information expected. Follow-up (14Jul2016): Follow-up attempts completed. No further information expected.
Swollen lymph node on the side of injection. 99.9 fever and body aches. Tylenol and ibuprofen.
tested positive for Covid-19; I took her in to see the Dr for a urinary tract infection; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 30-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) (seriousness criterion medically significant) and URINARY TRACT INFECTION (I took her in to see the Dr for a urinary tract infection). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), URINARY TRACT INFECTION (I took her in to see the Dr for a urinary tract infection) and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  It was reported that the patient had been feeling weak a few days before getting the vaccine.  Patient was treated with one dose of IV Bamlanivimab etesevimab to treat Covid.and was sent home.  Company comment: SARS-CoV-2 test: positive is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-138839, US-MODERNATX, INC.-MOD-2021-138859 (E2B Linked Report).; Sender's Comments: SARS-CoV-2 test: positive is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-138859: US-MODERNATX, INC.-MOD-2021-138839:Crosslink
Shortness of breath after 2nd dose; Heart palpitation after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (Shortness of breath after 2nd dose) and PALPITATIONS (Heart palpitation after 2nd dose) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced DYSPNOEA (Shortness of breath after 2nd dose) and PALPITATIONS (Heart palpitation after 2nd dose). At the time of the report, DYSPNOEA (Shortness of breath after 2nd dose) and PALPITATIONS (Heart palpitation after 2nd dose) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.
This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions, allergies or concomitant medications reported. On 20-JUN-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, frequency and route of administration were not provided) lot # M027348 with expiration date of 27-JUL-2017, that were reconstituted with diluent MRK (injection; lot # L005461 with expiration date of 28-OCT-2017), for prophylaxis. The temperature of the ZOSTAVAX was between 15 °F and 46 °C for a time frame of 96 hours. No previous temperature excursion occurred. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
Pt was given an expired vaccine Tdap (exp 10/8/22) Boostrix Pt did not have any adverse reaction
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown ages and genders. On an unknown dates the patients were vaccinated with VAQTA (route, dose number, dosage and lot number unkonwn) that was improperly stored. No adverse effects were reported. The physician also reported that improperly stored PEDVAXHIB (MARRS no. 1410USA006928) and GARDASIL (MARRS no. 1410USA003800) were also administered. This is one of three reports on the same reporter. Additional information has been requested.
Admitted to hospital for slurred speech and unsteady gait. Tested Covid(+) 9/23/2021, PTA patient had chills for 2 days.
Information has been received from a physician concerning three patients who were vaccinated with Rotateq 2.5 ml PO to prevent Rotateq. The physician reported that all three patients experienced intussusception and were hospitalized. The length of hospitalization was unknown. The three patients requires surgery to correct the intussusception but the outcome of the surgery and the type of surgery is unknown. Intussusception which required surgery was reported to be an other important medical event. Additional ifnormation has been requested.
Systemic: Exhaustion / Lethargy-Medium, Systemic: Tachycardia-Medium, Additional Details: patient stated she had trouble walking home and ended up needing to go to emergency room
Severe chills, shaking from chills that started 12-hours post shot and lasted for 12-hours