chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fatigue; mild headache; elevated temperature; sweating concurrently with temperature; very sore arm; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date patient experienced fatigue, mild headache, elevated temperature, sweating concurrently with temperature, very sore arm. It was reported that in the evening after receiving the vaccine, patient reported fatigue, mild headache, and elevated temperature (patient reported sweating concurrently with temperature). The morning after receiving the vaccine, patient reported very sore arm. Outcome of the events was unknown.  The batch/lot number for the vaccine, BNT162B2, is not available despite the follow-up attempts made.
No adverse event; HCP stated they administered a dose of Moderna COVID-19 Vaccine on 14-MAR-2023 but the vial expired on 12-MAR-2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a dose of Moderna COVID-19 Vaccine on 14-MAR-2023 but the vial expired on 12-MAR-2023.) and NO ADVERSE EVENT (No adverse event) in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a dose of Moderna COVID-19 Vaccine on 14-MAR-2023 but the vial expired on 12-MAR-2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a dose of Moderna COVID-19 Vaccine on 14-MAR-2023 but the vial expired on 12-MAR-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they administered a dose of Moderna COVID-19 Vaccine on 14-MAR-2023 but the vial expired on 12-MAR-2023.).    No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP stated no Adverse' s event were reported No treatment information was provided.
body aches and muscle cramps, especially in legs and shoulders 12ish hours after; swollen and very sore lymph nodes in armpits beginning 12 hours after and lasting 4 days, chills and low grade (99*) fever 30ish hours after vaccine, lethargy and brain fog for 48 hours.
pt recv vax; 10 hr of cont screaming, nonresponse to comforting; apap or local care to inject site;
Child inadvertently given an expired dose of ProQuad.  Vaccine expired on 05/09/2022, and was given on 05/16/2022.  Telephone call to mother to report vaccine error.  Pt.'s mother reported no adverse effects and stated she would bring pt. back to the office on 06/13/2022 for re-dosing of vaccine.
2hrs p/vax in mom's arms had abd heaving-then stiffened, then pale & flaccid for several mins then OK; to ER by Ems-ok-ok today @ PMD
Joint pain in left wrist. Joint pain in knuckle of left hand at ring finger. Involuntary movement of left ring finger when making a fist (intermittent). Weakness in left hand and left hand ring finger.
myalgia, headache, and necrotizing adenopathy. Right axilla. Warm pack application, Augmentin po bid x 7 days, monitor and follow up to PCP.
Rapid heart rate, dizziness, light headed, felt like i  was going to pass out - lasted a few minutes then went  away. Maybe I was having a panic attack?
4hrs later entire body became itchy, HR increased to 118 when she noticed the hives-she thinks it could be r/t the anxiety; hives were noted on her back, on her stomach; all resolved within 3 hrs.  Lt arm site of injection was slightly sore.   Did not take any OTC medication or take any actions....self limiting
Patient was accidentally given Kinrix (containing polio vaccine) at the same time as IPOL Polio Vaccine. Called and spoke with patient's mother. She states that patient had sore arms on 9/13/22, but today, 9/14/22, he is doing well with no symptoms.
The day after receiving 1st dose, patient experience burning pain at injection site which radiated to chest
This spontaneous report was received from a medical assistant, concerning unspecified patients of an unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unspecified date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot #, expiration date, strength, dose, route of administration or anatomical location were not reported) for prophylaxis. The storage temperature was reported as 9 to 25 degrees Celsius (°C) for a time frame of 32 hours and 19 minutes. There was no previous temperature excursion reported. No adverse effects were reported. This is one of two reports received from the same source. No product quality complaint (PQC) was involved. Additional information is not expected as there was no consent to contact the reporter.; Sender's Comments:  US-009507513-1706USA003747:
Headache, Myalgia, Fever, sore arm, sweating, stuffy nose Narrative:
About 1 and 1/2 month later on 4/4/2021, I got a rash on my head and came down on my right side and chest and back. It was very itchy, red and very painful. I went to the dermatologist right away and was diagnosed with Shingles infection. The doctor gave me an injection (don't remember name) and prescribed Valtrex and Pepcid. The medication did not help resolve the shingles and it got worse. I went to the hospital 4/6/2021 and I was admitted to the hospital for 7 days.  I was admitted because I was dehydrated and had an allergic reaction to the shot the dermatologist gave me. I also pneumonia and septic.  They ran every test they could run and gave me antibiotics for the pneumonia and infection. I was discharged to follow up PCP.
pt recv vax 18MAR96 & later devel case of varicella wild;
Patient reported feeling short of breath and lightheaded within 1-2 minutes after the vaccine. Her pulse was not elevated. After a few minutes, her breathing had returned to normal, but she was complaining of back pain. She was provided an ice pack which she said helped. First responders were called as a precaution and upon their arrival and evaluation her BP was 120/60. The first responders evaluated the patient and did not feel she needed further care at that time. She was provided a quiet room to relax in and after 5-10 minutes she was comfortable with leaving.
discomfort in the elbow; swelling on the outside and inside of her elbow; swollen lymph node; A spontaneous report was received from a consumer concerning herself, of unknown age, female patient who experienced discomfort in the elbow/musculoskeletal discomfort, musculoskeletal discomfort/joint swelling, swollen lymph node/lymphadenopathy.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   The patient received their second of two planned doses of mRNA-1273 (Batch number: Unknown) on 25 Jan 2021 at unknown injection site for prophylaxis of COVID-19 infection.    On 25 Jan 2021 the patient discomfort in the elbow of the arm where she got the injection. Later that evening, she noticed a swelling on the outside and inside of her elbow. It was larger and harder but did go down a bit and was still swollen. She thought it was a swollen lymph node and wanted to make sure this was normal. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events discomfort in the elbow, musculoskeletal discomfort, swollen lymph node was not provided.
Information has been received from a physician concerning a 7 month old female patient who on 05-MAR-2008 was vaccinated orally with a second 2ml dose of ROTATEQ (lot # 659775/1664U). The first dose of ROTATEQ (lot # 657518/1192U) was administered on 18-NOV-2007. Subsequently, on 27-APR-2008 the patient had intussusception and was hospitalized until 29-APR-2008. It was unspecified if lab studies were performed. A surgical correction was done and the patient recovered on an unspecified date. There was no product quality complaint involved. Additional information has been requested.  8/11/2008 MR received for DOS 4/28-29/2008 with D/C DX:  Intussusception. Infant presented with 24 hr hx of frequent emesis, intermittantly green with blood. Fussy for several days prior to admit. Later had bloody stool in hospital. Surgical consult noted fullness to abdomen with mass effect on R. BE done which identified and reduced an ileocecal IS. PO advanced post-procedure, tolerated well.
pt recv vax 5JAN98 & 26JAN98 pt devel a rash in the groin area that became extremely itchy;
Positive Covid w/symptoms on 10/30.  Sore throat, dry cough, weakness/fatigue, congestion and sinus pressure, some tightness in chest. Paxlovid started on 10/30 in the afternoon (4pm). Symptom decrease through time to approx baseline by 11/6 (negative antigen test on this date). Some sinus congestion and fatigue persists.
Feeling very sleepy; Tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Feeling very sleepy) and FATIGUE (Tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced SOMNOLENCE (Feeling very sleepy) and FATIGUE (Tired). On 25-Mar-2021, SOMNOLENCE (Feeling very sleepy) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported. No treatment information was provided.
sinus; tested positive on 18Feb2021; This is a spontaneous report from a contactable consumer (reported for herself) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (solution for injection, Lot number was not reported) via an unspecified route of administration on 05Feb2021, as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 18Feb2021, the patient was tested positive, without fever and no chills, only sinus. She was under quarantine for 10 days; quarantine would be finished by 28Feb2021. Her second dose was scheduled on 01Mar2021. The outcome of the events of tested positive for Covid and sinus was unknown.  No follow-up attempts were possible. No further information was expected.
The patient received the immunization on 10/21/2017. He was complaining that the injection site muscle was still sore on 11/10/2017.
hives-- all over body. never experienced before. confirmed they are hives at urgent care. the hives come and go, worse at times and better at times.  really debilitating.
This spontaneous report as received from an office manager refers to a four unspecified patients of unknown age and gender. No concurrent conditions and medical history reported. On 21-JUL-2015, four unspecified patients were vaccinated with improperly stored (Oka/Merck) VARIVAX lot # L012034, expire date 07-APR-2017. No concomitant medications reported. No adverse effects were reported. Additional information has been requested.
Pt recvd 3 doses of HIB (3rd given 24APR92) & on 26MAY92 devel HIB meningitis; hospitalized for approx 10 days; tx included IV Rocephin & steroids;
feeling tired; injection site soreness; chills; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th June 2019, the patient received Shingrix. On 18th June 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and chills. On 19th June 2019, the patient experienced tiredness. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, chills and tiredness were unknown.   It was unknown if the reporter considered the injection site pain, chills and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On 18th June 2019, the patient experienced chills and soreness around the injection site. On 18th June 2019 evening, the patient took ibuprofen 600mg and was able to sleep. On 19th June 2019, the patient still felt very tired. The patient referred back to the health care professional if symptoms persist. This was all the information collected.
I had a cough that I could not explain, a runny nose and headache. I tested because I was going to lunch with some friends and the home COVID 19 test came back negative. I went to lunch and later that evening started to run a low fever so I decided to test again, this time the test came back positive. I called and had a virtual appointment with my doctor on Wednesday she prescribed PAXLOVID, I am feeing better, I actually started feeing better after the first dose.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 26-APR-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Patient first passed out, then began having a seizure. The seizure lasted 20-30 seconds but was not particularly violent. After the seizure ended she was in shock, but otherwise reported to feel fine. We observed her and let the patient have some water, but provided no other interventions. The patient left after 15 minutes of her own volition without speaking to any staff.  She reported no history of seizures and confirmed this verbally after the adverse reaction.
pt brought to ED via EMS from SNF with fever, SOB, AMS; O2 supplementation; septic shock secondary to aspiration pneumonia; found to be positive for COVID; given ABX; placed in ICU for vasopressor support; dexamethasone; encephalopathic; pt had increase in O2 needs; repeat CT (head) showed extensive area of stroke left MCA, likely subacute with evolving infarct; family transitioned pt to comfort care only; he passed away in the hospital
Pt recvd 3 doses of Engerix-B, 3rd dose given 30OCT90 & it was determined that pt did not convert to a protective surface antibody level;
9/23 Patient received 0.3 ml of unreconstituted vaccine.  Approximately 2 hours after injection, pt complained of chest heaviness, and nausea.  Advised to take Claritin, and increase fluid intake as tolerated.  Later that evening denied chest pain, SOB, fever, or difficulty swallowing.  9/24 Seen by PCP, reported sleeping more than usual, V & D, and ongoing chest heaviness.  Referred to ER.  Cardiac testing unremarkable.  Diagnosed with UTI and treated for same.  Discharged home with family
On 07/07/2022 I started to experience, I had sharp pain on my kidney. I can't sit up. I can't do anything. On 07/14/2022 I thought I pulled a muscle and I thought I had kidney stone. 07/27/2022 I was diagnosed with bladder infection. She prescribed me antibiotics for 10 days. On 08/03/2022 the bacteria was gone but the sharp pain was getting worse. She ordered an ultrasound because she thought it was a kidney stone. She ordered some labs to see if it was a kidney stone or not. I went back on 08/12/2022 and on left side of my kidney there was a kidney cyst size 3.5 centimeters. On 08/18/2022 am going back to my doctor to see what should be done with my cyst. I will find out if I any procedure needs to be done.
Pt received immunization in (L) arm exited exam room 3 minutes later. Walked down the hall to the rest room and felt dizzy she was assisted to the floor without injury and quickly came around. She was moved to an exam room where a neuro exam was done before pt left the building.
She got her vaccine, area was about the size of a half dollar, no rash or black or blue, and by afternoon she felt like her arm was hit by a baseball bat.  Then pain went from her ear to the pinky of her left arm.  The following afternoon it was from her ear all the way down her left side to her toes.  She has chronic pain back and neck issues.  She went to the ER and was totally upset, called the nurse line and they told her to go into the ER.  She was upset as she had spoken with a specific nurse and couldn?t she got upset.  The doctor was rude and said that she was rude and told her that he would put in his notes that she was rude, and he told her that he would not treat her.  He told her that she was experiencing flu-like symptoms.  He told her that it was a reaction to the vaccine and that she would get over it.  It lasted until Sunday, yesterday 1/22/22 and about 2:00 PM it instantly went away.  It didn?t go on the left side of her body, and it did not help which is on pain medicine for her chronic pain.  She took several medicines and nothing helped.  She told him that she had tried everything, and needed something to  help her and he refused and said he would not give her drugs and that she wanted advice and he wanted her out of his ER.     Had lab work the day of the vaccine, establishing care with new provider as previous one retired.
RECEIVED ANTHRAX VACCINE ON 14 APRIL 03.  PT FEELS PAINFULL ARM SWELLING THAT AFTERNOON.  ERYTHEMA 4X5.5 IN ON LEFT UPPER ARM WORSENED.  TREATED WITH KEFLEX 500MG QID X 10 DAYS.
received vaccine, breastfeeding the whole time; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (received vaccine, breastfeeding the whole time) in a 10-week-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Concurrent medical conditions included Maternal exposure during breast feeding.    No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced EXPOSURE VIA BREAST MILK (received vaccine, breastfeeding the whole time). At the time of the report, EXPOSURE VIA BREAST MILK (received vaccine, breastfeeding the whole time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Pt recvd 3 doses of Engerix-B vax 12JUL91, 12AUG91 & 22JAN92 & pt did not exp any events following 1st dose; following both 2nd & 3rd dose exp redness radiating from the inject site to the upper arm (almost to shoulder) which was very itchy
Hard red area appx 2" in diameter at site of injection. Dr. concerned about cellulitis in area concerned prescribed cephalexin 500mg.
Minimal side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minimal side effects) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-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 VACCINATION COMPLICATION (Minimal side effects). At the time of the report, VACCINATION COMPLICATION (Minimal side effects) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) dosing remained unchanged.       No concomitant medications were reported No treatment medications were reported   This case was linked to MOD-2021-383001 (Patient Link).
Vaccine administered to 17-year-old male patient; arm soreness; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17-year-old male patient) and VACCINATION SITE PAIN (arm soreness) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17-year-old male patient) and VACCINATION SITE PAIN (arm soreness). On 15-Feb-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to 17-year-old male patient) had resolved. On 16-Feb-2021, VACCINATION SITE PAIN (arm soreness) had resolved.        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.   Treatment information was not provided.  This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # 015M20A with associated AE vaccination site pain.; Sender's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273, lot # 015M20A with associated AE vaccination site pain.
Pain at injection site started on 8/28 (evening). Fever, body aches, dizziness on 8/29 (morning).
Headache, dizziness, temporary tingling and numbness of lips and loss of smell;  foggy brain , inability to complete sentence and thoughts lasting 3-5 hours with slightly slurred speech
Patient started to feel right leg pain the evening of 3/2/2021, four days after receiving the COVID-19 vaccination. Patient came to the ER where a DVT was discovered in the right popliteal, peroneal, and posterior tibial veins. Patient was given apixaban 10 mg x1 and a prescription to continue apixaban outpatient. Patient was discharged from ER to home.