chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath; tension on back; sore arm at injection site immediately after the 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), BACK PAIN (tension on back) and VACCINATION SITE PAIN (sore arm at injection site immediately after the 1st shot) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009b21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced DYSPNOEA (shortness of breath), BACK PAIN (tension on back) and VACCINATION SITE PAIN (sore arm at injection site immediately after the 1st shot). At the time of the report, DYSPNOEA (shortness of breath), BACK PAIN (tension on back) and VACCINATION SITE PAIN (sore arm at injection site immediately after the 1st shot) outcome was unknown.        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 Relevant concomitant medications was reported.  Treatment information was not provided.
malaise; soreness at injection site; Body temperature increased; This case was reported by a consumer and described the occurrence of malaise in a 83-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise, injection site muscle pain and body temperature increased. On an unknown date, the outcome of the malaise, injection site muscle pain and body temperature increased were unknown.   It was unknown if the reporter considered the malaise, injection site muscle pain and body temperature increased to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced the symptions like the body temperature was recorded as 99.3 degree F, general malaise and muscle soreness other that the site of the injection. The patient asked how long could expect the symptions. Fore assistance the chat was directed to a Shingrix product specialist. The pharmacist asked the patient to take note that anything they chat about should not be taken as medical advice. The pharmacist refered the patient to the patient's health care provider as their primary resource for patient care.      Lab Comments: On an unknown date, the patient's body temperature was recorded to be 99.3 degree F.
Weird headache at top of head which would come on quickly for a minute or two then vanish and repeat every 10-15 minutes or so. Very tired. Had started menstrual cycle on March 17, but post vaccine it was lighter than normal and then on the 22nd it became very heavy and there were lots of large blood clots. This has lasted an additional three days. My cycle usually lasts 5-7 days but day 2/3 are the heaviest and it?s usually very light by day 6/7. I have not had blood clots in several years. These are very large.
Child received DTAP-IPV-HIB and Hep A on 3/34 at will 3 hr later developed vomiting, crying no fever then hives on chest and back. No known exposure to anything else. No fever.
Temperature 105.2F, headache, chilling then, on 10/5/16 at 9:00 AM parent notices pt. talking loudly, possible hearing difficulty, on 10/5/16 at 3:15 PM pt woke from nap screaming and thrashing arms & legs, unable to calm, motioned she needed to urinate, when she did speak said "don't touch me", "I'm cold" mother suspects it was a possible seizure, lasted appr. 4min.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 15-AUG-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N023828 and expiration date 25-JUN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 17-JAN-2013 at 07:45, ZOSTAVAX lot # H01999 was exposed to -14C for an estimated total time out of range of 14-25 hours. On 30-JAN-2013 at 18:00, ZOSTAVAX lot # H01999 was exposed to -14C for an estimated total time out of range of 10.5 hours. On 04-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to exact time not recorded, noted as equal to or > 12C for an estimated total time out of range of 10.5 hours. On 12-MAR-2013 at 17:00, ZOSTAVAX lot # H019999 was exposed to -14c for an estimated total time out of range of 9.25 hours. On 13-MAR-2013 at 18:00, ZOSTAVAX lot # H019999 was exposed to -14C for estimated total time out of range of 10.5 hours. On 10-APR-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number H019999). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Fever, severe chills, very nauseous, lower stomach pains, pain in arm from shoulder to elbow (couldn't use), exhausted, passed out. Had shot 10:20 in morning that day around 6 pm - 6:15 started feeling really bad. Next morning at 7:30 is when I passed out. Felt pain across the braline and stomach.
Client reported signs and symptoms began 12-18 hours, post vax. Complained of palpitation and problems breathing like panic attack, lasting approx. a couple of hours.
Within less than one minute of receiving the influenza vaccine, the patient had a snycopal episode in which he went limp on the exam table. Woke up within a few seconds. His vital signs were taken and his blood pressure and heart rate were normal. He recovered to his baseline within 1-2 minutes, and was then observed for 30 minutes after, and given orange juice and graham crackers.
Client received immunizations without problems. Approx. 5-10 minutes later, after her sister had received an immunization, she was sitting on mother's lap and suddenly became limp.  She was assisted to lay down on the floor by mother and myself.  Within moments her eyes opened and she said, What just happened? She was assisted to lay down on exam table and cool packs were applied to back of neck and abdomen.  She was somewhat clammy and complained of nausea.  These symptoms subsided within a few moments.  She sat up for a few minutes, then asked to lay down again due to feeling nauseous.  Again the nausea subsided and she sat for a few minutes before leaving at 5:00 p.m.
Swelling and bruising at injection site, fatigue, sore, fever (102°) headache
very hot; left arm and shoulder hurt; whole body aches; little bit of cough; fever (temperature was not taken); headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (very hot), LIMB INJURY (left arm and shoulder hurt), PAIN (whole body aches), COUGH (little bit of cough) and PYREXIA (fever (temperature was not taken)) in a 27-year-old male 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced FEELING HOT (very hot), LIMB INJURY (left arm and shoulder hurt), PAIN (whole body aches), COUGH (little bit of cough), PYREXIA (fever (temperature was not taken)) and HEADACHE (headache). At the time of the report, FEELING HOT (very hot), LIMB INJURY (left arm and shoulder hurt), PAIN (whole body aches), COUGH (little bit of cough), PYREXIA (fever (temperature was not taken)) and HEADACHE (headache) outcome was unknown.            No concomitant medications reported by investigator.   patient drunk a lot of water, no other treatment medications provided by the reporter.   This case was linked to MOD-2021-133190 (Patient Link).
2 white bumps around where vaccine was administered. Pt also has a red area about 2x4. She says it doesn't itch & is not painful. Pt will start to use Hydrocortisone cream.
Pt recvd 1st dose of Hep B vax on 22MAY91 & on 28MAY91 pt devel severe hives over entire body; tx DPH & Atarax; sx lasted x 3 days;
The patient fainted at around 1:10pm (for less than<5 sec.). Per father, son has a history of fainting with vaccines. The patient was reclined on chair and I waited until the patient was completely responsive. No treatment necessary. Symptoms subsided, and patient left the store/pharmacy after more than 30 minutes of wait time.
No additional AE reported; Nurse reported two temperature excursions on multiple refrigerated vaccines.  There was a prior excursion on 5/3/2022 and a recent excursion on 5/26/2022.  She said it was very likely all vaccines had been administered since the excursions occurred.; This spontaneous report has been received from a nurse, concerning a 12-months-old male patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 03-MAY-2022, the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # U014656 experienced a temperature excursion of 47.3 Fahrenheit degrees (F) for 5 minutes, if a digital data logger was involved was not reported (product storage error).   Consequently, on 24-MAY-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot number reported as U014656 confirmed as valid, expiration date reported and stablished as 07-MAY-2023) administered as prophylaxis (formulation, strength, dose, vaccination scheme, route of administration and anatomical location were not provided) (product storage error). No additional adverse events (AE) reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2206USA001103:
She got her vaccine, had a sore arm which she took Tylenol for.  The next morning she had fever to 102.3 throughout the day, chills, body aches, couldn't get warm, couldn't hold food down, tried to stay hydrated and drink water, and then tried to eat toast or crackers and threw up twice.  Was mostly shivering under 5 blankets with hat and gloves and couldn't do much, pretty out of it, light headed and dizzy the entire day.  At 11:00 PM her fiance checked on her and threw up again and after that she went back to sleep and slept throughout the night.  The next day 5/2/21 she felt so much better, still felt light headed but was able to eat, able to hold food down, her fever started going back down throughout the morning, she did not have the body aches and chills.  The pain in her arm then transferred to her underarm and lymph node.  Had APT with her oncologist who told her it was normal, and that everything she experienced was normal and advised her to get the 2nd one.   By the next day she was well enough to go out to dinner, but felt very tired, a little light headed.  She still felt light headed for her oncology APT on Monday, thirsty, a little tired but was able to drive herself.  Today, 5/4/21 she can actually lift her arm higher and has less pain that she did yesterday.    She has also noticed that she has some hair loss, more so than usual in clumps.  She did have COVID in December for a month, and she had to go on oral steroids for that.  She was not hospitalized but she did have low grade fever spikes every day for 2 weeks.  She had a telehealth APT and they gave her oral steroids which did help.
Pt. recieved vaccine greater than 12 hours after being drawn up. No adverse event. MD contacted pt. Pt. recieved 2nd dose 11/6/21.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of currently 55 years old. No information was provided regarding concomitant medications, concurrent conditions or medical history.  On or about 11-JUL-2017, the pt was vaccinated at a pharmacy/drug store with a dose of zoster vaccine live(ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions (strength, dosage schedule, route, lot number and expiration date were not provided).  On an unknown date, the pt developed herpes zoster and as a result was treated by a healthcare provider. The outcome of herpes zoster was unknown and the reporter considered the event to be related to Zoster Vaccine Live(ZOSTAVAX).
Mild headache, soreness and swelling of the injection site, fatigue for 24-48 hours.
felt fatigue and headache after the second vaccine; felt fatigue and headache after the second vaccine; This is a spontaneous report received from a  program from a contactable nurse and consumer. A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 5 mg, twice a day for rheumatoid arthritis.  Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. It was reported that the patient held Xeljanz per MD instructions for COVID vaccine 72 hours prior to first vaccine and then resumed for approximately 5 days and then 72 hours prior to second vaccine and recently resumed. It was reported that the patient felt fatigue and headache after second vaccine and states "i have spoken with my MD and will speak with MD again next week we have a plan". The severity, any medication(s) patient was using at or around the time of the adverse event and dates of therapy and any relevant tests/laboratory data including dates were not applicable. The outcome of the events was unknown. The action taken in response to the event for tofacitinib citrate was post therapy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Woke up morning after 2nd vaccine was administered, felt okay enough to work. (6am) Went back to bed for another hour and a half due to late opening at work, (8am) by then the symptoms had kicked in and I was feeling muscle aches, chills, headache.
On top of my arm feeling extremely sore I became tired and have developed a sore throat throughout the night. I feel heavy-headed also with no symptoms of sickness before the shot.
Bell's palsy; A spontaneous report was received from a consumer concerning a patient of an unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, approximately 11 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 026L20A) for prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient was admitted to the hospital and diagnosed with Bell's palsy. On 06 Feb 2021, the patient was released from hospital. Treatment for the event included cortisone and antiviral medications.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event Bell's palsy was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Awoke to rapid heart rate and dangerously high BP. He was sweaty and light-headed. Couldn?t reach cardiologist so called PCP. She told him to take another Metoprolol and Multaq. She called in an emergency prescription in case needed during winter freeze we were under.  Then the Oncologist reduced his Inlyta dosage.
Myalgia, Fever, Diarrhea, GI upset and arm pain (started 12/29), all other symptoms including chills started this morning, flushed
face getting red; little red rash on his face that started to grow; tiredness; sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (face getting red), RASH (little red rash on his face that started to grow), FATIGUE (tiredness) and MYALGIA (sore arm) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041j21a) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ERYTHEMA (face getting red), RASH (little red rash on his face that started to grow), FATIGUE (tiredness) and MYALGIA (sore arm). At the time of the report, ERYTHEMA (face getting red), RASH (little red rash on his face that started to grow), FATIGUE (tiredness) and MYALGIA (sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medication was reported as none.  Treatment information  was reported as none.
Injection site redness; swelling is coming down; the site was burning; headache; chills; joint pain; muscle aches; fever; throat hurting (not swollen, but itchy); diarrhea; throat hurting (not swollen, but itchy); This is a spontaneous report from a contactable consumer (patient). A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 16:00 (age at vaccination 40-years) (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus, cancer and tooth infection. Concomitant medication included a steroid shot in between these 2 covid doses, it was a steroid injection, an epidural. Caller stated that she had no Lot number to share for the epidural and amoxicillin taken for tooth infection from 10Feb2021 date. She is directed to take 1 tablet by mouth twice a day for 10 days , Lot SM8719299 Exp Nov2021. She had no vaccines on the same day or in the 4 weeks prior. She had not been to the ER or seen a doctor in regards to her symptoms. she was a single mom, and has a 6yr old son, that will not her rest and so she had gotten no rest. On 20Jan2021 at 1:15PM, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, (Batch/Lot Number: EL1283) as DOSE 1, SINGLE for covid-19 immunisation. On 13Feb2021, patient underwent lab tests and procedures which included body temperature and showed results of 104 and weight might had dropped. On 13Feb2021 at 3AM or 4AM Saturday in the morning, patient experienced headache, chills, joint pain, muscle aches. Also of Saturday by afternoon she has a fever up to 104 and that was without medications, ever since the fever she has been bad. On an unknown date in Feb2021 patient had throat hurting (not swollen, but itchy) and diarrhoea. Her headaches come and go she took Advil and ibuprofen. She had diarrhoea, anything she eats goes right through her. The injection site was noticed on Sunday 14Feb2021 it felt like she got the injection all over again, the site was burning and hurting. On 14Feb2021, she experienced injection site redness, swelling is coming down, the site was burning. Therapeutic measures were taken as a result of headache. At the time of this report the outcome of headache, chills, throat hurting (not swollen, but itchy) was unknown. Joint pain, muscle ache, diarrhoea was not recovered. Fever recovered on unknown date in feb2021 and other events were recovering.  Follow-up attempts completed. No further information expected.
He got it on 2/26, that night he was sluggish, had a headache and a fever of 100  degrees.  On 2/27 his fever was 100.4, and on 2/28 he took tylenol and his  temperature was 98 degrees.
2 days p/vax devel low grade temp lt upper arm warm, swollen, reddened, 4" inj site, 2" diameter had DTAP also same arm;
Severe total body tremors/trembling; inability to get warm or to stop trembling for 4-5 hours followed by 104 degree fever and sweating. The fever began shortly after the trembling stopped and lasted for 4-5 hours. With the fever came redness and swelling of the face, joint pain and body aches. 3 doses of Naproxen Sodium relieved the fever, but the joint pain and fatigue remain.
Information has been received from a physician's office manager concerning a 13 year old female with asthma and a history of hypoglycaemia who on 31-OCT-2007 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (Lot # 659437/1266U). On 20-JAN-2008, the patient was vaccinated intramuscularly in the left deltoid with her second dose of GARDASIL (Lot # 659657/1487U). On 30-MAY-2008, the patient was vaccinated intramuscularly in the left deltoid with her third dose of GARDASIL (Lot # 660391/0062X). Concomitant therapy included and albuterol inhaler (unspecified). The office manager reported that on 30-MAY-2008 "the patient experienced a syncopal episode after receiving her third dose of GARDASIL". She reported that the patient collapsed as she attempted to leave the office and hit her head on the wall as she fell. The patient did not lose consciousness. The patient was examined in the office and vital signs monitored (not otherwise specified). It was reported that on 30-MAY-2008, the patient recovered from both events within an unspecified amount of time. There were no other symptoms and no treatment reported. No additional information was provided. Additional information has been requested. Follow-up information. Additional information is not expected.