chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe chills for 2 hours (onset 15 hours following administration; aching  joints; fever (~101 F) persisting for approximately 24 hours; aching muscles; very minor pain to the touch at injection site; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old, male patient received second dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 24Mar2021 at 09:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Patient had no medical history. The patient did not receive any other medication within 2 weeks of vaccination. The patient previously received first dose of BNTI62b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 04Mar2021 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 25Mar2021, the patient experienced chills, muscles pain, joints pain, fever and vaccination site pain. It was reported that patient had severe chills for ~2 hours (onset 15 hours following administration), fever (101 F) persisting for approximately 24 hours, very minor pain to the touch at injection site. No therapeutic measures were taken as a result of the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of muscle pain, joint pain and vaccination site pain was recovered. The clinical outcome of the events chills was resolved on 25Mar2021 and fever was resolved on 26Mar2021.   No follow-up attempts are needed. No further information is expected.
Bruise on injection site; Face was really red.; Rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Rapid heartbeat), INJECTION SITE BRUISING (Bruise on injection site) and ERYTHEMA (Face was really red.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-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 PALPITATIONS (Rapid heartbeat), INJECTION SITE BRUISING (Bruise on injection site) and ERYTHEMA (Face was really red.). At the time of the report, PALPITATIONS (Rapid heartbeat), INJECTION SITE BRUISING (Bruise on injection site) and ERYTHEMA (Face was really red.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 120 (High) 120bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sick; Arm was sore for weeks; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick) and pain in arm (Verbatim: Arm was sore for weeks). The outcome of the sickness was not reported and the outcome of the pain in arm was resolved.   The reporter considered the sickness and pain in arm to be related to Shingles vaccine.     The company considered the sickness and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-APR-2023 This case was reported by a patient via interactive digital media. The patient reported that the shingles vaccine sucked. The patient had never had a vaccine which made him or her sick and his or her arm was sore for weeks. Follow-up was not possible as no contact details were available.
Donor  came into the donation center 2 days after receiving her tetanus shot. Donors right shoulder is red and sore to the touch. The redness is approx. 6 inches x 4 inches wide .
Patient reports area of redness, slight swelling, and significant itchiness at the injection site. Area is the size of a softball, approximately 4 inches in diameter, pink color. No other symptoms reported. Symptoms started Day 5 after vaccination (Sunday, vaccine given Tuesday).  Advised icing the area, applying topical hydrocortisone 1% to help with itching, and continuing her Tylenol which she takes regularly for pain. Patient plans to see PCP in 2 days (on Thursday) for an appointment she already had scheduled, so he will see it then.
NOTE:  I'm not sure of the Influenza type of Vaccine. I had severe mental decline for a period of time that was extreme on the second day after the influenza shot. The first day afterwards was mild but on the second day, I had cognitive decline to the point that I was unable to do basic office work duties/ work due to extreme headache and brain fog and mental confusion. This lasted at least 8 hours.
chills with shaking and headache. Took Tylenol to control shaking and chills which turned to feeling very hot after taking Tylenol. Foggy head with headache. Still have chills 4/8/21. Still taking Tylenol
female presenting with dizziness, nausea, vomiting, shortness of breath after receiving her second Covid vaccination, Pfizer.  She had no adverse reactions with the first vaccination.  She reports that approximately 10 minutes after the vaccination, she started to feel dizzy and "drunk".  She felt that the room was spinning.  She then became very nauseated and started dry heaving.  No emesis but she arrives dry heaving.  She reports that she started having shortness of breath after the nausea and dry heaving but feels like it is more because she is feeling very panicked.  No cough.  No wheezing.  She has some throat soreness.  No syncope or fall.  She does have several allergies and carries an EpiPen for coconut allergy
Tested positive for Covid on 20 September 2021. headaches, fever, loss of taste, smell. sore throat, cough, chest pains, lethargic, weakness, tiredness. diahrea, loss of bladder control. brain fog. loss of concentration.
On 07/19/2022 began to have a stiff neck with a lot of pain and fatigue. Went to PCP was tested for COVID, negative. Dr. Symptoms having could be related to Thyroid issues because of the pain. Prior to reaction, my PCP had ordered a Thyroid Blood test and the results came back and had a THS of 0.54. On 07/22/2022, Dr. (endocrinologist) ordered an ultasound of Thyroid, and noted Thyroiditis. Started taking Ibuprofen to release the pain. Dr. ordered a Dexa Bone Density Scan for 08/05/2022. Currently (07/26/2022) still feeling pain and fatigue.
This spontaneous report was received from a female consumer of unknown age (reporting on herself). It was reported that around 1975, during childhood, the patient was vaccinated with a dose of M-M-R II (Lot # 9912202) (dose and route not reported) and did not report having had any booster doses since then. Concomitant therapy was not reported. On an unknown date an unspecified titer level test for the vaccine components showed that the patient was currently low in only the measles component of the vaccine. She sought medical attention for the low titer reading by talking to a couple of different unspecified healthcare professionals to see if she should be re-vaccinated. At the time of the report the patient's outcome was unknown. Additional information is not expected.
Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 26 November 2013. A 26-year-old male subject received the following vaccinations on 07 October 2013: an injection of ACAM2000 (lot number not reported) and FLUMIST (lot number not reported). On 17 October 2013, the subject was diagnosed with unspecified disease of pericardium and non-specific myocarditis. The subject had no significant past medical history. On 16 October 2013, the subject had an abnormal ECG and on 17 October 2013 the subject had a normal troponin I and abnormal echocardiogram. On 18 October 2013, the subject had an abnormal cardiac MRI. MRI of the brain and spinal cord and spinal tap were not performed. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: None.
Left arm swollen, red warm to touch, 1st day measured 4x3, 2nd day 4x4. gave Benadryl, cold compress and antibiotic.
approx 15 p/vax both arms became extremely red & hives began to appear on both arms;
ADULT OBSTRUCTIVE SLEEP APNEA, MILD ACUTE STROKE DUE TO OCCLUSION OF LEFT MIDDLE CEREBRAL ARTERY
Don?t know think it?s connected but wanted to report. Left side of face started to swell. Within 5 minutes I left for Urgent Care as it was not normal.  Got into a room within 5 minutes and while waiting for the Dr the swelling already started to go down.   He diagnosed as Parotid Duct Obstruction.  He stated he saw where the duct was blocked as he looked in my mouth/left cheek.
3:15PM PT GOT VERY 'WARM'.  PLACED IN WHEELCHAIR; SYNCOPAL EPISODE/EYES ROLLED BACK APROX 30 SECONDS. PLACED ON FLOOR, ELEVATED LEGS AND PT BECAME RESPONSIVE. PT GOT ONTO COT PER SELF. ELEVATED HEAD OF BED; DRINKING TEA. STATES SHE DID'NT HAVE MUCH TO EAT TODAY AS SHE WAS HAVING A DENTAL PROCEEDURE DONE THIS AM. BP 120/68, HR 60, R 20, 02 SAT 98%. A/O, PINK, W/D, RESP WITH EASE. 'FEELS MUCH BETTER NOW'. 3:45PM HUSBAND HERE TO DRIVE PT HOME. PT AMBULATORY TO EXIT- GAIT BRIS AND STEADY.
Stroke and blocked carotid artery.  Clots filled the artery and then broke of into  the brain. Cause of the clots are unknown. An ultrasound prior showed no blockage
itching at the injection site; redness at the injection site; injection site swelle to the size of a silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (injection site swelle to the size of a silver dollar) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (injection site swelle to the size of a silver dollar). At the time of the report, INJECTION SITE PRURITUS (itching at the injection site), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (injection site swelle to the size of a silver dollar) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Concomitant medication included unspecified medications for blood pressure and diabetes.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 64-year-old male patient who received SHINGRIX for prophylaxis. On 6th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 7th December 2018, 1 days after receiving SHINGRIX, the patient experienced chills, headache, muscle pain, nausea, injection site pain, weakness and fatigue. On an unknown date, the outcome of the chills, headache and muscle pain were recovered/resolved and the outcome of the nausea, injection site pain, weakness and fatigue were not recovered/not resolved. It was unknown if the reporter considered the chills, headache, muscle pain, nausea, injection site pain, weakness and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient received the 1st dose of SHINGRIX in left deltoid. The patient planned to follow-up with his physician on 10th December 2018. The reporter gave consent to follow up.
Parent phoned PHN and was immediately referred to the ER or doctor for complaint of hives that began on the evening of the IZ's, followed by vomiting and headache incidents; medical care was delayed initially to rule out allergic reaction. On 11/18/02, parent reports that the pt initially received oral Benadryl and a Claritin RX at the ER. She delayed filling it for 1 day, then PHN left a phone message on 11/19/02, as no one was home PM. On 11/20/02, the mother reported the intention to immediately visit the ER for worsened hives. On 11/21/02, she reports that she did not wish to wait in line at the ER and went to the pediatrician's office. She reports that the pt is ok, and that she continues on Claritin and Aveeno bath for itching. She was told to take her shot record to the pediatrician, as there are enough doses for immunity and that the doctor may decide to do allergy testing. No further shots of DTAP or IPV unless the doctor gives or approves 5-10 years. She had been on an accelerated schedule with the last DTP-IPV doses given 9/02.
Patient states that she had soreness at injection site, fever, and body aches that began 24 hours after administering the vaccines. Then on 9-14-2018 in the evening she states that her feet, arms, hands and face began to swell. She also stated that she was extremely tired and unable to move. She states that she did not call 911, or seek medical attention. She instead went to a friend's house.
Began with tingling sensation in fingers then arms felt bloated. Later that evening excruciating pain in body insides felt very hot. Got cold chills. 2 days later still having it.
ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 34 year old male. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 23/JUN/2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included omeprazole for drug used for unknown indication. On 16-APR-2021, the subject experienced abdominal pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain. This report was non-serious.
a patient received a dose of FLUBLOK QUADRIVALENT instead of FLUZONE QUADRIVALENT /No AE; A 17 years old female patient received a dose of FLUBLOK QUADRIVALENT /No AE; Initial information was received on 18-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA258133 and 2020SA257773 (Same reporter).  This case involves a 17 years old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [lot number: UJ455AAA, expiry date: 17-May-2021] via an unknown route at the left deltoid for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered and product administered to patient of inappropriate age) .   Medical history, medical treatment, vaccination and family history were not provided.   Patient did not received concomitant vaccines.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (Latency: at the time of vaccination).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
1st Dose: Woke up with a severe pain in arm with muscle tightness and extreme headache with lots of sweating failed to go to work. Felt better around 10pm. 2nd Dose the one reported: No arm pain. Seeing spots and crying from any and all lights due to the extremeness of the headache. Attempted to work but had to leave in under a hour due to the headache, being light-headed and disoriented. Didn't remember drive home. Cried from headache till around 9 pm. The next 2 weeks were met with frequent headaches, disorientation, brain cloudiness, rapid heart rate when going from sitting to standing, body temperature would bounce from extremes, extreme dehydration and cottonmouth. Felt like I was in a dream and didn't feel right or like myself for a few weeks.
Sharp pains all over body that were sporadic, along with tingling sensations throughout the body.  12/1/21 had Tinnitus 12/2/21 Noticed the left side behind my left eyelid felt slightly warmer than right...ongoing and sporadic. 12/11/21  Noticed that tingling was mostly gone, but still had some slight sporadic pains. 12/14/21 Left eye problems continued - saw eye doctor to check eye pressure, which was only at 14, but more than right eye. 12/12/21 Headache for a few hours By 12/20/21, the problems were mostly gone.
Pt developed a fever and generalized rash on her face that has persisted.  The rash is located on both cheeks and is described as being like a wind burn.  The skin is red and somewhat chapped looking.
After the vaccine around like 7 minutes I was feeling dizzi, I also starting to  was swaet and cold. I told the nurse on the side but he didnot belived me. Than that night I was having fever 38.9 C and 39.4 for the next two days. I also have muscle pain, headache, join pain , chills nasal congestion. I try to call my provider the CDC and many others facilities, but nobody cares what hapen
soreness and redness around injection site; soreness and redness around injection site; This is a spontaneous report from a contactable consumer (patient)   A 70 years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 10:58 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation  . Age at vaccination 69 years Medical history included osteoporosis from 2002 to an unknown date , herpes in her eye, Blood pressure high from 2010 to an unknown date , High cholesterol from 2010 to an unknown date.     The patient experienced soreness and redness around injection site on an unspecified date with outcome of recovered , The patient underwent lab tests and procedures which included blood thyroid stimulating hormone: 4.94  on 03Feb2021  .  The reporter stated that She says she had no symptoms after the first dose other than soreness and redness around injection site that went away within 2-3 days. The patient get the second shot on second dose 25Feb2021 at 12:27PM, and both were given in her left arm.She developed several issues upon second shot.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021229265 same patient and drug, different dose and event.
Flu like symptoms and red area at injection site that gradually got redder and larger.Main area was approx 4x5 inches and below main area was slightly smaller.
chills, nausea, feeling unwell, decreased appetite, vomiting, arm pain, tiredness and severe headache
Fever after Second Shot/ Body temperature very high after Second Shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after Second Shot/ Body temperature very high after Second Shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced PYREXIA (Fever after Second Shot/ Body temperature very high after Second Shot). At the time of the report, PYREXIA (Fever after Second Shot/ Body temperature very high after Second Shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Body temperature: unknown (High) Unknown.         Concomitant product use was not provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was  not applicable.
Pt received IM PNEUMOVAX 23 injection - 2 days later arm still painful at injection site radiating to shoulder. Pt saw primary care MD - arm still stiff and sore after 7 days pt put on prednisone and PERCOCET for pain and inflammation.
No problems until the 29th (Day after shot) got very red and had a fever in arm, got very itchy and sore and was swollen, bumped up.
This spontaneous medically confirmed report (initial receipt 12-SEP-2014) concerns a 32-year-old male patient. The patient had a medical history of diabetes. On 12-SEP-2014, the patient received intramuscular AFLURIA (batch number T50407, expiry date 30-JUN-2015) at 0.5 ml. On 12-SEP-2014, while removing the needle from the patient's arm, some of the vaccine came out of the injection site and ran down the patient's arm. This resulted in the patient not receiving a full dose of vaccine. The patient did not experience any adverse reaction due to the event. The outcome was not reported. Reporter's comments: The reporter assessed the events as non-serious.
pt recv vax 13MAR95 9AM;5PM screaming thru night-inconsolable,t103 called ER;instructed to keep APAP going some fever next day;states had same problems w/the first set of immunizations
My arm was sore for about a day and that was it.  I had a very mild case of COVID-19. I felt like I like I had a bad cold or a minor case of flu. I called my doctors  office and they prescribed Paxlovid. I really don't think it helped that much. As of today I still have the congestion and runny nose. I do go out with a mask.
-On second day, began to develop low grade fever (up to 99.9), chills, and body aches. Tylenol helped somewhat.  -On third day, became lethargic and extertional fatigue with shortness of breath symptomology and mild nausea; no fevers/chills on this day -On fourth day, mild diarrheal episodes (x 3, within 45 minutes), no abdominal pain/vomiting, but nausea persisted, in addition to worsening lethargy, and exertional fatigue with shortness of breath upon ambulation and climbing stairs  - On fifth day, dry cough symptoms upon awakening for 1 hour, then continued lethargy and exertional fatigue with shortness of breath upon ambulation and climbing stairs, with somewhat improved nausea, oxygenation saturation 100%; by 9pm on fifth day, 30-40% improvement in symptoms
The student was administered a MMR vaccine (lot number T025927) on 8/9/22 with an expiration date of 7/30/22 at a immunization clinic.   Notified parent and rescheduled a re-vaccination appointment for 9/15/22 Inventory to be returned to the health department at the end of each year. Summer clinics will be stocked with a fresh inventory during the summer for clinics.