chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My left arm had a knot in it right below the shot; the entire top of my left arm from shoulder to elbow hurt very badly with nerve pain for about 10 days; could not sleep; Off Label; Booster; This is a spontaneous report from a contactable consumer (patient).   A 71-year-old non-pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: 301358A, Expiration Date: 01Jun2021), dose 3 via unspecified rout administered in left arm on 28Sep2021 at 03:00 PM (at age of 71-year-old) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient medical history included lyme disease and concomitant medications were not reported. Patient was not pregnant at time of Vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known allergies. Previously patient took bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199) dose 1 on 05Mar2021 and bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727) dose 2 on 26Mar2021 in Arm Right for covid-19 immunization. It was reported that "On the 13th day after I got the booster, my left arm had a knot in it right below the shot. I massaged out the knot and the entire top of my left arm from shoulder to elbow hurt very badly with nerve pain for about 10 days. I had to take 2 pills of 300 mg. of gabapentin at 2 pm and 10 om daily or could not sleep since pain was so severe. Could only sleep on my back. I have fully recovered now". On 11Oct2021, the patient experienced left arm had a knot in it right below the shot, the entire top of left arm from shoulder to elbow hurt very badly with nerve pain for about 10 days and could not sleep since pain was so severe. Treatment was received for the events with two pills of 300 mg. of gabapentin twice/day. Outcome of the events was resolved on an unspecified date in Oct2021.  Follow-up attempts are completed. No further information is expected.
His current temperature is 99; Diarrhea; Fatigue; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (wife) reported for a male patient (husband) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown, Expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included cancer. The patient concomitant medications were not reported. The patient experienced diarrhea, fatigue and his current temperature is 99 on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 99 on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Client report receiving second COVID vaccine on 04/24/2021.  Adverse reaction began on 04/25/2021, of a itchy, red, raised rash and a hard swollen knot.  The rash is 1.5 to 2 inches in width.  There is no pain, but is warm to touch.  Today on 04/26/2021 had tingling down her right arm.  Client has not report symptoms to medical provider, but has taken Benadryl  and used an anti-itch cream with little relief on site.  Client report rash has not spread or noted on any other parts of her body.
Pain and swelling in left arm. Pain in joints,  Pain in every joint has persisted for months. Left elbow swollen to  2 inches.  The swelling in the elbow still exist.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient received the first and second dose of GARDASIL (lot number not provided) in February 2012 and April 2012, respectively. The patient was in the office to receive the third dose of GARDASIL (lot number not provided) on 04-APR-2013. No adverse event reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
headache; A spontaneous report was received from a reporter like consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event like  headache. The patient's medication history was not provided. Concomitant medications reported include5mg Levocetirizine daily. On 11th Feb 2021, prior to the onset of the events, the patient received the second of the two planned doses of mRNA-1273 (lot/batch unknown) in the anatomical location for prophylaxis of COVID-19 infection. On 15th Feb 2021, following vaccine administration the patient experienced events like headache. Laboratory details were not provided. Treatment details included Tylenol. Action taken with mRNA-1273 in response to the events were not reported.
Client awoke and felt like she was burning up, lightheaded, stumbling across room and a pounding headache. Client didn't take temp. No redness at shot site.
Presented to the ED with c/o cough for 2 months, loss of taste and smell for the past 7-10 days and a (+) COVID-19 test on 8/14- on 2 abx and prednisone.Admitted for Pneumonia due to COVID-19 virus, Acute hypoxemic respiratory failure due to COVID-19 -oxygen supplementation,steroids ,Lovenox.-Acute deep vein thrombosis of calf-bilateral- to d/c to LTAC.
Possible tacharrhymia? pmh MVP.  1 10 second episodes over past 48 hours.  Halter and echo card occurred.  Follow up daily.
developed a swollen stomach; hardness in her stomach; diarrhea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07May2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient said she was perfect, perfect, perfect until yesterday (16May2021) and she developed a swollen stomach, hardness in her stomach, diarrhea and vomiting. Her stomach was swollen up to her breasts and felt like it was up to her throat. She did get some sleep and it did go down but since been being on the phone it was swollen up again. She mentioned she didn't take any of her medications yesterday. She took two sugar pills- Farxiga and Januvia, a heart pill Metoprolol 200mg XL, and then three stomach medications Protonix, Pepcid, and Nexium, but she said the Pepcid didn't really do anything. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Irritation, itchiness, several hive type rashes around area of injection - duration ongoing 4/26
This spontaneous case was reported by an other health care professional and describes the occurrence of RASH MACULAR (big blotchy and red raised welts and hives), SWELLING (big blotchy and red raised welts and hives), URTICARIA (big blotchy and red raised welts and hives), SKIN LESION INFLAMMATION (red and inflamed bumps with tissue swelling,spread to buttock and down knees and to forearm) and BURNING SENSATION (itching and burning) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced RASH MACULAR (big blotchy and red raised welts and hives), SWELLING (big blotchy and red raised welts and hives), URTICARIA (big blotchy and red raised welts and hives) and SKIN LESION INFLAMMATION (red and inflamed bumps with tissue swelling,spread to buttock and down knees and to forearm). On an unknown date, the patient experienced BURNING SENSATION (itching and burning). The patient was treated with HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH MACULAR (big blotchy and red raised welts and hives), SWELLING (big blotchy and red raised welts and hives), URTICARIA (big blotchy and red raised welts and hives), SKIN LESION INFLAMMATION (red and inflamed bumps with tissue swelling,spread to buttock and down knees and to forearm) and BURNING SENSATION (itching and burning) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood mercury: high (High) High. 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. Concomitant medications included Anti-thyroid medications.
PATIENT RECIEVED THE VACCINES LISTED ABOVE ON THE AFTERNOON OF JUNE 3 AND FELT FINE LAST NIGHT, BUT WOKE UP  THE MORNING OF JUNE 4 WITH SHORTNESS OF BREATH AND SELF-REPORTED LOW O2 SAT  (USED HOME FINGERTIP MONITOR).
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
This case was reported by a consumer and described the occurrence of general body pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. On 1st August 2018, the patient received the 2nd dose of SHINGRIX. On 2nd August 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain, lower extremities weakness of and headache. On an unknown date, the outcome of the general body pain, lower extremities weakness of and headache were unknown. It was unknown if the reporter considered the general body pain, lower extremities weakness of and headache to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the GlaxoSmithKline's employee for herself. On Wednesday, the patient received SHINGRIX. On Thursday in the morning, the patient woke up to go to work and her body ached, her legs were weak such that she was not confident to use the stairs. The patient informed her supervisor and colleagues that she would not be in the office on Thursday and would get on her laptop later if she could. On Thursday, by around 2 PM, she felt confident walking around but still she had aches and a severe headache. When the patient's sister called her later that day to ask if she could meet up with her, the patient told her that she had a shot at the doctor's the day before and had a reaction. The patient's sister then immediately asked her if the shot was the shingles vaccine. This case has been linked to the US2018GSK141419, reported by the same reporter.
DRY HEAVES AT 2 AM. RASH ON INNER THIGHS + ARMS + ITCHING NERVOUS FEELING + NUMBNESS IN  RIGHT HAND - STARTED THAT WEEK
We see a volume left over in the vial after 20 doses were drawn; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (We see a volume left over in the vial after 20 doses were drawn) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (We see a volume left over in the vial after 20 doses were drawn). At the time of the report, INCORRECT DOSE ADMINISTERED (We see a volume left over in the vial after 20 doses were drawn) had resolved. Not Provided    Reporter stated that they saw volume left over in the vial that varies from zero through to 1.5 mls when 20 doses were drawn. Hence, they were concerned on whether the vaccine amount was correct. They used BD-Flu needles to draw up to 0.25 mls of vaccine.  No concomitant medications were reported No treatment drugs were reported
GENERAL WARM RED SWOLLEN AREA (INSIDE OF LEFT UPPER ANTERIOR ARM). WARM, RED SWOLLEN AREA LEFT UPPER POSTERIOR ARM (BELOW INJECTION SITE). NOT AFFECTING SHOULDER AREA. NOT AFFECTING ELBOW AREA.
tired; fever; general malaise; diarrhea; sweating; muscle aches; headache; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262; Expiration Date: May2021), intramuscularly, administered in left arm on 04Feb2021 12:15 pm as SINGLE DOSE for covid-19 immunisation. Medical history included neuroendocrine tumour of the lung and ongoing chronic obstructive pulmonary disease (Diagnosed 15 or so years ago). There were no concomitant medications. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): N/A. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Any AE(s) did not require a visit to Emergency Room and Physician Office. It was nothing severe. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations: n/a. The patient experienced headache (non-serious) on Feb2021, fever (pyrexia) (non-serious) on 06Feb2021, general malaise (malaise) (non-serious) on 06Feb2021, diarrhea (diarrhoea) (non-serious) on 06Feb2021, sweating (hyperhidrosis) (non-serious) on 06Feb2021, muscle aches (myalgia) (non-serious) on 06Feb2021 and tired (fatigue) (non-serious) on 08Feb2021. The caller is 82 years old. She received her first COVID-19 vaccine on 04Feb2021. She was fine 04Feb and 05Feb2021. On the 6th and 7th, she had muscle aches, fever, she was sweating and had general malaise. These symptoms felt important enough to report, she doesn't know if Pfizer is keeping track of it or what. When probed for consent to contact, the caller explains the doctor she had been seeing is no longer practicing, and she just started seeing this doctor. She doesn't know how much this new doctor is going to help. Caller adds that she also experienced diarrhea. She was a little bit better yesterday, but she feels fine today. She states she maybe a little tired today, but nothing else. She is fine. Her daughter had a question that she wanted the caller to ask. These symptoms do not mean she should not get the second shot? These are pretty normal side effects, aren't they? From what she has read they are. She is scheduled for her second vaccine on 26Feb2021. Vaccination Facility Type: there is a special area roped off just giving shots to public. The outcome of events was recovered on 08Feb2021 and for event (tired) was unknown.
The symptoms started next day was 101 fever and rash on back of legs. These symptoms progressed over the next few days with congestion and chapped lips that bled. On Friday, 27th the rash consumed his whole body and face and his temp hit 102.5. His congestion was impeding his ability to nurse. I took him to urgent care, they sent me to ER. ER Dr took blood sample and insisted of a Spinal tap. We were sent to hospital where they took a urine sample and mouth swab for more testing. By this time his rash was subsiding and his fever gone. They put him on two different antibiotics until tests came back. At 34 hours, all test came back negative and we were sent home. He is still suffering from trauma and painful headaches. His fingers and toes are peeling.
Medical Assistant accidentally gave patient a dose from a Janssen vial that was no longer viable. Vial was initially punctured on 9/29/21, and thus should not have been used today (date of service was 9/30/21). Medical director did call and speak with patient. Patient is aware that she was given a Janssen dose that was no longer viable. Patient denied adverse effects at time of this call between patient and medical director.
Headache and low grade fever 1 day after vaccine. Syncope 2/16/18. Seen at ER. Still with headache and chills 1 week after vaccine.
Fever, chills, intense pain in low back, pelvis shins lasting 48 hours. Had large raised reddened area surrounding injection site for both doses. No side effects otherwise after first does. 2nd dose...injection site extremely painful. Large reddened hard area surrounding injection site.
Raised red rash at injection site.  Approximately 3" diameter, hot to touch, bumpy, itchy and very tender. As of 11:45 pm on October 6 it continues to be very uncomfortable.
pt. c/o of cold sweats, right upper limb numbness/ tingling; patient states she did not eat this AM which is contributed to her dizziness. Symptoms resolved at 10 m minutes with rest, breathing and food.
Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21). On 08-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients, vaccinate past its expiration date of 10/1/21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-352611 (Patient Link).
diffuse rash started on abdomen spread to arms and back, no mucosal involvement, no resp symptoms, rash not painful or itchy; This is a spontaneous report from a contactable physician. A 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were unknown) intramuscularly on 31Dec2020 at a single dose for COVID-19 immunization. The patient's medical history included gout and glaucoma, both from an unknown date and unknown if ongoing. The patient had no known allergies to medications, food, or other products. Concomitant medication included allopurinol; patient received allopurinol within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Jan2021, the patient experienced diffuse rash started on abdomen spread to arms and back, no mucosal involvement, no resp symptoms, rash not painful or itchy. Therapeutics measures were taken in response to the event; patient took Medrol pack. The outcome of the event at the time of last observation was not recovered. The report was considered as non-serious; the event did not result in death, was not life threatening, did not caused/prolonged hospitalization, was not disabling/ incapacitating, and did not caused any congenital anomaly/birth defect.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
pt seen 25MAY w/URI/conjunctivitis given polytrim drips;29MAy seen in MD ofc w/ c/o hives-none noted;dx bilat OM, rx ATB;mom took pt to pharm had pt had 1 1/2-2min sz w/gen trembling & eyes rolled back;taken to ER-t104.6R;
Information has been received from a physician concerning a female who in October 2007, "about two weeks ago" was vaccinated with the first intramuscular dose of Gardasil (lot # not reported).  In October 2007, "around two weeks ago" the patient fainted and became nauseous.  Subsequently, the patient recovered, on an unknown date.  Additional information has been requested.
Approximately 1 week prior patient was admitted into the hospital after a 2-story fall that subsequently required her to undergo a splenectomy on 7/27/09. Prior to discharge the vaccinations were ordered and given on 8/1/09. The patient returned to the Emergency department with fever of 104, increasing abdominal pain, severe pain in left lateral thigh where vaccines were given and some dyspnea. Patient became increasingly lethargic and developed a macular rash. She reported urinary urgency but unable to void. Mother accompanied patient to the ED and reported that every time she received vaccinations as a child the patient would develop terrible fevers and injection site reaction. Patient was admitted into the intensive care unit and medically managed for serum sickness secondary to vaccine administration. 8/31/09-records received for DOS 7/28-8/1/09-DC DX: Systemic inflammatory response syndrome from immunization (serum sickness). Hyponatremia. Dehyrdration. Fever. Lethargy. Hypoabluminemia. Thrombocytosis. On day of discharge received vaccines subsequently seen in ED for fever. Developed truncal rash, complaints of left thigh pain, lethargy, tachycardic, hypotensive. Impression: systemic inflammatory response syndrome most likely related to vaccine and allergic reation.  ICD-9 codes: 865.03. 958.4, 864.85, 285.1, E882, E849.0, 300.00 and 238.71.
This case was reported by a consumer via call center representative and described the occurrence of swelling of knees in a adult female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included drug hypersensitivity (medicines) and multiple allergies. On 19th June 2018, the patient received the 1st dose of SHINGRIX .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced difficulty in standing. On 19th June 2018, the patient experienced knee pain. On 21st June 2018, the patient experienced swelling of knees, nausea, headache and dizziness. On an unknown date, the outcome of the swelling of knees was not recovered/not resolved and the outcome of the nausea, headache, knee pain, dizziness and difficulty in standing were unknown. The reporter considered the swelling of knees to be probably related to SHINGRIX. It was unknown if the reporter considered the nausea, headache, knee pain, dizziness and difficulty in standing to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. At 10:30, the patient received SHINGRIX on the left arm. Less than a day after vaccination, the patient experienced soreness. Two days after vaccination, the patient experienced swelling, nausea, headache and dizziness. The patient stated that even though her knee felt a little better, she was unable to stand on it for extended periods of time.
I developed severe abdominal pain 3 days after injection that turned out to be pancreatitis