chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (10 years before the date of reporting). On 14th September 2018, the patient received the 2nd dose of SHINGRIX. On 14th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 17th September 2018, the patient experienced upset stomach, generalized muscle aches, shoulder pain, joint pain and back pain. On an unknown date, the outcome of the injection site pain was recovered/resolved and the outcome of the upset stomach, generalized muscle aches, shoulder pain, joint pain and back pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, upset stomach, generalized muscle aches, shoulder pain, joint pain and back pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in left arm. The patient experienced soreness at the injection site the day of the vaccination. Three days after the vaccination date the patient experienced muscle aches all over and upset stomach presented. The aches were in shoulders, all joints, ankles and back. The soreness at the injection site lasted for 2 to 3 days. This case has been linked to the US2018172508, reported by the same reporter.
On the day of vaccination, groggy and very tired, pain at lymph nodes of arm and under armpit, pain at injection site, throbbing and radiating, to lymph nodes and elbow and wrist. Felt chills on the first day.  Pain at lymph nodes continued 4 days post vaccination. Patient is starting to feel better on day 5
Initial report received from non-health care professional on 16-Dec-2013. A 58 years old female patient, medical history included hypertension and migraine, concomitant medications were not reported, had received FLUZONE (batch number UH909AB, expiry date September 2014) intramuscular in the left deltoid right arm on 06 September 2013. On 06 September 2013 1 hour after vaccination, the patient's the left arm where she got the flu shot got bigger between elbow and shoulder. She went to the pharmacist who told her to go  home and take a Benadryl which she did. The swelling then went up her neck and 4 inches around injection site was solid red and she could not lift her arm. She then went to the ER. Three days later the swelling started to go down. All symptoms are now gone. The events were recovered at the time of this report. List of documents held by sender: none.
Pain, soreness, swelling at the site of injection, headache, muscle aches, fever, shivering, fatigue, hives. Fever was close to 102 - by the third day fever was gone, felt much better but hives remain.
Patient received the 4th dose Pfizer on 5/5. Patient then was experiencing a rash and warm to touch sensation to the area. Patient went to the health care center where they were prescribed an antibiotic due to an "injection site infection".
After vaccine was given pt stated "she felt like she was going to pass out" she turned pale and rigid and lost conscious for about 1 min and when she came to she had post ictal s/s of a blank stare for about 5-10 sec and no response. Pt did walk back to a room without much time, when she got back to the room she became "limp" and needed to be lifted onto a tablet. Went home A+o x '53
Vaccine may have been stored under conditions that departed from the manufacturer's recommended specifications. Pharmacy consulted with the vaccine manufacturer regarding this issue.  In such a circumstance, the manufacturer deems the vaccine not to be viable.  Additionally, the CDC recommends that patient repeat 1 dose of the same COVID-19 vaccine immediately (no minimum interval). Patient may not have received the full benefits of the vaccine. The additional dose is provided at no cost. Patient will consider it and will call back if she wants the additional dose.
After receiving flu vaccine at my local health department, the following day I was subject to severe headache, which has lasted 4 days on a continuous basis. On Sunday, December 13, 2020 (11:00 am EST), I woke up and left arm was partially paralyzed, no useful function for a period of 10-15 minutes, extreme redness, and stiffness. No other issues on right hand side of body.  No prior issues with arm or hands in the past. Also had severe headache on this day as well.
The symptoms was severe headache and nausea. I had a blood clot in my main artery. The neurosurgeon put in a stent. It impact the the nerve in my left eye for 3 months and now it has started to open up again. They diagnosed it as Cavernous Sinus Thrombosis. I am still in recovery from it.
This spontaneous report as received from a healthcare worker refers to a 21 year old female patient. Pertinent medical history, drug reactions or allergies were unspecified. On 10-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 "1 shot", lot # K004542, expiration date 19-AUG-2015, (dose, dose number, route, anatomical location were unspecified). Concomitant therapies were not reported. On 12-OCT-2014 the patient experienced cellulitis. The patient sought medical attention (unspecified). The patient received an unspecified antibiotic for the treatment of the cellulitis. The outcome of cellulitis was reported as recovering. The relatedness between cellulitis and PNEUMOVAX 23 was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 12/26/01 at 15:30, left arm starting feeling itchy and noticed red, warm rash. On 12/27/01, AM, started on armpit, torso and now all over body and still persisting now. No other symptoms noted. Didn't seek medical care due to no insurance and no doctor. Referral given to clinic and no MC for medical treatment. Last flu vaccine was 5 years ago. On 1/10/02, no answer for update. On 1/29/02, telephone call; no answer and no message left.
First day after shot:  Fatigue. Second and third days:  Diarrhea. One week after shot:  Painful and itching hives and rash all over body, with blotchy rash around shot site.
pt recv vax & pt devel erythematous wheat & flare around inj site followed by deep, firm nodular rxn which was quite persistent;
Fever, chills x 1 day left upper arm: erythema, warmth, tenderness, swelling, early abscess formation . left upper arm pain x 5 days
Patient is complaining that she is having headache, dizziness, muscle pain, and pain all over her body; arm is hurting and she had upset stomach; all this problems occurred in the morning, after she received the shots the night before.
I've had unusual light menstrual spotting since the day after I got the vaccine to today, almost a week later. Usually I don't have much spotting throughout the month.
Severe shaking. Chills, headache,acute srvere sharp pain in both feet . Began after a short sleep period. Lasted for 3 hours. Then wesknesd and headache tiredness until bedtime the next eve. No isdued after 2nnd night sleep.
7/14/2023 - 7/18/2023 (4 days) presented to emergency room with syncopal episode remdesivir IV/Decadron IV  013M20A 3/3/2021 035C21A 11/3/2021 AS7148B 9/14/2022
Broke out in a rash and heard people say that is normal.; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route on an unknown date, dose number unknown, single for COVID-19 immunization. The patient was allergic to bactrim, nickel and gold from an unknown date and unknown if ongoing. The patient medical history were not reported. The concomitant medications included baby aspirin. The patient had broke out in a rash and heard people say that is normal. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a 30 year old female who on 27-SEP-2006 was vaccinated with a 0.5 ml dose of Pneumovax 23 (Lot #651322/1044P). Concomitant therapy included an unspecified blood thinner. Subsequently, "several days later after administering vaccine", the patient experienced sweating that turned out to be a fever of 104 degrees. The injection site was red and swollen. Later she had cellulitis, became septic and had to have the wound opened at the injection site. She was hospitalized for 8 days and was on 4 different unspecified antibiotics. Subsequently, symptoms improved and on an unspecified date the patient recovered. Additional information is not expected.
Information has been received from a medical assistant, concerning an 83 year old female patient with lisinopril (manufacturer unknown) allergy. On 22-JUL-2010, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency were not reported) (Lot #: 665532/0711Z; Expiration date: 29-APR-2011). Concomitant medications included atenolol, triamterene HCTZ, amlodipine, losartan potassium (manufacturer unknown), aspirin, pyridoxine (Vitamin B6) and cholecalciferol (Vitamin D3). The medical assistant reported that on 07-SEP-2012 (also reported as a couple of weeks later after vaccination), the patient developed shingles (also reported as full blown shingles). The patient sought medical attention by contacting the physician. Valacyclovir, prednisone (manufacturer unknown), LIODERM patch and TYLENOL 3 were given as treatments for the event. At the time of the report, the patient was recovering from shingles. The relatedness of full blown shingles, and shingles was unknown for ZOSTAVAX. Additional information has been requested.
About 9:30pm on 6/8/2019 I began to feel muscle aches. At midnight  uncontrollable trembling, chills, difficulty walking, possible fever - I did not take my temperature. This lasted for approximately 5 hours. I also had sudden and severe cramps in my calfs and feet from about 11:00pm till about 5:00am on 6/9/2019.
Had sever Chills and Cramps in thighs of legs and very bad cramps in my left foot. Enough to wake me up when I was finally sleeping.
diluted with sterile diluent instead of the sodium chloride provided with vaccine with no reported adverse event; diluted with sterile diluent instead of the sodium chloride provided with vaccine with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult female patient of an unknown age and reporter reported YELLOW FEVER VACCINE - [YF-VAX] diluted with sterile diluent instead of the sodium chloride provided with vaccine with no reported adverse event.  The patient had no medical history, concomitant disease or risk factor.   On 11-Apr-2023, the patient received an unknown dose of suspect Yellow Fever Vaccine - Solution for injection (with an unknown strength, expiry date and lot number) via subcutaneous route in unknown administration site for Prophylactic vaccination (Immunisation).  On 11-Apr-2023, the reporter reported  YELLOW FEVER VACCINE - diluted with sterile diluent instead of the sodium chloride provided with vaccine with no reported adverse event (product preparation error) (poor quality product administered) (Latency: same day).  Patient did not experience any additional symptoms/events.  There were no lab data/results available.  It was reported, Patient traveling overseas and required YF-Vax. Administered subcutaneously, but diluted with sterile diluent rather than provided sodium chloride.  Action taken: not applicable.  Outcome:  Unknown   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 the 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.
This spontaneous report as received from a male consumer of unknown age reporting himself with allergy to VIDOCIN. None pertinent medical history was provided. In October 2014, the patient was vaccinated with a dose of ZOSTAVAX in the right side (dose, route, lot number and expiry date were not reported). It was reported that the patient was on therapy with an unspecified blood pressure and cholesterol medication. In approximately October 2014 reported as three days after receiving the ZOSTAVAX, the patient was in pain. The patient stated that had a swollen gland from his ear to the side of his neck, the pain was also in his throat. The patient stated that he has difficulty eating and swallowing soft food. It was also reported that there was a "sensation in his neck and shoulder on the right side". None laboratory diagnostics studies were performed and the patient did not seek medical attention. The outcome of pain, swollen gland from his ear to the side of his neck, "sensation in his neck and his shoulder on the right side", difficulty eating and swallowing soft food and pain in his throat was reported as not recovered at the time of the report. Relatedness between the therapy with ZOSTAVAX and the events: pain, swollen gland from his ear to the side of his neck, "sensation in his neck and his shoulder on the right side", difficulty eating and swallowing soft food and pain in his throat was not reported. Additional information is not expected, because reporter refused additional contact.
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 28-OCT-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # reported as J002618, exp date: 01-MAR-2015, 0.5 milliliter (ml), subcutaneous (strength ans indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Left arm, red the initial day. The next area of injection was dark purple and larger than the initial day. Vessel nicked while receiving vaccine and bleeding pooling underneath skin
Redness about 6 or 7 hours after injection and swelling. Continued to spread redness after. Area is hot to touch, and painful, cellulitis is spreading.
Patient fainted in the observation area,  woke quickly, alert and oriented. Able to ambulate without any assistance.
Client was given 2nd dose at 21 days instead of 28 days.  She wrote the wrong day down for her appt and had an appt in  Client was dizzy/light headed after first dose also, and after other shots - but was able to go home after the first shot. After this 2nd dose, client because light/headed/ dizzy, and continued x 1 hour -- unable to sit up without being dizzy so was sent via EMS to ER.
Arm was sore; Sore throat; Sneezing; Headache; Fatigue; This spontaneous case was received on 16-Sep-2020, from consumer via agency (reference number: SEQW20-01821) and concerned a female patient of an unknown age.  The patient's past medical history included bladder cancer. It was reported that the patient was in remission and healthy. The patient's concomitant medications were not reported.   On 15-Sep-2020, patient was vaccinated with Fluad Quadrivalent [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose, indication, route of administration, anatomical location: not reported]. The batch number was not reported.  On an unspecified date in Sep-2020, unknown amount of time after vaccination with Fluad Quadrivalent, the patient's arm was sore. The patient had a sore throat, fatigue, headache and was sneezing. She was concerned about sore throat since she did not think this was side effect of the vaccine and she was wondering if she should get a COVID test.  The outcome of the events was not reported.  The reporter did not provide a causality assessment.  Company comment: The patient developed all events on an unknown date but within the same month after vaccination with the suspect product, Fluad Quadrivalent. Chronology is unclear. No information regarding concomitant medications was provided. Based on this information, causal relationship for all events is assessed as unassessable, due to the lack of information regarding events onset date.; Sender's Comments: The patient developed all events on an unknown date but within the same month after vaccination with the suspect product, Fluad Quadrivalent. Chronology is unclear. No information regarding concomitant medications was provided. Based on this information, causal relationship for all events is assessed as unassessable, due to the lack of information regarding events onset date.
After second injection,  arm site was red, hot, sore, and itchy for 8 days.  5 days later, my legs and feet started swelling considerably and became tight and blush colored.  Have not had this before.  May not be associated with vaccine, however unusual.
Had the feeling in both hands that pins were being poked in all areas and became very itchy.
26 year old year old female who developed pain and swelling at the immunization site in her left arm after receiving the varicella vaccine two days ago.  The pain and swelling have begun to dissipate, but she is now having a rash on the left arm.  Her pain is now 2/10, located in left tricep area and is described as dull in nature.  Denies paresthesia, numbness, or motor weakness.
Left arm pain more than the usual annual flu shot. Having the symptoms of a heart attack (arm pain extending all the way down) without the sweating or indigestion. Eventual discomfort and mild pain from extending arm upward, outward or inward.  Today is the 16 and mild pain and discomfort when raising left arm.
At 1700, felt malaise. .Woke up next morning on January 9th with 102 temp, 3cm lump at infection site, body aches, chills, headache. Still feeling poorly on January 10th.
He threw up within an hour of receiving the shots. This is very rare for him to vomit (hasn't vomited in 1 year or longer prior to now), and he did not display any other symptoms of a stomach illness.
hard to get my breath for 3-4 hours/hard to breathe; a concrete block laying on my chest/chest discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (hard to get my breath for 3-4 hours/hard to breathe) and CHEST DISCOMFORT (a concrete block laying on my chest/chest discomfort) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced DYSPNOEA (hard to get my breath for 3-4 hours/hard to breathe) and CHEST DISCOMFORT (a concrete block laying on my chest/chest discomfort). At the time of the report, DYSPNOEA (hard to get my breath for 3-4 hours/hard to breathe) and CHEST DISCOMFORT (a concrete block laying on my chest/chest discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter  No treatment information  were provided by the reporter
Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021; dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose was given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13-Oct-2021 and then stored in refrigerator on 26-Oct-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned. The patient did not experience any adverse event.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-491837 (Patient Link).
who is not on hemodialysis, who received 2 doses of the 20mcg/ml formulation in order to achieve a 40mcg dose; This non-serious case was reported by a pharmacist via other manufacturer and described the occurrence of overdose in a adult patient who received HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included cancer. Additional patient notes included The patient was not on hemodialysis.. Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On an unknown date, the patient received the 2nd dose of Engerix B 20 mcg/mg. On an unknown date, an unknown time after receiving Engerix B and ENGERIX B, the patient experienced overdose (Verbatim: who is not on hemodialysis, who received 2 doses of the 20mcg/ml formulation in order to achieve a 40mcg dose).  The outcome of the overdose was unknown.   Additional Information: GSK Receipt date: 16-AUG-2023 A pharmacist reported that a patient who received 2 doses of adult Engerix B. Pharmacist stated that the patient was a cancer patient, who was not on hemodialysis, who received 2 doses of the 20mcg/ml formulation in order to achieve a 40mcg dose which led to Overdose. No patient demographics were provided, and no additional information provided
The patient is a 55-year-old female who presents for a possible allergic reaction status-post receiving her 1st COVID vaccination at 1820 this evening. Approximately 15 minutes after receiving the injection, she developed palpitations, tongue swelling, and tongue tingling. The patient reports an improvement in her tongue swelling, but the tingling still persists. She denies difficulties with breathing. No rash. She reports normal urination and bowel movements..  The onset was 2  hours ago.  The course/duration of symptoms is constant.  Location: face. The character of symptoms is tingling.  The degree at onset was minimal.  The degree at present is minimal.  Risk factors consist of none.  Therapy today: none.  Associated symptoms: denies chest pain, denies abdominal pain, denies nausea, denies vomiting and denies shortness of breath
Sore arm and fatigue for a few days after the injection. Woke up on 3/9/21 with reaction 2-3" large around injection site. Red area was like a hive, sore, with mild itching. Spot is still present today 3/11.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE RESPIRATORY FAILURE 11/29/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS