chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date in 2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Information has been received from a physician concerning a 14 year old female who on 24-AUG-2007 was vaccinated with the first dose of Gardasil (lot # not reported).  There was no concomitant medication.  On 24-AUG-2007 the patient experienced syncope three to five minutes after vaccination.  She fell and scraped her elbow but did not suffer any serious injuries.  Subsequently, the patient recovered from syncope.  It was reported that the patient sought unspecified medical attention.  Additional information has been requested.
pain right armpit; pain right arm; pain right chest; This case was reported by a consumer via interactive digital media and described the occurrence of axillary pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received Shingrix. In November 2022, less than 2 weeks after receiving Shingrix, the patient experienced axillary pain, pain in arm and chest pain. On an unknown date, the outcome of the axillary pain and pain in arm were unknown and the outcome of the chest pain was not recovered/not resolved.   It was unknown if the reporter considered the axillary pain, pain in arm and chest pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received a dose of Shingrix ten days ago and reported he/she got lot left arm, but after that, he/she got pain in right armpit, in arm and in right chest for now.  Additional Supportive Information: Follow-up would not possible as no contact details were available.  From the narrative the statement got lot eft arm' was not clear but seems that patient got lot left arm so conservatively anatomical location added as left arm.
This spontaneous report as received from a registered nurse refers to a 54 years old male patient with gout and hypertension. The patient was vaccinated with 3 doses of hepatitis b vaccine (recombinant) (manufacturer unknown) (Lot #, dose and route not reported) on an unknown schedule at an unknown time. No other co-suspects were reported. No concomitant medications were reported. It was reported that now the patient had a hepatitis B titer of 7.1. The patient had seen in office for medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Fever of 103.2; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th January 2021, the patient received the 2nd dose of Shingrix. On 19th January 2021, 1 days after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient patient experienced fever and body temperature was 103.2 degree F.
nausea; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at SINGLE DOSE for covid-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient received almost exactly the covid 19 vaccine 48 hours before 19Dec2020 and now experiencing nausea in Dec2020. The patient wanted to know the time to onset of the side effects. The action taken in response to the event for BNT162B2 was not applicable. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
PATIENT HAD REDNESS SPREAD DOWNWARD FROM INJECTION SITE WITH ABOUT 4 INCHES WIDE AND 7 INCHES LONG. PATIENTS PHYSICIAN PRESCRIBED BETAMETHASONE VALERATE 0.1% CREAM TO BE APPLIED TWICE A DAY AND PREDNISONE 10 MG TABLETS 2 TAB PO BID FOR 3 DAYS, THEN 1 TAB QD FOR 4 DAYS.
myoclonus- muscle twitching in the entire arm that was vaccinated. patient states it feels electrical as muscles twitch at rest and was arm is being used
Red rash, pain, and swelling on left arm beginning two days after injection and continuing. It is now fourth day from injection with rash extending several inches from injection site, with nausea and headache, and lethargy included.
Report 2000030253-1 describes gastroparesis in a 41 year old male who received the hepatitis-B vaccine for prophylaxis of hepatitis-b.  The vaccinee is allergic to pork, Vancoled (?) and Compazine. His medical history includes end stage renal disease, type 1 diabetes, hypertension, and gastroesophageal reflux disease. He had positive hepatitis B antibodies before his first dose of the hepatitis-b vaccine. He has been a dialysis patient since 1994. His concomitant medications include erythromycin elixir, metaprolol, dilatiazem chydrochloride, omeprazole, ascorbic acid/folic acid and insulin 70/30  On 01-Sep-00, the vaccinee received his forth dose of the hepatitis-b vaccine. Approximately two weeks later on 15-Sep-00, he experienced vomiting and diarrhea. His primary nephrologist and an associate felt that the vaccinee's  symptoms were related to gastroparesis. The vaccinee was subsequently seen by a gastroenterologist who specialized in hepatology who suggested a casual relationship between the vaccinee's symptoms and the hepatitis-B vaccine. Stool culture were ordered but a stool speicman was never collected. The vaccinee was started on metronidazole (Flagyl) 250 mg bid or qid for approximately 7-10 days. The vaccinee's vomiting and diarrhea resolved sometimes during the course of Flagyl. As of 02-SEP-00, the outcome of the event is resolved
Information has been received from a Registered Nurse with no known drug reactions or allergies, who on 14-MAY-2008 was vaccinated with first dose of VARIVAX (Oka/Merck) (lot # 660037/1848U), 0.5ml subcutaneously, then on 16-JUN-2008 she received second dose of VARIVAX (Oka/Merck) (lot # 660037/1848U).  Concomitant therapy included ZOLOFT, XANAX, estrogens, PREMARIN and LASIX.  On 10-NOV-2008 VARICELLA antibody titers were tested and the result was negative.  At the moment of the report the patient status was not recovered - negative titers.  No further information is available.
Rash, erythematous papules, pain, itchiness lasting 4 weeks post shot.
Received my second shot on 2-08-21 at 12:30 am ,next morning  my left hand on arm I received my shot all my finger were numb and cold to touch. Tips of my fingers were blue and tingly like they had no blood flow. As of 2-12-21 only slightly improved
Screaming high-pitched scream, inconsolable, non-stop until 9:35 PM.
This case was reported by a healthcare professional and described the occurrence of wrong route of administration in a 19-year-old male subject who was vaccinated with FLULAVAL, GlaxoSmithKline. Concurrent medical conditions included drug allergies to AMOXICILLIN, penicillin, and ROBUTUSSIN. The subject is a smoker. There were no concurrent medications. On 7 January 2009 at 13:30 the subject received a dose of FLULAVAL at 0.01 ml, intradermally, in the left forearm. This was the wrong route of administration and an inappropriate dose of drug administered. The nurse administering FLULAVAL was thinking about how purified protein derivative is given instead of the way flu vaccine should be given. Following administration of FLULAVAL, the subject developed a local reaction immediately, which was defined as within one hour. The reaction consisted of a 2cm by 2cm area of redness and swelling. The area was also inflamed. The events were not resolved at the time of reporting and were being monitored and measured. No treatment was required. In the reporter's opinion, the events were probably related to treatment with FLULAVAL. The invalid FLULAVAL dose was repeated at the full 0.5 ml dose and was given via the appropriate intramuscular route. The repeat dose was given in an unknown deltoid muscle and there were no reactions reported.  The reporter did not know if the repeat dose of FLULAVAL was administered in the same arm as the invalid dose or the opposite arm.
Soreness; Round area of redness in arm; Itchy; round hard area; A spontaneous report was received from a (Consumer) concerning a  77 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: if reported or unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On 11/Jan/2021, The patient experienced the events list (verbatims).  Warm Transferred from Moderna Customer Care-Case Number:00031631 She experienced soreness/tenderness, round area of redness, hard, itchy in her arm after receiving vaccine on 11JAN2021. Received it in left arm. Medical history includes allergic to PCN and Bactrim. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.
Injection site swelling, redness, warm to touch, mildly tender that did not start until today-11 days after injection. I had none of the above directly after or in the 48 hours after the injection. There was absolutely no tenderness to injection site.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On23-SEP -2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
10-19-13 Fever (103.9) 10-20-13 Fever (102.5) red bumpy rash started on trunk. Throughout the day it spread all over her body. 10-21-13 Fever (100.1) rash all over (head, face, arms, legs, trunk, etc) ADVIL only treatment given 10-23-13 rash/fever resolved.
Onset of reaction about 12 hours after injection. Shivering and chills, followed by sweats, then nausea. Headache, weakness, pain in the arm at injection site. Nausea and weakness continued throughout the next day. Symptoms seemed better second morning, but alternating chills and sweats returned later the second day, along with headache--throughout the second day after shot. Diarrhea the third morning--pain the the arm is worse. General feeling of being miserable and weak. Took tylenol and Advil to help with headache and tried to drink water when nausea permitted.
States that his arm was sore after immunization and worsened after the first couple of days.  Has pain in the right shoulder with limitations in the ROM noted to elevation anterior and laterally. Cannot sleep due to pain, has limited strength in the shoulder due primarily to the pain. Has some paresthesia in the right thumb, first and second finger.  Saw Dr in ER and was prescribed prednisone for 10 days.  Pain eased during prednisone and resumed at the end of the dosage.  Still having difficulty.
MENSIS; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included break through menstruation, and other pre-existing medical conditions included patient had allergy to benedryl causes break-thru vaginal bleeding and prednisone-causes break-thru vaginal bleeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Concomitant medications included progesterone.  On 11-APR-2021, the subject experienced mensis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mensis. This report was non-serious.
Pt recvd Recombivax-HB vax on 17DEC91 & approx 45 min later exp chest pains, lightheadedness & palpatations; Pt was seen 12 hrs later in ER w/same sx; pt also c/o short term memory loss up to 5 days later; also broke out in a rash;
Muscle aches, chills, and fatigue started at 4 pm on 1/13/2021. Low-grade fever set in around 6 pm on 1/13/2021. Symptoms lasted until the next morning of 1/14/2021.
Case PHEH2016US023445 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to a 56 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into right arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
Serious side effect of tachycardia; Side effects; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tachycardia (serious criteria other: Serious per reporter) and adverse reaction. On an unknown date, the outcome of the tachycardia and adverse reaction were unknown.   It was unknown if the reporter considered the tachycardia and adverse reaction to be related to Shingrix.  Additional details were provide as follows: The age at vaccination was not reported. The patient had serious side effect of tachycardia. Also, not only did the patient have the side effects, but have to pay over 200 dollar for the shot which gave the patient side effects and not sure what emergency room and hospital visit bill was yet. The reporter wanted to know, what were the ingredients in it so the patient would know what to be on the alert for in any other products.
L SORE ARM AT INJECTION SITE; INTERMITTENT HEADACHE; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808607, and expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-APR-2021, the subject experienced l sore arm at injection site. On 02-APR-2021, the subject experienced intermittent headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent headache, and l sore arm at injection site. This report was non-serious.
Information was received from a pharmacist who stated that a female patient "received either one or two injections of GARDASIL, intramuscular, about three years ago, then she received another injection on 09-AUG-2012." No known adverse effects. No further information was available. Additional information has been requested.
Pt had imms (L) arm 6-22-10. 6-23-10 onset erythema. Increased erythema, on 6-24-10.
Pt developed shortness of breath, itchiness in her throat, and chest pain 15 minutes after receiving her first dose of the moderna vaccine. Pt received 0.3mg epinephrine, 50mg benadryl. She did not initially improve. 0.5mg epinephrine was given, along with 40mg methylprednisolone. Pt was transported to the emergency department where she remained for 5 hours in observation. She received medication in the ER. She was discharged home. She is now experiencing generalized fatigue.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received INFANRIX (batch number 907CM, expiry date 27th February 2017). On 12th December 2014, the patient received INFANRIX .5 ml. On 12th December 2014, an unknown time after receiving INFANRIX, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information: INFANRIX mistakenly given to an 11 year old female instead of BOOSTRIX.
First week after vaccine: fatigue, body aches, congestion, chills, loss of appetite.    Ever since vaccine: chronic fatigue, body aches, joint pain, knee pain and swelling, tension and tightness in legs, tension and pain in neck, jaw, and head, headaches.
PATIENT STATE SYMPTOMS DID NOT START RIGHT AWAY. HAPPENED A DAY OR SO AFTER SHOT. REDNESS HAS BECOME WORSE OVER THE DAYS, MOVING DOWN HIS ARM, TO HALFWAY BETWEEN HIS ELBOW AND SHOULDER. PATIENT STATES SITE IS VERY SORE, LYMPH NODES UNDER LEFT ARM SORE. DOES FEEL WEAK. STATES DID HAVE DIARRHEA AND SEVERE HEADACHE ON 2/9/19. STATED SITE WAS SO HOT LAST NIGHT COULD NOT SLEEP WELL. THIS RN CONSULT WITH IMMUNIZATION NURSE. DECISION TO INSTRUCT TO SEE DOCTOR IF STARTED TO RUN A FEVER OR HEADACHES BECAME SEVERE. PATIENT HAS ALREADY BEEN DOING TYLENOL/IBUPROFEN, ICE. TEMP 97.5 F IN CLINIC. HEART RATE 100. 94% OXYGEN. 124/88 BLOOD PRESSURE.
Information has been received from a physician concerning a 12 month old male with no drug allergies or medical history, who on 24-JAN-2011 was vaccinated with a dose of VARIVAX (Merck) (lot # not provided). On the same day, 24-JAN-2011, the patient was also vaccinated with a dose of PREVNAR 4 and a dose of PREVNAR 13. The next day, on 25-JAN-2011 (also reported as 24-JAN-2011) the patient had a swollen eye. No treatment was given for this adverse event. No lab diagnostics studies performed. Patient did not seek medical attention. At the time of reporting, the patient's status was not provided. Additional information has been requested.
Throat tightened slightly and tingled right after shot was given.  Loud ringing in ears began the evening of the shot and ringing continues daily.  Sometimes it is louder than others but is always there.
BRIGHT RED 6 INCH CIRCLE AROUND PUNCTURE. VERY HOT. PAINFUL. SKIN RAISED.
side effects following vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects following vaccination) in a female patient of an unknown age 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 VACCINATION COMPLICATION (side effects following vaccination). At the time of the report, VACCINATION COMPLICATION (side effects following vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided.  No treatment medications were provided.
Patient stated that he had a seizure 13 hours after receiving Moderna booster vaccine. Patient stated that he went to ER for treatment.
New onset of tinittus; Rash; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (New onset of tinittus) and RASH (Rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced TINNITUS (New onset of tinittus) and RASH (Rash). At the time of the report, TINNITUS (New onset of tinittus) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  The patient had the events 24 hours after the first dose.   Treatment medication was not provided by the reporter.
Woke 9/18/11 with racing heart, itchy eyes, weakness and balance concerns. Went to ER. Also saw MD 10/31. Getting better but still weak. Reports otherwise healthy with some arthritis. Plays golf regularly including yesterday, but weak now.
Within 15 minutes, hives and blood blisters from left shoulder to my wrist, and bruising around the left rotator cuff. Vomiting one hour later. Chest and arm numbness three hours later, lasting 2 weeks. Migraine six hours later (lasted 48 hours.) Kidney pain and bleeding 18 hours later, which has never subsided. Overactive bladder. Tested positive for Covid 5 days later. Chest pains 14 days later, which still occur. Muscular pains in limbs and torso approximately 21 days later, which have never subsided. Pain in injection site at unpredictable intervals, up to present time, worse than initial pain of injection. Kidney damage and muscular pains are potentially permanent, as they have continued unabated for 9 months. Note that the positive Covd test was immediately after the vaccine. I had never had tested positive for covid before, and I had no symptoms of covid prior to the vaccine. None of other adverse effects had occurred at any point in this life prior to the vaccine, except for one migraine in 2005 (not associated with any particular event or activity). I have no other prior history of migraines, chest pains, heart disease, neuropathy, kidney disorders, muscular pains, hives, etc. The kidney pain has been continuous with a constant moderate pain and acute spasms of higher-intensity pain. Concurrent to this I have been experiencing overactive bladder symptoms to the point of dry incontinence. A urinalysis conducted on 1 June 2022 showed turbid appearance, occult blood of 3+, RBC of 20-40, and trace protein levels. I also had two breakouts of subcutaneous swellings or pustules in the left armpit, one of which surfaced, ruptured and drained, the other of which never surfaced and which subsided. This is also something that never occurred before the vaccine.