chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health care worker concerning a patient "over 55 or 60" years of age who "two weeks ago" was vaccinated with a dose of Pneumovax 23 (lot #651399/0486F). Subsequently, the patient experienced redness and swelling at the site of injection. The patient was reportedly recovering. Additional information has been requested.
DIFFUSE MACULOPAPULAR RASH COVERING TORSO AND ARMS.  PATIENT GIVEN BENADRYL 25 MG, AND SAINA LOTION.
On 30November2021 the patient tested positive for Cocid-19; Slight fever after second dose; Chills after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (On 30November2021 the patient tested positive for Cocid-19), PYREXIA (Slight fever after second dose) and CHILLS (Chills after the second dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 007B21A) 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 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PYREXIA (Slight fever after second dose) and CHILLS (Chills after the second dose). On 30-Nov-2021, the patient experienced SARS-COV-2 TEST POSITIVE (On 30November2021 the patient tested positive for Cocid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (On 30November2021 the patient tested positive for Cocid-19), PYREXIA (Slight fever after second dose) and CHILLS (Chills after the second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment received by the patient.  Company Comment-This spontaneous case concerns of 67 years -old female patient with no relevant medical history reported who, experienced non- serious unexpected event of special interest (AESI)of COVID-19 test positive. The event occurred  8 months 18 days after the second dose of properly scheduled dose of mRNA-1273 vaccine . In addition to that symptoms of pyrexia and chills were reported after the of second dose of mRNA-1273 vaccination whose outcome is unknown. The rechallenge is not applicable, as the event happened only after the second dose. The benefit -risk relationship of drug is not affected by this report.; Sender's Comments: This spontaneous case concerns of 67 years -old female patient with no relevant medical history reported who, experienced non- serious unexpected event of special interest (AESI)of COVID-19 test positive. The event occurred  8 months 18 days after the second dose of properly scheduled dose of mRNA-1273 vaccine . In addition to that symptoms of pyrexia and chills were reported after the of second dose of mRNA-1273 vaccination whose outcome is unknown. The rechallenge is not applicable, as the event happened only after the second dose. The benefit -risk relationship of drug is not affected by this report.
red at injection site and fever, 2 more red spots have come up under vaccine site like lines
Patient received the Pfizer covid vaccine and appeared to tolerate it well during the 15 minute observation period. Patient and his mother left the practice and patient fainted in the elevator at minute 18 post vaccination. The patient hit his head but there were no apparent physical injuries. He lost all color. Patient was unconscious for about 1 minute. After 15 minutes, vitals were stable. Mom declined going to the ER.
no adverse affects reported; patients received doses of improperly stored Varivax; This spontaneous report was received from a health professional and refers to a patient of unknown gender and age. The patient's concurrent conditions, medical history, concomitant therapies, drug reaction and allergies were not reported.   On an unknown date in April 2019 (reported as 25-APR-2019 or 26-APR-2019), the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneously, lot # R034396, expiration date 27-NOV-2020, (dose was not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 38 degrees Fahrenheit for 72 hours. Sterile diluent was stored properly. There were no previous excursions reported. Data logger was not involved. No adverse effects was reported.  This is one of eleven reports from the same reporter.; Sender's Comments:  US-009507513-1904USA013269: US-009507513-1904USA013210: US-009507513-1904USA013270: US-009507513-1904USA013268: US-009507513-1904USA013265: US-009507513-1904USA013272: US-009507513-1904USA013276: US-009507513-1904USA013278: US-009507513-1904USA000187: US-009507513-1904USA000191:
Dad present for vaccine, after a few minutes post vaccine, pt ws unresponsive and had a syncopal reaction, sterna rub, unresponsive to name, pale, diaphoretic., weak pulse of 40, legs raised 0947 81/43-41-12- then 107/56-77-18 responded to voice comands, oriented times 3 and transfered to cot and observation area. Parent instructed to call pediatrician and have him seen for a work up. Parent advised to have him laydown for immunization when he returns. 1015 home to the care of parent.
Is nausea a common side effect of the second shot; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were received as follows: This case was reported by patient self. The age at vaccination was not reported. The patient experienced nausea after vaccination. The patient asked is nausea a common side effect of the second shot.
feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced MALAISE (feeling sick). At the time of the report, MALAISE (feeling sick) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported. .
pt recv vax 28AUG95 & 27NOV96 pt devel a varicella-like rash w/approx 10 lesions;
Shortly after my second dosage of the vaccine I started to develop recurrent dorsal vein thrombosis (blood clots) on my penis. I also experienced fatigue and shortness of breath.  Then on December 28 of the same year I had a stroke caused by clotting in a right intracranial artery branch. This was an ischemic basal ganglia stroke that resulted in paralysis on my left side. I was hospitalized for 30 days and I am no longer able to work.  While in the hospital I was also diagnosed with stage four heart failure. Reduced ejection fraction but asymptomatic.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST Quadrivalent (intranasal), 0.2 milliliters, unknown. The patient had been administered the vaccine after it had been outside of the recommended storage range within the last 2 weeks in Oct2015. The outcome of the event of administered the vaccine after it had been outside of the recommended storage range within the last 2 weeks is unknown. The report was considered to be non-serious.
This spontaneous report received from a registered nurse referred to a 4 year old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 19-SEP-2016, the patient was vaccinated with M-M-R II (lot number: M004305), dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA014830: same reporter US-009507513-1609USA013814: same reporter US-009507513-1610USA004339: same reporter.
This spontaneous report was received from a health professional refers to unspecified patients of unknown demographics. On unspecified dates these patients were administered with unspecified doses of with PROQUAD (Merck) (lot # and expiry date unspecified) which was improperly stored throughout March 2015. No adverse effects were reported. Outcome of the event was unknown. Reporting health professional considered the event to be not related to PROQUAD (Merck). This is one of several reports from the same reporter (MARRS # 1503USA013938, MARRS # 1503USA014260, MARRS # 1503USA014261, MARRS # 1503USA014262, MARRS # 1503USA014263 ad MARRS # 1503USA014265). Additional information has been requested.
flu shot started having sore throat, coughing, sneezing, eyes watery, chest soreness; t100;
Can barely lift arm without pain. Can't cross arms over head to pull off a shirt and it aches all the time.
This spontaneous report as received from a healthcare worker refers to a female patient of unknown age. No concurrent condition or medical history reported. On an unknown date, the patient was vaccinated with the complete series of 3 doses with RECOMBIVAX HB vial SD, intramuscularly. On 14-NOV-2014, the patient had a blood titer that was low for Hepatitis B antibodies which was confirmed by the blood titer test which was done on the same day. Action taken with the RECOMBIVAX HB was not applicable. The patient's present status was unspecified. No treatment was provided for the event. No product quality complaint reported. Causality was not provided. Additional information is not expected as the physician did not wish for further contact.
Misadministration of flu vaccine. Previous flu vaccine had been administered on 10/27/2017; the next vaccine was not due until next flu season.
1545 TO NSG DESK POST INJECTION. COMPLAIN OF FEELING FLUSHED AND LIGHT HEADED. PT ASSISTED TO STRETCHER.BP 143/110 HR 134  DENIES SOB, NO RASH NOTED. PT WITH NO OTHER COMPLAINTS 1550 BP 156/92  HR 140, ENCOURAGED TO RELAX. NO RAPID BREATHING, DENIES SOB. 1555 BP 154/94  HR 130 1558 BP 152/98  HR 142 1607 BP 141/89  HR 115   EMS HERE SO AT BEDSIDE TO AMBULANCE VIA STRETCHER
Patient called to report that she doesn't want second covid vaccine because she experienced side effects 30 to 45 minutes after getting first Pfizer vaccine on 9/10/21.  She said she waited in the lobby for 15 to 20 minutes, then left and went shopping.  She experienced light headedness.  So she went home, then started experiencing her heart racing and a a friend gave her 100mg of Benadryl and took her to the ER.  She said she felt heavy chested and throat tightness, but never had difficulty breathing or swallowing and never lost consciousness.  She says her blood pressure was elevated at the ER.  She said she was told she had a panic attack and was released and in 5 hours from receiving the vaccine she was feeling normal.
Today 2/1/23 the patient reported to us that: a day after getting shingrix she started to have blisters inside the mouth, and around her lips & chin, and a burning sensation in her left ear, these side effects were getting worse over time. At her first phone encounter with her family dr, she was given peridex for mouth lesions, but it has not worked. She just had the 2nd phone encounter with her dr today 2/1/23 & waiting for the provider to decide if anything else would be prescribed for her.
This spontaneous report as received from a healthcare worker refers to a 4 years old patient of unknown gender. Concurrent conditions and medical history were not reported. On 30-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
itchy red circle; red splodges; This spontaneous case was reported by a non-health professional and describes the occurrence of ERYTHEMA (red splodges) and PRURITUS (itchy red circle) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALFUZOSIN and SIMVASTATIN for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (red splodges). On 13-Feb-2021, the patient experienced PRURITUS (itchy red circle). On 16-Feb-2021, ERYTHEMA (red splodges) and PRURITUS (itchy red circle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Follow up information received on 26-Apr-2021 Contains No New Information. On 01-Jul-2021: Follow-up information received on 01-Jun-2021 Contains No New Information.
Patient received vaccine on 3/16 @ 1:30 PM. Rash developed 3/21....turn into painful red rash on 3/22 in the morning  (pt had hard time putting on shirt). Rash is on left lower arm/left side of body. Patient describes it as pulsating. I informed patient that it may be related to the vaccine, to contact her primary or got to an Urgent care ASAP and recommended OTC products in the mean time (anti-histamine+iburpofen/apap for pain) Patient will report back to me what her physician thinks is causing the rash. I will continue to document and follow up with patient
mom reported pt staring into space & was easily startled 4-5PM then nap @ 5PM; a little cranky p/awakening; okay during noc & today 8SPE95; no swelling or redness @ site;
10:33am Pt c/o  difficulty swallowing, and swelling of throat. BP: 147/89 )02sat 99%RA, HR 91 Temp:36.8 RR :16 10:35am Benadryl 50mg IM given of Left deltoid 10:50am: Patient reassessed symptoms not progressing 11:15am: symptoms resolving
Received 0.5 ml dose for their booster; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Received 0.5 ml dose for their booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that 5 patients got a 0.5 ml dose instead of a 0.25 ml dose for their booster.   No concomitant medications were mentioned. No treatment details were reported.   This case was linked to MOD-2021-363552, MOD-2021-363577, MOD-2021-363591, MOD-2021-363626 (Patient Link).
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756551A, A0756553A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The reporter indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
VACCINE SITE HAD KNOT AND GREW RED AND HOT TWO DAYS BEFORE RASH DEVELOPED OVER BODY
Pain at injection site (left shoulder muscle) did not dissipate as expected.  Instead, it spread to the left shoulder joint.  Within a month, there was swelling in the left knee joint, then right shoulder, then right hip, then right knew.  Massive inflammation of major joints led to swelling, excruciating pain, severely limited range of motion, an inability to sleep for more than two hours - inflammation becomes so bad when trying to sleep, that any significant movement causes intense pain, leading to very uncomfortable wakefulness and all the problems that come with sleep deprivation.  Including severe impairment of work.  Now, three months after vaccination, the inflammation has settled primarily in both shoulder joints, leading to Adhesive Capsulitis (frozen shoulder) and less than 10% mobility without taking NSAID's, somewhat better with.  Inflammation at shoulder joints is still very active, with no end in site - and much misery.
Initially, there was redness, swelling and pain at the injection site. Within two days (by morning of 1/30/2015) I developed swollen lymph node on the left side (same side as injection) and a lump, along with a fever, headache and increased pain. I saw my doctor the evening of 1/30/2015, which resulted in a visit to the emergency room to rule out more serious conditions. I'm still experiencing swollen lymph nodes and a lump, although the fever and headache have lessened somewhat.
My wife and I both contracted COVID while away from home. My wife got exhausted at dinner and she tested positive for a home test. The doctor gave her the antibodies. On my home test, I had a faint line reflecting positive. I was feeling tired and was coughing. The doctor completed the PCR test which was positive. She had me to take the monoclonal antibodies. It knocked the symptoms out within a day. We isolated and extended our trip by a couple of days. We completely recovered. We moved our return date to come back on the 13th so that we were symptom free for a week.
I had the Singles and had the shot/Suspected vaccination failure; I had the Singles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 26-Jul-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shot and had the shingles. The patient stated that thank you for the shot it would had been a lot worse. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a nurse. She states that doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. The patients were vaccinated with MMR II. Other suspect therapies included ROTATEQ. No concomitant medications were reported. On an unknown date the patient experienced doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients. No treatment information was reported. Doses of MMR II and ROTATEQ that were exposed to 50F for 48 hours were administered to patients is not related to MMR II nd ROTATEQ. At the time of the call, she does not know who received the doses of improperly stored vaccine, but she would like to know if they should be revaccinated. She will call to provide details when she is able to retrieve the information. SR # provided. It is not known at this time if there have been any adverse effects. Rotavirus vaccine Date given 11/01/0212. Lot # 0057AE. Additional information has been requested.
LT showed redness, swelling, hot, tender to touch 2 days after setting DTAP and PPV 23 in same leg. (local reaction). Better with Benadryl, ibuprofen, Tylenol with Codeine.
Patient is a minor under 18 and received the Moderna COVID vaccine on 2 different occasions. She did not have any adverse reactions to receiving the doses
Persistent sore throat and sever cough at night especially causing lack of sleep.  Difficulty in swallowing and gulping. Feeling of an object lodged in back of throat. Tonsils, esophagus hurts with so much coughing. Irritating sensation in throat.
4 1/2 hours following vaccination, I began experiencing anticipated common side effects (sore injection site, fatigue). I finished working remotely without issue at 17:00, and noticed that I felt unusually warm and my face was flushed. Took my temperature and was running a fever of 100 degrees Fahrenheit. Minor side effects presented over the course of the evening and by 22:15, I had a headache and muscles and joints were painful. Next morning (4/17/21) I began my menstrual cycle. I immediately noticed it was significantly heavier, thicker and a bright red color. It was not anything I had ever experienced before, and was a little uneasy. The rate at which I was having to change tampons was overwhelming, but I had a feeling it had possibly to due with receiving my second dose. The cycle continued in this manner for another 3 days, which is also not typical for me, as it usually lasts a full week.
received vaccine 11/4 11/5 had nausea, fever, chills, very painful arm where she received the injection Felt better by 11/8