chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vivid dreams; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (vivid dreams) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUDESONIDE (PULMICORT) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABNORMAL DREAMS (vivid dreams). At the time of the report, ABNORMAL DREAMS (vivid dreams) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2021: No specific follow-up information recorded.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. No concurrent conditions, medical history and concomitant therapies were reported. On an unknown date, the patients were vaccinated with improperly stored (Oka-Merck) PROQUAD (dose, frequency and route of administration were not reported) with lot number of M007963 and expiration date of 15-AUG-2017. No adverse effects were reported. No further information was provided. Additional information has been requested. This is one of the several reports received rom the same reporter.
pt recvd vax 4AUG94 & next day had hx of crying & fever sinc vax given; on exam pt had temp of 104.1 & was very irritable;
This spontaneous report as received from a consumer refers to a 60 years old wife. On 07-AUG-2014 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, route, lot#, expiration date and frequency were unknown) in the upper right arm for vaccination. On an unknown date in August 2014 (post ZOSTAVAX vaccination) the patient experienced red circle at the injection site and pain. The outcome of pain and red circle at the injection site was reported as recovered/resolved on an unknown date in August 2014. This is one of several reports from the same reporter. Additional information is not expected.
Recvd vax 10AM. Fever @ 2pm t104(R),APAP given & 2-baths; dec to t102(R) & has been all night for 24hrs; Respirations-raspy & rapid;
His wife had to go to the hospital and got COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (His wife had to go to the hospital and got COVID) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (His wife had to go to the hospital and got COVID). At the time of the report, COVID-19 (His wife had to go to the hospital and got COVID) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Dosage text was reported as Additional Booster.  Unknown if patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Reporter stated that his wife received 2 primary series doses and 2 boosters, she was going to get another booster but in the meantime, she had to go to the hospital and got COVID there, she was told that she should wait 3 months to get a booster and she was receiving conflicting/different information about how long she should wait to receive a booster.  Treatment information was not provided.
Feet & calves extremely warm, no fever. Upset stomach, malaise, slight difficulty breathinh
Injection sight left red rash ( about 2inches 5 inches high) itches , warm to touch. Still red , itches,
Patient received first dose Moderna vaccine elsewhere and came to the clinic today for his second dose. Unfortunately he received Pfizer vaccine as his second dose By mistake. Dr. called & informed. Patient denied any symptoms. No adverse reactions noted.
12/4/21: 74 years old male patient with past medical history significant for diabetes mellitus type 2, hypertension, sleep apnea, hyperlipidemia, coronary artery disease status post PCI status post CABG that presents to the emergency department with a chief complaint of shortness of Breath, general malaise for the last 6 days.  Patient refer tested positive for COVID 19 last Wednesday.  Refers into has been worsening.  Upon initial evaluation emergency department vital signs:  Hypoxia oxygen saturation 75% at room air, Low blood pressure.  Laboratory reveals anemia, hyponatremia, non-anion gap metabolic acidosis, hyperglycemia, elevated creatinine, elevated proBNP.   Please note: Patient received first dose Pfizer vaccine on 1/11/2021 Lot # EL1283 and the second dose on 2/10/2021 Lot # EL9265
Generalized maculopapular rash with pruritus. Area of redness and swelling at site of hepatitis B shot. Atarax 2ml PO QID for 1 week.
2 days after receiving H1N1 vaccine, pt. developed rash (vesicular) on back, abdomen, legs. Otherwise feels well. OTC topical treatment prn.
This is 1of 4 pt to exp adverse rxn p/vax at this site. Pt exp inj site rxn of redness. No further info
Patient came in for 2nd dose of Pfizer on 3/23/2021 and received Moderna in error. No adverse events have been reported by the patient. This report is for reference only at this time.
Positive COVID test on 16Dec2021.; Positive COVID test on 16Dec2021.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 16Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 16Dec2021, outcome "recovering" and all described as "Positive COVID test on 16Dec2021.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Dec2021) positive. Therapeutic measures were not taken as a result of covid-19. The 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient is a resident at Nursing Home. The adverse event was a vaccine administration error. The patient received a 4th dose of Pfizer COVID-19 vaccine (0.3 mL dose) on 12/2/2021. She had received the booster/3rd dose of Pfizer COVID-19 vaccine on 9/30/2021. Upon follow-up with staff after we discovered the administration error, they reported that the patient experienced no adverse outcomes.
15 mins after receiving vaccination lips began to burn, lips began to swell, took Benadryl every 4-6 hours, tongue began to swell, hives all over body, was prescribed prednisone 40mg, symptoms reoccur out of the blue.
In May 11th 2021, I had heartburn, diarrhea and it stop and started again for a week and diarrhea for one week. Till today I have nausea and heartburn. The heartburn never left in Jun 2021; Referred to a GI doctor.
Injection site pain and tenderness (3/10 worsening to 6/10 within 24 hours then 0/10 at 48 hours).  Chills developed at 24 hours post injection and lasted 30 mins.  Fatigue onset at 24 hours, persisted through 48 hours post administration.  Headache onset at 24 hours (pain rate 8/10 and persisted for 6 hours).
Chills, sweating, vomiting, fever (102.4), pain in the left arm at the injection site, headache for 12 hours. Muscle ache, fatigue, nausea, headache, chest pain/tightness 72 hours. Chest tightness, nausea, headache, fatigue, muscle ache, general bad feeling current as of 3-14-21.
Excrutiating leg pain from knee to groin  began on day after first shot 1/28/2021 then after 2nd dose was given on 2/24//2021  a massive stroke occured within 8 hours.
After the first few days, I felt tired and out of it. I also experienced some aches and pains. I started to notice that in my right arm, from shoulder to fingers, I was feeling like I was having an arthritis flare up. On 12/09/2022, I started to experience cold symptoms. The symptoms I experienced were similar to the flu. I was feverish, but I did not have a fever, I had sweats, nausea, brain fog, a headache, coughing, congestion, had to use my inhaler and fatigue. I took a COVID-19 test on 12/12/2022, and the result was positive. I called the doctor's office. I visited with my doctor on 12/22/2022, and she listened to my lungs, which were clear. By 12/25/2022, I was still feeling run down. I am currently to the point where I feel that I am getting over this, even though I have lingering fatigue.
SLIGHT HEADACHE, AND TIREDNESS FOR FIRST TWO DAY. RASH STARTING ON THIRD DAY AND CONTINUES
prone to hypoglycemia; This is a spontaneous report received from a contactable consumer (patient).  A 51-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left in Mar2021 12:45 PM (Batch/Lot Number: EN6204) as single dose at the age of 51-year-old for COVID-19 immunisation.  Medical history included cholesteatoma, known allergies: Sulfa drugs, cephalosporins and strawberries. The patient's concomitant medications were not reported. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced prone to hypoglycemia on an unspecified date with outcome of unknown. The course of events was as follows: After the first dose of Pfizer vaccine, the patient had almost no side effects, just more prone to hypoglycemia.  The patient subsequently received the 2nd dose on 01Apr2021. Since the vaccination, the patient has been tested for COVID-19: lab tests and procedures included Sars-cov-2 test: negative on: 11Mar2021, 18Mar2021 25Mar2021, 08Apr2021, 19Apr2021, and Sars-cov-2 test: pending on 28Apr2021.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a doctor of pharmacy refers to an approximately 68-year-old patient of unknown gender. On 23-SEP-2012 the patient was vaccinated with a dose of 0.5 milliliters (ml) PNEUMOVAX23 lot # (667915/1111Z, expiration date 02-MAR-2012) intramuscularly. No concomitant medications were reported. On 23-SEP-2012 the patient was administered expired dose of PNEUMOVAX23. No adverse effects reported. No further information is available. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a healthcare professional (nurse) and described the occurrence of regurgitation in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received a dose of ROTARIX (oral). At an unspecified time after vaccination with ROTARIX, the subject experienced regurgitation. At the time of reporting the outcome of the events was unspecified.
Swollen lymph node in left armpit. Vaccine booster was given in left arm. Lump is swollen and hard painful and is the size of a golf ball.  Other symptoms included muscle and joint pain in neck, back, hips, legs. Chills throughout body.
Information has been received from a pharmacist who reported that on 15Sep2012 an expired dose of PNEUMOVAX 23 (lot # 669579/0595AA, expiration date 30Aug20120, 0.5ml, intramuscularly, was administered to a patient. No adverse effects were reported. No additional information was provided. No further information is expected.
Patient received fluzone HD on 9/5/2023. Next day started with hot flashes (fever), Next day no appetite, nausea, chest tightness and diarrhea. Went to Urgent care on Friday 9/8/23. Urgent care sent her to ER. ER admitted her overnight to run test. Discharged on Saturday 9/9/23. Hospital said it may have just been a virus. Covid test was negative.
Information has been received from a nurse concerning a 16 year old female with epilepsy and no known allergies who on 28-MAY-2008 was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL vaccine (yeast) (lot no. 659653/1448U). Concomitant therapy included CARBATROL and ASTELIN. A few days after her second vaccination, the patient developed some mental confusion that lasted several days. On an unspecified date, the patient recovered from mental confusion. The patient sought unspecified medical attention at routine office visit. Additional information has been requested.
Chills; Headache; Sore arm; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received meningococcal group b Rlp2086 (TRUMENBA), as dose 1, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Myocarditis; Superventricular Tachycardia of 239; This is a spontaneous report from a contactable consumer(Patient). A patient of unspecified age and gender received bnt162b2 (COMIRNARY; Formulation, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced myocarditis and superventricular tachycardia of 239 on an unspecified date. The patient underwent lab tests and procedures which included heart rate: 239 on Superventricular Tachycardia of 239. The outcome of an event is unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Ibuprofen for 6 days in diminishing amounts. Very Sore muscles in shoulders and arms then in back, then legs. Within one week I was limping and unable to bear weight on left leg upon waking. Recovery 1 month
I had gotten my second Covid shot in my left arm at 9:30 Saturday morning (2-20-2021), the shot was pretty high up to my shoulder.  By 1pm my arm was feeling sore just to lift it up. By 2pm the same day I could not move my left arm up at all. I couldn?t hold on to my steering wheel, I couldn?t pull my pants up from going to the bathroom, I couldn?t put my arm in my jacket. That night I couldn?t sleep at all. I was in so much pain. The next day I could 4 ibuprofen and 2 Tylenol pain would not go away. The pain was in my shoulder. For a couple days moving it anyway was nothing but extreme pain. I went to the Doctor March 2 and explained what I was feeling. The dr or the NP said to take ibuprofen and moist heat.  She said she could of hit a nerve but also could of been a side effect from the shot. So two weeks after the shot was given, my shoulder is still in pain, it?s a lot worse at night time and right when I wake up. I have been doing what my NP told me to do but no relief. She wants to me to call her in a couple weeks if it doesn?t improve. But recently, I?ve been feeling tingling going up to my neck on the left side and my fingers as well.
About 8 hours falling the shot I experienced mild to moderate symptoms  for about 12 hours.  Low fever 99.8, chills, lethargy. 2 weeks after the shot I started experiencing swollen hands and trigger finger (right hand, ring finger). 2 months after the shot I still have swollen hands and trigger finger in both the right and left hand ring finger. Also dull aching in my fingers. I can no longer wear the rings that I had sized on April 21, 2021.
Irregular menstruation, uterine pain, ovarian cysts, loss of hair on head, increase of hair on upper lip and chin, diagnosis of Polycystic Ovarian Syndrome in October of 2014 and prediabetic condition from the PCOS.
ADMINISTRATION ERROR: Immunizer, reports an incident in which she immunizes a 10-year-old male minor with his second dose in the left arm and when removing the needle, she realizes that the syringe did not have the dose of the vaccine. talks to the mother about what happened and explains that he would investigate what happened, for which he proceeds to estimate the syringe in the presence of the nursing director, I. and the shift leader, Indeed, the syringe was completely dry and without any residue of the COVID-19 vaccine dose. Doctor is notified and the mother of the minor is spoken to to explain the situation and the patient is vaccinated correctly.
given APAP w/inject; 4 hrs p/inject temp w/repeat APAP given; some whining-irritability & dec appetite noted; t102 ax for 12 hrs despite repeated APAP;  noted to be seeing dragons-unusual laughter & starry eyed;
fever; body aches; headaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (fever), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills). At the time of the report, PYREXIA (fever), MYALGIA (body aches), HEADACHE (headaches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 11-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R034700, expiry date 16-JUN-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 Fahrenheit degrees for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000926: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000888: US-009507513-1907USA000927: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000928: US-009507513-1907USA000936: US-009507513-1907USA000923: US-009507513-1907USA000938: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000903: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000882: US-009507513-1907USA000925: US-009507513-1907USA000924: US-009507513-1907USA000862:
EVENT: Patient called the office on 06/14/2007, stating that starting on the afternoon of 06/12/2007, she felt like the inside of her body would get really hot and then it would cool off and then she gets nauseated.  She states that this happens intermittantly and only last for about 10 minutes.  She also noticed that the injection site was red and puffy and was warm to the touch.  TREATMENT:  Instructed patient to take Tylenol and Benadryl OTC as directed.  If her symptoms continued or became worse - or if she developed any fever or neurological symptoms, i.e. confusion, dizzyness, to return to the clinic or go to the ER immediately.
Information has been received from a 73 year old female with no reported medical history and a sulfonamide allergy who on 30-AUG-2007 was vaccinated with Zostavax (Oka/Merck) (lot # 656858/0356U). Concomitant therapy included glyburide, metformin HCl (GLUCOPHAGE) and ramipril (ALTACE). The patient reported experiencing a warm, red, and swollen rash around the injection site a few days after receiving Zostavax. On approximately 03-SEP-2007 the patient experienced fever, chills, sore throat and other unspecified flu symptoms. As of 10-SEP-2007 the patient is recovering. Additional information is not expected.
Client fainted helped to the floor elevated legs cool wash cloth to forehead. Client came to within couple of seconds, water provided. Client helped to waiting room, mother present 5-10 minutes mother and client feel comfortable to leave. Client walks out per self, accompanied by mother and sister.
Rapidly progressive dyspnea and fatigue, worse with even light exertion, at night and laying down.
I developed generalized skin rashes the day after my 2nd dose , fever, chills, weakness. Relieved by taking Tylenol, Zyrtec, Benadryl. Rashes goes on and off. When it reappears theres more clusters and it spread all throughout the body.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Weakness-Severe
BIVALENT PEDS PFIZER 5-11 YO GIVEN AS FIRST DOSE INADVERTENTLY. CLIENT DID NOT HAVE ADVERSE REACTION. ACCORDING TO CDC INTERIM GUIDANCE, IT WAS NOT NECESSARY TO REPEAT THE DOSE. PARENT NOTIFIED OF ERROR, CORRECTED INFO IN VACCINE RECORDING SYSTEM TO REFLECT ACTUAL VACCINE GIVEN.
This case was found during archiving activities and has not previously been entered into the global safety database. The case was processed using procedural documents and current labeling documents. This spontaneous report from a physician concerns a 41 year old female: US-TEA 9306. The subject's concurrent conditions included: ear ache. The subject's height and weight was not reported. The subject received typhoid vaccine oral ty21a (capsule, hard, oral) administered on an unknown date for prophylactic vaccination and tetanus vaccine (unspecified, batch 12124-1, expiry AUG-1993) initiated on an unknown date for prophylactic vaccination. Concomitant medications were not reported. On 29-APR-1993, the subject experienced redness and itching around the injection site, chills and fever. On 05-MAY-1993 erythema was 1x2 centimeters with central necrosis 'with skin of dead tissue'. Action taken with typhoid vaccine oral ty21a and tetanus vaccine was unknown. The subject had not recovered from the events. This report was serious (medically significant).