chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist, refers to about 200 patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The pharmacist stated that on an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L004754, expiration date: 10-NOV-2016 and lot # L016427, expiration date: 13-APR-2017, (dosage and route were not provided). Concomitant therapy was not reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time frame were: 1.4 C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. Additional information has been requested.
Information has been received from a registered nurse concerning an anonymous of 8 to 8.5 months old patients who "sometimes in early 2009" was vaccinated with "one dose" of ROTATEQ after 8 months of age (Lot number not reported). No adverse effect reported. No expiration date or patient demographics provided. No further information is available.
6 to 10 hours after the vaccine injection on the same day, my nose started bleeding for 10 to 15 minutes
Pt stated her left upper arm got red, sore and swelled and felt hot. Pt said she felt hot. She reported this the day following the injection. Her doctor was called and she was instructed to take Tylenol. On 10/9/00, there was no redness or soreness at the injection site, only a small bruise at the injections site.
I had in April and December of 2020. When I got the vaccine I was in a care facility for my Long Haul Covid-19 symptoms. Two hours after getting the first dose I developed a headache which has persisted for nine months. Currently I am taking Magnesium and Vitamin B2/Riboflavin and it has given me a little relief. I also developed Tachycardia after the first dose. When the headache started it was so severe I could barely stand up. I went to the ER two days after the vaccine and again two weeks later. My CT scan showed a Sinus infection but when it cleared up the headache persisted. I had suffered headaches while I had Covid-19 the first time but I haven't had any since then until the vaccine. I have seen a Neurologist and a Rheumatologist as well as multiple medications but the headaches were still severe and happening daily. The headaches are always the same. They feel like Sinus pressure but it is all over my head. Sometimes I had throbbing and sometimes dizziness.
Information has been received through the Merck pregnancy registry for GARDASIL, from a medical assistant concerning a 16 year old pregnant female who on 28-FEB-2007 was vaccinated with a dose of GARDASIL. Follow-up information has been received from a medical assistant and a cardiologist who reported that the patient delivered, vaginally, a healthy, normal, female, weighing 8 pounds, 3 ounces, at term. The pediatrician heard a "slight heart murmur" and the baby was sent to a cardiologist for an evaluation. On 27-MAY-2008 the patient was evaluated by a cardiologist. It was reported that a heart murmur was noted some time after birth. The patient had no cardiac symptoms and had normal growth and development. There was a history of hypertension in the family but not hyperlipidemia or premature coronary artery disease. On physical examination the baby's length was 66 centimeters and her weight was 7.5 kilograms, both of which were of the 50th percentile for age. Her resting heart rate was 135, respiratory rate was 32, and blood pressure was 94/54 in the right arm, 95/44 in the left arm, 105/60 in the left leg and 88/46 in the right leg. There was no pallor, cyanosis, or clubbing. Her chest was clear. There was no hepatosplenomegaly. Brachial and femoral pulses were adequate. There was no brachia-femoral delay. First and second heart sounds were normal. There were no clicks, thrills, rubs, or bruits noted. There was a grade 3, harsh systolic ejection murmur at the left sternal border. Diastole was clear. Her electrocardiogram demonstrated right ventricular hypertrophy. An echocardiogram was performed and demonstrated a mildly dilated and hypertrophied right ventricle with good systolic function. There was a dysplastic pulmonary valve with moderate pulmonic stenosis. The clinical impression was moderate pulmonic stenosis. The patient will be re-evaluated in one year with an electrocardiogram and echocardiogram and most likely will need to have the valve ballooned when she is about 2 or 3 years of age. In the interim, she was to have a normal activity level. Additional information has been requested.
8/24/12 Patient developed redness and swelling at site. She presented at office 8/27/12. Swollen area measured 3 1/2 x 4 1/2 inches. Treated with MEDROL dosepak. 8/29/12 - patient reports symptoms resolving.
DIARRHEA; EXTREME TIREDNESS; This spontaneous report received from a patient concerned a 57 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 28-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 29-MAR-2021, the patient experienced diarrhea. On 29-MAR-2021, the patient experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness, and diarrhea. This report was non-serious.
Presented to the ED 6 days after receiving Pfizer vaccine with chest pain; pressure and burning with nausea and vomiting.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6201), in left arm, on 26Mar2021 as dose 2, single (Lot number: EP6955), in left arm, on 06Oct2021 as dose 3 (booster), single (Lot number: EW0185), in left arm and on 05Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", stop date: 2008, notes: Breast cancer (cancer free since 2008), acoustic neuroma surgery (2014).; "acoustic neuroma surgery" (unspecified if ongoing), notes: Breast cancer (cancer free since 2008), acoustic neuroma surgery (2014).; "known allergies: Shrimp" (unspecified if ongoing), notes: known allergies: Shrimp; "known allergies: contrast dye" (unspecified if ongoing), notes: known allergies: contrast dye. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were not taken as a result of drug ineffective. Therapeutic measures were taken as a result of covid-19. Anti-viral details reported as COVID 19 Treatment, treatment start date was 04Jun2022, treatment stop date was 08Jun2022 and indication was treatment of COVID-19. Other medication in 2weeks reported as no. No chronic health conditions.
Hand and arm numbness, shortness of breath, partial face numbness, red coloring in both palms, rash started to develop on top of hands and legs,  chest tightness.  Went to local hospital was given steroids, tramadol, Fluids and benedryl Thru IV.   Was admitted to ER by 11:30 and released at 4:00PM with the diagnoses of moderate allergic reaction.
Patient was feeling chest pain after receiving the vaccination, patient had previously had a similar issue in the past and was told he was having a "pre-heart attack". Patient was taken via ambulance to the ER after the vaccination.
received 2nd dose on 4/14/2021. Became symptomatic with cough, shortness of breath, extreme fatigue on 8/15/2021. Tested (+) on 8/17/2021 and admitted to Hospital. Discharged 8/21/22021 to home
Patient was given a GARDASIL subq (L) outer arm and 3 hr later had 2mm of mild erythema. 8 hrs later - no erythema, only a little increased irritability.
Skin broken out in hives and eczema.  Home treatment the first 7 days . Then called Prescribed  hydr-oxyzine. I did want the steroids treatment. My skin cleared up on my neck and back of neck. I still have issue on my arms with the break out. I have a second dose 10.25.21 @12:00PM.
Diarrhea, Palpitations, Tachycardia, Fatigue; Tachycardia;Generalized weakness Narrative:  Fatigue; Tachycardia;Generalized weakness- trasfered to ER-Benadryl 25 mg IVP. recovered after 1 hr of benadryl.  12/31-mild discomfort at injection site
p/vax pt devel an inj site rxn characterized by swelling, tenderness, warmth & redness;tx w/keflex & hydrocortisone cream & recovered;
Information has been received from a health professional concerning an adult patient who was vaccinated with MMR II vaccine as a child and had a negative titer in the Fall of 2007. The patient was vaccinated subcutaneously with a 0.5 ml booster dose of MMR II 0.5 ml in the fall of 2007. A titer was redrawn in December 2007, and the patient remained negative for rubella. No additional information is available.
She was having difficulty moving her arms and legs; She did have a bump on the side of her head; fallen off her bed another time; she kept saying "I think I'm gonna die"; She felt delirious; did have pain with the second injection; She did have a bump on the side of her head; she experienced fever; strange behavior; chills; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (She felt delirious) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced ABNORMAL BEHAVIOUR (strange behavior), CHILLS (chills) and PYREXIA (she experienced fever). On an unknown date, the patient experienced DELIRIUM (She felt delirious) (seriousness criterion medically significant), HYPOKINESIA (She was having difficulty moving her arms and legs), the first episode of HEAD INJURY (She did have a bump on the side of her head), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), VACCINATION SITE PAIN (did have pain with the second injection) and the second episode of HEAD INJURY (She did have a bump on the side of her head). At the time of the report, DELIRIUM (She felt delirious), ABNORMAL BEHAVIOUR (strange behavior), HYPOKINESIA (She was having difficulty moving her arms and legs), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), CHILLS (chills), VACCINATION SITE PAIN (did have pain with the second injection), PYREXIA (she experienced fever) and the last episode of HEAD INJURY (She did have a bump on the side of her head) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
MILD BODY ACHE; MILD FEVER; SWELLING THE SIZE OF A FIST ON LEFT ARMPIT/ SWELLING THE SIZE OF A GOLF BALL ON RIGHT ARMPIT; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 230 pounds, and height was 180.34 centimeters. The patient's pre-existing medical conditions included patient had no known drug allergies and no pre-existing conditions. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 30-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAY-2021, the subject experienced swelling the size of a fist on left armpit/ swelling the size of a golf ball on right armpit. On 31-MAY-2021, the subject experienced mild body ache. On 31-MAY-2021, the subject experienced mild fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from mild body ache, and mild fever on 01-JUN-2021, and had not recovered from swelling the size of a fist on left armpit/ swelling the size of a golf ball on right armpit. This report was non-serious.
Clinic received Pfizer vaccine on 07/06/2022 at 11:09 AM. We utilized the ten week rule which would have the vaccine expire on 09/14/2022 at 11:09 AM. At time of administration we believed the vaccine was not expired. Pfizer changed expiration dates and we did not learn that our particular lot number expired until time of business close.   We gave an expired vaccine to the patient.
Swelling all over body. Low grade temp 99 degrees. Dizziness. Sensitivity to light. Treatment of steroids times 4 days.
Bad taste in my mouth; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 09Apr2021 at 12:15 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. Patient had no known allergies to food, medication or other products. The patient did not receive any other medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 09Apr2021, the patient experienced bad taste in mouth. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for event. The clinical outcome of the event bad taste in mouth was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
After each Covid vaccination (1/28/2021, 02/25/2021 and 10/28/2021) I suffered acute mouth sores (all reported on V-Safe). After actually getting Covid in Demeter 2021, the same mouth sores appeared, and continued on and off until now.  A blood check last week indicated a very low WBC.
Vaccine at 9 AM Monday starting at 5 PM that same day started to feel unwell at 6 PM low-grade fever 8 PM chills bodyaches increase and fever by 9:30 PM fever was up to 101.7 chills, body aches, severe arm pain at injection site.  following day(Tuesday) headache fever continued, no chills, bodyaches were less, arm pain at injection site continued. Wednesday headache continued and had neck pain as if the lymph nodes were swollen no more fever no more chills, body aches very limited. Thursday back to my baseline all symptoms resolved.
3x3 inch well circumscribed, red rash with that lasted for 4 days. The rash was erythematous, hot to the touch, firm, and was extremely itchy. The rash was localized and there were no systemic symptoms. I took 50mg diphenhydramine every 6 hours for 3 days and iburpofren 400 mg every 6 hours for the first 24 hours. The rash began to dissipate after 2 days. After 5 full days it has fully resolved.
4 clusters of itchy vesicles on rt side of upper trunk & rt back;mom applied topical iodine from mexico;DPH & calamine topical given;
Two weeks after the vaccine on March 29,2021 all day that day right arm was stiff and felt like every nerve in her body was in pain. stated she felt like somebody was ripping her arm off it. Tried taking extra strength acetaminophen but it still didn't work. Range of motion with moving her arm didn't bother her at all it was just pain in her arm.
lethargy; fever; chills; headache; This spontaneous case was reported by a health care professional and describes the occurrence of LETHARGY (lethargy), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced LETHARGY (lethargy), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, LETHARGY (lethargy), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
At Clinic, box of Hepatitis A pediatric put in cooler instead of adult formulation. Pediatric dose given instead of adult dose. Revaccinated 11-2-2018 Hepatitis A VAQTA R018775 exp 2019Aug09.
This is a spontaneous report from a contactable consumer and from a contactable physician. A 65-year-old healthy female patient received PREVNAR 13 (Lot Number J498U2 or J49842, NDC number 0005-1971-01) at 0.5 ml single via intramuscular route into the left deltoid on 16Dec2014 at 10:00. Relevant medical history included tonsils out for surgery (when she was a teenager), cataract surgery (she was taking eye drop), high blood pressure, transient ischemic attack (TIA) stroke 10 years before this report, and pneumonia. Concomitant medications included ongoing atenolol at 50 mg since 2000, ongoing amlodipine at 5 mg since 2014, both for high blood pressure, and ongoing atorvastatin at 10 mg since 2005 for an unspecified indication. On 16Dec2014, 12 hours after the shot, the patient woke up at night and experienced excruciating pain of her arm (from her shoulder injection site to her finger tips). She got up and trying to shake her arm over the next 24 hours, she began to feel better but she was just shocked, she had such a painful reaction in whole arm. The reaction lasted for 2 weeks and included also 4 inch diameter swelling at injection site that was red and hard as a rock. After a few days a rash appeared and it began to itch. On 17Dec2014, the patient also developed extreme chills and her joint began to ache painfully that lasted for a few days. She was not aware of the side effects of PREVNAR 13. She thought she was coming down with the flu and after 48 hours she went on a website to look up adverse side effects and she had every single side effect. The patient did not receive treatment for the events. The patient recovered from the reported events on an unspecified date. She asked if this reaction was more likely in a person who had already had pneumonia and if the other pneumococcal vaccines currently on the market caused a similar reaction. Follow-up (28Jan2015): New information reported from a contactable physician includes: drug data (added suspect drug PREVNAR 13 with Lot Number J49842, Expiration Date 30Mar2016, dose of 0.5 ml, single, via IM route, anatomical location, start and stop time). Follow-up (18Feb2015): New information reported from the same contactable consumer includes: suspect product details (suspect product was confirmed PREVNAR 13, it was unknown if its lot number was J498U2 or J49842), additional details on concomitant medications (start date), reaction data (new events 4 inch diameter swelling at injection site that was red and hard as a rock, after a few days a rash appeared and it began to itch were added), reporter queries.
Information has been received from a physician concerning the father of his patient developed mumps after the patient received MMR II. The father experienced mumps 2 weeks after his son was vaccinated. The father's diagnosis was made by physicians in the Emergency Room. The physician did not want to report this as an adverse event because he was skeptical of the diagnosis. No further information is available.
2nd dose of Moderna COVID-19 vaccine not administered 46 days after the first dose; 1st dose of Moderna COVID-19 vaccine administered to patient under 18 years old; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna COVID-19 vaccine administered to patient under 18 years old) and PRODUCT DOSE OMISSION ISSUE (2nd dose of Moderna COVID-19 vaccine not administered 46 days after the first dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna COVID-19 vaccine administered to patient under 18 years old). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose of Moderna COVID-19 vaccine not administered 46 days after the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna COVID-19 vaccine administered to patient under 18 years old) and PRODUCT DOSE OMISSION ISSUE (2nd dose of Moderna COVID-19 vaccine not administered 46 days after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment and concomitant product was reported.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Medium, Additional Details: FOLLOWED UP WITH PATIENT 12 HOURS POST EVENT- REPORTS FEELING NORMAL,WITHOUT ANY/NEW SYMPTOMS
I have Post Herpetic Neuralgia as a result of severe non-erupting Shingles in 2017 and it is controlled with 300 mg Gabapentin 2x day.  I can be sensitive to touch and fabric throughout my entire back and across my midriff and sides below by bra line.   The sensitivity varies day to day and I live with it.  When I woke up the at 3:30 am the day after the 2nd dose of vaccine my entire back,  midriff and sides were significantly aggravated and it was difficult to move against the sheets in bed.   Today is day 18 post second dose and every day since 2/11 I remain in increased sensitivity and discomfort.  I have to keep changing to one piece dresses after 5 hours of daylight  that just drape over me with no seams.    I have not increased my Gabapentin  dosage (I could but try not to) and in when there are VERY sore locations, applying CBD cream will relieve the pain in 20 minutes.    The pain/sensitivity locations change daily.
Nausea, vomiting for 24 hours. Joint and muscle pain/aching still going. Eye pain, swelling, redness still going. Blurry vision in eye still going. Headache/migraine still going.