chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 11-MAR-2016, the patient was vaccinated with improperly stored dose of RECOMBIVAX HB (Lot No. K007263; expiration date 09-JUN-2016) "SDV;10 pack", (Route of administration and anatomical location were not reported). There was no concomitant therapy reported. On unspecified dates, the RECOMBIVAX HB had three temperature excursions: one of 16 hours, 920 and 168 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was 34 F (1.111111111 Celsius). No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
little dizziness that was not bad; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 11Mar2021 (Lot number: EN6200) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "little dizziness that was not bad". Additional information: The patient took Pfizer COVID-19 vaccine as a protection from the various strains of COVID-19. The patient was not taking Other Products and with No Patient History. The patient states that, he never had fit BMI index,  very muscular and very fit and he lifts 4 times at least a week. He get on a trail and hike 15 miles and be fine, he was in the upper percentages of health for his age. No follow-up attempts are possible. No further information is expected.
In September of 2007, one month after receiving the third installment of the Gardasil vaccine, I began to have joint pain and body aches.  The pain increased through October and November.  The joints throughout my body were inflamed, I had a fever, disruption of sleep due to pain and discomfort, and severe restriction in movement.  Tests revealed that I had severe inflammation.  I was treated with Prednisone and Methotrexate as a preventative measure for arthritis.  The inflammation decreased following medication treatment.  However, when the medicines are reduced the inflammation of joints returns.  There was also calcification in my wrist joints following the inflammation, causing restriction in joint flexibility.  1/16/2009 MR received from Rheumatologist. DX:  Polyarthritis. Pt initially presented 11/26/07 with c/o abrupt onset of pain-joint pain: hands, knees, PIP, MCP, wrists, feet, hips, shoulders, lumbosacral spine and cervical spine, morning stiffness x 2 hrs, sleep disturbance, low energy and feeling moody and depressed.  Initially thought to be RA with (-) markers. C/o sore throats, H/As and mild upset stomach 12/6/07. Tx with anti-inflammatories, Pred and Methotrexate with some improvement, however worsening with reduced doses. Reported chest pain, nausea and bruising 1/8/08. Increased H/A, neck pain and knee tightness 3/08.  Increased fatigue despite sleeping well 11/08. Pain improved.
No adverse event; Expired dose of VAQTA was inadvertently administered to a patient.; This spontaneous report was received from health care professional and refers to an 80-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 29-MAR-2023, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA), 1mL, (lot #, route of administration and anatomical location were not reported) expiration date: 02-MAR-2023, administered for prophylaxis. At the reporting time, no adverse events were reported.
Tenderness in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness in the injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Tenderness in the injection site). At the time of the report, VACCINATION SITE PAIN (Tenderness in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use in December 2020. Family history included Dwarfism (Mother had one child with dwarfism with no bones. Did not survive.) and Congenital heart disease NOS (Sister-in-law had a baby with heart syndrome. Did not survive.). Concurrent medical conditions included Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 12-Mar-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Dec-2020 and the estimated date of delivery was 21-Sep-2021. On 12-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  On 12-Mar-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Pregnancy test: positive (Positive) Positive. On 05-Mar-2021, Ultrasound uterus: on track (normal) On track. In 2021, Ultrasound uterus: positive (Positive) Positive pregnancy confirmation at 6 weeks.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       NIPT (Noninvasive Prenatal Testing) was performed on 05-Mar-2021, results are pending. Estimated Date of Conception: 29-Dec-2020
pt recv vax 22MAY97 & on 18JUN97 pt reported to the ER w/nausea, vomiting, viral gastroenteritis & subconjunctival hemorrhage;pt hosp;
covid vaccine breakthrough   dose 1 Pfizer 3/11/21  EN6207 dose 2 Pfizer 4/5/21 ER8730
Felt light-headed and woozy; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 07Apr2021 at 17:30 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included COVID-19 on an unknown date. The patient did not have any known allergies to food, medications, or other products. The patient's concomitant medications and past drugs were not reported. Prior to the vaccination, the patient was 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 vaccination. On 07Apr2021 at 17:30, the patient went to stand up about 1 minute after the vaccination, the patient immediately felt light-headed and woozy and had to sit down. If the patient had not sat down, the patient believed she would have fainted. The patient was monitored for 30 minutes and then she was able to leave. The patient did not have low blood sugar or high anxiety about getting the vaccination. The patient's vitals came back clear. It was unknown whether any therapeutic measures were taken as a result  of the event. It was unknown if therapeutic measure were taken as a result of adverse event. The clinical outcome of the event felt light-headed and woozy was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
some aches; swelling; lymph node in her neck; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (some aches), SWELLING (swelling) and LYMPHADENOPATHY (lymph node in her neck) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included SUMATRIPTAN for Migraine.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN (some aches), SWELLING (swelling) and LYMPHADENOPATHY (lymph node in her neck). At the time of the report, PAIN (some aches), SWELLING (swelling) and LYMPHADENOPATHY (lymph node in her neck) had not resolved. Not Provided          Treatment medications included  Medicine for migraine after shot.  On 4 March lymph node was bigger.
Complaints of headache, sinus pressure 9/8/03. 9/9/03 was better; received Hepatitis B vaccine. 9/12/03 felt poorly, nausea, pounding headache, low grade fever, eyes burning. 9/13/03 same symptoms progressed; emesis. Went to hospital ER at 18:30; received Tylenol #3 times 5 for pain. Returned to school 9/15/03. 4 days diarrhea; no further problems.
Experiencing itchy skin rash on left side of neck and small spots in a few other places. Began on September 20 and still present September 24.   Received vaccine on 33W+2D pregnant. Uncomplicated pregnancy thus far.
Patient had a very sore arm for 5 days, nausea for 45 minutes, and body aches.  Her primary complaint was very bad muscle pain, especially in her legs and groin.  She felt that it was very hard to walk for several days.
Headache & Arthralgia Narrative:  Symptoms occurred day after injection. Felt better in a day or two.
Extreme fatigue initially and high body temperature. All on the same day. Sore arm at injection start.
VACCINE VIAL WAS PUNCTURED AND LEFT IN THE FRIDGE FOR OVER 6 HOURS PRIOR TO ADMINISTRATION; POTENTIAL ADMINISTRATION ERROR (EXPIRED JANSSEN COVID-19 VACCINE ADMINISTERED); This spontaneous report received from a consumer concerned an 18 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced vaccine vial was punctured and left in the fridge for over 6 hours prior to administration. On 22-SEP-2021, the patient experienced potential administration error (expired janssen covid-19 vaccine administered). The action taken with covid-19 vaccine was not applicable. The outcome of the potential administration error (expired janssen covid-19 vaccine administered) and vaccine vial was punctured and left in the fridge for over 6 hours prior to administration was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946821.
1) Severe PMS and off-cycle period 2) Cystic acne which I have not had in over a decade
10min post vaccine, patient reported feeling flushed, hot, and sweaty.  No SOB nor difficulty breathing. BP 132/82 normally 110/60s. HR 70. 30 min post vaccine, palms felt itchy and slightly more sweat but overall improved.  Within the hour, symptoms resolved and patient returned to work
Information has been received from a physician concerning a 4 year old male patient with no past medical history and no known drug allergies, who on 02/15/2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  There was no concomitant medication.  On 02/18/2000 the patient's "eyes were crossed".  Subsequently, the patient was seen by an eye doctor who diagnosed "Ethatropia, palsy of eye."  It was noted that the eye doctor could not be sure if the measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) was the cause of the palsy, but it was probably caused by a virus.  The patient recovered in a "couple of months".  Additional information has been requested.
Information has been received from a nurse concerning to a currently 25 year old female patient. There were no pertinent medical history, drug reactions and allergies. On 06-APR-2016, the patient was vaccinated with the first dose of GARDASIL 9, via intramuscularly route, (lot number L019287, with an expiration date of 14-SEP-2017) (strength, dose and anatomical location were not reported), and on 06-JUN-2016, she was vaccinated with the second dose of GARDASIL 9, via intramuscular route (lot number L019287, with an expiration date of 14-SEP-2017) (strength, dose and anatomical location were not reported). The patient was not taking concomitant medications. On an unknown date, the patient became pregnant with an estimated date of last menstrual period (LMP) and 06-JUN-2016 and estimated due date (EDD) of 13-MAR-2017. The nurse stated that the patient was currently 8 weeks pregnant that was confirmed by an "at home pregnant test" on an unspecified date in 2016. At the time of reporting, the pregnancy outcome was pending. No product quality compliance (PQC) was involved. Additional information has been requested.
Red, swollen and hot. Fever 100 given Motrin q 4hrs with cool clothes applied. Also pain in right upper leg.
Information has been received from a registered nurse concerning a 70 year old female patient who on 03-FEB-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot # 665400/1315Y). It was reported that on 04-FEB-2010, the patient experienced redness and swelling around the injection site where the PNEUMOVAX 23 vaccine was given. According to the nurse, the patient also had fever. At the time of the report the patient had recovered. The patient sought medical attention by an office visit. This is one of several reports received from the same source. Follow up information has been received from the registered nurse who indicated that the patient was a retired female with no pre-existing allergies, birth defects or medical conditions who on 03-FEB-2010 was vaccinated with the first dose of PNEUMOVAX 23 (Lot # 665400/1315Y) into her right deltoid at 08:05 AM as part of preventive care. It was reported that on 04-FEB-2010, the patient's right deltoid was warm, red and edematous. The patient was treated with KEFLEX 500 MG TZD and cold compresses. At the time of the report the patient had recovered. No relevant diagnostic tests were performed. No further information is available.
Information has been received from a pharmacist referring to unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with M-M-R II (lot#, expiration date, dose, frequency and route were not reported) which were exposed to temperatures outside of the recommended range. No adverse effects had been reported. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of abdominal pain in an adult subject of unspecified gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On 27 December 2011 the subject received a dose of ENGERIX B (20 mcg/ml, unknown) as the 2nd or 3rd in the series. On 29 December 2011, 2 days after vaccination with ENGERIX B, the subject experienced abdominal pain, fever and nausea. At the time of reporting the events were resolved. The healthcare professional reported a second adult with same events following ENGERIX B vaccination (see case ID A0960622A for further details).
She got her vaccine, her arm hurt like crazy.  She already has a left shoulder impingement and did not need excess arm pain.  She is 1 hour from the office to her home, and by the time she got her home the pain was so great that she used a pain patch, and the injection site pain and the shoulder and put a Diclofenac patch on the injection site.  She had normal arm pain with the Moderna vaccines, but this was extremely painful.  She had a mild headache and feeling nauseous before she got home.  Within 6 hours after the vaccine she had what she calls a heart beat that was so loud and fast that she could feel and hear it, it was 121/91 with a pulse of 108 when she took her BP.  It went up as high as 130/88 with a pulse of 110 . She normally runs very low with her BP 94/67, pulse of 79 is normal for her.  So, her BP was 20-30 points higher than normal.   When she got home and inside she was dizzy, nauseous and felt like somebody ran over her with a truck.  She also had chest discomfort, felt like she had an animal sitting on her chest, and under her left arm felt like she had pulled a muscle.  She also had injection site pain, tiredness, headache (so bad she had to take a migraine pill - 2 extra strength Tylenol), muscle pain, chills, joint pain, fever up to 102.4 by the next morning.  She also had injection site swelling, feeling unwell, no appetite, and everything she tried to eat tasted like cardboard.  She also had diarrhea, and had Compazine that she took for the nausea and probably would had vomited if she hadn't taken it.  The dizziness got to the point that if she did not sit down she would have fallen down.  Was wondering if she would pass out or not, and spent that evening and the rest of the next day in bed.  This is the first day in 13 days that she did not have diarrhea.  She has also had severe cough, runny nose, like she had gotten a cold/flu on top of the COVID vaccine.  She took the shot that day as her immune system was in a good spot and agreed to do it, and probably felt as miserable for the past 12-13 days as she did when she had COVID, which was 8/17/22.  She had the worst headache she had ever had when she had COVID.  Due to her being high risk due to asthma, had an infusion on 8/23/22.   The infusion affected her with BP fluctuations for a week.    She is due for a physical in the beginning of the year.  Today, is the first day that she has not taken Tylenol.  She had coughed so bad that she has pulled a muscle under her right rib cage, under hear arm and right groin area/hip area, and took Coricidin HBP to alleviate the pain from that.  She had more symptoms and felt sicker with the vaccine than she did with COVID.  She states that she will never take another Pfizer vaccine, never had a problem with Moderna vaccine.   She basically did not get out of bed for about 12 days other than an hour or so here and there, but would be so exhausted in just a short period of time.  Her BP this morning was 120/83 pulse rate of 58, and will still be higher and pulse rate over 100 as of today.  The cough is pretty much under control.
patient had dime sized rashes/bumps on arms and back develop about a week after receiving the first dose. His pcp took biopsies of the bumps and shown to be inflammatory growth, not cancerous or due to other causes.
Pt recvd vax 6JUN91 fever (mom said pt had fever but did not take temp) 7JUN91; On 10JUN91 pt broke out in rash which started in diaper area & spread to trunk & arms & legs; Rash dx as yeast;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 63 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unknown date in 2008, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
There was no adverse reaction.  Patient received the J&J vaccine on 03/20/21.  On 08/05/21, he received Pfizer.
pfizer jan 29 pfizer feb 19 Pfizer #1 EL 9263  Pfizer #2 EL 9267 low grade fever of 99.0, palpitations,  and diarrhea yesterday. Recommended that she see her primary provider if symptoms worsen.
Patient received DTaP, IPV, MMR and VARIVAX on 3/9/2009. Pt developed blistery rash on 3/10/2009 and temperature. Patient presented on 3/11/2009 with same symptoms. Dr diagnosed patient with drug reaction from vaccines. Pt had hives.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 15-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was unknown. Treatment information was unknown  This case was linked to MOD-2021-327879.
Mother reports:  Student had 2nd Varicella on 9/17/2010.  On 9/18/2010 developed major edema of right upper arm. Arm very hot to touch. Was seen at ER. Was placed on antibiotics.
PULMONARY EMBOLISM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown exp:unknown) frequency one total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced a pulmonary embolism. She was hospitalized on an unspecified date and the duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210547188 -covid-19 vaccine ad26.cov2. s-Pulmonary embolism. This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.