chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 1st dose of Pfizer COVID vaccine on 4/1/21. On ~ 4/9/21, patient developed nausea, vomiting, diarrhea, and abdominal pain. He presented to the ER on 4/11/21 and was admitted for observation due to severe nausea and inability to take PO.  He tested positive for COVID on 4/11 in the ED. COVID treatment was not started on admission due to lack of respiratory symptoms.
This spontaneous report was received from a patient's mother refers to a 2 year old male patient. No concurrent condition or medical history was reported. On 29-OCT-2014, the patient was vaccinated with MMR II (dose and route of administration not provided) and RECOMBIVAX HB (dose and route of administration not provided). No concomitant therapy was reported. Since an unknown date after vaccination the patient began to experience intermittent fevers. The patient sought medical attention. The patient currently experiences intermittent fevers. The causality assessment was not reported. No product quality issue was involved. Additional information is not expected since no healthcare professional contact details were provided.
Spoke with the patient's husband, who stated that the patient is doing fine. Per patient's husband, they think that the patient has food poisoning. The patient developed diarrhea and vomiting after the vaccine. The last time the patient experienced vomiting and diarrhea was the night before yesterday. Yesterday, the patient drank water and is back to normal. The patient and husband belief that the symptoms came as the result of her eating sushi from store. The husband did not eat any of the sushi, but one of their neighbor's wife at sushi from the same store, and they developed the same symptoms. Inquired if the husband contacted the store where the sushi was purchased; patient denied contacting the store that the sushi was purchased from. Adv gentle rehydration with small sips of fluid and or ice chips, popsicles. If sx persist or worsen to call back, if any sx of dehydration or issues lasting longer than 24 hours, adv ED eval.   Provided phone number for FU and PCC will check on tomorrow, call back if issues worsen/persist overnight
I have been experiencing clotting, pain and bruising in my legs and arms since receiving the J&J vaccine
No adverse effects noted; product storage error; This spontaneous report was received from a registered nurse and refers to a 41 year old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 25-OCT-2019, the patient was vaccinated with an improperly dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # R036582, expiration date 17-DEC-2020 (dose, route and anatomical location were not provided), and on 06-NOV-2019, with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S000132, expiration date 02-JAN-2021 (dose, route, and anatomical location were not provided) for prophylaxis. No adverse events were reported. The vaccines experienced multiple temperature excursions where the highest temperature was 42.2 degree celsius. There was not previous temperature excursion. It was reported that digital data logger was involved.
Days 1-3 headache and severe fatigue with Menses starting at  5 days post vaccine which is almost 2 weeks too early.  Blood is very dark almost black.  Started as dark spotting.
Chills; Muscle Pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and MYALGIA (Muscle Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and MYALGIA (Muscle Pain). At the time of the report, CHILLS (Chills) and MYALGIA (Muscle Pain) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided.
Miscarriage - first vaccine at 10 weeks and 3 days with prior proof of heartbeat/movement, second vaccine at 13 weeks and 3 days; learned of miscarriage at 14 weeks 3 days with measurements of 12 weeks 3 days on U/S
Patient reports pain upon movement, specifically lifting up arm since date of administration (receiving) of vaccine. Patient was seen by worker's comp MD on 11-13-12 & was prescribed six visits of physical therapy. Has received 3 sessions of P.T.
developed swelling of the eyelids, nose, and lips; developed swelling of the eyelids, nose, and lips; developed swelling of the eyelids, nose, and lips; a rash at the injection site; a rash on certain finger and toes on both the left and right side; lip swelling; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiry date: not reported), via an unspecified route of administration on 07Sep2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 08Sep2021, the patient experienced lip swelling. On 09Sep2021, the patient developed swelling of the eyelids, nose, and lips, a rash at the injection site, a rash on certain finger and toes on both the left and right side. Caller received her second dose of the bnt162b2 vaccine on 07Sep2021. Last night (day before reporting date) she noticed some lip swelling and then day of reporting date she developed swelling of the eyelids, nose, and lips as well as a rash at the injection site, and a rash on certain finger and toes on both the left and right side. The outcome of all the events was unknown.   No follow up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101183653 mom/baby case
headache, sinus pain, shortness of breath, body aches. starting 12/15/21
27 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (27 weeks pregnant) in a 36-year-old female patient (gravida 5, para 3) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy on 21-Feb-2017. Concurrent medical conditions included Allergy (Codeine Allergy). Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 04-Aug-2020 and the estimated date of delivery was 14-May-2021. On 12-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (27 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-seventh week of the pregnancy.  On 12-Feb-2021, EXPOSURE DURING PREGNANCY (27 weeks pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2020, Pregnancy test: positive (Positive) positive pregnancy test. On 22-Nov-2020, Ultrasound scan: normal (normal) nuchal ultrasound. On 02-Dec-2020, Alpha 1 foetoprotein increased: normal (normal) Alpha fetal protein panel-normal. On 29-Dec-2020, Scan: normal (normal) 20 week anatomy scan.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment details were reported.
muscle pain in my arm; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 12:00 (at the age of 24-year-old) as dose 1, single for COVID-19 immunization. Medical history reported as no. The patient concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines in 4 weeks prior to the COVID vaccine. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021 the patient experienced muscle pain in arm. The clinical outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Arm felt warm, fatigue, swollen arm & redness at site of injection 6 inch diameter (lasting 2 days). On the third day I applied a cold compress from the freezer. On day 4 arm is still slightly swollen & mild soreness.
8/1/21 (day after administration) red, bumpy rash appeared. the following day (8/2/21) he went to md and received steroid shot. 8/10/21 he got steroid cream. still on his arm but does not itch.
Patient 4 months old at time of inadvertent COVID-19  vaccine administration, and therefore patient did not meet EUA criteria for age 6 months. No adverse symptoms or reaction reported per Mom and no adverse reaction witnessed by RN vaccinator or site leader during 15 minute observation after administration.
1 of 3 pts vaxed from same lot who exp an adverse event;pt vaxed 6JUN94; several days later began to cry unconsolably on & off throughout noc;crying was not high-pitched;crying has cont to date 30JUN94;MD visit;no fever or other sxs;
Vertigo, first noticed when I bent down to get a pan to cook breakfast. Vertigo has continued for 2 days whenever I move my head quickly.
Information has been received from a physician concerning a 5 year old male patient who is immunocompromised and who in approximately 2002 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot # not reported). it was reported that the patient did not respond to an initial dose of pneumococcal 23v polysaccharide vaccine. No other information was provided. Unspecified medical attention was sought. Additional information has been requested.
27SEP91 recd call from friend of family informing Health Unit that PT died night of 26SEP91 @ hospital p/immunizations 26SEP91;
Had sore right arm injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Had sore right arm injection site arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Breast cancer (The patient first had breast cancer 10 years ago). Concomitant products included EXEMESTANE for Breast cancer. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Had sore right arm injection site arm). In 2021, VACCINATION SITE PAIN (Had sore right arm injection site arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient received her first Moderna COVID-19 vaccine in January or February 2021. The sore arm lasted for a week. No treatment medication was provided. This case was linked to MOD-2022-542707 (Patient Link).
Pt. experienced mild itchiness under eyes and a "tingle" sensation in throat. Pt.'s skin color normal w/o any signs of a rash or swelling, no SOB, and no c/o nausea/vomiting. b/p 108/68, RR 20, pulse/HR 68 and regular with no arrhythmia. Pt states symptoms were much improved when she was leaving the post vaccination area. Pt. was discharged, ambulatory, and was was escorted out to vehicle (driven by her sister). Sister and pt. instructed to seek medical attention immediately should symptoms return.
On 12/2/21, patient received the 1st dose of Pfizer COVID vaccine. On 12/5/21, patient started complaining of left ear pain and swelling. On 12/6/21, patient complained more left ear pain and swelling. On 12/7/21, patient looked normal before going to school. During school, patient started to experience left facial swelling. When returned to school around 3:40 PM, patient's mother noted slurred speech, patient's inability to smile on the left side as well as inability to move his left eyebrow. Patient brought the patient to Hospital's emergency department on 12/7/21 and was diagnosed with left Bell's palsy. Patient followed up with Family Practice office on 12/10/21 where patient continued to have motor deficits on the left face. Patient followed up 393  Family Practice office on 12/20/21, which showed moderate improvement but continued to have motor deficits on the left face. Patient will continue to follow up to monitor the recovery.
Area where the shot was injected is sore/sore in the area on the injection; the area where the shot was injected swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Area where the shot was injected is sore/sore in the area on the injection) and VACCINATION SITE SWELLING (the area where the shot was injected swollen) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007521-28, 004s21a and 006o21a) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Area where the shot was injected is sore/sore in the area on the injection) and VACCINATION SITE SWELLING (the area where the shot was injected swollen). At the time of the report, VACCINATION SITE PAIN (Area where the shot was injected is sore/sore in the area on the injection) and VACCINATION SITE SWELLING (the area where the shot was injected swollen) had not resolved.            Concomitant product information was not provided.  The patient asked if it was safe to take something for pain and it did not work, and still sore and swollen.   Most recent FOLLOW-UP information incorporated above includes: On 06-Feb-2022: Reporter details, patient demographics, suspect doses details were updated.
19DEC95 c/o h/a, backache, myalgia, sore throat, cough, T100.8, P120, R24, BP 130/70; no rashes, lungs clear; beta strep screen neg;dx flu like synd s/p vaccination
Case number PHEH2017US002218, is an initial spontaneous report received from a pharmacist on 17 Jan 2017. This report refers to a 52-year-old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUAD (lot number: 166002, expiry date: Apr 2017) at a dose of 0.5 ml intramuscularly 17 Jan 2017. No adverse event was reported following this medication error (drug administered to patient of inappropriate age).
Information has been received form a nurse concerning a pt who on 21AUG2003 was vaccinated IM with a dose of pneumococcal vaccine 23 polyvalent. On 22AUG2003 the pt notified the physician's office to report that she had developed redness and itching at the site. Unspecified medical attention was sought and it was unknown if a prescription drug was required. No product quality complaint was involved. It was also reported that another pt was vaccinated with a dose of pneumococcal vaccine 23 polyvalent and developed a fever, itching and redness at the injection site. Additional information has been requested.
patient felt weak and sat on floor and 911 was called and patient was keep alert and conscous while ems got to pharmacy. patient has history of syncope with blood draws and was taken to hospital to be checked out
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 14-MAY-2014, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, 2 ml, which had a lot # of H017721 and an expiration date of 31-MAY-2014 (dose number was not reported). The vaccine had the following temperature excursions: 32, 584, 152 and 288 hours with the lowest recorded temperature reported were 31, 33, 32 and 34 Fahrenheit (F) (-0.555555556, 0.555555556, 0 and 1.1111111111 Celsius (C)) respectively. The storage criteria and the storage type were reported as "refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse, refers to a 4 week old patient (gender was not reported). On 07-OCT-2013 the patient was inadvertently vaccinated with ROTATEQ, 2 ml, oral. The patient's date of birth is 06-SEP-2013. No adverse effect reported. Additional information has been requested.
Information has been received from a physician concerning a 14 year old male patient who on 29-OCT-1997 and 14-SEP-1999 was vaccinated with the first and second doses of MMR II (HSA). On 15-JAN-2010 the patient experienced left parotitis. It was noted that the patient had exposure to others with mumps. On 17-JAN-2010, the patient was diagnosed with mumps. No blood works were done. At the time of the report, the patient's outcome was unknown. No further information is available.
Pt received 1st dose of Moderna COVID 19 vaccine on 4/19/21 the following Friday patient reports going to ED and dx with Bell's Palsy. This pt only came to our clinic for the COVID vaccine. We do not see him regularly and have no previous medical records.
1st and 2nd night after vaccine had sleeplessness (I do not normally have sleeplessness).  3rd night ok (slept 5 hours before waking).  4th night - worst sleepless thus far:  Slept 2 hours and woke up.  Went back to sleep, but woke up about every hour for the next 3 hours.  Could not get back to sleep after 5 hours.
she has a fever of 101.5; headache; nausea; This spontaneous report was received from a company employee (also reported as the patient's grandmother) and the patient's mother, referring to a 17 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown by reporter.  On 11-FEB-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis.  On 12-FEB-2021, the patient had a fever of 101.5 (units not provided), headache and nausea. The patient sought medical attention by seeing the administering physician in afternoon and was tested for flu, strep, and Covid, all of which were negative. The patient was diagnosed that her symptoms were an adverse reaction to the vaccine. The outcome of fever of 101.5 (units not provided), headache and nausea were unknown. It was reported that the patient would not be receiving the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The reporter considered the causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was related.
Sudden onset weakness, emesis x1, syncope about 90 minutes later, low-grade fever (99.6) for about 24 hours.  Largely resolved next day.  Seems to have completely resolved day after that.
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 037F21A, 022M20A and 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient received Moderna Covid-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna Covid-19 vaccine was stored in. The Nurse had used the online Temperature excursion tool and was comfortable that her patient dose was valid and that the affected vaccine was viable for future doses. Side effects after any doses was unknown.  No treatment medications were reported.
Patient experienced vertigo, dry heaves and back spasms 5 days after the shot, and felt like it was related to the vaccine.
In August the patient developed breast tenderness and symmetrical breast growth of one cup size. Although the patient has an IUD, she experienced breakthrough period bleeding the next month. The patient has a history of dysmennorhea and experienced menstrual pain and headaches.