chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extreme exhaustion lasting for longer than one week. Headaches, joint inflammation and pain in hands feet and knees as well as up and down spine.
The next day upon applying lotion, patient experienced what she felt were allergy symptoms: itching and difficulty breathing. Husband took her to EMS. Heart rate also dropped very low.
Pt is a 42 YO female who has received her full Pfizer vaccination: first dose on 1/23 and second dose on 2/13. She developed headache, congestion, and loss of taste and smell on 5/12. Tested positive for COVID-19 on 5/13.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 28-NOV-2018, the patient was administered impoperly stored LIQUID PEDVAXHIB for prophylaxis lot #R005118 and expiration date 28-NOV-2020 (strength, dose, frequency and route of administration were not reported). No adverse effects were reported. The lowest temperature of excursion was below 36°F / 2°C (34.9°F) for 28 minutes including below 32°F for 15 minutes. There was no previous temperature excursion. There was no digital data logger involved. This is one of several reports received from the same reporter. Sender's Comments: US-09507513-1901USA007858.
patient called pharmacy and reported a severe site reaction, she can not move her arm and the arm is very soar. patient went to doctor and did x-ray but not damage was showing in the x-ray. patient said that she had tried topical cream to relieve the pain but no success.
FEVER; HEADACHE; This spontaneous case (PVX2019-1452) was received from a physician on 05-Jun-2019. It describes a 9-year-old female consumer who had fever and headache, after the administration of Vivotif for an unknown indication.  Case report: The consumer took the second dose on 03-Jun-2019. On 04-Jun-2019, he had headache and fever (101.4 degree Fahrenheit)  The consumer had no medical history.  The consumer had not taken any concomitant or treatment medication.  Action taken with Vivotif was unknown.  The consumer had not recovered from the event fever while the clinical outcome of the event headache was unknown.  Company's Comment: In this case, it was reported that a 9-year-old female consumer who had fever and headache after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever and headache are labelled as per agency. Hence, the causality of the events with Vivotif is assessed as possible.; Sender's Comments: Company's Comment: In this case, it was reported that a 9-year-old female consumer who had fever and headache after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, fever and headache are labelled as per agency. Hence, the causality of the events with Vivotif is assessed as possible.
@1725Pt c/o needing to sit down post flu vaccine. Offered water, but pt declined. Pt remained in room for 15 min while other family member received their flu vaccine. @1738 pt walking away from Clinic, but still in store and slid to the floor (unwitnessed by staff, but reported to staff by family members who was w/ him). Pt escorted to waiting room and dad grabbed sugary drink. Pt reports to only eating small amount today.  @1755 - pt tolerated 3/4s of snapple and states he is feeling better. Pulse steady w/ RRR @1815 - pt left clinic w/ family.
Information has been received from a 20 year old female consumer for GARDASIL, Pregnancy Registry product, concerning herself with no drug reactions or allergies and no pertinent medical history who on 23-JUN-2011 was intramuscularly vaccinated with a dose of GARDASIL (Lot# and expiration not reported). There was no concomitant medication. Consumer reported that she became pregnant after received GARDASIL. The consumer stated she was pregnant since "six weeks ago", approximately on 24-MAY-2011, EDD approximately on 28-FEB-2012. Patient did not seek medical attention. No laboratories were performed. Follow-up information has been received from the registered nurse via a completed pregnancy questionnaire concerning the female patient. The patient has a history of 2 previous pregnancies and 2 pre-term deliveries and the last baby had heart murmur. The patient was intramuscularly vaccinated with the first dose of 0.5 ml GARDASIL (lot # 666595/0096Z) on 23-JUN-2011. Then the patient became pregnancy. The LMP was 24-MAY-2011, and the estimated delivery date was 28-FEB-2012 (also reported as 06-MAR-2012. It was reported that on 17-FEB-2012 the patient delivered a viable normal male baby. The patient's due date was 06-MAR-2012. The baby weighted 7 pounds 4 1/2 ounces, length 19 1/2 inch. The infant's APGAR score was unknown. There were no complication during pregnancy or delivery and had no congenital anomalies. Additional information is not expected.
I received the vaccine on Thursday, January 20, 2022, at 5:15 pm,  Having experienced side effects with the first shot, I took two Tylenol at about 9:30 p.m..  The symptoms started at 6:00 on Friday, January 21, 2022, and lasted most of the day. I felt achy in my joints and body, my skin felt very hot. I didn't take my temperature but whatever I was feeling was not like when you have temperature and it breaks, then you sweat and feel better.  I just felt hot all day.  I took one Tylenol at about 9:00 a.m. which helped with the symptoms a little. I did not feel like eating although I was not nauseous. I drank a 2-liter bottle of warm ginger ale during the day. I was very tired and kept falling asleep while doing nothing for the whole day.  I ate a light meal (cannot remember what it was) and felt a little nauseous afterwards but that was all and it went away after a couple of hours. I took one Tylenol at 3:00 p.m., then two more at 10:30 p.m. I slept well and was tired Saturday, January 22, 2022, but otherwise felt fine, although a little weak from not eating. The symptoms were totally gone by the end of the day Saturday. I will add that these symptoms were experienced after the first shot as well, which was in August and I don't know the date.
Arm pain - can not lift arm or put jacket on, tenderness, headache, fatigue, muscle and body pain, chills
Approximately 15 minutes after Hepatitis B injection given employee was working on donor floor and started to have symptoms. She started with generalized warmth, headache and nausea. Employee taken to office and cool compresses applied and lab jacket removed. Employee's vitals taken 126/71, heart rate 71. Employee then started with dizziness, lower extremities elevated. Vital signs taken again 117/66, heart rate 78. Employee states stomach feeling better at this time.
Harder time breathing  Chills Slight fever Sore throat Slight fever Fluid around the heart
Shortly after receiving the injection, I had a headache. Then pain in my right arm. The headache subsided in a few hours and the pain in my arm got progressively worse over the first 24 hours and then began to subside. I began to experience memory lapses after 24 hours and made many mistakes that are unusual for me. I would describe it as severe brain fog. All of that I assumed was normal.   However, this afternoon (about 55 hours after injection), I had heart palpitations that were quite alarming. The initial incident lasted for a few moments (less than 5 minutes). First I felt that my heart rate was accelerated for no reason. Then it got very strong and pounded erratically. Then it got weaker but remained erratic. It alternated between these states and then returned to normal. Less than an hour later (while filling out this form), my heart became erratic again, but this time only for 10-15 seconds. It is currently back to normal, though I feel a bit funny.
At approx 8:05 pm, He began vomiting, no other symptoms of illness had been present. Vomiting continued every 30-90 minutes through the night until approx. 7:30 AM, 11/17/2011.
Mom called to report that after she left the clinic pt complained of arm pain and had fever the same night, she did not take temp and did not give her medication since she had none at home. Per mom she had not eaten and went to eat after the vaccine, the whole arm was in pain and had a hard time sleeping do to feeling like she had fever and pain, fell asleep around 2am. Mom did not have any TYLENOL/MOTRIN to give for fever/pain. The next morning she did not have breakfast because she eats at school, she was at the bus stop when she started to feel dizzy, shortness of breath and fainted. She landed hard and injured her right side of face, had a big cut beside the eye and needed stitches. She went to ER. Notes are attached. Was taken to ER by ambulance, bus driver, police office took a report. Mom called to get information about the vaccines since ER told her that it was a reaction to vaccines. She was also dehydrated. Pt was seen for a follow up and was referred to cardiologist do to history of dizziness.
Patients arm became sore on the evening of the vaccination 9/23. Her arm was very sore on 9/24 and she could hardly move it. On 9/25/19, she noticed it started bruising; however, the soreness started to subside
second dose 10/25/2021, 11/1/2021 diagnosed with shingles; nerve sensitivity on right side of head and eye; This case was reported by a consumer and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 25th October 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 26th October 2021, 1 days after receiving Shingrix, the patient experienced shingles and nervous system disorder. On an unknown date, the outcome of the shingles and nervous system disorder were not recovered/not resolved.   It was unknown if the reporter considered the shingles and nervous system disorder to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received the Shingrix at her doctor's office on her right arm (unsure).  The patient experienced symptoms of shingles on 26th October 2021 and went to urgent care on 1st November 2021 where she was diagnosed with shingles.  The patient experienced nerve sensitivity and head and eye.  The reporter also inquired if Shingrix could cause shingles, If the 2nd dose was still effective or if she needs another dose of Shingrix, any problems if receive Shingrix whilst had shingles. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. Consent obtained to contact HCP and patient.
Information has been received concerning a person who was vaccinated and 6 to 8 hours later she experienced soreness, redness and induration of the right arm, body aches, nausea and vomiting and a fever of 102 F. She sought unspecified medical attention. The pt's fever went down after taken Motrin.
Burning entire body, headache, body aches, fever, chills, head cold, swollen glands, severe body fatigue, couldn?t move right arm all day and night when shot was given, rash on face and chest, day two of shot I can now move arm but body is still burning and site of injection feels like it?s on fire.  Body aches are relieving after day two and it?s 9:39 in the morning. Headache is still there but able to function, throat still swollen and hard to swallow, still low grade fever.  Have been taking aleve for pain and fever. Rash is now gone.
This spontaneous report as received from a registered pharmacist refers to a female patient of unknown age with no pertinent medical history. On 07-AUG-2012, the patient was vaccinated subcutaneously with, 0.65 ml ZOSTAVAX (lot # not reported). There was no concomitant medication. The pharmacist stated that a patient received ZOSTAVAX and on unspecified date, she had 2 tiny red spots 4 inches away from the injection site, injection site was red and the size of a quarter, and itching at the injection site. The patient sought medical attention by having a pharmacy visit. No treatment for the events was given. Laboratory and diagnostics was not performed. At the time of the report, the outcome of injection site red and the size of a quarter, itching at the injection site and 2 tiny red spots 4 inches away from the injection was unknown. Additional information has been requested.
Information has been received from a female consumer who on 05-Dec-2007, was vaccinated with a second dose of pneumococcal 23v polysaccharide vaccine. On 07-Dec-2007 two days after the vaccination, the patient experienced "after effects" from the vaccine. It was reported that she developed a fever, shivers, flu like symptoms, stiffness in her neck, pain on the top of her head, and pain down the front of her legs. After receiving the vaccine the consumer was out of the country for business and stated that the pain was so bad that she had to see a physician there. She stated that blood tests were performed and she was told that she did not have meningitis and that these problems were from the vaccine. Her symptoms have lessened over the past three weeks except for the leg pain that persists. It was reported that she could not walk upstairs and that she had been crawling up the stairs. She also had trouble driving due to the leg pain. She had been taking acetaminophen (Tylenol) which was reported to give her some relief. It was also reported that the patient's first dose of pneumococcal 23v polysaccharide vaccine was administered 14 years ago. No product quality complaint was involved. Fever, shivers, flu like symptoms, stiffness in her neck, pain on the top of her head and pain down the front of her legs were considered to be disabling. Additional information has been requested.
booster; her booster dose a month ago but was exposed to the virus from her coworker; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 32 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: REMICADE taken for crohn's disease. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown, Dose number Unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; EXPOSURE TO SARS-COV-2 (non-serious) with onset 2021, outcome "unknown", described as "her booster dose a month ago but was exposed to the virus from her coworker".  Additional information: The reporter wanted to know if there is any data or studies done to people who are taking immunosuppressant drugs and were fully vaccinated with the vaccine as she cannot find any data about this. She stated that her daughter takes Remicade, a monoclonal antibody, every 4 weeks for her Crohn's disease and she (daughter) received her booster dose a month ago but was exposed to the virus from her coworker. Her (caller) main concern is, even with the booster, that the monoclonal antibody her daughter is taking will make her more likely to be infected after an exposure. Response: Provided the disclaimer. Spoke from General Drug Interactions (v12.0): Ongoing Phase 1/2/3 Trials, Adolescents and Adults Aged =12 Years. Use of the following medications was prohibited and defined as exclusion criteria during the phase 1/2/3 study:3,4. Receipt of medications intended to prevent COVID-19. Treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt throughout the study. Systemic corticosteroids administered short term (<14 days) for treatment of an acute illness had to be discontinued for at least 28 days before study intervention administration. Clarified to the caller that since this a on going clinical trial, no further information found.  Follow-up attempts completed. No further information is expected.
local rxn to MMR site, approx 5min p/vax;redness about 40min length x 24mm in width, pt check by PNP & kept for observation;redness dec in size about size quarter;
Pt states that she awoke through the night with pain @ injection site/left arm- states that injection site was approx 2" in diameter, red and swollen with discomfort radiating to axillary and "streaking".
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Lot number: Fm9992) at the age of 65 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Splenectomy in 1975", start date: 1975 (unspecified if ongoing), notes: Splenectomy in 1975; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Known allergies: Wasp venom" (unspecified if ongoing), notes: Known allergies: Wasp venom. Concomitant medication(s) included: SPIRONOLACTONE; LISINOPRIL; ZETIA; DILTIAZEM; FISH OIL; COENZYME Q10 [UBIDECARENONE]; LIVALO; PEPCID [FAMOTIDINE]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Still testing positive on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 30Sep2022 to 04Oct2022.  Clinical course: Event as reported by primary source: Feeling better on day 3-5. Symptoms began to get worse on day 7. Still testing positive on day 11. The patient received other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to its Lack of efficacy cannot be ruled out.
23 hrs following virivax injection local induration around site of injection approx 1" x1" lasting 2 -3 days
Dizziness, extreme fatigue/lethargy, muscle numbness and muscle fasiculations.
PATIENT WAS MONITORED FOR 15 MINUTES BUT STATED SHE FELT LIKE SHE HAD A LUMP IN HER THROAT.  SHE HAD NO SHORTNESS OF BREATH OR ANY OTHER REACTIONS.  SHE KEPT SAYING HER THROAT WAS BOTHERING HER AND SHE ASKED US TO CALL EMS.  THEY ARRIVED AND SHE LEFT WITH THEM.
Patient did not describe any adverse events. Patient received Moderna Bivalent booster instead of the 2nd dose of the original series. In addition, the bivalent booster that was given to the patient was also over the beyond use date of 3/3/2023.
Vomiting for 2 months. Lost of 25lbs (she weighs 87 lbs now!) hospitalized for dehydration and malnutrition.  9/11/08 Vax rec and office notes received from OBGYN. Weight 110# at time of 1st HPV 8/15/07. Wt 100# at time of Gardasil #3 on 7/30/08. No problems noted at that time. 09/23/2008 MR received for DOS 9/6-8/2008 with D/C DX:  Intractable vomiting, questionable 2' to HPV vaccine. Pt presented with 7 month hx of intractable vomiting with 20# wt loss. Pt reports sx coincide with receipt of Gardasil vax. Tx with Rocephin for UTI and Reglan for symptomatic relief. Was able to tolerate diet and D/C to f/u as out pt.  9/26/08 PCP records received.  Seen 8/15/08 with c/o intermittent unexplained vomiting since spring 2008 about the time Paxil was abruptly discontinued. For past week pt has been vomiting almost everything she eats. Wt 94#. PE WNL. F/U 8/22/08 with 2# weight loss since 8/15. Referred to GI.
pt recvd vax & approx 4 hrs later, pt began crying episode which lasted for 3 hrs; crying persistant & inconsolable; APAP given @ time of immun;
This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported radiating pain down her arm 6 consecutive days after receiving vaccine. The reporter agree for follow up contact.
This spontaneous report as received from a nurse refers to a 8 months 8 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Caller returning call with patient information regarding improperly stored vaccine administration; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot number S038702, expiration date 01-DEC-2021, 0.5 milliliter (route of administration was not provided) for prophylaxis.      The vaccine had a temperature excursion of -9.5 degrees Celsius for 8 hours and 53 minutes, and -10.1 degrees Celsius for 6 hours and 40 minutes. The excursion was called by a digital data logger. No previous temperature excursions were reported.; Sender's Comments:  US-009507513-2009USA008377:
covid vaccine breakthrough case  dose 1 Moderna 3/3/21 029A21A dose 2 Moderna 3/31/21 045A21A dose 3 Moderna 11/16/21 058F21A
April 10 - 21 hours after getting the vaccine I noticed a red swollen rash at the injection site that measured 2.5 x 3.8 cm. April 11 - The rash is spreading, feels hot to the touch, is raised and hard.  It measures 4.5 x 5 cm April 12 - The rash is still spreading.  It is darker red, it still is raised and feels hard, and is hot to the touch.  It measures 5.7 x 6.6 cm
SIRVA Narrative: On 2/6 (day after 2nd COVID vaccine) pt had stabbing pain 10/10 from left shoulder (injection given in left deltoid) to left neck, and down to his belt line on the left. Pt states "it hits and about drops you to your knees". Pt got very little sleep because of the pain. Pain is now more in the front of the shoulder and neck, not down to the belt line. Certain movements, like getting dressed, cause the pain to go to  5-6/10 or higher. Pt states that "squeezing" that shoulder can help with the pain. Did not improve after treating with diclofenac gel and APAP.