chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SENSITIVE SKIN STOMACH AND BACK; FOGGY; MUSCLE PAIN; FEVER; FATIGUE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced sensitive skin stomach and back, foggy, muscle pain, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from muscle pain, sensitive skin stomach and back, foggy, and fatigue. This report was non-serious.
Information has been received from a nurse on 11-FEB-2015 referring to a patient of unknown age and gender. On 15-JAN-2015 the patient was vaccinated with a dose of PROQUAD (Merck) injection, 0.5 ml, subcutaneously (lot# was not reported) which underwent a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient reported that vaccine injection site is still itchy and sore since 10/31/2020, and he showed the site and it seems bruised and sore. I suggested  cortisone OTC and calling his doctor if situation complicated.
Talked on phone with mother on 9/10/04-she told me about these events that happened after receiving immunizations on 6/15/04...pt became lethargic and slept more than usual starting the evening of 6/15/04. Remained lethargic with low grade temp (IOD/rectal) until rash onset on Monday 6/20/04. She was seen by physician on Monday 6/20/04. No treatment-lethargy cleared up after rash appeared. No problems since.
She had to be given epinephrine; This spontaneous information has been received from a female patient of unknown age via Pfizer. The patient had history of multiple vaccine allergies which was reported as follows: smallpox and rubella vaccine caused an adverse event that made her went to the hospital and got a spinal tap. She received 2 rounds of anthrax vaccine and her lip got very swollen the next day, therefore she received diphenhydramine (BENADRYL). Typhoid vaccine got her arm swollen more than regular and meningococcal made her had a small reaction. Patient's concurrent conditions included rhabdomyolysis, malignant hyperthermia and tuberculosis (TB) positive. It was reported that she did not complete her isoniazid (INH) treatment because her joints hurt. Patient's concomitant medications were not provided.  On an unknown date, the patient was vaccinated with a booster of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided).   On an unknown date, the patient had to received epinephrine after the vaccine (ill-defined disorder). The outcome of the ill-defined disorder was not provided.  The causal relationship between ill-defined disorder and hepatitis a vaccine, inactivated (VAQTA) was not provided.
34 y/o male with no known medical history, who presents with seizure like activity lasting 2-3 seconds post vaccination. Patient states that this is his second vaccination in the two-dose series. Patient denies previous reaction with the first vaccination. Patient states that he fears needles. Patient was witnessed with upper arm stiffening, convulsions and syncope lasting 2-3 seconds. RNs lowered patient to the ground with legs elevated. Patient regained consciousness within seconds. Patient was not post ictal. Patient denies headache, sore throat, difficulty breathing or itch. Patient vitals (151/79 BP, 98% O2, 74 HR, 14 Resp, Glucose 125, EKG NSR). Fire rescue was called. Patient was placed in wheelchair and taken to private area where he was further assessed by the Paramedics, NP and RN. Patient was noted to be diaphoretic. Water provided and patient placed in Trendelenburg position. Fire rescue arrived. Patient refused to be transported to the ER, although it was advised by the NP. Fire rescue did not have the patient sign out AMA. AMA form provided and signed, witnessed by the NP. Patient aware of risk involved with no seeking further medical evaluation, such as worsening adverse reaction, subsequent seizures, cardiac event, MVA and/or death. Patient verbalized understanding. Patient ambulated to his car without difficulty.
PT REPORTED THAT SHE HAD BLEEDING FOR 6 HOURS AFTER ADMINISTRATION, ON MONDAY THE AREA WAS SWOLLEN, RED, WARM AND PAINFUL. I INSTRUCTED PATIENT THAT SHE COULD BE HAVING AN ALLERGIC REACTION OR SIGNS OF INFECTION. I TOLD HER THAT IF SHE DIDN'T WANT TO GOT TO THE DOCTOR IMMEDIATELY, SHE COULD TRY A COLD COMPRESS AND BENADRYL EVERY 6 HOURS, BUT IF SYMPTOMS GOT WORSE SHE WAS TO SEEK MEDICAL ATTENTION IMMEDIATELY. SHE STATED SHE WOULD NOTIFY ME OF ANY CHANGES. CALLED PATIENT ON 1/8 TO FOLLOW-UP AND SHE STATED THAT THE BENADRYL AND COLD COMPRESS WAS EFFECTIVE. THERE WAS STILL A KNOT AT THE INJECTION SITE BUT ALL OTHER SYMPTOMS SUBSIDED.
5 pts recvd 3 doses of Engerix-B on JAN90, FEB90, & JUL90; AUG91 Antibody titers were drawn & reported as undetectable;
Within a couple months of having the first HPV vaccine, pt. began having symptoms of what was eventually diagnosed as Idiopathic Severe Aplastic Anemia in December 2020.  Initial symptoms included extreme fatigue, petechiae, bleeding of gums, and extremely pale skin.  The cause for the disease could not be found by her medical team and genetic factors were ruled out.  There was no active virus in her body at the time of diagnoses.  Pt have a BMT in February of 2021.  Additionally, due to treatment of this disease, pt. suffered from ovarian failure in July 2021.
101 Fever; This spontaneous case was reported by a consumer and describes the occurrence of Fever 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 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced Fever. At the time of the report, Fever outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high, 101 Fever.         Concomitant medications were not provided.  No Treatment information was provided.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were not reported. Since an unknown date in November 2015, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose, route, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
About an hour and a 1/2 after injection I was on virtual call with my sister and she asked what's wrong with my eye?  I hadn't noticed anything.  In looking in the mirror, my left eye lid was drooping, swollen and red.  My right eye was  a bit red and slightly swollen but not droopy.   I double checked my vision but was not having any disparity.  The droop, swelling and redness lasted for many hours but was gone by morning.    Between getting the shot and the virtual call, I had gone to the store to pickup some replacement prescription glasses.  It is possible they sprayed a cleaning agent on them (though I didn't notice them do that or smell any chemical agents, which I am sensitive to notice).  I got pregnant (with donor sperm) in April 2014 with twins. Miscarried at 9 weeks. Got pregnant with (now) husband March 2015.  Daughter born 7 lbs 3 oz. Did IVF this past winter/Spring.  Now about 14 weeks pregnant. EDD 10/22/2021
numbness in hands and legs; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), dose number unknown, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced numbness in hands and legs on an unspecified date. The event outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Mild, Systemic: Nausea-Mild, Additional Details: Patient stated felt like she might faint but did not faint, she felt hot visibly sweating was given water, cold compresses and laid on floor, BP/HR/Temp WNL. Patient stated did not eat breakfast, given granola bar at 1001, reported feeling better after additional 15 min of monitoring. Sent home but instructed to go to hospital or call 911 if symptoms reappear.
Headache, fever beginning about 7pm, fever of 103.7 at about 1am in the morning lasting until Tylenol onboard about 10am 2/16, nausea and voimiting about 7am 2/16/21, fever lasted until 6am 2/17/21.
Received vaccines 3/14/03 afternoon, noticed red, warm area the next afternoon/evening. Child has no complaints at all. On exam on 3/17/03, had 5 cm x 5.5 cm warm, indurated area left thigh.
The day after getting the vaccine, I developed a tingling that started on left leg and continued to spread to the upper body. Then, I developed muscle spasms throughout my body but mostly on the left side. I have been also experiencing facial twitching that comes and goes at resting time or randomly during the day.  I am looking forward to effective treatment to alleviate the symptoms and go back to I was before getting the vaccine.
Hives on face and neck with water contact at any temperature. New to her. Started since she completed vaccine series. Hives last 5-10 minutes and resolve on own.
Breakthrough COVID Infection Narrative: Patient with breakthrough covid infection after 2 doses of moderna vaccine
(L) deltoid with erythema/induration, tender, warm approximately 2 cm diam. No fluctuance. (+) fever 103.
This case was reported by a healthcare professional (nurse, subject) and described the occurrence of injection site redness in a 50-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medical conditions included seasonal allergy. Concurrent medications included Vitamin D supplement. On 28 October 2013 at 08:20 the subject received a dose of FLULAVAL (.5 ml, unknown route, left arm). On 28 October 2013, immediately after vaccination with FLULAVAL, the subject experienced injection site redness, injection site pruritus (described as "itchy"), and hardness injection site (described  as "hard area at injection site). On 28 October 2013, minutes after vaccination with FLULAVAL (described as "shortly after vaccination"), the subject experienced feeling lightheaded. At the time of reporting the events of injection site redness, injection site pruritus, and hardness injection site were unresolved. The feeling lightheaded improved within 5 to 10 minutes. The healthcare professional considered the events were probably related to vaccination with FLULAVAL.
back & neck muscle aches for 5-6 days post vax;fever 100-101;no medical treatment needed;
Pt. states when she received vaccine in (L) arm it felt heavy immediately and has continued to hurt since. C/o soreness & states hurts to lift arm. States went to chiropractor last wk & he did ultrasound treatment & rec. ice. Still no improvement.
This case was reported by a healthcare professional and described the occurrence of hives in a 3-year-old female subject who was vaccinated with ENGERIX B, (GlaxoSmithKline).  Concurrent medications included TOBREX and BACTROBAN.  On 28 December 1993 the subject received 1st dose of ENGERIX B at 0.5 ml in an unknown thigh.  Twenty four hours after vaccination with ENGERIX B, the subject experienced hives and a high fever.  A systemic reaction.  The subject's mother attempted to use BENADRYL to treat the hives with no relief.  She contacted the physician's office who then prescribed ATARAX.  At the time of reporting the events were resolved.  Follow-up information was received on 25 August 2008 via a nurse, who reported that the onset of the events was on 29 December 1993.  The reporting nurse considered the event to be related to vaccination with ENGERIX B, but did not consider the events to be serious.  The nurse indicated that the ENGERIX B vaccination series was discontinued, and that the events were resolved on an unspecified date.  The nurse indicated that this case was reported to a Regulatory Agency (VAERS number was not provided).
Narrative:  Pt received two doses of Moderna COVID 19 vaccine in Jan/Mar 21. The patient tested positive for COVID 19 on 22 Sep 21 and was hospitalized with Sepsis and COVID 19. The patient was treated and discharged on 30 Sep 21. Reported per EUA.
major confusion 9 hours after first administration continuing on to the next day, pain at wound site, itchy feeling
Redness on R arm, felt like there was a "lump", warm to touch, evaluated by EMS, advised Benadryl. Cleared
Flu like symptoms: chills, fever, aches, fatigue, nausea, loss of appetite.
Currently experiencing extreme redness pain itching and swelling in the muscle right arm. Taking benadryl and advil and applying a corticosteroid cream.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-JUN-2007, the patient was inoculated with ZOSTAVAX at a medical center-primary care as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 15-DEC-2015, the patient was treated by a physician at a medical center-ophthalmology for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Case previously recorded as MA2009-4543. Case report received from a nurse, on 18 NOV 2009. Patient 2-years-old female was accidentally vaccinated with  S-OIV FLUVIRIN (batch no. 102126P1A) 0.5mL i.m. on 17 NOV 2009. No adverse effect was reported. Reference no.:NA09-008426.
had a lot of lymph node swelling, and they were painful; had a lot of lymph node swelling, and they were painful; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY and LYMPH NODE PAIN in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY and LYMPH NODE PAIN. At the time of the report, LYMPHADENOPATHY had not resolved and LYMPH NODE PAIN outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-405000 (Patient Link).
26Jan Rt arm slightly swollen, 27Jan more swollen, warm to touch, T 101, seen by MD on Tylenol & ice, 28Jan Rt arm swollen from shoulder to mid forearm, Seen by MD RX:Penicillin, Atarax, & warm compresses.
The left Arm shot location is very sore and I am unable to have full rotation of my arm. Sometimes arm also goes numb.
Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 23-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. An elderly male patient of an unspecified age (above 65 years), race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date post vaccination the patient experienced redness and swelling around the vaccination site. Outcome was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016574245 Same reporter, suspect product, events, different patient.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender (no demographic information was provided). No information regarding the patient's medical history was provided. On 23-JAN-2014 the patient was vaccinated with ZOSTAVAX, with valid lot # J000492, which had been expired (expiration date 19-JAN-2014). No concomitant medication was reported. No adverse effects were reported. No outcome was reported. Additional information has been requested.
angioedema of left lower lip; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729, expiration date not reported), via an unspecified route of administration, administered in the left arm on 09Apr2021 17:00 at single dose for covid-19 immunisation. Medical history included asthma, degenerative disc disease, migraines, allergies: shellfish intolerance, nickel allergy, skin allergy to some kind of plastic/foam. The patient was not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); sertraline; ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE); fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); minocycline. The patient experienced angioedema of left lower lip on 16Apr2021 01:00. The patient was given methylprednisolone 4 mg dose pack as treatment for the event. The patient has no prior vaccination and no covid test post vaccination. The patient had not recovered from the event at the time of the report.
Information has been received from a healthcare worker concerning a 75 year old female who on 16-MAY-2008 was vaccinated with a dose of VARIVAX (Merck) rather than ZOSTAVAX (Merck).  No product confusion, just nursing error.  No problem reported.  Follow-up information was received on 20-JUN-2008 from a health professional concerning a 75 year old female with no pre-existing allergies, birth defects or medical conditions who on 13-MAY-2008 (previously reported as 16-MAY-2008) was vaccinated in the left deltoid with a first dose of VARIVAX (Merck) (Lot #656078/0169U) rather that ZOSTAVAX (Merck).  The patient had no reactions.  On 16-JUN-2008 the patient was vaccinated in the right deltoid with a second dose of ZOSTAVAX (Merck) (Lot #658395/0966U).  There was no illness at the time of vaccination.  Additional information is not expected.
Heart rate affected - going from 57 to 118 with little or no activity, O2 levels ranging from 77 - 98 (after a few minutes of long slow deep breaths when level is low), BP 3 days after injection was 90/60 - had 2 nurses advise not to take cardevilol that evening.  (in fact that same day -Sunday- at 4 am, my cat woke me up doing hard chest "paws", realized horrible headache, checked O2 level was 80 . Can tell when O2 level drops - feel lightheaded, sometimes to the point of touching walls, touching backs of chairs when walking to feel secure, Have kept a record for most of the time for first week after 2nd injection, last few days only occasionaly written down information.  319/2021 approx 4:45 pm O2 was 92 HR was 118.  On 3/20/21 felt lightheaded, O2 level 73 HR 52 approx 4;25 had walked approx 150 steps to mailbox and back, at 6:09 pm O2 was 93, HR 58, 3/21/2021 8:30 am O2 97, HR 100;. 3/22/2021 12:58 O2 74, HR 52. Today at 8:41 am O2 95, HR 103.
Sarted as hyperventilating cold chills, and than Ibegan to shake and tremor, and than I lost consciousness.
mRNA primary series dose administered prior to the recommended interval.  Moderna was given at 21 days, instead of 28 days.  Spoke with patient one day after, no adverse effects reported.
3/9/23 that evening I had sinus congestion and pain, a little bit of a sore throat and then chills in the middle of the night. I felt like I had fever and it broke. The next morning, I still felt warm like I had a fever. It was a couple of degrees above normal. I was more congested, and throat was more sore. I took an at home COVID test and it was positive. I called the doctor. We discussed PAXLOVID and he thought because of the interaction with the medication I am on and because I am in good shape, a marathon runner, it wasn't necessary. I took TYLENOL to bring down fever and it was down by the next morning 3/11/23. I had severe fatigue on 3/10 and 3/11. My congestion started to clear. My sore throat became a lot worse. On 3/12/23 I lost about 80% of my sense of smell and taste. On 3/13/23 pretty much all symptoms were gone, except a scratchy throat and a little bit of a cough. My blood oxygen was running 97-99. My fever remained down. My sense of taste and smell have not returned. I am still tired, but not exhausted. I have not recovered.
Patient has history of vasovagal response, especially with getting vaccines.  Precautions took/monitoring at vaccination station after vaccine given, and patient stated "here I go" and slumped forward in chair. Pale, unresponsive for about 10-20 seconds,followed by mild shaking of upper extremities and then resumed consciousness.  BP 50/P Pulse 44 and O2 sat start at 92 up to 99% while monitored. Refused transfer to hospital/urgent care once feeling better.