chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke with hives on neck; Normal arm pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Woke with hives on neck) and PAIN IN EXTREMITY (Normal arm pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided by the reporter.  Concomitant products included CLONAZEPAM (CLONOPIN) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Normal arm pain). On 28-Feb-2021, the patient experienced URTICARIA (Woke with hives on neck). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives and Pain in arm, at an unspecified dose and frequency. At the time of the report, URTICARIA (Woke with hives on neck) and PAIN IN EXTREMITY (Normal arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Pt arm became very sore. Lost range of motion. Seemed to improve some but still extremely sore and "fees' wrong.
Information has been received from a consumer concerning her daughter who on approximately 22-JAN-2009 "1-2 years ago", was vaccinated with a dose of GARDASIL (lot # not reported). It was reported that on an unspecified date the consumer's daughter experienced hair loss and a lot of side effects. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. No further information is available.
After the third shot of the Hepatitis B vaccine I experienced extreme fatigue, loss of appetite, insomnia, blurred vision, and depression.  I sought treatment after many sleepless nights.  He gave me a low dose of ametrytoline (sp?) so that I could sleep.  It was obvious to me that my symptoms were the result of the vaccine because they began the day after I took that last shot. No one, as far as I know, took a report to alert the drug company or any government agency that might be concerned with this.  Fast forward to today.  I am experiencing dizziness and neurapathy in my legs.  I know I am not the only one out there who has had a bad reaction to this vaccine from my reading on the internet.  Do you know of any treatments that could help with my current symptoms?
Urticaria, pruritus and redness, warmth, pain at site of injection, area got larger.
Pregnant patient received the 1st dose of the Moderna Covid 19 vaccine.; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna Covid 19 vaccine.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 611L(2 or Z)OA) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Apr-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna Covid 19 vaccine.). On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the 1st dose of the Moderna Covid 19 vaccine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Company Comment : This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. without any associated AEs.  Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 29-year-old female. without any associated AEs.  Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Information has been received from a medical assistant(also reported as office manager) referring to a 3 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 26-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
21SEP96 called c/o itchy, rash;rx APAP 1/2 q6hr & calamine lotion;
Vertigo - woke up and the room was spinning. I couldn't turn over or move. Husband had to help me go to bathroom. I threw up a few times that morning for dizziness. I tried to take a shower and threw up again. By the evening, I was feeling pretty good. It kept coming back for the next few weeks. Have had a doctor office visit - June 8th.  So that was May  Dr. said to do the  Eppley manuvuer - ear crystals in the ear loose. Still have a slight dizzy feeling when I'm doing things. But it is manageable now. Two mornings ago, I woke up and I was pretty dizzy - I had to sit around and wait for it to go away. The room wasn't spinning as much but it was bad enough where I had to stay still. Dr prescribed dizziness meds and I took two different times and it didn't help so I stopped. It's slowly getting better but still there.
This spontaneous report was received from a nurse and refers to a 61 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-MAR-2017, the patient was vaccinated with expired dose of ZOSTAVAX lot # M003486, expiration date: 27-MAR-2017 for prophylaxis (route and site of administration were not reported). No adverse effects were reported. No product quality complain (PQC) was involved. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 09-MAY-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 "10PK-0.5 ml SD-PFS LLok wTip (lot # M005286, expiration date: 08-OCT-2017, dose and route were unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 8 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
by 7pm I had the expected fever headache body aches irritable.  next day still had trouble walking  due to pain and weakness and heavy feeling in chest.  continued to have heaviness in chest and hr was 159 with minimal walk to bathroom . hr improved but still 120  at times as of today. my hr is normally in the 70's  chest heaviness has improved but what is concerning I have had stab pains in heart at times.  also headache improved over the three days but started to have stab pains in the head. As of today I still am having stab pains in head specifically the left side of head above temple and top left side. happens frequently multiple times a minute. item 21 asked if dr visit. not as of today but plan on seeing dr for this as it has not gone away.
Child developed intermittent fever approx. 24 hours after vaccine administration. Presented to ER on 3/17 with fever 105.3. Received acetaminophen and discharged home. Treated with alternate acetaminophen and Motrin. Child afebrile 3/18/2012.
pt recv vax & post vax pt devel h/a & nausea;a physical was done: vital signs were OK & pt returned to work;that noc pt had h/a, fever & chills;pt medicated self w/APAP & sx resolved;there have been no problems since;
Mild Pain in left arm developed about 1 1/2 hrs after shot (5:30 pm) . Same time runny nose began with mild cough .  Pain became much more sever several hours later and spread to chest , back , rt arm , joints in hands and shoulders . The pain was above the waist and did not spread . Runny nose and cough became more severe had to get over counter meds for the runny nose and cough . Tylenol did not mitigate the pain only aspirin did . Pain became very severe by 1am 1-21-2022 ( Wednesday ) with no relief from Tylenol only aspirin . As quickly as the symptoms developed they began to slow in 48 hrs . 4 pm Thursday ( 1-22-2022 ) the symptoms became less and the pain reduced greatly . Runny nose and mild cough due to the congestion is still present at the time of this writing ,( 6 pm ) .
This spontaneous report as received from a nurse refers to an unknown number of patients. No further information regarding the patients was available. On an unknown date the patients were vaccinated with improperly stored M-M-R II. Strength, dose, route and lot number were not provided. M-M-R II was exposed to a temperature between 46.5F and a highest of 48F for a total of 45 hours and 5 minutes from 10-APR-2014 to 02-MAY-2014; Out of range for 2 hours from 10-APR-2014 to 11-APR-2014; out of range for 10 hours and 15 minutes on 12-APR-2014; out of range for 12 hours and 25 minutes on 13-APR-2014; out of range for 1.5 hours on `4-APR-2014; out of range for 9.5 hours on 01-MAY-2014; out of range for 9 hours and 25 minutes on 02-MAY-2014. No adverse effects were reported. Follow up information has been received from two registered nurse (R.N.) reported that a 1 year old patient (gender not reported) who on an unknown date in 2014 received the M-M-R II (lot # reported as J004210 expiration 12-APR-2015; lot# J007155 expiration 20-JUN-2015) (the R.N. was unable to break out per Lot number of vaccine) (dose and route not reported) that had a temperature excursion and were found to be unstable. The M-M-R II was unstable after 12-APR-2014. The registered nurse stated that the patient needed to be contacted for re-vaccination. This is one of several reports received from the same reporter (other case IDs: 1405USA004214, 1405USA004215, 1405USA002823, 1405USA012476, 1405USA012477, 1405USA012478, 1405USA012480 to 1405USA012482 and 1405USA004216). Additional information has been requested.
Small (<5mm) superficial blisters noted at ant upper thighs bilat - 2 on the rt, one of which is unroofed, and one on the left. Not vesicles. Not fluid-filled. Also, on the rt ant upper thigh, multiple (15-20) small avg 6mm diameter blanching erythematous macules - not raised, no blister or skin disruption, not indurated, not painful. No other lesions noted anywhere else on the skin.
Severe fever. Treated with motrin as usual. Did have a lot of diarreah. Slept for an unusually long time the next day. 12/17/09 Pediatric Medical records received for DOS 3/17/04. 8 month well baby visit.
(R) arm painful, swollen, red, hard to touch. Appx. 30 minutes after vaccine admin. Pt advised to use acetaminophen or ibuprofen, and ice.
Rash on left arm started the day after the injection.  Gradually became worse .  By 1 week, large  red spots, extremely itchy,  hot to touch.  Small spots appeared on left side of abdomen and lower right arm.  Started calamine lotion and Benadryl cream.  Rash continues on but  has not spread any more.  At 2.5 weeks  rash still noticeable but less itchy.  Pain at times to left arm, left side of back and left abdomen.  Symptoms seem to be getting better at almost 3 weeks.
This child's left arm was red and swollen from 1" above the elbow to the shoulder, temp 100.2 (ax).
COVID-19 Vaccine EUA-FDA/CDC Vaccine Adverse Event; Onset: 3:30 pm  Headache, fatigue, dizziness, joint pain, muscle pain, chills, rapid heart, some GI distress.  Duration: 28 hrs. Tylenol 500 mg. kept it under control.
first shot has had several adverse reactions and there not getting better; feeling exhausted; headaches; not feeling well; couldn't sit up for awhile to get out of bed; sleep apnea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 78 -old female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ADVERSE EVENT (non-serious), outcome "unknown", described as "first shot has had several adverse reactions and there not getting better"; FATIGUE (non-serious), outcome "unknown", described as "feeling exhausted"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; GAIT DISTURBANCE (non-serious), outcome "unknown", described as "couldn't sit up for awhile to get out of bed"; SLEEP APNOEA SYNDROME (non-serious), outcome "unknown", described as "sleep apnea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red bumpy rash (did not itch) on both arms, both legs, and both cheeks. The rash lasted for about 4-5 days (June 10 - June 14/15, 2019). She also had a fever that reached 103 with no other symptoms that lasted for a few hours (May 24, 2019).
The pt experienced redness at the injection site beginning the evening of the vax. Increased redness over the next 48 hours to 12 x 12 cm, was warm and swollen. Fever to 101.0 for 2 days.
This spontaneous report as received from a consumer refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route of administration, lot# and expiration date were not reported) or a dose of GARDASIL 9 (dose, frequency, route of administration, lot# and expiration date were not reported). It was unknown if product was GARDASIL or GARDASIL 9. On an unknown date, the patient experienced adverse event unspecified. The outcome of adverse event was unknown. The relatedness between the adverse event and therapy with GARDASIL or GARDASIL was not reported. This is one of six reports received from the same source.; Sender's Comments: US-009507513-1712USA014392: US-009507513-1712USA014393: US-009507513-1712USA014395: US-009507513-1712USA014396: US-009507513-1712USA013057:
PATIENT SHOULD HAVE RECEIVED MODERNA 2ND DOSE FOLLOWING FIRST MODERNA DOSE ON 3/11/21 BUT RECEIVED PFIZER INSTEAD
4/30/18 Afternoon of vaccination: sore L arm at injection, became swollen. Next day 5/1/18: nausea, cold sweat, chills, very pale at breakfast so had to lie down; muscle aches throughout day; low grade fever in evening; injection site swollen, red and hot to touch. 5/2/18: fever, muscle aches gone; arm still significantly sore, swollen, red and hot. 5/3/18: arm soreness and swelling improving; redness migrating downward. About 5/5/18: swelling down and soreness gone.
Screaming (was sleeping), lethargy, staring, twitching/seizing (leg, arm, head); lasted about 15-20 minutes; transferred to ER; bld work normal; suggested EEG for follow-up.
Child had a fever of 100 to 100.6 after vaccines. At 430 am child had a seizure and was taken to the ER.
Woke up Friday morning and arm was red, warm to touch, itchy, and hard to lift.  Saturday morning she put a warm wash cloth on and it made blisters.
A non-serious, spontaneous report of snoring and nasal congestion was received from a consumer concerning a five-year-old female subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 27-Jan-2009 (four weeks prior to date of report). The patient began having problems with nasal congestion on 24-Feb-2009 and snoring at night after receiving FLUMIST; the patient does not have a history of snoring. The patient's pediatrician says there is not a problem. The outcome for the reported adverse event was not reported.
Patient was inadvertently give 3rd Dose of MENACTRA. Prior doses were given on 12-23-11 and 2-1-17.
Normal symptoms on 10/29/2013 (slight fever, chills, light-headedness, nausea) 10/30/13: sugar dropped extremely low suddenly, paramedics called to revive, stayed low till next day. Sugar is now very high & still requires observation in  rehab facility. Never dealt with extreme fluctuation in sugar levels ever before. Always well maintained.
The next day ran fever up to 102.1. Treated with ibuprofen 600mg tid. Fever resolved by 6-10-12.
Patient presents today for sore throat and chest pain/tightness.  She complains that 'it feels like a knife in my throat'.  She has had the throat pain for a few weeks, but it is worsening.  The chest pain has been on and off for a few days, it is mid-chest/midline in nature and has accompanying mid-back pain.  Patient is eating and drinking normally and has no pain with swallowing.  She has been having chills, but does not believe she has had a fever.  She has no prior history of covid and she is fully vaccinated.  She was seen in the ER 'a couple weeks ago' for the sore throat symptoms and it did not improve since then.  She states that she was never tested for strep throat at that time, however. She denies GI symptoms, loss of taste/smell, ear pain, sinus pain, SOB.  She has chronic knee pain and is scheduled to have knee surgery on Monday.      Chest pain, unspecified type    2. Elevated troponin level    3. Neck pain      soft tissue 4. Cervical lymphadenopathy    5. Primary hypertension    6. Gastroesophageal reflux disease without esophagitis   I  Patient had desaturation to 87% while at rest in bed. Respirations were unchanged and lung sounds clear. Patient rated chest pain at a 2/10 with no other symptoms or complaints when asked by nurse. Placed patient on 1L oxygen to maintain saturation above 90%. Improvement with this intervention. Saturations returned to mid-up 90's. Currently titrated to .5L while at rest.
FACIAL CELLULITIS ON RIGHT CHEEK SIDE; This spontaneous report received from a patient concerned a 46 year old  female. The patient's height, and weight were not reported. The patient's past medical history included: COVID-19 antibody test, and COVID-19 in DEC-2019, and concurrent conditions included: epilepsy, and thyroid abnormality. The patient never had facial cellulitis before the vaccination. The patient was not pregnant at the time of report. The patient experienced drug allergy when treated with phenobarbital, and ethosuximide.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: Unknown) dose was not reported, 1 total, administered on 02-OCT-2021 to left arm for prophylactic vaccination. Concomitant medications included carbamazepine for epilepsy, and armour natural desiccated thyroid hormone for thyroid abnormality.  On 09-OCT-2021, the patient experienced facial cellulitis on right cheek side and went to the urgent care physician. On 11-OCT-2021, patient had an appointment with regular provider. The patient was prescribed with clindamycin 300 mg three times a day for 15 days and ibuprofen 800 mg one tablet every 6-8 hours as needed for pain. After completing the therapy, facial cellulitis was resolved. The patient had no other symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from facial cellulitis on right cheek side on 23-OCT-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211110578-covid-19 vaccine ad26.cov2.s-facial cellulitis on right cheek side . This event(s) is considered unassessable. The event(s) 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(s).
Information has been received from a 76 year old female consumer who on 26-JUL-2010 was vaccinated with ZOSTAVAX (Merck). After she received the shot she began to feel hot in her legs and arms. The sensation continued to worsen, developing into numbness by the time she went to bed that night. She reported that upon awakening, her neck and face felt "puffy" and numb. She consulted with her doctor who recommended she take BENADRYL. The consumer reported only taking the BENADRYL late in the day because it "makes her sleepy." She said that her symptoms were resolving, but that her neck and face especially still felt "warm, puffy and numb." She said, "To me, I look red under my skin," but denied ever developing a rash. She denied beginning any other medications at the time of the administration. Follow-up information received from the administering facility indicating that the patient with hypertension and anxiety, was experiencing red arm and throat swollen on 29-JUL-2010 and recovered from the events on 30-JUL-2010. There were no labs or diagnostic tests performed. The reporter reported that they did not give the vaccine. Additional information was not expected.
Pt had 2 prior episodes of illness/hospitalizations. 11/9/18 - pharyngitis and fever - 11/13/18 viral syndrome. She was admitted 11/30/18 for fever and leukocytosis.
Approximately 2 minutes after vaccines pt stated his throat felt funny, then became SOB - wheezing O2 sat 83% O2 given - Xopenex nes 1.25 given. Gave epinephrine 0.15 given SC and 25 mg Benadryl IM. 911 Notified - transferred via ambulance to hospital - admitted.
Headache, Arthralgia, FATIGUE, CHILLS, SORETHROAT, SITE PAIN/SWELLING, Narrative: