chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FLU LIKE SYMPTOMS; HORRIBLE FEELING; PROFUSE SWEATING; EXTREME NAUSEA; RASH ON STOMACH; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included muscle disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 11:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced rash on stomach. On 09-APR-2021, the subject experienced flu like symptoms. On 09-APR-2021, the subject experienced horrible feeling. On 09-APR-2021, the subject experienced profuse sweating. On 09-APR-2021, the subject experienced extreme nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on stomach, extreme nausea, flu like symptoms, horrible feeling, and profuse sweating. This report was non-serious.
This spontaneous report as received from a healthcare worker refers to a 4 year old patient of unknown gender. Concurrent conditions and medical history were not reported. On 22-JUN-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number K010211, expiry date 17-JAN-2016; dose and route were not provided). No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Woke up with chest pains when breathing, overall tightness with sharp pain in the right pectoral as well as neck pain. Waited a week and then went to an urgent care for symptoms and they sent me to ED. After evaluation I was admitted for more testing and started on treatment. Discharged on 6/10 taking ibuprofen and colchicine with outpatient follow-up on 6/17/2021.
myocarditis; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a lawyer concerning a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions and concomitant medications were not provided. On or about 10-MAR-2010, the patient was vaccinated with ZOSTAVAX as recommended for routine health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent and chronic strain of herpes zoster.  On or about 15-MAY-2015, the patient was treated by a physician for the onset of a vesicular rash accompanied symptoms of weakened immunity, and severe discomfort and distress, which was diagnosed as severe herpes on the face. The patient was referred to an ophthalmologist for this encounter, in which the blistering vesicles were in and around the eye. On or about 14-AUG-2015, the patient was treated by the physician for new and worsening outbreaks, which were diagnosed as herpes zoster. On or about 28-JAN-2016, he was again treated by the physician for shingles that had transferred to new locations on the body, including the arm and chest. On or about 06-JUN-2016, the patient was again treated for similar and worsening symptoms, at which time his condition was diagnosed as recurrent and chronic herpes zoster. He was prescribed acyclovir and acetaminophen and PERCOCET to manage his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further and proximate result, the patient has suffered and will continue to suffer significant, medical expenses, pain and suffering, and other damages. The outcome of the events was not recovered. Upon internal review, ophthalmic herpes zoster was considered medically significant. Additional information has been requested.
Administered to left arm, 9/18/11. Injection felt like an electrical shock. Slight pain over last couple weeks continued from shoulder to elbow to thumb.
soreness in left injection site arm after first Moderna Covid-19 injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in left injection site arm after first Moderna Covid-19 injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PAIN (soreness in left injection site arm after first Moderna Covid-19 injection). At the time of the report, VACCINATION SITE PAIN (soreness in left injection site arm after first Moderna Covid-19 injection) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided Treatment medications were not provided   This case was linked to MOD-2021-390870 (Patient Link).
mild soreness at the site of the injection; "feels like 1 drop came out" after the vaccine was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (mild soreness at the site of the injection) and UNDERDOSE ("feels like 1 drop came out" after the vaccine was given) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION SITE PAIN (mild soreness at the site of the injection) and UNDERDOSE ("feels like 1 drop came out" after the vaccine was given). On 03-Apr-2021, UNDERDOSE ("feels like 1 drop came out" after the vaccine was given) had resolved. At the time of the report, VACCINATION SITE PAIN (mild soreness at the site of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment was provided. Second dose was scheduled on 01-MAY-2021.
Facial swelling, skin blotching 3 days after vaccination, then recurrence of symptoms 4 weeks later.
Fever (101-102 deg F), chills, whole-body joint pains (odd localized neck and back pains), could not work, had to sleep 9 pm + and next day.  Felt giddy with high fever when visiting the bathroom.  Recovered after 1.5 days.
C/O nausea an vomiting x 2 days starting approx. 6-8 hrs after receiving Anthrax #4. Pt. c/o "blotchy" skin and itching all over.
Moderna COVID-19 Vaccine EUA Booster 11/8/2021 - several hours after vaccine administered, left arm shoulder area was very painful, tender to the touch and painful to move. Slept poorly. 11/9/2021 - left arm/shoulder remained painful to touch and move and also felt swollen or hardened. Overall fatigue, chills, body aches, and a mild fever towards the end of the day with symptoms largely improving by the evening. 11/10/2021 - continued soreness of arm/shoulder but was far more mild and much easier to move. No other apparent symptoms. 11/11/2021 - completely symptom and pain free until evening and discovered light vaginal bleeding/spotting. This shouldn't have happened because the last date of menstrual period was over one week prior to vaccination. 11/12/2021 (date of filing report) - continued irregular light vaginal bleeding/spotting.
Hives on her back; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her back) and PYREXIA (Low grade fever) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced URTICARIA (Hives on her back) and PYREXIA (Low grade fever). At the time of the report, URTICARIA (Hives on her back) and PYREXIA (Low grade fever) outcome was unknown.        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.   Concomitant medications details were not reported by the reporter. Treatment included Benadryl.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
9/1/10 2p - patient had a vasovagal  reaction lasting 2-3 seconds after vaccine was given. Patient's exam nl sp event. 9/2/10 Patient had another syncopal episode at home. He was unresponsive for 1-2 minutes. Pt. was sent to hospital for further evaluation after he was seen by PCP on 9/3/10.
mild headache started on Aug 8th 2021 and has continued.  Crescent floaters and black dot floaters started on Aug 17th.  Headache has continued, sometimes getting worse.  At first it was in the front of my head, as if I was wearing a tight visor.   For the last week it starts from the back of the base of my head to behind my ears.  Continues in the front of my forehead.  On Aug 24th I woke up with a very sensitive temple area on the right side.  I couldn't touch it.  PCP referred me to Urgent Care or ER, went to Urgent Care. Was given a  steroid injection with a diagnosis of possible temporal arteritis.  Went to a Eye Institute on Sept 1.  Eye tests suggest not temporal arteritis.  Met with Endocrinologist on Sept Sept 14th. thyroid labs are all level, thyroid antibodies elevated from  previous month.   The first 3 weeks after 1st shot I was VERY tired, not able to articulate sentences well, stuttering and feeling very anxious.  Currently waiting for Neurologist appointment.  Receiving 2nd shot Friday Aug 17th.
Redness, induration & itching about 8 inches from her elbow to her shoulder.
fourth dose Ipol administered on 06/05/2019 and Extra dose (5th dose) administered 08/06/2019; Initial information received on 06-Aug-2019 regarding an unsolicited valid non-serious case received from a non-health care professional (office Staff).  This case involves a five years old female patient who was vaccinated with a fourth dose of vaccine IPV (VERO) [IPOL] on 05-Jun-2019 and vaccinated with a 0.5 ml fifth dose of same vaccine on 06-Aug-2019 via intramuscular route in the left deltoid on 06-Aug-2019 (lot P1A371M and Exp. Date 27-Apr-2020).  The patient's medical history not reported and concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error case due to extra dose administered.  It was unknown whether the patient experienced any adverse event post vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
FATIGUE, CHILLS, PAIN/SWELLING INJ SITE Narrative:
Developed abdominal discomfort and nausea. Vomited next day. Physical exam unremarkable but Ss persist leading to 3 ER visits for hydration. 6 days/dx classic rash or Henoch-Schonlein Purpura (HSP).
Received 1st dose of SHINGRIX 50 Mcg Inj Glax, NDC: 58160-0823-11 and within 8 hours had loose stools and diarrhea, stomach pain, bloating and lethargy. This is continuing into the 2nd day.
Congenital dislocation of hip - was seen 8/23/16 by Dr., used double diaper for 4 weeks, f/u 9/27/16 was normal, will f/u again at 12 months old. Seizure - (10/17/2017) a few hours after DTaP, PREVNAR, and Flu. Generalized complex, status, Head CT normal, intubated at ED, flown to another hospital, spent the night in the PICU, d/c 10/19.
2/16  10PM  felt soreness in neck and shoulder area. Soon developed chills. Had trouble sleeping. Took temperature at 2AM (2/17) - 100.4. Got out of bed 7AM - temperature 100.3. Took 2 full strength asperin. By noon on 2/17 temperature down to 98.8, still soreness neck and shoulders and very tired. Less discomfort at 10PM and got good night sleep. Still somewhat sore and tired 2/18 and 2/19. No ill effects at all by 8AM on 2/20
pt exp subjective fevers, measured temp of 102, rash starting above lt eyebrow & side of neck-eventually @ extrem low grade temp;
pt recv vax; very swollen, red, indurated, hot 4cmx4cm area for 4 days; seen in er; tc w/ augmentin;
Headache, aching body, nausea, hypertension, dizziness, blurred vision.
Patient marked that he had received the flu vaccine 7 days ago. This was missed on screening procedure and patient received the vaccine today. Contacted the CDC and instructed to enter a VAERS report.
Rash that has continued to spread,  Extremely itchy ,  bumpy and warm  to touch. Seems to be getting worse not better.
Five days after receiving the vaccine, I began to experience extreme chest and back pain in the area of my heart.  I did not feel as if I were having a heart attack, yet I experienced intense pain that was amplified when I would lie down - it was aggravated by even subtle movements.  Self guided research brought be to, "Pericarditis," as a very plausible explanation as the symptoms mirrored online descriptions.  I did contact my primary care provider, however did not schedule an office visit as symptoms were manageable and improved across a period of several days.
her arm was sore from the injection site all the way up to her neck for 2-3 days; all the way up to her neck; This non-serious case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: her arm was sore from the injection site all the way up to her neck for 2-3 days) and neck pain (Verbatim: all the way up to her neck).  The outcome of the pain in arm and neck pain were resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingrix.     It was unknown if the company considered the pain in arm and neck pain to be related to Shingrix.   Additional Information: GSK receipt date: 13-Sept-2023 The health care professional shared that she own experienced after having received Shingrix dose, her arm was sore from the injection site all the way up to her neck for 2 to 3 days. The reporter did not consent to follow-up.
It was on a Sunday, I had been on a long trip driving and felt perfectly fine, but on the way home I began to feel flushed and hot. By the time I got home about 7PM I was very flushed and my temperature was elevated. I began to feel really bad, sweaty, and dreadful. I did a home COVID19 test kit and I think the first one was negative but I can't remember if this was the same incident or not. I continued to feel worse, so I did another test 3 or 4 hours later and it came back positive. I called the Doctor and told them I had tested positive but didn't get a response at that time. I went to bed and wasn't able to sleep much. I got up in the morning and still felt lousy.  I called Doctor's office again and was able to speak with the Nurse Practitioner. She prescribed the less frequently prescribed antiviral, not Paxlovid because it interfered with my medications. By that evening the fever started going down and I started to feel a little better. This entire thing was accompanied by a huge amount of phlegm, I was blowing my nose constantly. I went through two boxes of Kleenex in one day. Over the next four or five days the symptoms gradually diminished, the fever was gone almost immediately after taking the medication. The nasal drainage and phlegm was gradual, it was mostly gone by the end of the week. I still feel it a little but its like a minor irritant.
No additional AEs; HBP reported that VARIVAX was administered to a patient on 01/05/2023 after a temperature excursion; This spontaneous report has been received from  an office manager concerning to a 6-year-old patient of an unknown gender. The patient's medical history, previous drug reactions or allergies, concurrent conditions, and concomitant therapies were not provided.   On 05-JAN-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, vaccination scheme frequency, route of administration and anatomical location were not provided; lot number W017551 that was verified to be valid, expiration date reported and established as 01-JUN-2024) for prophylaxis (product storage error).  The administered vaccine underwent a temperature excursion of 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (F) with a time frame reported as 0 hours and 0 seconds; and 14 degrees Fahrenheit (F) up to 46  degrees Fahrenheit (F) (34.3 F) with a time frame reported as 0 hours 40 minutes and 0 seconds.There was a previous temperature excursion reported.  No additional adverse event (AE) was reported (no adverse event).
PATIENT FAINTED AFTER THE VACCINE AND WHILE FAINTED TONGUE BLOCKED AIRWAY AND PATIENT STOPPED BREATHING. PT WAS MOVED FROM SITTING POSITION TO THE FLOOR AND TONGUE WAS DISLODGE SO PT ABLE TO BREATHE AGAIN AND REGAINED CONSCIOUSNESS.  911 WAS CALLED AND EMS ARRIVED. PARENTS ELECTED FOR PT TO BE TAKEN TO HOSPITAL.
Had acute respiratory failure, dysuria NSTEMI after Dose #1 Lot # 025L20A (Moderna) hospitalized same day 12/31/20 administered @ 1040 back to baseline. 2nd Dose on 1/27/21 0950 Lot as above. Unknown exact onset same day, ED by EMS @ 1745, respiratory distress, febrile 39.4 degrees C BP 150/105 RR 29
Neck and bilateral arm and shoulder achy and sore evening after injection Apr 18. "The more active I was the more serious the discomfort became over next 48h. At one point I felt weak and had to sit and couldn't do anything due to overwhelming achy feeling. The sx appeared evening after injection and were completely gone 3 days later".
Swelling, redness, pain an injection site since got a flu shot. Pt. filled KEFLEX antibiotic from her primary physician.
A few minutes after administration of the vaccine the patient began to feel strange. He had trouble seeing and breathing and felt nauseas.  I called 911 and checked his blood pressure while we waited. It was 81/57 and then 92/62 the second time. The paramedics showed up shortly after and examined him and asked if the patient's mother wanted him to be taken to the hospital. She did want him to go to get additional testing done
soreness in arm; lethargic; burning pain in armpit; large red spot on her arm 2 inches below the shot; hard little lump; slight low grade fever; soreness in arm after first dose; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (soreness in arm), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (large red spot on her arm 2 inches below the shot) and VACCINATION SITE ERYTHEMA (soreness in arm after first dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included SUMATRIPTAN SUCCINATE (IMITREX DF), OMEPRAZOLE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (soreness in arm after first dose). On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (large red spot on her arm 2 inches below the shot), VACCINATION SITE SWELLING (hard little lump) and PYREXIA (slight low grade fever). At the time of the report, PAIN IN EXTREMITY (soreness in arm), LETHARGY (lethargic), BURNING SENSATION (burning pain in armpit), ERYTHEMA (large red spot on her arm 2 inches below the shot), VACCINATION SITE ERYTHEMA (soreness in arm after first dose) and PYREXIA (slight low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-065400 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065400:2nd dose
Fever started on May 15, 2021 and patient was given antibiotics at the urgent care. Fever kept increasing upto 102F and patient was taken to the emergency. He was admitted to the hospital with a WBC of over 20000, Inflammation markers above 100 times normal range (CRP - ~400). He was discharged from the hospital after 2 weeks with no diagnosis after consultation with infectious disease, hematologist and rheumatologist doctors. WBC counts were trending down, but fever did not stop for another 5 weeks (Total of 8 weeks of fever). With biweekly bloodwork, the inflammation markers are still not normal (as of 9/9/2021). follow ups with Hematologist, rheumatologist, and PCP (with tests like PET scan) did not lead to any specific diagnosis.  Patient was tested multiple times for Covid at the hospital and had negative results.
Fainted, nauseous, light headedness, fever, chills, weakness, exhaustion.
LETHARGIC, NON-RESPONSIVE TO QUESTIONS ASKED. PATIENT STATED THAT HE COULD HEAR US TALKING BUT COULD NOT ANSWER QUESTIONS.  PATIENT BEGAN TO REGAIN NORMAL STATUS IN ABOUT 10 MINUTES AFTER TALKING TO HIM.  WE HAD EMTS COME AND CHECK HIM OUT. PATIENT REFUSED TO GO TO THE HOSPITAL.  WE CALLED SEVERAL TIMES DURING THE DAY TO CHECK ON THE PATIENT, AND HE SAID THAT HE WAS DOING FINE.
Severe headache beginning the night after injection (2/10) that lasted 60 hours. Tingling arm  on side of injection that night. On night of the 10th, I woke up with muscle aches, joint aches, headache, shaking, chills, fever (would go up and down, top temp was 103), nausea, racing heart rate that would go up to 145 while sitting for a few minutes at a time, swollen lymph nodes in neck, throbbing face, ear pain, and fatigue. The nausea lasted 20 hours. Fever wasn't as  severe on the 11th  beginning mid day. Fever lasted about 24 hours. Night sweats have occurred for 5 nights in a row. Fatigue lasted for 72 hours. All other symptoms lasted for about 24-30 hours.
severe headaches, tinnitus, overall feeling of being unwell, all lasting about 10 days.  Tinnitus continued a a week or two longer.
Sick for 3 days with chills, fever, headache, aches, fatigue. At the 5th day - I developed a rash from top to toe, with painful arm from shoulder to elbow.