chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle pain; shivering / CHILLS; diarrhea; swollen area around the injection site; sore arm; exhaustion; experienced headache; achiness; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, chills, diarrhea, injection site swelling, pain in arm, exhaustion, headache and pain. On an unknown date, the outcome of the muscle pain, chills, diarrhea, injection site swelling, pain in arm, exhaustion, headache and pain were unknown.   It was unknown if the reporter considered the muscle pain, chills, diarrhea, injection site swelling, pain in arm, exhaustion, headache and pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not applicable for this report. The patient experienced headache, achiness, exhaustion, sore arm, chills, swollen area around the injection site, diarrhea, shivering, and muscle pain after receiving the first dose of Shingrix vaccine. The reporter stated that experienced the events but did not have specific patient identifiers. The reporter did not obtain any additional information from caller because adverse events filed after the call. The reporter did not gave consent to follow-up. This case had been linked with US2020239760, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020239760:same reporter
Patient reports having high blood sugar (200-300 range) starting day after vaccination. She has diabetes and states she normally stays within the 100s. Advised patient to continue to monitor and contact endocrinologist to see if MD wants to make any medication adjustments.
Pt states on 12-24-10 at 7am she had intense ringing in her ears, and her hands & fingers were tingling, her vision was spotty. Episode did not last long.
Within 5 minutes of vax the pt complained of strange taste in mouth, dyspnea, anxiety, became ashen color, then cyanotic. Pulse ox decreased to 44%, pulse 140, incontence of urine, extremely restless. Complained of feeling hot. Adrenaline, nebulizer treatment with albuterol.   Transferred to ER at another medical center.
No additional AEs or PQC reported.; Caller reports vaccine administered after temperature excursion.  No other information provided.  No additional AEs or PQC reported.        ?    Names of vaccines involved (including lot/exp) PNEUMOVAX 23  U034712  7/30/2023        ?    Temperatu; This spontaneous report was received from a medical assistance, referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 09-JUN-2022, the patient started therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml im, lot #U034712, expiration date: 30-JUL-2023, administered for prophylaxis (strength, and route of administration were not provided).  The administered doses of the vaccines were stored with the temperature of 34.2 degrees Fahrenheit, the time frame was 12 hours. There was no previous temperature excursion. No adverse effect reported.
I went to bed feeling fine but experienced chills, achy joints and headache until the next afternoon.   That was fine, expected that.   On about the 4 or 5th day.   I thought I had full blown Covid.   Had all the symptoms.   As this progressed my fatigue was overwhelming.   I lost my appetite, had a bad headache, joints and muscles ached, etc.   No fever at this time though and breathing was ok.  Texted  Dr.  and was told it was my immune system overreacting and he prescribed oral steroid to calm it down.   My fatigue lasted for a good 3 weeks.   This was as sick as I have ever been.
Mother states 3 hours post vax the patient developed a rash around the injection site. The patient developed a fever of 102.7F. The patient was treated with ice to the injection site and with Tylenol. Two days post vax the rash had resolved and the fever was gone. The patient remained fussy for two more days, but no other complaints.
Information has been received from a physician and a registered nurse concerning a male child who on 15-MAY-2007 was vaccinated with a dose of measles virus vaccine live Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown). By 25-MAY-2007 (also reported as "about six weeks after vaccination") the patient developed a disseminated rash, sore throat and fever. Unspecified medical attention was sought. The physician indicated that the rash looked like measles and was IGM positive. The patient did not have a high temperature and was not very ill. On 13-JUN-2007 the patient again developed a disseminated rash. The child was not hospitalized. No further information was provided. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Tinnitus; This spontaneous case was reported by a non-health professional and describes the occurrence of TINNITUS (Tinnitus) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PANTOPRAZOLE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 21-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Outcome reported as Unknown
Heartburn - lasting all day; stomach cramps; muscle aches; headache; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 28Apr2021 at 15:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included graves' disease, hypothyroidism and bariatric surgery. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 07Apr2021 at 15:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient previously took Tapazole for unknown indication on unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Apr2021 at 08:15 the patient experienced heartburn - lasting all day, stomach cramps, muscle aches and headache. The clinical outcome of the events heartburn - lasting all day, stomach cramps, muscle aches and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
8 day history of sinus congestion, was better for a few days, getting worse in last 3 days.  Nasal discharge, PND, facial pain, teeth ache and cough.  Cough that is from PND, coughing up green with blood tinged mucus.  Fever, chills, body aches since last night.   Was seen earlier this week and started on azithromycin 12/1/10.  Has been using Theraflu without relief.
No adverse event; an expired dose of GARDASIL 9 was administered to a patient on 30-DEC-2021; This spontaneous report was received from a nurse (also reported as registered nurse) regarding a patient of an unknown age and unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-DEC-2021, an expired dose human papilloma virus (HPV) rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (lot # S010729, expiration date: 01-DEC-2021), dose: 0.5 ml (strength, dose number, frequency) for prophylaxis was administered to the patient (Expired product administered). There was no temperature excursion. Not additional adverse events were reported. This was one of several reports received from the same reporter.  ; Sender's Comments:  US-009507513-2202USA003414: US-009507513-2202USA003516: US-009507513-2202USA003778: US-009507513-2202USA003751: US-009507513-2202USA003543: US-009507513-2202USA003627: US-009507513-2202USA003651: US-009507513-2202USA003569: US-009507513-2202USA003660: US-009507513-2202USA003658:
5 hours after getting the vaccine I started to have body aches and fatigue. I took ibuprofen and I sat in a chair. At 3:00am I woke up with chills and severe aches in all of my joints. I took 2 ibuprofen and since then I have been switching between ibuprofen and Tylenol. When I got up yesterday, I realized my face was swollen and my hands and feet were swollen. I could barely move my fingers. I called my doctor and I am awaiting a callback. My face is flushed but I have not had any fever. I am still having achiness but the swelling has gone down. It was so severe that I missed work yesterday. I have an appointment to see the provider on Monday. I also noticed that my glands were swollen in my underarm, neck and groin area.
Hives started 12 days after vaccination and hives are still present 10 days later. Increased dosage of Antihistamine. It helps symptoms but does not get rid of hives.
Fever of 102.4 for 2 days, extremely achy skin from head to toe, teeth hurt, very weak, headache, chills
Information has been received from a registered nurse concerning her daughter, possible allergy to aluminum, with was vaccination with hepatitis b vaccine (manufacturer unknown). Subsequently the patient experienced "knot in her arm around the injection site", swollen and warm to the touch and extreme pruritis. The patient's outcome was unknown.
Information has been received from a physician concerning a female who "a month ago" approximately in February 2008, was vaccinated 0.5mL with Gardasil (lot# not reported). Concomitant therapy included MENACTRA (lot# not reported) in the same arm. Subsequently, the patient developed a lump in her arm and soreness up and down her arm. It was not reported if these symptoms occurred immediately or within days after vaccination. The patient recovered from the lump in her arm and soreness up and down her arm. No further information is available.
This spontaneous report as received from a nurse refers to a 5 years old patient of unknown gender. On 10-JUL-2014 the patient was vaccinated with (Oka-Merck) PROQUAD (second dose in series, 0.5 ml once, subcutaneously, lot# K004713, expiry date: 02-OCT-2015) which was exposed to 1.5C for 1 hour, 15 minutes. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mother of patient came by clinic at 8pm 8/5/09, patient is not with her.  She reported that patient had headache and fatigue all day requiring him to take tylenol and stay in bed.  Mother denies any fever, rash, vomiting, or change in behavior.   Nurse Practitioner working at this location 8/5/09, advised Mother to have patient see PCP tomorrow (8/6/09) or to bring patient to ER tonight if headache worsened or new symptoms started.   Mother verbalized understanding.  Nurse called patient's home on 8/6/2009 9am and spoke with Mother.  Mother reported that patient was much improved, no complaints of headache and feeling better in general.   Mother agrees to watch patient carefully today and will bring him to PCP if she has any concerns today.  Nurse informed Mother that she would be completeing a VAERS report on the reaction in case they contacted her with questions.
swelling of face & body;also hives & itching first noticed 6DEC in AM & worsened throughout day;went to hosp treated for allerg rxn;
Tingling all over body, headache, increased heart rate, dizzy, pain all over body
Aches, chills, hot bumpy and sore injection site, and headache started on Wednesday 8/7 and continued to today (8/8).
needed a nap; I was "wiped out" / fatigue; This case was reported by a physician via sales rep and described the occurrence of fatigue in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced fatigue and somnolence. On an unknown date, the outcome of the fatigue and somnolence were recovered/resolved.   It was unknown if the reporter considered the fatigue and somnolence to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the next day of vaccination, the patient was wiped out and needed a nap. The fatigue lasted about 12 hours, then was ok again.
pt recvd vax 7SEP94 & 15SEP94 to MD office-rt deltoid swollen & tender;not red or hot to touch;also fever of 99.4;no med prescribed;
administration error. Vaccine given prior to approved age.  Proquad and Quadracel
My left hand is swollen and extremely sore. Hard to hold anything in that hand. Taking Advil constantly
Information has been received from a health professional concerning a 40 year old white female nurse who on 29 DEC 2006 at 10:35 was vaccinated with a fourth dose of RECOMBIVAX HB (yeast intramuscularly into the deltoid). The patient received a third dose of RECOMBIVAX HB (yeast on 19-APR-2006). Concomitant therapy included LIPITOR. The patient was expected to received a second series in MAR 2007. The patient did not seroconvert. Unspecified medical attention was sought. There was no product quality complaint. Additional information is not expected.
eye has been itching a lot; tiny bump around her eye; Now her skin changed to very dark, like black; This spontaneous case was reported by a pharmacist and describes the occurrence of EYE PRURITUS (eye has been itching a lot), PAPULE (tiny bump around her eye) and SKIN DISCOLOURATION (Now her skin changed to very dark, like black) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atopy.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EYE PRURITUS (eye has been itching a lot), PAPULE (tiny bump around her eye) and SKIN DISCOLOURATION (Now her skin changed to very dark, like black). At the time of the report, EYE PRURITUS (eye has been itching a lot), PAPULE (tiny bump around her eye) and SKIN DISCOLOURATION (Now her skin changed to very dark, like black) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up document attached - Medical History reported
Pt. had an episode of syncope which lasted only a few seconds after administration of final vaccine HPV 9. Pt. was alert and orientated. Pt. given juice and cool cloths. Pt. laid down. After pt. a few min. pt. retained color. Pt. then began to become very lethargic for about 30 min. Pt. would respond to name and open eyes. Pt.s body noted to be limp. After approx. 1 hour in office pt. was still not completely functional.
Patient's mother reported that she noticed on 8/12/20 (the day after receiving vaccinations) redness and swelling on the patient's left leg at the site of injection. Upon examination, the area was warm and swollen, with a diameter of redness of approx. 40 mm. The patient's mother reported that the patient suffered no systemic issues; no difficulty breathing or dizziness. The patient reported that the swollen area was painful. This nurse recommended to the patient's mother that an option would be to give the patient Tylenol for discomfort and to continue monitoring the area, and to call the patient's doctor if the area got worse. This nurse advised the patient's mother that if the patient began having difficulty breathing to take her to the Emergency Room.
This spontaneous report as received from a registered nurse refers to a 4 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 22-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Herpes zoster; The spontaneous report was received from a lawyer and refers to a currently 78-year-old female patient. There was no information about the patient's concomitant therapies or medical history provided. The patient was married.  On 28-JAN-2018, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX), subcutaneously for prophylaxis (long-term prevention of shingles and zoster-related conditions) (strength, dose, lot # and expiration date were not reported). On an unknown date, the patient experienced herpes zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Week 1 flu symptoms chills, fever ,fatigue, headache  Week 2 chills, fever, fatigue Week 3 intermittent chills, fever, fatigue, night sweats week 3 continuing, some days no issue, next day  all symptions
pt recv vax 19AUg97 pt recv vax 430PM mom describes sz approx 6PM very high fever x 2 days (mom does not have thermometer) mom did not work on 20AUG;only had one sz but 2 days inc temp;doing well today;
Lips swelling; strong taste of having chewed rubber bands on lips and inside mouth; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Oct2021 at 11:15 (at the age of 80-year-old), as a single dose for COVID-19 immunisation. Medical history included foramen ovale patent (PFO), osteoporosis, osteopenia, high blood pressure, high cholesterol, acid reflux and known allergies reported as many. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included unspecified medications received within two weeks of vaccination. On 01Oct2021 at 16:30, the patient experienced lips swelling and strong taste of having chewed rubber bands, on lips and inside mouth. The patient described it as maddening. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lips swelling and strong taste of having chewed rubber bands on lips and inside mouth was not resolved at the time of this report  The lot number for BNT162b2 was not provided and will be requested during follow up.
My left ear had been clogged since 3/5/2023, which is the day that I tested positive for COVID-19. I also developed other symptoms during my bout with COVID-19, but they eventually went away after treatment with MUCINEX D and remdesivir. However, the clogged ear persisted afterwards. I saw my doctor on 4/5/2023, and he prescribed me oral methylprednisolone and azelastine nasal spray. In his comments, he mentioned that I had Meniere's disease in the left ear, plus he diagnosed me with chronic mucoid otitis media of the left ear. I also underwent a hearing test that day and was diagnosed with conductive hearing loss induced by L-based middle-ear effusion. His notes also read that I had "L. hydrops otherwise stable." In conjunction with the medications he prescribed, the doctor also recommended that I use an ear popper. The ear congestion went away maybe a week or two later. The congestion returned in the same ear on 5/6/2023, though. I saw the doctor again on 5/10/2023. At that point, my ear was still congested, and I was then diagnosed with a sinus infection after I was tested. He treated my infection by prescribing more methylprednisolone, plus cefdinir. I was also told to continue taking the azelastine nasal spray and using the ear popper. As of today, the ear congestion is 90% gone, and I am still taking the prescribed medications.
Since injection develop red band around bicep, had constant dull ache, numbness, itch. The center of injection dark in color and very sensitive to touch. Rash and Urticaria Pruritus. Methylprednisolone, diphenhydramine.
Patient's HR director called 10/13/2016 and reported to me that the patient had gone to a physician and diagnosed with bursitis. The HR was wanting to know the length of needle used on the patient in order to report back to the physician. HR director states that treatment will be for 3 month.
I?m currently 16 weeks pregnancy. After receiving the shot, on the way home the injection site was leaking blood down my arm (even with a bandaid on). I?m concerned that the individual did not inject me properly.
Extreme chills/shakes started around 8pm. Diarrhea in the morning. Major headache and sensitivity to light. Acetaminophen helped.
This spontaneous report as received from the health care worker refers to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On 10-NOV-2015 the patient was vaccinated with improperly stored PNEUMOVAX23, lot# L013428, expire date 03-FEB-2017, (dose number, frequency, route not reported). No adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Migraine (2PM - 8PM) Fatigue (2PM - 8PM) Nausea (2PM - 8PM)
reactions began on 7JUN92 about 4PM pt began gagging & coughing for no apparent reason; coughed so hard began vomiting, turning red & purple in the face; cont off & on for 1 wk; gagging, coughing & vomiting for 4 days straight; redness cont
Patient is experiencing 2 numbness that starts where shot was given and radiates toward wrist. Also is having difficulty holding things. Patient describes as a spasm.
I started to have severe inner ear pain and headaches the day after the third COVID shot. I assumed it was pain from wearing a mask every day and having it tug on my ears, but it continued for months.
Administered vaccine 10/6/10 in left arm. On 10/9/10 patient complained of painful injection site. It was red, swollen and warm to touch. She went to WNY Immediate Care and received CEPHALEXIN 500, 1 tid for 10 days to treat cellulitis (The redness began the evening of her shot).
inject site became red, tender & indurated p/inject on 25JAN95; 31JAN95 inject site 1/2 inch induration;