chrisvoncsefalvay/vaers-outcomes huggingface dataset:
deep muscular sore; dizziness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced muscle soreness (Verbatim: deep muscular sore) and dizziness (Verbatim: dizziness).  The outcome of the muscle soreness and dizziness were not reported.   The reporter considered the muscle soreness and dizziness to be related to Shingrix.     The company considered the muscle soreness and dizziness to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-SEP-2023 This case was reported the patient via interactive digital media. The patient got the 1st shot and would be leaving the country last September and could not got 2nd shot until late October and if it was ok. The patient play competitive golf and had shot gave the patient deep muscular sore and dizziness.  The patient also getting on Cruise ships, so wanted to delay shot until returned to country. The follow-up could not be possible as no contact details were available.
Pt called the day after her PNEUMOVAX shot (10-25-08) and said that her arm was very sore, swollen, red, and that there was a large bump under her skin, I advised her to take 400mg ibuprofen every 4-6 hours and apply a cold compress
Patient came in for her 3rd dose of covid-19 moderna vaccine. pt stated that after the first dose she had a rxn where her lips swelled up. After speaking with her allerigist/immunologist, she was given a drug regimen protocol to follow when receiving vaccines. She had the second covid-19 vaccine and did not experience an allergic reaction. today, on her 3rd vaccine, she reported having difficulty breathing. She gave herself an EpiPen injection (from her own supply). after 15 minutes she did not feel relieved, and said she couldn't swallow. she gave herself a second EpiPen injection (from her own supply) and asked me to call 911.  The paramedics came and took the patient away. She was alert and oriented x 4 when leaving the pharmacy. It seemed to be more of a panic attack than an anaphylactic reaction
Have large rash on arm and pain is still continuing at injection site (large red dot on arm) 8 days later.  Difficulty sleeping on my left side due to pain.   Will seek medical attention if it does not resolve in the next few days.
Red hard lump on left thigh, warm to the touch size of a quarter. Dose not bother child, recc. to be seen if not improving in 5 days.
This spontaneous report was received from a certified medical assistant (CMA) and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patients may have received doses of improperly stored GARDASIL 9 (route of administration was not reported) (L037554 expiry date: 25-DEC-017, M011840 expiry date: 01-FEB-2018, L023905 expiry date: 27-MAY-2017 and L037003 expiry date: 27-MAY-2017.) No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Received Tdap (L) deltoid 4/7/15- developed redness/swelling 2x4 cm at injection site. (+) very warm to touch.
On 5/3/99, the pt experienced hives on her face and hands described as 5 itchy red bumps on the outer edge of both index fingers, right cheek, and forehead. The reaction was noted as lasting 3 days.
armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand; muscle aches; joint pains; headaches; dizziness; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 23 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 05May2021, when the patient was 22-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Misplaced/discarded, Location of injection: Arm Left), administration date: 11Jun2021, when the patient was 23-year-old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), PAIN (non-serious), NEURALGIA (non-serious) all with onset 21Jan2022, outcome "not recovered" and all described as "armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand"; DIZZINESS (non-serious) with onset 21Jan2022, outcome "not recovered"; HEADACHE (non-serious) with onset 21Jan2022, outcome "not recovered", described as "headaches"; ARTHRALGIA (non-serious) with onset 21Jan2022, outcome "not recovered", described as "joint pains"; MYALGIA (non-serious) with onset 21Jan2022, outcome "not recovered", described as "muscle aches". The events "armpit pain a couple hours after booster shot that progressed into armpit ache/full pain with some nerve pain into hand", "muscle aches", "joint pains", "headaches" and "dizziness" required physician office visit. Therapeutic measures were taken as a result of pain in extremity, axillary pain, pain, neuralgia, myalgia, arthralgia, headache, dizziness.  Additional information: Patient did not received any other vaccine in four weeks. No Covid prior vaccination and patient did not Covid tested post vaccination. Patient experienced leg armpit pain a couple hours after booster shot that progressed into armpit ache or full pain with some nerve pain into hand that has persisted ever since (now being June 2nd). Also experiencing muscle aches, joint pains, headaches and dizziness. Adverse event treatment: Celebrex for armpit nerve pain: unresolved.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 4 hour of 3:15pm injection: severe sore throat, inflammation and redness of mucosa under my tongue, and feelings of tongue slightly swollen, fever of 100 degrees, eyes tearing throughout the night.  sll symptoms were gone within about 20 hours except for slight swelling and redness under my tongue.
One week after vaccine, I was diagnosed with pulmonary embolism. Then today, echo showed small pericardial effusion
I took the first dose of the vaccine (EW0196) on 06/16/2021, And I took the second dose (FA6780) on 07/07/2021. The injection site started to swell and be very painful , I also had tiredness and a headache, and I don't really get headaches. The whole left arm was also very painful. I also had a fever. And my back and joints started hurting.
17apr90 pt vax hepta B.  w/i 12 hrs pt devel nausea and diarrhea. pt recovered w/i 72 hrs
p/vax pt exp vague sx of arthralgias & weakness;it was reported that pt labs were nl @ that time;pt cont to not feel well;pt exp weight & hair loss;pt lost 14 pounds since last visit in12/98;60 day follow-up received on 10/25/00 provided no additional data.
Rash (pustular) - generalized since 09/23/2008 - No fever
Sudden onset of left arm, neck, back pain, slight headache, rapid heartbeat and body shakes/fever 30 hours after vaccine was administered
Case reference number 1998004046-1 is a clinical trial report from study number 208355/117 (Tripedia at 2m and 4M) which is a single-blind study referring to a male aged four months. The patient's past medical history included cough and congestion. The following drugs are also known to have been taken by the patient prior to this event: OmniHib and Orimune on 09/24/97, Tylenol starting 09/24/97, and Dimetapp starting 09/24/97. The patient received his first dose of study vaccine (Tripedia) on 09/24/97, for Diphtheria-Tetanus-Pertussis Prophylaxis. A lump in the right groin was noted the morning of 10/09/97. The infant began treatment with Keflex. Upon recheck, with the physician on 10/10/97 the area was larger, slightly more red and his temperature was up to 101.3 rectal. Ultrasound indicated and inflammatory process. The infant underwent incision and drainage of the right inguinal / femoral lymph node abscess under general anesthesia and spinal block on 10/10/97. The infant was released, and at home his parents gave him a dose of 1-2 ml of Tylenol with Codeine for the pain at approximately 20:30 on 10/10/97. (At 21:30 he was given his 4th dose of Keflex). A few minutes after 21:30 the infant was noted to have his head turning to the right, pupils dilated and he began arching his back with stiffness of all extremities and was unresponsive to parents. The stiffness lasted approximately 1 1/2 hours, with symptoms resolving slowly during the last 30 minutes. He became responsive and started to feed. He was seen in an ER at 22:50. His eyes had become less dilated. The infant did not have a fever. The eventual diagnosis was dystonic reaction to Tylenol with Codeine. The most recent info received reports the event resolved. The investigator reported the dystonic reaction to Tylenol with Codeine not related to the treatment with the study vaccine., but related to Tylenol with Codeine.
pt recvd vax on 12AUG92 & approx 5 days p/2nd dose devel pain in the rt wrist which persisted a couple of days; devel pain & swelling in lt knee & lt ankle; lab eval revealed an elevated white blood cell count; approx 1-1/2 wks p/lt knee;
She struggled with COVID-19 for weeks; She struggled with COVID-19 for weeks; then COVID-19 again; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001224 (Novavax).  A 60 (unit of measure not reported) female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She struggled with COVID-19 for weeks"; DISEASE RECURRENCE (medically significant), outcome "unknown", described as "then COVID-19 again". On 26Sep2023, it was reported that a patient started treatment on unreported dates with Pfizer BioNTech COVID-19 vaccine for the primary series and "at least 1 Pfizer booster" for COVID-19 immunisation. It was reported the patient had COVID-19 once, and then COVID-19 again. She struggled with COVID-19 for weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Peri-orbital swelling, conjunctival injection, mild bilateral wheezing, a few hives on face.
100 degree fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 19:00 (Lot number: 301558A) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (2nd dose, Lot- EL9263), administration date: 28Jan2021, when the patient was 69 years old, for Covid-19 Immunization; Bnt162b2 (1st dose, Lot- EL3246), administration date: 07Jan2021, when the patient was 69 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 29Sep2021 16:30, outcome "not recovered", described as "100 degree fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient stated she had her booster AT 7PM yesterday, 28Sep2021, states she is 69 years old, was it okay, she took her temperature, feels like she has a fever, states she has a 100-degree fever, wants to know if it was okay to take Tylenol. felt like she got a fever this afternoon around 4:30. Stated she got the booster dose at pharmacy.  No follow-up attempts are possible. No further information is expected.
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Infection / Cellulitis (diagnosed by MD)-, Additional Details: Pt reports needing antibiotic for surface infection. Also reports bruising and that injection was given too low.
dizziness /felt lightheaded; Low grade fever; nonstop headache; typical soreness in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (typical soreness in the arm), DIZZINESS (dizziness /felt lightheaded), PYREXIA (Low grade fever) and HEADACHE (nonstop headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (typical soreness in the arm) and HEADACHE (nonstop headache). On an unknown date, the patient experienced DIZZINESS (dizziness /felt lightheaded) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at a dose of 1 dosage form and NAPROXEN (MOTRIN [NAPROXEN]) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (typical soreness in the arm), DIZZINESS (dizziness /felt lightheaded), PYREXIA (Low grade fever) and HEADACHE (nonstop headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Follow-up received does not contains non significant information (contact information updated)
Stroke like symptoms 12/01/2022 losing sight /vision on one side, limb weakness on one side of body, difficulty with speak; aphasia. Went to ER. CT scan performed at the local medical center, cleared from stroke. Diagnosed with A-typical migraines, reoccurring symptoms on 12/09/2022, went back to ER, propranolol was prescribed started with 80mg than lowered to 60mg.
Runny nose, sore throat.  Admitted to hospital 10/7 with back pain, generalized weakness and myalgia, trouble moving hand. Diagnosed with Guillain-Barre.
Patient here for adult booster dose Moderna Covid-19 vaccine. Nurse inadvertantly gave Pfizer Covid-19 vaccine for children age 5-11 dose (0.2ml).  This was during a clinic time for Pfizer children age 5-11 only appt. The patient had an appt. for vaccination . Children's vaccine was on counter where gave vaccine.  The Moderna Covid-19 vaccine was drawn up and on counter across the room. This medication error was noted later and the patient was notified later that same day.  No adverse event was reported.
1/25 @ 3:30 Laid down and had a sudden racing heart rate. Maxed in the 150s, staying around 135 for a prolonged period of time. No activity during this time.  Lasted 40-45 minutes. Not sure if related to vaccine, but no other changes in routine/diet/medications.
pt passed out immed p/veing vaxed w/MMR; No further details were provided;
Numbness and tingling on left & right arm, numbness and tingling on left & right leg. My Extremities turned very cold while other parts of my body were at normal temperature. It felt like I was losing my arms & legs due to loss circulation(?). Rapid heart beat(118 bpm) & feeling my heart beat through  my chest.  Insomnia. Long term side effects which I am still dealing with 3 weeks post vaccination are joint pain and numbness & tingling in wrists & ankles.
Severe diarrhea, blurry vision, inability to focus, inability to "have a normal conversation" (all started today, per patient report).
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-JUL-2017, the patient was vaccinated with improperly stored dose of PNEUMOVAX23 lot # N010105, expiration date 15-NOV-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 9 Celsius degrees to 25 Celsius degrees for 5 days (120 hours). Data logger was not involved. There were no previous excursions reported. Additional information has been requested.
had your two shingles shots and still got the shingles/suspected vaccination failure; shingles; Very painful; itch on head; burning in your face cheek; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus and burning sensation in face. On an unknown date, the outcome of the vaccination failure, shingles, pain, pruritus and burning sensation in face were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus and burning sensation in face to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had two dose of shingles vaccine and still got the shingles, also mentioned very painful. The also asked what the best thing was to stop itch on head and burning in face cheek. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
allergic reaction to DTP? according to mom the reaction appeared immed p/DTP; erythema & vesicular lesions around the inject of DTP extending behind the knee; dx widespread cellulitis;
Pt to ED 6/7 reporting vommiting, abdominal pain, nausea and constipation. COVID+ 6/7, occasional non-productive cough. 6/8 Pt alert and oriented x3-4, denies any pain, tolerating fairly well, on RA O2. 6/10 no apparent distress noted. 6/12 pt alert,orient x4, no distress noted. 6/13 pt currently on room air, complains of no pain or discomfort. 6/14 pt discharged back to group home.
Tested positive for Covid-19 on 2/11/2021. Admitted into hospital. Stayed for 7 days.  Released on oxygen
2 days after my shot I had to go to ER suffering from irregular heart beat caused by Atrial flutter with rapid ventricular response(CMS/HCC). Treated with metoprolol tartrate and heart rate returned to normal. Spent approximately 3 hours in ER.
Menactra administered at 6:30 pm, 1 minute later patient stated to feel faint.  Patient then sat down and eyes stated to roll back in her head for no more than 15 seconds.  EMS was then called to transport patient to the hospital.
Headache, Myalgia, Fever, Diarrhea, adenopathy Narrative:
Case previously recorded as MA2009-5169. Initial case report received from a physician, via Novartis Medical Communication, on 20 Nov 2009. A 3-year-old male patient was vaccinated with 0.5 ml of S-OIV FLUVIRIN (batch no. 102124P1, expiration date 1 MAR 2010) i.m., an off-label indication. No adverse event was reported. Agency reference no.: NA09-008303.
Hot, painful, red welt developed at injection site 7 days after receiving the first dose of Moderna COVID vaccine. Welt remained hot and grew in size over the next three days before subsiding.
dizziness; vomiting; headaches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), HEADACHE (headaches) and DIZZINESS (dizziness) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (vomiting), HEADACHE (headaches) and DIZZINESS (dizziness). At the time of the report, VOMITING (vomiting), HEADACHE (headaches) and DIZZINESS (dizziness) outcome was unknown.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe malaise and joint pain, bilateral lower extremity edema, neuralgia, fever 101.5, night sweats, chills, heart palpitations and tachycardia. Intermittent chest pain.
legally blind in both eyes; bedridden; extreme light sensitivity; had double & triple vision; in pain; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (legally blind in both eyes) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical reported history provided by the reporter.  Concomitant products included PREDNISONE for an unknown indication.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (legally blind in both eyes) (seriousness criterion medically significant), BEDRIDDEN (bedridden), PHOTOPHOBIA (extreme light sensitivity), DIPLOPIA (had double & triple vision) and PAIN (in pain). At the time of the report, BLINDNESS (legally blind in both eyes), BEDRIDDEN (bedridden), PHOTOPHOBIA (extreme light sensitivity), DIPLOPIA (had double & triple vision) and PAIN (in pain) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Patient had a history of bletherakaretoconjuntivitis, and uvetitis among many other diseases dating back to 30 years. Patient went to two different hospitals and a another major eye clinic for treatment after the 2nd shot & they never connected it with the vaccine.  They found multiple diseases on multiple layers of his eyes.  Treatment medication was  not reported. Company Comment: 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.  However, patient's underlying disease (history of eye problem) remains a contributory factor.   This case was linked to MOD-2021-292109 (Patient Link).; 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.  However, patient's underlying disease (history of eye problem) remains a contributory factor.