chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shot gave shingles\ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had shingles shot and experienced shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Patient had a small knot at site of injection.  Size of pinky fingernail. There was no pain or bleeding. Applied cold compress to injection site and monitored the site for 30 minutes. Instructed patient to continue with cold compress for next 48 hours. If the site became larger or worse with redness/fever told patient to seek medical attention. Patient notified us 1-21-22 that she had issues with site and she  did see a Dr for treatment.
A pharmacist reported a pt received vaccine on 8/1/00, later that day he developed injection site reaction characterized by redness, swelling and pain.
Sore arm, swelling in armpit area of same arm of injection site. Pain in armpit area of left arm as well. Have taken Tylenol for pain, but nothing else.  Called my doctor, was told by staff they were on lunch and to call back later.
7 weeks after HPV #2 patient blacked out and c/o severe headache, stiff neck. Admitted to hospital (after ER visit) all tests were negative. She has since had several seizures and c/o muscle and joint pain so severe she has missed 3 weeks of school. 6/2/08-records received for DOS 1/30/08-C/O morning stiffness, fatigue neck and back hurt. Back pain began in January.  Knees, ankles hurt since January, tender to touch. Last week with fever 102 and diarrhea. PE WNL. Assessment: Pain 7/2/08-records received for DOS 1/6-1/9/08-DC DX: neck stiffness, headache, joint pain, cervical muscle spasm.  C/O blacking out and nausea next day followed by headache and paleness. Next day increased neck stiffness and shooting pains down shoulder.
Swollen lymph nodes the size of a golf ball near the breast underarm of the vaccination arm.  (Right arm).  I called my doctor office and the staff said it can be a side effect but to report it.
Pt developed purpuric vasculitis approximately 10-12 days after receiving vaccine. It started on legs then spread to arms and hips. Spoke to Dr. on 5/18/20 and it turns out dx is Henoch-Schonlein Purpura
site of injection is swollen; Site of injection has redness; Site of injection is tender to the touch; Left lymph nodes are swollen on clavicle; Night sweats for 2 nights; Very, very fatigued; Muscle soreness; chills; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats for 2 nights), FATIGUE (Very, very fatigued), MYALGIA (Muscle soreness), CHILLS (chills) and VACCINATION SITE SWELLING (site of injection is swollen) in a 32-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 History information was reported.   On 29-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats for 2 nights), FATIGUE (Very, very fatigued), MYALGIA (Muscle soreness) and CHILLS (chills). On 03-May-2021, the patient experienced VACCINATION SITE SWELLING (site of injection is swollen), VACCINATION SITE ERYTHEMA (Site of injection has redness), VACCINATION SITE PAIN (Site of injection is tender to the touch) and LYMPHADENOPATHY (Left lymph nodes are swollen on clavicle). At the time of the report, NIGHT SWEATS (Night sweats for 2 nights), FATIGUE (Very, very fatigued), MYALGIA (Muscle soreness), CHILLS (chills), VACCINATION SITE SWELLING (site of injection is swollen), VACCINATION SITE ERYTHEMA (Site of injection has redness), VACCINATION SITE PAIN (Site of injection is tender to the touch) and LYMPHADENOPATHY (Left lymph nodes are swollen on clavicle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No known drug allergies.
Initial unsolicited report received from a healthcare professional via other company (Pfizer, Manufacturer report number: 20166568559) on 31 January 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (batch number, expiration date, dose, site and route of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient was allergic to tetanus toxoid. Lab data and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
can't sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 21Aug2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid 19 virus", start date: 2021 (unspecified if ongoing), notes: She has a caller on the line who had the Covid 19 virus about one month ago.; "having problems sleeping" (unspecified if ongoing), notes: She was having problems sleeping before the Covid 19 vaccine. The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset Aug2021, outcome "unknown", described as "can't sleep". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No additional AEs were reported; Medical assistant reported that a patient received an expired MMRII vaccine today 9/7/2022.; This spontaneous report has been received from a medical assistant concerning to a 17-year-old- patient of an unknown gender.   The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies were not reported.   On 07-SEP-2022, the medical assistant reported that a patient was vaccinated with one dose of an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin [rHA] (M-M-R II), prophylaxis, (lot number T027935 that was verified to be valid with an expiration date reported and established as 18-AUG-2022; (dose vaccination scheme, route of administration and anatomical location were not provided) (expired product administered) in combination with sterile diluent (dose not reported) (lot number T020663 had been verified to be a valid number wiht an expiration date reported as and established as 02-FEB-2023).  No additional adverse event (AE) was reported.
PATIENT SIGNED UP FOR A WORK PLACE CLINIC PROVIDED BY AN OUTSIDE PHARMACY. PATIENT SIGNED UP FOR BOTH FLU AND PFIZER BOOSTER. AFTER CHECKING IN FOR BOTH SHOTS AND RECEIVING FLU VACCINE, PATIENT STATED SHE ALREADY RECEIVED A FLU SHOT THIS SEASON. DISCUSSED WITH PATIENT TO WATCH FOR TYPICAL SIDE EFFECTS INCLUDING BUT NOT LIMITED TO PAIN AT INJECTION SITE, GENERAL TIREDNESS,  HEADACHE, MILD FEVER, ETC.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were unknown. On 18-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N000508, expiration date 19-OCT-2018 for prophylaxis (dosage and route of administration were not reported). Other suspect therapies included PREVNAR 13. According to the reporter, the patient's vaccination history was unknown and was unclear if the patient received a prior dose of PNEUMOVAX 23 or PREVNAR 13. No adverse effects were reported.
Grandmother called this RN to report- staring for about 10-15 minutes, lying around, making little noise. Then, states made a noise followed by vomiting so much was gasping for air. Took to ER. States had elevated BP/Temp/HR. States temp was 103.8. States blood tests/urine/throat cultures done and all negative. States illness lasted about 3 hours but were in the ER for about 8 hours. States by 9am the next morning saw pediatrician and child was back to usual. States no rash, no bruising, swelling, or redness at the injection site. States child was eating and drinking and back to normal by the morning after the incident around 9am.
A non-serious report was received from a nurse concerning a five-year-old male with influenza, fever, headache, sore throat and vomiting. The child had no known allergies and had a flu shot in the past. FluMist was administered on 06-Nov-2007. Two days later on 08-Nov-2007, the child presented with a fever of 102-103, headache, body ache and vomiting. A rapid flu test revealed positive results and a strep test was negative. The nurse wanted to know if FluMist could cause a false positive flu test. The event outcome was not provided. Additional FluMist dosing is not indicated. The reporter did not provide a causality assessment for the adverse events reported. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
bone pain; pain when lifting arm, pain when moving arm, painful to move arm up and down; pain from arm to elbow to shoulder; joint pain, shoulder pain; slight headache; felt nauseated; had loose stools; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bone pain), PAIN (pain when lifting arm, pain when moving arm, painful to move arm up and down), DIARRHOEA (had loose stools), PAIN IN EXTREMITY (pain from arm to elbow to shoulder) and ARTHRALGIA (joint pain, shoulder pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, the patient experienced DIARRHOEA (had loose stools) and NAUSEA (felt nauseated). On an unknown date, the patient experienced BONE PAIN (bone pain), PAIN (pain when lifting arm, pain when moving arm, painful to move arm up and down), PAIN IN EXTREMITY (pain from arm to elbow to shoulder), ARTHRALGIA (joint pain, shoulder pain) and HEADACHE (slight headache). At the time of the report, BONE PAIN (bone pain), PAIN (pain when lifting arm, pain when moving arm, painful to move arm up and down), DIARRHOEA (had loose stools), PAIN IN EXTREMITY (pain from arm to elbow to shoulder), ARTHRALGIA (joint pain, shoulder pain), NAUSEA (felt nauseated) and HEADACHE (slight headache) outcome was unknown.            No concomitant medications were reported.  Patient stated that she usually does not get headaches.  No treatment medications were reported.   This case was linked to MOD-2022-547032, MOD-2022-547037 (Patient Link).
Many lasting for 2 weeks - pain, nausea, diarrhea, extreme weakness and fatigue, dizziness, fever and chills, cold sweats,, headache, brain fog, dyspnea on exertion, dry mouth.  Medicated with Tylenol, bananas, oatmeal and herbal tea.  Documented on pdf form, but unable to use "continuation page", so added sheet that unable to attach.  Will try again to upload and send separately to this.  NO forms given to me at pharmacy for reporting anything.  I called several times and left messages, but no return call.  Sent email, but response saying unable to help at this time.  Very frustrating as I continued having severe symptoms and unable to get help.  Finally feeling better enough today to send form.
Patient received four vaccinations, tolerated them well, waited to leave until time elapsed, walked out to the waiting room, client sat down, per family member she stiffed up and peed her pants, he eyes rolled back to her head, but she did not lose consciousness per family, client knew where she was and aware of what happened, 911 called, BS 122, BP 85/45, temp 97, family declined to go to the hospital, per Mother they will follow up with a doctor, possible seizure that happened.
Tachycardia; lump is hot, burning, warm to the touch; had a bit lump in the injection site,lump quadrupled its size in 48 hours; swelling in the injection site; had redness in the injection site and lump is red; This spontaneous case was reported by a pharmacist and describes the occurrence of TACHYCARDIA (Tachycardia), VACCINATION SITE WARMTH (lump is hot, burning, warm to the touch), VACCINATION SITE INDURATION (had a bit lump in the injection site,lump quadrupled its size in 48 hours), VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE ERYTHEMA (had redness in the injection site and lump is red) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced TACHYCARDIA (Tachycardia), VACCINATION SITE WARMTH (lump is hot, burning, warm to the touch), VACCINATION SITE INDURATION (had a bit lump in the injection site,lump quadrupled its size in 48 hours), VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE ERYTHEMA (had redness in the injection site and lump is red). On 05-Jan-2021, TACHYCARDIA (Tachycardia) had resolved. At the time of the report, VACCINATION SITE WARMTH (lump is hot, burning, warm to the touch), VACCINATION SITE INDURATION (had a bit lump in the injection site,lump quadrupled its size in 48 hours), VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE ERYTHEMA (had redness in the injection site and lump is red) had not resolved.        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 medication include Birth control pills.  No treatment information was provided.; 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.
Reports 1 week after immunization developed swelling and pain left side of throat.  Reports eyes becames swollen and puffy for a few days.  Had a rash on upper torso. Also complains that left ear feels blocked. Reports low grad temperature.  Saw her physician on Thursday July 26th for persistant symtpms and was placed her on a Medrol dose pack and zovirax. On 7/31 still has swelling in Left throat gland and difficulty swallowing. Reprts medicaton took rash away and has only had slight relief of symtpoms.
Large red wheal - 6 x 6 cm with hard knot. Redness now decreased after 1 wk, still 1 nodule.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  9/20/2021 Is this your first or second dose- 1st Date of symptom onset - ? 9/21/2021 Symptoms - ? headache, body aches, and tiredness Last day of work and shift - ? 9/20/2021 Home remedies- NA Any improvement- NA Recommendation- Advised employee to Take Tylenol and/or Ibuprofen if not allergic per pack instructions as needed for headache and body aches. Also advised employee to monitor symptoms and if they worsen, new symptoms develop, or they feel like they need to be seen by a provider to call us.  Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
Inpatient level of care as he has a current diagnosis of Acute respiratory failure secondary to pulmonary embolism with community acquired pneumonia, which has not improved enough to allow for a medically safe discharge despite receiving appropriate treatment.  Patient discharged on 12/22/2021, and 3 hours after returning home, patient passed away.
Chest tightness and itching. Pt called a local 24 hour pharmacy at 11:45 and took diphenhydramine oral and remained at home. Continued diphenhydramine the next day, but did not feel she was in her usual health, and visited a walk in clinic the following day. Unknown drugs administered.
The correct vaccine was ordered, but the bivalent Moderna vaccine for ages 6-11 years at a dose of 0.25 mL/25 mg was administered.
Varicella illness 7.5 years after varicella vaccination.  Patient has been started on Acyclovir.
Facial/ocular swelling less than 24 hours after vaccines. No respiratory distress symptoms, no vomiting and no fevers. Lasted few days.
Initially, patient reported soreness at the injection site.  On 03/13/2020 at ~0900, the patient fainted at home while walking out of the bathroom. Patient reported feeling  "strange" for the rest of the day. Patient also reported a low-grade fever reported at this time. The patient reported that the injection site was raised and red.
5 x 5 cm area of erythema & edema & tenderness over (L) deltoid & 101 degrees fever last PM.
Red, itchy, swelling at site of Tdap injection. Began within 3 hrs of getting injection. Minimal erythema. Treated with KEFLEX 500mg TID x 10 days.
APPROX. 6 HOURS AFTER BOOSTER, PT REPORTED TACHYCARDIA, NAUSEA, VOMITING, DIZZINESS, HEADACHE, AND FEVER
lost his sense of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost his sense of taste) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced AGEUSIA (lost his sense of taste). At the time of the report, AGEUSIA (lost his sense of taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Pain at injection site and surrounding area lasting less than 7 days. Advised patient to follow up with physician to rule out other causes.
One day post vax, 10/20/00, pt developed a red, hot, tender, swollen area on the inner aspect of her left lower arm measuring 17 cm by 24 cm. Therapy with cephalexin (Keflex) and diphenhydramine HCl (Benadryl) was initiated. The symptoms resolved on 10/27/00. The reporter indicated that other pts experienced events post vax: WAES 01020487, 01020488, 01020489 and 00102088. Addtl info has been requested.
Patient states via email "Got my flu shot Friday a.m. and by late Friday night I started with a rash, which continues today (9/21).  Little itchy bumps.  Seems to like my joints.  Started on the elbows, then to knees, today ankles and wrists starting to itch.
Admitted 10/10/2021 with cough, sob, and hypoxia; Patient expired 11/09/2021;  past medical history significant for Anemia, Aortic dissection, Diverticulitis, Hemolytic anemia on chronic prednisone pta, HTN, and Hyperlipidemia who was admitted to the hospital on October 10, 2021 with complications from COVID 19 infection.  She was started on standard treatment with dexamethasone; remdesivir was held due to elevated LFTs; intubated 10/19 no ecmo no dialysis
Extremely potent vertigo, couldn't stand on my legs; looks like the muscle will become a cramp; the pain has been progressive on a daily basis to a point where; pain on left arm, but nothing spectacular/ pain is getting stronger; slight fever 38.5C; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on left arm, but nothing spectacular/ pain is getting stronger), INJECTED LIMB MOBILITY DECREASED (the pain has been progressive on a daily basis to a point where), VERTIGO (Extremely potent vertigo, couldn't stand on my legs), MUSCLE SPASMS (looks like the muscle will become a cramp) and PYREXIA (slight fever 38.5C) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 208L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PYREXIA (slight fever 38.5C). On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on left arm, but nothing spectacular/ pain is getting stronger). On 11-Feb-2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (the pain has been progressive on a daily basis to a point where) and MUSCLE SPASMS (looks like the muscle will become a cramp). On 18-Feb-2021, the patient experienced VERTIGO (Extremely potent vertigo, couldn't stand on my legs). On 10-Feb-2021, PAIN IN EXTREMITY (pain on left arm, but nothing spectacular/ pain is getting stronger) had resolved. On 22-Feb-2021, VERTIGO (Extremely potent vertigo, couldn't stand on my legs) had resolved. At the time of the report, INJECTED LIMB MOBILITY DECREASED (the pain has been progressive on a daily basis to a point where), MUSCLE SPASMS (looks like the muscle will become a cramp) and PYREXIA (slight fever 38.5C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, Body temperature: 38.5 degree Celsius (abnormal) Slight fever of 38.5C.         Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to events were not applicable.
My adverse event started after receiving the 2nd dose. I never used to have this kind of cough but now I have it. Every 2 weeks I go to my doctor to see if we need to change medication. I took over the counter MUCINEX which helped but not much. I also stayed on my allergy medication it helped but it doesn't get rid of my cough. I tried all kinds of methods but nothing gets rid of my cough. The cough is severe. It's always there. My sleep is interrupted by cough.
The next day after vaccine on 04/13/2021 I was lethargic. I drank lots of liquids. I was very tired with a headache, nausea, chills (very slight). 04/15/2021 I woke up in the middle of night and it felt like the nerves in my body were exposed and the next day I didn't have that pain anymore but I was still very lethargic. Nausea went away pretty quickly. The 2nd week after vaccine, I had the same pain but in my upper thigh and wrist. The following week I ended up with shingles. I did go to the Doctor that diagnosed me with shingles. 2 weeks after I noticed a thick red band on my mouth towards my neck. I started on antiviral medications that the Doctor prescribed me.