chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inch diameter ring around my injection; FATIGUE /tiredness; headache; chills; chills like the flu.; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2020, the patient received the 1st dose of Shingrix. On 3rd October 2020, 1 days after receiving Shingrix, the patient experienced fatigue, headache, chills and flu like symptoms. On 8th October 2020, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown and the outcome of the fatigue, headache, chills and flu like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, fatigue, headache, chills and flu like symptoms to be related to Shingrix.  Additional details were provided as follows:  This case was reported by patient itself. The patient had bad headache fatigue tiredness and chills like the flu symptoms. At the time of reporting, the symptoms pretty much went away. The 4 inch diameter ring around injection site was very red.
I was seen for an irregular heartbeat. It turned out to be A-Fib with RVR. My resting heart rate was 190. I was hospitalized for the night for observation and it was confirmed that I was in a thyroid storm. After all of the testing it was confirmed also that I have Grave's disease.
10cmx11cm red, raised, hard warm area about immunization right thigh. Treated for cellulitis.
She had her vaccine at 10:30 a.m.  around 5 p.m. we noticed a few small red bumps on her left knee.  We thought at first they were mosquito bites.  We administered some Benadryl gel.  The next day around 6 p.m. she woke up from a long nap and noticed she had several raised bubbly itchy bumps on her hands, legs, and feet.  I immediately gave her one benadryl tablet.  After taking to the triage nurse around 7 p.m. I gave her another benadryl tablet plus two Advil Dual Action tablets.  She awoke the morning of June 8th and all the symptoms she had the earlier night were gone.
Miller-Fisher variant Guillain-Barre syndrome; rapid onset diagonal diplopia and gait instability, improved initially over 2 months then further worsening requiring IVIg treatment.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A little sore left shoulder injection site after 2nd booster) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 013F21A, 013F21A and 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Lumbar disc disease (spinal problem (Spaces between L3 and L4)). On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, the patient experienced VACCINATION SITE PAIN (A little sore left shoulder injection site after 2nd booster). At the time of the report, VACCINATION SITE PAIN (A little sore left shoulder injection site after 2nd booster) outcome was unknown. It was reported that patient receives Steroid injections from time to time for long time medical condition with his spine in the lumbar region. The shots did not make his pre-existing spinal problem worse. After the first dose, he did not have any side effects. Patient does not recall if any side effects after second dose. No treatment medications were reported. This case was linked to MOD-2022-553179 (Patient Link).
Fever 102, nausea, headaches, muscle pain, lightheaded, chills
Initial injection slight pain; I could not raise my left arm, very sore; I could not raise my left arm, very sore; my hearing felt like I was in a bubble, continued to walk slow to my car still felt like head in a bubble; feel slightly dizzy; This is a spontaneous report from a contactable consumer.   A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number ), dose 1 via an unspecified route of administration, administered in arm left on 12Feb2021 (Lot Number: EN6201) as single dose for covid-19 immunization.  Medical history included sulfa allergy (reported as sulfa based) from an unknown date and unknown if ongoing. Concomitant medications reported as in two weeks included unspecified allergy nasal spray. The patient previously took codeine and experienced allergy.  On 12Feb2021, at 13:00, the patient experienced initial injection slight pain; I could not raise my left arm, very sore; my hearing felt like I was in a bubble, continued to walk slow to my car still felt like head in a bubble; feel slightly dizzy. There were no treatments provided for the events, and no noted COVID testing post vaccination. The outcome of events was not recovered.
crohn's disease pain; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 25Mar2021 (Lot Number: ER8730) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The reporter stated that she and her spouse received the 1st dose of ther COVID-19 vaccine last 25Mar2021 and scheduled for the 2nd dose tomorrow 16Apr2021 (22 days apart). She was requesting to reschedule the 2nd dose on 20Apr2021 because she is currently experiencing Crohn's disease pain and can't drive. They have an appointment today for their second dose/second shot and they aren't going to be able to make it. She was wondering if there is anyway possible to reschedule the vaccine for tomorrow, Monday or Tuesday. Outcome of the event was unknown.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Chrons disease. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Lump under skin and pain in right shoulder at injection site.  Pain still persists and has become more intense.  Lump has become larger since 2/11/2011
Client recieved Pnuemovax 23 Rt arm on 10/27/2009 at 1035 am. reports that afternoon she began having arm discomfort and swelling at site of injection. Reports that she keep a cold compress on the site of injection site through out night. Presnted to clinic the following day- RN observed client gaurding rt arm, same arm appears swollen and warm to touch. Called clients MD - he is out of office today, and on call Dr. informed. Clinet choose to go to Hospital ER for treatment. Client called and states ER Dr. told her to take OTC pain medication, no other meds given.
pt recv vax 3MAR97 & 6MAR97 pt devel a red generalized rash w/approx 30 lesions on the trunk & sl itching;
Patient presents after falling in her shower. She has been having dark stools for a couple weeks and weakness and dizziness for a couple days. In the emergency room, she was found to have macrocytic anemia and thrombocytopenia. Treatments patient has received include steroids, rituximab, and eltrombopag
Did not feel good for a day; Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not feel good for a day) and VACCINATION SITE PAIN (Sore injection site arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  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, the patient experienced VACCINATION COMPLICATION (Did not feel good for a day) and VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION COMPLICATION (Did not feel good for a day) and VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.      No concomitant medication reported. No treatment information was provided. It was reported that the patient received the third dose full dose of the Moderna Covid-19 vaccine in early October.   This case was linked to MOD-2021-369081 (Patient Link).
Moderna vaccine.  A few weeks after the second vaccine the patient was diagnosed with DVT of the lower right leg.
I developed Tinnitus about 48 hours after the 2nd vaccination.  It started late in the day for a few days and then progressed to all day long.  It sounds like cicadas buzzing constantly.  It does not prevent me from going to sleep or wake me up at night, but I do hear it if I get up in the middle of the night.
04/18/2022 vaccination. 06/11/2022 I had a sore throat like a cold coming on. My husband tested COVID-19 5 days ahead of me. 06/12/2022 I tested COVID-19 positive. I got on a test to treat program; a clinic at a pharmacy. Didn't recommend unless I had more symptoms as I didn't have any other risk factors. I did not take the medication.
DEVELOPED URTICARIA/HIVES ON 4/30/10 AND WAS INTERMITTENT X 5 DAYS ON FACE, NECK AND ABDOMEN
rt upper arm erythematous, tender, swollen around inject site 3cm diameter, ant aspect upper arm 2x5 cm area of urticaria;
no adverse reaction, but patient was determined to have low varicella zoster titers and should have received the varicella vaccine, not the Shingrix
Chills, excessive fatigue, runny nose, scratchy throat, sore throat (09/02/12), nausea (intermittent), pain in chest when coughing.
life has spiraled out of control with Anxiety/morning had a terrible anxiety attack'; life has spiraled out of control with Depression; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (life has spiraled out of control with Anxiety/morning had a terrible anxiety attack') and DEPRESSION (life has spiraled out of control with Depression) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 025L20A and 025L20A) for COVID-19 vaccination.     Previously administered products included for Depression: Prozac. Past adverse reactions to the above products included No adverse drug reaction with Prozac.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, 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 experienced ANXIETY (life has spiraled out of control with Anxiety/morning had a terrible anxiety attack') and DEPRESSION (life has spiraled out of control with Depression). The patient was treated with DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) (oral) for Adverse event, at a dose of 100 milligram once a day; MIRTAZAPINE (oral) for Adverse event, at a dose of 7.5 milligram once a day and CLONAZEPAM (oral) for Adverse event, at a dose of .5 milligram three times a day. At the time of the report, ANXIETY (life has spiraled out of control with Anxiety/morning had a terrible anxiety attack') and DEPRESSION (life has spiraled out of control with Depression) outcome was unknown.            Patient was reported to take the treatment medications previously but had stopped taking it.
27 days after my first shot, I had a physical where routine blood work was ordered. I had my second dose of the Covid vaccine that same afternoon (4/19). Blood taken prior to my second shot showed my platelet count had dropped unexpectedly to 50,000. Further blood work was ordered, and on 7/2/2021 my platelet count dropped further to 24,000.  An immediate high dose of dexamethasone was prescribed, and an urgent referral to hematology was made. After the dexamethasone treatment, blood taken on 7/6 showed platelet count of 100,000 and a diagnosis of Immune thrombocytopenic purpura (ITP) was made. Bi-weekly blood draws beginning on 7/19 will track platelet counts for 2 months with a follow up appointment at hematology on 8/12/2021
This spontaneous report was received from a pharmacist refers to 61 year old female patient. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date and route was not reported). On an unspecified date, the patient complained of burning sensation and stinging. The outcome of the reported events were unknown. This is one of the 8 reports received from the same reporter. Additional information is not expected.
developed hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (developed hives) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-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. In July 2021, the patient experienced URTICARIA (developed hives). At the time of the report, URTICARIA (developed hives) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up information received contains non-significant information.
29 y/o female receives AVA # 2 on 30 Nov 2007 in preparation for upcoming deployment in Jan 2008. Member reports the developed of increased soreness in the right arm 2 days after vaccination receipt. The rash appears on day 3 after AVA vaccine receipt.
Left shoulder pain, started after PREVNAR 13, had not which resolved but pain in upper left arm persistent.
Foaming from the mouth and eyes rolling in the back of  her head.  The child had two seizures following the vaccination.
About 6 hours after immunizations were given, he became very lethargic and almost unresponsive.  This lasted about 4 hours.  No seizure activity noted by mother, although patient has a history of meningitis at 4 months of age.  After about 4 hours, he was acting fine.  Is fine today.  (He has not had seizures after 5 months of age and is off sz meds).
tired later in the day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired later in the day) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 FATIGUE (tired later in the day). At the time of the report, FATIGUE (tired later in the day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported. Treatment information was not reported.
Patient complaining of tingling to chest and neck, mild itching, tightness to throat with swallowing and sips of water, and dizziness at 10:15. Blood pressure was elevated. At 10:21, dexamethasone 4 mg was given by mouth. At 10:24, patient noted dizziness upon standing. At 10:53, patient was ambulating in the hallway without dizziness and left symptom free.
Patient received first Pfizer vaccine; while standing to schedule appointment for second dose, patient stated the following:  "I feel like I am going to faint."  Patient was guided to nearby chair and assisted to sit in an upright position.  She was vitalized and  found to be hypotensive and bradycardic.  Patient's other vitals were with normal limits.  Patient stated she have any food or water for most of the day.  After close monitoring for approximately 30 minutes she was given water and orange juice.  Patient's BP and HR normalized; she was monitored for an additional 15 minutes and left the Medical Center without accident or injury
Muscle aches, headaches, fatigue, chills, acute fever treated with Tylenol and Ibuprofen.
cellulitis in arm given an antibiotic and a steroid  right arm is swollen red and hot cause pain to chest back and i developed a lump in a armpit
Headache, sore throat, and mild fever (100) all began on Day 2 after vaccine was administer. By day 5 new symptoms presented with cough, stuffy nose,  and diarrhea.
The child experience the adverse event 5min after the shot was administered. He was unconscious for 30 seconds then woke up and was talking and breathing fine then all of a sudden he turned really pale and was warm. I immediately called 911 who instructed me on what to do. After ambulance came i was in the background to see if they needed anything. He was not taken to the ER but parents will call pediatrician to see if he needs to be seen.
Began with "tickling" in throat, severe coughing, dizziness, weakness followed, then went into an "asthmatic" type cough and airway exchange.
Note: intradermal flu vaccine given. Pain in injection arm and loss of mobility in at shoulder joint worsening with time up to and including today. Pain is deep in shoulder joint, not just surface/skin pain. I will now seek medical help.
Hives after ZOSTAVAX vaccination; persisting through present - 1/12/2009-, and worsening -more; more places on body-; effectively treated with non-prescription anti-histamine -daily dose ---but what have I done to myself?
Narrative: Per 1/11/22 note: Influenza vaccine is contraindicated: Severe allergic reaction (e.g. anaphylaxis)j to a vaccine component Comment: Patient stated that she had ANAPHYLAXIS REACTION to the flu vaccine This reaction occurred at another clinic. No other documentation available.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. It was reported that since 24-JUL-2014 the patients were vaccinated with the doses of improperly stored ROTATEQ (dose, route and lot number were not reported). No adverse effects were noted. No additional information was reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
ERROR in giving vaccination, wrong vaccination given. Should have given Meningococcal vaccine and not Hib (HbOC). No adverse reaction or symptoms as a result of wrong vaccine given.
Syncopal episode 2-5 minutes after administration of vaccine. Patient was sitting in chair, had brief episode of head dropping, eye twitching, head shaking and momentary loss of consciousness. Came to awareness within seconds then second similar episode occurred few minutes later. No incontinence. Appeared pale and drowsy immediately after event but became fully alert within minutes.
Swelling at injection site 48 hours after injection, site was painful to touch, swelling last about 3 days and after it went a away a know formed under the skin about 1 inch in diameter, it is still present 2 months after vaccination. There is also a "dip" in the muscle above the injection site
Information has been received from a certified medical assistant, for the GARDASIL a Pregnancy Registry, concerning a 14 year old female patient with no pertinent medical history and no drug reactions or allergies who on 02-FEB-2009 was vaccinated with the first dose of GARDASIL (lot # 661531/1311X). Concomitant therapy included HAVRIX. It was reported that the patient received her first dose of GARDASIL while pregnant. LMP was in January 2009, EDD was approximately 08-OCT-2009. The patient was seen at the physician's office for vomiting and feeling ill. Laboratory test performed on an unspecified date included urine pregnancy test. Patient's outcome for vomiting and feeling ill is unknown. Additional information has been requested.
Painful arm and entire side of body, leg hurt x 24 hrs. Hot flashes, tingling in arm, onset of palpitations. ? arrhythmia about 2 months post vaccine.
Started with a big ball under injection site. Then became bruised. Then the shoulder pain began. Its been hard to do normal activities and even lying on my right side was painful. 7 months later and I still have some residual issues from it.
HEADACHE & HTN REQUIRING EMERGENCY ROOM  VISIT AT APPROX 9PM, 5/26/21.  NEGATIVE CT OF BRAIN. UNKNOWN IF ANY TREATMENT WAS ADMINISTERED AT THE ER.  RESIDENT WAS RETURNED TO NURSING HOME  AT APPROX  1AM  ON 5/27/21  WITH NO DISTRESS NOTED.
A few weeks after the second dose I started to get headaches that were in the back of my head. Then I started to get them every other day. Sometimes they woke me up during that night. The headaches come out of nowhere and sometimes I wake up with a headache. I tried Tylenol and Ibuprofen and they did not work. The headaches got worse after I got the third dose of the vaccine. I was having headaches every day and the pain got worse. I went to the ER the third week in September and they did a CT scan but they didn't find anything. They have improved a little since then and they are not coming as often. I was given some medication but I have not tried it yet.
Pt experiencing sharp pain in the muscle w/ stretching movements. Started at onset of flu shot and has continued since.
two bumps on left hand side above breast plate; itching rash on right side of neck; rash around her breast plate; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (two bumps on left hand side above breast plate), PRURITUS (itching rash on right side of neck) and RASH (rash around her breast plate) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (to Prozac). Concomitant products included ARIPIPRAZOLE (ABILIFY), ATORVASTATIN, LISINOPRIL, OXYCODONE and DIAZEPAM (VALIUM) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST MASS (two bumps on left hand side above breast plate), PRURITUS (itching rash on right side of neck) and RASH (rash around her breast plate). At the time of the report, BREAST MASS (two bumps on left hand side above breast plate), PRURITUS (itching rash on right side of neck) and RASH (rash around her breast plate) 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.   Treatment included Cortisone Plus
Information has been received from a medical assistant on 02-JUL-2015 concerning a patient of an unknown age and gender. On 03-APR-2015, the patient was vaccinated with a dose RECOMBIVAX HB 0.5 ml, lot # K010535, (expiration date, route and site of administration were not reported) that underwent 72 hours temperature excursion outside of the recommended range. No adverse effects had been observed or reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient given wrong dose for age.   Inadvertent temperature excursion, vaccine was stored in freezer temperatures (-50° C to -15° C)   beyond the allowable two-week excursion then administered to patient.  No patient issue to report from vaccine.