chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt burn; pain; bruise; This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season).   On 14th September 2020, the patient received the 1st dose of Shingrix. On 14th September 2020, immediately after receiving Shingrix and not applicable after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced injection site bruising and pain. On 17th September 2020, the patient experienced injection site burning. On 17th September 2020, the outcome of the injection site bruising was recovered/resolved. On an unknown date, the outcome of the injection site burning was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site bruising, injection site burning and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was administrated 1st dose of Shingrix.  The vaccine was administrated on her left arm and she felt burn when the vaccine was injection. Then she felt pain and still having it. Three days after the administration bruise appear.  The same day the flu vaccine was administrated but in her right. arm.  The reporter did not consent to follow up.
I really did not experience many symptoms, maybe some fatigue. The reason I got tested was because my granddaughter had been visiting and she had a headache and fever. Husband took her home and I went and got tested. I tested positive, she tested positive, but my husband never did. They prescribed a steroid, a Z-pak, it was a virus but I took it anyway. I did also go and get the monoclonal antibodies at the local hospital clinic was where I got my COVID-19 test and was diagnosed. Nothing major. One thing that has been lingering since COVID-19 itself has been a chronic cough.
Vaccine was administered 1-8-16. Patient had redness and swelling. Blister formed at injection site 1/8/16. Patient broke out in rash and had fever on 1/13/16. Came to clinic on 1-15-16 w/rash and itching.
developed a knot in her left arm at the site of the injection and that arm is sore and red at the site; developed a knot in her left arm at the site of the injection and that arm is sore and red at the site; red at the site; Fever; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the parent.  A 2-year-old female patient received BNT162b2 (BNT162B2), on 22Jun2022 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in left arm for covid-19 immunization. The patient's relevant medical history included: "allergy to eggs" (ongoing), notes: diagnosed at age 6 or 7 months old. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 22Jun2022, outcome "recovering", described as "Fever"; VACCINATION SITE HAEMATOMA (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 22Jun2022, outcome "not recovered" and all described as "developed a knot in her left arm at the site of the injection and that arm is sore and red at the site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 22Jun2022, outcome "not recovered", described as "red at the site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Reporter stated that after her niece received the vaccine on 22Jun2022 she developed a knot in her left arm at the site of the injection and that arm was sore and red at the site. Stated that started later in the afternoon and was persisting. Stated that she also developed a fever of 102 degrees Fahrenheit last evening, 22Jun2022 around bedtime which was about 8:30pm. Caller stated the fever was improved but they are treating with Children's Tylenol. Stated at this time her sister feels it was not serious. Stated no change to dose at this time as they have not notified their physician.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Seriousness criteria: other - medically significant.  Initial non-serious report received from a consumer on 08 November 2007.  A male patient (age and date of birth not reported) had received a dose of flu vaccine (trade name, lot number, route/site of administration not reported) on an unspecified date in 2005 and developed a tingling sensation in the crown of his head, sometimes accompanied by headaches and dizziness (onset dates not reported).  No additional information was provided at the time of this report.  Follow-up information received on 04 December 2007 from the patient.  Following review of the reported events, this case was upgraded to serious.  An approximately 60-year-old male patient had received an injection of influenza vaccine, manufacturer not reported, lot number not reported, on an unspecified date in 2005.  The symptoms that the patient experienced lasted eight to nine months and had also included a numbness sensation in the crown of his head.  The patient recovered from the event.  Contact information was provided for the patient's personal physician.  The reporter of this case is the same as for cases 2007-03791 and 2007-03793 and involve the same patient who experienced events following influenza vaccination in 2006 and 2007.
Expired vaccine vial was stored in the refrigerator; No adverse event; They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May), PRODUCT STORAGE ERROR (Expired vaccine vial was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine vial was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May), PRODUCT STORAGE ERROR (Expired vaccine vial was stored in the refrigerator) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (They gave some Moderna vaccine on 12Jun2023 Monday, and they actually expired the end of May) and PRODUCT STORAGE ERROR (Expired vaccine vial was stored in the refrigerator).    The case was for Patient 4 out 12 patients.  No concomitant medications were reported.   It was reported that the vial size was 2.5 ml. On 12-Jun-2023, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. The reporter asked to escalate the case to Tier-2 for a lot analysis.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-729389 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2023: Live follow-up received, updated patient gender and suspect drug information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729389:Master case
anaphylactic reaction; Initial information received on 25-Oct-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a female patient (age unknown) who experienced anaphylactic reaction (anaphylactic reaction), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2012, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number and expiry date not reported via unknown route in unknown administration site.  On an unknown date, the patient experienced a serious anaphylactic reaction (anaphylactic reaction) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was anaphylactic reaction.   It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for anaphylactic reaction.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient who presented with anaphylactic reaction after vaccination with FLUZONE QUADRIVALENT. The time to onset is unknown. Moreover, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients (demographics unknown). Pertinent medical history, drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with PNEUMOVAX 23 (dose, lot and route were not reported) which was improperly stored outside the temperature stated in the prescribing information. No adverse reactions reported. This is one of multiple cases from the same reporter. Additional information is not expected.
10-10-14 TC from FNP reports client with erythema, whelp with bruising (L) deltoid down to antecubital space. Bruising may be related to MOTRIN. BACTRIM given to cover cellulitis. Pt to call her Monday 10-13-14. Also to use BENADRYL topical.
There was no adverse event, patient was not eligible to receive the vaccine based on her age.  Patient guardian signed consent the patient was at least 18 years of age, however date of birth did not indicate that patient met the age requirements.
Developed herpes zoster in a dermatomal distribution to right mandible. Saw general practitioner on 10/3/2016 and received Valtrex prescription
05/01/2021 Muscular Neuro Joint issue in my arm and throughout my arm and fingers. Also, had this occur later in my legs, neck and shoulders. In June Anaphylactic reaction to ant bite and an unknown bite that caused hives and swelling. Angioedema after second bite and had to quit my job because a trigger was temperature change (from outdoor heat to A/C indoor for example). July 12 had a visit with an Allergist who diagnosed my issue and was advised not do any allergy test. Oct 12 received a flu shot that triggered my angioedema.
heart attack after Moderna vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (heart attack after Moderna vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MYOCARDIAL INFARCTION (heart attack after Moderna vaccination) (seriousness criteria medically significant and life threatening). At the time of the report, MYOCARDIAL INFARCTION (heart attack after Moderna vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Tenderness noted at 0700 on 01/08/15 and then at 0700 on 01/09/15 area was noted to be swollen, red, and warm. Swelling noted to be 40 mm in diameter at 1430 on 01/09/15.
Initial On Call Documentation 2/5/21 at 20:36:  Patient called after-hours line with complaint of swollen tongue 5 hours after her second Covid vaccine.  She reported initial lip swelling with the first vaccine.  She took Benadryl when she had lip tingling initially this afternoon.  However, now she is noting indentations on her tongue.  Heart rate around 125. Patient with no previous history of allergy and anaphylaxis. No epi-pen in home. Patient is tearful over the phone requesting advice. Discussed with patient that the safest option would be for her to report to urgent care versus ED for further evaluation and potential management for impending anaphylaxis, especially given lack of EpiPen in the home.  Patient voiced understanding and is getting a ride to an urgent care.  Follow Up Message from Patient 2/8/21 at 11:23:  Update: I developed sudden swelling of my tongue on Friday night approx. 4 hours after receiving my second dose of the Moderna vaccine. I spoke to on call Dr. She advised me to go to urgent care if still open or ER. Throat started to tingle on the way their urgent care. I was given a dose of EpiPen, Pepcid, Benadryl, and Solu-Medrol. They wrote prescriptions and recommended following up with you this week. I've been taking prednisone, Benadryl, and Pepcid. Tongue is still a bit swollen, but it has not worsened. I now have two EpiPen's to use if needed.  Follow Up PCP Appt 2/11/21 at 15:46: S/O: Patient had the second COVID 19 vaccine on Friday 2/5 and she premedicated with 10mg of Pepcid 10mg and post medicated with Benadryl 25mg. Later that evening she was resting when she felt some swelling of her tongue.  She called the Dr who was on call and she was advised to go to the urgent care.  She felt some tingling of her throat on the way there.  She had no rash, difficulty breathing, or difficulty swallowing.  She was given Solu-Medrol, Benadryl and Pepcid IV and was given a dose of an Epi-pen.  She took Benadryl for 3 days.  She finished a round of 60mg daily prednisone (for 5 days) yesterday.  She felt jittery on the prednisone and this has persisted but is improving. She continues to have a feeling of chest pressure.  First dose Moderna 025J20A 1/8/21; second dose Moderna 031L20A 2/5/21.  She continues to note some mild swelling of her tongue but is otherwise improved.  She does continue to have some pressure type pain in her chest which is also somewhat improved and more diffuse in nature.  A/P: She is okay to taper off of her Benadryl.  She has an EpiPen should she need it, though I do not anticipate this being necessary.  She should note continued improvement in her symptoms to include the mild swelling that is persistent in her tongue.
Weak; white pus in eyes; disorientated; incoherent; immobile; symptoms lasted two days.
feeling cold; body aches; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling cold), PAIN (body aches), HEADACHE (headache) and PYREXIA (fever) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M020A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (feeling cold), PAIN (body aches), HEADACHE (headache) and PYREXIA (fever). At the time of the report, FEELING COLD (feeling cold), PAIN (body aches), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Tylenol. No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information, temporal association cannot be established between the use of mRNA-1273 and the onset of the events. Hence, causal association cannot be established.  However, fever and headache are consistent with the product safety profile.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on 08-JUN-2012 at a pharmacy, for routine health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. In approximately June 2012 [reported as shortly after receiving the ZOSTAVAX vaccine], the patient developed severe and painful itching on the left side of her chest and on her back. Thereafter, the patient presented to a physician and was diagnosed with shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events is unknown. Additional information has been requested.
Swelling, redness at injection site with red spots also occurring on legs within a few seconds. Red spots on legs generalized remained for about 3 minutes, then disappeared. NO swelling or redness ever noted on stomach, arms, face, only legs. NO breathing complications. Baby was not crying and showed no signs of distress.
Case number PHHY2011CA81189 is an initial spontaneous report received from a consumer on 09 Sep 2011. This case refers to a 52-year-old female patient. The patient got bitten by a rabbit and 20 days after she was vaccinated with RABAVERT vaccine (batch number: unknown). She did not receive RIG. Her white blood cell decreased in the last year (current value 3). She had blurred vision that varied to double vision and also had cataracts. She also experienced sore throat, fatigue and fever (value of 101). She was faint and dizzy on unspecified date. The patient was fit before but now she had difficulty coping with work and her condition declined over 1 year. She would be tested for lupus. Her glycaemia was ok. The event outcome was not reported.
Flu shot @ 4:00 - Coughing at 7:00 - difficulty breathing 7:45 - hoarseness, hives, weakness, dizziness, lips and  gums stinging - lips, eyes swollen
This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis in a adolescent patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis. On an unknown date, the patient received Tdap Vaccine at an unknown dose. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced rheumatoid arthritis (serious criteria GSK medically significant) and activities of daily living impaired. On an unknown date, the outcome of the rheumatoid arthritis and activities of daily living impaired were unknown. It was unknown if the reporter considered the rheumatoid arthritis and activities of daily living impaired to be related to Tdap Vaccine. Additional details were provided as follows: This case was reported by the reporter's nephew. The patient was went full blown after his 12 years booster. The patient's mother investigated and she realized that the patient was always having side effects from his vaccines. The patient was missed a whole year of school (had to be home schooled).
Upper left arm red and swollen at varicella vaccine site. 4 cm circular area of erythema, warmth, swollen and firm. Received varicella vaccine 4/21/10, started with symptoms 4/23/10.
Sudden onset of intense chills, low grade (100 degree) fever, body and persistent headache. Lasted for approximately 8 hours (2am to noon).
After covid second shot I had fever i took Tylenol, fever gone. 01/08/2021 I went to work. Next morning 01/09/2021 . I was stroked out taken to er.  Still I have weakness on left , hearing loss, loss taste, even I drink water taste bitter. Loss smell. I am doing physical and speech therapy.  Still not recovered.
Two months after receiving my final dose of Shingrix, I began have shingles outbreak approximately every month. I now have chronic recurring shingles.
the First Booster was given one day before the leway allowed from the CDC per Pfizer medical team THERE was NO adverse event from the early vaccination Call made Pfizer for recommendation, primary prescriber informed, patient informed, VAERS and error reporting system
Patient received the moderna covid vaccine on 4/6/21. Developed general malaise and fever 4/7/21 around 1pm.  Then developed acute sharp, pinching retrosternal, non-radiating chest pain at 9pm on 4/7/21.  Chest pain was intermittent and nocturnal. no relief with nitroglycerin.  He was admitted to the hospital 4/9/21 and started on colchicine 0.6 mg PO BID and indomethacin 50 mg PO TID  with improvement.  Troponins  trended down with significant symptomatic relief following anti-inflammatories. At follow up visit 3 days after discharge (4/15/21) , patient reported continued improvement, reporting sternal chest pain 1 out of 10 . Also reported dyspnea that has improved since discharge from hospital but still worse than baseline.
At first I started to feel tired and achy. A couple days later a cough came and fatigue got worse. It was mostly body aches, chills, sore throat, stuffy nose/congestion and a cough.  I got released to go back to work on Jan 26 and I worked all day and that night I woke up with serve shortness of breathe and a temp a 103. I went to the ER and had pneumonia. I tested positive on Jan.11 for Covid, I tested on Jan. 4 and it was negative. I still have not went back to work.
An incident occurred where a patient of 10 years old was given the Pfizer Bivalent booster approved for 12+. This occurred while the pharmacist was occupied with resolving a customer issue. The technicians were told prior to bring the forms to the pharmacist for final verification before allowing the student to administer the vaccine. However, the techs allowed the student to administer the shot before the pharmacist perform the final verification. The mother was notified of the incident after they had left the pharmacy when the incident was discovered during batching of the shots. The mother was told to watch out for any adverse effects and to notify their doctor if anything serious occurs. The mother thanked us for notifying  her of the incident.
Information has been received from a female patient who on an unspecified date received an "oral" dose of ZOSTAVAX and developed a metallic taste in her mouth after receiving the vaccine.  Medical attention sought and current patient status was not reported.  A product quality complaint was not reported.  Additional information has been requested.
At approximately 6 PM, on the evening of the fourth dose of Prevnar, the patient woke from a nap and he was febrile. He experienced a two minute general tonic clonic seizure. He was well and acting normal the following day. He experienced his first febrile seizure February 2006.