chrisvoncsefalvay/vaers-outcomes huggingface dataset:
concern for injection to the subcutaneous tissue/concerned about improper administration/patient has a mark where you can see the vaccine and it's higher up where you expect it to be; induration at the injection site; felt induration was moving down his/her arm/can feel it migrated down her arm, 7 inches below injection site; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176), subcutaneous (reported as injection to the subcutaneous tissue to deltoid) on 09Jan2021 at 0.3 mL, single to prevent from getting COVID. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on Dec2020 for COVID-19 immunization. On 09Jan2021, within a couple hours after, the patient experienced induration at the injection site. The patient felt induration was moving down his/her arm with concern for injection to the subcutaneous tissue. The patient can feel it migrated down his/her arm, 7 inches below injection site. The reporter assessed that the causality was yes for the suspect drug and the patient was concerned about improper administration. The reporter was unsure if it is administration or vaccine, the patient has a mark where you can see the vaccine and it's higher up where you expect it to be. Outcome of the vaccination site induration and induration was not recovered. The events were considered medically significant by the reporter.; Sender's Comments: Based on the available information a causal relationship between reported events induration at the injection site / induration and incorrect route (subcutaneous) of BNT162B2 vaccine administration cannot be excluded. The case will be reevaluated should additional information become 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.
07/26/2005 Mother called PHN saying child had extensive swelling in left upper arm to shoulder.  Area was red and very warm to touch.  No fever.  This was 24 hours after shot was given.  Patient was seen by md and treated for infection with antibiotic - Keflex.
We got vaccinated and boosted; we recently tested positive for COVID; we recently tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "we recently tested positive for COVID"; IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "We got vaccinated and boosted". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive, notes: we recently tested positive for COVID. It was reported that reporter husband and patient have pre-existing conditions, so we have isolated and wear masks on the rare occasions we go out. We got vaccinated and boosted with Pfizer as soon as we were eligible. Despite our continued efforts to stay safe, we recently tested positive for COVID. Thanks to your company, our symptoms are manageable. We are so grateful to you and your scientists for coming up with this life-saving vaccine on such short notice. We are in deep gratitude to your company.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101874392 Same reporter/drug/event for different patients.
Patient reports sx of foul taste in mouth as well as a tingling sensation. This started after waiting for 15 minutes after the 2nd Moderna vaccine. Describes sensation as "feeling swollen" like "lidocaine". Tongue feels "thick". Sensations primarily ipsilateral from injection site (rt arm). Reports fever, body aches after prime dose starting approx. 16 hours after the inocculation.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information was provided. Beyond use date was reported as 17-Feb-2022. Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 days beyond use date. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up received: Patient information and vaccination details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
still got flu; Initial information was received on 26-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a patient  This case involves a patient with unknown demographics who still got flu after being vaccinated with Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient still got flu (influenza) (unknown latency) following the administration of Influenza vaccine.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.
Lingering, ongoing, and severe: Headaches, Brain Fog, Nausea, Fatigue
Patient has severe allergy to Latex. Men B (Bexsero) was administered in an error.  Patient called to ensure that she did not have any adverse reaction at 1:07 pm on 06/06/2023.  Pt denied any adverse reaction at the time of call.
pt recv vax & devel 8 or 9 chicken pox lesions;No further details were provided
Dtap was given to an 11 year old instead of Tdap. No adverse reaction has been reported.
After receiving her second vaccine shot, while in the observation area approximately 20 minutes after recieving the shot, patient became light headed and dizzy.  Firefighter / EMT  assessed vitals and reported that pt had high blood pressure and a rapid pulse.   Chief / Paramedic  spoke with pt also.  Based upon her continued symptoms and no resolution of the dizzy feeling, an ambulance was summoned and pt was moved to a less crowded location for further observation.  She walked with assistance to the kitchen in the fire station due to her dizziness.  Lt.  completed patient assessment while FF  gathered vitals. EMS personnel recorded that pt had no medical history, no medications, and was allergic to penicillin. Patient continued to feel cold and light headed.    Ambulance arrived and patient care was transferred to the medics.  Medics then transported the female to  hospital.
Metallic taste in mouth. Progressed to numbness of throat and tongue. No swelling. No rash. No shortness of breath. Remained alert and oriented and speaking full sentences throughout. Benadryl 25mg PO. EMS in to assess. 186/98, HR 94, SpO2 100% Remained onsite for extra 30 minutes. Patient refused transport to BMC for monitoring. Patient refused to be driven home. Throat/tongue numbness improved. BP before leaving 156/90, HR 82, SpO2 99%. Patient stated when she received Flu shot in early October this year, 2020, she had scratchy throat which resolved independently.
I had a very bad headache, sounds became muffled. When my headache started to recede that evening the ringing in my left ear got louder and louder. I already had tinnitus, but now it is much louder and makes it hard to sleep.
Pt states she had swelling in her throat, not her airway. No trouble breathing, no fever, no induration in vaccine administration areas (deltoid).
Sudden, intense itching of the front of neck and upper chest began 2 hours after receiving the vaccine. Treated with Benadryl and triamcinolone cream. The itching returned the next day and also included skin redness, warmth to the touch and skin feeling raw and sore.
No adverse event patient received adult dose of Pfizer vaccine of 0.3ml instead of 5-11 dose
Headache after 24HRs. Pain after 36 HRs COVID Arm  after 48 HRs (& Heating Pad!)
In the middle of the night patient experienced increased heart rate (>100bpm) and almost went to the ER.
Information has been received from a health professional concerning a 7 year old female pt who on 26Jun02 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approx 04May04, the pt developed breakthrough chickenpox with less than 50 lesions. Follow up information indicated that there was no a single report of adverse reaction following varicella vaccination. The reporter indicated that 49 other pt's developed breakthrough cases of chickenpox (WAES0404USA02615, WAES0405USA00572, WAES0405USA00573, WAES0405USA00574, WAES0405USA00575, WAES0405USA00576, WAES0405USA00577, WAES0405USA00578, WAES0405USA00579, WAES0405USA00580, WAES0405USA00581, WAES0405USA00582, WAES0405USA00583, WAES0405USA00584, WAES0405USA00585, WAES0405USA00586, WAES0405USA00587, WAES0405USA00588, WAES0405USA00589, WAES0405USA00590, WAES0405USA00591, WAES0405USA00593, WAES0405USA00594, WAES0405USA00595, WAES0405USA00596, WAES0405USA00597, WAES0405USA00598, WAES0405USA00599, WAES0405USA00600, WAES0405USA00601, WAES0405USA00602, WAES0405USA00603, WAES0405USA00604, WAES0405USA00605, WAES0405USA00606, WAES0405USA00607, WAES0405USA00608, WAES0405USA00609, WAES0405USA00610, WAES0405USA00611, WAES0405USA00612, WAES0405USA00613, WAES0405USA00614, WAES0405USA00615, WAES0405USA00616, WAES0405USA00617, WAES0405USA00618, WAES0405USA00619). No additional information is expected.
Recieved iMMuNiZatioN iN 12/16/19. Awoke on 12/17/198 at 3:00 AM with Headache, Nausea and Vomiting, and body aches. Right ARM was swolleN aNd hot, and had trouble lifting it. She went to her physician oN 12/17/19 at 6:30 pm. Was told to use a heating pad and Rest. Took off work 12/18/19
A report has been received from a Pharmacist concerning a 52 year old, male subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The reporter stated accidentally gave FLUMIST to a 52 year old patient which started on 09-Jan-2014. The reporter stated accidentally gave FLUMIST to a 52 year old patient is unknown. The report was considered to be non-serious by the reporter. Corrected report 22-Apr-2014: Coding of the event was corrected from wrong drug administered to drug administered to patient of inappropriate age. Narrative updated.
During the second vaccination I was on my period. After 3 hours of  getting the vaccine I started having large emotional spells. It made me start to have suicidal thoughts, a panic attack every other hour and overall get overwhelmed very quickly. The suicidal thoughts specifically started 6 hours after the vaccine and lasted through the whole night and day after receiving the vaccine. Thankfully I was able to reach out to other people in my support system, but I was not expecting to feel that way and get those thoughts and feelings right after receiving the shot.  I think that there should be more research done with females who are on their periods when getting the shot because I cannot be the only one who was affected by that factor.
Before DTaP 3 was given mom states child had bad reaction after the last shots. Mom also states that the child cried a lot for 2 days and had a high fever. Baby was very fussy throughout holidays. She called and talked to the doctor on call at that time.
Approximately a round red sore area at site injection about 2-3 inches in diameter.  Right axillary glands swollen and tender. for about a week after injection
After about 1 hr after vaccination dizziness and headache started and going on x1 week.
Awoken from sleep with rapid heart beat for sustained amount of time (average 109 over approximately 2 hours), dizziness, nausea, dehydration, headache, increased blood pressure.
Puritic rash with multiple sites of itching all over patient's body. Lasted for about 30 minutes after onset of symptoms. Given 50mg Benadryl after initial onset of itching & 125mg of Solu-Medrol 10 minutes later.
Information has been received from a registered nurse concerning multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On 05-AUG-2016 or 12-AUG-2016, the patients were vaccinated with doses of improperly stored VARIVAX (lot # L011084, expiration date 01-APR-2017; strength, dose, frequency and route were unknown). The vaccines were exposed to temperature excursion of -14.7 degree centigrade for 15 minutes; -13.0 degree centigrade for 15 minutes; -11.6 degree centigrade for 15 minutes; -10.2 degree centigrade for 15 minutes; -8.9 degrees centigrade for 15 minutes; -7.9 degree centigrade for 15 minutes; -6.7 degree centigrade for 15 minutes; -5.8 degree centigrade for 30 minutes; -9.8 degree centigrade for 15 minutes and -13.5 degree centigrade for 15 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Childs parents stated it started the day after vaccination 1/18/23 with a rash to L inner thigh and spread outward.  Childs developed small pimple like blisters with the rash. Parents stated child was taken to local ER on 1/19/23 where physician diagnosed child with chicken pox and provided treatment. Parents did state that they told the physician that the child recently received vaccines.
if the pain continues and gets worse, does she report that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "she has A-fib for years" (unspecified if ongoing), notes: she has A-fib for years. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "if the pain continues and gets worse, does she report that".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received 2nd dose of Pfizer on January 19, 2021.   3 days post vaccination (January 22, 2021) I developed right eye discomfort/irritation,  prickly sensations in throat.     On Jan 25, 2021 I developed tinnitus in right ear  which has still not resolved.     On January 30, 2021, went to ED with elevated BP 170/110, abdominal pain and tinnitus.    Had an abdominal  CT scan with contrast  which showed mesenteric inflammation (idiopathic etiology).   Was seen and evaluated by GI and had colonoscopy and endoscopy with no significant findings.    Took solu-medrol dose pack and abdominal pain symptoms  improved, but still not fully resolved.   On Feb 16 was seen by PCP for persisting, unilateral tinnitus.   Sent for MRI Brain which was normal .   Referred  for further evaluation by audiologist and otolaryngologist .  Was seen on  February 25, 2021 for right ear fullness, tinnitus.    Hearing test normal.   Diagnosed with right sided tinnitus.
Moderna COVID 19 Vaccine was administered to 8 patients after the beyond use date. Director of Clinical Services and Vaccine Coordinator are working with local DOH to reconcile the errors and provide appropriate follow upto affected patients.
Husband called on 9/10/14 at 1:44PM to notify us that his wife had a reaction to the flu shot a few hours after it was administered (approx. 3pm 9/9/14). She reports that she had some itching and today reports a mild puffy face. Pharmacist followed up with wife on 9/12/14 she reported that her symptoms have improved somewhat - at that time she had puffy dry red itchy face that goes down to her upper neck. She had been taking Benadryl on her own accord.
Started feeling cold symptoms and took the home COVID-19 test and was positive. This happened a week before a surgery, so it had to be postponed. Doctor prescribed Lagevrio.
I had Covid-19, I had a headache; body aches, wasn't feeling very good and I was very sick; I went to the doctor and he told me I have post Covid syndrome, I'm also very weak.
flu-like symptions (fever, muscle pain, headache, fatigue) and injection site pain.  Fever occurred during the night but went away in the morning (8 hrs).  Muscle pain about12 hours.  Headache about 3 hours.  Fatigue over 2 days.  Injection site pain 36 hours (decreased each day).  After injection, site ached constantly.  After 36 hours, only hurts if touched.  Took ibuprofen 200 mg twice a day over two days helped lessen symptoms.
Immunization 3/26/2021  COVID Vaccine Clinic Need for vaccination +1 more  Pt. who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 originally but ended up for 30 due to how she was feeling waiting period after the injection, the patient began to experience lightheadedness and nausea with brief "funny taste in mouth".  She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, facial swelling, lip swelling and tongue swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality  and rapid progression of symptoms.     ALLERGY REVIEW OF SYSTEMS:  Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, frequent throat clearing, eyes watering, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, itching of skin, vomiting, abdominal pain, muscle aches, joint pain, dizziness and headaches    + nausea:  + lightheaded:     Previous Reactions: none    Objective    Vitals Vitals:   03/26/21 1230 03/26/21 1330 BP: (!) 138/92 108/68 Pulse: 92   SpO2: 98%          Physical Exam Constitutional:      Appearance: She is not diaphoretic.     Comments: Flushed.   HENT:     Mouth/Throat:     Mouth: Mucous membranes are moist.     Pharynx: Oropharynx is clear.  Eyes:     Extraocular Movements: Extraocular movements intact.     Conjunctiva/sclera: Conjunctivae normal.     Pupils: Pupils are equal, round, and reactive to light.  Cardiovascular:     Rate and Rhythm: Regular rhythm. Tachycardia present.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal. No respiratory distress.     Breath sounds: Normal breath sounds. No wheezing.  Skin:    General: Skin is warm and dry.  Neurological:     General: No focal deficit present.     Mental Status: She is alert and oriented to person, place, and time.     Gait: Gait normal.  Psychiatric:        Mood and Affect: Mood is anxious.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.    Pt with int waves of nausea. Treated with pepcid and zofran x 1 with temporary relief.     1250 pt with emesis in bay, good amount   1252: pt given zofran and more ice packs.   1300: pepcid given again   1310: pt with emesis again.   Assessment/Plan  Treatment included: water and pepcid, zofran Follow up response to treatment Patient discharge: Transported to ED by ambulance.  Differential Diagnosis: Red flag symptoms (CP, SOB, NVD, Visual/Neuro concerns)   Pt unable to tolerate po fluids. Emesis frequency not changed. Discussed with patient about options, she wishes to be taken to ED via EMS  Husband and daughter will meet her there. ED manager updated.
pt recvd vax on 26AUG93 as a net pt/pt was in good hlth w/no complaints x/was behind on vax; mom called MD pt cried over 3 hrs & vomited 4 to 5 times;
Painful, swollen and purplish ankles, which I never have any other time, but the same thing happened after my second shot in April 2021. The swelling started 10 days after my second shot and again 13 days after my booster.
Pt vaccinated with Meruvax II developed hives, a rash covering whole body & dyspnea swollen throat, increased heart rate, itching. Treated w/Epinephrine, Benadryl.
Redness, swelling. induration, at injection site, elevated temp 100.5, sensorium effect, fatigue...for three to four days...site continued to become more red & swelling with itching ...2+ weeks ongoing....skin became flaky, at and slight small rash.
At the time of both shots I have to lay down with fatigue and extreme dry mouth excessive thirst.  My lumps on breast that have been presnet for years as my breast are dense became tender. Later present lump swelled and there was a new lump in the nipple that I saw my Dr. for in July 2021.
The day after I received the flu vaccine, I began having flu-like symptoms with bad headaches. The other symptoms disappeared after a few days, but I had a following 3.5 months of relentless headache thereafter.