chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain/ she suffered some localized reactions. The area was painful and swollen.; swollen/ she suffered some localized reactions. The area was painful and swollen.; This case was reported by a nurse via call center representative and described the occurrence of pain localized in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced pain localized and local swelling. On an unknown date, the outcome of the pain localized and local swelling were recovered/resolved.   It was unknown if the reporter considered the pain localized and local swelling to be related to Shingrix.  Additional details were reported as follows: The case was reported by the nurse who reported herself. The patient stated that after her 1st dose of Shingrix, she suffered some localized reactions. The area was painful and swollen.  The reporter did not consent to follow up. This case has been linked with US2020AMR074123, reported by same reporter.
reported slight fever x 24hrs only; The dose the patient received however was of an undiluted product; The dose the patient received however was of an undiluted product; This is a spontaneous report from a contactable registered nurse.(Other HCP) from medical information team.  A 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported),  intramuscular, administered in deltoid right, administration  on 11Nov2021 as Dose 2, Single (at the age of 18-year-old) for covid-19 immunization. Relevant medical history included: "Prosthetic valve functioning normally", start date: 24Nov2015 (ongoing), notes: Patient Medical History (including any illness at time of vaccination):, Illness/AE: Prosthetic valve functioning normally, Onset date: placed 24Nov2015 , 18Oct2021, stop date: Ongoing. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Pfizer/BioNtech COVID-19 Vaccine Details:, Dose: 1st, Date: 18Oct2021, Time (24hr): Approx. 16:40 , Anatomical site of Location:  Right deltoid, Batch/Lot number: 30145BA, Route of administration: Intramuscular, Illness/AE: Tetralogy of Fallot, Onset date: 18Oct2021, stop date: Ongoing checked), administration date: 18Oct2021, when the patient was 18 years old, for Covid-19 immunization, reaction(s): "Tetralogy of Fallot", "Prosthetic valve functioning normally". The reported stated that the patient that received his 2nd dose of the Pfizer COVID 19 Vaccine yesterday (11Nov2021) and was of an undiluted dose of the vaccine and they wanted to know what to do next or what guidance Pfizer may have pertaining to this situation. The patient was monitored in clinic for 30 minutes post administration and no adverse reactions were reported that the reporter was aware of at this time. They haven't reached out to the patient yet, but he was fine that they knew of, but they're in the process of reporting this and they need to know what they need to do and when they need to do it if anything should be done differently. She said that she needs to know how much she should freak out right now. No investigation assessment was reported. The events that are reported as OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 11Nov2021 16:42, outcome "unknown" and all described as "The dose the patient received however was of an undiluted product"; PYREXIA (non-serious), outcome "recovered", described as "reported slight fever x 24hrs only".  Follow up(18Nov2021): Additional Information:Patient provided information regarding the adverse event(s) with the use of the product: Yes, There is no causal effect to the adverse effect. Patient did not take any vaccine prior vaccination (within 4 weeks). Patient concomitant drug therapy was none. Patient Family medical history relevant to AE was none. Specific Relevant Test for thromboembolic events with thrombocytopenia was None  Follow-up attempts are completed. No further information is expected.
Significant pain in the area, worse with flexion of his shoulder x 2 weeks. This is concerning for "SIRVA" or shoulder injury related to vaccine administration or an adverse reaction related to the vaccine. Pain following TdaP is not uncommon but this is prolonged.
This was my daughter's 2nd dose of the vaccine.  After she got up on the morning of the 12th, I heard her in the shower and went to check on her.  Her face looked gray and she said that she needed to sit down.  After sitting for a bit, she was able to stand up, but then proceeded to fall forward, as if she were passing out.  I was able to steady her and sat her back down.  Her eyes looked like they were staring off into space.  She said that she couldn't see me and everything was "purple and yellow."  This lasted a few minutes and then I was able to get her out of the shower and dressed.  She then began to regain some normalcy and was fine after that.  She ate breakfast and rested.  She didn't have any more episodes after that, but I could tell that she wasn't as perky that day.  This episode was definitely not normal for my daughter, so I felt that I should report it.
Patient filled out paperwork to receive MODERNA Covid-19 Vaccine. Once in vaccination room patient confirmed all information with pharmacist. Pharmacist prepped deltoid (right) for vaccine administration, applied alcohol, put on protective band-aid and injected needle into skin. Before pharmacist could inject the dose, patient pulled pack. Pharmacist discarded unused vaccine and needle into sharps. Patient asked pharmacist what that was and pharmacist confirmed moderna vaccine. Patient said he did not want it and tried to grab vaccine card. Pharmacist took vaccine card away from patient and explained he needed the dose in order to have card. Patient claimed he had recovered from COVID-19 2 days prior and did not want to get vaccine. PATIENT REQUESTED CARD FOR TRAVEL AND PHARMACIST DECLINED. Patient left
Information was received on 29-AUG-2017 via phone call from a healthcare worker and medical assistant who reported that multiple unspecified patients received improperly stored doses of RECOMBIVAX HB (unspecified lot#/expiration date) or VAQTA (unspecified lot#/expiration date) on "either yesterday or today". Temperature was -5C for a time frame of 24 hours. No previous temperature excursion. Call was because of a "data logger". No further information to report as the call was disconnected and an outbound call was made to the office however a voicemail was reached. No adverse effect reported. No further information was provided. Additional information has been requested.
1 week after Pfizer 4th dose developed a flat purpuric rash on bilateral legs. No pain. No signs of systemic involvement. No definite treatment.
achy; Feeling unwell; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), MALAISE (Feeling unwell) and PYREXIA (Fever) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy), MALAISE (Feeling unwell) and PYREXIA (Fever). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN (achy), MALAISE (Feeling unwell) and PYREXIA (Fever) outcome was unknown. Unknown    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7 (High) Body temperature-high.         No concomitant medications were provided.   Treatment with Aspirin was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
A report has been received from a Health Professional concerning a 53 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on 02-Nov-2013. The reporter stated that there was FLUMIST QUADRIVALENT administration to individual over the age of 49 which started on 02-Nov-2013. The outcome of the event of administration to individual over the age of 49 is unknown. The report was considered to be non-serious by the reporter.
Hospitalization for COVID PNA 1/9/22-1/14/22. Treated with dexamethasone, Remdesivir, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily.
Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna; Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna) and MYALGIA (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 MASS (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna) and MYALGIA (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna). At the time of the report, MASS (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna) and MYALGIA (Im I suppose to still the knot/soreness in my are 3 months after receiving the moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.
almost died from mine , never; Initial information received on 02-Feb-2022 regarding an unsolicited valid Social Media serious case was received from a consumer/non-hcp (non health care professional) via social media.  This case involves an unknown age and unknown gender patient who almost died from the vaccine while receiving vaccine 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 (lot number and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination. Information on batch number was requested.  It was reported that on an unknown date the patient almost died from the vaccine, never (near death experience) (unknown latency) following the administration of influenza vaccine. This event was assessed as medically significant.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (almost died from mine, never).  At time of reporting, the outcome was Unknown for the event (almost died from mine, never).; Sender's Comments: Sanofi company comment dated 07-Feb-2022: This case concerns a patient of unknown age and gender who had almost died after vaccination with vaccine Influenza Vaccine. A significant temporal relationship cannot be established due to lack of information on event onset date and product start date and hence, causal role of suspect vaccine cannot be excluded in occurrence of the event. Further information such as condition at the time of vaccination, medical history and concomitants would be needed to rule out alternative etiologies. Based on the reported information, the role of an individual vaccine cannot be assessed.
Pt recv vax on 10/13/98; on 10/21/98 pt exp red, raised rash over body & fever (103) x 1.5 day
Doing well, Please see his hospital discharge summary from 7/5-18 where had an admission for intermittent vomiting. He developed persistent vomiting and had an upper GI that showed reflux, but no pyloric stenosis. He also had an ultrasound that was negative. When his vomiting became more pronounced in the hospital he began to look ill, developed respiratory distress, transferred to the pediatric ICU where they diagnosed an aspiration pneumonia. He also had fine motor tremors consistent with a hyponatremia seizure. Sodium was 118. That was correct with IV fluids, hypertonic saline. He had a negative sweat chloride in the hospital. Serum amino acids showed an elevated glycine. Dr was consulted apparently remotely and she felt that that was not of concern particularly, but recommended a better screening profile would be the AC carotene profile. That is pending today. Dr of pediatric GI consulted and placed the child on Prevacid. They'll follow up with him. Mom says that he's stooling six times a day, soft, for the last few days. He's eating well. He's sleeping well. He is on an apnea monitor. Lowest weight in the hospital 7lb 2 oz. Pulse 160, resp 32 wt 8lb 2ox, room air O2 sat 97%, temp axillary 98.0. General alert no distress. He attends to mom and talks to her. He looks quite healthy, well hydrated. Physical examination is unremarkable, as documented on the encounter form.
My son was supposed to have recieved injectable H1N1 and seasonal mist, but was instead given injectable H1N1 and H1N1 mist at the same time in error.  The clinic caught the error within a couple hours of administration and then notified us.  My son has since developed hoarseness, fever and cough, which the doctor's office feels is merely a coincidence.
This event occurred in the patient's home. At 15 minutes post vaccination, the patient reported dizziness. At this point, we had the patient drink some juice, water, and eat a banana, then lay down with legs elevated above heart. Patient had not eaten anything prior to receiving the vaccine. After about 5 minutes, the patient reported no improvement in dizziness and starting have chills. Vital signs (blood pressure and pulse) were stable throughout. No thermometer was present to check temperature. After another 15 minutes with no improvement, patient had more juice. Around 45 minutes post vaccination, the patient began to experience improvement in his dizziness and after 60 minutes, the dizziness resolved with only mild chills remaining.
Pt c/o of vertigo, weakness, nausea, Bp 108/60; P88.  Placed in supine position with BLE elevated.  Fine generalized tremors.  Vertigo worsened; c/o of headache and generalized tingling of body.  Skin remained warm, dry and color good.
4cm indurated area rt deltoid;vaccine left @ room temp 48-72hr prior to receipt of vax by nurse;
muscle weakness, side effects; tiredness; general malaise; This case was reported by a consumer via call center representative and described the occurrence of muscle weakness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle weakness, tiredness and general malaise. On an unknown date, the outcome of the muscle weakness, tiredness and general malaise were not recovered/not resolved.   It was unknown if the reporter considered the muscle weakness, tiredness and general malaise to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-JAN-2023 Reporter's Comment: The case was reported by the patient. The patient had been given Shingrix and had been experiencing muscle weakness, tiredness and general malaise. The reporter wanted to know how long it would take for these side effects to end. Additional Supportive Information: As the future vaccination date was reported so it was not captured and clarification was raised for the same.
Inflammation causing tendinitis in both arms on both sides of the arm (tennis and golfer's elbow) to flare up painfully, the pain was not present prior to the inflammation
Mostly Reactogenicity post Vax2; Burning eyes; Moderate pain at IP site; Pyrexia; Moderate muscle pain; Moderate headache; Runny Nose; Moderate Chills; first dose on 02Mar2021 and 2nd dose on 19Mar2021; This is a spontaneous report from a contactable consumer (parent). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: ER2613 and expiration date: not reported), via an unspecified route of administration, on 19Mar2021 (at the age of 56-year-old) as DOSE 2, SINGLE for covid-19 immunization.  Medical history included type 2 diabetes mellitus, hypertension, and deep vein thrombosis. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6205 and expiration date: not reported), on 02Mar2021 (at the age of 56-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 19Mar2021, the patient was mostly reactogenicity post vax2, experienced Moderate pain at IP site, Pyrexia, Moderate muscle pain, Moderate headache, Runny Nose and Moderate Chills. No treatment was received for the adverse events.  The outcome of the events was not recovered at time of report.  No follow-up attempts are needed. No further information is expected.
Mild rash and hives that started on both forearms and progressed to trunk and down both legs over course of 10 days. Treated herself with 12.5mg of Benadryl without relief. Advised to see own physician and take 25-50mg. Benadryl Q6H.
Pt recvd vax & 23 hrs p/3rd dose became acutely ill & was in bed for days w/ a t103, chills, weakness; pitting edema, arthralgia-type sx, loss of appetite, jaundice, loss of energy, pt states MD had dx serum sickness;
Information has been received from a pharmacist concerning a 71 year old male patient. The patient's pertinent medical history was not informed. Concurrent conditions included hypothyroidism, chronic obstructive pulmonary disease (COPD) and diabetes. Concomitant therapies included levothyroxine, tamsulosin, montelukast (manufacturer unknown), paroxetine, glipizide, lorazepam (ATIVAN), albuterol sulfate, ipratropium bromide (DUONEB), fluticasone propionate, salmeterol xinafoate (ADVAIR), brimonidine and loxatine. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiration date were not reported), administered per subcutaneous route to prevent shingles. On an unspecified date in the summer of 2016, the patient developed shingles. On an unknown date, during the summer of 2016 the patient recovered. Then, on 25-JAN-2017, the patient received another dose of ZOSTAVAX lot # L046896, expiration date 23-FEB-2017. The causal relationship between shingles and ZOSTAVAX was not reported. No product quality complaint (PQC) was involved. Additional information has been requested.
I had a mouth ulcer a day after vaccine, It stayed a day or 2. I went to see my doctor, which he prescribed me some Valtrex.  It took at least 3 weeks until I seen a difference.
ABD pain  Narrative:  Patient received 2nd dose COVID vaccine. Patient states "My chest  hurts" points to left side of substernal area and reports pain . States he feels "that  someone is punching me in my chest." Patient also complains of abdominal pain.  Denies SOB, N/V, dizziness, no radiating pain. States pain is a 6 on scale of 1-10,  BP 145/68, HR -75, RR - 18, 94% on room air. Rapid response team called;  patient escorted to ER Dept. by team staff.
Headache lump in throat, difficulty swallowing Narrative: Patient reported with a lump in the throat and difficulty swallowing. EPI administered
swelling starting 8 days later and continuing two weeks; Lymph nodes under arm and near breast, swelling starting; burning in arm immediately after injection; This is a spontaneous report from a contactable consumer (patient). A 66-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9263), via unspecified route of administration on 28Jan2021 at 1:00 PM (at the age of 66-years-old) in left arm at a single dose for covid-19 immunisation. No Other Vaccination within 4 weeks. The patient medical history included hashimoto's disease. The patient had known allergies with morphin based drugs. Concomitant medication patient had in two weeks included thyroid medication. The patient experienced burning in arm immediately after injection. Lymph nodes under arm and near breast, swelling starting 8 days later and continuing two weeks on 04Feb2021 at 08:00 AM. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the events was not recovered. .
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Fever-Medium, Systemic: Headache-Severe, Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Partial Left Bundle Branch Blockage. Swelling of extremeties, chest pain, hot spots on legs
About 10 days after the vaccine, leg started hurting. After a week of pain, went to doctor and was diagnosed with a blood clot via ultrasound.
Itchiness, redness, discomfort at the site of injection and noticed a small skin blister at there too. Pt denied fever, chills, generalized skin rash, nausea, vomiting, headache, SOB after flu shot. Pt never receive flu shot and this is her first time getting flu shot.
Dizziness, Headache, Myalgia, Arthralgia, Fever, Tachycardia, cough;fatigue Narrative:  1000 12/29 dry cough, extremely achy joint pain, fever <100 degrees Farenheit, tachycardia 120-130, headache, dizziness, and fatigue. 12/30 symptoms subsided approximately 1200 12/30
Employee came back to the flu clinic to show me her rash that she had, which was hives. She was itching all over and while we were talking I notice she was clearing her throat and she was hoarse. I immediately took her to the ER with acute allergic reaction.
Patient was given the wrong vaccine for her age.  She was given the Pfizer 5-11 year old vaccine instead of the 12 and up vaccine.   After contacting the DH and patients primary care provider no additional vaccine was given.
Reported by mother.  Awoke in morning following receipt of H1N1 vaccination with a shooting pain in her leg.  Soon a blotchy, red itchy rash developed all over the child's body.  The child's physician was consulted by phone.  The child was treated with over-the-counter Benadryl every four hours, with gradual resolution of symptoms over the course of four days.  Has had influenza vaccinations previously without trouble.