chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mild rash on the hands; Headache; Administered the full regimen of Vivotif while the vaccine was stored at room temperature; A spontaneous report was received from pharmacist on 05JUL2023 regarding 24-year-old female patient who "administered the full regimen of Vivotif while the vaccine was stored at room temperature" (PT: Product storage error) and experienced "mild rash on the hands" (PT: Rash), and "headache" (PT: Headache). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003907) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient administered the full regimen of Vivotif while the vaccine was stored at a temperature of 75 degrees Fahrenheit (F) for a duration of seven days. The patient administered the fourth dose of Vivotif on 03JUL2023 and developed mild rash on the hands and headache. Reportedly, the patient took Benadryl and Claritin for the rash.  The outcome of the event "administered the full regimen of Vivotif while the vaccine was stored at room temperature" was not applicable and for the event's "headache" and "mild rash on the hands" it was unknown.  The action taken with Vivotif with respect to the reported events was not applicable.   No additional information was reported.  Company comment: It was reported that a patient received Vivotif and he developed a "mild rash on the hands" (rash), and headache after the fourth dose. Considering the case information, the role of Vivotif cannot be ruled out and the causality of rash and headache is assessed as possible. Furthermore, the patient had administered the full regimen of Vivotif while the vaccine was stored at room temperature (product storage error). The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient received Vivotif and he developed a "mild rash on the hands" (rash), and headache after the fourth dose. Considering the case information, the role of Vivotif cannot be ruled out and the causality of rash and headache is assessed as possible. Furthermore, the patient had administered the full regimen of Vivotif while the vaccine was stored at room temperature (product storage error). The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Indurated warm, 4 cm erythematous area with blanched area.  Painful with moderate pressure.  Surrounding area is pruritic.  Afebrile.
warm injection site; swelling injection site; redness injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE WARMTH (warm injection site), INJECTION SITE SWELLING (swelling injection site) and INJECTION SITE ERYTHEMA (redness injection site) in a patient of an unknown age and gender 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 INJECTION SITE WARMTH (warm injection site), INJECTION SITE SWELLING (swelling injection site) and INJECTION SITE ERYTHEMA (redness injection site). At the time of the report, INJECTION SITE WARMTH (warm injection site), INJECTION SITE SWELLING (swelling injection site) and INJECTION SITE ERYTHEMA (redness injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
anaphylactic--started with mild itching, progressed to throat tightness--patient was given IV Benadryl, Pepcid, Solu-Cortef, Epi-pen x 2, oxygen
Tired; This is a spontaneous report from a contactable Nurse.   A 17-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA; NDC: 0005-0100-01, Lot: S58896, Expiry: 31Aug2019) at single dose on 26Jul2018 via intramuscular route at the right deltoid. Relevant medical history included penicillin allergy in 2006. Concomitant medications were not reported. On unknown date the patient experienced tired feeling.   Information on the batch number has been requested.
muscle aches; Fatigue; This is a spontaneous report from a contactable consumer (patient himself). A 54-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EL3302), via an unspecified route of administration in left arm on 21Jan2021 07:30 at SINGLE DOSE for Covid-19 immunisation. Medical history included hypertension, obesity and had PCN Allergy.  The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included carvedilol (COREG), testosterone, valsartan, fexofenadine hydrochloride (ALLEGRA). The patient experienced muscle aches and fatigue on 22Jan2021. No treatment for the events. The outcome of event was recovering.
Patient suffered a severe asthma attack the day after flu shot. Causing him to enter asthmaticus and respiratory failure and was intubated, during this period of respiratory failure he didn't receive oxygen and has hypoxic brain injury. Patient is a 5 year old male with a past medical history of severe asthma. Recently, patient suffered a severe asthma attack causing him to enter status asthmaticus and respiratory failure. Patient was intubated and spent a day in our Pediatric ICU before being able to transfer into our Pediatric Intermediate Care Unit and finally to General Pediatrics. During patient's period of respiratory failure, he did not receive sufficient oxygen to his brain for a sustained period which resulted in a diffuse hypoxic brain injury as evidenced by MRI and EEGs. This has left patient with severe physical and cognitive impairments. Patient is currently working very hard with therapy to regain his normal function but at present is confined to a wheelchair for an unknown amount of time until able to safely bear weight. Patient's family is unable to provide handicapped accessible transportation on this short notice and is requesting assistance in getting transportation to patient's several follow up appointments as they have spoken to staff. We are requesting handicapped-accessible transportation to patient's medical and therapy follow up appointments.
I tested positive for Covid 19 on September 27, 2022 and I experienced sore throat, fever, coughing, and congestion also a fever of 102.7. I was prescribed Paxlovid for my symptoms. I also was taking Advil as well which helped reduce my  fever.
Mild flu like symptoms first 24 hours, soreness and swelling at injection site.  On third day started experiencing moderate to severe heart palpitations.  Heart rate monitor showed 111 bpm while resting, fluctuating, but staying above 89.  Baseline is around 60 - 65 bpm resting.  the increased heart rate and palpitations continued night and day, restlessness and sleeplessness occurred as a result.   Dizziness and mental fog, loss of ability to concentrate and focus.   I have a heavy feeling in my chest that has not subsided.  breathlessness and chronic fatigue.    It has been almost 7 weeks and palpitations are still occurring though less frequent, occasionally moderate to severe.    My energy level has not returned to normal, I still have a heavy weight on my chest.  My focus and ability to concentrate have not returned.    I have had to undergo a dye contrast CT scan to rule out pulmonary embolism and EKG.  Both presented within normal limits; however with the continuing symptoms I have grave concerns for my health.
High fever (103) that would not come down with Advil or Tylenol, VERY fatigued, just felt like garbage,  missed several days of work, injection site got very red and warm. Went to see Dr. Diagnosed him with cellulitis and gave him an Rx of Augmentin. Went to fill it at the same pharmacy that he had the injection and they refused to write it up or document it in any way. Staph infection requiring antibiotics is NOT a side affect of the Shingrix vaccine but she would not take responsibility for what happened to my husband. Cellulitis can be deadly.
Moderna COVID-19 Vaccine EUA  Lip Swelling Started on April 8th 2021 at 9 PM. Itchy and swollen lips. Visited urgent care based on recommendation from primary care doctor. On medication right now for 5 days.   Other symptoms: Headache chills Sore arm Heavy eyes
This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (the patient). A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blood pressure shot sky high when he got the vaccine on an unspecified date. The outcome of the event was unknown.
As of the second day after the shot, I am experiencing vertigo symptoms.  Lightheaded when standing quickly, head feels like its "swimming" when I am walking around, balance is off, feels as though the room may start spinning at any moment.  Never felt like this before in my life.
After a day patient feels pain in the area of the vaccine in the right arm, also redness, warmth, and swelling. Symptoms consist with description of COVID arm.
Left leg 4" diameter erythema with minimal edema feels hot.  Suggested TYLENOL every 4 hours prn & cold compresses.  Mom does not want to use BENADRYL or other antihistamine because she reacts to them.
Information was received from a physician referring to a 21 years old female patient who was not pregnant. The patient had no pertinent medical history or drug reaction/allergies. Concomitant therapy included MACROBID. On 22-AUG-2016, the patient received her first dose of GARDASIL injection (lot # K016966, expiration date 10-MAY-2017, dose unknown) intramuscularly. On 25-AUG-2016, patient developed hives all over her body. On 26-AUG-2016, the patient went to an unspecified urgent care facility and was prescribed prednisone (manufacturer unknown) and BENADRYL there. No lab diagnosis was performed. On 30-AUG-2016, the patient returned to the physician's office for evaluation, and patient reported to the physician that the hives were getting worse. No additional treatment was prescribed. At the time of this report, the patient had not recovered from the event. The causality assessment between the event and GARDASIL was not reported. Additional information has been requested.
Shoulder Injury Related to Vaccine Administration. Continuous pain in left shoulder upon movement. Achiness when still. Throbbing and stiffness upon waking.
Baby received vaccines 11a-PREVNAR, PENTACEL, Rotavirus at routine WCE. At approx 4 pm, mom who is also a physician noted baby was gray, pale and listless and belly seemed tense. She was brought to office and baby was pale, listless, screamed when not held for approximately 1hr and then improved, transported to hospital for observation with full recovery.
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Feb-2021 at 11:14 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 11:51 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 59.03 and 59.10. Concomitant products were not provided. On 27-Feb-2021, Excursion time was 09 AM, 11 AM, 12 PM, 1 PM, 2 PM, 3 PM, 4 PM, 5 PM, temperature was 33, 35, 35, 35, 35, 34, 34, 35, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 27-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 35, total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 3 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. Vial was stored on cooler 1, on 27-Feb-2021, Excursion duration at 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34, 5 PM: 35. Vial was stored on cooler 1, on 27-Mar-2021, Excursion duration at 8 AM: 48, 9 AM: 35, 10 AM: 35, 11 AM: 38, 12 AM: 43, 1PM: 41, 2 PM: 41, 3 PM: 41, 4 PM: 40. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Pharmacist calling to report multiple patients, a total of 70, were given PROQUAD that had been stored outside of recommended storage range with a non supported disclaimer; No additional Adverse Event details; This spontaneous report was received from a pharmacist regarding to a patient of an unknown age and gender.   The pertinent medical history, medical history, previous drug reactions or allergies were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT).   On an unknown date, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, lot number U029147 with expiration date: 16-MAR-2023, indicated as prophylaxis (dose and route of administration were not provided). (Product storage error).    The administered dose of the vaccine experienced a temperature excursion of  menus 58 Degree Fahrenheit to 5 Degree Fahrenheit with average of menus 7 Degrees Fahrenheit for 2 hours and below menus 59 Degrees Fahrenheit with average of -65.2 Degrees Fahrenheit for 46 hours. Pharmacist would like to know when the patient could be re-vaccinated.   No additional adverse events (AE) reported.  This is one case of the several cases received from same reporter.; Sender's Comments:  US-009507513-2204USA006370: US-009507513-2204USA006506: US-009507513-2204USA006513:
Welting on shoulder and face; itching of mouth; Really bad rash all over face and the arm she got the vacicne/rash on left side of face; rash on left side of face; Really bad rash all over face and the arm she got the vacicne; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welting on shoulder and face), ORAL PRURITUS (itching of mouth), RASH (Really bad rash all over face and the arm she got the vacicne/rash on left side of face), RASH (rash on left side of face) and VACCINATION SITE RASH (Really bad rash all over face and the arm she got the vacicne) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) and MONTELUKAST SODIUM (SINGULAIR) for Asthma, RIZATRIPTAN BENZOATE (MAXALT) for Migraine.    On 19-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 URTICARIA (Welting on shoulder and face), ORAL PRURITUS (itching of mouth), RASH (Really bad rash all over face and the arm she got the vacicne/rash on left side of face), RASH (rash on left side of face) and VACCINATION SITE RASH (Really bad rash all over face and the arm she got the vacicne). The patient was treated with PREDNISONE at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; EPINEPHRINE (EPIPEN) at a dose of 1 dosage form and METHYLPREDNISOLONE (MEDROL DOSEPAK) at a dose of 1 dosage form. On 24-Mar-2021, URTICARIA (Welting on shoulder and face), ORAL PRURITUS (itching of mouth), RASH (Really bad rash all over face and the arm she got the vacicne/rash on left side of face) and RASH (rash on left side of face) had resolved. At the time of the report, VACCINATION SITE RASH (Really bad rash all over face and the arm she got the vacicne) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up received on 09-APR-2021.Reporter details was reported. Patient DOB, gender, age was updated.Patient medical history was reported.Lot number and Concomitant medication , treatment medication was reported. Events was reported. Outcome was reported.
Left Arm Single Lymph node pain /swelling/hardening  in axilla on same side of Vaccine site.
Chills, Fever, Headache, Joint Pain, Muscle Aches, Nausea, Intestinal Cramping, Fatigue.
several episodes of high pitch crying lasting approx 10 mins; inconsolably crying for 6hr w/brief quiet periods;low grade temp;non aspirin product given q 4 hr
Information has been received from a consumer concerning her 4.5 year old daughter with no medical history and drug allergies who at 15 months of age was vaccinated with the first dose of MMR II a couple days later experienced high fever and a rash.  On an unspecified date the patient was recovered.  Additional information has been requested.
This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender. On 22-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J003483; expiration date 29-JUN-2014), 0.65 ml, subcutaneous. The pharmacist reported that she administered dose of ZOSTAVAX (that was not supported in a temperature excursion) to a patient. No adverse effects were reported. Additional information is not expected.
Itching at site of injection; became a slightly raised, reddened area, ~ 1" wide x 3" long.  Somewhat rash-like. At 10 days, redness and area size diminishing but still itchy. No medical consult pursued.
Pt vaccinated with DTP/OPV experienced high pitched cry after vaccination lasted 2hrs, temp 103. F/U  "high pitched cry, 103 T, fussy, treated /w Tylenol
Afterward, severe pain working up (area of injection) then chills, fever, sweating 24-36 hours. As of 72 hours later there still is a large red welt approximately 7 inches surrounding the site. Severe pain in armpit and numbness of area near shot
Dad checked on child during night since he was crying Mom noted mucous on mouth, baby was sweating and not making eye contact. Mom stated he looked like a drunk person. took child to er. DX with febrile seizure temp 102.9
Customer reported numbness and tingling in her left arm after receiving  the vaccine on 9/7/22.  The  numbness and tingling was more prominent after several weeks after receiving the Shingrix vaccine.  It has subsided but not completely gone.   Customer stated that she's afraid to get her second series of the vaccine.   She reported that her doctor has ruled out any heart issues based on tests.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: 2 days post vaccine sore welt on arm at injection site. 5 days after shot ring shaped rash at site and spread out. 7 days post vaccine hives on left arm. 8 days post vaccine hives on right arm. still has hives 17 days later, and is experincing itching on both arms
headache runny nose Nausea severe muscle aches fever 102 degrees chills muscle fatigue shortness of breath cough congestion
A serious report of sleep apnea and pneumonia has been received from a study investigator concerning a four-year-old female participating in a post-marketing study for FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history and concomitant medications were not reported. On 04-Nov-2008, the subject received FLUMIST. The subject was admitted to the hospital for sleep apnea and pneumonia on 04-Dec-2008. The length of stay was three days. The outcome of the events was not reported. The investigator assessed the causality for the events to FLUMIST as not related. The severity of the events was moderate. The sponsor also assessed the causality for the events as not related to FLUMIST.
Patient noticed some swelling and pain at the injection site after vaccination but 2 months after vaccination has a bump still at the injection site and when goes to raise their arm, notice a nerve type burning sensation when raising their arm.  This does not happen all the time but is debilitating when it does happen.  Just happens in the vaccination arm.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 15-OCT-2014, the patient was vaccinated with ROTATEQ oral (dose, strength, lot number and expiration date were not reported). Physician reported that on 15-OCT-2014 a patient was administered ROTATEQ which underwent a supported temperature excursion. No adverse effects reported. Additional information has been requested.
Hospitalized with a TIA (transischemic attack) slurred speach, cognitive abilities effected, left-sided weakness
15 - 20 minutes post vax while at home pt complained of SOB, itching, tight throat. Brought back to office, pulse ox 92-93. Given epinepherine and her pulse ox increased.
Patient came to the pharmacy on 6/22/21 stated she had a red rash all over her body and on her face and head. She stated it started 4 days after she received her vaccine. She stated she was using OTC meds to help with rash. I informed her that if it doesnt go away by next week to follow up with a physician.