chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very mild rash and self limited; This case was reported by a physician via call center representative and described the occurrence of rash in a 64-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2E3EH, expiry date 31st October 2021) for prophylaxis.   On 27th January 2020, the patient received Boostrix. On an unknown date, less than 9 months after receiving Boostrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Boostrix.  Additional details were provided as follows:  The patient received Boostrix and might had a very mild rash and self limited earlier this year and reporter asked would be able to receive Shingrix.  The HCP reported this would be 1st dose of Shingrix in case patient receives it and was not sure if the rash could be related to any vaccination. The reporter consented to follow up. All patient identifiers were provided as well as Batch Number and Expiration Date.  No further clarifications made.
Patient was given an extra dose of Menquadfi. Pt was originally scheduled to receive Bexsero second dose. Pt completed their series with Menquadfi. No reaction after vaccination and followed up with pt's parent and states that they are good. Spoke with vaccine manufacturer and states that there is no harm to patient in receiving an extra dose.
Pt admitted to hospital on 2/12 with covid and pt died on 2/18
Administered  above vaccine past the 75days of storage in the frig to 25 days past BUD. I'm calling all 55 patients to let them know their options.
Clammy; Within 18 minutes, temperature of 99.9; BP 188/82 and as high as 196/88; Odd/metallic taste in throat; Flush; This is a spontaneous report from a non-contactable consumer. This 67-year-old female (Non pregnant) consumer reported for herself that patient received second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number: unknown Expiry date: unknown), via an unspecified route of administration in left arm on 03Feb2021 at 10:00 AM, and first dose BNT162B2 (Pfizer covid 19 vaccine solution for injection, Batch/Lot number: unknown Expiry date: unknown) via an unspecified route of administration on unspecified date both as a single dose for COVID-19 immunization. Patient medical history included hypopituitarism, coronary artery disease. Patient other concomitant medication included in two weeks toprolol, amlodipine, levothyroxine, hydrocortizo. Patient had known allergies to 2 shingles vaccine. Patient has not taken any medications within four weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient experienced within 18 minutes after the vaccination temperature was of 99.9, BP 188/82 and as high as 196/88, odd/metallic taste in throat, flush, clammy on 03Feb2021 at 10:30 AM. No therapeutic measures were taken for the events occurred. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
MD working in Urgent Care clinic called re: 44 yo male who received primary SPV 13 Oct 2018 in right arm. Patient also received IIV, and ViCPS, in left arm the same day. Patient presented today (11 days after vaccination) with swelling and redness at the SPV site, swollen axillary lymph nodes, fatigue, and mild body aches. No fever, no chest pain, no SOB, no GI or other sxms. At the end of day, patient reported that vaccine site has actually improved throughout today, as he has had the opportunity to leave it more open with breathable dressing. He continues to report no fever, no chest pain, and -- other than fatigue -- no systemic sxms. Dr called CDC and they suggested considering antibiotics and calling. Symptoms: OTHER ERYTHEMATOUS CONDITIONS(L53), LOCALIZED ENLARGED LYMPH NODES(R590), OTHER FATIGUE (R5383), OTHER MALAISE (R5381), MYALGIA(M). Pt seen at Medical Center. Discharged same day.
diarrhea; cannot sleep; really bad headache; chills; running a "slow-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), INSOMNIA (cannot sleep), HEADACHE (really bad headache), CHILLS (chills) and PYREXIA (running a "slow-grade fever) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (diarrhea), INSOMNIA (cannot sleep), HEADACHE (really bad headache), CHILLS (chills) and PYREXIA (running a "slow-grade fever). At the time of the report, DIARRHOEA (diarrhea), INSOMNIA (cannot sleep), HEADACHE (really bad headache), CHILLS (chills) and PYREXIA (running a "slow-grade fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. Patient concurrent conditions and medical history were not reported. On 26-MAR-2014 the patient was vaccinated with PNEUMOVAX lot # J014401 (Expiry: 26-NOV-2014) (also reported as lot check was requested) by intramuscular route (dose and frequency was not reported). On an unknown date in March 2014 patient experienced severe redness and swelling at the injection site where the PNEUMOVAX was injected. Patient had difficulty in lifting the arm that had received PNEUMOVAX injection. The patient visited physician (reporter also mentioned 3 patients received PNEUMOVAX from same lot# and an unspecified patient among 3 visited an unspecified emergency room). Reporter was not sure whether patient received treatment with either DECADRON or SOLU-MEDROL. The outcome of the event was reported as recovering. The reporter did not provide the causality between event and the suspect drug. Additional information has been requested. This is one of several reports from same reporter and case is linked to same reporter link of case 1403USA014602, 1404USA001442.
Presented to ED w c/o fever; admitted for acute resp failure d/t COVID-19 pna; tx w/abx, remdesivir, Vit C, steroids, melatonin, zinc, O2. Weaned to RA for dc.
I experienced severe pain under my right armpit down to my fingers on the 05/19/2020 and I went to go see my surgeon on the 05/25/2020. He did an examination and felt that I may have Lymphatic cording which caused him to send me to imaging to get an ultrasound to make sure there were no masses or tumors. He sent me to Lymphedema physical therapy to have an assessment for what was causing the severe pain under my right armpit. The pain has subsided but I still have slight pain from my right armpit down to my fingers which sometimes become numb.
Difficulty breathing (intermittent 10/6/2021-10/13/2021), Rapid heat rate (10/8/2021-10/13/2021),  Intermittent dizziness/weakness (10/7/2021-10/13/2021), Tingling, numbness in right non-injected arm/hand (injection received in left arm); Chills (10/6/2021), Migraines (10/6/2021-10/8/2021); "chest felt full" 10/14/2021 , Nose bleeds (10/7/2021), fatigue.
nausea; diarrhea; headache; dizziness; fatigue; I've been sleeping a lot / she is really tired, she is falling asleep all the time; feeling bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6206) dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: NAUSEA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "nausea"; DIARRHOEA (non-serious) with onset 05Mar2021, outcome "not recovered", described as "diarrhea"; HEADACHE (non-serious) with onset 05Mar2021, outcome "not recovered", described as "headache"; DIZZINESS (non-serious) with onset 05Mar2021, outcome "not recovered", described as "dizziness"; FATIGUE (non-serious) with onset 05Mar2021, outcome "unknown", described as "fatigue"; SOMNOLENCE (non-serious) with onset 05Mar2021, outcome "unknown", described as "I've been sleeping a lot / she is really tired, she is falling asleep all the time"; FEELING ABNORMAL (non-serious) with onset 05Mar2021, outcome "unknown", described as "feeling bad".  No follow-up attempts are possible. No further information is expected.
Patient received the Moderna vaccine that was out of the fridge for 25 hours.  Patient has not reported any symptoms  on follow up on 5/13/2021.
Pt. suffered a vasovagal response within about 2 minutes after recieving vaccine. Pt reported feeling faint and her skin color turned pale. BP Was 70/41, was layed supine in the observation area. 2nd Blood pressure was obtained once Pt. was laying down 110/70, After about 2 minutes of waiting she sat up in observation and another BP Reading was obtained 120/80 and she was placed back into a seated position, Pt reported feeling better, however we did observe her for a full 30 minutes to ensure no other reaction was noted. Final Blood pressure at discharge of  care was 121/85 Pt. reported feeling good, Pt was given ER Instructions if anything got worse.
Swollen lymph node in left armpit for ten (10) hours. Painful to the touch and with arm movement, felt like a Charlie horse. About the size of a chicken egg. No treatment given. Swelling subsided in late morning. Arm soreness persisted for two more days (through 16 JAN).
pt recv vax & devel an inj site rxn characterized by swelling & pain;3 days p/vax the swelling extended almost to the elbow, & the pt bicep was inflamed;
This spontaneous report was received from a physician referring to a 14 year old female patient. Concurrent conditions or pertinent medical history were not reported. On unknown dates, the patient received her 3 doses of GARDASIL (lot numbers, expiration dates, doses, routes of administration and frequency were unspecified), and was stated that she received one of the doses at the age of 12 years (unspecified dose number on approximately in 2013). However, her pediatrician vaccinated her with the first dose of GARDASIL 9 (lot#, dose, route and frequency were unspecified) in August 2015. No adverse effects were reported. No product quality complaint was involved. Additional information is not expected since the reporter did not want to be contacted.
Pt received 1st dose of Moderna vaccine and was in post observation. Per RN Staff to this writer: Pt c/o dizzy, agitated, not wanting to sit. translator located explained that he should lie down and relax. Given 2 juice boxes and water. He felt well and left with 2 of his friends. Vitals taken listed below.   VS  at 0925 BP 120/70 HR 97 O2 sat 100% on RA
Pt recvd Hep B vax on 9APR92 & on 10APR92 devel flu-like illness & general malaise which persisted 3 wks; No further details were reported;
Right L2 dermatome shingles 24-48 hours after second covid vaccination received on 2/9/2021.
Information has been received from a 73 year old female consumer with penicillin allergy and no pertinent medical history who on 22-APR-2008 was vaccinated with zoster vaccine live (Oka/Merck) (lot # 659614/0161X). Concomitant therapy included VOLTAREN, atenolol and glucosamine. Subsequently, on 23-APR-2008 the patient developed redness, swelling, itching, and a 4 inch hard lump at the injection site on the back surface of her arm after receiving a singe dose of the vaccine. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report the patient was recovering. There was no quality complaint involved. Additional information has been requested.
Pt developed fulminant myocarditis. No other etiology other than recent booster vaccine has been identified. Appears to be improving at this time but is still requiring inotropic support and is intubated
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 14-OCT-2015, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # K019502 with expiration date 14-FEB-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Cellulitis right thigh from DTaP site-warm 6x5cm erythematous even R Thigh for two days following injection. Slightly tender.
3/18/2021 3pm started with fatigue, 6pm slight nausea, stiff neck and shoulders, 7pm chills and body aches, 10pm nausea gone, other symptoms still present and headache started.  All of 3/19/2021 fatigue, body aches, head ache, chills on and off. All of 3/20/2021 fatigue, body aches and headache. All of 3/21/2021 until about 8pm fatigue, headache. Soreness at the injection site was mild from about 1pm 3/18/2021 to present 3/24/2021.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: pt stated "im going to pass out" rn help her to floor she recovered immediatly. gave water and candy.  pt forgot to mention and document history of passing out or black out after immunization.  pt is fine and doing well
Swollen up lip; Very light chest tightening; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the left arm on 18Mar2021 at 14:00, (at age of 41-year-old) as a single dose for COVID-19 immunisation. The patient medical history included high blood pressure and pulmonary hypertension due to left heart disease. The patient was allergic to garlic. Concomitant medication included Atorvastatin (MANUFACTURER UNKNOWN), Lisinopril (MANUFACTURER UNKNOWN), vitamin-D (MANUFACTURER UNKNOWN), Iron (MANUFACTURER UNKNOWN), and Q10 for an unspecified indication from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 14:00, patient experienced swollen up lip for 10 mins and very light chest tightening. The patient did not receive any treatment for the events. The clinical outcome of the event swollen up lip recovered on 18Mar2021 14:10 and the event very light chest tightening was recovered on an unspecified date in Mar2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist concerning a male patient who was vaccinated in the arm with a dose of pneumococcal vaccine 23 polyvalent.  Concomitant vaccination on the same day included a dose of influenza virus vaccine in the other arm.  Subsequently, the patient developed an injection site reaction that included itching, swelling and redness on the underside of the arm that was injected with pneumococcal vaccine 23 polyvalent.  Additional information has been requested.
On 6/1/01, the pt received the MMR, Prevnar #3 and a PPD and on 6/13/01, the pt was seen in the ER for a febrile seizure.
No additional adverse effect reported; patient was administered an expired dose of GARDASIL 9; This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and previous reactions or allergies were not reported.  On 21-JUL-2020, the patient was administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # N023952, expiration date 12-JUL-2020, for prophylaxis (dose and route of administration were not reported). No additional adverse effect reported.
left sore arm; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to case 2020SA006336.  This case involves an elderly female patient who experienced left sore arm (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, concomitant,  medical treatment, vaccination and family history were not provided.   On an unknown date in 2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, (lot number not reported, of unknown Expiration date, via unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious left sore arm (pain in extremity) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory data was not provided.  Final diagnosis was pain.   It was not reported if the patient received any corrective treatment.  The patient recovered after 1 day.  Information on the batch number is requested.
EMT Called took blood pressure (120/70) and counseled patient to stay seated for 10- 30 minutes.  Paramedics reassured patient that it as more so a fear of needles then allergic reaction.  Pt was pale, sweaty, heart rate monitor stated that pulse was falling to approximately 46.   Person accompanying patient said that patient fainted while seated.
Pt presented to clinic on 09/20/2010 with cellulitis at injection site, characterized by left arm & axilla pain w/ shoulder pain & redness at injection site (measuring approx 10cm in diameter around injection site); fever of 101F; chills; body aches. Treated with Keflex 500mg PO TID x 5 days.
Child found unresponsive at 6:30 am on 1/13/2018, transported to ER via rescue squad, failed CPR, pronounced dead in ER. Mother last saw him alive at 1:30 am on 1/13/2018. Found unresponsive. This occurred several hours. Pt's parents found patient (3moM unresponsive at approx 630 am. Last seen at 130am. Arrives in full arrest with CPR in progress. Pt is cyanotic, unresponsive. No lividity but stiffness noted. Cool to touch, emesis noted. Pink froth noted in OP. Emesis pink indicating recent tx w/ PO TYLENOL (confirmed by Mother). Pt saw PCP earlier in the day for routine vaccinations. No sx/sx of acute allergic/hypersensitivity rxn. The patient was found unresponsive. Down time before CPR (Unknown - likely hours given hx.). Paramedics findings: The patient was apneic and pulseless. Prehospital treatment: Compressions performed.
This spontaneous report as received from a healthcare worker refers to an unspecified amount of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of VARIVAX (Merck) (strength, dose, route and lot# unknown) injection, which underwent multiple temperature excursions. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Day 8, post smallpox vaccination: "felt very bad... no appetite.  Also c/o mild night sweats.  On day 12, the day Specialist corresponded with me, he claimed to have had body aches for 3 days ("more like joint pain"), no muscle aches or headache... "Just pain and stiffness in my distal joints. Both ankles and feet, both wrists. Right wrist is very bad. It's only been bad for a couple of days.... Yesterday morning, and this morning [January 28, 2003] they're real bad. It's not the cold weather. It's all-day. They're stiff and very sore when I move them. Like the tendons are inflexible. It'll probably go away in a couple of days, so I'm not going to sick-call or anything. I'm taking ibuprofen with some relief."  Patient was seen in ER on Jan 29, diagnosed with Atypical Pneumonia (told it could be Bronchitis)...  received 3 days home in bed.  All symptoms resolved within 2 or 3 weeks.
She said the child is doing fine. No additional AE reported.; HCP reported that a 15 month old child was administered a dose of PNEUMOV AX 23 in error.; This spontaneous report has been received from a medical assistance, concerning to 15-month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 12-APR-2021, the patient was vaccinated in error with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (product administered to patient of inappropriate age) (lot number T033369 has been verified to be a valid lot number and expiration date.) as prophylaxis (dose, dose number, vaccination scheme frequency, route of administration, and anatomical location of vaccination were not reported). No additional adverse events (AE) reported (no adverse event).
This spontaneous report as received from a pharmacist refers to an approximately 65 year old male patient with codeine allergy. The patient's medical history included shingles. On 08-OCT-2013, the patient was vaccinated with ZOSTAVAX (lot # J001004, expiration date 24-APR-2014, 0.65 ml, subcutaneous. Concomitant therapies were reported as none. In October 2013, the patient developed shingles. The patient told the pharmacist he believes he was already in the beginning stages of a shingles episode at the time of administration because he already had 2 preexisting "spots" on his stomach when he received ZOSTAVAX. These two spots had developed shortly before receiving vaccination with ZOSTAVAX. The patient sought medical attention (office visit). No lab diagnostics studies were performed. The patient received treatment with VALTREX and gabapentin. The outcome of the event was reported as recovering. Additional information has been requested.
memory loss; fog; administration date: 09Jul2021, dose number: 2/prev dose administration date: 03May2021, prev dose dose number: 1; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Jul2021 as dose 2, single (Lot number: Ew0196) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma; "known allergies: Seafood" (unspecified if ongoing), notes: known allergies: Seafood; "known allergies: tomato" (unspecified if ongoing), notes: known allergies: tomato. There were no concomitant medications. Past drug history included: Reglan, reaction(s): "known allergies: regland", notes: known allergies: regland. Vaccination history included: BNT162b2 (Dose lot number: Ew017, Dose number: 1, Vaccine location: Left arm), administration date: 03May2021, when the patient was 27-year-old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 09Jul2021, outcome "unknown", described as "administration date: 09Jul2021, dose number: 2/prev dose administration date: 03May2021, prev dose dose number: 1"; FEELING ABNORMAL (non-serious) with onset 18Nov2021, outcome "not recovered", described as "fog"; AMNESIA (non-serious) with onset 18Nov2021, outcome "not recovered", described as "memory loss". Therapeutic measures were not taken as a result of amnesia, feeling abnormal.  Additional information: Prior to the vaccine, patient a sharp memory. Since the vaccine she has been experiencing memory loss and fog. Patient did not take other vaccine in four weeks. Patient did not have Covid prior vaccination. Patient not tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Chills & fever with swelling at site & pain (R) deltoid. Throbbing in the arm, feels weakness in arm. Started 3-4 hrs after the injection. Pt use heat = told to stop heat & use ice, BENADRYL. Pt requested report be submitted.