chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and an a Medical Assistance referring to three patients of unknown age and unknown gender. The patient's concurrent conditions and medical history were not reported. On an unknown date the patients were vaccinated with a dose of ROTATEQ (lot # L035276: expiration date: 09-JUN-2017), oral (dose was not provided). Concomitant therapy included M-M-R II (Lot No: L024268; expiration date: 01-JUL-2017). The physician reported that the patients received improperly stored ROTATEQ. The vaccine was improperly stored for a time frame of 17.5 hours. There was not previous temperature excursion. No adverse effects were reported. The M-M-R II remained in recommended storage range. This is one of several reports from the same source. Additional information has been requested.
On 25JAN92 pt returned to center c/o pain & tenderness lt deltoid since recvd TTOX vax 26DEC91; 3cm soft, tender swelling, sl warm to touch;
Information has been received from a 63 year old female consumer with no known allergies or pertinent medical history who, "three weeks ago", on approximately 28-JUN-2007, was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included furosemide, metoprolol, ELMIRON, PROTONIX, simvastatin (manufacturer unknown), etodolac and DEMEROL.  Subsequently the patient reported "becoming very itchy all over her body" a few days after receiving the vaccination.  There was no visible rash.  Unspecified medical attention was sought.  The patient reported ineffective therapy to ease the itching with hydroxyzine HCl and hydrocortisone cream.  There were no lab studies performed.  No further information was provided.  There was no product quality complaint involved.  Follow up Information from the patient indicated that she was still in "excruciating pain" and has severe itching and severe "needle-like" pain all over her body, from her head to her toes.  She said she has a history of rheumatoid arthritis and fibromyalgia.  She tried taking prednisone, but it did not help at all.  No further information was provided.  Additional information from the physician indicated that the patient has also had sweats and insomnia for weeks. The patient was given ZYRTEC, DECADRON, MEDROL, TAGAMET, SARNA, TOPICORT, hydrocortisone cream 2.5%, CETAPHIL and calamine (+) camphor (+) diphonhydramine hydrochloride as well as ice packs and vinegar. The patient was seen by urgent care, dermatology and internal medicine physicians. Multiple lab studies were performaed. Abnormal labs included RDW was 15.3%, calcium was 10.6 mg/dl, parathyroid hormone 86 pg/ml, and estimated CPR of 53 ml/min. All other labs performed were within normal limits. There was no illness at the time of vaccination. At the time of this report the patient had not recovered. The patient had no adverse events following prior vaccination . No further information was provided. Follow-up information was received from the physician which indicated that the patient had been seen in the doctors office on 29-AUG-2007 when symptoms has subsided. The physician reported that there were no significant signs on exam. No additional information is expected.
Fatigue-January 10-12. Low fever (99-100)-January 10-11. Injection site soreness--ongoing.
pt recvd vax & 24 hrs later exp pruritus; progressed w/erythematous plaque over upper arm for 3-5 days; seen by MD,, 55 x 65mm erythematous plaque w/warmth;
This spontaneous report was received from a registered nurse regarding two pediatrics patients of unknown age and gender. Pertinent medical history, drug reaction/allergies were not provided. On an unknown date, on approximately June 2013, "recently", patients received a first dose of VAQTA, (Lot number and expiration date were not provided). Co-suspect therapy and concomitant medication were not provided. On an unspecified date, a second dose of VAQTA was recently administered at a 5 month interval from the first dose. No adverse effects were reported. Additional information has been requested.
Severe body aches, chills, high fever over 102, headache, throwing up, extreme tiredness, chest congestion, and a cough. Took advil to lessen fever. The body aches, chills, fever lasted around 3 days. The throwing up and headache lasted 1 day. The tiredness, chest congestion and cough have lasted 2 weeks.
Two days after receiving the second dose I woke up with a very painful shoulder and upper back, but only on the right side. That developed into back spasms lasting more than 24 hours. The pain caused throughout the injection site, shoulder and upper back was so severe I couldn't type or answer calls at work without shooting pain. The spasms and pain caused me to not be able to sleep and even driving is painful.
Hives (or urticaria) all over the body and extremely uncomfortable itching including sking being warped upon scratching along with headaches and dizziness
Right thigh, swelling, pain, 3 hours after vaccine. No, At and around injection site. When cradled face down not improved.
Fever for 9 day then two days after broke out in a rash. Also has cough, runny nose. Was given prednisone in the ED.
Information has been received from a physician via Pfizer referring to a 65 years old patient of unknown gender. Medical history of the patient was not reported. In 2014 ("last year"), the patient was vaccinated with PNEUMOVAX 23 (lot#, route and dose not reported). It was reported the patient had swelling, redness and discomfort upon PNEUMOVAX 23 "last year" (in 2014). The outcome of the events was unknown. The reporter asked if it is recommended the patient should have a PREVNAR 13, or would that be also a problem for adverse reaction. Additional information has been requested. This is a corrected report. The Aware Date for the initial version should have been 03-JUL-2015 instead of 06-JUL-2015; therefore, MARRS # 1507USA003280 will be deleted from our database and replaced with MARRA # 1507USA011492.
No other adverse events; PROQUAD was administered after the excursion occurred; This non-valid spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 23-MAR-2021 the patient was vaccinated with incorrectly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 ml, lot # T029103 with expiration date on 23-FEB-2022, therapy type rHA (route of administration was unknown) for prophylaxis. The vaccine underwent a temperature excursion of 6 degrees Fahrenheit for 1 hour and 54 degrees Fahrenheit for 50 minutes. No adverse event was reported. Digital data logger was not involved.
Following vax pt devel t104 & was taken to ER on 20MAY91 @ 10PM; Given APAP & was told to give APAP q4hrs during nite & next day; mom states was ok p/that;
9-26-20 Redness, swelling to entire left thigh 9-26-20 Itching and Drainage
Diarrhea for 7 days, stomach felt awful but never vomited - 3 to 4 days of feeling awful and low grade fever - headache as well.
10/13/15 Immunization given about 4:28 pm. 10/15/15 9:58 am patients daughter called and said patient was experiencing pain and stiffness from injection site of left deltoid up shoulder to back of neck. Pt applied ice and had taken ALEVE and at afternoon was not getting worse and doing better. At 8:00 pm patients daughter said patient was feeling better.
the day after vaccination, I had a recurrence of severe pain in my left knee (arthritis) and both shins and calves (myopathy).  In the past I have managed my arthritis and myopathy through stretching, exercise and weight management. I had no pain prior to the injection for many many months. I could not exercise for several weeks because of the pain. Given the severity of the pain and the fact I had not experienced it for several months prior to the injection, I strongly believe the reaction was caused by the vaccine (Pfizer).
S: Adverse reaction following administration of COVID-19 vaccine   B: Patient received COVID-19 vaccine at 1630 and was monitored for 15 minutes post vaccination.    A: Before leaving following appointment, patient reported that her throat "felt scratchy" and "didn't feel right." Patient denies shortness of breath and stated that her scratchy throat was her only symptom and stated that maybe it was not a big deal. She was given a cup of water and took a drink. She then stated that she felt it was getting worse. She stuck her tongue out and stated that she felt like it was swelling up. Her lips appeared to be swelling as well.    R: At 1648, epi pen was administered to patients right thigh. Patient was transported to the ER via wheelchair. Call placed to ER and report was given.   Patient was not seen in the ER, reason unknown.
Shoulder discomfort, tension. Red raised area in middle of injection 1 1/2-3cm. Pink area 4x6inches, elm leaf shape.
Case had a cough on 7/29 then the AM of 7/20 had "dry heaves, cough worsening and terrible tremors". They went to UC who sent them to ER and they diagnosed COVID. Admitted to Hospital- on 07/30/2022 with COVID-19.
Patient received a dose of ADACEL on 28Apr2021, that was expired on 26Apr2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00582362) and transmitted to Sanofi on 29-Apr-2021.  This case involves a 12 years old female patient who experienced patient received a 0.5 mL expired dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6272AA and expiry date: 26-Apr-2021) via intramuscular route in the left deltoid (expired product administered) for prophylactic vaccination on 28-Apr-2021.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was an actual medication error case due to expired vaccine used (latency: same day).   It was reported that they administered expired vaccine. The vaccine expired on exp 4/26/2021 and was administered on yesterday. They wanted to know if they needed to redose the patient at some point or is okay since the time frame was so close. Reporter asked if it would be okay since it was just a few days past the expiration date. They stated that they had a plan to repeat the ADACEL dose in three months and is asking if that would be okay. They asked if it would be okay since it was just a few days past the expiration date. They stated that they had a plan to repeat the ADACEL dose in three months and is asking if that would be okay.  At the time of reporting, the patient experienced no specific adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On 12/07/2001, patient c/o dime-sized abrasion-like local reaction. He states it baecame red and "itchy".
Patient reported shortness of breath, Vital Signs WNL, epipen administered at 0957. Transported to ED at 1004.
she didn't die but she knows 2 people that did; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "she didn't die but she knows 2 people that did". The patient date of death was unknown. The reported cause of death was "she didn't die but she knows 2 people that did". It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between  Death and the vaccine (BNT162B2 )cannot be excluded. The case will be reassessed once new information is available.; Reported Cause(s) of Death: she didn't die but she knows 2 people that did
Sever fatigue, aches, chills.  And approximately 6 hours after the shot, I began vomiting.  I had nothing to eat that day.  And then I vomited again approximately 1-2 hours later.  This morning, April 17, i vomited around 10am.  All without eating, just drinking liquids.
Approximately 24 hours following the shot, I had fever and body aches for 2 days. The 3rd day my fever was gone but then I had a dull headache with body aches for additional 5 days. After 5 days the body aches have continued resulting in the need to take pain reliever daily.
Initial report received from a healthcare professional on 13 August 2013 and follow up information received on 15 August 2013. A 02-month-old female patient had received intramuscular first dose of PENTACEL vaccine (lot number: C4485AB) in the left thigh, a dose of PREVNAR vaccine from Pfizer (lot number G57196 and route of administration was not reported) in the right thigh and intramuscular dose of Hepatitis B vaccine from other manufacturer (lot number J005078) in the left deltoid on 12 August 2013. The patient was well and had no illness at time of vaccination. On 12 August 2013, the patient developed large area of redness that spread to the entire left thigh (front and back) to the knee and up to hip and leg immediately after vaccination and the patient was crying immediately after vaccination. Laboratory investigations and corrective treatments were not reported. As of 13 August 2013, the outcome of the events was unknown. List of documents held by the sender: None.
A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV received from a registered nurse/health professional concerning a 43-month-old female out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine was expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Significant left-sided facial drooping.  Left (hand) grip slightly weaker than right grip.
Numbness to left side of face; Low grade tremor in left jaw; pins and needles up left jaw and cheek; weakness across left cheek; Feels like whole muscle jaw is under tension; potential for Bell's Palsy; weird sensation left flickering in left eye immediately; Fever; Headache; This is a spontaneous report received from a contactable other health-care professional. A 64-year-old-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8730), via an unspecified route of administration at the right arm on 27Mar2021 13:00 at single dose for COVID-19 immunization. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN6202), via an unspecified route of administration at the left arm on 06Mar2021 at single dose for COVID-19 immunization. The patients medical history included Sjogren syndrome (states is an autoimmune disease that she was diagnosed with a really long time ago; maybe around 2005 and ongoing) and on unspecified date either on 2018 or 2019 patient had administered with Whooping Cough Vaccine for which she experienced Sore Spot on Arm. Concomitant medications were not reported. It was reported that after first dose states of the vaccine patient had immediate numbness to the left side of her face that went away after a while. The patient had a low grade tremor in her left jaw and a twitching, flickering in her eye. Patients jaw feels dull like the whole muscle is under tension. It was reported that she didn't have much of a reaction after her second vaccine besides a fever and a headache and stated that they started about 5 hours after the vaccine and were gone the next day. The patient had a fever and headache after the first vaccine also; they started about the same, 5 hours or so after the vaccine but they lasted for about 5 days. On 06Mar2021 13:00 patient got immediately dull, pins and needles up left jaw and cheek. went away and has left tremor in lower jaw and now flickering twitch in left eye. weakness across left cheek continues. Outcome was reported as unknown for potential for Bell's Palsy and Feels like whole muscle jaw is under tension, not recovered for weird sensation left flickering in left eye immediately, pins and needles up left jaw and cheek and weakness across left cheek, recovered from pyrexia and headache, recovering from Numbness facial and low grade tremor in left jaw.   No follow up attempts are needed. No further information is expected.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the event  potential for Bell's Palsy cannot be excluded.  This 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 to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Local induration, pain and swelling at right deltoid, within 24 hours, post vax, lasting several days and gradually resolving. Transient bilater lower motor weakness for 10-10 hours, which resolved.
Area of redness (L) thigh 1 cm at PCV #13 site.
Weak; Headaches; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the right arm on 17Apr2021 at 10:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included thalassemia minor and cervical dystonia. The patient had known allergies to mushrooms. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the right arm on 27Mar2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously took cefalexin (KEFLEX) and ciprofloxacin (CIPRO) for unknown indication on an unknown date and experienced drug allergy. On 18Apr2021 at 19:00, the patient experienced weak, headaches and tiredness. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcomes of events weak, headaches and tiredness were resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE DEMAND ISCHEMIA HYPOTENSION 12/28/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Breakthrough case of Covid-19, first symptoms observed on December 24 As of the date of this report, December 29, symptoms are abating and I appear to be recovering
Arm hurt; Night sweats; Loss of appetite; Swollen lymph node on the left side of the neck; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LIMB INJURY (Arm hurt), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Loss of appetite), LYMPHADENOPATHY (Swollen lymph node on the left side of the neck) and FATIGUE (Fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced LIMB INJURY (Arm hurt), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Loss of appetite), LYMPHADENOPATHY (Swollen lymph node on the left side of the neck), FATIGUE (Fatigue) and HEADACHE (Headache). On 23-Jan-2021, LIMB INJURY (Arm hurt), NIGHT SWEATS (Night sweats), DECREASED APPETITE (Loss of appetite), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen lymph node on the left side of the neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the event, a causal relationship cannot be excluded. Headache, fatigue and lymphadenopathy are consistent with the product safety profile.
During the 15 minutes that the patient was waiting in the store the patient said he did not feel well. Patient had sweats and felt cold. Patient reported feeling dizzy. Asked patient if he had any trouble breathing. Said he could breath OK but had some burning sensation in the throat. Patient's BP was somewhat low in the pharmacy, recorded at 105/65 with a pulse of 60. Had patient lie down. Patient said dizziness was getting worse and was fearful he would blackout. Patient requested help for EMS. Called EMS and we instructed patient to not get up and not eat or drink anything. Patient never lost consciousness in the pharmacy.
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer. This consumer reported for self that the male patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. On 10Jan2021 the patient developed symptoms and was diagnosed with COVID-19 (unrelated to vaccine obviously). He was fully recovered as of 26Jan2021. He was scheduled for the second doze of vaccine for 28Jan2021. The outcome of the events was recovered.   Information on Lot/Batch number has been requested.
8 days later presented with unsteady gait. Neurologist diagnosed ataxia S/P varicella.
Headache, Arthralgia,  injection site pain, swollen glands  Narrative:   Other Relevant History:
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ (lot # L035510 expiry date: 13-MAY-2017 and lot # M025565 expiry date: 06-NOV-2017 for prophylaxis, which was exposed to a temperature of 54.08 F for 198 hours and to 30.4 F for 333 hours (incorrect product storage). The temperatures were logged with a data logger, and there were no prior excursions. No adverse effects reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA006419: US-009507513-1612USA001439.