chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 11:15 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022 at 11:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  Patient received additional vaccine past its 30-day expiry date. Vaccine went into 2-to-8-degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Reporter no longer possess this lot number.   This case was linked to MOD-2022-542869 (Patient Link).
Patient reports 3 hours after vaccine administered in left deltoid all joints on left side of body locked up and symptoms lasted 1 week.
I have been experiencing a shingles type sensation on my left abdominal area below the ribs and above the hip to navel, and still do.  There has not been any rash just sensitivity to touch and motion, similar to what you would feel with a severe sunburn.   I did have shingles on my right hip area in 2013 and the shingles vaccine in 2017 with a very minimal local rash around the injection site that lasted a couple if days.
Lymph node swelling; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lymph node swelling on an unspecified date. The clinical outcome of lymph node swelling was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Neck pain, shoulder pain at injection site, nerve pain, muscle atrophy, lost strength in left triceps, pectoral muscle pain in nerves from left side of neck scapula to left arm and fingers. Intense pain.
Gave patient vaccination, patient rolled eyes back and then started having seizing activity. This happened at around 10:30 AM, held patient head to make sure he did not hit his head, patient was not responsive for about 1-2 minutes, 911 was called, EMT came.
Patient received his first dose of COVID vaccine on 4/27, and began having cough, fever, chills on ~ 4/29. Patient tested positive for COVID on 5/4 and presented to the ED on 5/5. Patient was found to be hypoxic and was admitted to the hospital on 5/5 for COVID treatment (remdesivir and dexamethasone started).
15:50 complained of "not feeling well," dry mouth, lightheadedness and chest pressure. VS: BP 221/110, HR regular 78, oxygen saturation 99%. Denies history of HTN. Refused EMT transport to the hospital. Waited 10 mins, chest pressure, dry mouth and lightheadedness, BP resolved.
Swollen and pain on light upper arm. Upper 2/3 injection site on left upper arm.
I developed Guillain-Barre syndrome; partial numbness on left leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 12:00 (Lot number: FF8841) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6200, Location of injection: Right Arm, Vaccine Administration Time: 12:30 PM), administration date: 25Feb2021, when the patient was 35 years old, for COVID-19 IMMUNIZATION; Bn2162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Right Arm, Vaccine Administration Time: 12:45 PM), administration date: 04Feb2021, when the patient was 35 years old, for COVID-19 IMMUNIZATION. The following information was reported: GUILLAIN-BARRE SYNDROME (disability) with onset 29Oct2021 13:00, outcome "recovering", described as "I developed Guillain-Barre syndrome"; HYPOAESTHESIA (disability) with onset 29Oct2021 13:00, outcome "recovering", described as "partial numbness on left leg". Patient developed Guillain-Barre syndrome. Spent a lot of money on testing. Still had partial numbness on left leg. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No other vaccine in four weeks. No treatment for events. No covid prior vaccination. No covid tested post vaccination.
Finding of microhematuria on a routine urine dipstick. Repeat urine test confirmed microhemtutria and CBC showed 30,000 platelets. WAs admitted to hospital. No purpura or other signs of bleeding. Was diagnosed as Idiopathic Thrombocytopenic Purpura. Started on steroids with good response.
Parents reported to us today (9-2-16) that their baby experienced about a 10 minute period of "being pale and limp" app. 30 mins after his 2 mos. vaccines. Resolved on its own.
Chills; Nausea; Fatigue; Headache; Bitter taste in mouth; Cough; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30155BA) via an unspecified route of administration in the left arm on 28Sep2021 at 14:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin and contrast dye. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN) and assorted vitamins (unspecified); all for an unknown indication on an unknown date and unknown if ongoing. On 28Sep2021 at 17:00, the patient experienced chills, nausea, fatigue, headache, bitter taste in mouth and cough. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 30Sep2021, the patient underwent nasal swab test for COVID-19 and the result was negative. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events chills, nausea, fatigue, headache, bitter taste in mouth and cough was resolving at the time of this report.
No adverse event; Medical assistant calls to report AE.  GARDASIL 9 given during a temperature excursion.  No further AE.  No PQC.  GARDASIL 9 was evaluated as supported see TE case 02465982.  TEs were on Aug 2, 2023 and Aug 4, 2023.  Called in on 9/6/2023.  AE cases; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-SEP-2023, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #w026152, expiration date: 29-JAN-2025 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  On 02-AUG-2023, and 04-AUG-2023 administered dose of vaccine was exposed to the temperature excursion (product storage error). No additional adverse event reported (no adverse event).
Patient was given the full dose of the adult formulation of the Pfizer/BioNTech COVID-19 vaccine instead of the (PEDS) pediatric formulation. Patient and her parent were informed immediately on site, and patient was monitored for any sign of adverse reaction, but none presented. Clinic staff are in contact with patient and family to monitor any adverse reaction or side effects, but none reported as of 11:00AM on 12/13/2021.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Revax wanted
Breakthrough case admission after three vaccines Moderna 1/26/21 Lot# 027L20A;  Moderna 2/23/21 Lot# 043L20A;  Moderna 8/9/21 NO LOT NUMBER RECORDED
Multiple drug allergy; Initial information regarding an unsolicited case was received from Pfizer (MFR Control No: 2020364462) in the form of courtesy via physician assistant and transmitted to Sanofi on 24-Sep-2020  This case involves patient who experienced multiple drug allergy (Drug hypersensitivity), while treated with received vaccine tetanus toxoid and while treated with lithium (salt not specified), clemastine fumarate, phenylpropanolamine hydrochloride, triprolidine hydrochloride, varenicline tartrate [chantix], Benadryl, sulfa drugs  and pseudoephedrine.  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient started taking lithium (salt not specified) dosage unknown (with an unknown batch number), clemastine fumarate dosage unknown (with an unknown batch number), phenylpropanolamine hydrochloride dosage unknown (with an unknown batch number), triprolidine hydrochloride dosage unknown (with an unknown batch number), varenicline tartrate) 1 mg twice daily oral (with an unknown batch number) and pseudoephedrine dosage unknown (with an unknown batch number) for an unknown indication.  On an unknown date, the patient received a dose of suspect tetanus toxoid produced by unknown manufacturer lot number not reported.  On an unknown date (unknown latency) after the initiation of the suspect drugs the patient experienced multiple drug allergy (Drug hypersensitivity).  No relevant laboratory data was reported.  Action taken, corrective treatment and event outcome was unknown.  No further relevant information was reported.
PT GOT IZ (MENVEO) CAME IN NEXT DAY WITH SYMPTOMS OF UNABLE TO BREATHE, CHEST PAIN, NAUSEA, HEADACHE, LOW GRADE TEMP AND ACHY. LEFT ARM WHERE GIVEN RED ON SITE SWELLING AND TENDERNESS.
Hepatitis vaccine in left deltoid caused huge bruise after 13 days; extreme pain in left arm has continued to this day - limited movement in left arm, extreme pain.
At 3pm on 4/7 (the day of the vaccine), I started to feel ?out of it? with chills. At around 4pm, a mild headache started, and I was experiencing cramping from my chest down to my stomach. I had no appetite that evening. By 8pm, I had a 101.0 fever, and by 9:30pm the cramps were severe in my lower stomach. I was sweating profusely and shaking until I vomited, which helped to relieve some of the stomach pain. Before I vomited, I was in intense pain- possibly some of the worst pain that I have experienced in my life. The sweats and chills alternated throughout the night, and the headache was intense. The next day, the chills, sweats and headache persisted until mid-afternoon, in addition to the occasional stomach pain and diarrhea. The side effects slowly subsided, and I was feeling better by 4/9. The sweating was the longest lasting side effect.
PAIN, REDNESS, SWELLING, HOT TO TOUCH AT INJECTION SITE.
An hour after the vaccination, pain, swelling, and heat in right arm at injection site. Too painful to sleep the night after the injection. Could not use right arm without moderate pain. Second day after vaccine, chills, and fatigue. Third day arm still hurt but felt better. Fourth day, headache, more chills and fatigue. Ten days after vaccine, no pain in arm but there is swelling, redness, and mild itching at vaccination site and the skin feels hot.
Two days after vaccine experiencing worsening Tinnitus; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: FC3180, expiration date was not reported), via an unspecified route of administration, administered in left arm on 09Aug2021 11:15 (at the age 56-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, two days after vaccine on 09Aug2021 11:15 AM patient experiencing worsening tinnitus. The adverse events resulted in healthcare professional office/clinic visit. No treatment was received for adverse events. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Patient took the vaccine, was moved to the post vaccination waiting area. Patient had a fainting event approximately 5 to 6 minutes after the vaccine being administered. It was a sudden onset.
30 minutes post 1st dose an ache across my clavicle, lasted for approximately one hour; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 12:00 (Lot number: EW0150) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient was not pregnant at time of vaccination. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: DULERA; MONTELUKAST; AZELASTINE. The following information was reported: PAIN (non-serious) with onset 21Apr2021 14:00, outcome "not recovered", described as "30 minutes post 1st dose an ache across my clavicle, lasted for approximately one hour". Therapeutic measures were not taken as a result of pain.  Additional information: 30 minutes post 1st dose an ache across my clavicle, lasted for approximately one hour. 26 hours post 2nd dose experienced Supraclavicular Lymphadenopathy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received dulera, montelukast, azelastine other medications in two weeks. The second dose was received 20Apr2021.  No follow-up attempts are possible. No further information is expected.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that an employee of the hospital experienced the events. No product or patient information was available.
Severe shoulder and elbow pain, headache.  By Friday 9/11 blisters were starting to form on left hand.  More blisters and worsening pain on Saturday.  Went to urgent care.  Prescribed Prednisone 20mg and cyclobenzaprine 5mg for 5 days. Went to work Monday, was told to leave at the end of the day and not return until it clears up.  have appt with primary doctor today 9/15/20
Patient given PNEUMOVAX on 9/14/09 at 12:00 in left deltoid. Patient called 9/16/09 11:35 - fever 102.4 - c/o headache and chills- left arm pain. 9/18/09 patient admitted to hospital -Adm DX is sepsis- + fevers >101. No cx. Available. Currently in hospital. 10/30/09 DC summary received for dates 9/16/09 to 9/19/09. DX: Acute febrile illness of unknown etiology, sepsis, leukocytosis. Secondary DX: dehydration, iron deficiency anemia. Presented to ER with SX: fever, dizziness, achiness, tachycardia, dehydration, left shoulder pain x1 day after receiving the pneumonia vax. At time of vax did not feel well and had c/o HA. Assessment: Relative to c/o. PE WNL except left arm was warm to touch... Labs drawn, pt. later D/C AMA.
The shot did not hurt or bleed when administered.  As I was walking around the store, I could feel it moving down my arm.  It felt numb like how you feel after having dental work.  The numbness traveled down my arm to the wrist, then back up the underside of my arm.  The numbness and tingling went into my shoulder and then split to travel down the left side of my back. The other split went to my neck then chin.  At this point I had spoken to 2 pharmacists and 1 covid question center all of whom gave me the same answer that it was nerves and it was just a pain reaction.  This was not pain i was feeling, but numbness where you know you are touching your arm but can't feel it.  I knew something was not right..  i know my body.  I took a benadryl when the numbness hit my neck and chin.  Within 20 of taking benadryl all of the numbness had subsided (at about 3:15ish).
Several local reactions; This case was reported by a nurse via call center representative and described the occurrence of local reaction in a adult female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was recovered/resolved.   It was unknown if the reporter considered the local reaction to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was registered nurse and reported on behalf of patient. The patient was approximately in her 40s. The patient had several local reactions with prior unspecified flu vaccine. The reporter was consented to follow up. This was 1 of the 2 cases reported by same reporter.
thickening and discomfort in throat within 5 minutes; thickening and discomfort in throat within 5 minutes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid 19", start date: Nov2020 (unspecified if ongoing); "hyperthyroidism" (unspecified if ongoing), notes: was diagnosed after she had Covid in Nov2020; "allergy to corn" (unspecified if ongoing), notes: experienced thickening or discomfort in her throat/ she gets that when she eats corn or bi products. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, LOT- EL3246), administration date: 16Jan2021, for Covid-19 immunization. The following information was reported: The patient had both Pfizer COVID vaccines, had second one in "Jan2021 or Feb of last year" and stated she had a reaction to the second one. She experienced THROAT TIGHTNESS (medically significant), OROPHARYNGEAL DISCOMFORT (medically significant) all with onset 06Feb2021, outcome "unknown" and all described as "thickening and discomfort in throat within 5 minutes". The event "thickening and discomfort in throat within 5 minutes" and "thickening and discomfort in throat within 5 minutes" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of throat tightness, oropharyngeal discomfort.in the emergency room and included PEPCID, BENADRYL, and prednisone for treatment. There was no additional investigation. When she was treated they gave her some solumedrol pack to take at home, finished that dose pack at home. She wanted to know if there is corn in the Pfizer vaccine. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided, and a close temporal association, a causal association between the reported events of oropharyngeal discomfort and throat tightness cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
left arm red; left arm swollen; nauseous; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unk date, the patient did not recalled the vaccination date).   On 6th July 2019, the patient received the 2nd dose of Shingrix. On 7th July 2019, 1 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and nausea. On an unknown date, the outcome of the erythema of extremities, swelling arm and nausea were recovering/resolving.   It was unknown if the reporter considered the erythema of extremities, swelling arm and nausea to be related to Shingrix.  Additional details were reported as follows: The patient stated that, the  experience with her 2nd dose of Shingrix was very different from the 1st. The patient stated that her left arm was red and swollen. The patient felt nauseous. The patient did not know if vaccine was administered intramuscular but said did not hurt at the time of injection. The reporter did not consent  to follow up.
Dose 1, sore arm, headache about 14 hours post injection.  Lasted 24 hrs.  Dose 2, headache, sore muscles, and joints, fatigue, flu like symptoms, lasted 24 hours.  Usually never gets headaches, but had headaches often post vaccine, also trouble sleeping at night.  About 2 months later, he experienced, fatigue shortness of breath, swelling and discoloration of lower extremities, brain fog,.  AS time went on , this worsened, also had sharp pain in mediastinal epigastric region at night.  His symptoms worsened until he is now off on disability, sleeps all the time, can't function.  He has small clots in the superficial vessels of the legs, ground glass opacities in the lower lobes and fluid in the lungs.   He is under doctors care.