chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 4:22 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 4:22 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided by the reporter. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. No treatment medications was provided by the reporter.  Patient received vaccine which was stored in an ultra cold freezer at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
Pt. briefly had a fainting spell for 2-3 seconds regained consciousness immediately and is doing fine now.
severe chills, fever of 100.  Lasted 20 hours.  Then felt ill 5 days later for a couple of hours
Fever, headache, sinus infection symtoms followed by acute neck and shoulder pain, wieght loss and muscle weakness.  Dx of brachial plexus neuritis.
Heart palpitations, intermittent for about 5 minutes, chest/lung pressure for about 3 hours, 24hours of nausea, temp 101.5, Throbbing headache, fatigue and sore neck /shoulder & swollen glands in neck. Soreness in ALL joints for 1 Week.
No ADR timing ERROR 2nd dose given 45 days after 1st  Narrative: No ADR, timing ERROR 2nd dose given 45 days after 1st
This spontaneous report as received from medical assistant refers to a male patient of unknown age. Patient's medical history and other drug allergic reactions were not reported. On 07-JUL-2013, the patient was vaccinated with first dose of GARDASIL (strength, dose units, route, lot number and frequency unknown). On 06-DEC-2013 the patient was vaccinated with second dose of GARDASIL (strength, dose units, route, lot number and frequency unknown). No adverse effect reported. The outcome of the patient received first dose of GARDASIL on 07/01/2013 and their second dose on 12/06/2013 and no adverse effect was unknown.  No further information was provided. Additional information has been requested.
Malar rash - not raised on face. Petechial blue - mostly red. Sclera - scattered, small isolated hemorrhages.
get in to the hospital due to my heart, AFib; Shortly after, his heart rate went up/Heart beat jumped so fast, sudden rapid heartbeat; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.  A 48-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Apr2021 13:30 (Batch/Lot Number: EW0151) as single dose for covid-19 immunisation. Patient received the first dose on 14Mar2021 at the age of 47years old. The patient medical history was not reported. The patient's concomitant medications were not reported. Shortly (about an hour) after vaccination, his heart rate went up to 190 bpm and into atrial fibrillation. Heart beat jumped so fast, sudden rapid heartbeat. Caller sought medical care via emergency department, and went to doctor couple of times specially to heart doctor to make sure things are good. Patient was hospitalization for event Atrial fibrillation. Patient had Echocardiogram and PET scan on unknown date with result unknown.  Outcome of events was unknown.   Follow up needed, further information was requested.
This case was reported by a healthcare professional and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 1 October 2008 the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced extreme injection site redness and extreme injection site soreness. At the time of reporting the outcome of the events was unspecified. The reporter stated that this event occurred in three additional subjects. Linked cases include: A0752833A, A0752836A and A0752837A.
9/27/99:pt rcvd tetanus vax.9/28/99:Pt. complained of redness,swelling, & pain at site of injection & feeling listless. 9/30/99:pt dvlped a fever.10/1/99:pt. dvlped chest tightness,dry mouth,& semi-consciousness.12/8/99:bump at inj. site.
Pt developed redness at injection site of hepatitis B. Pt c/o soreness radiating up to neck within 30 min of receiving vax. Mother states vax given with wrong needle. Nurse reports she gave injection with 25 gauge 5/8" needle. As of 3/30/01, there was no redness and no soreness.
Pt reported severe dizziness and nausea.  Also mentioned odd taste in mouth.  Was evaluated by EMS and determined to be non-emergent.
Patient came into office today c/o swelling, redness left deltoid area 6 cm x 6 cm area noted, warm to touch, red swollen, slightly raised.
Within a few minutes tingling in my left arm/hand. Head felt ?fuzzy? not headache but heavy. Left after 15 minute observation period without reporting anything because it didn?t seem significant. In the 7 hours since injection I?ve had tingling in my extremities- arms, hands, legs, feet. Legs are heavy. Head ?fuzzy?/heavy feeling. Cold/chills although that seems to be disappating.
Pt recv vax on 1/18/99; on 1/20/99 pt exp diarrhea (12 stools a day), weight loss, fatigue, less active
patient called to report a vaccine related side effect from Prevnar 20: patient is feeling cold, has a headache and achy. patient's voice is also hoarse. Counseled patient to take tylenol
A report was received on 02-JAN-2002 from concerning a 51 year old male pt who was hospitalized for chest pain after receiving Fluvirin vaccine on 11-DEC-2001.
Patient's daughter states that the patient started having a sore throat on 9/30. She was taken to the hospital on 10/4 (reason not available currently). The patient was then found deceased at her home bent over her empty bath tub on 10/6/21. She had a bloody nose when she was found. Cause of death was determined to be a heart attack or stroke.
Influenza IIV4 (Quadrivalent) 0.5mL (90686) 2 inch diameter red hard welt, tender and warm to the touch. No other symptoms have developed. Treating with ibuprofen or Tylenol as needed for pain. Ice as tolerated but doesn't prevent normal activities.
This initial spontaneous report was received from a lawyer regarding a case in litigation concerning an adult patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2012, the patient was inoculated, by a physician, with a dose of ZOSTAVAX as recommended for routine adult health maintenance and for the long-term prevention of shingles (strength, route, anatomical location, dose number, lot/batch # and expiration date were not reported). On an unknown date in 2015, the patient was treated, in a hospital, for the onset of a vesicular rash, which was diagnosed as herpes zoster. The vaccine did not prevent shingles as intended, and subsequently contracted a persistent strain of herpes zoster or shingles (vaccination failure).  As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages (injury), and required extensive medical care and treatment. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering (emotional distress), and other damages (injury). At the time of reporting, the outcome of vaccination failure, herpes zoster, emotional distress, injury and pain was unknown. The reporter considered all the events to be related to ZOSTAVAX.
flu like symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms".  Additional Information: Verbatim and event description was swap from Pfizer-sponsored program patient had both of the Covid vaccine. Patient mention first shot he had flu like symptoms and after his second shot of the vaccine he had a seizure and wanted to report his experience. Patient refused to speak to medical profession. Urgent sent due to caller having seizure and ending up in the hospital Transferred to program department  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever of 102.2, possibly higher, day after Moderna booster. Also chills, fatigue, dizziness, headache.
powder component of Menveo mixed with sterile water instead of the provided diluent; the diluent that had not been used to reconstitute the powder component was administered to the patient alone (without powder component); This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA926A, expiry date 31-MAY-2024) for prophylaxis.   On 08-AUG-2023, the patient received Menveo. On 08-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: powder component of Menveo mixed with sterile water instead of the provided diluent) and inappropriate dose of vaccine administered (Verbatim: the diluent that had not been used to reconstitute the powder component was administered to the patient alone (without powder component)). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-AUG-2023 The nurse informed that the patient received the powder component of Menveo mixed with sterile water instead of the provided diluent, which led to wrong solution used in drug reconstitution.  After that, the diluent that had not been used to reconstitute the powder component was administered to the patient alone, without powder component, which led to inappropriate dose of vaccine administered. The reporter consented to follow up.
Sudden onset hearing loss in left ear with dizziness and tinnitus on 2-26-21.  Woke up with tinnitus, as day progressed I got dizziness, by late afternoon was deaf in left ear. Went to Urgent Care/ER that night where ENT was consulted.  Was put on 60 mg prednisone daily for 1 week, taking first dose in the ER. The next morning I had regained a little hearing and was no longer completely deaf in that ear.  Dizziness was severe for several days, continued for 2-3 weeks. I  followed up in clinic with ENT MD 4 days after onset of symptoms. Hearing test showed severe hearing loss in left ear.  MRI ordered and completed which showed left ear signal alteration with possible labrynthitis. My next clinic appointment with Dr. was 1 week after the first appointment, with hearing test showing no improvement in hearing.  I then started a series of 3 steroid injections in my left ear.  The injections were one week apart.  Very little to no improvement was achieved with the injections.  I then started hyperbaric oxygen therapy which has helped some patients in the past but is not consisitently effective with all who try it.  I did 22 sessions of hyperbaric oxygen therapy with no real improvement. Dr. approximated I have 80% hearing loss in my left ear.  I have not noticed any improvement in my hearing since completion of treatments.  Tinnitus is still constant in that ear.  I have nerve damage also so any hearing I do have in my left ear is distorted, like a broken speaker.  I use a Private system hearing aids to aid in my hearing.  I have also tried accupuncture with no improvement.
has full symptoms, the patient thought of might having Covid; has full symptoms, the patient thought of might having Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "wasn't feeling well from the morning before receiving the vaccine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "has full symptoms, the patient thought of might having Covid". It was unknown if therapeutic measures were taken as a result of drug ineffective, suspected COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
First experienced shingles symptoms (soreness on forehead and around right eye) about 10 days after the first Pfizer vaccine. Soreness turned into a blistering sore 2-3 days later, and went to dermatology 4/19/2021. Diagnosed with shingles and given the antiviral acyclovir. Took 3x day for 7 days. Symptoms have improved gradually over 7 days. Second injection to be administered on day 7 after shingles diagnosis, 4/26/2021.
headache; 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 67-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster) , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown".  Additional information: Caller stated she and her husband received the Pfizer covid vaccine booster dose a week ago on Saturday, they mixed his vaccination information with her information. Caller stated she wanted to report the side effect she was experiencing, headache. She was stated it was worse today, had severe headache; she said today it was more than anything, it was terrible. Caller wanted to know if she experiences it again should she go to emergency department since her PCP was not in today.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Skin felt like it was on fire; Hyperhidrosis; Throat irritation; Pain in extremity; Cough; Chills; Pyrexia; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Hyperhidrosis), THROAT IRRITATION (Throat irritation), PAIN IN EXTREMITY (Pain in extremity) and COUGH (Cough) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 20-Dec-2020 to 30-Dec-2020. Concurrent medical conditions included Gluten sensitivity and Milk allergy (milk sensitivity). Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for BPH, LEVOTHYROXINE and THYROID (ARMOUR THYROID) for Disorder thyroid, LAMOTRIGINE and ALPRAZOLAM (LAMPRO) for Mood alteration NOS.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Hyperhidrosis), THROAT IRRITATION (Throat irritation), PAIN IN EXTREMITY (Pain in extremity), COUGH (Cough), CHILLS (Chills), PYREXIA (Pyrexia) and FATIGUE (Fatigue). On 20-Feb-2021, SKIN BURNING SENSATION (Skin felt like it was on fire), HYPERHIDROSIS (Hyperhidrosis), THROAT IRRITATION (Throat irritation), PAIN IN EXTREMITY (Pain in extremity), COUGH (Cough), CHILLS (Chills), PYREXIA (Pyrexia) and FATIGUE (Fatigue) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Swollen lymph nodes, swelling in her arm in the lymphatic reason; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes, swelling in her arm in the lymphatic reason) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Mastectomy bilateral.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes, swelling in her arm in the lymphatic reason). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes, swelling in her arm in the lymphatic reason) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reported.   This case was linked to MOD21-038326 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time. No further information is expected.
3-4 days after receiving his 2nd dose, both of his arms have been aching; inability of hardly being able to lift them in the morning; pain more of a muscle pain than joint; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (3-4 days after receiving his 2nd dose, both of his arms have been aching), MOVEMENT DISORDER (inability of hardly being able to lift them in the morning) and MYALGIA (pain more of a muscle pain than joint) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 06-Nov-2020. Concomitant products included VALSARTAN, SIMVASTATIN and VENLAFAXINE for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (3-4 days after receiving his 2nd dose, both of his arms have been aching), MOVEMENT DISORDER (inability of hardly being able to lift them in the morning) and MYALGIA (pain more of a muscle pain than joint). At the time of the report, PAIN IN EXTREMITY (3-4 days after receiving his 2nd dose, both of his arms have been aching), MOVEMENT DISORDER (inability of hardly being able to lift them in the morning) and MYALGIA (pain more of a muscle pain than joint) outcome was unknown. Not Provided.
pt recvd vax & 4 dasy following vax devel upper resp infect; No further details were provided;
Patient was given injection on 3/12/14 at 1:00 pm. Came on 3/17/14 with antibiotic script for bacteria infection on site of injection. Further questioning revealed that MD thought it might be a bacteria infection. Upon examining, area looks warm, non purulent swelling.
PATIENT RECEIVED 2ND DOSE OF COVID IN ANOTHER COUNTRY ON 07/15/2021. PATIENT CAME FOR A PFIZER BOOSTER DOSE ON 01/04/2022. DOSE WAS INADVERTENTLY ADMINISTERED DESPITE IT NOT BEING 6 MONTHS (IT HAS BEEN 173 DAYS). PATIENT STATES SHE JUST HAS PAIN AT THE INJECTION SITE.
arm still hurts.; has nerve pain shooting down it into my hand.; hard large lump at the site of injection.; This is a spontaneous report from a contactable nurse, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an intramuscular route of administration in the left arm on 26Feb2021 at 14:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included mast cell activation (MCAS), Ehlers-Danlos syndrome (EDS), postural orthostatic tachycardia syndrome (POTS). The patient was allergic to pineapple. 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 did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included metoclopramide (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), propranolol (MANUFACTURER UNKNOWN) and duloxetine hydrochloride (CYMBALTA); all taken for unknown indications from an unknown date. On 26Feb2021 at 16:00, the patient arm still hurts, had nerve pain shooting down it into the hand and a hard large lump at the site of injection. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events pain in arm, nerve pain and vaccination site lump were not resolved at the time of the report.  Information about lot/batch number cannot be obtained. No further information is expected.
Fever 102, vertigo, sore throat, fatigue, nausea. Took Tylenol for fever.