chrisvoncsefalvay/vaers-outcomes huggingface dataset:
14 DAYS AFTER 2ND VACCINE "I" HAVE VERTIGO; swelling of lymph nodes under left arm and neck for 5 days; Ringing in ears; This is a spontaneous report from a contactable other healthcare professional, the patient. A 62-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6208) via an unspecified route of administration in the left arm on 15Mar2021 at 17:15 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. 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 were not reported. On 16Mar2021, the patient experienced swelling of lymph nodes under left arm, neck for 5 days and ringing in ears. On 30Mar2021, 14 days after second vaccine, the patient had vertigo. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. It was unknown whether therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling of lymph nodes under left arm and neck was recovered on 21Mar2021 after the duration of 5 days, while the events ringing in ears and vertigo were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Mixed dose series. Previously vaccinated with Pfizer on 3/17/21 and 4/7/21
Knees hurt; This is a spontaneous report from a contactable consumer (patient) via a  Sponsored Program. This female patient of unspecified age received the first dose of BNT162B2 (UNSPECIFIED TRADE NAME; lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported that she took numerous medications; she received the first dose of COVID vaccine last week (as of 02Mar2021) and stopped taking "1/2" of her medications and was wondering if she could start them again. She was also wondering if she needed to stop taking medications during the second dose as well. She further reported that she needed to take acetaminophen (TYLENOL) for her knees after taking the first dose of the vaccine as her knees hurt. The clinical outcome of knees hurt was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
2 days following receipt of immunization developed palpable fevers. The 3rd night had generalized seizure associated with fever 102.5. Seen in ER, no source of fever found. Since discharge from ER, no further seizures or fever. Blood cultures still pending. Treated symptomatically.
Sore arm - 2.5 weeks  Bruised arm (circle)- current Extremely painful and heavy 1st menstrual cycle since booster Top of stomach pain Restless legs - feels like trembling inside Back of thighs and glutes sore and stiff
8 days after receiving the booster shot I broke out in full body hives. Virtually unbearable for six days, even Benadryl hardly helped. Was prescribed prednisone for ten days. Hives came back. Now I am managing with 30mg Zyrtec supplemented with Benadryl but still suffer red splotches and dermatographia. Hives come back if I stop medication, it has been 21 days, still has not cleared.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: After administration of first vaccine patient was having lightheadedness/dizziness. Patient was also flushed and experiencing sweating. Had patient lay on floor with feet elevated and symptoms improved within 5 minutes.
Patient woke up early hours in the day after shot, with uncontrollable chills. She went to ER, was likely given ATIVAN, and was fine later that morning/day - per husband.
tightness of chest weakness difficulty breathing prescribed for anxiety  even on non stressful situation the attack come into my body.
nausea and vomiting; Nausea; Dizziness; ; Fatigue/worst fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MYALGIA (Mack truck hit), FATIGUE (Fatigue/worst fatigue), VOMITING (nausea and vomiting) and NAUSEA (Nausea) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Allergy to antibiotic. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) from 2020 to an unknown date for Heartburn, EZETIMIBE, SIMVASTATIN (VYTORIN) from 2010 to an unknown date for Hypercholesterolemia.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness), MYALGIA  and FATIGUE (Fatigue/worst fatigue). On 23-Feb-2021, the patient experienced VOMITING (nausea and vomiting) and NAUSEA (Nausea). On 28-Feb-2021, DIZZINESS (Dizziness) and MYALGIA  had resolved. At the time of the report, FATIGUE (Fatigue/worst fatigue), VOMITING (nausea and vomiting) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2020, Polymerase chain reaction: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient reported that she felt fatigue, dizziness and myalgia which were similar to her chemotherapy 25 years ago. In concomitant medications patient also reported Claritin 10mg orally for allergy. She started taking it since 2015. Treatment details were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-074321 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: This follow-up was received on 31-MAY-2021 which updated patient demographics, allergic conditions, lab data, re-challenge date, concomitant medications and event outcome.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074321:CROSS LINKED TO DOSE 1
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    No relevant concomitant medications were reported.  It was also reported that there was potentially a second lot number that was expired on 28 Feb 2023 and was administered to patients on 3 Mar 2023, but HCP did not had any details on that event at that time. The vial size was reported as 10 dose vial.  The vial had not  undergone any temperature excursions. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Headache, Myalgia, Fever, chills, generalized itching 7 days later Narrative: Took Benadryl and Zyrtec for the itching.
Passed out, catatonic response, tonic response, Revived with ammonia inhalant sent to PCP office.
This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (had a fever) and NAUSEA (nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (had a fever) and NAUSEA (nausea). At the time of the report, PYREXIA (had a fever) and NAUSEA (nausea) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications was reported. It was unknown if the patient had allergy, but was taking allergy shots. It was also unknown if the patient was tested or diagnosed with COVID and unknown if the patient experienced a similar event in the past. It was unknown, if the patient was taking any other vaccines within 1 month of staring COVID-19 vaccine. No treatment drug details was reported. This case was linked to MOD-2022-630193 (Patient Link).
Received dose from expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). In October 2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received booster dose of vaccine on 23 Oct 2021 and 24 Oct 2021.  No concomitant medication was reported. No treatment medication was reported.
sore l arm ist day - then fever body aches chills head ache starting on day 2-3
Arm went numb up into the side of my face. right side where I got shot. Dizziness, short of breath,and nausea. The next day I got sick again. I had shortness of breath and pains going up my arm and extremely weak. First day symptoms lasted around 5 hrs and 2nd day only 2 or 3 hours, till I got medicine. I was sick feeling for 5 days . i was prescribed Claritin and Vioxx.
Vaccine administered on 3/28/08.  Significant pain and swelling began on 3/29/08.  Swelling extended to under the arm and below the elbow.  Treatment: ice, heat, Tylenol, Benadryl.
3:05 PM - vaccinations administered, nurse administering shot left the room. 3:07 PM - patient was still complaining of the site still stinging/burning and I checked both sites. Noticed that the MMR injection site was hot, rapidly swelling, and had a rash about the size of my hand (adult female). 3:09 PM - collected children and things. Carried patient to the doctors station and flagged someone down to look at the injection site. The administering nurse called for Dr. to come look saying "She is having an allergic reaction to the MMR". 3:10 PM - Dr. confirmed reaction. We were shown to a different room and the patient was given 30mg of Orapred ODT. We were told to wait for 15 minutes. 3:25 PM - Dr. returned to check on the patient. Swelling had gone down and redness had decreased. Pain at the site was gone. We were told to wait another 5 minutes. 3:30 PM - The PA came and checked the patient. Swelling had reduced further, but not totally gone. We were released to go home. We were to call back the next day if it had not gotten better. 3:50 PM - Swelling and redness completely gone. I called back the next day to ask if a VAERS report would be filed on my daughter's (the patient) behalf by our doctor. We were told no because it was an "expected" reaction and that future vaccinations of this type may cause such a reaction. All my online research classified this as adverse and I decided to report it.
Felt warm to the touch; itching; Redness; Swelling; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Felt warm to the touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Felt warm to the touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever). At the time of the report, VACCINATION SITE WARMTH (Felt warm to the touch), VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE SWELLING (Swelling) and PYREXIA (Fever) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.
headache; little tired; feeling so sick; dry mouth; body shaking temperature; could not get out of bed; night chills/ teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling so sick), DRY MOUTH (dry mouth), BODY TEMPERATURE ABNORMAL (body shaking temperature), ASTHENIA (could not get out of bed) and CHILLS (night chills/ teeth chattering) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MALAISE (feeling so sick), DRY MOUTH (dry mouth), BODY TEMPERATURE ABNORMAL (body shaking temperature), ASTHENIA (could not get out of bed) and CHILLS (night chills/ teeth chattering). On 22-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (little tired). On 22-Mar-2021, MALAISE (feeling so sick), DRY MOUTH (dry mouth) and CHILLS (night chills/ teeth chattering) had resolved. At the time of the report, BODY TEMPERATURE ABNORMAL (body shaking temperature), ASTHENIA (could not get out of bed), HEADACHE (headache) and FATIGUE (little tired) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-117279 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Updated patient initials. No other new information was received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-117279:Reporter's case
HEADACHE, DIZZINESS, EXTREME FATIGUE, BRAIN FOG, VISION (BLURRINESS, FLOATERS, LIGHT SENSITIVITY), MUSCLE TWITCHING, ITCHING, INSOMNIA, JOINT PAIN, MUSCLE WEAKNESS, NECK PAIN, EARS CLOGGED, EARS RINGING, LEFT ARM AND LEG TINGLING, HEART RACING, HIGH BLOOD PRESSURE
febrile status epilepticus 12hr p/vax;mom w/epilepsy
Client received CanSino COVID vaccine, no reaction. CanSino vaccine not approved. Janssen given as an alternative on 09/15/21.
23OCT91 arm swollen, red, inflamed, itchy approx 3" around inject site no better 25OCT91;
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD21-068620 (E2B Linked Report).; Sender's Comments:  MOD21-068620:Cross link
Pt recvd MMR vax yesterday & c/o began 2 hrs p/immun w/itching began 5 hrs p/vax w/rash that began on legs & moved upwards to trunk, arms, hands & face & still itching; Began yesterday afternoon w/sore throat & sweaty;
Hives starting on right elbow, progressing to scalp, left arm and face/neck. 12 hours later: swelling of joints in hands wrists and elbows. Joint pain, stiffness in joints in arm.  Lump in throat near thyroid.
Excessive sweating, severe headache, ringing in ears, dizziness, syncope, and rapid heart beat.
A 16 year old accidentally received the Moderna Covid 19 vaccine/ A person younger than 18 years old received the first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old accidentally received the Moderna Covid 19 vaccine/ A person younger than 18 years old received the first dose of the Moderna Covid 19 vaccine) in a 16-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 066K21A) for COVID-19 prophylaxis.     Patient had no Allergies. The patient had not tested positive for Covid 19.     On 25-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old accidentally received the Moderna Covid 19 vaccine/ A person younger than 18 years old received the first dose of the Moderna Covid 19 vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old accidentally received the Moderna Covid 19 vaccine/ A person younger than 18 years old received the first dose of the Moderna Covid 19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported.  Reporter did not reported any side effects.  Treatment information was not reported.
Gave the patient 2 doses of the Pfizer vaccine, gave her two shots of covid one in each arm both with the same lot number.
got sick with the first one; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 27Jan2021 (Lot number: EL9261) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing). Concomitant medication(s) included: RISPERDAL taken for anxiety. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got sick with the first one".  Additional information: He became sick with the first one. Its been over a week and the symptoms come and go. He went to urgent care on Saturday they felt it was the vaccine. He hearing that some people have these last for 5 or so days, he just concerned. No any additional Vaccines administered on same date of the pfizer suspect. No emergency Room required. He had a Tetanus shot back in May2021 with no issues. No any event prior to vaccination, no family history and relevant test reported.  No follow-up attempts are possible. No further information is expected.
Evening of May 18, strange sensation over entire body, kept coming in waves, really hot, nervous, anxious, lasted 5-10 minutess, was then sick with flu like symptoms for a few days.  For the next two month I didn't feel right, something was amiss. Evening of July 22, strange sensation over entire body again, kept coming in waves, this time more intense, nervous, anxious, thought I was going to die, really hot with profuse sweating, heart palpations, ringing in my ears became maddening, my body was shaking and trembling, dizzy and was nauseous.  Smaller bad episodes for the following 4-6 weeks all the while have body aches and feeling spaced out, both arms and both legs are wanting to tremble and shake.  At one point there was deep bruising deep in my right arm all the way into my hand.  My eyes were blood shot for several days. Now my entire body feels constantly sick and my arms and legs just want shake and tremble.
Joint pain x 3 weeks. Began the day following vaccine injections. Initial onset also had "fever and chills -" temp on 10/31/11 99.0 degrees F.
Information has been received from a nurse concerning an 11 year old female patient with no pertinent medical history and no known allergies who on 17-AUG-2009 was vaccinated SQ with the second 0.5 ml dose of VARIVAX (Merck) (lot number 664507/0689Y). There was no concomitant medication. On 18-AUG-2009 the patient developed a red raised area about 2.5 to 3 inches in size at the injection site. Unspecified medical attention was sought. There were no lab studies performed. At the time of the report, the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
child began w/fever of 104-105 1hr p/vax;was given motrin;to hosp twice stated was told by MD that fever d/t excessive number of vax being given @ once;5/24/99 child w/rash to face & neck some to body;to MD told rash was d/t intoxication
No adverse event, was administered on 8/31/2022 and was advised to submit VAERS event.  " It was brought to our attention from Agency that we must submit a VAERS report for any patient that received a monovalent booster dose as of Wednesday, 8/31. The rationale is due to FDA pulling the authorization for Covid-19 Vaccine monovalent boosters (1st booster and 2nd booster) on 8/31/22 so according to Agency any doses administered on or after 8/31 are considered "administration errors" This is despite the fact that Agency failed to inform the providers to stop administering the Monovalent Booster doses until much later in the day.