chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 1:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 2:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.43.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 2 PM and 3 PM, temperature was 32, 32, 32, 35 and 35 respectively, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 21-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 32, 11 AM: 34, 12 AM: 43, 1PM: 40, 2 PM: 40, 3 PM: 41, 4 PM: 41 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pt vaccinated on 2/3/21... started with Rt sided Bell's palsy on 2/9/21. given antivirals and steroids
Discomfort in chest area; Rusty colored urine for 3 days; Mild heartburn for 8 days; 3 small red dots on lower left arm; Possible blood clots on lower arm; Soreness in the kidney area; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Possible blood clots on lower arm), RENAL PAIN (Soreness in the kidney area), CHEST DISCOMFORT (Discomfort in chest area), CHROMATURIA (Rusty colored urine for 3 days) and DYSPEPSIA (Mild heartburn for 8 days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced THROMBOSIS (Possible blood clots on lower arm) and RENAL PAIN (Soreness in the kidney area). On 18-Aug-2021, the patient experienced CHEST DISCOMFORT (Discomfort in chest area), CHROMATURIA (Rusty colored urine for 3 days), DYSPEPSIA (Mild heartburn for 8 days) and VACCINATION SITE RASH (3 small red dots on lower left arm). On 28-Aug-2021, CHROMATURIA (Rusty colored urine for 3 days), DYSPEPSIA (Mild heartburn for 8 days) and VACCINATION SITE RASH (3 small red dots on lower left arm) had resolved. At the time of the report, THROMBOSIS (Possible blood clots on lower arm), RENAL PAIN (Soreness in the kidney area) and CHEST DISCOMFORT (Discomfort in chest area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.; Sender's Comments: This case concerns a 61-year-old male patient with no details on previous medical history, who experienced the unexpected events of Thrombosis (reported as possible blood clots on lower arm) after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred after the first dose of Spikevax, temporal relationship is unknown. The rechallenge was not applicable since only information about one dose was disclosed. The benefit-risk relationship of Spikevax vaccine is not affected by this report. Thrombosis was automatically upgraded as serious as per Regulatory authority list. However,  based on information available and due to the lack of evidence of seriousness from a regulatory or clinical standpoint, it was assessed as non-serious. Medical confirmation has been requested.
Left arm warm to touch, firm, red, tender to touch, no streaking. Sent to CR per doctor for eval/tx as needed.
Pfizer FL2757 vaccine expired on 09/30/22, given on 10/03/22.
She could not move her arm or joints; She could not move her arm or joints; This spontaneous report was received from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2107USA004314) and concerns female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date in 2005, the patient was vaccinated with hepatitis B vaccine (manufacturer unknown) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, after the vaccination, the patient could not move her arm or joints.  The outcome of the events was not reported. The reporter considered the events to be related to hepatitis B vaccine (manufacturer unknown).  This is one of two reports regarding the same patient. Sender's Comments: US-009507513-2107USA004314.
First day and second day  with chills, body aches Third day fine Fourth and fifth day felt little dizzy and weak Six day full vertigo.  Had to go to the doctor
6 days after receiving 1st dose, she noticed that her arm was itching on muscle part closer to her; It is burning; She noticed a bump (a circle of red area) on side of injection site; It is sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (6 days after receiving 1st dose, she noticed that her arm was itching on muscle part closer to her), BURNING SENSATION (It is burning), VACCINATION SITE MASS (She noticed a bump (a circle of red area) on side of injection site) and BREAST PAIN (It is sore) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PRURITUS (6 days after receiving 1st dose, she noticed that her arm was itching on muscle part closer to her), BURNING SENSATION (It is burning), VACCINATION SITE MASS (She noticed a bump (a circle of red area) on side of injection site) and BREAST PAIN (It is sore). At the time of the report, PRURITUS (6 days after receiving 1st dose, she noticed that her arm was itching on muscle part closer to her), BURNING SENSATION (It is burning), VACCINATION SITE MASS (She noticed a bump (a circle of red area) on side of injection site) and BREAST PAIN (It is sore) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up appended
Fever, low grade, every few days, in cycles, then joint pain, hands, elbows, then some later extremities.  Joint got worse, as fever improved.
Pfizer BioNTech COVID-19 Vaccine EUA.   Dizzy, lightheaded, nausea
Patient given bivalent as 1st dose in primary series, no adverse effects but upset since needed to complete series before starting a new job.
This solicited report as received from a Pharmacist via Company Representative refers to a multiple patients of unknown ages and genders enrolled in a Patient Support Program. The patient's pertinent medical histories, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (lot number and expiration date were not provided). No other suspect medications or concomitant therapies were reported. On an unknown date that multiple unspecified patients experienced a case of Herpes zoster after receiving a dose of ZOSTAVAX. The outcome of the event and the causality between the event and the therapy with ZOSTAVAX were unknown. Additional information has been requested.
his pain in his 3 left rotator cup, left hand/pain in left shoulder; feeling "dizzy"; sore arm after first dose; fell; This is a spontaneous report from a Pfizer-sponsored program,  from a contactable consumer. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wanted to know if he should postpone second dose of covid-19 vaccine due to him receiving steroid shot on Tuesday, 23Feb for his pain in his 3 left rotator cup, left hand. Clarified he received first dose of covid-19 vaccine 3 weeks from today (unspecified date). His second dose is scheduled today. He fell after first dose of covid-19 vaccine due to him feeling "dizzy" which then caused pain in left shoulder, also stated "sore arm after first dose" of covid-19 vaccine. Therapeutic measures were taken as a result of his pain in his 3 left rotator cup, left hand/pain in left shoulder. The outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Intense diarrhea; Soreness in the area of administration; Rash in the area of administration; Redness in the area of administration; Nauseas; Lost 10 pounds; This spontaneous case was received on 25-Oct-2022 from pharmacist via Communications (reference number: SEQW22-05019) and concerned a 54-year-old female patient.  The patient's medical history and concomitant medications were not reported.  On 13-Oct-2022, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 350379 and expiry date: 30-Jun-23.   On 14-Oct-2022, one day after receiving Flucelvax Quadrivalent the patient experienced soreness, rash and redness in the area of administration, and also experienced intense diarrhea and nausea.   On an unspecified day in Oct-2022, the patient stated that had lost 10 pounds.  On an unspecified day in Oct-2022, the patient visited physician's office, however, further details were not reported.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 54-year-old female patient experienced pain, rash, and erythema at vaccination site, intense diarrhea and nausea one day after being vaccinated with the suspect Flucelvax Quadrivalent vaccine. As reported, the patient also had lost 10 pounds. Information regarding the underlying medical history and concomitant medications has not been provided. Based on  information provided causality for the event of weight decreased is not related. Causality for the remaining events is assessed as possibly related. The reported events meet level 2 of diagnostic certainty for Brighton Collaboration criteria for cellulitis.; Sender's Comments: A 54-year-old female patient experienced pain, rash, and erythema at vaccination site, intense diarrhea and nausea one day after being vaccinated with the suspect Flucelvax Quadrivalent vaccine. As reported, the patient also had lost 10 pounds. Information regarding the underlying medical history and concomitant medications has not been provided. Based on  information provided causality for the event of weight decreased is not related. Causality for the remaining events is assessed as possibly related. The reported events meet level 2 of diagnostic certainty for Brighton Collaboration criteria for cellulitis.
Warm places on skin.  Seems to be various places with pressure on them ie. chair, another body part, socks.  There is no pain, no fever.  It's just weird.  Feels like sitting on the heated seats in my car.
Received 3rd Anthrax vaccination in his L deltoid region on 22 Aug 08 @ noon.  Approximately 18 hours later he noticed tingling and numbness in his L ring and pinky fingers and lateral side of left arm in a line toward the deltoid injection site.  Symptoms have remained consistant from the onst to this report date.
hives on arm/neck/up into her hair/shoulders/legs/itchy hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, 35 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   The reporter considered the hives to be unrelated to Shingrix.  Additional details were provided as follows: The case was reported by the daughter of the patient. The batch number was not reported. The patient received the vaccine at the end of February or early March.  Five to six weeks later in April, she developed hives on her arms, neck, up into her hair, on her shoulders and legs. A biopsy was done which confirmed it was hives.   Emergency room visit required. The reporter did not know the specific dates or which arm the vaccines were administered.  For tolerances of 2nd dose, refer case US2019AMR124345, reported by same reporter.
lung problems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient. A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: LUNG DISORDER (non-serious), outcome "unknown", described as "lung problems". Additional information: The caller wanted to verify the RSV vaccine Abrysvo because it depends on her life. She said she spoke to her doctor and with the pharmacy needed to get some information about the vaccine for she has a lot of lung problems. She said her doctor gave her the RSV vaccine Abrysvo, Pfizer COVID vaccine and booster all three of them. She wanted to know information about the RSV vaccine, Abrysvo because she said don't want to die but she did need something in her lungs because this is really bad.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
there was a temperature excursion; This spontaneous report as received from a nurse referring to a 7 months old female patient . The patient's drug reactions/ allergies were not reported. The patient had no illness or prior birth defects at the time of her vaccination. The patient had no vaccines within 4 weeks prior to rotavirus vaccine, live, oral, pentavalent (ROTATEQ).        On 02-NOV-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (0.2 ml once, lot#1684163 has been verified as valid, expiration date 26-JUN-2021, strength was not reported) orally for prophylaxis.         The administrated rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced product storage error with temperature excursion: 12.8 degree Celsius, time frame: 3 hours, no previous temperature excursion, not recorded by data logger. Rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was administered to the patient prior to the nurse knowing there was a temperature excursion.   This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA001021: US-009507513-2011USA001454:
COVID Breakthrough Dose 1: 04/07/2021, Moderna, 040B21A Dose 2: 05/05/2021, Moderna, 033C21A Dose 3: 11/19/2021, Moderna, 067F21A
Pain on the right side of my head; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient started to receive BNT162B2 (lot number: EH9899), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for exposure to COVID. There were no medical history. Concomitant medication included ibuprofen (ADVIL) and unspecified birth control. The patient experienced pain on the right side of her head on an unspecified date. No treatment received for the event. The outcome of the event was unknown.
This study case was received from the investigator in a trial on 16 March 2013. A female subject (birth date not reported) with no significant medical history had received the ACAM2000 (lot number and route not reported) in the left arm on 29 October 2012. The subject also received the following vaccination on 29 October 2012: anthrax vaccine (manufacturer, lot number, route and site not reported). On 01 November 2012, 3 days post vaccination (also reported as 2 days post vaccination), the subject experienced chest pain and chest pressure accompanied by shortness of breath. The symptoms began while standing and lasted approximately 1 minute. Symptoms were ongoing and sporadic since 01 November 2012, with 5 episodes of all listed symptoms. Subject reported "sharp" chest pain and pressure with shortness of breath while exercising, lasting 15 minutes and subsided with rest on 05 November 2012. The chest pain/pressures were moderate in nature. The shortness of breath was also mild. The subject reported no additional symptoms of myopericarditis. The onset date for possible myopericarditis was reported as 01 November 2012. Any actions taken were unknown. The subject took no medications and no medical treatment was sought for these issues. The subject did not deviate from usual daily functions. The subject reported pustules at vaccine site beginning on 02 November 2012 (also reported as 03 November 2012) and ongoing. The shortness of breath, chest pain, and chest pressure were considered possibly related to the vaccine. The pustules were considered very likely related to the vaccine. No additional adverse events were reported. On 05 November 2012, the lab troponin 1 was < 0.10 ng/mL and interpretation of the electrocardiogram (ECG) was normal. The subject was scheduled for an ultrasound of the heart on 08 November 2012. The subject was a 2 on the 5 scale Wong-Baker FACES Rating Scale on 05 November 2012. Subject reported no allergies to medications and no concomitant medications. The subject's status was reported as not recovered. According to the investigator, the event of possible myopericarditis was considered possibly related to vaccination. Documents held by sender: Medical Records.
Chest (heart) pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Feb2022 12:15 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single and administered in arm right, administration date 01Feb2022 15:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfur" (unspecified if ongoing), notes: Known allergies: Sulfur; "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?: Yes. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 01Feb2022 18:00, outcome "not recovered", described as "Chest (heart) pains". Therapeutic measures were taken as a result of chest pain. The lot number for bnt162b2 was not provided and will be requested during follow up.  Since the vaccination, the patient has not been tested for COVID-19.
Body Aches - mainly on Left side - arm and leg - muscle and joint.  Arm Sore at injection site.   Took Tylenol, symptoms subsided
A mother reported that her son received his thirds doses of Prevnar, DTP (manufacturer unknown), IPOL (Aventis) and Hib (manufacturer unknown) vaccines in May 2002 at 6 months of age and developed an ear infection in both ears in Jun2002 at  7 months of age. He was treated with Augmentin (amoxicillin/ clavulanate)and recovered. No further information was available at the date of this report. The patient also developed an ear infection in both ears following receipt of his first and second dose of Prevnar, DTP, IPOL and Hib vaccines. See MCN HQ2727714JUN 2002 and MCN Hq2846617JUN2002.
Received immunizations Thursday afternoon Friday afternoon developed redness rx BENADRYL Saturday our redness increased and strek up (R) leg and only node (R) groin rx BACTRIM.
Information has been received from a pharmacist concerning a 91 year old female with a latex allergy who on 08-FEB-2007 was vaccinated SC with a 0.65 ml dose of Zostavax (lot #656413/1477F). There was no concomitant medication. On 21-FEB-2007 the patient experienced experienced pain in her side and back and was diagnosed with shingles. Another pharmacist reported that the patient stated she was in severe pain and insisted her shingles were from the vaccine. The pharmacist did not know the number of lesions. No laboratory tests were performed. At the time of the report, the patient had not recovered. The patient never had any adverse experiences with other vaccines in the past. Shingles was considered to be disabling. Additional information has been requested.
HARD AND HOT, NOT RED, EXTREMELY PAINFUL. HURT EVEN WHEN NOT MOVING. WANTED TO PUT IN A SLING. COULD NOT SLEEP. PAIN WAS ALSO EXPERIENCED IN THE ARMPIT.