chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-526778, MOD-2022-526820, MOD-2022-526823 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2022: Non-significant follow up appended. No new information was added
I have "covid arm"--a rash on the arm where I received the shot. I noticed it about a week after receiving the injection.
Went home after the standard 15 mins of waiting, my throat was scratchy but I didn't think anything of it. Took benadryl and within 3 hours it was much worse and felt like it was closing. Shortly after I began having asthma attacks, couldn't breathe and couldn't stand up without feeling like I would pass out. Had to use my nebulizer just to get a good breath. This went on for about 6 weeks, where I would need to use my nebulizer every 4 hours like clockwork, until recently it has dropped to about once a day. Previously, I was not using it ever except in the need of an emergency. I still cannot breathe as well as I could prior to the shot. This made exercising and caring for myself extremely difficult. I was unable to even go on a short walk without having to come home (would only be able to go .25 miles before needing to turn around).   With the first shot, Moderna on 9/23/21 lot number 045C211A, I had the chest tightness, but not as bad, and headaches and migraines daily up until the second shot. Once the second shot happened, the lung problems overtook everything else
15 min after vaccination patient complains of tachycardia, headache and general feeling unwell.  Instructed patient to put head between knees and to lie down if need be. Patient requested we call 911. Advised pt to sit until paramedics arrived. Went they arrived pt walked up to them at the front of the store. Patient states he did not need to go to hospital because vitals were WNL. Followed up with patient @ 1300 and patient is fine, no more side effects.
about 5 mins after receiving the vaccine-patient completely pale, eyes rolled into the back of her head. her face almost looked as it was shaking. she basically passed out. pt came too and was fine. the paramedics came and assessed pt. her mother thought she was well enough to go home.
Patient got dizzy a couple minutes after the shot, got up from chair and seemed to lose consciousness and stumbled to the ground.  Pharmacist ran over and checked on patient. patient was responsive immediately after fall but was still confused, etc.  911 was called and patient walked out with the paramedic.
Administered 4/19. 5/2 - Small red area (less than quarter size). 5/3 - Enlarged red area - no pain/itch, oblong shape. 5/4 - Same size, but no longer red.
A request has been received from a Health Professional concerning an 8 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on an unknown date. It was reported that patient was accidentally administered expired FLUMIST Quadrivalent to a patient on 11-DEC-2014. The outcome of the event of accidentally administered expired FLUMIST Quadrivalent to a patient is unknown. The report was considered to be non-serious.
The injection was administered in my right deltoid muscle.  The site began to ache, then swelled up, turned red, became hot, forming a solid red welter.  The symptoms spread down my biceps muscle, and I had difficulting moving the arm.  That evening I had a temperature of 99+ degrees, felt milding nauseous, and had difficulty sleeping. I awakened the next morning with a right biceps that looked like Popeye the sailor man's.  The back of the arm was (and still is) red and painful.  Although I can now move my arm, the facial region at the top of the radius and ulna are swollen, but white (in contrast to the reddened muscular regions above my elbow).  I reported this to my doctor's phone line early on, but have yet to hear back.  I cannot find anything useful on the web (which is interesting and a bit alarming).  From the little I have found, it appears that this is an allergic reaction to the PPSV 23 vaccine.  I'm wondering if it would have/would helped to take an antihistamine (e.g., Benadryl),but have not done so because I do not want to impede the immunization process.
Patient began to notice rapid HR alerts on her smart watch HR >200 Felt SOB, dizzy sometimes with rapid HR- Events usually happen with dancing- hip hop contemporary- on a dance team per smart watch, first event HR was elevated Sept 26- 193 , Nov 28th was 200  increasing events the last few weeks, but preparing for a dance competition  has not counted peripheral or central pulse
No side effects. No medical adverse event; Patient given an VARIVAX injection during Temperature Excursion.  No side effects.; On 01-AUG-2023, 1 day after onset of therapy the patient experienced product storage error.  On an unknown date the patient experienced no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to varicella virus vaccine live (Oka/Merck)(VARIVAX).     This spontaneous report was received from an office manager and refers to a 22-month-old. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 01-AUG-2023 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection, one time, lot #u025202, expiration date: 13-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided) in the left arm.  The administered dose of the vaccine experienced a temperature excursion on 27-JUL-2023. Temperature and time ranges not reported.  There was no adverse effect reported. No product quality complaint was involved
Patient has no issue with first dose of vaccine on 02/25/2020, but noticed nearly 24 hours after her 2nd dose that she had a 2 inch red circle of inflammation around the injection site. It is warm to the touch, does not itch, is not painful to the touch. She reported standard arm soreness with IM injection. She is using ice to help reduce the swelling and unfortunately cannot take NSAIDs d/t an allergy.
About a week after receiving the vaccine, I went to the ER and was diagnosed with costochondritis, inflammation of cartilage in chest. It hadn't subsided a week later, so I contacted my rheumatologist. I was put on prednisone for a month and methotrexate. The methotrexate affected my kidneys and liver, so I had to stop taking it. I am now barely able to get out of bed due to the inflammation being so severe. I have been trying to avoid going back on steroids.
Itching, redness, rash, bumps affecting hands, arms, face, neck, head, shoulders, back, feet, eyes, ears, lower abdomen (ongoing as of 12/12). Seems to be worsening.
The patient came into the pharmacy and reported experiencing loss of hearing a few days after receiving the second moderna vaccination.  She has been to an ENT.
Severe diarrhea; body ache; pain in the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Severe diarrhea), MYALGIA (body ache) and VACCINATION SITE PAIN (pain in the injection site) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 942371) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2020 and COVID-19 in October 2020. Concurrent medical conditions included Celiac disease and Gluten sensitivity.    On 09-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Severe diarrhea), MYALGIA (body ache) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, DIARRHOEA (Severe diarrhea) and VACCINATION SITE PAIN (pain in the injection site) had resolved and MYALGIA (body ache) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient height was reported as 5.3. Events Intestinal issues,  Abdominal pain upper, Asthenia ,Pyrexia and Vomiting are subsumed under the event Diarrhoea. It was reported that patient was taking thyroid medication, acid reflux medication and blood pressure medication. Patient was allergic to all pain medications & preservatives in medications. Patient had intestinal issues, low grade fever, pain in the injection site, severe diarrhea and real bad stomach cramping. This went for hours and hours. Throwed up. She experienced this with every vaccine. This were the same symptoms that she experiences when she was contaminated with gluten. Patient received Dose Number: 1 of Moderna with Lot number: 026A21A on 09Mar2021 Patient received Dose Number: 2 of Moderna with Lot number: 038A21A on 12Apr2021 Patient received Dose Number: 3 of Moderna with Lot number: 032F21A on 25Oct2021 Patient received Dose Number: 4 of Moderna with Lot number: 0542AA2on 18May2022  No treatment information provided   This case was linked to MOD-2022-657008 (Patient Link).
Rash and flushing of skin; Flushing of skin; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the right arm on 23Mar2021 at 08:30 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included thalassemia beta, Hashimoto's (thyroid) and allergic to tree nuts. Concomitant medications included magnesium vitamin C (MANUFACTURER UNKNOWN), vitamin B complex (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and probiotic nos (MANUFACTURER UNKNOWN); all for unspecified indications from unknown dates. The patient previously received betamethasone (MANUFACTURER UNKNOWN) and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021 at 17:00, the patient experienced rash and flushing of skin. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the rash and flushing of skin were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On 20-MAY-2013, the patient was vaccinated with ZOSTAVAX (lot # J000443 and expiry date 11-APR-2014) (dose and route were not reported). No concomitant medication was reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. At the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX were administered. The reporter called back again on 05-NOV-2013, and stated that he thought the ZOSTAVAX might had been stored improperly since May 2013 and that the temperature of the ZOSTAVAX had ranged between 15F and 20F for an unspecified amount of hours. At that time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would had been administered. On further investigation, the pharmacist reported that ZOSTAVAX had been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effect. Further investigation stated that the pharmacist had determined that this case might involve approximately 5 different lots of ZOSTAVAX (details unspecified) stored improperly at temperatures up to 21F. He stated the time frame for the excursions would be as of the day each of the ZOSTAVAX lots was received at his facility through the date of patient administration, which he believed might had been months, dating back to an unknown date in May 2013. These involved approximately 40 patients. He had no specific breakdown of time frame as his records didn't indicate when he received each lot but he was calling further for the data. He also could not identify, at this time, which Lot# was administered on which date. Pharmacist would call back after he had compiled all of the necessary information and would like revaccination recommendations for any excursion that could not be supported. Pharmacist stated there had been no adverse effects noted by any of the patients. The pharmacist faxed a spreadsheet which included the 38 patients names, the date of administration as well as the lot and expiration dates of ZOSTAVAX which was unsupported an administrated. This is one of several reports from the same source. Additional information has been requested.
Red Rash on Left Neck, Left Hairline. Patient reported some pain (3-4 on pain scale) associated with affected area. Rash appeared, progressed, and then slowly improved with treatment with Valacyclovir 1 gram TID x 7 days initiated on 11/11/13 by Urgent Care.
Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion).    No concomitant product was reported.  It was reported that the facility had a temperature excursion in the freezer, the DDL was not recording the temperatures. Patient received the vaccine after a temperature excursion. Storage condition at the time of the excursion was frozen. Temperature was unknown and only manual recording of temperature was done twice a day. Vials were within unbroken cartons and were of the size 2.5 ml and 5.5 ml. The vials were returned to the freezer and were still frozen.  No treatment information was reported.
Received DTap in Left arm 7/10/06. Noted swollen size of baseball, hot and bright red. Seen in office on 7/13/06 pink, slight warm to touch, decreased size, DX'd immunization reaction VS infection. RX for Keflex provided to be used only if increased redness, tenderness, fevers.
Patient received PREVNAR 13 (Pneumococcal conjugate) vaccination on Jan 22nd 2016, and approx. 1.5 hrs later she developed some redness at and around the injection site on her left upper arm (deltoid) the redness spread with itching and hot to the touch. Patient was seen on Jan 27th for skin rash and treated with KEFLEX for 7 days for skin infection/cellulitis. Rash (macular) extends from just below left shoulder to about 8 cm above the elbow. No joint swelling or fever or chills, sore to the touch.
having some arm soreness at the injection site after getting the vaccine; This is a spontaneous report from a consumer (patient). An 84-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On unknown date, the patient experienced arm soreness at the injection site after getting the vaccine. The outcome of the event was unknown. Information about lot/batch number has been requested.
Besides the aches, pains and fatigue I also had a sore throat & ear ache (right side only). This is probably something underlying that my immune system was suppressing and became apparent after the vaccine, Seems to be clearing up now?
101+F Fever, severe chills, severe body aches, moderate headache, moderate lethargy, inability to think clearly.  Onset 10 hr after injection and persisted 2 days.
Patient was dizzy and then passed out. It was two minutes after vaccination   that patient passed out. Patient was pale and clammy.
Vaccine reaction 1 day after the administration. Swollen lump 6" x 4" left arm, with redness and itchiness.
The first 24 hours Chills, headache,body aches; 30 hours of itching at injection site; golf size lump at injection site ; reddness size of golf ball at injection site. 40 hours later still here,still itching and tender but not any larger. The itching and swelling started within an hour of feeling much better from the first 24 hour symptoms of headache,chills etc.
big red area on arm; a litte swollen; Fever in arm/ arm was really hot; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), ERYTHEMA (big red area on arm), PERIPHERAL SWELLING (a litte swollen) and FEELING HOT (Fever in arm/ arm was really hot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 030M20A) for COVID-19 vaccination.     no medical history was provided by the reporter.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FEELING HOT (Fever in arm/ arm was really hot). On an unknown date, the patient experienced ERYTHEMA (big red area on arm) and PERIPHERAL SWELLING (a litte swollen). At the time of the report, PAIN IN EXTREMITY (Sore arm), ERYTHEMA (big red area on arm), PERIPHERAL SWELLING (a litte swollen) and FEELING HOT (Fever in arm/ arm was really hot) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment and concomitant edications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: NNI
This spontaneous report was received from a 56 year old female patient regarding herself. Concurrent condition and medical history were not reported. On 07-JUL-2015, the patient was vaccinated with ZOSTAVAX (lot # and expiration date were not provided) subcutaneous, dose was unknown. Concomitant medication included unspecified medications for unspecified reasons. On 10-JUL-2015, the patient started noticing a red dot around the injection site, she thought it was a bug bite, but then she started noticing new red dots after a few days, until she had five or six red dots around the injection site. She called her provider, who stated to use NEOSPORIN on the site (also reported as the patient did not received any treatment). At the time of the report, the patient was still seeing red dots appearing. The reporter would refer back to the provider for an appointment. There were no lab diagnostics studies reported. The reporter did not provide if the red dots around the injection site were related to ZOSTAVAX. Additional information is not expected since no contact details were provided.
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 2:01 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 1:40 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses 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.   No concomitant product reported by reporter.  The reported condition of the vial was not frozen.   Dose taken on 28-Feb-2021 with batch number 014M20A underwent temperature excursion twice on 28 Feb 2021 till 27 and 26 degrees Fahrenheit at 09 AM and 01 PM. Vaccine was moved to fridge on 24-Feb-2021 and Beyond Use Date for the vaccine was 26 Mar 2021. Product moved to clinic on 27-Feb-2021. Age of the patient at the time of vaccination was 81.02 years.  Dose taken on 28-Mar-021 with batch number 019B21A underwent temperature excursion on 28-Mar-2021 till 35 degrees Fahrenheit at 10 AM. Vaccine was moved to fridge on 23-Mar-2021 and Beyond Use Date for the vaccine was 22-Apr-2021. Product moved to clinic on 27-Mar-2021. Age of the patient at the time of vaccination was 81.09 years.  No treatment medication reported by reporter.