chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain after getting the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain after getting the vaccine). At the time of the report, PAIN (Pain after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medication details not provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Follow up received. Reporter address updated.
Left arm redness and swelling, no fever, taking TYLENOL for pain. Also BENADRYL for itching. To be seen if worsens.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 12-MAY-2016 the patient was vaccinated  with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion two times. The total cumulative excursion time of the first time was 168 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 31 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
No adverse event; A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022, Date(s) of administration of vaccine were 26-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022, Date(s) of administration of vaccine were 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 014F21A, 030L20A and 025L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022, Date(s) of administration of vaccine were 26-Jul-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022, Date(s) of administration of vaccine were 26-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (A pharmacy staff reports that they inadvertently administered 51 doses of the monovalent vaccines/ expiration date 13Jul2022, Date(s) of administration of vaccine were 26-Jul-2022).    No concomitant medications was reported. No treatment drug details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704260 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704260:Master case
CDIP/IgM Kappa MGUS. Patient has had progressive weakness and gait instability since 11/21. The patient states his symptoms began shortly after receiving an additional COVID vaccine dose.  First step was IVIG. If symptoms not improved, the plan was to treat with rituximab 375mg/m2 weekly for four weeks.
Ocular migraine--It was intense for about 45 minutes.  It cleared up significantly as the day progressed.  However, I was left with cloudy or snowy vision that still exists today.    I also experienced tingling around the mouth and lips.  I called my primary care doctor.  They said it was a possible side effect of the vaccine.  I should contact my eye doctor, if it was not better in 3-5 days.  I went to the eye doctor, as instructed.  They completed all kinds of tests. I was told there is no way to determine if there is a direct correlation with the vaccine. I decided to self report.  Doctors office seemed reluctant to  do so.
Info has been received from a physician concerning one pt with an egg allergy who was vaccinated, SC, with a 0.5 ml dose of varicella virus vaccine live. Subsequently, the pt experienced an allergic reaction following vaccination. Unspecified medical attention was sought. The pt required hospitalization. It was reported that the pt recovered. No further info was available. No product quality complaint was involved. Additional info is not expected.
Small round lump swollen at site of injection. Sore and achy to the touch, but not red. Slight soreness and ache within the shoulder joint hours later. Swelling within the shoulder jointfollwed with pain. Increasing unexplained pain within the shoulder joint. Great pain within shoulder joint and inability to raise or turn or twist left arm to normal range. Unable to bear weight or sleep well or exercise or swim. Exeriencing numbness and tingling in fingers of left hand. Aching down my arm to elbow and to mid-forearm. Continued aching and great pain within the shoulder joint. See below for treatment.
COVID 19; COVID 19; Dose 1, dose 2: Moderna, Dose 3: Pfizer: Dose 4: Moderna, dose 5: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9695) at the age of 40 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Mar2021 as dose 1, single (Lot number: 036A21A), in left arm, on 05Apr2021 as dose 2, single (Lot number: 026B21A), in left arm and on 04Apr2022 as dose 4 (booster), single (Lot number: 027L21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Eggs" (unspecified if ongoing), notes: known allergies: Eggs; "Sunflowers" (unspecified if ongoing), notes: known allergies: Sunflowers. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Oct2021, outcome "unknown", described as "Dose 1, dose 2: Moderna, Dose 3: Pfizer: Dose 4: Moderna, dose 5: Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" (29Jan2023) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (29Jan2023) Negative; (31Jan2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid from 23Jan2023 to 28Jan2023, Lot number: GF7317 used for treatment of COVID-19. Covid Reinfection, Confirmed positive via test on 02Feb2023. Initially took Paxlovid on 23Jan2023. Tested negative on 29Jan2023. Tested negative again on 31Jan2023.
sinus surgery; This daughter got really sick after the first doses; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A female 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. Past drug history included: Motrin, reaction(s): "allergic"; Tylenol, reaction(s): "allergic". The following information was reported: SINUS DISORDER (medically significant), outcome "unknown", described as "sinus surgery"; ILLNESS (non-serious), outcome "unknown", described as "This daughter got really sick after the first doses". Therapeutic measures were taken as a result of sinus disorder.  Additional information: Reporter asked in pregnant ladies Pfizer also, okay and that's the one patient was receiving. Side effects have been lower. She waited in line nine house cause they were going to [DEIDENTIFIED] and no virus was going to keep [DEIDENTIFIED]. Reporter stated before patient second dose we did a pretreat with some. Patient the one that had three hundred thousand dollars' worth of sinus surgery that came out of nowhere.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events sinus disorder and illness and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Rash where injection site is; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Rash where injection site is) in a 31-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced INJECTION SITE RASH (Rash where injection site is). At the time of the report, INJECTION SITE RASH (Rash where injection site is) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by the reporter. Treatment information was not provided by the reporter.
Patient was given updated pfizer as a first dose instead of original pfizer vaccine. There were no adverse events or signs or symptoms.
On third day after eight vaccinated, I developed a round, raised wheal about 3 inches below the  injection site. It was very warm to the touch. Thenext day, this same wheal had grown larger in diameter,  and was a deeper color. I saw an MD at an urgent care the following day. She said it was an infection from the vaccine,  and could abcess.
Patient experienced swelling, redness, itching at injection site with red welts down the arm about 45 minutes after injection. Symptoms went away after about a day. One week later, patient is experiencing redness, swelling and itching at injection site again.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, strength, frequency, lot# expire date, route were not reported). No concomitant medications reported. The physician stated that he had ben administering (confirmed not GARDASIL 9) to an unspecified number of patients greater than 26 years of age (Inappropriate schedule of vaccine administered). No adverse effects were reported. Product quality complaint was not filed. Additional information has been requested.
Hives (rash, itching, & swelling) under left armpit around noon on 08/06/2021, By 5pm both underarms were circled with hives.
On the day of the vacinnation (Monday, 11/14/22), I went to bed around 11 pm. I was feeling some chills but otherwise ok.  I wasn't sleeping very well and around 3 am I had to get up with significant chills, body aches, and nausea/vomiting.  Fever up to 101 F.  Didn't have much in my stomach but every time I tried to drink some water it would come back up.  Mostly dry heaves.  I spent most of that day (Tuesday 11/15/22) feeling much the same.  Fitful sleeping.  Tried to drink as much as I could.  Mostly small quantities of water and diluted apple juice. Acetaminophen to reduce fever and body aches. Gradual improvement in symptoms Wednesday, Thursday and Friday.
Pt received her vaccine and completed the 15 minute observation period with no adverse event.  She felt dizziness upon standing.  She drank a bottle of water, but remained dizzy.  Pt was escorted to the restroom by medical reaction nurse, at which time she reported ongoing dizziness.  She was brought to medical observation unit at 2:33pm.  Associated symptoms included shortness of breath.  SPO2 was 86 upon arrival to medical observation unit.   2:39pm- pt reports resolution of SOB; 2:44pm- pt reports resolution of dizziness while lying supine; 2:52pm- pt reports slight lightheadedness while sitting upright; 3:00pm- pt denies dizziness/lightheadedness while sitting upright; 3:02pm- pt denies dizziness/lightheadedness while standing  PT discharged home at 3:04 by herself  Vitals as follows: 2:34pm- HR- 74, RR- 18, BP- 174/75, SPO2- 96 2:39pm- HR- 66, RR- 16, BP- 166/90, SPO2- 97 2:44pm- HR- 69, RR- 18, BP- 147/93, SPO2- 96 2:52pm- HR- 69, RR- 18, BP- 164/80, SPO2- 95 2:55pm- sitting- HR- 70, RR- 16, BP- 156/96, SPO2- 96 3:00pm- sitting- HR- 70, RR- 16, BP- 151/85, SPO2- 97 3:02- standing, HR- 79, RR- 16, BP- 144/86, SPO2- 96
PATIENT DEVELOPED AN ITCHING SENSATION TO HER THROAT WHICH SHE THOUGHT WAS GOING TO GO AWAY, BUT IT IS CONTINUING TO LINGER.
Flu like Symptoms ,  Headache , Tired ,Chills. Symptoms gone the next Day
Information has been received from a physician concerning a 23 month old male patient who on 11/20/03 was vaccinated IM in the right thigh with a dose of varicella virus vaccine live (lot # 646230/0541N). On 7/13/04, the patient presented with a mild zoster like rash under his left arm. No other symptoms were noted. Unspecified medical attention was sought, but treatment was not required. PCR testing was offered, but declined. At the time of the report, the rash was crusted over and healing. A product quality complaint was not involved. Follow up information from the physician indicated that the patient was seen in the clinic on 7/13/04 with multiple papular and vesicular lesions in his axilla along T1 dermatome, which started on 7/9/04. The patient was diagnosed with  herpes zoster. Subsequently, the patient developed similar lesions on his left axilla, same dermatome and a couple other lesions in other areas which was diagnosed as chicken pox. The patient was treated with Acyclovir for 5 days. The lesions cleared but the patient developed a few lesions on his abdomen. The diagnosis was then changed to impetigo and lesions were treated with mupirocin. No further information is expected.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 30-APR-2019, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number reported as R021930 with expiration date in 18-JUN-2020) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  Lot number R021930 is an invalid lot number for Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1906USA011434: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA001847: US-009507513-1907USA000952: US-009507513-1907USA000989: US-009507513-1907USA000962: US-009507513-1907USA000988: US-009507513-1907USA000963: US-009507513-1907USA000953: US-009507513-1907USA000959: US-009507513-1907USA000968: US-009507513-1907USA000967: US-009507513-1907USA000964: US-009507513-1907USA000966: US-009507513-1907USA000954: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000965:
Breakthrough case admission after 3 vaccines Moderna 1/22/21 Lot# 037K20A;  Moderna 2/19/21 Lot# 037K20A;  Moderna 11/20/21 Lot# 052E  THIS IS THE LOT # AS LISTED IN DATABASE
Started feeling tired and drained around 10pm the same day of receiving the vaccine and then after going to bed around 11pm I felt body aches, chills, and I assume I had a fever. I could simply not get warm or comfortable and tossed and turned for hours. Felt like I had the flu. Finally fell asleep around 2am. Woke up the next morning around 6:30am and took Tylenol but no longer had a fever or chills. I felt drained and tired throughout the whole next day but unsure if that was vaccine related or simply due to lack of sleep. Slept fine that evening and had no other effects.
Developed cellulitis 7 1/2 x 9 1/2 cm to left posterior arm.
3 days of severe flu like symptoms... running nose, runny eyes, dry cough, severe fatigue
Severe injection soreness, headaches, tiredness  and on  & off temperature up to 101.3
This spontaneous report was received from a pharmacist via an unspecified person in leadership of the company and field representative and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions and concomitant medications were unknown. The patient was immunocompromised. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU vial (lot and expiry date not reported) reconstituted with sterile diluent (Manufacturer unknown) injection (lot and expiry date unknown) for prophylaxis. Pharmacist mentioned that on an unknown date after vaccination, the patient died due to an unknown cause. Causality assessment was not provided. Upon internal review, death was considered to be medically significant. Additional information has been requested.; Reported Cause(s) of Death: unknown cause of death.
tingling sensation on the injection site to the thumb.; numbing; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported for a male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On an unknown date, the patient experienced numbing and tingling sensation on the injection site to the thumb. The outcome of the events was reported as unknown.  Follow up attempts are needed. Further information has been requested.  Follow-up (22Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Suspect product BNT162B2 recoded appropriately.
Fever - 101.0F Chills Headache Fatigue Bodyaches  Symptoms have been treated with Tylenol.  Most of the symptoms still linger; however, the fever did break earlier.
On the day she received her second Pfizer COVID-19 vaccine, she began to experience severe bilateral upper outer breast/axillary pain with swelling the next day. Experienced such severe breast pain with mild swelling that she was unable to rest or tolerate her breasts hanging without support/lift. SHe denies any redness or nipple discharge. Also has felt worsening diffuse joint pain, fatigue, and depression since second COVID-19 vaccine.
Child mother stated she had vomiting 2 1/2 days, fever, H.A., pain at site and swelling. Onset 7:30 PM on 11/15/10-through Thurs. 11/18/2010. did not see her PMD. Stayed home from school for the week per mother.
Pt was given Covid-19 vaccine (unknown brand) then came to see me for upper back pain, chest pain and sob. pt was sent to ER.
Had COVID vaccine on Wed Feb 3,  had seizure-like symptoms last night,  her body mostly went stiff, happened at least 3 times during the night.  Was very limp afterwards;  has not had any issues since waking up this AM,  has headache and body aches.
patient received Pfizer COVID booster; Mild headache; body aches for 12 hours; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 43 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 43 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown; manufacturer unknown), when the patient was 43 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "patient received Pfizer COVID booster"; HEADACHE (non-serious), outcome "unknown", described as "Mild headache"; PAIN (non-serious), outcome "unknown", described as "body aches for 12 hours".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.