chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jun-2021 at 8:44 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Jun-2021 at 8:44 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome 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 information was provided.  Age of patient was reported as 22.17.  Batch number 008C21A underwent temperature excursion on 22-Jun-2021 with temperature 35 degrees Fahrenheit from 08:00 AM. This vial was moved to fridge on 27-May-2021 and beyond use date for the vial was reported as 26-Jun-2021. Product moved to clinic on 22-Jun-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.   This case was linked to MOD-2022-566976 (Patient Link).
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 25-OCT-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions by healthcare provider in a pharmacy. On an unspecified date, the patient experienced shingles.Subsequent to pt's inoculation, pt was treated by a healthcare provide for shingles. As a direct and proximate result of pt's use of zoster vaccine live (ZOSTAVAX) vaccine, pt has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future.   The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Pt was exposed to rabid bat on 5/7, started Rabies vaccine and RIG on 5/10. Pt  noted, at the time of injection, that this vaccine was the most painful, (had 13 ml of RIG-at other sites) of the other vaccines. On subsequent vaccines of Rabies, he did not have the same degree of discomfort. The evening of the original vaccine, he complained of pain in the R shoulder, noting decreased ROM.  The decreased ROM, perceived weakness and pain have persisted for the last 3 wk, but vaccines administered at other sites are not. Pt reports he is unable to reach up to push his garage door opener. Pt notes that he has difficulty raising the R arm higher than his shoulder.
swelling, soreness, tenderness at injection spot. A few days after injection with compress, swelling and soreness began to drain pus
Information has been received from a consumer concerning her daughter, with latex allergy and no medical pertinent history, who on 19-JUN-2009 was vaccinated with 0.5 ml of the first dose of GARDASIL intramuscularly in her left arm. On the same day the patient received one dose of MMR II (manufacturer unknown) and VARIVAX (manufacturer unknown) in her right arm. There was no concomitant medication. The reporter stated that she noticed "swelling" in the left side of her daughter's neck on 30-JUN2009. She took her daughter to see her doctor that day and the swelling was diagnosed as swollen lymph nodes. The reporter did not know when the swelling actually started. The swelling has "gone up and down" since it first started, and at the time of reporting on 09-JUL-2009 "I think it's the worst that it's ever been". Since GARDASIL was given in her left arm the reported thought that the symptoms may be due to GARDASIL. Additional information is not expected.
Vaccine administration error of Moderna, not associated with an adverse event  manufacture has been contacted no recommendations given at this time.
No treatment for side effects. Head would hurt and I would just lay down, go to sleep and when I woke up, head would no longer hurt. I experienced this each time after receiving shot.
Patient received the Prevnar vaccine, Comvax vaccine, Varivax vaccine, and athe Fluzone vaccine on 11-29-05 around 9 am.  Patient's mother called at 138 pm to report that the patient was very fussy, acting like his entire body was in pain especially the leg area.  She was advised to give a dose of Tylenol and call back in 45 minutes if there was no improvement. The patient's mother called back at 405pm to report that he had fallen asleep after the tylenol but when he woke up he is crying when any pressure is applied to the legs and was refusing to stand or walk on it, the patient's mother was advised to bring the child back in to the doctor's office to be re evaluated.  Mother returned with the patient at 7pm and was seen MD the patient's legs were found to have small red puncture marks but no swelling and the patient was doing beter by the time of the visit.
I started to have axillary swelling and pain on the same side as the injection site. I had axillary tissue removed back in 2015 and never had any issues with this arm since. There is a lump after receiving the vaccine and it's tender to touch.  There was also some numbness at times.
Patient experienced red rash, hot to touch, possible cellulitis, swollen, well below the injection site -close to elbow. Symptoms started 24 hours after immunization.
A report was received from a health professional on 16Nov01, concerning a 6 year old male pt who experienced an injection site reaction which was considered to be serious as medical intervention was required, several hours after receiving the Fluvirin vaccine on 15Nov01. Relevant medical history include eczema, and seasonal  and food allergies. The pt was received concomitant medication Montelukast sodium for over 6 months. On 15Nov01, the pt developed a local erythematous, edematous, itchy and red reaction at the injection site (approx 13cm by 13cm in area), several hours after receiving the Fluvirin vaccine. Therapeutic measures taken as a result of this event included oral Cetirizine Hydrochloride, oral Prednisolone and topical Corticosteroids. The pt experienced a similar reaction last year after receiving the influenza vaccine (brand unk). At time of report, the pt had not recovered. The reporter has assessed the relationship of the study medication to the event as probable. A follow up report was received on 13Dec01: The reporter described the events as oedema, erythema and pruritus from which the pt recovered on 16Nov01. The pt had experienced a similar reaction last year on 01Nov00. The pt additionally had a medical history of RAD and insect bites. He also was taking budenoside and salbutamol as concomitant medication. The events were not considered to be serious as per telephone conversation 17Dec01.
Friday night had mild hives itching to abdomen.  Those symptoms were resolved by Sat. morning, however EE noted mild swelling to the lip left corner of her mouth. Saturday afternoon her entire lip surface was swollen. Sunday 09/29/13 noted sweiing to her periorbital area. Monday am entire face swollen and she sought care at an Urgent Care. She was given Hydrocortisone and placed on a Prednisone dose pack.
Approximately 1-2 minutes after injection, my throat began to close and I was having difficulty breathing and speaking. Dizziness followed. I told the attendant that I needed help. They knew that I had my epipen with me. From that time on, all I recall was asking someone to use the pen. An employee successfully administered the epipen. I was then placed on the floor with my head raised as I could no longer swallow or breathe. All that I can recall from that point was speaking with paramedics at the CVS and was feeling successful results from the epi pen. I was taken to Rockledge Medical ER where they took me in immediately and administered steroids and other antihistamines.
Patient states right after she received the vaccine, she had a small "coughing spell" for the first 15 minutes. The coughing stopped. When the patient went home she noticed hives on her face and upper chest that lasted 1-2 hours and went away on their own.
Patient never got 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose 2 years ago from reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient never got 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-MAY-2023 The pharmacist reported that a patient who got the first dose of shingrix 2 years ago and never got the 2nd dose. The patient not immunocompromised. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
FELT LIKE FLU WITH LOW GRADE FEVER; This spontaneous report received from a patient via a representative, concerned a patient of unspecified age and sex. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced felt like flu with low grade fever for about 48 hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) Low grade fever. The action taken with covid-19 vaccine was not applicable. The patient recovered from felt like flu with low grade fever (dose number in series 1). This report was non-serious. This case, involving the same patient is linked to 20211253778.
Arm swelled up and became hot, started running fever, arm pain due to swelling. Doctor explained the symptoms as similar to cellulitis. Prescribed medrol dose pack and bactrim, medication helped to a degree but did not completely resolve symptoms.
HEART ISSUES AFTER THE BOOSTER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2.s (dose number series 1) (suspension for injection, route of admin, batch number and expiry date not reported) dose was not reported for prophylactic vaccination (dose series 1). Following vaccination, no adverse events associated with previous covid-19 vaccine. The patient received booster with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry date not reported) dose, 1 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination (dose number series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced heart issues after the booster (dose number series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart issues after the booster was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Information has been received from a nurse concerning a 21 year old female with no pertinent medical history or history of drug reactions or allergies who in May 2008, was vaccinated intramuscularly with a 0.5 ml dose of GARDASIL vaccine (yeast) (lot no 660389/1968U). Concomitant therapy included LOESTRIN. The nurse reported that the patient was having amenorrhea. The patient's last menstrual period was April 2008. The patient took a few home pregnancy tests and was not pregnant. At the time of this report, the patient's amenorrhea persisted. The patient contacted the office to seek unspecified medical attention. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ALLERGIC REACTION, INIT 4/1/2022 -- RECURRENCE OF SAME SYMPTOMS
Patient experienced a red, spreading rash at the injection site.  She described a "hard area" on her arm and said the rash was itchy and spreading.  She went to the ER, where they prescribed her Keflex 500mg.
Initial unsolicited pregnancy report received from consumer on 12 August 2015. A 32-year-old female patient, whose concomitant medications were not reported, had received a dose of ADACEL (batch number, route of administration were not reported) in shoulder on 11 August 2015. On 11 August 2015, same day after injection the patient had experienced sore arm. The last menstrual period was not reported and estimated date of delivery was reported as 01 November 2015. At the time of vaccination the patient was pregnant. It was unknown whether patient received any treatment for infertility and patient had no current pregnancy history. At the time of report, outcome of the event sore arm was unknown. Documents held by sender: none. Follow up report received from consumer on 20 November 2015. No new information reported.
Client received H1N1 imm in (L) deltoid. Both client & mother denied any med issues. Client did not have any immediate problems. Went with sister & stood several feet away as mother got her immunization. After approximately 2-3 minutes, sister came to mom and said her sister was dizzy. I responded immediately but client had already fainted on concrete floor. Sent to ER for evaluation. Sent home from ER - no med f/up needed.
Vertigo off and on for 2 days followed by weakness and fatigue followed by severe headache and fatigue over 5 day period
Dose 1 given 2/16/2021 Pfizer Lot # EM9809  Patient was hospitalized with Covid 19 and discharged
7.27.2018 Patient got the 2nd dose of SHINGRIX. Developed rash at injection site, swollen face, and bloodshot eyes post-vaccination. Symptoms started on 7.28.2018. She notified her doctor on 7.30.2018 regarding her adverse reactions. Doctor told her to continue with BENADRYL and ADVIL. 8.1.2018 symptoms have subsided.
Within 24 hours post vax, the pt developed a fever of up to 100.5 degrees F. The reporter indicated that as of 09//, the child's fever rose to 102.2 degrees F.
Fatigue, chest pain, cough, shortness of breath, shortness of breath, choking sensation, burning sensation in the chest and heart, headache, pain in the throat.
Pt. reported swelling, erythema, tenderness. Was seen by MD- recommended diphenhydramine @HS and cool compress. No hospitalization.
A report has been received from a Health Professional concerning a patient born on 27-Jan-2010, Male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 17-Jan-2013. The Health professional reported that she had been accidentally administering expired FLUMIST to patient. The outcome of the event of ADMINISTERING EXPIRED FLUMIST/WE HAVE BEEN ACCIDENTALLY ADMINISTERING EXPIRED FLUMIST TO PATIENTS is unkonwn. The report was considered to be non-serious. Summary of follow-up information received by Astrazeneca / MedImmune 31-Jan-2013 from a consumer: Form completed date was updated. Reporters information updated.
Swollen arm; Feeling hot; Painful arm; Rash is less severe; Itching at injection site; Allergic reaction; Rhinitis; myalgia; arthralgia; Fever; Redness; Cough; Edema; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Painful arm), COUGH (Cough) and OEDEMA (Edema) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: SPIRONOLACTONE since 2003, CRESTOR since 2012, CO Q-10 since 2012, SINGULAIR since 2019, VIT D [COLECALCIFEROL] since 2019 and ALLEGRA (2o+ years) since an unknown date. Concurrent medical conditions included Drug allergy (omnicef,chlorhexidine) and Asthma. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol levels raised, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and MONTELUKAST SODIUM (SINGULAIR) for Seasonal allergy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency, SPIRONOLACTONE for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced COUGH (Cough), OEDEMA (Edema), RHINITIS (Rhinitis), MYALGIA (myalgia), ARTHRALGIA (arthralgia), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Redness). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Painful arm), HYPERSENSITIVITY (Allergic reaction), RASH (Rash is less severe) and VACCINATION SITE PRURITUS (Itching at injection site). The patient was treated with PARACETAMOL (TYLENOL) on 24-Feb-2021 for Fever, at a dose of 1 dosage form and PREDNISONE ongoing since an unknown date at a dose of 20 milligram. On 08-Mar-2021, COUGH (Cough), OEDEMA (Edema), RHINITIS (Rhinitis), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Redness) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm), FEELING HOT (Feeling hot), PAIN IN EXTREMITY (Painful arm), HYPERSENSITIVITY (Allergic reaction), RASH (Rash is less severe) and VACCINATION SITE PRURITUS (Itching at injection site) outcome was unknown and MYALGIA (myalgia) and ARTHRALGIA (arthralgia) had resolved.            For asthma patient using breo inhaler and albuterol inhaler. Patient took CO Q 10 200 g  orally once daily from 02/2012 used for statin as concomitant.
A nurse reported the occurrence of injection site swelling in an approximately 2 year old male  who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were unknown. The subject experienced no adverse events following previous immunizations. In approximately March 2003, the subject received his fourth injection of Infanrix. Within 48 hours post immunization , he developed swelling of the upper thigh into which the vaccine had been administered. The swelling resolved after an unspecified period of time.
After my second shot, my menstrual cycle shortened to 18 days, from start of cycle to the beginning of the next cycle. My periods were  heavier and much more painful than they had been. This lasted for 3 months (4 cycles). This past cycle seems to have returned back to relatively normal.
Nursing was at a vaccine outreach for public school administering several vaccine including flu shots. The influenza vaccine was in labeled zip lock bags in a cooler. This nurse grabbed for a regular influenza vaccine, but picked from the wrong bag and got a high dose influenza instead. The syringes for regular and high dose look very similar. The lot and expiration sticker was removed from the syringe. It was needled and then administered to the client's left deltoid. Well tolerated. Client then returned to class.  When the nurse returned to the clinic a few hours later to chart the vaccines administered at the outreach it was noted that a high dose vaccine was administered. This nurse reported to her supervisor. Called the school and spoke with the school nurse. The school nurse checked on the patient and she was "fine". This writer notified the client's physician and mother.  This writer called the mother this morning and she reports patient did complain of a sore arm today. Mother gave her Tylenol. No other complaints or side effects noted.
4-9-13 child woke up with blisters in mouth, bruising easily. Seen by PCP 4-9-13. Seen by PCP 4-11-13 - Blood work done referred to hospital 4-12-13 - Diagnosed with ITP.
immature granulocytes on CBC on 5/2/2022 and again on 11/7/2022.  Alkaline phosphatase 155 on 5/2/2022 and 158 on 11/7/22
itching all over, no hives or rash. No wheezing. TX self with OTC Benodryl.
After the 1st dose on 5/11/21, patient experienced a fever (99.6 to 102), rash at the injection site which then started itching, sinus pressure, chest/lungs were hurting.  After 2nd dose on 6/1/21, patient experienced a low grade fever (not as bad as the first dose), sneezing, coughing, congestion like she had COVID virus (she had covid twice previously), and raspy voice and throat. Shingles like symptoms started two weeks after her vaccine. Patient started having higher blood pressure readings (i.e. 161/102). The vaccine side effects are still going on for the patient after 15 days.   Patient stated her cardiologist increased her blood pressure medications. Patient stated that she also felt like her amyloid level was increasing and she did get that confirmed with her optometrist.
pt states couldn't move rt arm p/vax; pain in back of neck , arm & shoulder; can't do anything to make self comfortable; some redness & swelling @ site; no temp; pt consulted MD;
slept for 36 hours after vaccine very deep sleep a few weeks later began having ringing in right ear and significant vertigo - did not initially link to vaccine