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 PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 11:29 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 11:29 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as 68.97.  Concomitant products were not provided.  On 03-Nov-2021 vials were moved to clinic. On 05-Oct-2021 the vaccines were moved to fridge. On 03-Nov-2021, the vial underwent the excursion on the following timing: at 10 AM temperature was 35. The vaccine beyond use date was reported as 05-Nov-2021.  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 traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  It was reported that, the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
pt recvd vax & arm was swollen, red & hot; exp nausea, headache w/ t 100 x 3 days;
This spontaneous report was received from a certified medical assistant concerning to an unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On an unspecified date in January 2015, also reported as since 09-JAN-2015, an unspecified number of patients were vaccinated with PROQUAD (Merck), subcutaneously (dose, strength, frequency and lot number were not provided) which underwent supported temperature excursions. Co-suspect or concomitant therapies were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
My left shoulder is bigger than the right, slowly the center of my head behind my nose I started having a pulsating sensation and I told my doctors and couldn't put it together and my voice changed, and I get hot flashes and I've not had a hot flash in 15 years. Now I've progressively gotten pressure in my head and it's getting worse and worse going down back of my head into my spine. I had an MRI done yesterday. I'm in so much pain in my head now.  2nd dose vaccine was taken 1/27/2021
She got her vaccine, her arm hurt like about 20 minutes later.  She went to bed that night, had no problems, woke up around 3:30 with the most excruciating headache that she ever had in her life.  She has no history of sinus problems, no history of headaches.  She had shooting pain, throbbing between her eyes.  A couple of hours later she started having heart palpitations, racing of her heart, wondering if she had to go to the ER.  It would then slow down and then beat faster, and felt like her heart was going to come out of her chest pain.  It was different and very uncomfortable and felt like she had a weight on top of her chest.  She then got chills, like crazy and persisted and stayed.  She took Tylenol to get rid of the headache, then took a Motrin which nothing helped.  The headache persisted for 24 hours.  The heart palpitations and the chills lasted for about 3 days.  She is going to see her PCP with her heart, but feels that there is something there that she is not familiar with.   There is something different from her normal feelings.  She never had a fever, just the persisted chills.  Most of the symptoms lasted for about a week, the last bulk lasted for 72 hours.    She has never had a problem with her other COVID vaccines.
Child had three doses of Prevnar but did get Pneumococcal bacteremia on 8/19/02.  Had fever on 08/19/2002.  Treatment: Rocephin
No addional AE reported; a dose of PROQUAD was administered to the patient on 10AUG2022 after experiencing a temperautre excursion; This spontaneous report has been received from a medical assistant, referring to a patient with unknown age or gender.   The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 10-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliter (dose, vaccination scheme, frequency, route of administration and anatomical site of injection were not provided) (lot number U031560 has been verified to be a valid lot number with expiration date on 06-APR-2023), administered as prophylaxis.   It was reported that the vaccine was administered after temperature excursion occurred (improper storage of product in use). No additional adverse event reported.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2208USA004819: #02224251 US-009507513-2208USA004963 #02224316 US-009507513-2208USA005443: #02224322 US-009507513-2208USA005345: #02224333 US-009507513-2208USA005272:#02224325
patient had syncopal event after admin of all 3 vaccines. Easy to arouse but took approx 45-60 min to recover
Severe Abdominal pain starting 10/28/21. Elevated wbc count. Appendicitis with localized peritonitis resulting in appendectomy
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Chills-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: AFTER ADMINSTING THE VACCINE, IN FEW MINUTES PT STARTED CRYING, SHE HAS SHORT OF BREATH, Dizziness / Lightheadness, MILD RASH ON CHEST TRIED GIVING HER BENADRYL OR EPIPEN, PT REFUSED, SHE SAID SHE WAS FINE. CALL 911, PARAMEDICAS CAME CHECKED VITALS SHE WAS OK, SHE REFUSED TO GO TO ER. PATIENT LEFT PHARMACY AFTER 1/2 HOUR WALKING. PT WAS STABLE.
Patient complained after receiving flu shot (AFLURIA) of tingling, waited 20 minutes, after 1 hour everything was alright.
Patient began with what was assumed an injection site reaction approximately 3 hours after vaccination. After 4 days of symptoms of redness, swelling, soreness, spreading rash and pain the patient went to her pcp and they prescribed an antibiotic which has helped with the redness as well as recommending  advil and an antihistamine. She is now tracking the rash movement as it is going down her arm. The physician believes that this may be an allergic reaction to the vaccine.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender.  The patients medical history, concurrent conditions and concomitant medications were not reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of ROTATEQ, orally, from lot M040267 with expiry: 14-MAY-2018, for prophylaxis (dose and anatomical location not reported). The vaccine lot had a temperature excursions of -1.7 degree Celsius for 1 hour and 10.8 degree Celsius for 2 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA001439:
GIVEN EXTRA DOSE OF MEN ACWY.  REPORTED TO VAERS.  CONTACTED PATIENT TO COME IN FOR SECOND MEN B ON JULY 13, 2023.
4 days after TDAP developed persistence loss of vision left eye-followed by right parietal headache. Seen in immediate care with history of eye coming in and out of focus. 10/23 complained of left side of body heavy or weak and exam showed decrease strength left side of body and mild ataxia left hand. Saw 10/28/08 neurologist diagnosed migraine with focal neuro deficit 2 degree to TDAP subsequent neuro visit (s) diagnosis has been referred too as complicated migraine and weakness. Has been treated with PLAVIX PERIACTIN MOTRIN.
pt recv vax 27OCT95 & 20MAR97 pt devel a macular papular rash w/8 to 10 lesions;pt was seen @ MD office & dx w/varicella;
Patient received vaccine first dose For Covid-19  at approximately 10:15 AM. Around 10:23 AM, patient reported feeling nauseous had a trashcan next to them and vomited several times. Also stated short of breath at which two puffs of albuterol rescue inhaler was administered. Temperature at that time was 96.6°F and was taken back to the room around 10:45 AM. No rush or swelling of the lips and face was observed.
Received TC from mom. She was in ER with client requesting list of vaccines given 10/14/09. Client had rash on both arms. Chest pain and swelling in both arms. 10/20/09 TC to mom. She stated ER/MD said client had infection in both arms. L arm was worse. Placed on CEFTIN tabs x 7 days.
Pt woke on 6/18/15 at 11 pm screaming, not moving, then started jerking for at 5 min, no fever.
Patient's symptoms started out with overall irritability, low-grade fever and increased fatigue, noted by increase in naps. The symptoms persisted and intensified over night and into the next morning, with the fever rising to 103.5 degrees F by late morning. Dr. was called and advised administering Tylenol or Ibuprofen, however parents preferred a holistic approach. Consultation with a homeopathic relative was taken, and parents administered topical treatments of peppermint oil throughout the day, and later a cooler bath, which both aided in reducing the fever to 98.1. After the fever subsided, that night the patient experienced a breakout of an itching skin rash beginning on the back and spread over the body. Treatment for the rash included application of mostly Melaleuca (Tea Tree) oil and some Frankincense oil. Both were successful at controlling the itchiness associated with the rash. Symptoms cleared up after a few days.
Patient reported  dizziness and chest pain following administration of vaccinations. Patient reported experiencing chest pain prior to administration of vaccines earlier in the day. Chest pain was midsternal, worse with inhalation. Patient did not experience syncope.
Developed rash within 24 hours of req. vaccines. No difficulty breathing - seen at ER on 7/25/18 was given prednisone - followed up in office on 7/27/18 - rash resolved - see attached visit. 7/25/18 - given prednisone at ED - hyper. After Rx given - didn't fill prednisone. Rash on chest. Did have a loose BM and played in grass. Rash is gone now. No respiratory difficulty. Pic looks like an enteroviral rash.
Patient's weight was incorrectly calculated from kilogram to pounds and hence a 1 inch needle was used to give the vaccine in place of a 1.5 inch needle which should have been used. Patient was given standard counseling about the potential for side effects.
Pt recvd 1st & 2nd dose of Hep B vax in APR91 & mAY91 & 1 hr following 2nd dose of vax pt devel hives; No further details were provided;
Inflammatory reaction left thigh with crying 1 hour post injection. Rx with Tylenol and Benadryl.
Patient states that soon after receiving vaccine her arm began to feel "weird" and felt it moving up her arm. For the rest of the day, and a few days after, experienced hot and cold sweats. Pain scale 8. Reports of "dead arm" and husband had to help her in bed.
redness, swelling, itching, hot to touch; pt given DPH & advised to take DPH;
High fever for 2 days- 102.5-103. Treated with Tylenol 1000 mg every 4 hours and Aleve 440mg every 6 hours alternating doses. I was unable to care for my baby the day after. I was having to feed her while laying on the floor. I would get up to give her bite due to dizziness and high fevers. I was having cold sweats, dizziness, and unbelievable exhaustion. This lasting 48 hours. After 48 hours I had a low grade temp for a week which was bearable.
Muscle soreness, achey feeling all over body, chills, migraine, and a lack of appetite paired with slight upset stomach.
Fatigue, muscle aches, headache, swelling at thr injextion site, chills, and sweating.
Left upper arm red, swollen, hot to touch.  Area red is approximately 2 1/2 by 3 1/2 inches.  No fever.  C/O soreness in left arm.
experienced short episode of bronchospasm; This is a spontaneous report from a contactable physician (pulmonologist).  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, batch number and expiry date were no reported) via an unspecified route of administration on an unspecified date as Dose 1 single for COVID-19 immunization. Medical history included with longstanding asthma on an unknown date and ongoing and was controlled on ICS (inhaled corticosteroid)/LABA (long-acting beta-agonist). Concomitant medications were not reported. On an unspecified date, the patient experienced a short episode of bronchospasm with first dose of Pfizer BNT vaccine within 10 minutes of administration. The patient's second dose was scheduled on 10May2021. Outcome of bronchospasm was unknown at the time of reporting.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
A 7 month old received MMR vaccine as part of accelerated vaccine schedule; none of the patients developed symptoms of vaccine related viral illness;   This literature marketed report has been received from the authors of the published article, titled as stated above concerning a 7 month old male patient. The patient's concurrent concurrent conditions included critical aortic stenosis, biventricular dysfunction and ongoing partially ductal dependent systemic bloodflow. His pertinent medical history and concomitant medications was not provided by the authors.   On an unspecified date, as part of an accelerated vaccination schedule, the patient received two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) as part of an accelerated vaccination schedule; each dose was administered one month apart.  The second dose of the vaccine was administered 20 days prior to a scheduled orthotopic heart transplantation. The patient did not develop symptoms of vaccine related viral illness   This is one of several reports received from the same literature article.   A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2107USA002514:Original Case : 2107USA005481
This spontaneous report was received from a female pharmacist unknown age regarding herself. Her medical history, current conditions and concomitant medications were not reported. On 15-AUG-2017, the pharmacist was she was about to administer a dose of ZOSTAVAX for prophylaxis, lot number and expiration date unknown by the reporter, and the pharmacist accidentally squirted some of the vaccine into her eye. The pharmacist then used an unspecified eye wash containing benzalkonium chloride. She stated that her eye "stings a bit", but noted that "she had sensitive eyes" and that she anticipated that the stinging will resolve soon. Treatment was given for the event and no medical attention was sought. No other information was available. There was no product quality complaint involved.
Monday, I started feeling body aches and my throat was very sore and raspy. I just returned from my family vacation, and I thought my throat was sore because of the trip being with my nieces and nephews. When I went home Monday evening after dinner, I decided to take an at-home COVID-19 test. I took the first one and the line immediately turned positive. I took another test which was a different brand, and it was also positive as well. I took my temperature, and it was 101.4. My normal body temperature is 96.4, so this was high for me. I immediately quarantined in my household and Tuesday morning I called my doctor. I went at 2 pm later that afternoon. I waited and got tested, and the results returned positive. My doctor gave me several prescriptions. I was given Flonase nasal spray, Promethazine cough syrup, and Paxlovid. I started that Tuesday evening with Paxlovid being a 5-day treatment. I monitored my temperature every day and that fluctuated. Thursday, that fever finally broke and went back to normal. I had body aches all the way until Thursday. On Friday, I was still tired, but I still kept my sense of taste and smell. I tested myself Saturday, Sunday, and today, and all COVID-19 tests came back negative. I would say I'm recovered, but I'm not 100%. I would consider myself to be 80%. I don't usually take naps, but today was more tiring than usual.
I have a large hard lump a day after my second vaccine; I have a large hard hot lump a day after my second vaccine; There is a swollen lump at the vaccination site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (I have a large hard lump a day after my second vaccine), VACCINATION SITE WARMTH (I have a large hard hot lump a day after my second vaccine) and VACCINATION SITE SWELLING (There is a swollen lump at the vaccination site) in a patient of an unknown age and 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (I have a large hard lump a day after my second vaccine), VACCINATION SITE WARMTH (I have a large hard hot lump a day after my second vaccine) and VACCINATION SITE SWELLING (There is a swollen lump at the vaccination site). At the time of the report, VACCINATION SITE MASS (I have a large hard lump a day after my second vaccine), VACCINATION SITE WARMTH (I have a large hard hot lump a day after my second vaccine) and VACCINATION SITE SWELLING (There is a swollen lump at the vaccination site) outcome was unknown.            No relevant concomitant medications were reported.  Action taken with mRNA-1273 in response to the events were not applicable.  No treatment information was provided.
Lesion   Location:  left arm, deltoid area Color:   skin colored to faint redness Diameter:  10 width ( entire deltoid) of  tenderness and swelling with pain extending distally to 16 cm down arm  Border and Symmetry:  Ovoid, follows deltoid, no distinct border of enduration Inflammation:  present Given Injections for HPV and Influenza in left deltoid 10/7/2019 by Dr's nurse about 2 day(s) ago but is now concerned because:    Mother reports patient felt faint afterwards and laid down for about 15 min,  then 30 min later c/o "arm felt heavy" and pain, that progressed with swelling noted yesterday and pain spreading to neck and shoulder today   Other symptoms: tingling in fingers ( 3 lateral )  Noticed today
Heart palpitations which started later in the day after the vaccine and lasted with moderate to severe intensity/frequency (sometimes every few minutes) for 4-5 days, lessening over time. These palpitations are minimal but not completely resolved 8 days later upon submission of this form
27 Oct 2021 Medication: TACROLIMUS 0.1 % TOP OINT [30GM] Medication: CLOBETASOL PROP 0.05 % TOP CREA [30 GM]  24yo M with patchy areas of depigmentation, concerning for vitiligo. Discussed these findings with the  patient. Considered fungal, however symptomology and distribution made it unlikely. Discussed with Dermatologist who also agreed. Plan to treat depigmentation with steroid cream with exception of tacrolimus  for genital region depigmentation. 26 Apr 2022 Pt is a 24 y/o M who presents for follow up for Vitiligo. Pt was diagnosed with vitiligo on October 2021. On exam, pt has hypopigmentation of right and left forearms, hands, shins and groin area. Pt denies pruritus or burning. No known family hx of vitiligo or autoimmune disease. Pt was prescribed steroid cream and tacrolimus in October but hasn't been applying everyday. -Discussed with pt his diagnosis of vitiligo. Educated pt the importance of covering and applying sunscreen to exposed areas for sun protection. -Pt Education on vitiligo provided to pt. - Prescribed Fluocinonide 0.05% on arms and legs and Tacrolimus to apply to genital areas only. Medication(s): - Medication: FLUOCINONIDE 0.05 % TOP OINT [15 GM]; SIG: APPLY A THIN LAYER TO AFFECTED AREA 1 TIMES A DAY AS DIRECTED #1 RF3 - Medication: TACROLIMUS 0.1 % TOP OINT [60GM]; SIG: APPLY A THIN LAYER TO GROIN EVERY DAY AS DIRECTED #1 RF3 Laboratory(ies):
Patient is 63 years old and by accident received the high dose  flu shot recommended for patients 65 and older.
fever on 6/4/06. erythema multiforme started on 6/5/06 am.
Normal symptoms after second dose, however brain fog lasted a 3-4 weeks  Since then, brain fog seems to return every so often.  Feels a lot like when you take a strong dose of antihistamine.  Word recall and speech even has been impaired at times.   I've been looking for patterns and notice it most when my immune system is on the defense. For example, I was stung by a bee last week and was in a total fog for several days (was not taking an antihistamine).
tongue/face numb; tongue/face numb; Shaky/dizzy while sitting; reported arm pain; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3302), via intramuscular route of administration, administered in left arm on 20Jan2021 at 12:30 (at the age of 26-years-old) as dose 2, single for COVID-19 immunization in hospital. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, norgestimate (SPRINTEC) (Strength 0.25mg-0.35mcg) taken for an unspecified indication. It was unknown if the patient was pregnant at the time of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el1284), via intramuscular route of administration, administered in left arm on 30Dec2020 at 10:00 as dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no known allergies and other medical history was none. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccination. On 20Jan2021 at 12:30, the patient experienced tongue/face numb, shaky/dizzy while sitting and reported arm pain. Refused ED. The rapid response evaluated and the patient ambulated from cafeteria to home. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for the events. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.