chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 17 year old female who on 12-NOV-2007 was vaccinated with a first dose of GARDASIL (lot# 655154/1210U) IM. On an unspecified date the patient experienced "pain in her arm ever since her first vaccination". It was reported that when the patient visited the office to receive her second dose, this is when the patient informed the physician of the problems she was having from her first dose of GARDASIL. At the time of reporting the patient had not recovered. On 03-JAN-2008, the patient was vaccinated with her second dose of GARDASIL. No further information has been provided.
I exp uncontrollable itching will not go away after using the cream and antibiotics prescribed. Both of my ears were infected, right foot (athletes foot), my inner and outer left thigh itching and around vagina. The antibiotics helped for the 5 days after the symptoms started again to present.
terrible rashes all over her body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (terrible rashes all over her body) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced RASH (terrible rashes all over her body). The patient was treated with ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, RASH (terrible rashes all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
After receiving the vaccine on 1/5/21 that night i had hard chills during the night, on 1/6/21 I developed a goose egg size swelling under my left armpit,  numbness, tingling in my hands, and feet that proceeded with coldness and parlor of my hands, this has occurred daily along with headaches, reddish blotchy patches on my skin.  My symptoms progressed on 7 Jan to needle prick sensations all over my body, to include the numbness and tingling, cold hands and feet.  On 8 Jan I went to see my doctor and explained my symptoms, labs were drawn. 12 Jan i was placed on Medrol Dose pack, symptoms stills present.
3 days after vaccine pt came in with redness from inj. site almost to elbow. Mild swelling and warmth. Says started day after administration.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. Medical assistant reported that, on an unknown date, multiple unspecified patients received a dose of MMR II (dose, route of administration, lot number and expiration date were not reported) that were improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pfizer vaccine administer one day after the Beyond expiration date of 02/13/2023.
Received vaccines 1/22/08, onset of fever 2/4/08 with onset of 4 macules 2/5/08.  Rash progressed to generalized chest/back on 2/7/08.  High temperature.  Macules with vesicles, no pruritus.
2 inch area of swelling on left thigh at site of vaccine. Redness of area and extreme fussiness. Went to ER rectal temp there was 101. Symptoms improved overnight
Approx 65 hrs post vaccine: severe vertigo, room spinning, nausea (vommitted once), fog of mind, slight headache.  Now 122 hrs after 2nd shot and still positional dizziness, slight nausea, weakness.    On day 1 had flu-like symptoms. Day 2 only nausea. Day 3 per the above.
developed a headache; felt feverish/ did not have a fever; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date patient developed a headache and felt feverish about 36 hours after receiving COVID-19 vaccine. Upon checking her temp, she did not have a fever. She also stated she got headaches frequently so wasn't sure if it was related to the vaccine or not. She took aspirin which resolved her headache. The patient underwent lab tests and procedures which included body temperature: did not have a fever on unspecified date. Therapeutic measures were taken as a result of the event headache with aspirin. The outcome of the events was reported as resolved on an unspecified date.    No follow-up attempts are possible. Information on the batch/lot number cannot be requested.
Got flu shot at first only soreness at site. Progressively got worse until unable to use my right shoulder. This is the 3rd time it has happened. Alternate shoulders.
Depressed down due to personal issues; Sickness; Felt miserable; weakness; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Depressed down due to personal issues), ILLNESS (Sickness), FEELING ABNORMAL (Felt miserable) and ASTHENIA (weakness) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for an unknown indication.    No medical history was reported.  Concomitant products included FUROSEMIDE, LOSARTAN, TAMSULOSIN, DIAZEPAM, CYCLOBENZAPRINE, TRAZODONE, FERROUS SULFATE (FEROSUL), METOPROLOL and OMEPRAZOLE for an unknown indication.   On 11-Feb-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced DEPRESSION (Depressed down due to personal issues), ILLNESS (Sickness), FEELING ABNORMAL (Felt miserable) and ASTHENIA (weakness). At the time of the report, DEPRESSION (Depressed down due to personal issues) and ILLNESS (Sickness) had not resolved and FEELING ABNORMAL (Felt miserable) and ASTHENIA (weakness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The patient was sick after receiving the Moderna Covid Vaccine.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event of weak, depressed down due to personal issues, sick and felt miserable was not provided for Rinvoq.  No treatment medication was reported.
Patient arrived at 1:05 pm on 2/25/02. Pneumovax previous 5 years ago given IM left deltoid. Patient noticed itching/rash 1 hour post injection. Redness/ itching/ hot to the touch, swelling spread to shoulder and down to elbow. Patient applying ice to site. Advi.l elevate site, May use Benadryl cream, calamin, anti itch cream.
Red area where vaccine was administered. Itchy, somewhat swollen, happen a day later after injection - MD Called deemed local reaction. Suggested by MD BENADRYL.
lethargy; Dry Heat; Low grade temperature; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), HEAT ILLNESS (Dry Heat) and PYREXIA (Low grade temperature) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (lethargy), HEAT ILLNESS (Dry Heat) and PYREXIA (Low grade temperature). At the time of the report, LETHARGY (lethargy), HEAT ILLNESS (Dry Heat) and PYREXIA (Low grade temperature) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report as received from a healthcare worker who is an office manager refers to unspecified patients of unknown ages and genders. On an unknown dates the patients were vaccinated with a dose of VAQTA (dose, lot#, expiration date and route were not reported). The doses of the vaccine were exposed to temperatures outside of the recommended range since October 2014. No adverse effects have been reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information has been requested.
Admin at approximately 4pm. Reported diarrhea x3, vomiting, chills at 846pm. Husband called at 130am - fever 101.5 degrees F. APAP, fluids, prometh supp (at home).
Burning nostril, sinus pressure and extreme migraines daily until 3/1/2022.
pt recvd vax 330Pm later same noc 830 noticed water blisters on face;
vomit, diarrhea, fussiness, dx w/pneumonia;lost weight, irritable, would not eat;
RInging in ears, tinnitus.  Not sure if started earlier, but realized on the second day afterwards.  The ringing is constant and gets more profound in the evening.  (Has not subsided.) Tiredness was the day after, but that went away.
Kinrix given w/out incident. Proquad vaccine mixed w/ Menveo liquid conjugate instead of sterile diluent. Proquad then administered subcutaneously in R arm. Error noticed when entering vaccine into state registry. Manufacturer called, diluents are not interchangeable. No adverse events or side effects noted, parents made aware. Patient r/sd in 4 wks to receive right dose of Proquad.
Pain at and around injection site. Began about an hour after the vaccine was administered and became gradually worse. Waiting to see if it gets better.
About 5 minutes after the patient was in the waiting  room she told our cashier that her heart was beating fast and her hands were cold.  I went out there and took her BP and pulse.  It was 143/99, pulse 99, temp 98.7.  She was fine before the vaccine.  Showed no signs of anxiety.  We called 911 because of her BP and how she was feeling.  She started to get lightheaded but did not want to lay on the floor.  She took a few sips of water and said her heart was beating faster and she was visibly shaking (anxiety from rapid heart rate).  Her hands were also feeling colder.  EMS got there at 5:05pm and took her BP and it was 140/100.  She agreed to go to the hospital for treatment.
PNEUMOVAX 23 25 Mcg/0.5ml inj and Flu shot administered on 10/3/2017, Localized pain 3/10 in arm began 2 hours after. Pain overnight increased to 7/10 and 10/10 upon palp, arm had localized swelling. Within 12 hours of injection pain remained at 7/10, onset of nausea, dizziness, vertigo, mild fever, overall body ache, joint pain 4/10, unable o concentrate i.e. count to 10. Swelling and pain subsided within 48 hours of injection to 3/10, patient was on bed rest until 53 hrs after injection.
Tired; Arm sore at the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore at the injection) and FATIGUE (Tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 013A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced VACCINATION SITE PAIN (Arm sore at the injection). On 28-Oct-2021, the patient experienced FATIGUE (Tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 2. At the time of the report, VACCINATION SITE PAIN (Arm sore at the injection) and FATIGUE (Tired) outcome was unknown.            Patient was taking eye drops for glaucoma taking other medication.   This case was linked to MOD-2021-367418, MOD-2021-367411 (Patient Link).
Information has been received from a physician concerning a 25 month old male with an amoxicillin (Amoxil) allergy which caused a rash and hives (Jan 2005) who on Sept 26 2005 was vaccinated SC in the arm with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot 649675/0240R). Secondary suspect vaccinations on that same day included a SC dose in the arm of varicella virus vaccine live (lot 651177/0428R). Illness at the time of vaccination included rhinitis. The physician reported that on Sep 28 2005, 48 hours after being vaccinated, the patient developed a fever of 105-106, hallucination and shaking. The patient was noted to have Grand mal convulsions for 20 minutes. The patient was taken to the ER where his temperature was 103-105. A Complete blood count (CBC) and urinalysis were negative and he was subsequently discharge from the ER. About six hours later, in the physicians office the patients white blood count was 27.3. The patient was treated with ceftriaxone NA (Rocephin) (50 kg). Three hours later, the patients WBC was 19.0 and a SMA7 and Mg were negative. On Sept 30 2005, the patient recovered from the Grand mal convulsions. The physician considered the Grand mal convulsions to be an other important medical event (OMIC). No further information is available.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, multiple unspecified patients were vaccinated with improperly stored doses of VARIVAX (Merck) (dose, route of administration, lot # and expiration date were not provided). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient should have received Moderna 2nd dose; however, Pfizer was administered.  No adverse events related to Pfizer injection.
Information has been received from a Licensed Practical Nurse (L.P.N.) referring to multiple unspecified patients of unknown age and gender. Information regarding relevant history and concurrent condition were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, lot # and route unspecified). Information regarding concomitant medications was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Local reaction; This case was reported by a nurse via sales rep and described the occurrence of local reaction in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, unknown after receiving Kinrix, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown.   It was unknown if the reporter considered the local reaction to be related to Kinrix.  Additional details were received as follows: The age at vaccination was not reported. It was reported that patient experienced local reaction after receiving Kinrix.
Started happening like last Monday, been feeling like a sensation of pins and needles, it hasn't been bad but like 3 days ago while driving to the gym the pain was pretty unbearable, it lasted for about 20 minutes, I still get the sensation pretty often which usually it's not bad just uncomfortable, but sometimes the pain gets worse from time to time.
burns on ears, face, scalp; burns on ears, face, scalp; red and bubbling of skin on ears, face, scalp; blistering; burns from inside out; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (burns on ears, face, scalp), BURNING SENSATION (burns on ears, face, scalp), ERYTHEMA (red and bubbling of skin on ears, face, scalp), BLISTER (blistering) and BURNING SENSATION (burns from inside out) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 029A21A) for COVID-19 vaccination.    Co-suspect product included non-company product CEFALEXIN (KEFLEX [CEFALEXIN]) for an unknown indication.    No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started CEFALEXIN (KEFLEX [CEFALEXIN]) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced EAR DISCOMFORT (burns on ears, face, scalp), BURNING SENSATION (burns on ears, face, scalp), ERYTHEMA (red and bubbling of skin on ears, face, scalp), BLISTER (blistering) and BURNING SENSATION (burns from inside out). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at a dose of 1 dosage form. At the time of the report, EAR DISCOMFORT (burns on ears, face, scalp), BURNING SENSATION (burns on ears, face, scalp), ERYTHEMA (red and bubbling of skin on ears, face, scalp) and BLISTER (blistering) was resolving and BURNING SENSATION (burns from inside out) outcome was unknown. Not Provided          Concomitant medication included OTC allergy medication.  Action taken with mRNA-1273 in response to the event was not applicable.  Patient was received treatment of Valtrex, Keflex, ointment.  Patient has been to 3 doctors who has prescribed medications but no diagnosis.It was first thought to be shingles but all physicians involved were unsure. Symptoms was calmed down and burns were continuing to dry out.   This case was linked to US-MODERNATX, INC.-MOD-2021-116609 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116609:
pt presented in ER on 15OCT92 (evening) w/persistent crying; @ time of report, being treated w/APAP; no addtl info available;
Pox like rash on face, upper body with fever to 102 degrees F, duration approximately 3 days no treatment.
This spontaneous report received from a patient concerned a 26 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and alcohol user (not frequently). The patient has no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  and batch number: 204A21A expiry: 21-SEP-2021) dose was not reported, 1 total administered on 28-APR-2021 to the left arm for prophylactic vaccination. Dose number in series was 1. No concomitant medications were reported. On 13-DEC-2021 and 14-DEC-2021, patient developed cough and headache. On 21-DEC-2021 overnight, he developed fever, muscle aches, runny nose and fatigue. His fever broke as of in the morning on the day of reporting. On 22-DEC-2021 the patient tested positive for COVID-19 (suspected covid-19 infection and suspected clinical vaccination failure) by using a Binax Now Home Test Kit and had a doctor's appointment later to confirm. He believed that he might have been exposed to someone at work who had tested positive. He was in close contact with a co-worker who tested positive for COVID 19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint number 90000208522.; Sender's Comments: V0. 20211254230-covid-19 vaccine ad26.cov2.s -suspected clinical vaccination failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Itchy skin all over, then I had broken out in hives! I've been taken hydrocortisone and Benadryl but it's not really helping that much.
Pt rec'd influenza vaccine on 9/29/14 and developed a rash to her face and trunk 9/29/14 in the evening. Pt tx'd with MEDROL dose pak and VISTARIL. Pt to f/u in 48 hours.
Pt recvd vax MAY92 w/no adverse reaction; JUN the pt was vaxed w/2n dose & devel a burning sensation upon inject as well soreness & or an aching sensation in the arm; heaviness in the arm;
INCREASED SWEATING, WAS WORSE AFTER THE 3RD BOOSTER. FINGERTIPS AND TOES ARE BRIGHT PURPLE/BUE, ULCER TYPE RASH ON TIPS OF FINGERS, RASH ON BOTH FOREARMS, EXTREME TOE PAIN, ULCER LIKE WOUND, BIG TOE IS COMPLETELY PURPLE
Information has been received from a pharmacist concerning a child in a household who was vaccinated with a dose of varicella virus vaccine live. It was noted that the child's sibling acquired the varicella transmission virus. Addition information has been requested.
Felt dizzy, light headed and hot 2 min. after injection. Excessive perspiration. Provided ice packs, Power Aid. Had him lay flat. BP at 14:15 133/75 Pulse 56. Denied feeling sick before injection.
Patient described having a "full stomach immediately, that moved to her back and caused muscle spasms". Patient sat down and felt better after about 5 minutes.
PATIENT SAID SHE FELT NAUSEOUS AND DIZZY ABOUT 5 MIN AFTER INJECTIONS.  SHE WAS SENT HOME FROM WORK.
Received call from the patient's mother who refers that on the afternoon of 06/24/2020 the boy had a bowel movement, was pale, and eyes turn back and also had some weakness. Was instructed to call the patient's pediatrician for evaluation or take to an emergency room. Mother states she has called the pediatrician with no luck. Patient's mother was oriented to take him to the hospital but she stated she doesn't want to go to the hospital because she is concerned of COVID19. We recommended to call the tele consult line to explain to them his symptoms after vaccination. She was once again reminded of possible side effects after vaccination and reiterate to have the child seen by a clinician to get his vital signs and his current health condition be evaluated. I let the mother know to get back to me after the child has been evaluated by the clinician. Next day on 06/26/2020 at 2:56pm I take time to call the patient's mother to check how the patient is doing since the mother did not call back to let us know about the clinical evaluation. The mother said she did not take the child to get evaluated because after the first incident it had not reoccurred nor anything else had happened. The child has been well, with lots of energy, playing as normal. She says she tried to communicate with Dr by phone without success. The mother was grateful I had follow up with her but that the child had being doing well.
Nausea, diarrhea, fainting (pt fainted). "Not well" for 2-3 days real heavy headed. Around 6 hours post shot went to bed 5-6 hrs earlier than normal.
Pt experienced joint aches. On 9/15/99, the pt also experienced 5" lesion rash around injection site. The lesions were red, non-itchy welts in a circle around the injection site. "The pt sought unspecified medical treatment. Additional information has been requested.