chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health care worker concerning a 68 year old female with no allergies who on 16-FEB-2007 was vaccinated SC with Zostavax (Lot # 656608/0032U). Concomitant therapy included alendronate sodium, PREVACID, and AMBIEN. On 08-MAY-2007 the patient developed itchy, red, lesions near the injection site on her left arm. The rash was diagnosed as shingles. Unspecified medical attention was sought. A diagnostic laboratory test of skin scrapping for varicella zoster virus was undertaken which was positive. At the time of the report, the patient was recovering. A product quality complaint was not involved. Additional information has been requested.
Projectile vomiting (water based). Tired, weak, mental "fuzziness", dizzy.
PATIENT BEGAN SCREAMING AFTER SHOT. SHE SCREAMED A HIGH PITCHED SCREAM PERIODICALLY FOR ABOUT 3 WEEKS. SHE NEVER TALKED AGAIN, HAVING BEEN ABLE TO SPEAK BEFORE THE SHOT.
Disrupted sleep, loss of appetite,  increased weakness in affected left arm and leg, concentration issues.
11/18/04: Patient noted scab and redness at left deltoid. Applied Polymyxin to site. After application of Polymyxin, pruritic rash developed at site, spread to elbow under arm. Saw dermatologist for rash 11/23/04. Dermatologist could not determine cause of rash, ordered cutivate which worsened rash. Went to urgent care 11/27/04 for rash. Cutivate dc'd . Rash resolved 12/10/04.
Presented on 8/25/05 with c/o fever, aches, malaise and pain especially in the L shoulder. Vaccination site with 10cm local cellulitis. Had smallpox vaccination on 8/15/05. Tylenol #3 ordered for pain, profile for arm. Seen again on 8/26/05 and profile was extended to 8/29/05 due to continued pain in L arm. Decreased redness and induration to the vaccination site was noted on 8/26/05.
Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 16-AUG-2011, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
Small, red, splotchy, rash like area below the injection site.  Also warm to the touch. Noticed it when waking this morning.
This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The practice supervisor mentioned the patient had a reaction to a flu vaccine. The GSK agent said reporter had mentioned a flu vaccine reaction to her. She attempted to transfer call to GSK medical investigator. The call was disconnected. The patient reached out to speak with reporter via telephone number provided and was given an alternate number and connected with that number. The patient was unable to speak with her at time of initial report. The patient provided a case number to her voice mail.
Around 5:30PM I started feeling tired, like I was coming down with something. Then, at 7-7:30PM it came all of a sudden, the chills, the fever, and shivering. I always shaking so bad that I could not take the Tylenol from my hand to put in my mouth. My temperature fluctuated between 100F to 102.6F. I felt like I could not even move a muscle in bed. But then 12 hours later it all subsided. I woke up the next day no symptoms other than extremely tired and it only lasted for the rest of that day. I noticed my temperature was on the 99F range but did not progress.
felt chills; moderate headache; This is a spontaneous report received from a contactable consumer who is a Pfizer colleague. The reporter is the patient.  A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 15Mar2021 13:15 (Lot number: EL3247) at the age of 56 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: LEVOTHYROXINE. Past drug history included: Erythromycin, reaction: "known allergies: childhood erythromycin allergy". Vaccination history included: BNT162B2 (dose 1, administered in the left arm, Lot number: EL3247), administration date: 22Feb2021 10:15, when the patient was 56 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 16Mar2021 12:00, outcome "recovered" (2021), described as "felt chills"; HEADACHE (non-serious) with onset 16Mar2021 12:00, outcome "recovered" (2021), described as "moderate headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, headache.  Additional information: The patient had no other vaccines in four weeks prior to vaccination. He was not diagnosed with COVID-19 prior to vaccination, and he has not been tested for COVID-19 since the vaccination. He also stated that he checked his temperature but had no fever. The patient took ibuprofen 400 mg one time as treatment for the events.  No follow-up attempts are possible. No further information is expected.
Patient did NOT experience any adverse reactions. Reporting med error only,   One of the pharmacists drew up 0.25mL of Pfizer dose instead of 0.3mL. After the administration, a different pharmacist onsite caught the error, and the patient was given additional 0.05mL for a total of 0.3mL.  Checked with Pfizer, and the following is the recommendation when a patient receives a lower dose. From the recommendations, gave second 0.05mL dose, even though they don't have recommendation specifically for a 0.25mL dose.   Patient did NOT experience any adverse reactions. Reporting med error only.
TERRIBLE MUSCLE ACHES IN NECK BACK AND LEGS; HEADACHES; TIRED; This spontaneous report received from a patient concerned a 38 year old female. The patient's weight was 115 pounds, and height was 64 inches. The patient's concurrent conditions included seizure disorder, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 at left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced tired. On 02-APR-2021, the subject experienced terrible muscle aches in neck back and legs. On 02-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from terrible muscle aches in neck back and legs, and headaches, and the outcome of tired was not reported. This report was non-serious.
No additional adverse event; the patient was inadvertently administered a dose ofMMR II that was expired; This spontaneous report as received from a medical assistant refers to a 2 year old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 13-APR-2020, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(recombinant human albumin rHA)lot # R010474, expiration date: 10-APR-2020 for prophylaxis (dose number, dosing schedule and route of administration were not provided), reconstituted in a sterile diluent. No additional adverse event was reported.
Redness and swelling of the entire anterior right thigh area around the site of the KINRIX IM injection that was administered on 05/15/2017.
Redness at site of injection, itchiness, nodules. Started on 8/2 (1 week after injection)
Severe-to-profound sensorineural hearing loss-right ear cochlear implant and left ear hearing aid.
pt recvd Engerix-B in JUL & AUG92 & exp heaviness in arm, upper deltoid sore, numbness & tingling of extremities;
Pt. felt "loopy", difficult to focus & concentrate. Felt nervous & irritable, headache.
12DEC94 pr recvd vax & 20DEC woke up exp scratchy throat, aches & pains all over body, swollen glands, tiredness;21DEC94 sxs of the day a/intensified; 22DEC pt had earache as well as above; 23DEC woke w/hives all over body; 27DEC hives gone
Complete body aches and chills 14 hours after receiving flu shot on 10-15-07.
hives all over her body (chest, arms, legs, back) and she said her throat "tickled".
I felt a little bit dizzy and tasted like saline in my mouth. I kept feeling dizzy, like I had a brain fog and felt lightheaded and nauseous, I started having tunnelling vision, my BP as high, I got confused and nauseous, had headache and was sent to ER to be  observed. Had fever last night and still feel weird and still have headaches, treating it with tylenol.  Took the day off from work since symptoms did not subside.
Site: Redness at Injection Site-Mild, Additional Details: patient called pharmacy friday morning to ask about redness at and below injections site. Health Center called in the afternoon ,said patient called md to report redness at and below injection site
On 06/08/2000 the patient developed approximately 20 itchy chicken pox lesions. The patient was afebrile. Unspecified medical attention was sought. Follow up information from the RN indicated the final record was that the patient did not have chicken pox and that they were actually insect bites. Further information from the NP confirmed that the patient was unable to walk or talk (pre-existing condition). She had no report of the patient being vaccinated with MMRII on 05/02/2000. They only had a record of the patient being administered the Mantoux test on 05/02/2000. On 05/04/2000 a negative test result was obtained. Follow up information was received from an individual at the health center who confirmed that on 05/02/2000 the patient was administered a dose of measles-mumps-rubella vaccine. No further information is available.
THROAT IS STARTING TO GET SCRATCHY A BIT; CAN'T SLEEP; ENTIRE BODY IS NUMB; 38.30°C OF FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced throat is starting to get scratchy a bit, can't sleep, entire body is numb, and 38.30°c of fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 38.30 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the entire body is numb, can't sleep, throat is starting to get scratchy a bit and 38.30°c of fever was not reported. This report was non-serious.
I took the 1st injection on 2/6/21..pretty much okay in a couple of weeks 2nd injection on 3/6/21...site never healed..pain stayed and months following the use of arm and body weaken. I stopped walking on daily walks...upper back and body..pressure. Nothing is done on left arm because of previous breast cancer. Just concerned how I can get any type of injection into arm now. Dr. gave e a steroid injectionsback of right shoulder 3 wks ago..still painful.
Patient received influenza vaccine at PCP visit 10/21/14. Patient calls 10/23/14 c/o pain (6/10) in left arm at site of injection for the past 2 days. Patient also states that arm is swollen but denies any redness around the site. Patient was advised to put an ice pack on the arm and take ibuprofen and acetaminophen as needed for pain. Patient also advised to call back in a few days if no improvement. PCP was notified 10/23/14. On 10/24/14 patient was seen by PCP. PCP notes that patient has never received flu vaccines as injection in the past, has only receive nasal administration. It was noted that patient was not allergic to gelatin, antibiotics, eggs or latex. No Guillain Barre's syndrome in the past. Patient advised by PCP to not get flu shot in the future and to continue to take ibuprofen as needed. Patient also advised to go to ED if condition worsens or does not resolve.
Patient recieved his first dose Pfizer this afternoon and within about 8 minutes shouted he wasn't feeling good. He was pale and diaphoretic. Initial pulse was high 40s to low 50s. He kept saying he felt nauseous. Heartrate rebounded within minutes. States he had not eaten anything yet today. I gave him a nutrigrain bar and water bottle. Within 20 minutes his color returned to pinkish color, o2 was 97% and pulse was 77 when he left vaccine site. He was in our care for approximately 45 minutes.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Joint Pain-Medium, Additional Details: Reported pain and swelling of the left deltoid as well as redness.
Fever escalating to 104°F continuing on to the next day, pain in joints from 5 hours post vaccination, nausea, vomiting, headache
At 8:07PM client reported to RN feeling "anxious due to arm pain that was radiating into her neck and head." The client reported that she wanted to try meditating to calm herself and see if her symptoms would improve. RN was alerted and responded. When RN arrived the client was seated with her eyes closed and her arms in a meditating position. The client described the pain as an "ache, numbness, and burning." The client denied any signs and symptoms of anaphylaxis. The client stopped meditating and opened her eyes. The client reported persistent symptoms and muscle tension. Vitals obtained at 8:16PM were as follows: BP 126/86, HR 76, O2 97%. RN did not note any signs of swelling, bruising, or rash over the client's arm. The client stated it's "hard to tell if my arm is hot or cold." The client denied any pain with range of motion of the left arm or the neck. RN noted equal range of motion of the neck bilaterally. The client stated she drove herself to the vaccination site. The client reports a history of alopecia and diverticulitis. She currently takes vitamin D. The client reports a history of experiencing a panic attack after taking vicodin. The client reported that her left foot was "almost going numb." RN noted 2+ pedal pulse on the left foot and that capillary refill was less than 2 seconds on the left foot. Vitals obtained at 8:26PM were as follows: BP 121/84, HR 75, O2 98%. RN educated the client regarding s/s of anaphylaxis and when to seek EMS. The client voiced understanding of this education. Vitals obtained at 8:26PM were as follows: BP 121/84, HR 75, O2 98%. The client stood up unassisted and stated the leg numbness had resolved. The client stated she was, "okay to drive home." The client ambulated with a steady gait out of the vaccination site at 8:37PM. On 11/14/21 the client also stated she developed a headache or migraine around the circumference of her head after the vaccine on 10/17/21. The client states most symptoms resolved after 2 days, but reports persistent left arm pain around the left deltoid muscle and shoulder. The client reports occasional episodes of dizziness when she transitions from laying down to sitting or from sitting to laying. The client is unsure when the dizziness started but states she feels there is fluid in her ear. The client denied shortness of breath. The client took Tylenol at home and did not follow up with any medical providers regarding their symptoms.
Pt received more than the 30 mcg dose of Covid 19 vaccine. when injecting 1.8 ml of 0.9% sodium chloride diluent into the covid 19 vaccine bottle the syringe leaked. Only 5/6 doses were able to be draw. The 6th dose was .06 ml short.
Red round rash at injection site.; Rash at injection site.; Slept like a log; Fever; Chills; Was really tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept like a log), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Was really tired) and VACCINATION SITE ERYTHEMA (Red round rash at injection site.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 050A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced SOMNOLENCE (Slept like a log), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Was really tired). On 01-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red round rash at injection site.) and VACCINATION SITE RASH (Rash at injection site.). At the time of the report, SOMNOLENCE (Slept like a log), PYREXIA (Fever), CHILLS (Chills), FATIGUE (Was really tired), VACCINATION SITE ERYTHEMA (Red round rash at injection site.) and VACCINATION SITE RASH (Rash at injection site.) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter contact details updated.
Patient had moderna for first dose at different pharmacy for first dose and received pfizer for second dose at our pharmacy
child was  running high fever 103 degree through out the night with body pain there were no effect of prescribed dose of acetaminophen on him and hospitalized in early morning for 3 hr. he had prolong fever for 3 days and was on medication of fever for 3 days (tylenol-acetaminophen,motrin-ibuprofen)
This spontaneous report as received from a nurse practitioner refers to a 13 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 26-JAN-2015, the patient was vaccinated with a dose of PEDVAXHIB lot # K008874 (dose, route of administration and expiration date were not reported) which had temperature excursion. No information on patient's concomitant medication was provided. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Prolonged crying onset at 2-3 hours,  both outer thigh's red slightly warm.
This spontaneous report was received from a physician, concerning a 18 month old female patient. The patient's medical history was not reported. The patient did not have concurrent conditions. The patient had not had drug allergies, and was not taking any concomitant medication. The patient had no recent varicella zoster virus (VZV) exposure to chickenpox or shingles. It was also reported that the patient had no prior history of herpes zoster, herpes zoster ophtalmicus and that she never had chickenpox.  The physician reported that on 13-OCT-2017, the patient was vaccinated with the first dose of VARIVAX subcutaneously, on the left thigh, lot number lot # M048200  (strength, dose, frequency, and expiration date were not reported) for prevention of chickenpox; and with the first dose of M-M-R II subcutaneously, on the right thigh lot number M000768  (strength, dose, frequency and expiration date were not reported) for prophylaxis. The physician reported that on 22-OCT-2017, nine days after vaccination, the patient developed multiple lesions of an itchy, vesicular rash on her arms legs, chest, abdomen, back and face, on the same date, body temperature was 98.6 (units not reported). It was also reported that the patient was prescribed with an unspecified dose of diphenhydramine hydrochloride (BENADRYL) on 25-OCT-2017 (also reported as no prescription drug treatment for the experience required). The physician also informed that on 25-OCT-2017, the patient was seen at her pediatrician and was given a prescription for lab work for Varicella Zoster Virus (VZV) Immunoglobulin M  Antibodies (IgM) and Immunoglobulin G Antibodies (IgG) levels. The results of this test were 2.95 (unspecified units)for IgM and for IgG 1068 (units unspecified) both assessed as positive. It was also reported that the physician was interested on VZV analysis and wanted to send viral isolates. On 26-OCT-2017, the physician sent a swab of 2 vesicles and a scab, of the abdomen, for a Polymerase Chain Reaction (PCR).  And on 01-NOV-2017, a viral culture was obtained and sent to labcorp.  It was reported, that on 11-NOV-2017 the VZVIP results were Negative (no VZV identified, adequate specimen). The results of the viral culture were still pending. At the time of this report, the outcome of the  itchy, vesicular rash on her arms legs, chest, abdomen, back and face, was reported as recovering. The causal relationship between the vaccination with VARIVAX and M-M-R II and the event was not reported. No temperature excursion occurred as a result of a reading from  a Digital Data Logger.
broke out into hives consistent with an allergic reaction.  The hives continued to spread over other areas of the body.  Received a 10 day regiment of prednisone, however, hives continued after the dose was finished
This case was reported by a physician via call center representative and described the occurrence of tachycardia in a 66-year-old female patient who received BOOSTRIX (batch number 9GE5D, expiry date unknown). On 28th June 2016, the patient received BOOSTRIX .5 ml. On 28th June 2016, 6 hrs after receiving BOOSTRIX, the patient experienced tachycardia (serious criteria hospitalization). On an unknown date, the outcome of the tachycardia was unknown. The reporter considered the tachycardia to be possibly related to BOOSTRIX. Additional details were received as follows: The reporter did not have the expiry date of BOOSTRIX. The batch number reported for BOOSTRIX (9EGE5D) did not exist and was updated to be 9GE5D as per sales database.
Informed by receptionist that patient was requesting to see a nurse due to "hives on his back." I assessed patient in clinic room. He stated, "I got hep. vaccines and another shot on Tuesday. One hour later I started itching really bad to my back." Skin assessment was made. Noted that skin to patient's upper and mid-back was very reddened. Skin was intact. Photo was taken and sent to Dr. via secure mobile app. Dr. gave order to apply Sarna lotion to affected area. Sarna lotion was not readily available at clinic. Eucerin cream was applied until Sarna could be obtained. Director of Clinical Services, RN, was notified.