chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient given H1N1 Intranasal vaccine 12-2-09. Mother reported child developed hive-like rash and itching approx. 5:00 pm same day. Reported to pediatrician, was advised to give BENADRYL for 2 days.
At site of injection. Large ?ball? redness and warm to the touch. Tender and itchy. Injection was on 2.2.21. Today is 2.07.21. And is still mildly itchy and swelling is almost completely gone. . I DID NOT go to the Doctor for this.  I hydrated, took tylenol and went about my daily routine which included exercising. On my row machine an hour a day.   I did take photos on 2.03.21 and 2.5.21..
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021 at 2:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:56 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, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 22.74.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  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.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
tested positive for covid; cough; headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid), COUGH (cough), HEADACHE (headache) and CHILLS (Chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jan-2021, the patient experienced COVID-19 (tested positive for covid). On an unknown date, the patient experienced COUGH (cough), HEADACHE (headache) and CHILLS (Chills). At the time of the report, COVID-19 (tested positive for covid) outcome was unknown and COUGH (cough), HEADACHE (headache) and CHILLS (Chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) nasopharyngeal source of sample.         No concomitant medications were provided.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up received on 07-May-2021 in which contact Information was added and second dose details were added. On 26-Jul-2021: Follow up received. Asthma added as medical history. Events were added. Second dose information picked from follow up 1 source document and action taken with suspect product updated accordingly.
rash that is extremely itchy and covers front and back of legs, buttox, stomach, arms, hands and feet
This spontaneous case reported by a consumer, describes the occurrence of vaccination complication ("normal side effects" to the first two Moderna COVID-19 vaccinations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication ("normal side effects" to the first two Moderna COVID-19 vaccinations). At the time of the report, vaccination complication ("normal side effects" to the first two Moderna COVID-19 vaccinations) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not provided. This case was linked to MOD-2021-375294, MOD-2021-375331 (patient link). Reporter did not allow further contact.
Swelling of the left leg with erythema at the site of the injecton of.
Noted to be pale and was crying for 2 hours the day after the vaccine (Hep B #1) was given.
bathroom excessive-perspired profusely;passed out & fell injuring cheek bone & area around eye, injuring shoulder;rushed to ER;pt checked finding was dehydrated-given IV tx which returned BP to nl;
Tested positive for COVID on 2/23/23 when hospitalized for a fall. She died in the hospital on 3-5-23
Acute episode of urinary retention and constipation that occurred suddenly on 09/09/2021 requiring emergency department visit and plavement of foley catheter.
Pt received Pneumovax 23 on discharge 8/8/05. Two days later pt admitted with diagnosis of sickle cell crisis, chest syndrome, and cellulitis of arm. Significant right arm swelling and tenderness at vaccine site.
Admission Date: 8/12/2022 Discharge Date: Aug 14, 2022  PRESENTING PROBLEM: Acute COVID-19 [U07.1] COVID [U07.1] Urinary tract infection [N39.0]   HOSPITAL COURSE:   79-year-old female with past medical history significant for after another leukodystrophy, chronic recurrent urinary tract infections, urinary incontinence with bladder stimulator, CKD, hyperthyroidism, hypertension, depression and chronic pain of presented to emergency department on 08/12 with fever, fatigue, dry cough and nausea.  He was also having dysuria which she reports is chronic.  She is wheelchair-bound at baseline.   On arrival to emergency department patient is hemodynamically stable.  Labs were notable for stable white blood cell count, mildly elevated creatinine, urinalysis with large leukocytes, many bacteria concerning for urinary tract infection.  COVID-19 PCR was positive as well.  Chest x-ray was showing a patchy opacity in the right lung base.  Patient was given Tylenol and a dose of cefepime and admitted to medicine service for further evaluation and management.   As far as COVID goes, patient did not seem to be very symptomatic from this at all.  Her symptoms had largely resolved by the time she arrived to floors.  She was without chest pain, shortness a breath or cough.  She was afebrile.  She remained on room air therefore no role for Decadron either.  Monitored and treated supportively with subsequent improvement.   As far as acute on chronic recurrent urinary tract infection, patient has known prior urine infection with aerococcus resistant bacteria.  She was treated with cefepime. Urine cultures were obtained but pending at time of discharge. Patient was significantly improved in the hospital setting.  Prior microbiology data shows good susceptibility to ciprofloxacin so she was discharged on this oral antibiotic to complete an additional 5 days. Recommended follow up with PCP and review final culture data if symptoms recur.   Patient discharged home in stable and improved condition.
Reported to sick call AM 25APR99 w/pruritus, maculopapular truncal rash;tx w/DPH, rash resolved 2 days;no rash p/shots #1 & #2;
Patient reported having headache, eye pain, and acid reflux ongoing since shortly after receiving vaccine. Patient said he tried APAP, ibuprofen and Excedrin for the headache and eye pain but it was not working. He also said he took Nexium OTC for the acid reflux but it did not provide relief. Patient was advised to contact his primary care physician.
Headache, light headedness, spike in blood pressure of 180/106, fatigue, racing heart rate
2 days after 2nd dose, developed headache feeling pressure behind eyes and vision out of focus at random. Headache is current and has lasted longer than 8 days
HCP reported VARIVAX was administered after a temperature excursion to patient. Date of administration is Sep 1, 2023. No further information provided. No additional AE reported. No PQC reported.  Names of vaccines involved (including lot/exp): VARIV; No addtional AE; This spontaneous report was received from a nurse and refers to a male patient of unknown age. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.     On 01-SEP-2023, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # X006981, expiration date: 07-MAR-2025), given once (dose, route of administration, anatomical location not provided) as prophylaxis, which underwent a temperature excursion at 6 Fahrenheit (F) during 20 minutes (product storage error). No additional adverse event (AE) reported.
A few weeks after the booster, I noticed tingling in my toes and it started to get worse, hands, feet, thighs, moving around. It started small and began to increase to a full blown all day occurrence. It was worse at night.
Pain at site of injection, eyes, throat, face swelling. Unclear thinking, hoarse speech, headache, hives, swelling. Intervention taken immediately. Ongoing 11 days: SOB, headaches, nose bleeds, coughing, blood sugars triple, hair falling out, major swelling, dizziness.
About 20 hours after receiving the vaccine, my whole body began to ache like the worst flu I've had. Took 600 mg ibuprofen, 1 pill every 4 hours. I did not have a fever on the day after but a slight 99.8 temp the 2nd day after. My left knee, right hip and lower back were like 10 times a normal ache that I have in those areas. It is 7pm 53 hours after the shot and I'm still in bed feeling like I got hit by a truck.
Patient received Pneumovax in left deltoid on 9-6-07 at 2:30 on 9-7-07 AM left arm warm to touch, red, swollen, painful, fever. Doctor notified and examined patient T 98.5, ice pack, move arm, Motrin (fever, pain).
Approx 6 hour after vaccines, reported head pain, and eye blinking. Putting hand to head frequently. Vomited x 1 that evening. Seen 6 Dec 10 at clinic for continued eye blinking and touching forehead.
On 9/15 site of injection was red, itching and soreness. On 9/16 noticed arm was red, arm swollen, puffed up, red polka dots and diagonal strip going from site of injection that is bright red. Called doctor who recommended to ice arm. Applied ice and swelling reduced. Also applied Eucerin cream. By night diagonal strip not as red. By 9/18 showed area to NP. By 9/20 mark injection site with marker and redness was already 3 inches from site of injection went to ER. Admitted to short term stay and received intravenous antibiotics. Released on 9/22 with oral antibiotics. Today redness has diminished will follow-up with internist on 9/28.
itching; This is a spontaneous report from a contactable consumer (patient's friend). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 27Mar2021 at 18:00 (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter mentioned that she talked to her friend (patient) who got the vaccine on the same date and the patient says she is having itching. The patient had the first dose of the Pfizer COVID 19 vaccine on 27Mar2021 at 18:00 at unknown site. The patient started itching on Sunday, 28Mar2021. Therapeutic measures taken as a result of itching included Benadryl. The outcome of the event was not resolved.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Soreness and rash at injection site the next day, by 1/18/21 rash spread from shoulder to elbow, along with nausea and fatigue.
Below or on side of thigh (not at injection site) pt got cellulitis. The top of thigh was injection site no cellulitis formed on side.
Info has been received from a physician concerning a 6 year old Hispanic female with no allergies or medical history who on 10/15/99 (at 12 months of age) was vaccinated SC, in the right thigh with a 0.5 ml first dose of varicella virus vaccine live. The physician reported that the pt came into the office on 3/29/05, with a case of chicken pox. The pt had greater than 50 lesions. Unspecified medical attention was sought. Outcome unknown. No product quality complaint was involved. Follow-up info indicated that the pt recovered after one week. Additional info is not expected.
Shot was extremely painful; Arm was sore; Swelling; Warm to the touch; Red Spots / they were red with swelling; Spots were the size of quarters and they were painful, warm to the touch and sensitive; Spots were the size of quarters and they were painful, warm to the touch and sensitive; area was light pink; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Concurrent medical conditions included systemic antibacterial therapy (drug allergies including allergy to penicillin, Zithromax, Avelox and Sulpha drugs).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain, pain in arm, swelling, skin warm, erythromacular rash, painful rash, sensitive skin and skin discoloration. On an unknown date, the outcome of the pain, pain in arm, swelling and skin warm were recovered/resolved and the outcome of the erythromacular rash, painful rash, sensitive skin and skin discoloration were unknown.   It was unknown if the reporter considered the pain, pain in arm, swelling, skin warm, erythromacular rash, painful rash, sensitive skin and skin discoloration to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient received Shingrix on left arm her pharmacy. The shot was extremely painful and her arm was sore that day. 1 day after receiving Shingrix, the patient had three red spots that appeared and they were red with swelling. The other 2 spots were the size of quarters and they were painful, warm to the touch and sensitive. The first day the area was light pink. The second and third days they were red and swollen. By the forth day, the spots dissipated and her symptoms have full resolved at the reporting date.  The patient also reported that she had an allergy to some drugs so she was not certain if her reaction was a possible allergic reaction to the shot. The patient reported that she previously had the other shingles shot and had shingles after that shot. The reporter consented to follow up.
THROWING UP; NAUSEA; This spontaneous report received from a pharmacist 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced throwing up, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from throwing up, and nausea. This report was non-serious.
This case was reported by a physician via sales rep and described the occurrence of fatigue in a 16-year-old male patient who received BEXSERO. In April 2018, the patient received BEXSERO. In April 2018, less than a day after receiving BEXSERO, the patient experienced fatigue, stiff neck and neck pain. On an unknown date, the outcome of the fatigue, stiff neck and neck pain were recovering/resolving. It was unknown if the reporter considered the fatigue, stiff neck and neck pain to be related to BEXSERO. Additional details were provided as follows: The patient experienced fatigue with stiff achy neck. At the time of the report earlier this afternoon, the physician reported that the patient was better. This is the 2 of 2 cases reported by same reporter.
Red, puffy rash 7 cm circle at injection site.  Itching, and felt hard to touch.  Diagnosis: cellulitis right thigh.  Prescribed Augmentin 600/5 twice daily for 10 days.
Approximately 10 minutes after administration of vaccine, patient reports having dry mouth and some tightness and closure of esophagus (similar to what happens when patient eats shell fish), but not as severe.  Patient was offered Benadryl, but declined.  Patient drank some water to help relieve dry mouth.  Blood pressure @4:30pm was 136/84.  At approximately 35 minutes after symptoms started, patient reports being able to produce a little more saliva.  Blood pressure @4:55pm was 118/87.  Clinically stable.  Symptoms are not progressing.
Within 2-3 hours of vaccine developed swelling of tongue and throat with difficulty breathing.  Patient applied ice and took Aspirin.  Episode lasted 6 hours.  Patient did not seek medical attention.  This was revealed at the time of the second dose assessment.
Late menstration cycle. Terrible cramps, deep pressure before menstration occurs, flu like symptoms with period that have never occurred before. Chills, fever, nausea right before menstration starts.
Not been to sleep since the shot; This case was reported by a consumer via call center representative and described the occurrence of insomnia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th January 2023 15:00, the patient received Shingles vaccine. In January 2023, less than a day after receiving Shingles vaccine, the patient experienced insomnia. On an unknown date, the outcome of the insomnia was not recovered/not resolved.   It was unknown if the reporter considered the insomnia to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 05-Jan-2023. Reporter's Comment:The case was reported by patient. The patient took the shingles shot yesterday at 3:00 and the patient not been able to sleep since. The patient had been up so what he/she could do. The reporter did not consented to follow-up.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Patient reports a little dizzines and hot flashes for a few moments after vaccination, which went away failry quickly. Gave patient 7up and moved to a cooler room. Paitient indicated that she felt normal, may had been from the large meal she had, and that it was only for a moment.
No adverse effects from vaccine; contracted COVID in mid-January 2022, it lasted about a week and a half. I was lethargic, had a sore and swollen throat, body aches, a fever, a cough, congestion, and shortness of breath.
Second Dose Side Effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Second Dose Side Effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Second Dose Side Effects). At the time of the report, VACCINATION COMPLICATION (Second Dose Side Effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications information was not reported. Treatment information was not provided.    Reporter did not allow further contact
Patient complains of rash around the vaccinated area; includes burning sensation that radiates to her back and shoulders with muscle pain/aches. Patient states that it feels like she is getting the flu and chills. She emphasizes that the shot area is hurting, but while talking to us she says it is okay, but still has the burning sensation on her back and shoulders.
pt recv vax & 24hr post vax devel hives;sx resolved untreated;
SICK; OFF LABEL USE IN UNAPPROVED AGE GROUP; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media (J and J Corporate) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received 2 doses of covid-19 vaccine (dose number in series 1, unspecified manufacturer) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following covid-19 vaccine (dose number in series 1). The patient additionally received third dose of covid-19 vaccine ad26.cov2.s (dose number in series 2, unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was a revaccination with different covid-19 vaccine (dose number in series 2). The batch number was not reported. Per procedure, no follow-up will be requested for this case. The drug was associated with Off label use (off label use in unapproved age group) (dose number in series 2). No concomitant medications were reported.  On an unspecified date, the patient experienced sick (dose number in series 2). It was reported as "My ENTIRE fam has had 1,2,3x's-that's extended fam-- their kids-2 teens,1 elem. ALL jabbed- All sick now" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick, and the outcome of off label use in unapproved age group and revaccination with different covid-19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221210598, 20221210446, 20221210961, 20221211116 and 20221212903. This report was associated with product quality complaint: 90000261949.
Vaccine breakthrough, symptomatic.   Inpatient admit 8/31-9/6
Developed an itchy rash around the back of my head and neck.  Thought it was a spider bite, but went to urgent care and the doctor thinks it ?Shingles?.