chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hidradenitis suppurativa flare up/one spot at belt line; Hidradenitis suppurativa flare up/one spot at belt line; 12 Mar 2021 received first dose, 20 Mar 2021 received second dose; Fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare up/one spot at belt line), CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/one spot at belt line), FATIGUE (Fatigue), PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (12 Mar 2021 received first dose, 20 Mar 2021 received second dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On 20-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (12 Mar 2021 received first dose, 20 Mar 2021 received second dose). In 2021, the patient experienced FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare up/one spot at belt line) and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/one spot at belt line). In 2021, FATIGUE (Fatigue) and PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare up/one spot at belt line) and CONDITION AGGRAVATED (Hidradenitis suppurativa flare up/one spot at belt line) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (12 Mar 2021 received first dose, 20 Mar 2021 received second dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The reporter's causality for the events of fatigue and sore arm with humira (adalimumab) was no reasonable possibility. The reporter's causality for the event of hidradenitis suppurativa flare up/one spot at belt line with humira (adalimumab) was a reasonable possibility. 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.
Lower rib cage to feet causing gait abnormality and imbalance diagnosed with transverse myelitis.   given 3 days of IV Solu-Medrol at 1 gm daily x 3 days hospitalized for 4 days improving but not resolved
Fatigue, muscle aches, body aches, fever, chills, headache, joint aches, nausea.
Body aches / fatigue x 1.5 days  Itching over arms/legs started about 9 days after injection (8/16/21)
Flu like symptoms; Low grade fever; Came down with an upper respiratory infection at the same time as the flu like symptoms.; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: EN6200) via an unspecified route of administration in right arm on 27Feb2021 at 10:45 (at the age of 70-year-old) as a single dose for COVID-19 immunisation at other facility. The patient had no medical history and no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since vaccination, patient was not tested for covid-19. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on unspecified date (at the age of 70-year-old) as a single dose for COVID-19 immunisation at other facility. On 28Feb2021, the patient experienced Flu like symptoms that started 24 hours after the second dose, this lasted for five days and patient had low grade fever lasted about 48 hours and came down with an upper respiratory infection at the same time as the flu like symptoms. Patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Cough, fever, rash, Information has been received from a pharmacist concerning her 2 year old daughter with no known drug allergies who was vaccinated with two doses of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation by two different health care providers, the last in approximately 1999.  it was noted that the  doses were separated by several months and given due to a change in doctors and no available vaccination records. On approximately 13 mar 2001 the patient experienced a bronchitis like cough and on approximately 25 mar 2001 the patient experienced red rash over her entire body and fever of 103.  unspecified medical attention was sought.  No other information was available.  Additional information has been requested.
pt recv vax & some time p/vax pt devel pauciarticular juvenile rheumatoid arthritis;the exp was just in the elbow & considered not serious by the primary investigator;
No adverse event but received the incorrect vaccine.  Should have received Pfizer Bivalent Booster
Pericarditis requiring catheterization due to chest pain and abnormal EKG and 1 day hospitalization.
Tight/swollen throat within 15 minutes, Severe hip and lower back back within 18 hours lasting for two days, excessive fatigue within approximately 30 hours. Unable to stand completely upright for two days due to the pain even after taking 600 mg of Ibuprofen.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 13-AUG-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Three hours post injection: mild sore arm around injection site for 24-36 hours; mild fatigue for 72 hours minimum; low grade headache for 48 hours; muscle aches into shoulder blade and neck area for 72 hours minimum.
Feverish sweating; extreme fatigue; dramatic chills - whole body shaking including teeth chattering uncontrollably.  Elapsed time about 4 hours.   Presuming that this was a side effect of the vaccine(s), I stayed calm and crawled into bed to ride it out.  I took no medication. Four hours later, I was back to normal (literally as if it hadn?t happened, except for the sweat-soaked clothes).  I have previously had 4 Covid vaccination shots (all Moderna) without any side effects other than a sore arm each time at the injection site.  Also, I?ve had flu shots annually for as long as I can remember without a single incident or side effect.    Therefore, my unscientific (and therefore unproveable) presumption is that my dramatic but short-lived side effect was caused by the bivalent Covid booster.
left leg started throbbing; swelling of arm -feet; swollen face; dizziness; swollen head; chills - Shivers; Muscle aches; felt feverish; injection site is painful; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left leg started throbbing), PERIPHERAL SWELLING (swelling of arm -feet), SWELLING FACE (swollen face), DIZZINESS (dizziness) and SWELLING (swollen head) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced CHILLS (chills - Shivers), MYALGIA (Muscle aches), PYREXIA (felt feverish), VACCINATION SITE PAIN (injection site is painful) and FATIGUE (fatigue). On 28-Apr-2021, the patient experienced PAIN IN EXTREMITY (left leg started throbbing), PERIPHERAL SWELLING (swelling of arm -feet), SWELLING FACE (swollen face), DIZZINESS (dizziness) and SWELLING (swollen head). At the time of the report, PAIN IN EXTREMITY (left leg started throbbing), PERIPHERAL SWELLING (swelling of arm -feet), SWELLING FACE (swollen face), DIZZINESS (dizziness), SWELLING (swollen head), CHILLS (chills - Shivers), MYALGIA (Muscle aches), PYREXIA (felt feverish), VACCINATION SITE PAIN (injection site is painful) and FATIGUE (fatigue) outcome was unknown.            Concomitant details were not provided.  Treatment details were not provided.   This case was linked to MOD-2021-065338.
On left arm-deltoid, about 3" area of redness, swelling and heat.
Red, slightly raised area, itchy and painful  2x1inches area Lasted for 3 days
Menstrual spotting occurred for two straight weeks until period came on. This was not a normal cycle for me as I never experience this.
spiked a fever of 105 @ 2PM despite APAP- MD instructed to given cool bath & APAP q 2 hrs called every hrs; fever lasted to 115AM 19SEP then below 104-cont to have fever 100-101 till 6Pm on 19JUN then fever gone
Information has been received from a health professional concerning an 18 year old female who on 9/21/00 was vaccinated with the 1st dose of Hep-B. On that same day, the pt experienced faintness, pallor and stiffness of the neck. The pt was put into bed, her blood pressure was monitored (BP-92/43, 20 minutes later BP-108/54) and orange juice was given for her to drink. By 16:45, the employee felt better. No further information is available.
Weakness, dizzy, aches, very tired, slight nausea, soreness at injection site.
at about 7 am 4/8/2021 I had a fever of 100 and began to feel flulike, headache, body aches, very dry skin, felt bad, dizzy thought maybe had covid, also upset stomach and diarrhea
I just got the COVID and Flu shot, had symptoms of both; it hurt; had symptoms of both; had symptoms of both (Covid 19 on 7/2020); This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and COVID 19 VACCINE PFIZER for prophylaxis.   The patient's past medical history included covid-19.   On an unknown date, the patient received the 2nd dose of Flu vaccine, the 1st dose of Flu vaccine and COVID 19 VACCINE PFIZER. On an unknown date, unknown after receiving Flu vaccine and Flu vaccine, the patient experienced vaccination failure (serious criteria medically significant), influenza, covid-19 and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown, and the outcome of the influenza and covid-19 were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, influenza, covid-19 and pain to be related to Flu vaccine and Flu vaccine.     Additional Information: receipt date: 26-Oct-2022 Reporter's comment: The case was received from the patient via (social media) interactive digital media. The patient also got vaccinated in my left arm and it did not hurt in September and after 2 months the 2nd dose. The patient reported that they just applied him/her, the new one from Covid and derivatives, from Pfizer and the one from Fluo, yes it hurt. The patient had the symptoms of both for 3 days. Additional supportive information: It was unknown if the reporter considered the influenza, covid-19 and pain to be related to COVID 19 VACCINE PFIZER. This case was considered as suspected vaccination failure since the details regarding the completion time to onset and laboratory confirmation of influenza were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As per reported information, it seems that the patient was reporting that target disease did not hurt in September and after 2nd dose therefore assumption could not be applied to considered that patient got the doses 2 months apart and according to the medication error was not coded.
Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days; Administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration means they would be in fridge about 1-3 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  It was report that the vaccines were tend to store with 1 to 3 bottles in the fridge to thaw out and to be ready for the patients when needed and at worst scenarios vaccines would have been in the fridge for about a week if no one came in to be vaccinated.  No treatment medication information was provided.
Pt had 9:30 AM appt, reports during sleep that night after 12:00 AM woke up with swollen upper lip and rash around jaw line. Denies any tongue, throat, or orbital edema. H/o seasonal allergies. Mom reports provided BENADRYL and symptoms resolved w/o sequelae. Pt. lives in shelter system. PPD administered same day, left forearm.
I had COVID in March 2020 and tested positive for antibodies in December 2020.  Symptoms following vaccination were similar to when sick with COVID and began approximately 18 hours after receiving injection.  Fever of 102 degrees Fahrenheit, body aches, headache and extreme fatigue on first day after vaccination.  On second day, fever was 100 degrees, body aches, headache and fatigue.  Fever was gone by third day, but still had some fatigue in morning.  Completely recovered by day four.  Also experienced extreme soreness in arm.  Soreness was intense beginning approximately 18 hours after vaccine. On second day after vaccine, also developed an itchy rash at area of vaccination. Soreness and rash began to disappear on day three and was gone by day four.
Admitted to hospital 11/13/09. Expired 11/23/09. Doctor's note state pt received H1N1 and Seasonal flu vaccine 3 days prior to admission.  11/25/09 Hospital records received service dates 11/13//09 to 11/22/09. Assessment: Pneumonia, diphtheria Patient presents with cough and shortness of breath. Body aches, yellow sputum, right-sided chest pain with deep inspiration. Sore throat. Fever. Intubated and mechanically ventilated.   1/6/2010 Hospital discharge summary received. Service dates 11/13/09 to 11/23/09. Assessment: Severe bilateral pneumonia with adult respiratory distress syndrome. Respiratory failure with hypoxemia, sepsis, diarrhea,  acute renal failure, hypernatremia, hypoalbuminemia.  Patient seen at ED and diagnosed with pneumonia. Seen at PCP office later that day and admitted to hospital. Intensive care, intubation, ventilator.  High fever, hypotension, resusitation. Patient expired.
enlarged lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "enlarged lymph nodes". Therapeutic measures were taken as a result of lymphadenopathy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
arm soreness, tired, achy, headache. Sx onset was 3/21/21. Patient received initial dose on 3/2/21 and came back for second dose too early on 3/19/21.
Daughter called to state arm was still red, swollen and itchy from first dose of shingrix. I recommended they follow-up with PCP to take a look at it.
/W in 24 hrs developed small hematoma lt VL @ site of DTP. Irritability of 102 F /p Tylenol, cried excessively, wouldnt eat developed red rash over chest & abd. Seen by MD 4Mar91.Mom is young & very anxious & afraid
DIARRHEA; MUSCLE ACHES IN BACK, LEGS AND WHOLE BODY; CHEST PAIN; NUMBNESS; COLD; VOMITING; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: COVID JANSSEN 1805020, and batch number: 1805020 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced chest pain. On 08-MAR-2021, the subject experienced numbness. On 08-MAR-2021, the subject experienced cold. On 08-MAR-2021, the subject experienced vomiting. On 08-MAR-2021, the subject experienced muscle aches in back, legs and whole body. On 09-MAR-2021, the subject experienced diarrhea. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, numbness, cold, and vomiting on 09-MAR-2021, was recovering from muscle aches in back, legs and whole body, and had not recovered from diarrhea. This report was non-serious.
Papular rash over arms, legs and trunk very itchy. Fever with T max 100.4, irritability. Inconsolable crying, Insomnia.
Hoarseness starting 4/2 ending 4/4 Large painful itchy rash at site of injection Ranging 6? long and 4? width. Rash appears to me moving down and inside arm.
A nurse reported a non-serious case involving giving last years FluMist vaccine to a nine-year-old male.  No medical or drug history information has been reported for this patient.  The patient received a dose of FluMist on 15-Nov-2007.  The nurse reported that a coworker gave last year's FluMist vaccine to the patient.  The nurse was familiar with the frozen product and did not note the vaccine expiration date.  The product was hand awaiting return permission from the VFC agency.  No additional information is available.  No ill effects were observed as of 27-Nov-2007.  The child was also vaccinated with the 2007-2008 vaccine on 15-Nov-2007.  The reporter did not provide a causality assessment for this event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.  Linked to MEDI-0006196 reports the six-year-old sibling received last year's vaccine.
Dose 1EN6207, 03/20/2021, EN6207 Dose2,04/10/2021, EP7533 I started to have an increase in eczema that would not go away it was on the right hand. Then it travel to right wrist, then fingers, face around lips, mouth and into the hair line. I ordinally was prescribed Steroid cream after Dose 1 and by Dose 3 had the Prednisone. After Dose 3, eczema is presenting all over my body nothing is working on the treatment plan. Steroid creams, considering an allergist.
headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single), for Covid-19 Immunisation. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  Additional Information: Since she was attending a meeting on the day of the report. the patient was asking if she might be contagious   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a physician (a pediatrician), concerning a 14 year old, female patient, with an allergy to neomycin, who at 3:00pm, on 26-JUN-2007 (previously reported as 27-JUN-2007), was vaccinated IM in the left arm (also reported as left thigh), with the first dose of Gardasil (lot #657736/0389U). There was no concomitant medication. There was no illness at the time of vaccination. On 27-JUN-2007 ("less than 24 hours after"), the patient experienced left sided pain from her neck with inspiration, that radiated "down to her chest into the base of the lung." Treatment involved Motrin, which relieved the pain. Shortly after the pain had subsided ("within 24 hours" of the injection), she experienced severe generalized urticaria and lip edema. Treatment involved Benadryl and prednisone (manufacturer unspecified), and the patient "was better within 24 hours," with no permanent consequences. The physician confirmed the patient had recovered from the events on 28-JUN-2007. No further information is expected.
Right thigh slighly red, warm to touch, slight edema. DT fussy on and off. Afebrile T 97 degrees (parent refused to allow rectal temp to be taken). Tylenol 80 mg given when infant brought in. Tylenol given at home.
Presented to clinic with alleged impetigo. Physical exam conclusive with zoster and attenuated varicella.
Hives all over body. Did not go away. Still having hives everyday. Became even worse after second dose of moderna vaccine.
injection sight soreness red and hardness and developed a spreadable rash down her arm growing hard, itchy and fluids filled Pre-existing schedule with doctor the for pregnancy 04/29/2021. Discussed the rash and potential referral and she observe and had another college review the rash, feeling the area and looking at the rash. Best course of action of antibiotic- for infection  and antihistamine for the rash. Rash lasted from 04/28/2021- May 1, 2021 Rash  and effects of adverse condition cleared duration. Finished the antibiotics.  No issue with the pregnancy.