chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approximately 12-14 hrs after vaccine administration, pt developed urticarial rash all over body and mom denied any other new exposures (food, deterg) etc. in pt's environment. Pt treated with Benadryl 2-3d course and Prednisone.
Patient explained they had feeling faint/sweaty with first pfizer dose, but wanted to get 2nd dose; immediately after administering vaccine, patient got clammy/hot/sweaty and felt dizzy, patient was provided with an instant cold compress and advised to stay in pharmacy area until symptoms resolve
Four hours after vaccination, patient complained of sore arm, then started to complain of wobbly legs, blurred vision, and had high fever, and lasted 24 hours. (as reported by mother)
Patient had itchy red rash to arms and trunk. Patient took 50mg benadryl 1x.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The patient had no known allergies.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: COVID 19 Treatment; Negative, notes: testing negative for multiple days. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid Tablets from 21Oct2022 to 26Oct2022. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
CHILD BROUGHT IN FOR EVALUATION DUE TO POOR FEEDING X PREVIOUS 24 HRS, "LETHARGY" PER MOTHERS DESCRIPTION. DARK STOOL X 1 ( NOT SEEN IN OFFICE ) UA AND EXAM NOT REVEALING. SENT TO ER FOR PERSISTENT SYMPTOMS CHEM WNL, US AND AXR POSTIVE FOR INTUSSUSCEPTION. REDUCED BY BARIUM ENEMA ON 11/03/2013.
Red arm; Swollen arm; Wrong Route of Administration; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 3RN95, expiry date unknown) for prophylaxis.   On 30th October 2019, the patient received the 2nd dose of Shingrix (subcutaneous). On 30th October 2019, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities, swelling arm and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient presented to the pharmacy with a red, swollen arm. She had received the Shingrix at the pharmacy administered by a different pharmacist. The reporter stated that the reddened area was about 5.5cm away from the shoulder, and 6cm in diameter.  She states it appears the 2nd dose was given subcutaneously, which led to intramuscular formulation administered by other route. The patient reported to pharmacist she did not experience these symptoms after dose 1 of the series. The reporter consented to follow up. No further details were provided at the time of this call.
Patient received Pfizer booster at 13:24pm. While waiting in observation area patient began to feel bad at 13:30, He was placed on cot and vitals were taken. At 13:35 patient began to seize, patient was placed on his side and rescue was called. While waiting for rescue, patient had two repeated seizure of 30 seconds. At 13:45 rescue arrived and took over treating the patient. After assessing the patient rescue took him to the hospital.
Patient experienced a round bubble immediately following injection of the COVID-19 booster. Patient observed for 15 minutes. Instructed him to apply an ice pack to the site if needed.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild, Additional Details: Fainted and lost consciousness for 1 minute, woke up and came to confused.  was given water, blood pressure measured and monitored.  eventually felt fine enough to go home.
Tachycardia and chest pain lasting for about 5 minutes.  Admitted to emergency room (04/10/2021) and hospital ward Hospital, to 04/12/2021.  04/10/2021 to 04/12/2021: All clinical and laboratory tests, including stress test and echocardiogram were normal except low HDL (45) and high glucose (105).   Has remained symptom and sign free since single episode.
Patient developed nausea, chills, local reaction arm pain; swelling, redness, general malaise. She noted arm weakness secondary pain. She notes all overall myalgia. Requiring VICODIN for analgesic.
delayed shipment of Fluzone HD and Fluzone Quad shipped on 06Nov2019 and not received until 11Nov2019 at 13:08, Fluzone Quad was inadvertently administered to 19 patients/No AE; delayed shipment of Fluzone HD and Fluzone Quad shipped on 06Nov2019 and not received until 11Nov2019 at 13:08, Fluzone Quad was inadvertently administered to 19 patients/No AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp (lab technician).  This case is linked to case 2019SA320779 (same reporter).  This case involves 19 patients who inadvertently received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] after shipment delay.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage and product shipment delay.  Lab technician reported delayed shipment of Fluzone Quad which was shipped on 06-Nov-2019 and not received until 11-Nov-2019 at 1308. Caller reported that Fluzone Quad was inadvertently administered to 19 patients.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Information has been received from a physician concerning a 15-month-old caucasian male patient with and upper respiratory infection and bilateral otitis media and hydrocele, hypoplasia of left thumb, right inguinal hernia, and develomental delay who on 25-May-2000 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot 632400/10820) in the left thigh. Concomitant vaccinations that same day included a first dose of varicella virus vaccine live (MSD) (lot 632616/1688J) in the right thigh, a fourth dose of heamophilus B conjugate vaccine in the left lateral thigh, and a fourth dose of diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid in the right lateral thigh. On 03-June-2000, the patient experienced a generalized rash. the patient was seen by a physician who saw no evidence of a rash and the patient was afebrile. Follow-up information from a physician indicated that the patient's generalized rash was described as "faintly erythematous, macular blanching rash with no petechiae. Most lesions had a pale halo. There was no induration, swelling, or vesiculation and it was nonpruritic. The duration of the rash was 1 week. there was no treatment expect observation and diphenhydramino HCL (Benadryl)." No further information is available.
Bivalent vaccine incorrectly administered for the primary series - Patient was given Moderna Bivalent Booster as primary series shot 1
pt recvd vax & devel a 2" x 2" area of induration & tenderness @ the site of inject; pt was treated w/Parafon Forte & moist heat locally & has recovered;
6 days after I experienced severe abdominal pain. ER treated with opioids , abdominal pain subsided but joint pains exacerbated after that. Tested with cat scan and endoscope. Sent home 2 days later I think. About 5 days after I was admitted to u of p with extreme joint pains and low NA. Given NA infusions , spent 3 days I think. It took almost 3 months to return to normal. The reason I was told to get 4 th vaccine was because I never got any spike protein from first 3. I had Rituxan in March of 2020 .  I am now back to 100 percent but am concerned about ever getting another COVID vaccine ever again.
Menveo mixed with an unapproved diluent; Vaccine administered mixed with other dilueent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA768A, expiry date 31-DEC-2023) for prophylaxis.   On 03-APR-2023, the patient received the 1st dose of Menveo (left arm). On 03-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Menveo mixed with an unapproved diluent) and inappropriate dose of vaccine administered (Verbatim: Vaccine administered mixed with other dilueent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 03-APR-2023 The patient received the lyophilized portion of the menveo vaccine with an unapproved diluent. Menveo reconstituted with an unapproved diluent instead of the supplied CYW-135 liquid conjugate, which led to Wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter consented to follow up.
Myocarditis was suspected but not confirmed; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis was suspected but not confirmed) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis was suspected but not confirmed) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis was suspected but not confirmed) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medications were provided Company comment This is a Spontaneous case reported by a physician, concerning a female patient of an unknown age, who had no medical history reported and experienced the expected, serious, medically significant, AESI of Myocarditis and received a dose of mRNA-1273 vaccine. Exact vaccination date and event onset date are unknown, thus, exact latency between vaccination and onset of the event could not be assessed. Myocarditis was suspected but not confirmed. No further information regarding course of the event, lab tests, cardiac studies and treatment was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This is a Spontaneous case reported by a physician, concerning a female patient of an unknown age, who had no medical history reported and experienced the expected, serious, medically significant, AESI of Myocarditis and received a dose of mRNA-1273 vaccine. Exact vaccination date and event onset date are unknown, thus, exact latency between vaccination and onset of the event could not be assessed. Myocarditis was suspected but not confirmed. No further information regarding course of the event, lab tests, cardiac studies and treatment was provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was respectively vaccinated IM with the first and second dose of GARDASIL on 30-JUN-2011 and 31-JUL-2012. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Started with extremely sore arm right away.  As day went on, I started getting the chills, and shakes, then a low grade fever. About 15 hours after vaccination, my eyes became itchy and swelled up. I also then started feeling like I had a lump in my throat and it was a little hard to swallow.  I then had my husband take me to ER because it was 4:30 am.  I took Benadryl while waiting to be seen (I was there about 4 hours waiting). Once seen, they prescribed Prednisone twice a day; Famotidne, twice a day. They also told to continue to take the Benadryl that I bought over the counter. I then followed up with Dr. but was only able to see the PA. She said to continue with ER gave me but prescribed Cetrizine HCL, once a day. She said it worked better than Benadryl so I stopped taking Benadryl and switched to the Cetrizine.  My next appointment is via zoom on  Wednesday, 8/18/21.  To date, my eyes are still slightly swollen but almost back to normal.  Night sweats continued since vaccination.  Last night 8/16/21 was first night not having them.
Aching at the injection site. Rash at the injection site. I ran a temp ranging form 99 to 100.7 and lasted about 7 hours. Back to normal the next day.
joint pain , starting from left wrist and fingers,  then all joints in my arms and legs, knees, ankles, neck.   I was almost totally paralyzed.   I could not walk, change clothing, take shower,  turn my head, hold a cup of coffee,   I have been treated with Ibuprofen, Pravastatin, Indomethacin, Prednisone, Methotrexate, Folic Acid.   90% recovered so far.  I am still taking Methotrexate weekly and Folic Acid daily to avoid joint pain now.  my fingers stiff problem is the same.
I started having chest pains that got worse or more noticeable. Heart conditions were ruled out. They sent me to a gastroenterologist and they tested me and discovered that I had esophageal motility abnormality. They also did a 24 hour pH test and it was found that it was a non acid reflux. It was explained that non acid could be bile, mucus or saliva. I was recently referred to an ENT for next steps. It could be bile or stomach fluid because I feel it around my voice box. It was recommended that I get a procedure done to help close the flap in my stomach, which I don't want, which is why I was referred to an ENT. I was prescribed buspirone to see if it would calm the pain down. I also had a chest x-ray to make sure I didn't need to see a pulmonologist.
headache,  left upper extremity, left upper back, and left side neck feel sore and tight, with intermittent tingling radiating to her left hand.
The patient complained about feeling lightheaded, sweaty, and blurred vision. Spo2 99 HR 96, BP 124/98 T 95.1 The patient?s mother stated that he always gets that way when he receives a vaccine or donates blood. The clinical staff attended to him. He stated that he felt fine after about 5 minutes.
Patient was administered an undiluted dose (0.2 milliliters) of the vaccine for their first dose.
As described by parents on September the 14th, 2020, she developed an unusual vomiting, and she had a decreased activity, so as this clinic situation progressed infant had a decreased intake and had a bilious vomit so she was taken to ER were she was evaluated  IVFS RL bolus given 10cc/kg and IVFS maintenance started, while being evaluated she produced a frankly bilious vomit a pediatrics surgery consulted who ordered an UGI Series , which was negative for Volvulus or Malrotation. Trasferred  to the floor she developed a frankly bloody stool on September the 16th, 2020 she had KUB series twice since 6 hrs apart that could not ruled out Volvulus . An US performed after demonstrated an Intussusception and so she she was brought to Radiology urgently for a barium enema reduction . Multiple attempts at reduction were unsuccessful requiring a laparoscopic converted to open resection of distal Ileum (with resection of ileocecal valve) cecum and right colon with stapled IC anastomosis .She required aggressive IVFs a central line was placed for that purpose. Pathology revealed resection of 12 cm distal Ileum and 18 cm of right Colon . Transferred to PICU where found anemic 1 u PRBC given plus IVFs TPN and antibiotic treatment accordingly , she was started on progressive feedings until no further episodes of vomiting and with a appropriate stooling and voiding and she was well appearing she was discharge on September the 24th , 2020. Note this is a record taken from the hospital discharge note on record.
pt was taken to daycare p/immun; pt's lt eye was red & becoming swollen 430PM; pt got hives; MD told mom  allergic react;
Headache, Myalgia, Fever, positive COVID-19 PCR test, congestion, sneezing, loss of taste and smell, fatigue  Narrative:
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2017, the 13 year old patient was inadvertently vaccinated with a dose of PROQUAD (formulation, dose, frequency, route of administration and anatomical location of administration were not reported) lot # M043310, expiration date 24-APR-2018 for prophylaxis. Other suspect therapies included STERILE DILUENT used to reconstitute the dose of PROQUAD (lot # and expiration date were not provided). No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
6th nerve palsy. Resolved in about 2.5 weeks. Also had tachycardia and P. AFIB a few weeks later.
10 to 12  days after the vaccine I started to get Dermatographia all over my body.  It became more severe over time and is on going.  I was prescribed Zyrtec and Pepcid AC.
got something and was sick as hell; Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer (patient).   This case involved a patient with unknown demographics who got something and was sick as hell (Illness), while he/she received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got something and was sick as hell (Illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for the event, at the time of reporting.  There will be no information available on the batch number for this case.
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 15Feb2021 as dose 2, single (Lot number: EL3247) at the age of 49 years, in left arm and on 26Jan2021 as dose 1, single (Lot number: EL3247), in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient did not diagnosed as COVID prior vaccination. There were no concomitant medications. The patient did not receive other vaccine in four weeks or other medications in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022 at 21:00, outcome "recovering" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive, notes: test type: Nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Initial report received on 14 September 2009 from another manufacturer (document number 45224717) who had received the report from a health care professional. An anonymous patient had experienced vomiting after receiving a Flu vaccine (manufacturer unknown) on an unspecified date, and had to be admitted into the hospital (date not provided). The patient recovered and was released from the hospital. No further information is available. Follow-up information was received from a pharmacist on 09 November 2009. The pharmacist had no identifying information for the patient, other than the fact that she was female. He had no contact information for the patient, and could not provide any further information regarding the event. Documents held by sender: None.
Muscle aches and weakness over entire body, began with major muscles and gradually getting more severe and spreading to smaller muscles (hands).  I spoke to the pharmacist and she said she was not aware of any such reactions.  I have no insurance so finances are limited as far as tests go.
Patient received the hepatitis B vaccine first in the left arm, and was stable, after that she  was given the hepatitis A vaccine in the right arm. Patient was alert and oriented speaking to the provider, when the provider noticed the patient was falling off of the exam table. Provider was able to catch patients head before it hit the floor.  Patient then became very rigid, and had a gasping like sound when breathing. Patients O2 saturation dropped to 80% on RA, and patient was not alert at the time. about 3 minutes after patient had fallen to the floor she came to, and sat up on the floor where she was laying. O2 Saturation was still in the low 80's%. Provider called EMS, who checked patients glucose which was 108. Once patient was stabilized she became alert and oriented x 4, she did not have memory of what happened before waking up on the floor. Her heart rates was 91-110 bpm, and  her O2 saturation did stabilize at 99% o n RA.