chrisvoncsefalvay/vaers-outcomes huggingface dataset:
after a below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 9x3t5, expiry date 5th March 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th July 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that, the patient was administrated with Pediarix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case was 1 of 29 linked cases,reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164769:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
this is a solicited report received from contactable Consumer. The reporter is the patient. Other Case identifier(s): 22K-163-4504995-00. A 57-year-old female patient received BNT162b2 (BNT162B2), on 19May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), since 10Aug2022 (Batch/Lot number: unknown), subcutaneous for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE , intramuscular), administration date: 11Apr2021, when the patient was 56-year-old, for Covid-19 immunization. Solicited report by a consumer of a 57-year-old female with events of non-serious kidney infection and urinary tract infection with Risankizumab. In Aug2022, the patient experienced kidney infection and urinary tract infection. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. On 10Aug2022, the patient had her first injection of Skyrizi. Since then her back was hurting for a few days but that stopped. On 14Aug2022, she had been urinating a lot like every 45 minutes. She went to emergency room two days after first injection for back pain. She was diagnosed and treated for urinary tract infection and kidney infection. It was unknown if patient was enrolled in a covid-19 vaccine trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file. The action taken for risankizumab was unknown. Outcome of the events was recovering. The reporter's assessment of the causal relationship of "kidney infection" and "urinary tract infection" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter's causality for suspect drug Risankizumab in response to the events of kidney infection and urinary tract infection was not provided. No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Kidney infection and Urinary tract infection and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
no adverse event; Route of administration: IM; temperature excursion; This spontaneous report was received from a medical assistant and refers to a 4-year-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 15-FEB-2023, the patient was vaccinated at a private doctor's office/hospital with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) via intramuscular (IM) route at her right thigh (Incorrect route of product administration) as prophylaxis (lot # W019627 and expiration date 19-DEC-2023; dose not provided). It was reported that, on 20-JAN-2023, the vaccine underwent a temperature excursion in the range of 6°F to 14°F (-14°C to -10°C) for 1 hour. No adverse event occurred.  This is one of several cases received from the same reporter.
I started to get a headache and I had Sinus symptoms. I got tested the next day and the PCR test was positive for COVID-19. The next day I had some body aches and it felt like a Sinus infection. I was not given any medicine, but I used Mucinex. I had other family members that were positive, but my husband did not get it.  The headache lasted for two days. I lost my sense of smell on the third day for three days. All symptoms lasted about 10 days total. I got tested for my antibodies after my COVID-19 and my antibody level was double what it had been before.
Information has been received from a physician concerning a 24 year old female with no pertinent medical history or drug reactions/allergies, who on 08-Dec-2006 was vaccinated intramuscularly with Gardasil vaccine (yeast) (0.5 ml) (lot#653736/0868F). Concomitant vaccination given on an unspecified date included influenza virus vaccine (unspecified). Other concomitant medication included hormonal contraceptives (unspecified).On 09-Dec-2006, one day after receiving the Gardasil vaccine (yeast), the patient experienced breast swelling. It was reported that there was no significant pain, however the patient could not lie on her breast. Unspecified medical attention was sought. At the time of this report, the patient was recovering. Additional information has been requested.
Within about 15 min of receiving immunizations, child began breaking out in rash on chest just below neck. Child also had slight edema to (L) arm between site of varicella and Hepatitis A vaccination, but more prominent toward varicella. Area with slight head and redness measuring about 20 mm. 6.25 (1/2 tsp) Diphenhydramine oral liquid given. Encouraged f/u with MD. Parents left clinic to take child to MD or E.R.
71 year old with a swollen and tender Right upper arm. Stiff right upper arm. Onset 6/22/12 no clear trigger except she got a Tdap vaccine on 6/19/12. Pt reports itchy area, no fever, no chills. Does not recall getting stung by a bee or other insect. No other skin rashes is feeling well except increased anxiety with this rash.
patient presented to Covid vaccination clinic for scheduled second dose of Pfizer. Inadvertently patient received 0.3ml of Janssen vaccine instead of 0.3 ml of Pfizer vaccine.  As of 6/23 patient has had fatigue and headache since vaccination. Also has felt warm.
brief epistaxis which occured about 6 hours after immunization. epistaxis lasted 5-10 min total. otherwise had temp up to 101.3 but was otherwise well. had same epistaxis following the 4 month vaccines as well
lump on breast bone; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4388586-00 (AbbVie).  A 58-year-old female patient (unknown if pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous for psoriatic arthropathy. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BREAST MASS (medically significant), outcome "unknown", described as "lump on breast bone". The action taken for adalimumab was unknown. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No Known allergies. The reporter's causality for the event(s) of LUMP ON BREAST BONE was not provided with HUMIRA. Abbvie's opinion is that the event of LUMP ON BREAST is not assessable.  The reporter's assessment of the causal relationship of "lump on breast bone" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 70-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). Concomitant products included famotidine, Furosemide, Levocetirizine, glimepiride, JANUVIA, hydrochlorothiazide with losartan, Potassium, ranitidine and TRULICITY. On 23rd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, 1 day after receiving SHINGRIX, the patient experienced injection site swelling, injection site itching, injection site lump and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site itching, injection site lump and injection site erythema were not recovered/not resolved. The reporter considered the injection site swelling, injection site itching, injection site lump and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient experienced swelling and redness on her entire upper left arm (injection site) and the patient had experienced these symptoms for over 1 week following the administration of the SHINGRIX vaccine. The patient also reported that her upper arm was itchy and it felt like there was a lump inside.
This case was reported by a nurse to a sales rep and described the occurrence of an injection site reaction in a child who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The nurse reported that several children experienced swelling following the admin of Infanrix, however, pt identifiers were not provided. On an unspecified date, the pt received the fourth or fifth dose of Infanrix. At an unspecified period time following the admin of Infanrix, the pt experienced an injection site reaction characterized as swelling. The outcome of the event is unk.
10/18/19 Nursing noted right upper extremity redness, hot to palpitation 10/19/19 redness continues to right deltoid and noted on abdomen below umbilicus referred to clinic for possible cellulitis 10/21/19 initial clinic visit PCP noted redness to right upper arm and left lower abdomen given hydrocortisone 1% topical TID and to follow-up in 2 days. 10/24/19 At follow-up erythema noted from top of right shoulder to the wrist no pain or itching reported given triamcinolone 0.1% BID x 5 days and diphenhydramine 25 mg TID x 5 days 10/25/19 At follow-up erythema noted on left and right arm as well as lower abdominal area however stated improving stop diphenhydramine and add hydrocortisone topical 11/1/19 left arm resolved right upper arm some improvement since previous visit continue hydrocortisone for 5 days
headache; arm was a little sore; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 72-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EZ9204, Expiration date: unknown) via an unspecified route of administration, administered in left arm (left shoulder) on 02Feb2021 a little after 12:00 pm (age at vaccination was 72 years) as dose 1, single for COVID-19 immunization. The patient's medical history included ongoing blood pressure, ongoing sinus, ongoing acid reflux and ongoing stress from an unknown date. Concomitant medications included famotidine taken for acid reflux, amlodipine taken for blood pressure (her blood pressure was about normal but since she was on a low dose they told her to stay on it), montelukast sodium (SINGULAIR) taken for sinus pill, oxymetazoline hydrochloride (CLARITIN ALLERGIC) taken for sinus pill and vitamins. She also takes a medication as needed for stress, but she has not taken it recently. She couldn't remember the name of the medication. No additional vaccines were administered on same date of the Pfizer suspect. On an unspecified date, the patient had a headache after the first dose for 3 to 4 days and her arm was a little sore and it went away on the second day. She didn't have fever, chills, cough, or sore throat with the first dose. The adverse events did not require a visit to Emergency Room and Physician Office. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiration date: unknown) via an unspecified route of administration, administered in left arm (left shoulder) on 23Feb2021 a little after 12:00 pm (age at vaccination was 72 years) as dose 2, single for COVID-19 immunization. There was a Product Complaint. The outcome of the events was resolved on an unspecified date in 2021.  No follow up attempts are possible. No further information is expected.
pt recv vax 8FEB96&became pregnant (LMP 2FEB96);the pregnancy was confirmed by Beta HCG;11APR96 an ultrasound revealed an embryonic gestation w/subchorionic bleed;no further details were provided;
When filling out the consent, pt verbalized that she had some itching with the first dose that started when she got home about 30 minutes after she left the office.  She had spoken with rheumatologist who had urged her to get the 2nd dose and her PCP, who had told her to take Benadryl 25mg prior to the second injection.  Nurse had been observing pt and all seemed to be going well.  Had no complaints until she was about to be released from the office at 3PM and then she stated that the itching had started.  Was scratching on her thighs and then started itching on her arms.  A little anxious and skin was turning red.   Dr, collaborator for NP was in the office and asked to check pt.  No complaints of breathing difficulties and no uvula swelling.   Staff was instructed to administer 50 mg of IM Diphenhydramine in the left deltoid.  Itching started to ease within a few minutes and resolved in 8 minutes.  Pt was well enough to leave the office and was contacted at home at 3:45 and was resting quietly at home and a little drowsy
Pt. left POD after receiving vaccine and waiting allotted 15 minutes.  Pt. then returned to POD clinic because was feeling flushed.  Pt. also c/o headache.  Pt. was noted to be very shaky and have elevated blood pressure upon assessment.  BP: 198/92, rechecked 179/82, RR: 16, O2 sats: 98%.  Assessed by local EMS.  Pt. plans to follow up with PCP.
Covid symptoms started on 05/31/2022 with nasal stuffiness and congestion, and that was the biggest symptom apart from a slight headache that I thought was from a lack of caffeine. Last night I had a little fatigue and I still have the nasal congestion and sneezing but other than that I feel pretty good. I am still waiting on the PCR results but home test showed positive. I think by tomorrow I will feel better. I was a bit fatigued and a bit achy but not much.
Left arm with redness & swelling, hard to touch at injection site of DTAP.  Mom states "it is getting better."  Little girl c/o pain.
pt recv vax 6MAY95 & 17MAY97 pt devel chickenpox consisting of >50 lesions;the reporter described this as a moderate case;
On 12/16 about 10pm I began having arm pains and took tylenol.  12/17 woke up feeling exhaused with severe body aches, headache and a 101 temp. I went to work but had to leave because I just wasnt feeling good.  On 12/18 I went back to work but could not perform so I had to leave again and was still experiencing the severe body aches and headaches but no fever.  I was suppose to work on both 12/19 and 12/20 but had to call in.  On 12/19 still same symptoms with no fever but around 5pm I began to have palpations and heart racing which caused me to go to the ER.  I was given fluid and labs was done and monitored for a few hours and was released after the fluid was given.  On 12/20 felt pretty good still tired and exhaused feeling  and on 12/21 I  felt good but later that evening I noticed my forearms began to feel stiff, tingly and heavy.  My hands began to feel stiff and is very sore.  Continue to feel very tired with body aches and continued to take tylenol.  This morning I felt ok but after fixing breakfast the symptoms came back and they feel like the  same symptoms I had when I had the vasculitis in 2009-2010 and that concerned me so I discussed it with a Neurologist and Immunologist who I will reach out to after the holidays to schedule an appointment.  I have an appointment scheduled with my PCP for additional  labs on tomorrow 12/23 and I have not been able to work since getting the vaccine.  My hands feels clumsy and I am constantly dropping things since yesterday
Stomach upset leading to loss of appetite, Arm pain with swelling lasting for days. Symptoms started the day of vaccine administration, when they did not stop patient chose to visit doctor. She was given a medrol pack to help with symptoms.
Information has been received from a certified medical assistant referring to unspecified numbers of patients of unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates these patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L017146, expiration date: 13-MAY-2017, strength, dose and route unknown) (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
9 hours after receiving my first dose I had severe chest pains. tremors, insomnia, migraine headaches.  The symptoms lessened after the first 3 days but still come back randomly and are now becoming constant again- constant chest pains, dizziness, shortness of breath and fatigue. Pain is radiating down my left arm and legs as well. I have notified my cardiologist and will be requesting further evaluation of side effects.
Menveo reconstituted by using sterile water; Menveo reconstituted by using sterile water; patient has received on Jan 3rd 2022 Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 62-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 31st October 2022) for prophylaxis.   On 3rd January 2022, the patient received Menveo. On 3rd January 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong solution used in drug reconstitution, inappropriate dose of vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received Menveo vaccination but they reconstituted by using sterile water, which led to wrong solution used in drug reconstitution, inappropriate dose of vaccine administered. The patient received dose of Menveo at the age of 62 years old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Upper respiratory infection - sinus infection, sore throat, ear infection, conjunctivitis. 4 days of amoxicillin, 10 days of Augmentin, 3 weeks of Mucinex D, 6 days of oral steroids, 14 days of nasal steroids.
Patient received GARDASIL #1 on 2/24/16 and two weeks later developed an itchy red rash and on both hands. Rash still present on 3/7/16. Patient otherwise well, but hands are red with rash and itchy.
Day 4 after vaccination - dry cough. Day 6, productive cough - Avelox unhelpful, several days later Keflex seemed to clear the sputum, but coughing spasms continued. At 2 weeks wheezing began requiring steroids for most of a month. Advir inhaler about 6 weeks. (+) fluid filled bronchi with breathing, tracheitis with T pitch. WBC WNL. Raised atypical lymphs. Symptoms finally resolved about 6/3.
A few days after the vaccination date, once the pt gotten back from a camping trip, he discovered redness & rash on the vaccinated arm (left arm) under the vaccinated area) and it spread over a few days. Unresolved with oral  benadryl.  pt was waiting to see urgent care dr.