chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a unspecified number of patient of unknown age and gender. On an unknown date, the patients were vaccinated with LIQUID PEDVAXHIB (dose, route and Lot# not reported) which underwent supported temperature excursions. No adverse experiences were reported. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a physician via a company representative referring to a currently 20 years old female patient. The patient's pertinent medical history, drug allergies and concomitant medications were unknown. On an unspecified date when the patient was 17 years old, she was vaccinated with GARDASIL or GARDASIL 9 (lot#, dose, frequency and route were not reported). On an unspecified date after vaccination, the patient began having "myalgia and neuromuscular weakness" and was being treated by an unspecified health care provider who got her hormones checked regularly for an unspecified reason. The outcome of the events was unknown. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 4:53 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 4:53 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 39.66   Concomitant products were not provided.  On 11-Jan-2021 Excursion time was reported at 02.00 pm, with  temperature as 35 degrees Fahrenheit, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-Jan-2021 , vial was moved to clinic on 11-Jan-2021. 9 vials were sent to clinic. Vaccine BUD date was 07-Feb-2021.  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 Fisherbrand 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 on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
A few days post vax, pt experienced flu-like symptoms consisting of myalgias, headache, and malaise. These adverse events resolved after a few days.
10 days after booster shot: full body hives appearing in wheals, started off by just experiencing itchiness and then days later presenting with hives, hives that come in wheals last all day and have been ongoing for 3 days
Patient had a positive COVID test on 10/10/21; Patient passed away in the SNF due to COVID (limited medical records).
generalized tonic-clonic sz lasting 2hr, controlled w/valium in ER;
After receiving COVID-19 immunization administration, within 2 minutes patient complained about feeling dizzy, tingling in headsweating and looked pale. Administering Pharmacist and staff phamacist accessed the patient condition, asked him to relax on the chair. Patient continued to have the same symptoms. Pharmacist asked him to lie on the floor with fet raised up, if he was comfortable. The patient did lie down on the floor with the feet up. In about 15 minutes patient felt better, the pharmacist asked him to stay until he felt completely better and kept monitoring for another 30 minutes. The patient felt normal and was accompanied by his brother to his home. Pharmacist called at 7:32 pm to check on patient's status. Patient stated that he was feeling well .
Right thigh with injection site (PCV13) surrounded by 1 cm bruise with additional 2 in. area of erythema/warmth/edema. No tenderness.
Child appeared "glazed over", exhibited lethargic behavior, lack of eye contact, lack of (normal) response to voices, stopped making (verbal) sounds.
administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received DTPa-IPV (Kinrix) (batch number D24G7, expiry date 4th June 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comments: The licensed vocational nurse inquired regarding how to proceed and when to revaccinate.   The licensed vocational nurse (LVN) reported that they inadvertently administered an expired dose of Kinrix vaccine to patient. The reporter did not consent to follow up. Additional Supportive Information: The use of Kinrix dose which was already expired on 4th June 2022, which led to expired vaccine used.
pt recvd vax & exp achiness in shoulders; exp chest heaviness & pain down the rt arm & was weak; pt went to MD the same day 22SEP93 & exp an elevated HR (139) & elevated BP;
Seizure: apnea with full body stiffening, facial cyanosis, back arching x4 minutes with fever.
Per mom patient had diarrhea, vomiting and irritability after taking Rotateq.
Nauseated that evening. 11/17 weak, nausea, myalgia, headache, 11/18 weak, diarrhea, afebrile, no treatment.
high fever; Arm was sore where she got the shot for a few days after the Vaccine; chills; body aches and pains/pain; migraine headache; severe sinus issues; diarrhea; nausea; stayed in bed all day/has not had energy; not feeling good; flu like symptoms; sick; fogginess; vomiting; forgetfulness; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for three patients. This is the second of three reports.   A 67-years-old female patient received the second dose of  bnt162b2 (BNT162B2),  via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: were not reported) ) as SINGLE DOSE for covid-19 immunisation. The patient received first dose of bnt162b2 (lot and expiry were not reported) on an unspecified date for covid-19 immunization. The patient medical history and concomitant medications were not reported.  The patient experienced high fever (medically significant), arm was sore where she got the shot for a few days after the vaccine,  chills, , body aches and pains/pain, migraine headache, severe sinus issues,  diarrhea,  nausea,  stayed in bed all day/has not had energy,  not feeling good, flu like symptoms, sick, fogginess, vomiting, forgetfulness. The clinical course was as follows the reporter referred to her friend .This patient (name redacted) had the same symptoms as the reporter but did not have the burning lungs, but did have a high fever. Caller believes the patient is 67. Caller believes the patient received her vaccine while in Pennsylvania because that is where she lives. Caller does not have further information about the patient. No NDC, Lot or Expiration for the Pfizer COVID Vaccine, caller doesn't have the information. [Redacted] hers only last 24hrs after the 2nd shot. It was reported No Treatment was given. The clinical outcome of the events was unknown.    Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372305 same reporter/drug, different patient/AE;US-PFIZER INC-2021377357 same reporter/drug, different patient/AE;US-PFIZER INC-2021380809 same reporter, different patients/events
On 1/6/2021 I received my COVID 19 vaccine along with other staff members at the medical center. The following day my arm was sore. Within 48 hours any soreness went away and I was fine until Wednesday, 1/13/2021 afternoon. My injection site had become itchy and slightly sore.  By that evening the site was quite sore, red and slightly swollen. The following morning the site had swollen to a soft ball size, was an angry red, extremely painful and warm to the touch. At noon it was still worsening so I called and made an appointment with my doctor.  I am now being treated for cellulitis (a deep tissue infection). I was prescribed Anti-biotics. I have yet to see any improvement, in fact the redness is still spreading.
p/vax soreness in lt arm, Tuesday noc spiked a temp & noted dec lt arm mobility;Wednesday pt noted pain & tenderness to lt arm & temp cont;induration of 42mm in diameter to lt deltoid;hot to touch & swelling & redness inj site;
Based on additional information received on 03 August 2015, this case became medically confirmed. Initial unsolicited report received from consumer on 11 March 2015. A female patient, whose age, medical history and concomitant medication were not reported, had received a dose of ADACEL (batch number, dose, dose in series, expiration date were not reported) via intramuscular route into gluteal on an unspecified date. It was reported that after vaccination patient experienced a 5X7 inch red rash at the injection site on buttock, on an unspecified date. Patient's laboratory investigation and corrective treatment were not reported. It was reported that the patient required ER/ doctor visit. At the time of this report, the outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a consumer on 28 May 2015. It was reported that the patient went to her doctor because the rash increased in side about 5-6 inch in size. Corrective treatment included BENADRYL and some cream. Documents held by sender: none. Follow-up information received from a physician on 03 August 2015. It was reported that the physician had not administered the vaccine but agree with the events. Documents held by sender: none.
Itching on both arms two days after injection, red splotches on both arms three days after injection, this reaction is not as severe as the previous vaccine which lasted several weeks (did not report)
Very sore injection site with small lump for a week. The day after the vax my arm was hurting quite badly from my shoulder down to my hand, into my left shoulder blade, and around and under my arm just above the armpit. That is the part that was super painful to the point of tears. I couldn?t stand to move my arm or hand or lay on my back or on my left side.
Received Johnson & Johnson vaccine on April 1st. Had fever for one day (after 20 hours and lasted less than a day). Took Tylenol 2 doses in 6 hour interval. After a week or so, small red dots (few) under the skin appeared in my fore arms. Subsequently after another week or so, I noticed large number of red dots in my legs. Checked with my primary care physician on 4/28/21 and she ordered blood tests. Blood test report (CBC With Differential/Platelet; Comp. Metabolic Panel (14)) came back and my doctor said, no abnormalities were there. She also tested/checked my lungs, presence of fever (no fever), oxygen saturation - max present. She thought this seems like 'Petrichiae'. She recommended I see a dermatologist. Meanwhile, today (5/2/2021), I  noticed another large cluster of red dots on my left arm.
rash all over my body with intense itching; rash all over my body with intense itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (003110). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) 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 immunization; Bnt162b2 (dose 2, Single), for Covid-19 immunization. The following information was reported: RASH (non-serious), PRURITUS (non-serious), outcome "unknown" and all described as "rash all over my body with intense itching". Additional Information: Customer Verbatim reported as: I have received 3 Pfizer Covid-19 vaccines. One week after the booster shot I began breaking out in rash all over my body with intense itching. I now know that I am predisposed to eczema and should never have had the booster shot which pushed my body over the edge, so to speak. The vaccine was too much for my immune system. It is still a very bad situation and rash.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feeling tired Monday afternoon. C/O abd pain that PM kind of sick. Later in evening c/o abd pain-burped. Sore throat. Threw up once, felt better, was pale, 99.4. 3 A fever 100.5. TYLENOL went to sleep. To Dr. later.
The night of her first vaccine for Hep B she had "pain and swelling" from the injection site up the left side of her neck (from left deltoid). She was asymptomatic when she returned on 9/18/2003. Did not seek medical care, and self treat.
Developed a tic-within-24 hours of vaccine. Juts chin out/clears throat - worse at night. Bad headache after 2 days of vaccination.
My son was almost a month premature. The pediatrician chose to vaccinate him on schedule. He received all 6 vaccination all in one visit. When we got home that night he started spitting up an extreme amount and continued spitting up for the next week and a half. He was inconsolably crying very frequently and waking very frequently at night for about a week. About 10 days after getting vaccinated he started running a fever, broke out in a rash all over his body and had swollen hands and feet. The pediatrician diagnosed him with hand, foot, mouth. 5 days later he was still running a fever and symptoms were worse. He also had what appeared to be blisters on his penis and his testicles were swollen. We took him to the hospital. He got admitted to hospital and was diagnosed with Kawasaki disease the next day. He spent almost 3 weeks in the hospital and received 2 IVIG treatments, two treatments of REMICADE, steroids and aspirin.
This is a spontaneous report from a contactable medical assistant reporting on behalf of a physician. A 17-years-old female patient received single dose of TRUMENBA, via an unspecified route of administration on 08Aug2017 12:30 at 0.5mL (Lot Number: R94916, Expiry Date: 30Jan2019) in the Right deltoid for against bacterial meningitis. Medical history included heart murmur from 2005 and ongoing, seasonal allergy, acne, familial hyperlipidemia; Family Medical History Relevant included Dad: hypertension, gout, and hyperlipidemia, Mom: low back pain. Prior Vaccinations (within 4 weeks): None. Concomitant medication included MENACTRA Sanofi, Lot: U5823AB, Expiry: 22Feb2019, IM, left deltoid received on 08Aug2017, cetirizine for seasonal allergy, cephalexin capsule for acne. After receiving the vaccination, the patient experienced arm swelling of 10cm x 12cm with fever on 09Aug2017 and the patient was seen in the office on the 10Aug2017. The arm swelling was seen on the 09Aug2017 but was getting better by the time she was seen by the doctor on the 10Aug2017. It measured 10cm wide x 12cm long which is why the doctor felt it was a reaction to the vaccine instead of just cellulitis, because it was just so significant. Treatment for the swelling: Over the counter BENADRYL. The fever was 100.8F on 09Aug2017. It had gotten better with Ibuprofen. Outcome of events was recovering.
I initially had chills fatigue, muscle aches, joint pain, flank pain lower back pain , I urinated blood the AM of the 30th of Dec  and went to my doctor which resolved the next day.  I had a on and off headache. My symptoms lasted a total of 3 days.  I only took ibuprofen
Heart palpitations for months. Chest pain, numbness and tingling in extremity. Daily shooting pain across chest and back.
This spontaneous report was received from a registered nurse concerning an unknown number of patient of unknown age and gender that were vaccinated with a dose of VAQTA (dose, dose number, lot number, expiration date and route were not reported), that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports from the same reporter. Additional information has been requested.
Shingrix: only diluent administered; Shingrix: only diluent administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number Y7PP4, expiry date 07-MAY-2025) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix: only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Shingrix: only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-JUN-2023 The healthcare professional narrowed it down to 10 patients but not sure which of the 2 received only the diluent. No other information available of patient was available. The reporter consented to follow up. The reporter believed that the patient received only the diluent portion of the Shingrix vaccine and not the powder as they found 2 vial of antigen left in the box, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR091600:same reporter
pt had "incident"  eyes went up and then looked like she was going to pass out.  Mom got her to ground, she did not loose consciousness, but does not remember getting to floor.
Round deep red mark at site of vaccination almost 1/2" in diameter, and slight itching off and on there. This is one day short of the two week mark after dose 2.
Information has been received from a nurse practitioner concerning a 66 year old female with egg allergy, sulfonamide allergy and doxycycline allergy and a history of right kidney removing who on 06-FEB-2009 was vaccinated subcutaneously into left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (expiration date 01-MAR-2009, lot# 658863/1414U). There was no other vaccine administered. On 09-FEB-2009 the patient went to her primary health care provider with complaints of fever, chills, low back pain on left and right side. While at the provider's office it was found that the patient had a no shingles rash, 3 by 1 inch erythematous patch, induration, inferior to the left deltoid. The patient was diagnosed with cellulitis and was treated with KEFLEX. At the time of the report, the patient had recovered. Follow up information received from a nurse practitioner via medical records indicated that the patient was a female business owner with no acute illness, who on 06-FEB-2009 was vaccinated with a first dose of ZOSTAVAX (Merck) into her left arm. Concomitant therapy included LEVOXYL, PRILOSEC, simvastatin (manufacturer unknown), lisinopril (manufacturer unknown) and aspirin. The patient came to the physician's office on 09-FEB-2009 and reported that she had chills and some right and left lower back pain since 07-FEB-2009. Her left arm had been sore as well. The patient had presented with fever and back pain. On 09-FEB-2009 the patient was diagnosed with cellulitis by her primary physician; her blood pressure was 118/70 and also presented with a fever ( temperature was 99, units not reported), patient's urine was clear; she had a 3 inch by 1 inch patch of erythema and induration just inferior to the vaccination site on the left deltoid. No shingles rash. The back had no CVA tenderness. The physician's assessment was cellulitis left arm status post-injection; the patient was prescribed KEFLEX 500 mg TID x 5 days, ADVIL or ALEVE as directed. The reporter considered cellulitis, low back pain, chills and fever to be other important medical events. No further information is available.
Johnson and Johnson Vaccine 30 days prior, presents with 2 days of RLE swelling and pain. Pt found to have with doppler U/S fully occluded DVT RLE distal femoral vein to popliteal vein, + thrombocytopenia platelets 112.
administration of expired TENIVAC with no reported adverse event; Initial information received on 24-Jul-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 60 years old and unknown gender patient who had administration of expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-JUN-2023, the patient received a standard expired dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection at a dose of 0.5 ml  once (lot U7092AA, expiry date- 24-JUN-2023) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered)(latency- same day).  Reportedly, A nurse manager reported that they have administered an expired TENIVAC to a patient. caller asks if the administered dose is still valid and if not, should they be administering another dose to the patient.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.; Sender's Comments:  US-SA-2023SA228035: