chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2012US020887 is an initial spontaneous report received from a pharmacist on 17 Oct 2012 and a follow up report was received from Quality Assurance Department on 02 Jun 2014: This report refers to a female patient of unknown age group. She was vaccinated with FLUVIRIN (batch number: unknown) at a dose of 0.5 ml intramuscularly on 10 Oct 2012. On the same day after vaccination she experienced dizziness, upset stomach, tiredness, flushed face, hot, feeling of exhaustion, exhausted, cheeks red, rash (itching), redness all over, hives, whelps, lightheadedness, rash on neck and arms and was unable to breathe. Hence she was taken to the emergency room. No further information about outcome, causality and seriousness was reported. Upon follow up, Quality Assurance Department stated that the provided batch number 1206161, was invalid and hence this request was considered as batch unknown and would not be investigated. Follow up report received from Quality Assurance Department on 02 Jun 2014: Batch number 1206161 has been removed, the batch number has been considered as invalid.
Symptoms started 5 hours after administration with severe body aches, fatigue, lymph node under left arm swollen and painful, skin was sensitive to touch, fever, nausea, and intermittent episodes of abdominal cramping. The pain was worse on day 2 but has persisted for 4 days with significant back pain still happening.
Approximately 2 weeks after immunization, he states his muscles felt tight, and he states he felt more fatigued than normal. This lasted about 5 days.
Pt was given a vaccine past the 6 hour hold time after reconstitution. Pt had no signs or symptoms.
A few hours after my vaccine my arm swelled and the injection site was bright red, and I developed a fever. I felt awful and could barely get out of bed for 3 days. During this time I started to get a sinus infection. I've had them before in the past, but nothing this severe. I went to my PCP and he prescribed Cefdinir, prednisone and gave me a Z-pak. The Z-pak didn't work so I was given another antibiotic (name?). My sinus infection never got better, and I'm allergic to a lot of the medications, so I'm limited to what I can take. My Dr. has me come in every 3 months to keep watch on my blood pressure. My blood pressure has increased and it hasn't been controlled either. Tried taking amlodipine for my BP and it hasn't worked. Now taking losartan 100mg, nifedipine 60mg and I'm going back in for a check up 4/15/2022. I've also had more Orthopedic problems in the past because of a car accident. Now the pain has worsened, especially in my neck.
p/ pt vax in 12/97 in 6/98 pt devel chickenpox rash, productive cough & fever. it was noted pt was densely covered.
Transverse myelitis of acute onset on 8/29/09.  Vaccines given 8/12/09. DC'd from hospital 9/25/2009, DC DX 323.52 Myelitis following immunization procedure
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021 at 3:26 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:26 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 91.09 .  Concomitant products were not provided.  On 07-Jan-2021, excursion time was 09 AM and 10 AM  and temperature was 34 respectively, total doses given for the day was 96, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 06 vial was moved to clinic on 07-Jan-2021. Vaccine BUD date was 27-Jan-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 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.
developed rash to the chest, head and all over the body/Rash looked like measles; Scalp was extremely itchy; dermal hypersensitivity reaction; This is spontaneous stimulated report received from a contactable health care professional. A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in right arm on 04Mar2021 (Lot Number: EN2605) as single dose for covid-19 immunisation; hydrocodone bitartrate, paracetamol (NORCO), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included gastrooesophageal reflux disease (GERD), hyperlipidaemia, chronic lymphocytic leukaemia (CLL), Degenerative joint disease (DJD). No allergies to medications, food, or other products. Concomitnat medications the patient received within 2 weeks of vaccination including amlodipine, celebrex, lipitor, omeprazole. The patient previously took first dose BNT162B2 on 11Feb2021 for covid-19 immunisation via intramuscular at left arm, developed rash on chest bilaterally on 20Feb2021. Went to dermatology, doctor gave triamcinolone for treatment. The most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Few days after second dose patient developed rash to the chest, head and all over the body. He went back to dermatology and had biopsy near his hair line. Scalp was extremely itchy, so given clobetasol. Rash looked like measles. Not on face or hands. Saw derm again on 18Mar2021, received cortisone injection with second one on 25Mar2021- first shot-4 hours of relief from itching, rash lessened temporarily and then new areas started developing. BX results (as reported): some of the features raise possibility of angiolyphoid hyperplasia with eosinophilia but favors dermal hypersensitivity reaction. No swollen lymph nodes that patient notes. Patient is extremely itchy. Taking benadryl and taking allegra during the day. Only change recently has been switching norco from 7.5/325 three times a day to 5/325 four times a day.  Wonders if the increased APAP dose caused the rash. Events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment received for adverse events included pepcid, benadryl, clobesatol, allegra, Zyrtec. The event outcome for events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events measles-like rash, itchiness, and dermal hypersensitivity with BNT162b2 can not be fully excluded.  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.
Covid Arm.  I have had a red circle around the shot spot since the shot on February 5, 2021. As of a few days ago, around February the 14th to 16th, it has become hot and a bit raised, and sometimes itchy. It is about 2-3 inches across, and the skin around it is not hot nor itchy. It is just the red spot that is hot and itchy. I have not had any other symptoms.
Patient received dose 1 Moderna Covid vaccine on Jan. 15, 2021.  ~12 days later (Jan. 27, 2021), she started to develop mild Covid Toes symptoms on left foot, involving red and swollen big toe and adjacent 3 toes that peaked Feb. 3-5;   and resolved completely by Feb. 8, 2021.    She received dose 2 Moderna vaccine on Friday Feb. 12, 2021 (4 weeks after dose 1).  Over the weekend (Feb. 13-14) developed fever, chills, and severe fatigue that required bedrest.  ~One week after dose 2 (Feb. 19, 2021) , she reported return of Covid Toes symptoms  on left foot again; peaking ~Feb. 25 and waning by Feb. 27.  The patient has been well otherwise with no other symptoms or signs of COVID.  Other than the two vaccinations, she has left the house 5 times over the last month (3 stores, 1 dentist, 1 walk).
Tachycardia 192, fever 100.3, tachypnea (80-90), sub-coastal retractions, desaturation 80%. Diagnosis: Pneumonia versus immunization readiness. Follow up: Adverse Event Treatment. Amikacin 11/15/04-11/17/04. Tylenol PRN, Gentamycin 11/14/04. Oxacillin 11/14/04-11/17/04. Lasix 11/14/04
Consistently strong pain in both shoulders, both hips and both legs from hips to above knees.
Patient reported arm soreness at the injection site, she had swelling and redness as well. Recommended patient use OTC pain reliever such as Tylenol as well as using ice on the area on/off throughout the day. Also mentioned that if it gets any worse or something different happens to go to emergency room and contact her doctor.
Information has been received from a 67 year old female with penicillin allergy who on 31-AUG-2010 was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included COUMADIN, AVALIDE, NEXIUM and CRESTOR. On 01-SEP-2010 the patient experienced an injection site reaction. She had a 3 inch diameter of redness and swelling on her inner upper arm where she received the vaccine. At this time, the patient was recovering from the events. The patient sought unspecified medical attention. Additional information has been requested.
Unnecessary. Tdap administered at 0935. Had received dose of Tdap on 04/24/2015.
Nov 01, 2011 - redness & swelling to (Lt) thigh. Tx: BENADRYL, KEFLEX, & cool compresses.
The patient did not suffer any adverse events as far as I know, they did however receive a dose of Pfizer under the guise of it being a first dose after having received the Janssen vaccination in April 2021
Red, itchy, swollen lump that is hard and approximately 2' in diameter surrounding the injection site. The hardness and swelling was present from the time of the shot, and has stayed about the same. It got red and itchy about a week after the injection and has been the same for 4 days. No treatment sought yet, but will if symptoms worsen.
This is a 4Y 00M-year-old Female who presents to the ER today after being seen in clinic by Dr at clinic. She was noted to have petechiae and purpura after a bath yesterday. Family decided to take her to the clinic today, where a CBC was noted for platelet count of 4,000. Pediatricians were contacted, and the decision was made to admit her. Mother notes that this morning, the child did wake up at 3:30 with complaints of bleeding on the tongue, and mother notes that she had several sores on her mouth and tongue. No bleeding with urination. Platelet count of 4,000 consistent with Idiopathic thrombocytopenia.  Patient admitted, administered IVIG for Idiopathic thrombocytopenia starting upon admission to the floor.
First vaccination shot was on Friday afternoon, the morning after and for a week after I experienced vertigo/dizzy type symptoms, sore throat, fatigue  The second vaccination was on Friday afternoon and the next morning I experienced the following symptoms: Arm Pain in the injection site (could not lift my arm) - 3 days Chills, cough, body aches, extreme fatigue , dizziness, shortness of breath  (no fever)  - 3 days  The fatigue, dizziness, are still present as of 6/17/21.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022.; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022 at 11:23 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Feb-2022 at 11:23 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022.) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-FEB-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had received the booster vaccine . No concomitant medications were reported. It was reported that a series of an approximately 540 patients had received lot number of 066H21A in past and had an its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed. No treatment medications were reported.
Information has been received from a health professional concerning a patient (15 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
This is a spontaneous report from a contactable consumer (reporting for herself). A 70-year-old female patient received PREVNAR 13, via an unspecified route of administration on 07Nov2017 at single dose for pneumonia vaccine at Physician office. Medical history included depression and reflux. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) for depression and esomeprazole magnesium (NEXIUM) for reflux; both ongoing. Patient also reported she was taking vitamins. The patient previously took amoxicillin and experienced diarrhoea, hives, liver enzymes and potassium went off the charts and lost 25 pounds. It was also reported that the patient had a pneumonia vaccine prior but she does not think it was pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) because she did not have any reaction to it. It was reported that the night of 07Nov2017, patient woke up in the middle of the night with a violent headache. The patient could not sleep as the headache was so bad. Patient stated that her headache was much milder than it was. Patient also reported experiencing diarrhea. Patient was not sure when the diarrhea started but it has been constant. Patient informed that she read the side effect on the website. Patient also reported that she felt faint and vomited once in the middle of night on Wednesday, 08Nov2017. The patient reported that she cannot stand up or she will leak all over herself. Stated that she cannot even sit up and reported that there was not stool but it was a yellow liquid that looks like a bile. Patient also reported experiencing fever after the shot. It was reported that highest temperature was 102 yesterday (as reported). Patient stated that her fever usually stays around 100.3 or 100.4. Patient also reported that she thought diarrhea started when the fever may have started which she thought was on Wednesday (as reported) and that her fever was 100.3 then. Patient thought that something was really wrong since she could not get warm. The patient reported that she was healthy. Outcome of the events headache, fever, and diarrhea was not recovered, while felt faint and vomited was recovered on unspecified date in Nov2017 and outcome of other events was unknown.
Expired Pediarix administered; 1st or 2nd dose administered to a 6 months-old; This case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 934NJ, expiry date 10th December 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th December 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the expired vaccine used and inappropriate schedule of vaccine administered were 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: 9-Feb-2023 Reporter's comment: The patient's mother mentioned  that she thought this was the 1st or 2nd dose that the patient had received, but she was not sure, as the dose schedule was at 2, 4 and 6 months of age. The reporter also did not had the name of the product administered only the lot and she thought was administered in the patient 's right thigh muscle, but she was not sure. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Pediarix followed inappropriate schedule, which led to expired dose used and inappropriate schedule of vaccine administered.
Information has been received from a physician concerning 2 siblings who were vaccinated with Varivax. Subsequently, they developed chickenpox. It was unspecified if medical attention was sought. Additional information has been requested. It was reported that a younger female sibling developed chickenpox after varicella vaccination (WAES 0702USA00203).
Vaccine given 6/17/19.  Started methylphenidate on 6/29.   Developed diffuse urticaria to torso with some raised wheals to all extremities on 6/30.  Went to ED and given orapred 15 mg x 1 and famotidine 20 mg PO x 1.  Home with orapred 15 mg/15 ml - 5 ml BID x 2 days; 2.5 mg BID x 2 days and then 1.5 ml BID x 2 days.  On 7/2, rash worse with multiple scattered erythematous areas to body including left flank, upper chest and upper back.  Appear to be ruptured blebs.  Crusting noted to lips.  No oral mucosa involvement.  Given benadryl 12.5 mg IV x 1; famotidine 20 mg IV x 1 and solumedrol 40 mg IV x 1.  Given IV fluids.  Transferred to hospital.
Pt stated she received a rash that went around her arm for about 6 inches. It was warm to the touch & itched. Pt contacted MD & was told to take TYLENOL. Rash lasted about 4 days with no other problems.
First sign was extreme swelling at VX site and got increasingly painful/I started feeling lethargic/at 8:30 I started with chills and felt like I had a fever. I took my temp and it was 102.5F. I was very sleepy and felt lethargic. On 2/27/2016 I woke up about 6:00AM and still had a fever of 102.6F and ached all over plus had no appetite at all. I slept on and off all day and my fever started to decline about 6 PM  I still felt very sore all over and lethargic but slightly improved.  Temp started down to about 101.6F. The next day 2/28/2016 I was feeling a little better when I awoke about 5 AM.  My fever had decreased to 100.6F. It was all uphill from there. I was completely normal feeling in the AM of 2/29/2016.
BLOOD BLISTER; PETECHIAE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included stroke. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced blood blister, and petechiae. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood blister and petechiae was not reported. This report was non-serious.
Loss of appetite followed by vomiting - multiple episodes. Unable to drink or eat for 20 hours.
patient was administered the product BEXSERO instead of MENACTRA with no reported adverse event; Initial information received on 30-Jan-2023 regarding an unsolicited valid non-serious case received from a pharmacist. GMI number: 01469433.  This case involves 18 years old male patient who was administered the product MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO) instead of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Jan-2023, the patient received a 1 dose of suspect BEXSERO not produced by Sanofi Pasteur instead of Menactra at dose 0.5 ml once (lot: 3YB52, expiry date: 30-Apr-2024) via intramuscular route in the right arm for immunization with no reported adverse event (wrong product administered) at same day latency.  Action taken with Meningococcal Vaccine (Menactra) and Meningococcal Vaccine B RFHBP/NADA/NHBA OMV (Bexsero) was not applicable.  At time of reporting, the outcome was Unknown for the event wrong product administered.    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 guidelines. 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.