chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Boostrix below recommended temperature, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect product storage in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 6th April 2022, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.   Additional Information: GSK Receipt Date: 11-May-2022 Reporter's comments: Medical Assistant reported that, Boostrix went below recommended temperature range on 21st March 2022. The lowest temperature was 30.2F. The readings were then ranging from 32.9F to 41.8F. The duration was 7 hr. 45 min. A dose was subsequently administered. The reporter did not have lot number, expiration date, or patient information aside from initials. Till the time of reporting, the dose had not been repeated. The reporter consented to follow up. Additional Supportive Information: The patient received incorrectly stored vaccine, which led to product storage error.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022077005:Same reporter US-GLAXOSMITHKLINE-US2022077009:Same reporter US-GLAXOSMITHKLINE-US2022077007:Same reporter US-GLAXOSMITHKLINE-US2022077008:Same reporter
2/14/97-Eye discharge (yellow), fever for 2 days and a cough. 2/12/99-Hypotonia throughout extremities and trunk. 7/1/99-Speech, hearing, in-toeing and poor eye contact concerns. 8/11/99-Autism and significant delay in speech.
This vial was punctured more than 20 times.  This client was #24 vaccinated with this vial.
Both vaccines, I had a severe headache and a terrible stomach ache and really bad indigestion; nausea and fever. With both of the injections - dose 1 and dose 2, that lasted 7 days. It has made my reflux worse and that has been ongoing. I am on Nexium - but have been taking tums way more often. My reflux is still a little bit worse then it normally is but everything else is normal.
Outbreak of COVID-19 01/01/2022. I had the standard cold symptoms, stuffy nose, cough, headache, fatigue. I got a bunch of ulcers in my eyes and mouth. That was really it. My symptoms lasted until about 01/14/2022 before everything was gone. I did get a sinus infection after the COVID-19 and then I got Mono after that. It was a rough few months.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-OCT-2014 the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # J005661, expiry date: 26-SEP-2014, dose, units, route of administration, anatomical location were not reported). It was not clear if this was the patient's first dose of GARDASIL. No adverse effects reported. Additional information has been requested.
Hives; This is a spontaneous report from a contactable consumer.     A 53-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation  (age at vaccination 53 years).  Medical history included , lower limb fracture on an unknown date. Tetanus vaccine taken because of broken leg.  The patient's concomitant medications were not reported.  The patient experienced hives on 02May2021 with outcome of not recovered.  The reported event was considered an Important Medical Event. The event was treated with diphenhydramine (BENADRYL)  tablet and cream.  Course of the event. The patient  reported he got the first Covid shot on 08Apr2021 and everything was fine until about a week ago. He started breaking out in hives and going through Benadryl. States nothing in his life has changed, no change in detergent or what he eats, the only thing different was him getting the shot. Is due for the other one and is concerned if he should get the other one with him having the hives. Will this go away or will he get more hives with the second one. Has been taking Benadryl tablets and the hives go away but within 6 hours they come back and he has been using a Benadryl anti-itch cream so that he is not over doing the tablets. Has been through at least 7-8 tubes of cream in the last week or so. The patient also clarified he is actually using a generic Benadryl, its called generic healthcare allergy relief tablets. Has been taking 2 tablets every 8 hours for the last 7-9 days and when the hives come back he uses the Benadryl cream, it has diphenhydramine as active ingredient the same as Benadryl. As soon as the pills wear off he uses the cream.    Information on the Lot/Batch has been requested.
patient was administered with PENTACEL using only the dry component (Hib), reconstituted using sterile water, without the liquid component (DTaP-IPV). with no adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender to whom administered with diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine [Pentacel (Vero)] using only the dry component (hib), reconstituted using sterile water, without the liquid component (dtap-ipv). with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect diphtheria/tetanus/5 Hybrid Ac Pertussis/IPV(Vero)/Hib(PRP/T) Vaccine Suspension for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site as Immunization and using only the dry component (hib), reconstituted using sterile water, without the liquid component (dtap-ipv). with no adverse event (single component of a two-component product administered) (latency: same day). Information on the batch number was requested.  Action taken: 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.
8 days after first dose of Moderna Covid Vaccine the site of Vaccine was very itchy, swollen, red and hot to the touch.  It has now been 8 days and it is still flaring up.
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 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 9:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 9:56 AM, 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 62.49.  Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 09 AM, temperature was 22, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 11-Feb-2021, vial was moved to clinic on 17-Feb-2021. 05 vials were sent to clinic. Vaccine BUD date was 13-Apr-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 in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pt recv vax & w/in 12 hr post vax pt exp fever, h/a, pharyngitis, sinusitis, chills, & coughing;sx have moderated somewhat, w/pharyngitis being the most prominent on 16JUL96;
Fever 103/chills/headache/vomiting/swollen eye sockets/pain in neck - started about 8 hours post administration. Treated with acetaminophen and ibuprofen symptoms mostly resolved about 40 hours post administration.
Dizzy; Fever; sore at the injection site; Headache; weakness; Nausea; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2021 05:00, the patient received the 1st dose of Shingrix (intramuscular). On 31st August 2021, 3 hrs after receiving Shingrix, the patient experienced injection site pain, headache, weakness and nausea. On 1st September 2021, the patient experienced dizziness and fever. The patient was treated with paracetamol (Tylenol). On 1st September 2021, the outcome of the fever was recovered/resolved. On 2nd September 2021, the outcome of the dizziness was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the headache, weakness and nausea were recovered/resolved.   It was unknown if the reporter considered the injection site pain, headache, weakness, nausea, dizziness and fever to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient received Shingrix vaccine in the left arm and about 3 hours after receiving her Shingrix vaccine she experienced a sore arm at the injection site, a headache, weakness and nausea. The patient also stated that she felt dizzy during the night, but resolved this morning. The patient also had slight fever of 99 degree F. Health care professional told her to take Tylenol, which resolved the fever a few hours later. The patients left arm was still sore at injection site. The patient overall feeling better, the headache, weakness and nausea resolved on the day of reporting. The reporter did not consented to follow up. The reporter does not give permission to contact health care professional.
Elevated heart rate 108 bps constant with low grade fever on day 1; Severe dizzy spell on day 2 lasted 20 min
11/28/07 patient stated she had bruise on her left arm after getting flu shot 11/14/07; it hurt the day after and constantly since.  Bruise went away this past weekend.  Deep hurting inside arm with burning per phone call to clinic 3 PM today.  Information per phone 11/28/07 cancelled 3 PM appointment.
I felt sick (upset stomach) immediately after injection. I went home and slept for 2 hours, got up and felt under the weather the rest of the day, a lot of pain at injection site. Got up Sunday morning still feeling under the weather. Took a nap at 1 pm and woke up at 5:30 pm with fever of 101.5, shortness of breath, headache and chills. Drank some water, went back to bed with extra covers. Got up at 7 pm and took 2 ibuprofen as headache was unbearable. Fever was now 99.5 and I was sweating profusely from the fever and was restless, could not sleep. Finally slept at 1 am. Still have headache today.  I WILL NOT BE GETTING THE 2ND DOSE.
Shortly after the vaccination I stated experiencing the tingling and prickery sensation in my face, my HR was elevated and my throat felt like it was thinkening and getting swollen but I could still swallow and talk.  I was taken to the Urgent Care who sent me to the ER because I was having throat issues.  The urgent care had given me 2 benedryls  before going to the ER.   I sat there several hours in the ER but was never seen and went home because I had begun to feel a little better.  The next day I had to take benadryl in the morning and the afternoon because I still felt the sensation where my face felt a little stiff and shortly after the symptoms began to subside. I had a little body aches and sore throat but they were very minor.
After the 4th day of receiving the vaccine she had chest pain, it went away; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (After the 4th day of receiving the vaccine she had chest pain, it went away) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart murmur (heart murmur from birth).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (After the 4th day of receiving the vaccine she had chest pain, it went away). At the time of the report, CHEST PAIN (After the 4th day of receiving the vaccine she had chest pain, it went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. On 06-Aug-2021, the patient was due for the second dose.
5 to 10 minutes after receiving vaccine started  feeling "drunk", anxious, paranoid.  Muscles became mildly tense and teeth clenched.  The physical aspects only lasted a short time (10-15 minutes)the anxiousness paranoia and "drunk" feeling lasted approximately another hour.    An hour after receiving vaccine started experiencing nausea and vomiting with extreme muscle soreness that was generalized and fatigue.  After napping the nausea and vomiting resolved.  Woke up shivering in cold sweats and shivering.  Began experiencing forgetfulness and having problems thinking correctly.  Issues with finding words, conversing and conveying information to other people.   Shortly after waking up began experiencing severe back pain in lower to mid left back.  Pain was shooting and it did not seem to matter on positioning.  Back pain has resolved.  Day 2 still experiencing severe fatigue, extreme muscle soreness, forgetfulness and not thinking  correctly.  Having issues finding words to use and communicate.  Thinking process seems slow.  Occasional cold sweats and shivering.  Day 3 still feeling of forgetfulness, unable to find words and communicate correctly, slow thinking process, occasional cold sweats and shivering, occasional bouts of anxiety (lasts only 2-3 minutes at a time), short bouts of shortness of breath with exertion resolved quickly.  Some muscle soreness seems to be resolving.
Patient had informed healthcare worker of a previous anaphylaxis reaction to Toradol prior to vaccine. the patient was informed to  wait 30 minutes after injection. 15-20 minutes after the patient received the Pfizer covid vaccine, the patient was experiencing  headache, dizziness, chills and increased heart rate. Patient was assessed by healthcare worker and was walked down to the ER. As the  patient was walking the patient stated her throat was itchy and it was hard to swallow.  Once the health care worker and patient reached the ER, the patients face turned red and was given EPI and treated in the ER.
Caller stated she tested positive for covid the night of the first dose of the vaccine; This is a spontaneous report from a contactable nurse. This (Age: 25; Unit: Unknown) female Nurse (patient) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The patient tested positive for COVID the night of the first dose of the vaccine. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.
L arm feels numb and tingly to finger tips  Some L sided chest wall discomfort noted.
Seen in office 6/16/21 - Complaints of Shortness of breath, cough, nasal congestion X5 days. Received COVID #2 on 6/11/21. Got fever + chills  w/in 24 hours of vaccine. Treated w/ Duoneb + prednisone, QVAR + albuterol at home. Seen in ED 6/16/21 -abnormal EKG; Murmur; Labs ordered; Albuterol + Atrovent nebs, chest xray; Home w/ Albuterol, prednisone
Presented to ER 12/31/2020 red rash to chest, arms became splotchy, cough and shortness of breath. 25mg Benadryl and 1000mg Tylenol administered Chest x-ray completed-No acute intrathoracic process.  RX for Prednisone 50mg PO daily for 5 days given
The pt received her 4 month shots on the morning of March 2, 1995 at the Health Department.  She also received her 2 month shots at the same facility as well.  Referring back to her pediatric medical records, my husband and I contacted the after-hours pediatric office at 9:34 p.m. on March 2, 1995 to report frightening reactions she was exhibiting.  Her pediatrician contacted us at home, listened to a list of the reactions she had, and asked us to immediately meet him at his office so that he could evaluate the pt.  Her reactions included a fever over 103, high-pitched crying, projectile vomiting, pale complexion, lethargic, uncontrollable shaking/jerking motions with "grunting sounds", face and lips turned blue.  By the time she was seen by Dr, she had stopped shaking, her complexion returned, she still had a fever and was not "back to normal".  Dr. assessed her and believed she had a direct reaction to her immunizations.  He specifically singled out the DPT immunization and made the suggestion that for future immunizations we consider only the DT vaccine and not the DPT.  He felt that the older the child becomes, the stronger the reactions would be if indeed the child was reacting to an immunization.  I told him that she had had a milder reaction to her 2 month shots (which is also documented in her medical records) and that I had contacted the nurse at their office to discuss her reactions of being lethargic, pale, fussy and making "grunting sounds".  We followed Dr.'s recommendation and only had DT immunizations administered from that day forward.  Her reactions, the assessment that night by Dr and his analysis of "adverse reaction for pertussis" is all documentated in her medical records.  Other than mild reactions (swelling at sight of injection, fever, fussy, etc.) with other vaccinations, we believed at the time that the reaction was temporary and t
rash started 11-12 pruritic-febrile usually AM & PM; rash over entire body, enlarged cervical nodes; lungs clear; APAP for fever; rash improved over time;
patient contracted the flu every time patient received a vaccination; Initial information received on 13-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves a patient  with unknown demographics who contracted the flu (influenza) every time patient received a INFLUENZA vaccination.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date,the patient received a dose  of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, contracted the flu (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  The outcome was reported as unknown for event.  There will be no information available on the batch number for this case.
Fully CV19 vaccinated individual had a COVID-19 PCR test on 07Oct2021 with a positive result given on 08Oct2021; Fully CV19 vaccinated individual had a COVID-19 PCR test on 07Oct2021 with a positive result given on 08Oct2021; This is a spontaneous report from a contactable nurse. A 23-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0170; Expiration date: Unknown), via an unspecified route of administration on 27Apr2021 as dose 2, single, and received first dose of BNT162B2 (Lot Number: EW0150; Expiration date: Unknown), via an unspecified route of administration on 06Apr2021 as dose 1, single; both (at the age of 22-year-old) for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient after being fully COVID-19 vaccinated individual had a COVID-19 PCR test on 07Oct2021, nurse notified a positive result given on 08Oct2021. The patient underwent lab tests and procedures which included sars-cov-2 test resulted positive (Nasal Swab) on 07Oct2021, reported as COVID test post vaccination. It was unknown if patient received treatment as result of events. The outcome of the events was recovering at the time of report.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Vasovagal response, HR 91 BP 108/71, f/u vitals: 115/82, 81 HR
Caller stated that  she was given the flu injection and the next morning she was nausea with diarrhea throughout the day. Caller spoke with primary physician and didn't make an appt due to the corvid. Patient stated she has not had any adverse affects since 9/15/2020.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 18-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had six temperature excursions: 24, 336, 416, 168, 1172 and 80 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 49 (9.444444444 Celsius degrees), 47 (8.333333333 Celsius degrees), 59 (15 Celsius degrees) and 48 ( 8.888888889 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Case was vaccinated for Covid in October 2021, then hospitalized with Covid in January 2022.  Hospitalized in : Hospital . COVID-19 virus infection Assessment & Plan Diagnosed the day PTA (1/7/22). Symptoms were fairly mild per his wife. Has received 2 vaccine doses but not a booster. She also has covid. - Remdesivir x3 days ordered on admission. He never had hypoxia, no decadron prescribed. They will maintain covid precautions at discharge and follow instructions from Health Department