chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt vaccinated with a dose of MENVEO that expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA467A, expiry date 31st March 2022) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2022 Reporter's Comments: The reporter stated that a patient was vaccinated with a dose of Menveo that expired on March 2022. The reporter give consent to follow up. Additional supportive Information: The patient was vaccinated with a dose of Menveo which was already expired on March 2022 which leads to Expired vaccine used. This case has been linked to the case US2022000434 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022000434:Same reporter
chills, achy, tired, sore throat, ear ache, cough, loss of voice.
Patient develop redness and a rash on the face almost immediately.  Patient was administered 7.5 mL Benadryl
Urticaria rash to trunk, face, neck, arms and legs began 20 hours after vaccinations were administered.  Parent spoke with physician on 12/07/2013 to report the rash.  Instructed parent to begin Benadryl 1/2 tsp every 6 hours for next 24 hours.  Spoke with parent again on 12/08/2013 and rash was still present and becoming more erythmatous.  Ordered Prednisolone 1mg/kg divided to twice a day for 3 days.  Mom has taken pictures of this reaction and will keep those to show Allergist.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 08-OCT-2012 17:43, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report as received from a 63 year old male consumer regarding himself. On 06-DEC-2013 the patient was vaccinated with ZOSTAVAX dose unknown for vaccine. The patient was on unspecified blood pressure medications. On 07-DEC-2013, the patient experienced severe back muscle spasms. On 08-DEC-2013 the patient noticed an injection site an inch long red scratch mark (reported as mark) and a half-dollar sized lump. On 08-DEC-2013 the patient experienced arm having as stinging feeling like getting smacked by a ruler. No treatment was provided. The patient sought medical attention. At the time of report the patient stated that the redness was more of a pink but it stretched from below bicep to elbow. The patient also reported that the back muscles continued to bother him. The outcome of the events was reported as not recovered/not resolved. Additional information has been requested.
Feel extremely tired.; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration on 02Feb2021 as unknown,single for covid-19 immunisation.The patient medical history and concomitant medications were not reported.The patient experienced feel extremely tired on an unspecified date. The outcome of the event fatigue was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Initial medication error report received on 09 October 2013 from a nurse. A patients whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (route, lot number and site of vaccination was not reported) on an unspecified date. Patient received 2 shots 5 min apart. List of documents held by sender: none
2/8/2022- Patient called for Covid test: cough, congested and body aches.  Covid + test. 2/9/2022- Monoclonals ordered ( Sotrovimab) Benzonatate ordered for cough. Received infusion. Rheumatology advised of Covid status, hold Imuran for at least once a week or until  asymptomatic. 2/14/2022-Patient notes having body aches and SOB upon exertion, O2 sat at home 95% on RA. Advised to treat symptoms, seek immediate medical attention is SOB increases. 2/18/2022- Office visit for increased difficulty breathing on exertion and fatigue. Agreed to to hospital admission. Chest xray and labs were ordered,transfered to Medical Center.  2/18/2022-Presentated to ED, with complaints of  SOB upon exertion and fatigue. 2/18/2022 Additional information for Item 18: Admitted with Acute Covid multilobar pneumonia without hypoxemic respiratory failure and mild AKI. Afebrile, HR-93, RR-18 o2 sat 97% on RA. CXR -Bilateral pulmonary infiltrates not visualized previously. Chest Ct w/o contrast- bilateral multi lobar multifocal pulmonary infiltrates , emphysema with underlying fibrosis.  IV Ceftriaxone, IV Azithromycin  and IV Vancomycin ordered (given in ED) . WBC -13, CRP 21.3, creatnine 1.7 and EGFR 45.  On Bactrim for PCP prophylaxis, Lovenox,  IV Cefepime , inhaled tobryamycin and IV doxycycline ordered. Remdesivir held due to AKI. 2/19/2022- CT chest pulmonary embolism w IV contrast patient is high risk: No evidence of PE. EGFR now >60, WBC trending down-Pulmonary added Solu-medrol. 2/20/2022- CRP-16.7. Continue with Lovenox for another 24 hours and then transition to Eliquis. Vitals WNL no supplemental oxygen needed. 2/21/2022- WBC 7.5 and Creatnine 1.0.Vitals WNL.  Start Prednisone and d/c Solu-medrol. Continue current medications. Discharged to home.
client complained of dizziness after receiving 1st dose Moderna Covid Vaccine (lot# 0421321A, Exp. 5/7/21). At 1415 client reported to EMT feeling dizzy. EMT performed first assessment and gave water. Vitals: blood pressure: 110/70, pulse 77, oxygen 96%. Client alert and oriented. Current medical conditions: HIV and diabetes. Medications: clonazepam, alprozolam, aprovasc, metroprolol, bictegravir, metformin, and aspirin. Informed client we would extend his observation period. Within 5 minutes client stated improvement. 1530 vitals: blood pressure: 130/80, pulse 76, oxygen 96%. Client stated feeling much better. Vitals 1440: blood pressure 140/90, pulse 68, oxygen 97%. Client stated symptoms had resolved. Client advised to consult with provider prior to receiving second dose. Client drove himself today, stated feeling fine to drive. Last set of vitals at 1448: blood pressure 138/84, pulse 82, oxygen 96%. Per client dizziness resolved. ER precautions given. Client left facility at 1450 with steady gait.
1/7/16 PCV23 received on Rt Deltoid. 1/8/16 Redness and swelling 3 hrs after injection. Treated with antibiotic and warm compress sx resolved on 1/9/16.
Received injection Fri 06/07/02. Noticed site of injection "very swollen and warm to touch" on Sat 06/08/02. Seen and reported reaction on Mon 06/10/02 to this clinic.
About 4 hours after vaccine - patient lying down with daughter felt fluid in lungs, chest tightness, shortness of breath -> to Urgent Care- give Epinephrine -> HA, vomiting, IM PHENERGAN, IM TORADOL. Observed 1 hr -> then sent home.
3 doses of 0.3ml were drawn up in the zero deadspace needles provided with the vaccine. RN drew up the first and third doses, RN drew up the second dose. All three doses were verified by RN Monitor. Upon attempting to draw up the fourth dose RN was only able to draw .1.  Patient had no reaction.  MD made aware of situation.
My chromes medicine became ineffective and it developed antibodies. Due to my medication being ineffective because of the vaccine I and to switch medication.
Died of COVID; Died of COVID; BMI greater than 40; This is a spontaneous report received from a contactable physician communicated to a sales representative. A 23-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), first dose as dose 1 single and second dose as dose 2 single, both via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Event took place after use of product. The patient experienced died of COVID, BMI greater than 40 on an unspecified date. The events drug ineffective and covid-19 assessed as serious (death, medically significant) and while for other was non-serious. The patient underwent lab tests and procedures which included body mass index: greater than 40, COVID test: died of covid on unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events drug ineffective and covid-19 was reported as fatal and while for other was unknown.  Reporter does not wish to be contacted for follow-up.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: (Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events) 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.; Reported Cause(s) of Death: Died of COVID; Died of COVID
Hours after shot given, pain began and continues 10 mo. later. Her been seen by orthopedist and 2 internists, had xrays, medication, therapy and 2 cycles of steroids. Nothing helped. All 3 agreed shot given too high in bursa/tendon area and nauseous. This pain, pain is severe at night and I must sleep in "mummy" position. Can hardly use my left arm as movement or event even minor lifting causes additional pain. Tried to get help from pharmacy but they had a rude attorney call me. I just wanted freedom from pain.
This spontaneous report was received from a nurse prescriber regarding a multiple unspecified patients of unknown demographics. No pertinent medical history, drug reactions or allergies and concomitant therapies were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored VARIVAX (lot # M014908, expiration date 25-MAR-2018) (dose and route not reported). The administered dose experienced a temperature excursion of 4.9 degrees for 263 hours. No adverse effects were reported. No PQC (product quality complaint) filed. This is one of several reports received from the same reporter. Additional information has been requested.
Pt was born no w/no medical problems then all of a sudden got sz, vomiting, fever, cranky, limp, ill, ear infect, gum were clunch together, had trouble talking, breathing, stares in space;
That evening of injection, pt got a "massive" headache and vomited.  Pt did have VARICELLA #1 (before 4 wks previously) and same reaction and thought it was unrelated but exactly the same thing.
Information has been recvd from an MD concerning an unspecified number of patients who were vaccinated with 1 dose of pneumococcal vaccine 23 polyvalent (lot #1448K). The MD reported that over the past couple of months (prior to reporting the events on 1/15/01) it seems that a lot of pts developed "red, sore arms" post vax. The MD stated "We have been using your vaccine for many years for a (pneumococcal vaccine 23 polyvalent) but we're having an unusual amount of local reactions to the shots that we're giving patients to the point where they're really quite angry, red, sore, more so than in the past. Is this just peculiar to a Lot Number that we might have or is this something new that you put in the vaccine that you've been having trouble with?" It was also noted that the pts "can't use (their arm) for 2 or 3 days." The MD was unable to provide specific pt information at the time of the report. Medical attention was sought. Also noted, the MD stated that more than one lot was involved. The records of testing prior to release of lot #1448K have been checked by Biological Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biological Evaluation and Research and was released. Follow-up info for the MD stated that he has given this drug in the past years and "I don't think I've had more than 1 or 2 sore arms in whole year." It was also noted that the MD checked his records and noted having a total of 6 "reactions" this year already. Addtl info has been requested.
Developed temp of 104R one wk p/vax; Taken to ER on 6MAY91; Dx w/allergic rxn to MMR, also had sores in mouth; Ampicillin prescribed; now afeb; sores remain; appetite poor; minimal fluid intake;
3-4 hours after vaccination i was very itchy.   Didn't think to much about it and took a Zyzal.    around 10:00 pm  same day noticed my wrists were red and upon further inspection realized my arms and  trunk were covered in large red hives.   Felt fine other wise.     At  that point started taking two Benadryl  every four hours at 10:00PM, 2:00AM and 6:00AM   at this point 3:30 PM nday after vaccincation  I have   very little signs of the hives.  but my hands still itch and feel "tight"    but most symptoms are  gone.
This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 57-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. On 25th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 28th January 2019, 3 days after receiving SHINGRIX, the patient experienced cold sores. The patient was treated with VALTREX. On an unknown date, the outcome of the cold sores was not recovered/not resolved. It was unknown if the reporter considered the cold sores to be related to SHINGRIX. Additional details were reported as follows: After vaccination, the patient had an adverse reaction. On Monday, the patient broke out with cold sores in her mouth and nose. The patient still had the symptoms. The patient took two doses of VALTREX to treat the symptoms. The patient just told that, she received a prescription, but did not mention visiting physician. The reporter consented to follow up.
pink circular patch on her skin has gotten bigger since her second dose; pink circular patch on her skin has gotten bigger since her second dose; light fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (pink circular patch on her skin has gotten bigger since her second dose), RASH (pink circular patch on her skin has gotten bigger since her second dose) and PYREXIA (light fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis, Granuloma annulare, Patchy rash and Allergic reaction to food. Concomitant products included PARACETAMOL (TYLENOL) for Pain, MAGNESIUM CARBONATE (MAGENSIUM VITAFIT) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PYREXIA (light fever). On an unknown date, the patient experienced SWELLING (pink circular patch on her skin has gotten bigger since her second dose) and RASH (pink circular patch on her skin has gotten bigger since her second dose). On 26-Feb-2021, PYREXIA (light fever) had resolved. At the time of the report, SWELLING (pink circular patch on her skin has gotten bigger since her second dose) and RASH (pink circular patch on her skin has gotten bigger since her second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
GERD was amplified; arm was swollen; fever; chills; tired; arm was swollen and red; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE, PERIPHERAL SWELLING, PYREXIA, CHILLS, and FATIGUE in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cervical dystonia, Tremor and GERD.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE, PERIPHERAL SWELLING, PYREXIA, CHILLS, FATIGUE, and VACCINATION SITE ERYTHEMA. The patient was treated with TYLENOL for Symptomatic treatment, at an unspecified dose and frequency. On 13-Mar-2021, GASTROOESOPHAGEAL REFLUX DISEASE, PERIPHERAL SWELLING, PYREXIA, CHILLS, FATIGUE, and VACCINATION SITE ERYTHEMA had resolved.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The patient called the Pharmacist to see if she should go to urgent care or ER, who suggested the events were just side effects of the vaccine. Concomitant medications were not provided. Treatment also included Theraflu and stated that she treated it like a flu   This case was linked to US-MODERNATX, INC-MOD-2021-073937. Sender's Comments:  US-MODERNATX, INC-MOD-2021-073937: Second dose.
patient waited her 15 minutes and when she got ready to leave, she said she was feeling light headed and faint.  She went to front of store to get a coke and came back to pharmacy to ask what to do. RPh said to sit and put head between legs and take deep breaths, but before we could even suggest anything else, patient was swaying and fell into vaccination screen.  She immediately came to but had bit her lip when falling and her head on screen and side/back on chair. Ambulance arrived and took her vitals and everything checked out ok, but patient refused to go with them. Her husband came and picked her up and stated she would go see her dr.
Feer 101 degrees F for 2 days, rash around injection site, no treatment.
Left upper thigh redness with increased induration. Minimally tender- no swelling. Low grade fever 100.3. Treatment antipyretine
8:20 Am Projectile vomited, then 10 minutes later had a 5 minute long seizure (fell unconscious, eyes rolled back, seized). This happened 71 hours after vaccination. His temperature was normal 2 minutes after seizure.
Size of penny at shot site. Another one beside it, warm, itchy, bubbly or dry skin.
PT presented to ED complaining of fever (TMAX 102), frontal headache, chills, high heart rate (MAX 153), injection site pain PT took Tylenol at home, presented to ED r/t high heart rate
Miscarriage (spontaneous abortion). 3:00PM vaginal discharge. 3:30PM call doctors for advice. 4:30PM arrive at ER. 4:30PM~8PM tests performed, evaluated by Dr. Diagnosed "Spontaneous Abortion".
A four-year-old patient had received an intra-muscular injection of Tripedia, lot number U1342BC; a subcutaneous dose of IPOL, lot number Y0324-2; and a dose of Measles Mumps and Rubella vaccine (manufacturer reported), lot number 0603R, on an unspecified date.  The site of administration was not reported for any of the vaccines administered, in addition, the route of administration was not reported for the  Measles Mumps and Rubella vaccine.  Approximately 24 to 48 hours post-immunization, the patient experienced a local reaction on the arm at the site of the Tripedia and IPOL injection.  The patient required an emergency room visit and may have received treatment with either an unspecified IV antibiotic, an unspecified oral antibiotic, or other treatment.  The reporter did not specify which treatment was given.  The recovery status of the patient was reported as unknown. The reporter for this case is the same as for case 2006-01726 where three other patients experienced similar local reactions requiring emergency room treatment.
Headache, Malaise, Disoriented, Swelling and Rash on administered arm "Look like Australia".  Itchiness, and swollen.
Very itchy rash on upper chest, lower neck, upper back, and b/l armpits, b/l medial thighs, perianal area that appeared 2 days after second moderna vaccine and has improved with topical triamcinolone
2:13 pm - shots given,alert and oriented x 3 2:18pm - c/o "ears numb I can't hear", swaying in chair,alert x 1(person only), blowby oxygen given @10L. Skin cool and dry.  Pupils dialated, eyes rolling back.  General color pale, slightly green. Shortness of breath with slight wheeze. Called 911. 220p B/p 114/60, P-64, r-24.  2:22 pm complained of numbness in the hands. Blowby oxygen continues Ammonia spirit used. 0223p  Alert and oriented x2 (person and place) continued blowby oxygen, c/o hands shaking, states "It feels like a vibrating cell phone" No visable shaking. 226p p-60 R-28 color pale green no nausea, hands become cool and clammy. EMS arrives care turned over.2:29 pm - B/P 91/51, O2 saturation 100%. Alert x 2. 238p standing BP-102/63, O2sat- 98% breathing with ease. Remains pale and slightly green, asks "How long was I out"  Refused additional treatment.  Refused to go to Emergency room with EMT. Ambulated with nurse and mother to vehicle. Instructed by staff and EMT to seek immediate medical attention if breathing difficulty or altered mental stauts.
Patient called to report had reaction of small bump at site with discomfort. Reported by Patient 7-20-16.
Patient received the vaccine on 11/10/21.  She said beginning 11/12/21 an area covering about 2-3 inches on her vaccination arm became warm/hot to the touch and slightly swollen. She stated the area is a little pink, but not much different from her normal skin tone. She stated that on 11/13/21 the area began to itch, but that only lasted one day. Today (11/14/21) the area is still warm to the touch, slightly swollen, and "a little pink."
This spontaneous report as received from a healthcare worker refers to a 10 week old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 01-OCT-2015 the patient was vaccinated with improperly stored oral ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
patient came back and said his arm was still sore and he had trouble lifting it up all the way.  no swelling or redness, no knot, only pain when lifting arm and cant lift it all the way
Pt developed hives to her right leg and hip two days after the immunization. Localized erythema and induration at injection site. Hives also noted to R lateral torso.