chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The reporter stated that she had 22 forms (from the CDC) about patients that were administered expired vaccines, she was asking if they should revaccinate those patients. Number of doses/vials: 22 The date of vial initially stored in the refrigerator was unknown. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  Patient received his first booster in his left arm. Vials did not undergo any temperature excursions. No treatment information was reported.
Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022; Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 administered on 08-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 01-Apr-2022, refrigerated on 04-Apr-2022 and administered on 08-Apr-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 04-Apr-2022. The vial did not undergo any temperature excursions. It was reported that pharmacist thought that the vaccine was expired in Jun-2022, however it was expired on 01-Apr-2022.  No treatment information was reported.
Pt received first dose of COVID vaccine on 2/23/21. Returned to clinic on 3/16/21 for 2nd dose. Reported that he has chronic diverticulosis, but has experienced increased abdominal pain since first dose. Has appt with PCP in the next few days. Denies any other s/s.
The consent form that was filled out by the guardian was misread where the date of birth was filled in.  It was misread as 08/20/2008 and not the correct 08/20/2009 that it should have been.  During counseling before the vaccination that Pfizer was approved for 12 years old  and older but the guardian never disclosed that the child was 10 days younger than 12.  The pharmacy discovered the error upon entering the information.
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 13-NOV-2012 14:01, 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 the 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 pharmacist via a company representative refers to three patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, route, lot number and expiration date not reported). There was no concomitant medication reported. Pharmacist reported that there were "3 cases of cellulosis" that developed over the last few weeks "(on an unknown date in approximately 2014) after patients received ZOSTAVAX. The outcomes of the events were unknown. Additional information has been requested.
temperature excursion that was intermittent/involving PROQUAD states that there have been administered doses; This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapy was not reported.   On 21-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) (0.5ml, route of administration and anatomical location were not reported, lot # S031882 with an expiry date of 07-APR-2021 or lot# T009929 with an expiry date of 16-AEP-2021), for prophylaxis. Beginning from 28-JUL-2020, the temperature excursion of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) was between -14 Celsius degrees and -10 Celsius degrees (max -9.5 Celsius degrees) for a total of 38 hours and 30 minutes and was assessed as intermittent. There had not been previous temperature excursion. Digital data logger was used.
A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) while pregnant.  The patient's medical and pregnancy history was not provided. No concomitant medications were reported.  On 30 Dec 2020 , the patient received the first dose of mRNA-1273 for prophylaxis of COVID-19 infection.   The date of the patient's positive pregnancy test and first day of the last menstrual period were not reported. The estimated date of conception and due date were not reported.  Action taken with mRNA-1273 was unknown.  The event exposure during pregnancy was considered resolved on 30 Dec 2020.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Developed swollen lymph node in right inguinal area on 9/15/21, Diagnosed with Non-Hodgkins Follicular lymphoma on 10/28/21. Started Radiation treatments on 12/15/21 for 15 treatments. Will finish final radiation treatment on 1/6/2022 and a repeat PET scan will be done in 3months to see what future treatment is needed.
large blood clots during menstruation; irregular menstrual cycle; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (Lot Number: er8731), via an unspecified route of administration in Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced irregular menstrual cycle and large blood clots during menstruation, both on 04May2021. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.
9-1-09 DTAP in R thigh.  9-3-09 mom noted red raised area R thigh.  9-4-09 MD appt. Tx with ice + TYLENOL.
Pt reports getting a flu vaccine at the Flu Shot Clinic that was held on 10/7. Pt states on 10/10 she woke up with a red, swollen and sore left arm. Pt had a noticeable red/raised area at injection site with a white pustulal that is still intact. Saw provider today at the clinic was prescribed antibiotic.
Information has been received from a physician concerning an overweight 15 year old female with anxiety and no drug reactions/allergies history reported who on 18-JUN-2008 was vaccinated with a first dose of GARDASIL vaccine (yeast) 0.5 ml IM (lot# 660555/0279X). Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid. On 18-JUN-2008 the patient became lightheaded, diaphoretic and hypotensive after her first dose of GARDASIL vaccine (yeast). The patient had a consult with a cardiologist due to these adverse experiences and was diagnosed with a vasovagal response to the immunizations. Additional information has been requested.
resting heartrate 130 beats per minute; This is a spontaneous report from a contactable consumer or other non-HCP. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on Apr2021 as DOSE 2 ,SINGLE (Age of vaccination: Unknown) for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization. Medical history included blood donation. The patient's concomitant medications were not reported. On an unspecified date of Apr2021 the patient experienced resting heartrate 130 beats per minute. The patient underwent lab tests and procedures which included heart rate: 130 bpm on Apr2021 130 BPM. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Feb. 22  Red rash appeared on LEFT arm at vaccination site in the evening, just red, not itchy or bumpy, 3" diameter. Comes & goes, up to 4"x3".  Feb. 25  Woke up @ 5am with severe itching on inside of RIGHT elbow. There were hives which spread up to my shoulder, then appeared on LEFT arm in same locations. No antihistamine available; hives calmed down after an hour or so. Started up again that evening, took 2 Benadryl, and they calmed down.  Feb. 26  More hives in the morning, not as bad. Calmed down when I rubbed alcohol on them. Started Allerfex in the afternoon, but still got a few hives in the evening, same locations. Feb. 27 - Woke up with hives on both arms inside elbows and on right side of face and puffiness under right eye, gradually calmed down. One more hive @ 2:30, inside upper lip, took Allerfex a little early and it soon calmed down. Now taking Allerfex daily since hives continue to show up. March 4 - Saw allergist's physician assistant who advised continuing Allerfex daily until at least 2 weeks after second vaccine dose.
By 1pm patient could not move left arm. Patient reports feeling on fingers but could not move hand at all--it was numb; felt like it was not there. Had pulsating pain at injection site; it did not radiate. Could not drive and it was hard to continue daily activities. Took 2 ALEVE and that did not help; took 1 more and it finally helped. Took TYLENOL when it was time and put hot compresses; it helped a little bit. Finally went to bed. Went to work the next day and it was very hard because had limited movement on arm. Patient called the ER and talked to a nurse who recommended follow-up with doctor or to go to ER. Patient mentions that they did not have a fever or nausea. Today patient can move arm up and down but could not get it above head without help. Right arm is fine.
No additional adverse events; administration of PROQUAD to a 14 year old; This spontaneous report was received from a nurse referring to a 14 year old patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  The nurse reported that the patient had incomplete vaccination history and had a separate dose of "MMR and varicella" in May 2012. On 27-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # U015480, expiration date 13-NOV-2022 at a dose of 0.5 milliliter for prophylaxis (product administered to patient of inappropriate age). The patient was not experiencing any symptoms at this time. No additional adverse events reported.
Swelling, redness, pain at site of injection. Symptoms began 6 days after immunization. Induration 7 1/2x 8 1/2cm.
Headache, NauseaVomiting, L arm soreness, fatigue, 1/3/2020-L eyelid drooping and now inflamed L breast cyst that was previously stable for 4 years
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, immediately after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain, swelling and product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown and the outcome of the swelling was recovered/resolved. It was unknown if the reporter considered the injection site pain and swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient for herself. The age at vaccination was not reported. In 2018, the patient received the first dose of the SHINGRIX series about 4 months ago and the shot hurt, caused a lot of pain. Less than a year after receiving SHINGRIX, the patient had a bump that lasted a week. The patient was also concerned that she would be late for the second dose of the SHINGRIX series due to the current backorder. The patient did not want to provide contact information.
Patient developed dry mouth and dificulty swallowing 11 min after vaccination, lasted 30 min. Has lingering post nasal drainage.
Mother described area from shoulder area from shoulder to elbow swollen and red. Notified child's doctor who recommended Benadryl. Follow up with mother indicated problem resolved.
Heat sensation, and tingling in left arm that extended from site of injection to middle finger of left hand.
Patient came back to pharmacy about 20 minutes after receiving the vaccine with her son. He stated that she was not communicating and would not eat and not acting like self. As we were waiting to talk to her doctor she showed signs of a stroke such as drooping lip on one side of face. I instead called 911.
Entire left arm is in pain and hurts to move. Finger tips are slightly tingling.
Fever started 03/24/2006 approximately 5 hours after injection, 102 degrees continued until Monday, 03/27/2006, when it went to 104 degrees and has continued- no other symptoms.  No local reaction.  Does have loose stools.
The patient has a lot of localized pain and swelling in the immunization area and it seems to be spreading. She has been taking OTC ibuprofen but it has not resolved the issue. The event has not seemed to diminish her range of motion but it is still very sore and swollen at the site of injection so she will see her PCP.
vasovagal response to vaccine- about 10 minutes after vaccine patient began to pass out - did not hit her head- was laid flat with elevated legs and recovered- 911 was called and they examined her in the ambulance and possibly took her to the hospital
patient has the Pfizer vaccine for her primary series. The patient has the Modera vaccine for a booster dose.; patient has the Pfizer vaccine for her primary series. The patient has the Modera vaccine for a booster dose.; general body aches; headaches; low fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, he patient experienced no adverse reactions to the first Pfizer vaccine.), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "patient has the Pfizer vaccine for her primary series. The patient has the Modera vaccine for a booster dose."; PAIN (non-serious), outcome "unknown", described as "general body aches"; HEADACHE (non-serious), outcome "unknown", described as "headaches"; PYREXIA (non-serious), outcome "unknown", described as "low fever". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient was about to ride in the car to go home from the clinic, when she complained to the daughter/companion that she feels dizzy. She was brought back to the clinic. Initial VS were: BP 157/60 and HR 39. She was transferred to the UC via a wheelchair. At 10:50, at the UC, patient was placed at OBS room. Initial VS were: BP:160/69, HR: 46, O2 sat at 95% at Room Air. UC doctor was notified. Patient complained that her upper lip was sleeping and that her throat felt swollen. IV access was started with difficulty. Patient was given Solumedrol 125 mg/IV at 1110 AM, Benadryl 50 mg/IV at 1115 AM. At 1115, pulse was noted at 38. Patient was transferred to the ER via 911.  At the ER, EKG was done and patient was given Pepcid 20 mg/IV and Solumedrol 125 mg/IV.  Patient was discharged stable at 14:52.
4 year old child vaccinated 4/29/16 (L) upper arm; DTAP 5 Pertussis Antigens 0.5 mL left deltoid IM, IPV 0.5 mL left deltoid SQ (subcutaneous). The morning of 4/30, noted left arm swelling, itching and redness. Taken to hospital ED. 5/1/16 hospital ED visit - after initial visit 4/30/16 - begin on BENADRYL 5 mL QID prn, ibuprofen 100 mg po q 4-6 hours prn, cephalexin 250 mg po TID X 7 days. Follow-up primary care as needed.  Visited hospital 5/3/16.
Chest pains, heart palpitations and squeezing pains in heart continue more than 3 weeks later.  Also low grade fevers continue.
Face went numb about 30 minutes after receiving the 1st dose of vaccine. On her left side, patient thought she had a stroke because her arm went limp. She also experienced heart palpations, dizziness, headache and chills. Patient followed up with her MD for blood work and an MRI.
vial had been opened for 24 hours but kept in the fridge; Moderna Covid booster dose was administered to patient after its expiration time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid booster dose was administered to patient after its expiration time) and PRODUCT STORAGE ERROR (vial had been opened for 24 hours but kept in the fridge) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2022 at 8:24 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022 at 8:24 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid booster dose was administered to patient after its expiration time). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial had been opened for 24 hours but kept in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid booster dose was administered to patient after its expiration time) and PRODUCT STORAGE ERROR (vial had been opened for 24 hours but kept in the fridge) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was moved from freezer to refrigerator on 17-Mar-2022.  The vial of the vaccine was opened on 28-Mar-2022 at 08:06 A.M. The reporter would like to know about what action needs to be taken as the next step and whether the patient needs to repeat that dose or not.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2022: Follow-up document received contains significant information: batch number of suspect vaccine and narrative were updated.
Information has been received from a physician concerning a 11 year old female who on 05-JUN-2009 was vaccinated with VARIVAX (lot#, route and site of administration not reported). Concomitant therapy included Hep B (unspecified) (lot#, route and site of administration not reported) which was also vaccinated on 05-JUN-2009. On 05-JUN-2009 the patient developed extremely swollen arm from the shoulder down to the elbow right after getting the vaccine. Unspecified medical attention was sought. At the time of reporting the patient was recovering. This is one of several cases from the same source. Additional information has been requested.
Extremw chills, fever, headache, sore joints, soreness at injection site.
Pt with (L) arm pain, paresthesia and pain with motion. No swelling.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. No relevant medical history of the patient was reported. On 05-AUG-2014 the patient was vaccinated with PNEUMOVAX 23, (strength and lot number were not reported, expiration date: 20-JUL-2014) intramuscular. There were no concomitant medications reported. It was reported that on 05-AUG-2014, the patient was inadvertently administered with PNEUMOVAX 23, which expired on 20-JUL-2014. This was supported and the patient experienced no adverse effects. There was no product quality complaint (PQC) involved. The outcome was unknown. Additional information has been requested.
Information has been received from a medical assistant concerning a 6 year old male with no pertinent medical history and no reported allergies, who on 04-Mar-2009was vaccinated SC in his left arm with a 0.5ml dose of PNEUMOVAX 23 (lot number 1085X). Concomitant therapy included glucosamine, saw palmetto, vitamins (unspecified) and Naprosyn. The medical assistant reported that on 07-Mar-2009, the patient's left arm was swelled as if had cellulitis. The patient went to the emergency room over the weekend. The patient recovered from the event on an unspecified date. No labs studies were performed. Additional information has been requested.
Chills, headache, low fever, feeling dehydrated, dry mouth, aches all over my body.  Lasted until about 12:00 noon on February 13th, 2021.  I took one table of Alla-Seltzer Plus Cold, which helped.
Patient did "not feel well" while sitting in observation area after receiving shot.  No complaints of dizziness or lightheadedness.  Patient didn't eat breakfast.  Taking pravastatin, losartan and metformin.  Didn't take medications today - will do so after eating a full meal at lunch.  History of hypertension.  Vitals taken x2 - stable.  Offered powerade and granola bar, which patient drank and ate.  Patient felt much better after eating and drinking.  Conversing and laughing with clinic staff.  Left clinic area after 30 minutes.  Observed steady gait when leaving site.