chrisvoncsefalvay/vaers-outcomes huggingface dataset:
another vaccine diluent was used to reconstitute Shingrix and administered it to a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 5NT4N) for prophylaxis.   On 07-JUN-2023, the patient received the 2nd dose of Shingrix. On 07-JUN-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: another vaccine diluent was used to reconstitute Shingrix and administered it to a patient). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 13-JUN-2022 The physician reported that another vaccine diluent was used to reconstitute Shingrix and administered it to a patient. The vaccine administration facility was the same as primary reporter. No expiration date reported. The health care professional (HCP) reported a diluent for MMR vaccine was the one used, no further details reported. The reporter consented to follow up.  The patient received diluent of MMR to reconstitute Shingrix vaccine, which led to wrong solution used in drug reconstitution.
Menveo reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA763A, expiry date 20th November 2023) for prophylaxis.   On 2nd September 2022, the patient received Menveo. On 2nd September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 15-Sept-2022 Reporter's comment: Both of them received same Menveo lot number. The reporter consented to follow-up via email. This case is for 1 of 2 linked patients. Additional supportive information: The medical assistant reported that the patient received a Menveo vaccine (powder) reconstituted with sterile water, which led to wrong solution used in drug reconstitution.; Sender's Comments:  US-GSK-US2022133244:Same reporter
Loss of mobility in legs, intense joint pain at knees only - lasted 24 hours, Advil and heating packs provided some relief
Information has been received from a registered nurse concerning a female with a history of hernia and no drug allergies reported who on 08-Sep-2008 was vaccinated with the first dose of GARDASIL (lot # 0573X), 0.5 mL, IM. There was no concomitant medication. On 08-Sep-2008, after vaccination, the patient experienced pain at injection site. On around 12-Sep-2008, the patient developed shoulder pain. At the time of the report, on 26-Sep-2008, the patient was having constant pain on right arm. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 10/14/2008;  1/7/2009.  Follow-up information has been received from a registered nurse concerning a 25 year old female with mild dysplasia and a  history of hernia and no known allergies who on 08-SEP-2008 at 5:18 p.m. was vaccinated intramuscularly in the right deltoid with a 0.5 ml first dose of GARDASIL .  There was no concomitant medication.  The nurse reported that the adverse events resolved on their own.  No further information is available.
high fever (up to 102.5) for two days, then turned to low level fever. The low level fever lasted for over 3 weeks, The temperature went down every week, but it has been over 99 for the whole time except  the last few days, where only afternoon had fever. Besides the above, also had covid arm which lasted for 3 weeks, also had headache and muscle pain. The symptoms fully went away after totally 4 weeks after getting the 2nd shot.
Patient was monitored for 15 minutes, about 20 minutes after the Covid vaccine booster was administered at the school clinic, patient went to school nurse and complained of lightheadedness and palpitations. Denied shortness of breath or difficulty swallowing, Lung sounds clear. Patient laying down with feet elevated. Patient continued laying down for another 20 minutes and still did not feel any better. Rescue called and sent patient to be examined to the emergency room.
Initial misuse report receved from a healthcare professional (nurse) on 16 October 2013 and the case was recieved on 21 March 2014. A 31-month-old patient (gender was not provided) had received a dose of 0.5 ml of FLUZONE instead of 0.25 ml an unspecified date. No adverse event was reported. List of documents held by sender: none.
Information has been received from a physician, for the Pregnancy Registry for GARDASIL, concerning a 17 year old female who was vaccinated with GARDASIL.  It was reported that the patient was pregnant when she was given GARDASIL.  The patient had a miscarriage 1 week after the third dose of GARDASIL was given (date unspecified).  It was unspecified if the patient sought medical attention or not.  Upon internal review miscarriage was considered to be other important medical event.  This is one of several reports received from the same source.  Additional information has been requested.
PT STATES SYMPTOMS STARTED AFTER SHE RETURNED HOME AFTER RECEIVING VACCINATION. PT EXPERIENCED VOMITING, STOMACH ACHE, HEADACHE, BODY CHILLS AND HIGH TEMPERATURE (TEMPERATURE FLUCTUATIONS).
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021 at 11:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 73.30 years.  Concomitant products were not provided.  Number of vials sent to clinic were 9. Vial moved to fridge on 11-Jan-2021 and beyond use date for these vials was reported as 07-Feb-2021. Vial was moved to clinic on 11-Jan-2021.   Batch number 041L20A administered on 11-Jan-2021 underwent temperature excursion with temperature of 34 degrees Fahrenheit at 09:00 am and 35 degrees Fahrenheit at 02:00 pm.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour.  No treatment medications were reported.
Site: Pain at Injection Site-Mild, Systemic: Left Parotid Gland Swelling-Medium, Additional Details: Within an hour of receiving second covid dose, patient experienced facial swelling in her jaw. She visited an emergency dentist office who diagnosed her with left parotid salavary gland swelling.
covid 19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid 19) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jan-2023, the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 08-Feb-2021, patient received first dose Moderna COVID-19 Vaccine (lot number 066F21A). On 08-Mar-2021, patient received second dose of Moderna COVID-19 Vaccine (lot number unknown).Patient reports no adverse events to Moderna vaccines. The patient reports that patient had a positive experience to all her Moderna vaccines.  No treatment information was provided.
Day 1 - tingling/numbness both hands and fingers; Day 2 - progressed to include both forearms; Day 3 - progressed to include both legs - visit ER at local Hospital - no diagnosis - dismissed to see PCP; Day 4 - progressed to include severe numbness both feet; Day 5 - saw PCP - muted reflexes - preliminary diagnosis of GBS - orders to see neurologist; Day 6 - progressed to include severe burning in both thighs - returned to ER; Day 7 - transported to alternate Hospital - diagnosis of AIDP; Days 8 -12 treated with IVIG and dismissed; followed up with PCP for pain - treated with gabapentin 3 x 300mg/day;  Over next nine months weaned off pain meds and regained strength and have limited tingling in fingers of both hands.
The day after receiving my first dose of the vaccine, my neuropathy symptoms worsened significantly from their prior state. I felt increased nerve pain, twitching, numbness/tingling, and a feeling of weakness in my arms and legs. These worsened symptoms have persisted as of the date of this submission.  Additionally, 10 days after the first dose of the vaccine, I also began experiencing significant dizziness, weakness and shakiness throughout my body.  I went to the ER twice for these persistent symptoms to rule out emergency conditions. The first and second ER visits were on April 23, 2021 and April 25, 2021, respectively.  The testing done during my ER visits (various bloodwork, urinalysis, EKGs, CT scan of head, MRI and MRV of brain) did not find a specific cause of these symptoms. I am currently in the process of following up with a cardiologist and neurologist after my recent ER visits, so the results of some additional tests are pending.  The testing done so far has not identified any other cause of these symptoms.  I never had any dizziness prior to the vaccine, and my neuropathy issue has definitely worsened after the vaccine. I continue to experience the aggravated neuropathy and dizziness as of the date of this submission.
Seen in ER on 11MAY91 admited to hosp dx febrile seizure; occult bacteremia & anemia Hgb 7.3, Hematocrit 20.7; sx started 855PM on 11MAY91;
Dizziness, blurred vision, throat tightening, chills, sweats - about 2-3 hours after the vaccination.  Treated in ER with Tylenol, Benadryl and observation.  Felt fairly severe flu like symptoms for next 24-36 hours
No adverse event; lot 042J21A should have been reported with a BUD of Feb 17, 2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.).    No concomitant medication was provided by reporter. No treatment information was provided by the reporter.  NDC- 0777-273-10   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non-significant follow-up; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Patient has hx of anxiety, states she usually takes 0.5 mg, took only 1/2 prior to vaccine clinic.  After scheduling return visit, patient sat down and shortly c/o having problems breathing.  Line monitor noticed patient and called APRN and EMS.  Patient placed in WC and brought to a room.  VS monitored, patient called and spoke to husband and after about 30 mi she left.  VS normal, no SOB, calmed own.
Freezer that the vaccine had been stored in had been turned off and temperature monitoring not done prior to administering to patient.
17 hours after vaccination start of body aches, fatigue, feeling of heavy limbs. 24 hours after vaccine 2 degree F over normal temperature, continued aches, extreme fatigue, sluggish/heavy limbs, pain at vaccination site.  30 hours after vaccine 4 degree F fever over normal temperature and all other side effects continued. 36 hours after vaccination, fever is reducing, aches and pain begin to ease, tiredness reduces. 48 hours after vaccination all other side effects are gone except for mild pain at injection site. Never had redness or swelling at the site.
Received a Flu shot at our workplace Healthy Screening Event and due to the administration of the vaccine being placed too high on arm, the nurse hit my deltoid tendon. I now cannot move my arm and have a lot of pain.
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (received 3 years before the date of reporting). In April 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced joint pain, burning sensation, pruritus, sickness, influenza-like symptoms and adverse event. The patient was treated with BENADRYL and topical Steroid Cream. On an unknown date, the outcome of the joint pain, burning sensation, pruritus, sickness, influenza-like symptoms and adverse event were unknown. It was unknown if the reporter considered the joint pain, burning sensation, pruritus, sickness, influenza-like symptoms and adverse event to be related to SHINGRIX. Additional details were provided as follows: In late April 2018, the patient received SHINGRIX and four days after shot on inside of shot arm developed 5 cm raised irregular circle burning and itching. Pharmacy said it did not act like allergy. On an unknown day, 2 weeks later Dermatologist Doctor said it was hard to know but the patient took BENADRYL twice a day for 3 days then high dose steroid cream to area twice a day for 3 days. Since the Doctor cannot find if one seemingly hepatic type lesion amounts to an allergy reaction and no one told him. The reporter asked have you heard of this type of reaction. There was no local reaction 5 inches lateral to it at injection site but was very sick for 2 days with joint pain, HA and general feeling of flu like symptoms. The patient was wondering should get 2nd dose but no one could advise. After receiving clarification abbreviation for HA event was not clear hence adverse event was coded.
1418- C/O generalized itching, stomach cramps, became diaphoretic. Initial vital signs- B/P 171/143, HR 105, RR 22, O2 sat 100%.  Oral Benadryl 50 mg given. EMS called when p/t c/o  symptoms increasing to include itching and becoming diaphoretic. 1456- Patient transferred to EMS.
Patient notified RN that she was feeling itchy at the location of her left shoulder/ neck area. No visible rash or redness present. Patient stated she has seasonal allergies and takes zyrtec at home. Patient stated she has not taken zyrtec in the past 24 hrs.  One 10 mg zyrtec given. Vital signs taken, heart rate 75, BP 125/80, respiratory rate 16. Patient monitored for another 15 minutes.  Stated she was feeling much better, all itchiness subsided.  Patient sent home and advised to return to ED if symptoms worsened.
Information has been received from a female receptionist at a physician's office who on an unspecified date was vaccinated with the first dose of Gardasil.  Subsequently the patient developed a nodule that was painful upon pressure at the injection site.  Unspecified medical attention was sought.  Subsequently, the patient recovered.  The patient stated that she did not have this experience with the second dose.  Additional information has been requested.
My blood has been very thin since I got the vaccine. I did not take my Warfarin one day before the vaccine and then two days after on the advice of my doctor. My INR level was over seven without takin my Warfarin for the three days. was It is now down now to 4.5 and I am still withholding my Warfarin for two days and then taking it for three days.  I am going to continue monitoring my INR and withholding the Warfarin if needed as advised by my doctor. I have also been very short of breath since the vaccine. I have also been diagnosed by Nuclear MRI with a lung condition.  My MRI taken three weeks after the vaccine result listed Matched Ventilation/perfusion defect in the left lower lung. I am still very short of breath after three weeks I am on Oxygen now. I had shortness of breath before the shot but it was not as bad as it has been since I got the vaccine.
They received 3, 0.5mL doses of the Moderna covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (They received 3, 0.5mL doses of the Moderna covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 077C21B, 041L20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (They received 3, 0.5mL doses of the Moderna covid-19 vaccine). On 25-Oct-2021, ACCIDENTAL OVERDOSE (They received 3, 0.5mL doses of the Moderna covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported.
Pt received 2 Immunizations listed above and had a local scar on his left deltoid. Pt c/o slight stiffness but no pain. pt states he developed a scab and picked it. Pt states the site was not painful at all and received his second Rabies shot today. Pt was told to monitor the site and if it got worse to notify the clinic.
The patient had been in her usual state of health until late March/early April when pt began to experience extreme fatigue and dyspnea on exertion.  Pt was admitted to the hospital on April 3rd with a hemoglobin of 4.9 and transfused.   Patient received Pfizer vaccine on 2/1/21 & 2/22/21. Presented with acquired red cell aplasia on 4/3 with hgb of 4.9. Workup to date for aplasia has been negative, including viral panel and alternative drug causes. Myelodysplastic causes cannot be ruled out, but seem less likely given the abrupt onset of symptoms. Bone marrow biopsy was not pursued due to patient preference.   Given temporal relationship to the COVID vaccine, reporting this possible association to the Health Authority.
5mins p/2 DPT & 2 OPV given, pt became pale & c/o feeling weak, no LOC, no dizziness;
Pt reports being light headed Vitals: 9:45 115/55, 64, 18, 100% -- > 9:52 110/53, 60, 18, 100% pt now denies dizziness 9:55 pt sitting up in bed.  Given juice and crackers 10:05 pt escorted out w/ brother.  Pt is asymptomatic.  Pt stable and released from the vaccination site
Joint Pain in both arms, Elbows, Knees.  Throbbing, Achey feeling.  Patient followed up with PCP provider already for care.
Patient received the Jansen Covid-19 Vaccine on 10/08/21 and on 10/09/21 started having a rash and hives appear from head to toe. She reports that the rash was also itchy. She went to a telehealth visit in which she was prescribed a topical steroid cream. She later went to an Urgent Care and received a steroid shot.
Information has been received from a consumer concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced chickenpox. No other information was provided.  Additional information has been requested. OMIC
Subsequent to receiving one dose of varicella virus vaccine live the pt developed approximately 50 skin lesions and no fever. The pt woke up with about 10 spots on her upper back between the shoulder blades. The next morning the spots had multiplied and some had started to blister on the torso area, some on face, legs, and genital area. No new spots the following day.
This spontaneous case reported by a consumer, describes the occurrence of pruritus (itchy), pain (sore) and rash in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 26, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced pruritus (itchy), pain (sore) and rash. The patient treated with Zyrtec (cetirizine hydrochloride), at an unspecified dose and frequency; and Tylenol (paracetamol), at an unspecified dose and frequency. At the time of the report, pruritus (itchy), pain (sore) and rash outcome: unknown/not provided. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications reported.
Facial redness and swelling; periorbital and lip edema. No itching or dyspnea. Benadryl given.