chrisvoncsefalvay/vaers-outcomes huggingface dataset:
child was given an expired dose of the DAPTACEL on 21-MAR-22 , with no reported adverse events; Initial information was received on 23-MAR-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.   This case involves a 18 months old male patient who experienced child was given an expired dose of the daptacel on 21-mar-22 , with no reported adverse events while receiving vaccine Diphtheria-15/tetanus/5 AC pertussis vaccine [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine for Prophylactic vaccination.  On 21-Mar-2022, the patient received a dose of suspect Diphtheria-15/tetanus/5 AC pertussis vaccine (dose, formulation, and strength: unknown) (batch number: C5706AA Expiry date- 11-MAR-2022) via Intramuscular route in left thigh for immunization.  On 21-MAR-2022 the patient developed a non-serious child was given an expired dose of the daptacel on 21-mar-22 , with no reported adverse events (expired product administered) (latency: same day) following the administration of Diphtheria-15/tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event child was given an expired dose of the daptacel on 21-mar-22 , with no reported adverse events.  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.
Client received the 2nd dose of Moderna COVID vaccine lot #026C21A and expiration date 5/27/21 at 4:08pm.  Client's first dose reaction was reviewed by medical team and was approved to receive second dose.  Client reports at 4:27pm to vaccinator that she was a little nauseated and dizzy 15 minutes prior. EMT took vitals at 4:28pm: blood pressure: 166/113, pulse: 86 and oxygen: 98%.  EMT retook blood pressure and it was 160/110.  Client reports she did not want to report because she did not want PHN to call 911.  Client reports she still has nausea and dizziness and a mild headache. Vaccinator provides water bottle and offers gravity chair but client declines.  Nurse assisted with vitals at 4:35PM: blood pressure: 138/98 and client reports no chest pain, no shortness of breath, mild dizziness, no blurred vision. Client reports her head hurts towards the back and she still feels nauseated.  At 4:40PM vitals are: blood pressure: 136/90, pulse: 82 and oxygen:98%. Client reports headache is the same, no chest pain, no shortness of breath, dizziness still present, nausea improving, offer to call paramedics and client declines. At 4:45pm vitals are: blood pressure: 134/96, pulse:83 and oxygen:98%. Client reports no shortness of breath, nausea is improving and dizziness is slightly better. At 4:50pm vitals are: blood pressure: 138/92, pulse:88 and oxygen:98%. Client reports no changes in symptoms. At 4:55PM, vitals are: blood pressure: 134/94, pulse: 88 and oxygen: 99%. Client reports nausea is better, headache feels better and dizziness has resolved. Client walked out of the facility with a steady gait at 5pm.
Bursitis / had to stretch daily to get my normal range of motion back; right arm took a long time to recover; This case was reported by a consumer via interactive digital media and described the occurrence of bursitis in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 5 months after receiving Shingles vaccine, the patient experienced bursitis and arm discomfort. On an unknown date, the outcome of the bursitis and arm discomfort were recovered/resolved.   It was unknown if the reporter considered the bursitis and arm discomfort to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient received 2nd dose of Shingles vaccine this year. The patient right arm took a long time to recover. Bursitis set in and the patient had to stretch daily to get his/her normal range of motion back. It literally took months
Immediate Rxns:  Both injections I had the typical soreness at the injection site.  I reacted more adversely to the 2nd dose:  Much more swelling & pain at the injection site (size of a walnut), the next day I had fever of 100.6, body aches and chills, had to go to bed for the rest of the day after the injection.  Felt tired for a couple days, but all in all, not that bad.  I knew the reaction was a sign of actual immunity being built up, so I have no complaint.  Two adverse physical rxns a couple months after the shots:  1) I think I got a mild case of Covid toes mid-March through April, and was completely gone by early May.  I did not have any new shoes, and I do not get swelling of the cuticles or bruising like this was.  It progressed from painful red swelling to dark red, purplish to almost black small blood blisters before it resolved.  Never had that before.  I did not see a physician for it.  I saw pictures of mild cases on the internet and didn't think it was of much consequence.  2)  In April, 2021 I suddenly developed a very stiff left jaw that for a couple weeks made crunchy sounds.  The cracking stopped, but the joint became very painful all the way up into the left ear and my ability to open my mouth was much decreased.  I couldn't bit down on tough to chew food.  I didn't have good insurance coverage at the time, so I did not see a doctor about it.  The stiffness and radiating pain to my left ear jaw worsened over May & June, needed to take ibuprofen to handle the pain.  I figured it was TMJ - and can be related to stress which of course we all have through this pandemic.   I got Medicare in July, so I consulted my dentist and an ENT about it, but decided not to do a bite guard because I do not grind my teeth at night.  Interestingly, the symptoms have lessened since early August and I am almost back to normal now.  Seems the TMJ was temporary.
Patient reported soreness in her arm within an hour after vaccination. Within 48 hours of vaccination, patient reports numbness in arm of vaccination and also weakness when grasping or holding objects.
patient was given the immunization and immediately after the shot  his head fell backwards in the chair and his body stretched out for just a few brief seconds and then he said he did not remember what happened   His pupils were dilated for just a brief time and he was clammy.  but within minutes he was just fine and left the store with his father who was with him at the time.
temperature excursion involving PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 08-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis.  The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2012USA010555: US-009507513-2012USA010556: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010592: US-009507513-2012USA010629: US-009507513-2012USA010652: US-009507513-2012USA010667: US-009507513-2012USA010683: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:
inadvertently administering Adacel instead of Daptacel; Adacel administered at 15 month old female patient; Initial information received on 13-Aug-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 months old female patient who received 0.5 ml  vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot C5602AA via intramuscular route in the right thigh instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] on 13-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR).  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  It was reported that inadvertently administering Adacel instead of Daptacel to 15month old. Caller stated patient has had 3 doses prior of Daptacel, this was intended to be the fourth dose of Daptacel.  No adverse event reported at the time of report.  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 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.  List of documents held by sender: none.
6 min after receiving vaccine dose, patient stood up, reported feeling light-headed and lost consciousness, striking his head while falling to floor.  LOC x 10-15 sec, regained consciousness on own and was speaking immediately after.  EMS was activated and patient was transported to local ER for eval via ambulance.
Pt complained about cellulitis in upper arm which was spreading downwards, it was red and very inflammatory in beginning and was better 04/23/19.
rash going from her back into her side; Fatigue; Not feeling well; This case was reported by a nurse via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced rash, fatigue and feeling unwell. On an unknown date, the outcome of the rash, fatigue and feeling unwell were unknown.   It was unknown if the reporter considered the rash, fatigue and feeling unwell to be related to Shingrix.  Additional details were reported as follows: Information came through a voicemail. This case was reported by the nurse. The nurse reported that a patient experienced a rash going from her back into her side, fatigue and not feeling well one day after a dose of Shingrix. The follow up consent was denied.
Patient developed acute otitis media four days after hep A vax. Parents believe there may be a connection due to previous OM following Hep B. I, myself, see no connection other than contracting cold viruses when making office visit.
This case was reported by a pharmacist via call representative and described the occurrence of injection site pain in a male patient who received ENGERIX B. On 28th April 2016, the patient received ENGERIX B. On an unknown date, less than a month after receiving ENGERIX B, the patient experienced injection site pain and injection site nodule. On an unknown date, the outcome of the injection site pain and injection site nodule were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site nodule to be related to ENGERIX B. Additional details were provided as follows: The reporter stated that, after receiving a dose of ENGERIX B the patient came back into the office about a month later to report that he was still having some soreness and a hard knot at the injection site. No further information was reported regarding the event. The reporter did not feel comfortable providing further information regarding the event.
pain in the cheek; swollen cheek; swelling lip; This case was reported by a pharmacist via call center representative and described the occurrence of facial pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2019, the patient received the 1st dose of Shingrix. On an unknown date, between 3 and 5 months after receiving Shingrix, the patient experienced facial pain, cheek swelling and lip swelling. On an unknown date, the outcome of the facial pain, cheek swelling and lip swelling were unknown.   It was unknown if the reporter considered the facial pain, cheek swelling and lip swelling to be related to Shingrix.  Additional details were provided as follows: The patient developed pain in the cheek, which also became swollen and a swollen lip. On the day of reporting the patient had arrived to receive the 2nd dose of Shingrix and reported about the adverse events experienced. The reporter inquired if this patient should receive the second dose. The reporter consented to follow up.
Pt experienced dizziness, paleness, nausea, coldness of hands, and sweating for about 15 minutes about 10 minutes after injection. Paramedics were called and her vitals were checked and everything was in normal range.
Product preparation error; no adverse event; Office manager calling to report adverse event regarding administration of expired VAQTA vaccine.  Office manager originally called to inquire about expiration date of an administered VAQTA syringe.  Called stated the vaccine was administered on 4/10; This spontaneous report was received from a physician and refers to a 5-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-APR-2022, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 0.5 ml/once, (lot #T033304, has been verified to be a valid lot number, expiration date: 02-APR-2022) (Expired product administered), administered in left arm for prophylaxis (strength reported as 25/0.5, route of administration were not provided).  It was reported that the medication error (Expired product administered) was occurred at the point of preparation for administration (Product preparation error). Office manager stated that patient involved did not report any adverse reaction to this adverse event and the patient's physician was aware of the event and consented to correspondence regarding this adverse event. No additional AE/PQC reported (no adverse event). All the outcome was not reported.
Slight nausea, headaches; Slight nausea, headaches; my arm hurting but the shortness of breath bothered; my arm hurting but the shortness of breath bothered; fatigue; This is a spontaneous report received from a Pfizer Pfizer from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (BNT162B2, solution for injection; batch/lot number not reported), via an unspecified route of administration, on an unspecified date, as Dose 1, single for COVID-19 immunization. Medical history included melanoma. The patient's concomitant medications were not reported. Phone call received from the patient and during the call, the patient stated, "I'm in excellent health. I went to get the first Pfizer vaccine'. On an unspecified date, she stated that she received first dose of vaccine 4 weeks ago and had a horrible reaction. she had everything, slight nausea, headaches which did not bother her, and she did not care about her arm hurting but the shortness of breath bothered her, and it was the fatigue that bothered her beyond anything I had ever experienced before. After 3 days, it took her two days to recover from the reaction. Now last week, she was supposed to get the 2nd shot and quite frankly she chickened out. So, she made the appointment for this week and she was supposed to go this afternoon. She asked, there was anything she could do to lessen the reaction and she was scared of this vaccine. She had Melanoma and stated that she has never had an experience like this. Caller stated that her primary provider informed her, she might have to get Johnson and Johnson vaccine for second dose. The outcome of all the events was resolved.  Note: The patient's date of birth and patient's gender, were not provided during the call.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
She got injected with Pfizer vaccines 1st and 2nd dose last Mar2021 and Apr2021, respectively, and a Moderna booster shot last Dec2021.; tightness of chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (unknown if pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, lot number: unknown, Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion), administration date: Mar2021, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2021, outcome "unknown", described as "She got injected with Pfizer vaccines 1st and 2nd dose last Mar2021 and Apr2021, respectively, and a Moderna booster shot last Dec2021."; CHEST DISCOMFORT (non-serious) with onset Dec2021, outcome "not recovered", described as "tightness of chest". It was unknown if therapeutic measures were taken as a result of chest discomfort.  Additional information: Reporter type stated as Pfizer employee. The patient is an acquaintance. In a recent conversation, she mentioned that she experienced tightness of chest after taking her covid vaccine booster shots and the condition persists until today. Upon reporter further inquiry, reporter found out that she got injected with Pfizer vaccines 1st and 2nd dose last Mar2021 and Apr2021, respectively, and a Moderna booster shot last Dec2021. Reporting this in case this is considered an adverse event - since prior the Moderna booster shot, she took Pfizer vaccine shots for her 1st and 2nd Dose. If covid prior vaccination or tested post vaccination stated as unknown. Dose 2 Lot unknown reason stated as Not available/provided to reporter at the time of report completion.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe allergic reaction within 3 hours of vaccine, arm swollen and red, went to ER and was given MEDROL dose pack and told to buy BENADRYL.
Baby was given vaccines at 9:45am. Parents then took him to a public pool. He developed rash, red, blotchy on trunk, most prominent axillae diaper area. Returned to office 12:15pm. Given Benadryl about 1 hour later rash was gone never recurred, even after going to pool again.
This 15 year old minor patient was administered the Pfizer COVID-19 vaccine that is currently authorized for 16 years old and older. Patient's father was present during time of the vaccination. Patient self reported to vaccinator that she was 16 years of age. Patient received vaccine at 1730. Patient left clinic accompanied by her father with no known injuries. LPN attempted to call the patients parent/guardian on 05/12/2021 at 1417 and voicemail was left. Parent returned phone call at 1451. Parent confirmed that he was present at the time of the vaccination and gave verbal consent to the vaccinator at the time of administration and to this nurse via phone call. Patient's father was confused about the fact that the agency has approved to have 12-15 year old's vaccinated. He was educated about the fact that the facility has not been approved to start administering vaccines to 12-15 year old's.
LEFT ARM PAINX2 WEEKS, DECREASED LEFT ARM ROM.  ICE WAS USED AND  TYLENOL.  PAIN  AND DECREASED ROM REMAIN.  WILL BEGIN 600MG IBUPROFEN TID WITH FOOD BEGINNING TODAY.
Agency is a 61 y.o. male patient, CNP with history of MS, Trigeminal neuralgia, Depression, anxiety presented to Hospital with weakness, confusion, home positive Covid test .   Covid virus infection Acute Metabolic Encephalopathy - resolved Weakness  Mild Hyponatremia  P/w P/w 2 days of nasal congestion, cough,  sore throat, SOB, myalgias, weakness, high fevers , nausea, poor appetite, wife reports confusion .  Encephalopathy likely from Covid, weakness complicated by MS  Pt is vaccinated x 4 Date of onset of symptoms: 10/9/23  Date of covid positive test: 10/10/23  Oxygen requirements on admission: none  Current oxygen requirements: none  Medical therapy: not a candidate febrile on arrival 101.2, HR 98, RR 18, BP 11/62, satting 98% on RA Initial CBC w WBC 6, LA normal, troponin normal VBG 7.37/46  CXR: No acute process CT head white matter changes , could be amll vessel ischemic change or demyelinating process (h/o MS) CRP 110 => 143, discussed this with patient and dexamethasone initiated for 10 days Albuterol, robitussin-DM, tylenol PRN Lasix PRN for dry lung strategy, monitor I&Os Encourage IS use Contact precautions Lovenox  for DVT ppx   Progressive non-relapsing MS Trigeminal neuralgia  Neuropathy Was following with neurologist, unsure if he has established care here Continue Tegretol and Gabapentin Also takes Norco PRN, last filled 10/2/23 for 30 days Describes some worsened leg weakness today so will consult Neurology to assess for potential MS flare, appreciate assistance  Depression/Anxiety Resume home meds    Asthma Resume singulair
Sinus drainage; Dizziness and tiredness that comes and goes; Dizziness and tiredness that comes and goes; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 21Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, after receiving vaccine the patient then developed dizziness and tiredness that comes and goes. He also states he has sinus drainage which he says may have started before vaccine. The clinical outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient called in the morning saying that she had pain in her joint. At first, I thought it was at the injection site which is normal after a vaccination. I told her the pain will subside after a few days. She told me that the pain was at several joints and that she think it maybe the Guillain Barre. I told her to call her doctor.
Patient stated that left side of face become numb. Patient thought she was having a stroke. Malpasily.