chrisvoncsefalvay/vaers-outcomes huggingface dataset:
gave liquid portion of pentacel without re-constituting the powder portion with no reported adverse event; the liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portionthe liquid portion of PENTACEL only on 01AUG2022 without re-constituting the powder portion with no adverse event; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2022SA320954(CLUSTER).  This case involves a 5 months old female patient who experienced gave liquid portion of pentacel without re-constituting the powder portion with no reported adverse event and the liquid portion of pentacel only on 01aug2022 without re-constituting the powder portionthe liquid portion of pentacel only on 01aug2022 without re-constituting the powder portion with no adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination.  On 01-Aug-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE once (lot U7197BA; expiry date: 28-Jan-2024)  via intramuscular route in the right thigh for prophylactic vaccination.  On 01-AUG-2022 the patient reported gave liquid portion of pentacel without re-constituting the powder portion with no reported adverse event (single component of a two-component product administered) and (product preparation error)following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.   Action taken: not applicable.    At time of reporting, the outcome was Unknown for the event (single component of a two-component product administered and product preparation error)     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.
After the second dose, I had about four intermittent, minor aches in the region of my heart.  They would arise and then fade, lasting about two seconds.  Although they were minor, they were definitely noticeable.  Since then, I have had intermittent heart palpitations.  Again, they are minor but also very noticeable.  Even so, I still did a 5.5 mile walk and didn't not notice anything unusual during it.  I have not yet contacted my cardiologist about this and may not if the palpitations subside in the near term.
pt recv vax 15APR96 955AM & later 1030AM exp upset stomach;By 3PM called amb pt taken to hosp dx w/very low K, Mg, & P;
administration of the Adacel vaccine to a pregnant patient/ No AE; Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves female patient of 26 year old who was vaccinated with 0.5 mL single dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6141AB, expiry date: 15-Dec-2020 via unknown route in the left deltoid on 24-Jan-2019 while she was pregnant.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given on that day.  It was a case of vaccine exposure during pregnancy   No adverse reaction occurred after vaccination.  It was reported that the baby not due until 4-Aug-19.  Pregnancy outcome was unknown at the time of report.  List of documents held by sender- none.  Follow up information received on 22-Feb-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  Patients age was updated.  List of documents held by sender: none.  Follow up information received on 05-Apr-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  No new information reported.  List of documents held by sender: none.
Insomnia / trouble sleeping; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "Insomnia / trouble sleeping"; HEADACHE (non-serious), outcome "recovered", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated, "I have some question. I know the common side effects of covid. I am calling in regards to mother. My mother got the covid vaccine (Capture as verbatim). Is anybody reported any side effects like insomnia? That is my question. Even it is like small or rare or because my mom never had insomnia. After she took the first covid vaccine and she is been having like ongoing headache that was go away and trouble sleeping. So I am trying you know she went to go tested and she doesn't have covid. Her doctor doesn't understand why she has onset of insomnia happening. So our last step is to call you guys or may be we are hoping that somebody has reported you know some minor."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Began with a rash on right arm.  By the following day, my entire body seized with severe muscle pain which extended throughout my entire body but concentrated mainly in my legs and eyes.  I was also nauseous and had loss of appetite. On 13 August, my muscle pain became worse and walking became problematic.  I developed a 102 fever, had severe chills and by noon became extremely fatigued to the point of feeling lethargic.  My body also felt numb. On 14 August the symptoms had progressed to the point where I had to make an emergency visit to my doctor.  My eye muscles were intensely painful and I could hardly move them and I developed an additional headache.  The rash also began to spread to my left arm. At the time of this reporting, 16 August, I cannot contain the rash which is still continuing to spread up and down both of my arms, am nauseous and still experiencing slight muscle pain especially in my calves and eyes.  I also have not been able to eat in nearly 5 days and have experienced weight loss.
2/25/22 patient brought to ED by wife in car with CP, SOB, diaphoresis; became unresponsive in parking lot with cardiac arrest; CPR/ACLS with ROSC; patient in ED experienced another cardiac arrest; CPR/ACLS performed with success; to cath. lab; showed occlusion of proximal RCA with sluggish coronary flow through collaterals; experienced cardiogenic shock; intra-aortic balloon pump placed; found to be positive for COVID (no mention of treatment for COVID in medical records); 2/28/22 MRI of brain showed global ischemia; grim prognosis; patient transitioned to comfort measures; patient extubated and he passed away in the hospital.
Vaccine expired on 02-Apr-2022 and removed from the fridge on 06-Apr-2022; Patient administered vaccine on 06-Apr-2022 past the BUD date 02-Apr-2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 06-Apr-2022 past the BUD date 02-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from the fridge on 06-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 06-Apr-2022 past the BUD date 02-Apr-2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from the fridge on 06-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccine on 06-Apr-2022 past the BUD date 02-Apr-2022.) and PRODUCT STORAGE ERROR (Vaccine expired on 02-Apr-2022 and removed from the fridge on 06-Apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  The BUD date was reported as 02-Apr-2022.  The vaccines were stored in the freezer and only removed as needed to thaw and then administered. It was mentioned that vials were taken out at a time and thawed as they did not thawed an entire box.  Vaccine was removed from fridge on 06-Apr-2022.  Treatment information was not provided by the reporter.   This case was linked to MOD-2022-569375 (Patient Link).
I had my vaccination on 07/07/2022. On 12/26/2022 I went to urgent care for runny nose and sore throat. I was diagnosed with type Flu A Flu B and COVID-19 positive. This was the second time I had COVID-19 as I was first diagnosed in 12/2020. I was prescribed PAXLOVID. I presently feel better as of 01/09/2023.
When vaccine given pt experienced "pressure" as it was going in. Ached all night (pain scale of 6-7 per pt). Arm sore the next day. Gone by day 2 post shot.
COULDN'T BREATHE WHEN WENT UPSTAIRS; SEVERE BODY ACHES; FELT DRUNK; FELT LIKE GOT HIT/GOT HIT EVERYWHERE ON THE BODY/COULD FEEL IT IN BONES; FELT COMPLETELY OUT OF IT AND FELT LIKE NOT THERE; CHILLS/ CHILLS THAT SHE COULD NOT SHAKE OFF; FELT LIKE COMPLETE CRAP; HEADACHE/REALLY BAD HEADACHE AT FRONT OF THE HEAD; This spontaneous report received from a patient concerned a 25 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1808980, expiry: 20-JUN-2021) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced couldn't breathe when went upstairs. On APR-2021, the subject experienced severe body aches. On APR-2021, the subject experienced felt drunk. On APR-2021, the subject experienced felt like got hit/got hit everywhere on the body/could feel it in bones. On APR-2021, the subject experienced felt completely out of it and felt like not there. On APR-2021, the subject experienced chills/ chills that she could not shake off. On APR-2021, the subject experienced felt like complete crap. On APR-2021, the subject experienced headache/really bad headache at front of the head. The action taken with covid-19 vaccine  was not applicable. The outcome of the headache/really bad headache at front of the head, chills/ chills that she could not shake off, couldn't breathe when went upstairs, severe body aches, felt drunk, felt like got hit/got hit everywhere on the body/could feel it in bones, felt like complete crap and felt completely out of it and felt like not there was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious
I felt as if I was sick with Covid-19 again. I awoke at 3AM with chills, a splitting headache, and body aches all over. This lasted into the next day, until about 2PM. Tylenol did not alleviate symptoms. I became tired just from walking around my house.
Patient was waiting/ being observed after receiving the Janssen Covid vaccine. Approximately 10 minutes after the vaccine, he reported feeling very faint and was about to pass out. He wasn't feeling well so 911 was called. He also reported feeling hot and was visibly sweating. He drank some water and sat in front of a small fan until medics arrived. They assessed him and he walked out with them for further evaluation. I called patient at 7:30 to see how he was feeling. There was no answer and his voicemail didn't allow me to leave a message.
PT WAS AGE 17 AT TIME OF VACCINE.  NO KNOWN ADVERSE EVENTS
No additional AE/PQC reported.; Vaccine administered after temperature excursion; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's historical drugs, historical conditions, and concomitant medications were not reported.  On 12-JUL-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product storage error) (lot number U007860 and expiration date 14-JAN-2022 were verified as valid) 2 milliliters (ml) taken orally for prophylaxis.   The vaccine was exposed to a temperature excursion; it was stored at 9.6 Centigrade degrees for 11 minutes, which was detected by digital data logger; with no previous temperature excursion
This case was reported by a physician and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with Pediarix for prophylaxis. On an unspecified date before 08 November 2006, the subject received unspecified dose of Pediarix. Approximately 2 hours after vaccination with Pediarix, on an unspecified date before 08 November 2006, the subject experienced "a rash on the abdomen which faded and then goes to other areas." The subject was seen by a physician. The outcome of the event was not reported. The physician considered the event was probably related to vaccination with Pediarix.
Around the 6th day after the vaccination I experienced an aura while watching television. I began to experience a very bad headache my vision became very blurry and I could not speak.
He states that after receiving his vaccinations, he felt fine and proceeded to play basketball.  Around dinnertime last night he began experiencing severe chills.  He did not take his temperature at home but felt febrile.  He also experienced intermittent dry cough and shortness of breath.  He feels that he cannot take a full breath due to tickling in the back of his throat (not due to pain).  He endorses diffuse myalgias that kept him up last night.  He denies nausea, vomiting, and diarrhea.  He has diminished appetite but was able to tolerate oral intake yesterday and today.  He has taken Tylenol for his pain, last taken at 9:00 a.m. this morning.  Tylenol has not been effective at relieving his pain. Of note, he had 3 days of diarrhea prior to receiving his vaccinations yesterday.  His diarrhea has since resolved.  He did not have any blood in the stool but did have blood when wiping.  He denies sick contacts and does not have children.  He denies rashes and throat pain.
Information has been received from a physician concerning a 24 year old female who on 23-APR-2007 was vaccinated with Gardasil (Lot# 657617/0384U). On 23-APR-2007 the patient fainted before receiving dose two. The patient recovered and received the second dose that same day. Additional information is not expected.
atrial fibrillation; shortness of breath; This is a spontaneous report from a contactable consumer reporting for himself. This 69-year-old male consumer received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Apr2021 at 13:15, in left arm, for COVID-19 immunisation. The first dose of BNT162B2  vaccine was given on an unspecified date. No other vaccine was given in 4 weeks. Medical history included bladder cancer, blood pressure controlled by lisinopril and allergy to fentanyl. COVID prior vaccination: no. COVID tested post vaccination: no. Concomitant medication included lisnopril for blood pressure. On 07Apr2021 at 13:00 the patient developed shortness of breath and atrial fibrillation which never had before. No treatment was required. The events resolved on an unspecified date in Apr2021. Information on the lot/batch number has been requested.
Headache, Arthralgia, flushing, fatigue lasting 4 days Narrative:
excessive, prolonged crying p/1st DTP 5NOV92; did well p/peds DT on 13JAN93;
Patient is 16 years old and received the Moderna vaccine today around 3pm. Moderna is approved for 18 years and older.  She said she felt fine.(03/09/21 6:30pm)
Dizziness, Arthralgia, Fever, Rash, ErythemaMultiform, UrticariaPruritus, fatigue, chills Narrative:
Lost his muscle control again 24 Hours after the 2nd monovalent booster; Could not get out of the chair 24 Hours after the 2nd monovalent booster/Could not roll over in bed 24 Hours after the 2nd monovalent booster; Fell a couple of times 24 Hours after the 2nd monovalent booster; Sore left arm injection site  24 Hours after the 2nd monovalent booster; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE DISCOMFORT (Lost his muscle control again 24 Hours after the 2nd monovalent booster), MOBILITY DECREASED (Could not get out of the chair 24 Hours after the 2nd monovalent booster/Could not roll over in bed 24 Hours after the 2nd monovalent booster), FALL (Fell a couple of times 24 Hours after the 2nd monovalent booster) and VACCINATION SITE PAIN (Sore left arm injection site  24 Hours after the 2nd monovalent booster) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058A22-2A, 012F21A, 030M20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis (under control) since 1996.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2022, the patient experienced MUSCLE DISCOMFORT (Lost his muscle control again 24 Hours after the 2nd monovalent booster), MOBILITY DECREASED (Could not get out of the chair 24 Hours after the 2nd monovalent booster/Could not roll over in bed 24 Hours after the 2nd monovalent booster) and FALL (Fell a couple of times 24 Hours after the 2nd monovalent booster). 12-Jul-2022, the patient experienced VACCINATION SITE PAIN (Sore left arm injection site  24 Hours after the 2nd monovalent booster). On 14-Jul-2022, MUSCLE DISCOMFORT (Lost his muscle control again 24 Hours after the 2nd monovalent booster), MOBILITY DECREASED (Could not get out of the chair 24 Hours after the 2nd monovalent booster/Could not roll over in bed 24 Hours after the 2nd monovalent booster), FALL (Fell a couple of times 24 Hours after the 2nd monovalent booster) and VACCINATION SITE PAIN (Sore left arm injection site  24 Hours after the 2nd monovalent booster) had resolved.            No concomitant medications were reported.  On 01-Nov-2021, the patient received the 1st booster dose of Moderna COVID-19 vaccine. On 11-Jul-2022, the patient received the 2nd booster dose Moderna COVID-19 vaccine.  No treatment medications were reported.   This case was linked to MOD-2021-016707, MOD-2022-667351 (Patient Link).
Narrative: COVID infection following COVID vaccine series 01/15, Pfizer, dose #1 02/05, Pfizer, dose #2 08/14 pt cc: cough, chills, fatigue, rhinorrhea, frontal sinus congestion, loss of taste or smell exposure: unknown 08/15 -08/25 pt symptoms continue 08/19 COVID swab, result: detected 08/19 SARS-COV-2 Variant Seauencing result: pending
Angioedema Narrative:  swelling and pain of the left wrist on the same arm of the injection site within 2 hours of the vaccine administration. most of the swelling is gone, but a small amount is still present at day 28.
pt recvd vax & p/2nd dose exp fever, flu-like sx & arthritis; currently in good hlth;
Pain R arm shoulder to hand. Pain in underarm  swelling to underarm & breast region.
Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022; 21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 17-Feb-2022, expired on 1-Apr-2022 and administered on 07-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that the vials were initially stored in the refrigerator on 17 Feb 2022 at 10 a.m.  It was reported that the vials had not undergone any temperature excursions.  It was reported that no patients had come out with adverse events.  vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow up received contains non significant information.
8:27 dizzy and nauseous - brought to stretcher, laid supine 136/75 52, 126/77 59 sitting, chest CTA, CV RRR )m/g/r 8:35 nausea 8:53 pt thought she was going to have diarrhea, escorted to restroom urinated, no BM , just flatulence/belching 8:59 no longer dizzy, nausea mild, feeling better vital 147/77, 52 9:03 stood without difficulty, ok to go home
Edema in both hands on April 10, 2021 which continues Edema in both ankles in late April 2021. May  9, 2021 spontaneous bruise and swelling on bottom of right foot immediately behind the little toe.  This has resolved. May 27, 2021 spontaneous bruise on right forearm, inside.  This has resolved. July 4, 2021 spontaneous bruise and swelling on the bottom of left foot, immediately behind the little toe.  Bruise has resolved.  However, site is still tender to the touch.  I first reported this issue to my urologist , then my dermatoligist, then my PA at my GP.  NO ONE knew what to do or how to report.
This initial non-serious spontaneous case, was received on 12-Oct-2017, from other health professional, concerning a female pregnant patient of unspecified age. On an unspecified date, the patient was administered with FLUCELVAX QIV (dose, route of administration, anatomical site, batch number, expiration date: not reported). It was reported that a pregnant woman was administered with FLUCELVAX vaccine and further information were not available.