chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine past 6 hour Vial puncture expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past 6 hour Vial puncture expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past 6 hour Vial puncture expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past 6 hour Vial puncture expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Received vaccine past 6 hour Vial puncture expiry) to be not applicable.    Ten male patients received vaccine past the expiry date. Possible date of vaccinations suspected are 4-Mar-2021, 6-Mar-2021, 9-Mar-2021, 15-Mar-2021, 18-Mar-2021, 19-Mar-2021, 22-Mar-2021.Among them, 6 patients received 2nd dose and this case was created for them.   No concomitant medications were reported.  No treatment information was reported.
symptom onset 12/6/22. Treatment includes Paxlovid, therapy, and hospital admission.
ate for the second dose / First dose / adinistrated on November 16 2020 / second dose was not administered; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of shingrix received on 16th November 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received 1st dose of Shingrix at primary reporter's facility. The patient was late for the 2nd dose. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. The reporter consented to follow up.
Late Engerix-B second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix-B (received 1st dose on 24th January 2023).   On 05-MAY-2023, the patient received the 2nd dose of Engerix B. On 05-MAY-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late Engerix-B second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 15-MAY-2023 The pharmacist had a patient who received late Engerix-B second dose.  The reporter asked how could they proceed with third dose?  No further details were provided during the call such as lot numbers or patient´s date of birth The reporter did not consent to follow-up. The patient received 2nd dose of Engerix-B, later than the recommended interval, which led to lengthening of vaccination schedule.
pt reports that devel a severe red, raised itchy, rash all over body approx 3 dasy p/vax 13NOV95;pt seen in ER 17NOV95 & again 18NOV95;pt given DPH & Esgic-plus for rash & itching;
Initial and follow up information has been received from Nurse Practitioner and a physician concerning a 16 year old female patient with no prior reactions to previous vaccines and a resolving rash diagnosed as shingles. Who on 14-SEP-2007, at 12:00 p.m. was vaccinated in the right arm, with her second dose of GARDASIL, lot #655620/0171U). Concomitant therapy included a first dose in the left arm of BOOSTRIX (lot# AC528018BA, and HAVRIX (ALTAVRI87AA). The physician stated that almost immediately after vaccination the patient went pale and limp, and had a syncopal episode; the NP stated the patient "zoned out" for 3 to 5 minutes after receiving her second dose of GARDASIL, her complexion was gray and her head jerked. Medical attention was sought. The patient was helped to lie down, and her blood pressure within seconds was 110/72 mmHg. She recovered on the same day. Additional information has been requested.  Additional infromation is not expected.
loss of appetite x 1 month; Headache; belly ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 6-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jan2022 12:00 (Lot number: FL0007) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: cephalosporin" (unspecified if ongoing), notes: Known allergies: cephalosporin. The patient's concomitant medications were not reported. Past drug history included: Known allergies: amoxicillin, reaction(s): "Drug allergy", notes: Known allergies: Amoxicillin; Known allergies: cefdinir, reaction(s): "Drug allergy", notes: Known allergies: cefdinir; Known allergies: keflex, reaction(s): "Drug allergy", notes: Known allergies: keflex. The following information was reported: DECREASED APPETITE (non-serious) with onset 06Jan2022, outcome "not recovered", described as "loss of appetite x 1 month"; HEADACHE (non-serious) with onset 06Jan2022, outcome "not recovered", described as "Headache"; ABDOMINAL PAIN (non-serious) with onset 06Jan2022, outcome "not recovered", described as "belly ache". The events "loss of appetite x 1 month", "headache" and "belly ache" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of decreased appetite, headache, abdominal pain.  Additional information: Seriousness reported as No. 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. Patient received dose 2 vaccine on 27Jan2022 at 01:45 PM in right arm.  Follow-up attempts are completed. No further information is expected.
Chest Pain secondary to myocarditis.  Chest pain developed 10 days after vaccination and then lasted for 6 hours until Toradol was given.  Pt was diagnosed with myopericarditis and started on ibuprofen.  07/02/2007 MR received for o/n admission 4/29-30/2007 for c/o substernal chest pain w/ associated diaphoresis.  Pain worse with lying down and deep inspiration. Txd with Motrin and rest. DX: Myopericarditis as a rxn to smallpox vaccine.
received dose number one of covid pfizer on 9/9, second dose 9/30; presented to ED 10/2 with Guillan-Barre syndrome stating that symptoms started 5 days prior
I woke up the next day with a numb face and heart palpitations and chills with no fever. I had muscle aches as well. Urgent care did an EKG they saw PVC but I have no heart issues in my history so they were not too concerned. I also have headaches and muscle weakness and my extremities are intermittently numb.
Pt stated she had cellulitis that occurred 6 days after receiving the vaccination. Her right arm (from shoulder to below elbow) was red, swollen and very painful. The event resolved on 3/25 after iv fluid, rocephin and augmentin.
fever 100.4 (2 days duration), diarrhea ( on day 4), extreme fatigue ( durated 2 days commenced on day 4), erythema and swelling of right arm where injection administer( commenced day 1 , fading but not gone on day 8).
Headache and nausea on first dose; Headache and nausea on first dose; Thigh is painfully sore; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on 19Jul2021 at 17:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The medical history were reported as no. It was unknown whether the patient was allergic to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications were not reported. On 20Jul2021 at 07:00, the patient experienced headache and nausea on first dose, thigh was painfully sore. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, nausea and thigh painfully sore was not recovered at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
shot given 1030AM 23NOV93; cried, fussed, did not sleep over 15 mins until 930PM 24NOV93; fever 100-101; mom called pt MD & mom states MD said react to pertussis & pt is to get no more pertussis;
During screening client and father denied any difficulties with vaccines in the past 0940 Client received 4 IM vaccinations; pale appearing; given glass of water 0955 Dad stated that he needed to return to work and client denied dizziness and stated felt well. 1000 Client fainted after walking out of office and Dad caught her-no fall or injuries; given cool cloth, more water and snack
"Member got COVID vaccine and noted ringing in both ears. Got 2nd dose 4/20. Ringing started after the first, got worse after the second. Is constant. Not sure about hearing loss. Seems worse in left ear by a little bit. No dizziness or vertigo.  Was told it could be wax buildup or congestion but does not feel like this    No other unusual symptoms. No medication changes noted. No trauma to head  Diagnoses and all orders for this visit:
Metallic taste and tingling in throat about 14 mins after shot. This happened with the first shot too. With the 1st shot my throat was itchy/achy for a few days but nothing serious occured with the 1st dose so I said nothing about the sensation with the 2nd dose. About 5 minutes after leaving (20 mins after receiving 2nd dose) the sensation in my throat worsened and my throat tightened. My throat was itchy. Arriving home I took my inhaler (Albuterol) since the tightening feeling somewhat reminded me of the onset of an asthma attack. But finding no relief I took Benadryl and layed down. Since July 2nd my throat has on and off bothered me. Nothing severe or painful just bothersome. It's not constant. Its On and off sometimes I'll experience tightness scratchiness or a odd tingling taste and sometimes I'm fine.
The day after the shot I got like a baseball-size lump in my arm, nontender, but very firm and warm. It slowly went down over the course of 2 weeks but also became more and more itchy. A small irregular patchy colored area was left. That has also faded now. But the skin in the area is super sensitive now to light touch. The sensation of my shirt rubbing on my shoulder feels like there's thorns sticking into my skin or something. I've tried lidocaine cream but it doesn't really help. Now I'm wearing Tegaderms over the area so that nothing rubs on the skin because it's so sensitive.
Developed rash-Being tx for shingles Pt treated elsewhere reported to MD 8/6/07.  Pt did not followup here for her rash.  Date unknown when she developed.  She notified us on Aug 6 of event.
Dizziness, headache, at 30 mins post vaccines, progressing headache. Elevated legs and cool compress to head. Called ambulance.
SHORT-TERM MEMORY LOSS; FEELS LIKE GOING SENILE; CAN'T STAY AWAKE; FELT IN A FOG/FELT LIKE SYMPTOMS HIT LIKE A BRICK WALL; FEAR OF DRIVING; NAUSEATED; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, and other pre-existing medical conditions included patient described himself as healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for type 2 diabetes.  On MAY-2021, the subject experienced feels like going senile. On MAY-2021, the subject experienced short-term memory loss. On MAY-2021, the subject experienced can't stay awake. On MAY-2021, the subject experienced felt in a fog/felt like symptoms hit like a brick wall. On MAY-2021, the subject experienced fear of driving. On MAY-2021, the subject experienced nauseated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from short-term memory loss, nauseated, can't stay awake, feels like going senile, felt in a fog/felt like symptoms hit like a brick wall, and fear of driving. This report was non-serious. This case, from the same reporter is linked to 20210754945.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Rash on chest and shoulders, fatigue, lack of appetite, and chest tightness at 40 hours post vaccination. A few hours after injection, a sore arm. The next morning (16 hours post injection) a fever, dizziness, headache, nausea and sore arm.
Pt came to location for immunization. Verified pt name, DOB, and  allergies. Explained to pt what vaccines will be given. Pt verbalized  understanding. Vaccines administered. Pt tolerated the injections well. Pt  understood aftercare instructions for pain/fever.  Pt was observed and started to feel like vomiting. Pt escorted to nurse's room  by school nurse.  BP: 92/62 | O2: 97% | P:94 BP: 93/55 | O2:100 %  Pt felt better and was sent back to class in stable condition. School  contacted parents about the situation, and nurse also spoke with pt  parent about the situation.
Patient received 2nd dose of Hepatitis A vaccine on 2/16/10. 1st dose of Hep A vaccine given 8/4/09. On the morning of 2/17/10 patient awoke from sleep itchy and had hives around lower lip and on palmar surface of B/L wrists.
Unreconstituted dose adminsitered; Unreconstituted dose adminsitered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number 23YJ7, expiry date 12th October 2023) for prophylaxis.   On 4th November 2022, the patient received the 2nd dose of Shingrix. On 4th November 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-Nov-2022 Reporter's comment: The reporter did not consent to follow-up. Additional supportive information: The patient received an unreconstituted Shingrix second dose, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: eczema looking patch at injection site. size of a quarter-Medium, Additional Details: patient developed a round ezema looking patch the size of a quarted at the injection site. He developed 2 other ezcema looking areas, one below the injection site on the left arm and one near the elbow on the right arm. Patient indicates he will be reaching out to prescriber about the reactions.
This spontaneous report as received from a registered nurse refers to a male child of unknown age with egg allergy. The patient was vaccinated with a dose of M-M-R II (lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced "an allergic reaction", it was unknown what type of reaction. The patient was under another healthcare provider's care at the time of the reaction occurred which the reporter stated was awhile ago (unspecified date). No treatment information was reported. It was unknown if the patient sought medical attention. The outcome of allergic reaction was reported as recovered. The relatedness for the reported event was unknown for M-M-R II. Additional information is not expected.
pt brought in by fire/rescue to ER; pt was unresponsive, pulseless, found by mom w/blood around the nose; probable dx SIDS;
My wife received the 1st dose of the above Pfizer vaccine at 9:28 10/8/2021.  At 9:38 while waiting for the first 15 minutes to pass she stated that she felt ?woozy?.  I asked her if she felt like she would pass out and she stated ?maybe?.  Ten seconds later she passed out completely.  I held her in place and called for help. A wheelchair was brought and after being put into the wheelchair she seized.  Full body with posturing.  Rigid legs and arms.  The seizure lasted for 6-10 seconds. She regained consciousness within the next 2 minutes followed by nausea and vomiting that continued until 12:30.  Approximately 3 hrs.
It was with Dose #2.  I woke up at 0200 AM and I could not walk or feel my legs bilaterally or my hands bilaterally. I tried to get out of bed and fell because I could not walk. My husband got me back in bed.  had a fever of 102 degrees and I was very achy in addition. My husband gave me Tylenol at this time. Approx 45 min. later my legs hurt extremely bad. I eventually fell asleep. I woke up at about 0730 and my fever broke. I basically slept all day.
Pt reports after shot. Reports unable to lift arm overhead and swollen that night. By next day same symptoms, but redness. Resolving some on Sunday. PT called Monday to report. Also rashy to lower area of extremity. Pt called PMD, no tx needed. Pt was not seen by doctor, only phone conversation. Pt instructed to use warm compresses and Tylenol if needed. Pt reported vomiting 12/06/06.
A 12 year old patient received a 5-11 year old Pfizer vaccination, which is a medication error. When patient's father was asked to confirm age of child, he stated she was 11 years old and patient was not asked to validate her age. Patient's guardian was called by Health Manager and explained situation. Per current CDC guidelines, she will not return to be vaccinated with correct first dose, but will get Pfizer adult dose for her second shot. Patient did not suffer any adverse reaction to vaccine.  Troubleshooting: scribe and vaccinator did not verify child's age with patient. Unreported as error, found in data mining.
flu like symptoms; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative. An 18-year-old male patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history was not reported. Concomitant medication included meningococcal vaccine conj (MENINGOCOCCAL CONJUGATE) for immunization. The patient experienced flu like symptoms 12 hours post vaccination. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Death;  my question is, why wouldn't the CDC want to investigate/autopsy any individual who has an adverse event??? The body was sent to mortuary without autopsy, as the family wouldn't want one done at their expense.  However, it would seem feasible that the CDC would see this as an opportunity to add to the available statistics on vaccine recipients.  Its unknown whether the vaccine contributed to the adverse outcome, but given that this person had the vaccine recently, it should have been investigated.  It seems there should be a protocol for Drs and medical examiners to note ALL conditions in the patient not just cause of death, if vaccinated within a few months to a year.  It just seems like good research opportunities to me, and I have to wonder why it isn't being done.
Sore arm and sore neck and shoulders started at 5:00 PM - subsided by bedtime. Morning of 10/23 very red swollen area around vaccine, start neck pain, nausea, fever.
1/19/2023 - 1/20/2023 (23 hours) Hospital Emergency CHIEF COMPLAINT: POSSIBLE STROKE  The patient is a pleasant 85-year-old female who presents to the ER as a stroke alert.  She was seen in the Trauma Bay hot spot along with Stroke Neurology.  Patient reports that she was at home with her husband and around 16:30 today she started feeling confused.  She felt like she was having difficulty getting some of her words out.  Patient denies any unilateral numbness or weakness.  No headaches.  On initial exam, stroke scale is 3. Patient has some partial hemianopsia which appears chronic per previous records.  Patient also had 1 point off for knowing her age as well as 1 for mild aphasia.   After evaluation, patient is taken emergently to CT scan for CT head without contrast as well as advanced imaging.   Patient's records were reviewed.  Patient is on aspirin and Plavix.  No other obvious blood thinners.   In reviewing patient's records it does state she has had previous hemianopsia consistent with her symptoms today.   Patient's blood pressure would intermittently spike into the 190s to 200 systolic.  It would then come back down into the 160s.   After CT scan, patient was taken back to an ER room.  After speaking with the patient further, she feels more that she is confused rather than actually having difficulty speaking.   CT head came back showing no acute abnormalities.  CT angiogram and perfusion came back showing no large vessel occlusion or perfusion changes.   At this point, we did discuss giving TNK to this patient for mild language changes.  It does seem that patient's symptoms more consistent with confusion than actual dysarthria or aphasia.  Also patient's blood pressure does intermittently spike into the 200.  She is given IV labetalol.   After discussion with Stroke Neurology, it was felt symptoms are most likely secondary to patient's confusion from hypertension urgency.  However, we could have further discussion with the patient and shared decision making regarding giving IV TNK in the event of potential stroke.   At this point, patient was continually complained that she had to urinate but could not go.  At that point nursing staff did perform urine catheterization.  Approximately 1 L of urine was removed.  Patient did feel significantly improved after this.   We did discuss risks and benefits with patient and family at bedside.  In having these discussions, patient was actually able to speak quite fluently.  She would intermittently problems remembering things but was having less problem with her speech.  We did talk about risks and benefits of TNK and did offer this to the patient.  Given that the patient is already on aspirin and Plavix, she was more concerned about potential risk of bleeding.  Ultimately, she declined IV TNK.   The patient will be admitted for further blood pressure management and further workup.