chrisvoncsefalvay/vaers-outcomes huggingface dataset:
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    No concomitant medications were reported.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Patient received vaccine that had been out at room temperature for 25 hours; Moderna has been notified and will be contacting us with the outcome of a specific Lot test in 2 to 5 business days on how to proceed on whether the patient requires revaccination.  Patient has not experienced any ill effects or adverse symptoms after vaccination.
Information has been received from physician concerning a male pt who in Jan2002, was vaccinated with a dose of varicella virus vaccine live. On 17Mar2004, the pt presented to the office with 50 lesions. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Patient got the shot(Pfizer) in his right arm at 5:20pm by Doctor. He had some bleeding at the shot site when the needle was taken out of his arm. Doctor then put a band aid and cleaned up the blood that had dripped down his arm. Then filled out his covid-19 record card. Pt then stood up and put his jacket on while his mother put his brother in the seat vacated. Pt stood while his brother was put in the chair and while his mother was taking his brothers jacket off. Pt passed out and fell on the floor beside the chair. He was then picked up and seated at the table and given apple juice and crackers while the doctor and administrator asked health questions about pt's health.
24-year-old female patient oriented in time and space. She refers to feeling dizzy to EMT. Within 4 minutes of your first dose of Pfizer. At 12:32 p.m. the EMT obtains his vital signs are: B / P. 80/50 mmHg, P. 85, R. 18, Sat. 99% and Temp. 35.5 Celsius. The case is consulted with Doctor. His recommendation was to observe for 30 minutes and elevate his legs. Upon reevaluation of the patient after 30 minutes, her vital signs were B/P. 100/70 mmHg, R. 18, Sat 99% and Temp. 35.5 Celsius.
Information has been received from a registered nurse concerning a female patient who on 13-Dec-2006 was vaccinated intramuscularly in the left deltoid with the first dose of Gardasil vaccine (yeast) (0.5 ml) (lot#654389/0961F). There was no concomitant medication. On 13-Dec-2006, shortly after vaccination, the patient fainted and her skin color was pale. The patient was aroused by shaking her right arm and with smelling salts. The patient's vital signs were found to be normal upon discharge from the office. No further details were provided. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2007. Follow up information received from the physician stated that on 13-DEC-2006 the injection of GARDASIL was administered by a medical assistant. It was reported that immediately after receiving the vaccination the patient had a syncopal episode. It was reported that the patient became hypotensive (actual blood pressure measurement not provided) and diaphoretic and responded to ammonia salts, being placed in the Trendelenburg and hydration, taken by mouth. It was reported that patient recovered from the event. Additional information has been requested.
Patient without previous cardiovascular history with complaints of chest tightness and diaphoresis. Contacted the doctor's office and sent advise to go to ER for possible cardiovascular event.  Witnessed cardiac arrest at home with unsuccessful resuscitation.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300310568 same patient, different drug/AE;
This spontaneous report was received from a nurse regarding a patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 21-JUN-2017, the patient received for ZOSTAVAX and VARIVAX both together in the same syringe at the same time for prophylaxis (dosing details not reported). Both vaccines were reconstituted with one syringe vial of sterile diluent (Merck). No adverse effects were reported. Additional information has been requested.
Body aches, pain in feet and hands, immediatly after second shot tired and felt hot.   Nerve sentsation in stomach, feet, hands.  Inflammation in feet and hands. Stomach/GI issues. Feet and hands turn purple and white throughout the day, feel cold, numb, or pain. Balance is off and falling more as it progresses.  (It has been a year.)
Pain at injection site, slightly raised large red circle around injection site, arm is warm to the touch, fatigue, headache.  This started the day of vaccine and has continued every day since. It has been 6 days since patient was vaccinated.   She has been taking Advil and Tylenol for pain.
Initial report received from a healthcare professional on 30 October 2012. A 68-year-old male patient, whose medical history included lupus and concomitant medications were not reported, had received an intramuscular dose of FLUZONE (lot number: UH713AB) in left shoulder on 13 September 2012. On 15 September 2012, 2 days after the vaccination, the patient had developed the events of left shoulder soreness, limited mobility and ROM. Complementary investigations were reported as none, and patient did not seek medical evaluation and did not self-treat. As of 30 October 2012, the symptoms still persist. The patient's outcome was reported as "unknown". Documents held by sender: none.
Patient developed burning sensation on forearms and calves starting approximately 7 hour after administration of the vaccine, that would last between 30 minutes to 1 hour then would resolve and recur approximately 3-4 times per day. Patient reported this adverse event 7 days post vaccination and reported that it was still ongoing.
Information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, on an unspecified date, the patient experienced myalgia and headaches. It was noted that the reporting physician was not the patient's physician. At the time of this report, the outcome was unknown. No product quality complaint was involved. No further information is available.
I got my shingles shot about 16 months ago and forgot to go back for the second round/ I recevied the first dose about 18 months ago and forgot to get the second. Should I start over?; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (received the first dose about 18 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: I got my shingles shot about 16 months ago and forgot to go back for the second round/ I recevied the first dose about 18 months ago and forgot to get the second. Should I start over?). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-NOV-2023 This case was reported the patient via interactive digital media. The reporter asked she start over The PCP told to reached out to get the answer The patient received the 1st dose about 18 months ago and forgot to get the second, which led to incomplete course of vaccination. Follow-up not possible as no contact details provided.
I had some arm soreness that started the morning after (22nd) and that lasted until the 27th of January....it got better each day. I had fever to 102 that started on the 22nd. The fever ended on 23rd. I took Tylenol - it didn't help on the 22nd but by 23rd it did. I felt fatigue -22nd and went away on 24th.  I miscarried 27th-29th -30th- that timeframe. The miscarriage prompted care. I went to Medical Center. I was not pregnant at time first vaccination. Estimated date of delivery had been - September 22, 2021; I have no prior pregnancy history.
pt recvd 2nd dose of Engerix-B & exp h/a 8 hrs p/inject which lasted 24 hrs; treated w/APAP plain & codeine;
still itches a little and she develops tiny bumps when she scratches her arm; Nothing really bad but patient wasn't well; It still itches a little/Itchy upper right arm for a week or so; Very tired; Slight fever; Patient received a 3rd full dose for the booster; This spontaneous case was reported by a consumer and describes the occurrence of PAPULE (still itches a little and she develops tiny bumps when she scratches her arm), MALAISE (Nothing really bad but patient wasn't well), PRURITUS (It still itches a little/Itchy upper right arm for a week or so), FATIGUE (Very tired) and PYREXIA (Slight fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient confirmed that she had Hx relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. However, details were not provided.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAPULE (still itches a little and she develops tiny bumps when she scratches her arm), MALAISE (Nothing really bad but patient wasn't well), PRURITUS (It still itches a little/Itchy upper right arm for a week or so), FATIGUE (Very tired), PYREXIA (Slight fever) and ACCIDENTAL OVERDOSE (Patient received a 3rd full dose for the booster). At the time of the report, PAPULE (still itches a little and she develops tiny bumps when she scratches her arm) and PRURITUS (It still itches a little/Itchy upper right arm for a week or so) had not resolved and MALAISE (Nothing really bad but patient wasn't well), FATIGUE (Very tired), PYREXIA (Slight fever) and ACCIDENTAL OVERDOSE (Patient received a 3rd full dose for the booster) outcome was unknown.            The patient received 2 primary series and instead of the booster she received a full dose.   The patient was on unspecified concomitant/regular medication.  No information on treatment medications was reported.   Reporter did not allow further contact
AFTER OVER 5 MINUTES FROM GETTING THE FLU SHOT,PER PATIENT, SHE EXPERIENCED DIZZINESS,FAINTING IN THE BEGINNING THEN SHE MENTIONED SHE FELT TINGLING ON HER TOES & FINGERS.SHE ALSO FELT NAUSEATED LATER ON.
Patient received this vaccine before the 4 week time frame.  On 2-22-23 Received advisement from public health nurse to advise that this patient will need to have dose repeated after 4 weeks from date of last dose since it will not be considered as a valid vaccination. Repeat of primary 2nd dose is needed. And informed to input this AVERS.
Sore arm; Headache; Fatigue; Muscle pain; Flu-like symptoms; This case was reported by a consumer and described the occurrence of pain in arm in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, less than a day after receiving Shingrix, the patient experienced pain in arm, headache, fatigue, muscle pain and influenza-like symptoms. On 19th October 2020, the outcome of the pain in arm, headache, fatigue, muscle pain and influenza-like symptoms were resolved with sequelae.   It was unknown if the reporter considered the pain in arm, headache, fatigue, muscle pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the vaccine was given in right deltoid muscle.  The patient experienced sore arm, headache, fatigue, muscle pain and flu-like symptoms after the vaccine administration. All of those symptoms seemed to get better but on the reporting date, the patient was having a second wave of all those symptoms.  The reporter did not consent to follow-up. The reporter had also mentioned about unnamed pharmacy.
"Red spot" in the area of one of her shots on her lateral right thigh that began the day after receiving the vaccines (10 days). She has not had fever or chills.  She is eating and drinking well, but is more irritable than usual.  She is less active than usual. She has been itching the injection site. 2.5 mL of Benadryl ordered every 6 hours as needed for the itching and the injection site reaction. Advised that mom give it to her until the rash on her right leg is less red and much smaller.
I got floaters in my eyes. Numerous ones. My vision is obscured with these black floaters and strings.  When I went to see my retinal specialist 10/21/22 he said I had the beginning of inflammation in the epi membrane.  I was to return on 01/06/22. Dr. said I had increase pressure and inflammation. He gave me 2 different eye drops to reduce inflammation and possibility of eye surgery.
this wart is now "drying up and going away"; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 94-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "wart on her toe that she has had "for ages"" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunisation. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "this wart is now "drying up and going away"". Additional information: The patient was attributing the effect to the vaccine because she does not take anything for it and her podiatrist has told her in the past that there is nothing that can be done about it.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
rash all over body; head to toe, even in hair, on buttocks & pvt parts; rash was cluster of raised bumps; constantly itching & red; to PMD
About 12 hours after I received the second COVID vaccine, I experienced chills, weakness and headache. The following morning, the weakness continued along with body aches until that evening. There is also an area that spans about 5 inches in diameter at the injection site that is warm to the touch, red, sore and slightly elevated. Systemic symptoms lasted about 24 hours with only nausea and weakness at 48 hours. Arm still remains warm and red but less swollen.
Pediatric dose (0.2ml) was drawn up from Adult Pfizer vial. 8year-old patient received 0.2 ml of the 12+ Pfizer vaccine. The parent was notified on 12/3/21 that child was incorrectly given  0.2ml of adult Pfizer was discovered and told to monitor child for adverse effects. No adverse events were reported.
Patient notified the clinic that she received COVID vaccine less than 14 days after receiving her second dose of Twinrix vaccine. Patient denied any adverse reactions following her COVID vaccine and one week post vaccination. Report being submitted due to the inadvertent administration of COVID vaccine within 14 days of administration of another vaccine and the limited data covering vaccine to vaccine interactions.
I had a severe outbreak of Bells Palsy. Went to Hospital on 6/3/21 at 11 pm. Stroke symptoms diagnosed severe Bells Palsy. I was there for 8 hours in the emergency room. Very ill, severe left facial droop, blind in the left eye, unable to close left eye. Extreme pain in the left gluteal area, slurred speech. I have seen 7 MD,s since then. Have had a complete neuroscience exam, cardiology exam, MRI and MRA of brain and carotid arteries. Extensive blood work. The aortic exam was thoracic and abdominal. I still have a left eye unable to close or focus clearly. Saw eye Dr, specialist X2 yesterday also. Facial numbness.
elderly diabetic man with AFib/RVR who presented with multiorgan failure few hours after receiving his 2nd COVID shot today and ultimately expired.  he did well after the 1st COVID shot and subsequently developed this multiorgan failure after the 2nd shot.  had his second COVID vaccine shot around 4 pm, went home and collapsed, lay on the floor for a few hours refusing to call paramedics, eventually wife called 911, he arrived to ED and was dead a few hours later.  -on arrival the pH was 6.7, agonal breathing, low BP, lactate 18, but no MI, no stroke, no apparent infection/sepsis.  important to note that he had a covid vaccine just a few hours from collapsing and dying.
pt recvd vax; mild fever 6 days p/ vax;inc T 101-104; extreme irritability & runny nose; T down w/ apap;mom denied chest congestion; referred to PVT md;hlth dept felt sxs not related to vax;
recieved 2nd dose of pfizer vaccine on Sunday 04/18/2021 next day 04/19/2021 had headache sore injection site and muscle aches. next day 04/20/2021 had headache and sore injection site. on 04/21/2021 had headache but then began to itch and had blotchy red spots around upper chest and neck. i took some benydrl 25 mg.  which a helped, but then hours later i began to itch and see more rash and raised bumps. i took more benydrl. then when woke up on 04/22/2021 i was blotchy and itchy with rash on neck torso back  upper .thighs and on my head
You can still get it, but much smaller chance . I did/Suspected vaccination failure; You can still get it, I did; Horrible pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that after received Shingles vaccine you could still get the shingles but much smaller chance. The patient did and shingles was horrible pain. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Severe arm pain exacerbation 4 days after injection. Reports inability to use her arm for 24 hours. No fever, chills, erythema.  Normal exam 1 week later.
pt admitted with new onset atrial fibrillation. No recent illness or precipitating event to cause. admitted to ICU on Cardizem drip.
Received flu vaccine on Monday, 10/25/10.  Notice redness and swelling on 10/26/10 in the early morning.  Today have a 50 x 55mm reddened and swollen area on R upper arm.  Very itchy.