chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant who reported that an unknown number of unspecified patients (demographics not provided) were inadvertently administered "single" doses of VAQTA (lot # N005274, expiration date 03-APR-2018), PEDVAXHIB (lot #M036612, expiration date 19-MAY-2019), VARIVAX (lot #N001530, expiration date 13-JAN-2019 and lot #M043582, expiration date 28-OCT-2018), GARDASIL 9 (lot #M041990, expiration date 28-JUN-2019), and M-M-R II (lot #M040624, expiration date 03-OCT-2018) (routes of administration not provided) that had been improperly stored. Properly stored sterile water diluent (lot numbers unknown) was used to reconstitute the doses of M-M-R II and VARIVAX. No adverse effects reported. For VAQTA (lot # N005274), GARDASIL 9 (lot #M041990), M-M-R II (lot #M040624), and PEDVAXHIB (lot #M036612): Temperature: 51°F Time frame: 48 hours Previous temperature excursion: No Data logger involved: Yes. For VARIVAX (lot #N001530 and lot #M043582): Temperature: 10°F Time frame: 48 hours Previous temperature excursion: No Data logger involved: Yes. Additional information is not expected.
On 07/04/2021, 2 days after the vaccine, I had lightheadedness slight pain in my arm, it was very mild the 1st day or so. The site pain never amounted to anything at that point. My lightheaded lasted approximately for 2 weeks. It was very mild. I never had lightheadedness in my whole life. It was very insignificant and it disappeared. I did not have the lightheadedness in July when I received the 2nd dose of Moderna. I saw the doctor the day of the 1st shot. I had the shot at 09:00 AM at 11:30AM I saw PA. She took my BP- normal, checked my heart. All normal.
28NOV95 7AM awakened w/fever 102-racing pulse rate, SOB;vomited sometime that AM & was seen by MD;29NOV95 pt was feeling better-no fever, back to school; family MD requested that this be reported;
ABOUT 5 HOURS AFTER RECEIVING MY 2ND MODERNA INJECTION IN THE LEFT ARM, I EXPERIENCED BODY ACHES AND PAINS ALL OVER MY BODY, SIMILAR TO THE FLU.  THEN I HAD THE CHILLS.  BOTH MY ARMS AND LEGS WERE ICE COLD, AS IF I HAD BEEN SOAKING IN ICE WATER... I WRAPPED UP UNDER 3 BLANKETS TO SLEEP THAT NIGHT IN ORDER TO STOP MY CHILLS... I AM A HOT NATURED PERSON, SO WAS SURPRISED BY THE REACTION. I ALSO HAD TO WEAR SOCKS TO BED IN ORDER TO GET MY FEET WARM.  THE SECOND DAY, EARLY MORNING, I HAD A LARGE KNOT TO COME UP ON THE BACK OF MY ARM, THE ARM WHERE I RECEIVED MY INJECTION, WHICH HAD BEEN MY LEFT ARM FOR BOTH INJECTIONS.  NO SORE ARM, NO REDNESS OF THE ARM, JUST A KNOT THE SIZE OF A PLUM WHICH STAYED FOR A COUPLE OF DAYS BEFORE DISAPPEARING.  IT WAS SCARY!
Patient stated had no pain or discomfort until 10 pm the evening of the vaccine. Patient stated pain came fast after it began and was severe. Patient called morning after vaccine and stated pain was better but not resolved. Patient stated he looked on internet to find a reason for pain. Immunizing pharmacist asked patient if he was experiencing any radiating pain into the shoulder joint, shoulder blade area or down the arm. Patient denied any radiating pain stated pain is only at injection area. Patient denied any redness or swelling at injection site. Immunizing pharmacist called family doctor and his physician assistant, felt it typical pain and asked we communicate to patient if pain worsen or swelling is seen in shoulder immunizing pharmacist communicated this message on 05/02/19.
Information has been received from a consumer referring to her son of unknown age. Information about concurrent condition, medical history and concomitant medication was not provided. On an unspecified date in "the week of 09-OCT-2016" the patient was vaccinated with the first dose of GARDASIL (0.5 ml, intramuscular, lot# unknown). The patient received the second dose of GARDASIL series on 08-NOV-2016 which was given outside of the recommended dosing schedule. No other adverse event information was reported. Additional information has been requested.
Tonic clonic seizure lasting about 45 sec with post ictal phase of 5 min.
Patient was given Pediarix (DTaP, HBV, IPV) and HepB (Energix) on the same date (08/26/22), by accident. We mistakenly thought Pediarix contained Hib, not HBV. The patient experienced no adverse reaction during the 20 minute period after vaccine administration.
Arthralgia, fatigue, episcleritis l eye day 17 Narrative:
Piercing headache 5 hrs after injection. Used heated rice pack and took 2 ibuprofen. Subsided after 4-5 hrs. Following morning woke and severely nauseous and dizzy. Layed down and up a 1/2 hr later and gone. Very tired all day. Next day feeling fine. Sore arm for several days.
Lip swelling - (have had dermal fillers in the past) Breast tenderness (have implants)
died because of the drug; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "died because of the drug". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical information: In regard to the Pfizer Covid-19 Vaccine and stated that there are millions of people who died because of this drug, and as well that (name) died because of the drug. - Submitted Manual AE Form because there is specific person mentioned who died because of the drug/vaccine  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death
pt recv vax 5MAY97 & same day pt exp fatigue & muscle spasms which lasted until 12noon to 1PM on 6MAY97;muscle spasms were very severe wrist, elbow & shoulder joints were very painful;pt did not want to move lt arm;pain muscles;
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/07/21 2nd dose01/28/21 Diagnosed covid positive:08/28/21 Symptom onset:08/24/21 Exposure:community Symptoms:Cough, sorethroat,runnynose
Patient presented  with night sweats and shortness of breath the  day after receiving the second dose of the COVID vaccine. Initially presented to his PCP and received levaquin for presumed PNA, but subsequently presented to the ED with persistent SOB and fatigue. Admitted to the ICU on AIRVO for high O2 requirements. Chest CT showing dense ground-glass opacities with interlobular septal thickening and mild crazy paving pattern. Currently admitted and undergoing workup.
Received vaccine 8:30 Friday morning, Tuesday morning  At 4:00 I experienced fever chills body ache vomiting, diarrhea headache. For exactly 24 hours. Dr recommended getting covid test which I did Wednesday morning at 10:30, the result was negative.  So therefor I was thinking maybe it?s a reaction and do I still get the second vaccine?
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  HYPOTENSION  1/7/2023  --  RECURRENCE OF SAME SYMPTOMS
swelling in her left arm pit the size of an egg near her chest area; black and blue with a streak from the bottom of her armpit to her shoulder; drew her to tears and hurt like hell; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2020, the patient received the 2nd dose of Shingrix. On 27th April 2020, less than a day after receiving Shingrix, the patient experienced injection site pain and exacerbation of pain. On 28th April 2020, the patient experienced local swelling and injection site bruising. On an unknown date, the outcome of the local swelling was not recovered/not resolved and the outcome of the injection site pain, injection site bruising and exacerbation of pain were unknown.   It was unknown if the reporter considered the local swelling, injection site pain, injection site bruising and exacerbation of pain to be related to Shingrix.  Additional details were reported as follows: The patient received her second dose of Shingrix and reported that the injection caused her pain at the injection site and it drew her to tears and hurt.   The next day, she had swelling in her left arm pit the size of an egg near her chest area.   She was black and blue with a streak from the bottom of her armpit to her shoulder which was an inch wide.   Days went by and the black and blue coloring went to yellow and purple and was now fading but the area had gone down to the bottom of her bra.   The swelling has pretty much subsided in the armpit but a little bit of swelling was remaining today.   The patient had a concern that the pharmacist possibly did not inject the vaccine intramuscularly. The reporter consented to follow up.
Blood clot; burning sensation throughout my body; B2 glycoproteins I (igm) ab and the value is 73.6 high; cardiolipin AB (igm) and this value is 23.4 also high; This is a spontaneous report from a contactable consumer (patient). A 67-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 08Mar2021 (at the age of 67-years-old) at dose 2, single for COVID-19 immunization. Medical history included known allergies to penicillin and latex. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (METOPROLOL ER) and acetylsalicylic acid (ASPIRIN). She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En5318), via an unspecified route of administration in left arm on 13Feb2021 (at the age of 67-years-old) at dose 1, single for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as hospital. Since the vaccination, the patient has not been tested for COVID-19. The patient received the second dose of vaccine on 08Mar2021. She had no out of ordinary reaction, however, she has been experiencing a burning sensation throughout her body since 14Jun2021 (also reported as mid Jun). After many tests, her antibody level was only 2.93 on an unspecified date in 2021. A rheumatologist ordered two other tests: B2 glycoproteins I (IgM) AB and the value was 73.6 which was high and cardiolipin AB (IgM) and the value was 23.4 which was also high on an unspecified date in 2021. The patient was asked about blood clot experience (14Jun2021) but was never diagnosed with one. Her question was whether COVID vaccines play a significant role in these tests and if there could be a correlation. After all, they heard about people developing blood clots. The events required doctor or other healthcare professional office/clinic visit. She did not receive any treatment in response to the events. The outcome of the events was not recovered. The case was reported as serious, medically significant.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
This spontaneous report was received from a currently 73-year-old male patient reporting on himself. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (reported as "pneumonia shot") and experienced an adverse reaction to the vaccine of itchy rash that covered his entire body. The outcome of itchy rash that covered his entire body was not reported. The patient subsequently experienced persistent cough with phlegm and shortness of breath while on therapy with mometasone furoate (+) formoterol fumarate(DULERA) (captured in MARRS #1706USA011777).; Sender's Comments:  US-009507513-1706USA011777:
Cheeks bright red and hot to touch, chest and rest of face, deep pink, itchy eyes, tingling lips, started mid-afternoon, continued for about 24 hours.
Information has been received from a nurse practitioner concerning a 25 year old female who on 15-SEP-2010 was vaccinated with the 1st dose of GARDASIL and experienced a "small local reaction". On unspecified date, the patient was vaccinated with the 2nd dose of GARDASIL. The patient experienced a "rash on her thighs which spread to her neck and back" 24 hours after the vaccine was given. At the time of the report, the outcome was unknown. Follow up information has been received from the nurse practitioner who reported that the patient called the nurse a couple of days later to report that the allergic reaction was most likely not to the GARDASIL injection, but an allergic reaction to her Christmas trees. Information has been received from the nurse practitioner concerning a 26 year old female with no medical history or allergies, and no illness at the time of report who on 30-NOV-2010 was vaccinated IM with the second dose of GARDASIL (lot # 666931/0337Z) into her left deltoid. On 01-DEC-2010, 24 hours after injection, the patient experienced rash on her thighs which spread to her neck, back and arm. The patient realized that the rash was in location where she brushed against her Christmas tree. The patient took antihistamine and slowly resolved after 2-3 weeks. The patient did not touch the Christmas again. Additional information is not expected.
Pt came into the pharmacy today (11/17/18) stating that after receiving his flu shot on 11/13, he noticed hives on his chest. These were first noticed by the pt on 11/14/18, and spread from the chest around to his upper back. Pt reported no changes in breathing, blood pressure, or pulse rate. I instructed the pt to inform his doctor about the rxn and take Benadryl capsules to reduce the allergic response.
Pt received Influenza vaccine when awoke on the day after was in a semi-conscious state, grossly confused & weak; unable to recognize his wife or his doctor. This reaction has been previously reported to USP.
Booster dose of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-Dec-2021 at 4:17 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Booster dose of an expired vaccine) to be not related.    Concomitant product information was not provided. Treatment information was not provided. After receiving the booster dose of Moderna COVID-19 Vaccine, the patient did not have any immediate issues and had not contained CCHD to notify of any adverse reactions/events It was reported that patient was at high risk of occupational/institutional exposure to COVID-19.   This case was linked to MOD-2021-407228 (Patient Link).
Feeling hot; diarrhea; cramping; Chills; headache; Teeth hurting; Sore arm; a lot of itching; red mark(size of a quarter) at injection site; A spontaneous report (United States) was received from a consumer concerning a 88-years-old  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site, diarrhea, cramping.  The patient's medical history was not provided. Concomitant medications reported were HBP Medication, Allergy Medication, Antianxiety Medication ,vitamins(centrum silver),vitamin D,calcium+Z for drug use for unknown indication.  On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event(s) chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site. On 4 Feb 2021, the patient experienced the event(s) diarrhea, cramping.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site  was unknown and the event diarrhea, cramping was resolving.  Based on MSA comment Feeling hot coded to Vaccination site warm, Pain in extremity coded to Vaccination site pain and Injection site erythema coded to Vaccination site erythema
1st dose Pfizer COVID-19 Vaccine: Her issue is she can't see; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) The reporter is the patient.  An 84-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: ER9331) at the age of 85 years, in arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN (E.C.) taken for cardiac disorder; METOPROLOL taken for cardiac disorder. The following information was reported: BLINDNESS (medically significant), outcome "unknown", described as "1st dose Pfizer COVID-19 Vaccine: Her issue is she can't see". The action taken for BNT162b2 was dosage not changed.  Additional Context: Warm transfer from (name) with Agency. Consumer online states she got the Pfizer COVID-19 Vaccine 2nd booster. After the booster shot, she was completely paralyzed for 24 hours and was unable to walk for 3 weeks.  Caller clarifies details provided by transfer agent. She has been talking to the medical people. She had the 2nd virus shot and within the 24hours she was completely paralyzed and couldn't do anything, not crawl or go to the door. The facility she is living was taking her temperature and said go and get the nurse. She couldn't get to the door, and she got the ambulance and took her to the hospital where she was told she had rhabdomyolysis. This is where her body shoots poison into her body and muscles. She has no problem and in medical report. She was asking her doctor for a bed to put her feet up to get her blood and oxygen flowing to her heart and brain and wrote to the legal department and realized she doesn't know if she needs to report this. She doesn't know how long it's going to be and never sent this report to the legal department. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine.
Patient received Pfizer monovalent vaccine as a booster on 9/1/22. No symptoms.
5:30 PM Administered Pneumovax, 5:45pm patient stated both palms were red, left arm itched.  Kept her about 20 minutes, reported neck itchy.  10-15 minutes later no progression of symptoms.  She felt safe to drive home.  sent her home with Benadryl and she had an Epipen at home.  she stated she is well-versed in allergic reactions and knew what to do.  called her at 6:30pm when she was home.  had taken the 2 benadryl and no progession of itching or redness.
Felt tingling up my neck to face within 15 minutes of injection - 12 hours later, fever, chills, sweats, nausea, REALLY sore left arm, deep bone aches.  21 hours - dry heaves, strobing vision, headache, body aches, more fever, chills, sweat.  Anorexic 48 hours.
10DEC92 fussy & cranky all noc, t102; 3 hives @ inject site & few hives on cheek & under chin; called MD & ordered DPH; 11DEC92 temp103 & severe h/a did not want to lift head; 14DEC92 hives on back of both legs;
Described loss of sensation in her lower arm and inability to move her fingers or grasp her right hand.
BLOOD CLOTS; This spontaneous report received from a consumer via company representative via media concerned multiple patients of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients experienced blood clots and died. As per the reporter it was reported as "I have high blood pressure and take a statin, had phizer and had no problems with it. I have had friends die of blood clots from the J&J vaccine." It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221127438-Blood clots. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: BLOOD CLOTS
After both vaccines I have heavy menstrual bleeding and large clotting for 7-10 days. I had my normal monthly period 19 days prior to the first vaccine.
A physician reported that he treated several patients who inadvertently received Tetanus Toxoid subcutaneously at an unknown facility. The patients experienced injection site reactions characterized by redness, swelling and induration. As of 11/16/00, no further information was available. MANUFACTURER'S COMMENT: The reporter was unable to specify the number of patients who experienced this event. Additional reports will be generated when identifying information is provided.
Information has been received from a 62 year old female consumer with no known allergies who on 29-JAN-2007 was vaccinated with 0.65 ml dose of ZOSTAVAX. On 29-JAN-2007 the patient experienced "mirror ache" on her upper left arm after vaccination. Unspecified medical attention was sought. Lab studies were not performed. At the time of the report the patient had not recovered. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
She received a varicella shot as a part of the community college requirements on 7/10/2007.Three days after received this shot she developed a 2 x 2 in swelling that was red and hot to the touch abd itched as did her throat. She went to the MD and received a steroid shot and 3 steroid pills to take.  This reaction resolved within 2 days of having the steroid shot. She subsequently decided to have the 2nd varicella shot on 8/14/07 and was asked to call if this reaction repeated.
Patient is a 79-year-old male who presents to the emergency department today with complaints of cough and fatigue.  Patient shares that he tested positive for COVID-19 on October 27, 2021.  He reports that since this time he has experienced an intermittent dry cough.  He shares in addition to his cough he has had extreme fatigue.  Patient reports a low-grade fever today that responded to Tylenol.  Patient shares that 2 weeks ago with a get together with his family and his great grandson was ill later tested positive for coronavirus.  Patient shares that he also has had a headache and runny nose which seems to have gotten better today.  He reports being fully vaccinated with the Materna vaccination.