chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a nurse prescriber. On 27-DEC-2018, the nurse requested information regarding the dilution of a dose of GARDASIL 9 for prophylaxis (route, anatomical location, lot # and expiration date were not reported) with sterile diluent (MERCK STERILE DILUENT) lot # and expiration date were not reported (product preparation issue and product preparation error). Additionally, the nurse mentioned that this dose may have been administered to a patient of unknown age and gender (wrong technique in product usage process and product administration error), although this could not be confirmed at the reporting time, due to difference in time zone. No adverse effects were reported. This was a non valid case due to lack of patients identifiers and upon follow up this case is considered valid. Follow-up information has been received from the nurse prescriber (same reporter as before) on 03-JAN-2019. On 03-JAN-2019, a patient of undisclosed age and gender, received a dose of GARDASIL 9, for prophylaxis, administered intramuscularly (anatomical location not reported) lot # N035955, expiration date 09-OCT-2020 (wrong technique in drug usage process); this vaccine had been further diluted with sterile diluent (MERCK STERILE DILUENT) (inappropriate dilution of medication). This dose of GARDASIL 9 was the patient's third dose on the vaccination series. No adverse effects were reported in the patient.
reporter stated that "she heard from a MD in office there has been a 20% increase in HIB disease since state started using HIB/HEP vax".
Post vax, the patient recently developed "water warts". In follow up, the physician's office reported that, "the mother who reported that it was a reaction to the chickenpox apparently misunderstood the doctor, the "water warts" had nothing to do with the vaccine. Additional information has been requested.
approximately 15 minutes following administration, pt felt nauseous, diaphoretic and dizzy. pt did not feel sob or chest tightness. Pt escorted to room to lie down. VS obtained
15 min after shot started feeling dizzy and drunk. Blood pressure was elevated . Had to call rapid response team. Taste buds are off . Keeps tasting Tuna Fish
No adverse effect; Patient was administered a dose of PROQUAD which was improperly stored; This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported.   On 24-JUN-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose number, route and anatomical location were not reported) (Lot # S027463 with expiry date: 02-MAR-2021) for prophylaxis (product storage error). The vaccine was exposed to a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit: 9 degrees Fahrenheit for 40 minutes.  Previously the vaccine exposed to 6 degrees Fahrenheit to 14 degrees Fahrenheit: 9 degrees Fahrenheit for 40 minutes. It was reported that the call was because of digital data logger. No additional adverse effects reported. No product quality complaint (PQC) was involved.
Sever musle pain, left side of body, could not move. fever, headache, chills. Lasted 4 days
On the following day of my second dose of pfizer I noticed spots on my right hand and arm. The spots appear to be inside the skin. They are not itchy. They appear like freckles all over my right hand and arm and stop about half way my arm.
permanent disability severely limits the activities and work the patient can do. ultimately this has forced the patient into poverty without the ability to work a normal job the patient suffers without assistance from any disability benefits. forced to live a misserable life of pain and anguish realizing his entire life was derailed before he ever knew what had happened it was already done and irreversible.  shame on anyone that lead to this vaccine injury and may those responsible for this suffering that created and promoted these evil vaccines be tortured in hell for eternal ever after no mercy as I have had no mercy
had miscarriage after the vaccination; This is a spontaneous report from a Pfizer sponsored program received from a non-contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. This is a maternal report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was pregnant at the time of vaccination. The patient had miscarriage after the vaccination on an unspecified date. The mother reported she became pregnant while taking BNT162B2. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101144476 Same reporter/ event, diff patient
I woke up the day after my booster shot feeling ill, with vomiting and diarrhea as well as fever and body aches and headache., This lasted approximately four days.
Patient had shots on 7/27/2010. He did not return to us until 12-6-10, at which time Dad told us about reaction. He states child had increased temp 103-104 and vomited blood 1-2 days after receiving shots. He took him to Dr. at hospital.  He then was transferred to hospital.  A series of tests were done - including scoping. They could find nothing wrong.
Narrative:  Respiratory failure / respiratory depression went to ED / ICU 2/1/2021. Frail patient. 1st vaccine 12/23/2020 Moderna Lot 039K20A exp 6/20/2021, 2nd vaccine 1/20/2020 Moderna Lot 013L20A exp 7/8/2021
Developed neuro deficits starting in lower extremities within 2 weeks from vaccine #1; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 51 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (ongoing); "Hyperlipidemia" (ongoing); "Sinus tachycardia" (unspecified if ongoing); "Esophagitis" (unspecified if ongoing). Concomitant medication(s) included: HCTZ taken for hypertension. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "Developed neuro deficits starting in lower extremities within 2 weeks from vaccine #1". The lot number for bnt162b2 was not provided and will be requested during follow up.
large hives on the entire upper left thigh from front to back , redness mild swelling and increased warmth, tender to touch. No treatment needed at this time , it was improving at the visit on 11-23-21
Client received first dose of COVID vaccine @ 11:55am, began feeling dizzy @ 12:00pm.  Vital signs stable, placed in a zero gravity chair.  At 12:04 pm, client complained of tingling in lips, no shortness of breath.  Dizziness and tingling lips resolved @ 12:30pm, instructed to follow up with primary care MD.   Client walked out of observation area with significant other.
I have been experiencing racing, thudding and irregular heartbeat on almost a daily basis since the lasts vaccine on April 7th.
Developed a red rash at injection site that was painful and stings/burns. Rash spread down toward my elbow. Rash has healed by the top part of my arm but has since spread to my elbow and still hurts down there. Has shown some signs of clearing up.
Decreased ROM, no swelling or discoloration. Ibuprofen 600 mg three times daily. Seen by PCP on 9/15 and 9/21.
Swelling in the Arm at sight of Vaccine. Sore and Warm to touch
PATIENT EXPERIENCE SHORTNESS OF BREATH. 911 WAS CALLED PATIENT WAS TAKEN BY AMBULANCE. SPOKE TO PATIENT FOLLOWING WEEK AND STATED SHE WAS GIVEN OXYGEN AND BENADRYL.
received his first dose/on October 12, 2020 /got his second dose today/got it late due to the "craziness of COVID"; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number 1232023, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 12th October 2020).   On 12th July 2021, the patient received the 2nd dose of Shingrix. On 12th July 2021, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided are as follows: The patient reported that he got his 2nd dose of shingrix on 12th July 2021 (inappropriate schedule of vaccine) and patient stated that he got it late due to the 'craziness of COVID'. The lot number 1232023 was provided which could not be located in our system. No additional information were provided by the patient. The reporter consented to follow up.
Patient had complaint of soreness of arm since 12/9/04. Patient's mother noticed redness and swelling 12/11/04. Pt was advised to put ice on site and keep an eye on if worsen, go to ER. (sight was red, warm to touch, swollen, pain)
brainstem & cerebellar edema leading to brain death adm 11/12/99 w/nl LP, MRI;f/u MRI 11/14/ brainstem, cerebellar edema prior hx of CNS problems p/last year's vax also;acute demyelinating encephalomyelitis 10/98 w/bilat temporal lobe; Autopsy stated final diagnosis of seizure and fever,
Patient reported to the pharmacy on 07/29/22 stating that she had been feeling soreness and difficulty moving her arm since November of last year since she got her shingles vaccines. She felt soreness and difficulty moving the arm for a couple of months. However, after checking the patient profile, patient had gotten vaccine since July 17, 2022. Patient said that she still believes this reaction was due to the vaccine and she already went to go see her doctor and he did not find any other cause for the arm symptoms.
Vaccination 0828 0835 reports numbness & tingling in left hand.  Reports "random rashes" after 1st dose of COVID vaccine (not reported prior to vaccination). Also has history of anaphylactic reaction to mushrooms.  BP 121/80, HR 68, O2 98 0845 administered diphenhydramine 25 mg. Reports relief in numbness/tingling but hand "feels" swollen.  Cleared to leave at 0913 with instructions to seek care if symptoms persist or worsen.
Left arm at site:   Red, hot, painful morning until after bed time.  Fine the next day.   Hips painful:  Morning until after bed time.  Fine the next day. I failed to check my temperature
Elevated temp 102.3, near syncope x4, chills, joint pain especially in back and neck, nausea 12 hours, pulse 100, night sweats, dizziness and slight headache after Tylenol
Administered ZOSTAVAX approx 3 inches above elbow Sq. On 5/27/15 was swollen and red for 3-4 days. On Thursday June 4th 8 days later had pain and swelling on to of shoulder and pain in shoulder blade. On June 7th - 11 days later all symptoms gone. She did not go to her MD or any MD.
My daughter started to experience headaches 2 days after her first dose. On May 13th the headache had become so bad that she would cry and then suddenly became unable to speak or grab. She could not formulate actual words and was unable to smile . This lasted 15 minutes. A trip to the nearest Emergency room was inconclusive and resulted in discharge. 24 hours later , we had the same incident only this time magnified times 10. Where she remained in a catatonic like state for 7 hours only to snap out of it independently without medical treatment. After multiple test she was diagnosed with viral encephalitis. All major causes of encephalittis were ruled out and we were told it was possible a side affect of her first Moderna Covid Vaccine dose. We are still seeing doctors and testing but she seems to have improved without medication which is even more alarming .
One dose of Moderna vaccine given from a vial of Moderna vaccine expired on 10/13/2021 but kept in the refrigerator  Lot number 048c21A expired 10/13/2021 - Manufacture expiration date 11/09/2021 - removed from freezer on 09/13/2021 and kept in the refrigerator until 10/18/2021
Prolonged seizure lasting up to 3 hrs. Admitted to hospital and on ventilator for 2 days. (+) RSV due to prolonged seizure. Developmental follow up is suggested. The hospital discharge summary received on 4/2/04 states respiratory failure.
Rash & UrticariaPruritus Narrative:  DEVELOPED RASH ON DAY 7 AND IT LASTED TWO WEEKS
chills; nausea; diarrhea; loss of appetite; headache; bone pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), NAUSEA (nausea), DIARRHEA (diarrhea), DECREASED APPETITE (loss of appetite) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in June 2020.    On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced CHILLS (chills), NAUSEA (nausea), DIARRHEA (diarrhea), DECREASED APPETITE (loss of appetite), HEADACHE (headache) and BONE PAIN (bone pain). At the time of the report, CHILLS (chills), NAUSEA (nausea), DIARRHEA (diarrhea), DECREASED APPETITE (loss of appetite), HEADACHE (headache) and BONE PAIN (bone pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
pt recv vax 6MAY96 & 19FEB97 pt devel approx 50-100 vesiculo-pustular lesions on face & trunk which were described as classic chickenpox;
left side of face is numb; left side of face is now tingling; itching; swelling of the left side of her face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (left side of face is numb), PRURITUS (itching), SWELLING FACE (swelling of the left side of her face) and PARAESTHESIA (left side of face is now tingling) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (steroids), Caffeine allergy, Drug allergy (amoxicillin) and Anemia.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PRURITUS (itching) and SWELLING FACE (swelling of the left side of her face). On an unknown date, the patient experienced HYPOAESTHESIA (left side of face is numb) and PARAESTHESIA (left side of face is now tingling). At the time of the report, HYPOAESTHESIA (left side of face is numb) and PARAESTHESIA (left side of face is now tingling) had not resolved and PRURITUS (itching) and SWELLING FACE (swelling of the left side of her face) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported. No Concomitant medications were reported.
A minute or two after receiving the injection I began to have a strong pain that radiated through arm into my core, I began to feel nauseous and lightheaded. My face became red and face felt like it was swelling. Floaters in my vision began and continued for about 20 -30 minutes.
pt recv vax;exp fatigue & tiredness;sx persisted for 2 days;
The pt received his 1st IM, right deltoid, dose of Havrix on 6/22/00. Three days later, on 6/25/00, he experienced a severe migraine. No treatment was given. The most recent information, received on 6/26/00, reports the outcome of the event as resolving.
I experienced a fever of 100.4, 24 hours after the injection, accompanied by overall muscle aches, headaches, and difficulty sleeping. The fever was gone within 36 hours, but the other symptoms persisted.  My spouse, who also had Covid-19 at the same time that I did experienced the same symptoms.
A report was received from a health care professional on 12/4/03 concerning 3 to 4 children of unknown sex and under 4 years of age who inadvertently received Fluvirin on approximately 10/15/03. On approximately 10/15/03, 3 to 4 children inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 19-DEC-2013 the patient was vaccinated with expired ZOSTAVAX. The patient experienced no known adverse effect. This ZOSTAVAX had not been exposed to a temperature excursion. The outcome of expired dose of ZOSTAVAX administered and no known adverse effect is unknown. Additional information has been requested.
Bexsero administered instead of HPV; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-AUG-2022 Reporter's comment: The mother of the patient reported that the patient was given a dose of Bexsero instead of HPV at 11 years old. The reporter did not realize until she was reviewing her vaccine records. The reporter did not consent to follow up. Additional Supportive Information: The patient received a dose of Bexsero instead of HPV, which led to wrong vaccine administered.
My arm was sore and tender for 2 days after the vaccine which is considered normal but then 8 days after my arm became sore and tender again, hot to the touch and there's a bit of swelling. It is now Saturday May 22 and my arm is red, tender, swollen a bit and quite itchy.
Information has been received from two licensed practical nurse referring to a 12 year old female patient. The patient had no known allergy. On 11-AUG-2015 the patient was vaccinated with the first dose of GARDASIL 9 (lot # was reported as L004014 with expired date 04-MAR-2017, dose and route were unspecified) for HPV prevention. No concomitant medication was taken by the patient. On the same day, the patient experienced a syncopal episode immediately following the administration of the vaccine and recovered 15-20 minutes after the injection site in the care of the two reporters for medical attention. No lab tests was performed. The patient was fully recovered from the episode on an unknown date in August 2015. Lot number L004014 is an invalid lot number GARDASIL 9. This is one of two reports received from the same reporter. Additional information has been requested.
Immediately following injections, patient "passed out", arms and legs became stiff. Eyes rolled back and patient lost bladder control. Immediate Doctor assessment seizure activity, tonic body state. lasting about 45 seconds. Pulse OX 99% on room air Blood suger 94.Stepmother reports some syncopal episodes in the past- the last being 3 weeks ago. Patient recovered. A&O x3.
Injection site is itchy; Big orange puppy raised area at the injection site; Injection site swelling; Injection site pain; A spontaneous report was received from a consumer concerning herself, a 53-year-old, female patient who experienced pain at the injection site [Injection site pain], "a big orange puppy raised area at the injection site [Injection site erythema/Injection site swelling] and injection site was itchy [Injection side pruritis].   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 24-Dec-2020, the same day as the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (02FJ202A) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   The patient experienced injection site pain on the same day she received the vaccine. This pain went away. On 01-Jan-2021, she noticed a "big orange puppy raised area at the injection site". She also reported that it was itchy. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, injection site pain was resolved on 24 DEC 2020. The outcome of the remaining events, were unknown.; Reporter's Comments: This case concerns a 53-year-old female who experienced NS events of expected injection site pain, injection site pruritus, injection site erythema, injection site swelling. Injection site pain occurred the same day as the first dose of mRNA-1273, followed by other events on Day 9. Treatment not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sore red knot at the site of the injection; Warm to the touch at the site of injection; Itchy knot at the site of injection; Sore red knot at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore red knot at the site of the injection), VACCINATION SITE RASH (Sore red knot at the site of the injection), VACCINATION SITE PRURITUS (Itchy knot at the site of injection) and VACCINATION SITE WARMTH (Warm to the touch at the site of injection) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore red knot at the site of the injection), VACCINATION SITE PRURITUS (Itchy knot at the site of injection) and VACCINATION SITE WARMTH (Warm to the touch at the site of injection). On an unknown date, the patient experienced VACCINATION SITE RASH (Sore red knot at the site of the injection). At the time of the report, VACCINATION SITE PAIN (Sore red knot at the site of the injection), VACCINATION SITE RASH (Sore red knot at the site of the injection), VACCINATION SITE PRURITUS (Itchy knot at the site of injection) and VACCINATION SITE WARMTH (Warm to the touch at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
No AE reported; expired dose of PROQUAD was inadvertently administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 14-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) lot # S017256, expiration date 01-DEC-2020 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse event (AE) was reported.
Fever to 103 F with shaking chills day after vaccination. Also warmed patch (10cm) anterolateral arm that has not resolved.