chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose 10Nov2022, 2nd 10Mar2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old male patient who received HAV (Havrix) (batch number 2YZ9B, expiry date 07-DEC-2023) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 10th November 2022).   On 10-MAR-2023, the patient received the 2nd dose of Havrix. On 10-MAR-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 10Nov2022, 2nd 10Mar2023). The outcome of the drug dose administration interval too short 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: 10-MAR-2023 The provider gave information about the vaccine and agreed to be contacted by a second line agent. The vaccine administration facility was the same as primary reporter.  The reporter consented to follow up. The patient received 2nd dose after receiving 1st dose, which led to shortening of the recommended interval between vaccine doses.
I returned from a trip, and I was feeling fine for the first 4 days. I sat next to someone that was very ill because of the person sitting next to me on our way on the trip. I had a runny nose very mild cough. It was so mild I thought it was seasonal allergies. I took a at home COVID-19 test and it was positive and then went to the local clinic the next day. I was given some medication that I had never heard of, and I never got worse. My case was so mild that within days I didn't have any more issues. I am not sure if it was the medication (LAGEVRIO) or that my case was so mild.
Fever greater than 100 F despite antipyretics, severe body aches, chills, fatigues
Patient had been told to come in that day to receive her 2nd vaccination even though she had received her 1st one only 2 weeks prior. When arriving at the clinic, checking her in and the nurse administering the injection failed to recognize vaccine was early. Not until being added into her chart was the error noted. Patient was called and that is when she stated told her to come in.
Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose; Muscle cramps and shaking; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose) and TREMOR (Muscle cramps and shaking) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose) and TREMOR (Muscle cramps and shaking). At the time of the report, MUSCLE SPASMS (Muscle cramps , and shaking ("like when you drink a lot of caffeine") which started with the first dose , got worse on second dose) and TREMOR (Muscle cramps and shaking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Information has been received from a pharmacist referring to an 81 year old female patient. The patient's concurrent condition included asthma and hypothyroidism. The patient was allergy to penicillin. Concomitant therapies included levothyroxine sodium (manufacturer unknown), lorazepam and PROAIR. On 28-OCT-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose unknown, lot # M035104, expiration date: 06-MAY-2016) intramuscularly. On the same day, the patient called the pharmacy back to report swelling at the injection site. The patient then went to a hospital emergency room on 29-OCT-2016 because the swelling increased from the injection site down to her elbow and it was very painful. The patient was not admitted to the hospital, but discharged from the emergency department, on an unspecified date, with prescriptions for prednisone (manufacturer unknown), 60 mg for 5 days for the swelling and NORCO, 5/325 mg, 1 tablet every 6 hours as needed, for the pain. No lab was performed. The Pharmacist spoked with the patient again on 31-OCT-2016 and the patient stated the swelling and pain have subsided a little bit (recovering). The causal relationship between the events and PNEUMOVAX 23 was unknown. Additional information has been requested.
Lethargy followed by protracted inconsolable crying and screaming for two hours. Pustules formed on feet 3 days later and continue to breakout on and off.
Initial information received on 25-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who received 1 ml vaccine PENTACEL (lot C5444AA and expiry date 27-Oct-2019) via unknown route in unknown administration site, that was prepared with two vials of DTaP-IPV with no Hib on 25-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13; HEPATITIS B VACCINE; ROTAVIRUS VACCINE; and INFLUENZA VACCINE. It was a case of actual medication error due to inappropriate reconstitution technique and overdose. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient complained of dizziness, felt weak - was being assisted back to a room, went down to floor on his knees and fainted.  Laid patient on bed in room, was awake by this time.  Patient became coherent and oriented x 3.  Face was washed with wet towels and feet elevated.  Provider in room checking patient.  Patient states he had not ate this morning.
Verbal communication, patient reported approx. 3 days after injection, swelling and rash appeared in arms, legs, and back. Pt. saw doctor who gave prednisone to control. No further progression.
Rash, redness around injection area. BENADRYL 25-50mg q 6 hrs. Prednisone 20 mg, III day 1, II days 2-5, I days 6-10
11/2/21 presented as transfer from medical center "for gross hematuria and difficulty urinating for a couple of days". PMHx "of bladder cancer s/p TURBT and bovine treatments " and "prostate cancer s/p prostatectomy".
At first, chills and extreme fatigue, within 24 hours, which I expected. What I did not expect, and was surprised at its severity, was 72 hours after the chills subsided, (almost 5 days after my vaccine), was a depressive episode that lasted almost three full days. (Please note I am not a depressed individual nor was I sad before this event- that?s what made this so noticeable for me). On the fourth day after the depression hit, I felt fine. It was truly palpable: to the point I feel compelled to report this so you have data in case others are affected this way, as well.
Patient received Pfizer COVID vaccine on 2/23/21 (lot # EN6198), 3/23/21 (lot # ER2613), and 9/23/21 (lot # FF8839). On 3/10/22, patient admitted to our inpatient facility with acute kidney injury in setting of renal transplant, acute metabolic encephalopathy, and COVID pneumonia (mild-moderate, not hypoxic). As of today (3/11/22), patient is still admitted in the med/surg unit.
Pediarix given as 4th dose Dtap and IPV.  This also made the 4th dose for Hep B.  The child did not experience any adverse symptoms to our knowledge.  This event does not appear in the reportable list but the CDC recommended reporting.
11:00 am next day, moderate to severe body aches, joint pain, low fever, chills, headache, dizziness. Continued for 13-15 hours.
Pt reports headache, nausea, pain at site of injection. Saw in health services 9/14/15. Nausea and headache has resolved. Provided with 600mg ibuprofen for that day; 400 mg for next day if pain continued.
Same day of vaccine a couple of hour later I started sneezing , that night I had pain on my left arm, & I had a lift note on my left axilla. I couldn't lift up my arm, That night I had fever & the following day I couldn't go to work I felt very fatigue. Then when I was able to return to work I had to leave because I kept feeling sick & with a fever. On Sunday started getting a sore throat & the following morning it got worst & I had already started coughing, Then on Monday I went to go get tested for covid & it came back negative. I have recovered from everything except from my lift note, I did my annual check up & they did an ultrasound & they will put me on observation for another 2 weeks.
Swelling near injection site and swelling of right knee. Right knee tender to palpation. Painful to ambulate.
Pt had immunizations on 4/2/10. Pt started having reaction later that day. On date of exam, 4/5/10 right thigh area has a 14 cm by 16cm erythematous, warm to touch.
Sedation, Myalgia, Diarrhea, NauseaVomiting, fatigue and pain at the injection site Narrative:
Varicella in vaccinated pt.  Seen 03/18/2004 in office (Age 5 11/12 when examined to confirm diagnosis).
Info has been received from a physician concerning a 6 year old male who on 8/17/01 was vaccinated with an 0.5 mL dose of varicella virus vaccine live (lot 630975/1601K). The physician reported that on 10/25/05, the pt developed breakthrough chickenpox characterized by less than 50 lesions. No fever was noted. Unspecified medical attention was sought, but no treatment was ordered. Subsequently, the pt's breakthrough chickenpox resolved. Additional info is not expected.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Influenza vaccine and PREVNAR. On 18th September 2018 14:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th September 2018 22:30, 8 hrs 30 min after receiving SHINGRIX, the patient experienced fever, chills, bone pain, muscle pain, tiredness, nausea, vomiting, headache, appetite lost, influenza-like symptoms and joint pain. The patient was treated with TYLENOL. On an unknown date, the outcome of the fever, chills, bone pain, muscle pain, vomiting, headache, influenza-like symptoms and joint pain were recovered/resolved and the outcome of the tiredness, nausea and appetite lost were unchanged. It was unknown if the reporter considered the fever, chills, bone pain, muscle pain, tiredness, nausea, vomiting, headache, appetite lost, influenza-like symptoms and joint pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left deltoid. On the day of vaccination, at around 10:30 PM the patient experienced events. She took TYLENOL as soon as she got home after vaccination, and she took two TYLENOL 500mg tablets the night before the date of reporting. The patient recovered from everything except she still experienced nausea, tiredness and loss of appetite. The patient had denied permission to contact their physician. No further details were provided.
The patient had a rash all over his torso. He went to urgent care and obtained a prescription for prednisone and purchased Benadryl tablets and Benadryl cream over the counter.
Pt recvd 3 Engerix-B vax given 14JAN91, 13FEB91 & 5JUL91; 10AUG91 titer was neg; Pt was given a 4th dose of vax on 16AUG91;
Received the second dose on 2/11/21 and on 2/13/21 I started to experience severe headaches. This is highly unusual since I haven't had a headache in 30 years. I waited a few days to see if they would dissipate in a few days. It is now April 21, 2021 and I get headaches every day some more sever in the afternoon. If I sneeze or bend down it feels like my head is coming apart. Even at the time during the day when the headache subsides the pressure behind my eyes remain till the next flare up. The only time I get relief is when I lay down for bed. I sleep through the entire night. This is not fun. I need some help. I have MRIs, specialist prescribing pills
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Systemic: Vomiting-Severe, Additional Details: AFTER SHOT ADMINISTERED,PATIENT WAS WALKING TO WAITING AREA FOR OBSERVATION, WE FAINTED AND HAD 2 SEIZURES ABOUR 40 SECONDS LONG. NO PULS OR BREATHING. GAVE 10 CHEST COMPRESSIONS AND 2 BREATHS. EMERGENCY WORKER SHOPPING IN STORE HELPED ROLL TO RESCUE POSITION AFER FEEELING PULSE IN THE WRIST. HE SPIT UP A SMALL AMOUNT OF SPIT. HE SHORTLY CAME AORUND IN ABOUT ANOTHER MINUTE. NO EPINEPHRINE WAS ADMINISTERED.
13 X 8 cm area of induration and erythema and fever 100.1
This is a spontaneous report from a 52 year old male who on about 8/2/99, received his 1st dose of Lymerix. The pt is an outdoorsman and has, on occasion, taken ticks off himself. "Soon after" receiving the 1st dose, the pt experienced pain and stiffness in his left knee. He was treated with anti-inflammatory medicine and symptoms resolved. On 9/2/99, the pt received his 2nd dose and 1 hour later, the pt experienced pain and stiffness in his right knee. A doctor visit was required. The pt was treated with Advil. Lymerix was discontinued. The most recent information, received on 9/2/99, reports the condition of the pt is ongoing.
DATE OF ADMISSION:  10/27/2022   DATE OF DISCHARGE:  11/04/2022     DISCHARGE DIAGNOSIS:   PRIMARY DIAGNOSIS:  Acute COVID infection.   SECONDARY DIAGNOSES:  Acute bronchitis secondary to COVID, right eye blurred vision?, QT prolongation (455 milliseconds), hepatic steatosis, arthritis, obesity, gastroesophageal reflux disease, hyperlipidemia, bilateral leg edema, hypertension, carpal tunnel syndrome, vitamin D deficiency, coronary artery disease, uncontrolled diabetes mellitus (A1c 13.8).
She had a fever (101 degrees), she started staring for about 2 minutes every half an hour and refused to eat. She lost all her words and has not said a single word since.
This spontaneous report was received from a registered nurse refers to a 29-year-old patient. On 14-APR-2013 the patient was vaccinated with a dose of (merck) PROQUAD (lot#, expiration date and route not reported). No adverse effect reported. Additional information has been requested.
It was reported that a male pt received a TD adult vaccination administered on 04/12/2002, site not specified. Within 2 hrs the pt developed cellulitis at the injection site which spreac to his upper chest area. He was admitted to the hospital.
I was feeling sluggish and tired after the shot. The following week I started having joint pain and fluid on my knee. I went to work and noticed my knee was swollen.
12 hours post vaccination blacked out. Post regaining consciousness both hands and arms became numb; Mild migrane; Forehead felt numb for 3 d/Post regaining consciousness both hands and arms became numb; slight tingling in fingers; This is a spontaneous report from a non-contactable other hcp (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 23Apr2021 19:00 as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. The patient felt okay after vaccine. 12 hours post vaccination (24Apr2021 08:00) blacked out. Post regaining consciousness both hands and arms became numb. Felt slight tingling in fingers. Mild migrane. Forehead felt numb for 3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There is no known allergies and other medical history. The outcome of the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: The causal association cannot be excluded between the reported event of Loss of consciousness and BNT162B2. The impact of this report on the benefit-risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for AE. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, ethics committees and investigators, as appropriate.
All previous info given by text messaging was for the second injection and not the first. I was never notified after first injection.  Aweful  given around 11:30 AM 03/18/21 Chills, lethargy, nausea, dry heeves , diarrhea,  start 9:30 pm lasted for about 18 hrs. and lethargic for 2 days
Immediate pain at RUE injection site, progressive erythema, swelling, tenderness at injection site, mild increase in right 1st digit arthralgia, no systemic symptoms.
Information has been received from a nurse concerning her "14 year old" daughter who in June 2008, was vaccinated with the first dose of GARDASIL (lot number not provided). In June 2008 the patient completed vaccination with the series of GARDASIL (lot number not provided). There was no concomitant medication. The nurse reported that her daughter was using GARDASIL and experienced alopecia in September 2008. The nurse reported that the patient applied lotion to her scalp and got injections (unspecified). At the time of the report the patient had not recovered. Laboratory tests performed included thyroid testing with no results provided. The patient sought unspecified medical attention. No further information is available.
This is a spontaneous report from a contactable consumer (mother) who reported adverse events for PREVNAR in siblings.  This is the first of two reports.  A 2-year-old male patient received the fourth dose of PREVNAR in Jan2005.  Past vaccine history included the first dose on 30Dec2003, the second dose in Feb2004 and the third dose in Jul2004.  Relevant medical history and concomitant medications were unknown.  It was reported that in Jan2005, the child was very sick and was diagnosed with an urine infection.  The patient was reported to have a pneumococcal level in the blood of -1.3(unknown units).  It was also reported that the patient had an allergy and his immunoglobulin (Ig82) was low since an unknown date.  It was reported that the child discontinued the therapy since an unknown date in Jun2005.  Therapeutic measures taken in response to the events were unknown at the time of the report.  The clinical outcome of the reported events was unknown at the time of the report.
febrile sz ?time 3-5 mins per parent; temp > 102 occurred 2-3 hrs p/vax; seen @ ER
I tested positive for COVID-19 on 1/20/23. I was dizzy, runny nose, and congestion. After I tested negative, I started having a terrible headache and it just wouldn't go away. I had an appointment scheduled with my Neurologist and I brought the headache up to him at that time. He decided to do a medication change at that time. The headache finally went away after about 6 weeks.
Received Smallpox left shoulder 03Sep2011. Received 2nd Anthrax left shoulder 06Oct2011. Still having tremors in left arm and hand. Still having weakness. Still having shoulder pain. Started pt. on left shoulder. Still weakness.
Information has been received from a physician concerning his daughter who was vaccinated with Gardasil. A few days after Gardasil, she experienced flu-like symptoms, sore throat, and lesions on her throat. A few days after that, she experienced cutaneous lesions in her genital area. She was tested for herpes which was negative. "BBC" and complete work were performed (results not provided). The patient subsequently recovered. Additional information has been requested.
Intially after shot #2 & #3, I felt just fatigue and a headache but both symptoms subsided within 24 -36 of the shot.   I also have a delayed reaction to shot #3 (moderna Booster) where on 12 days after the booster, I have hives and dermographia in random parts of my body and it is not going away
10/18/99, Macular rash described by mom, with papules on top of macules (macular-papular). Rash on chest, back, neck & called later saying rash was spreading to vaginal area. Parent is not sure if pruritic rash.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 11:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 11:59 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 71.34 .  No concomitant medications were reported.  Batch number 019B21A  underwent temperature excursion on 28-Mar-2021 with temperature 35 degrees Fahrenheit from 10:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 27-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).