chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2022 at 10:00 as dose 4 (booster), single (Lot number: Fm0698) at the age of 41 years, in left arm 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Limited Wegeners Granulomatosis" (unspecified if ongoing), notes: Limited Wegeners Granulomatosis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (unspecified date) Positive, notes: I tested positive for another full week; (06Jun2022) Negative, notes: I tested negative on day 7; (11Jun2022) Positive, notes: On day 12, I tested positive for Covid again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. After taking Paxlovid for the prescribed 5 days from 31May2022 to 05Jun2022 for Treatment of COVID-19 and having a major reduction in symptoms of Covid, Patient tested negative on day 7. On day 11, Patient developed a runny nose and sore throat. On day 12, Patient tested positive for Covid again. Patient tested positive for another full week and during that time, exposed my family members. We didn't realize the likelihood of a Covid rebound.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Fever, Chills, and fatigue Narrative:
suffering from really blurry vision affecting both eyes/ blurry vision is also for up close objects/ not going away; really scary; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (suffering from really blurry vision affecting both eyes/ blurry vision is also for up close objects/ not going away) and ANXIETY (really scary) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VISION BLURRED (suffering from really blurry vision affecting both eyes/ blurry vision is also for up close objects/ not going away) and ANXIETY (really scary). At the time of the report, VISION BLURRED (suffering from really blurry vision affecting both eyes/ blurry vision is also for up close objects/ not going away) and ANXIETY (really scary) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had some blurry vision for objects at a distance  before the vaccination but now the blurry vision is also for close objects. Patient took dose 2 on 19-OCT-2021 with lot 011F21A. Concomitant medications were not provided. Treatment includes regular eye drops.
Within 1 minute of receiving vaccine, patient experienced seizure. Called 911 and got patient safe and stable while waiting for EMS.
Mom states child had a seizure 1/31/09 around 5am, lasting approx 3 minutes (stiffness, then body shaking), temp 99.8 F.  Called 911. Child taken to Hospital by ambulance.  No seizure during ambulance transport or at hospital. No treatment, just observation.  Child discharged to home.
Lumbar pain developed in the same evening as the vaccine given.  Seen in office next day for continued lumbar pain.
Case number PHEH2014US003786 is an initial spontaneous report from the pharmacist received on 21 FEB 2014. This report refers to a 16-year-old  male patient who was accidentally vaccinated with FLUCELVAX 2013/2014 (batch number: not reported) at a dose of 0.5 ml intramuscularly on 22 NOV 2013. No adverse event occurred to the patient following this medication error (inappropriate age of vaccine administration).   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "drug used in unapproved population".
102 degree fever within 6 hours of getting the vaccine with sever muscle fatigue. Wasn?t feeling better for 3 days.
no adverse event; a 4th dose of GARDASIL 9 was inadvertently administered to the patient; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-JUL-2022, the patient  was inadvertently vaccinated with the 4th dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) 0.5 milliliter, lot#U028826, expiration date 04-NOV-2023 (route of administration was not reported) as prophylaxis (extra dose administered). No adverse event was reported.
After completion of vaccination, patient lost consciousness and went limp. Patient was supported is seated position - did not fall or hit head/body. Patient remained unconscious for approximately 15 seconds with eyes remaining open, but unfocused. Additional pharmacy staff was immediately alerted and called EMS. When patient regained consciousness, he was pale/green in the face, sweating, and warm to the touch. He reported feeling "normal" but shortly stated he was thirsty, hot, and nauseous. Patient was wearing an Smart Watch that reported his heart rate at 63 bpm and regular rate and rhythm.
Headache (after 1st dose); Fever (after 1st dose); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache (after 1st dose)) and PYREXIA (Fever (after 1st dose)) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa Drugs).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced HEADACHE (Headache (after 1st dose)) and PYREXIA (Fever (after 1st dose)). At the time of the report, HEADACHE (Headache (after 1st dose)) and PYREXIA (Fever (after 1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medications reported included unknown thyroid and Blood pressure medication. No treatment information was provided.  The patient experienced headache and fever after the first dose.   This case was linked to MOD-2021-374535, MOD-2021-374553 (Patient Link).
a patient received an expired ACT-HIB vaccine with no adverse event; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an unknown demographic patient who received an expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (Lot number: UJ078AAA, expiration date; 02-Oct-2020) via an unknown route in unknown administration site for prophylactic vaccination on 09-Oct-2020 (expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug was not reported.   It was a case of an actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
Rash appeared on child's face 2 hours after immunizations as stated by child's mother.
On 11/15/2022 Pt was given Hepatitis A that expired on 11/11/2022
Hives; Bumps; Feel like has the "flu"; Rash; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), MASS (Bumps), INFLUENZA LIKE ILLNESS (Feel like has the "flu") and RASH (Rash) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A214) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced URTICARIA (Hives), MASS (Bumps), INFLUENZA LIKE ILLNESS (Feel like has the "flu") and RASH (Rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, URTICARIA (Hives), MASS (Bumps), INFLUENZA LIKE ILLNESS (Feel like has the "flu") and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
pt recvd vax & cried since shots w/exception of 20 mins nap, leg red from hip to knee, (lt leg where Tetramune given); t100 R;
Left side lymph nodes swelling (couldn't even put seat belt on chest when driving). Has subsided currently.  Lump located on collar bone - painful. Persisted for 3 weeks and still present.  Saw gynecologist, mentioned the swelling and bump. Gynecologist suggested CT scan.
C/o sore left deltoid muscle since getting the flu vaccine. Denies any redness or swelling at the site.
Vaccine frozen rather than refrigerated. Dose administered. Offered revaccination. Wants booster, not revax
2 weeks after the shot had a varicella rash outbreak lesions crusted over and then 1 week later had a second outbreak.
The 70 day thaw date of the Pfizer vaccine was 5/5/22. The vaccine  was given on 5/9/22, 4 days after the thaw date.  Per Pfizer there is a 2 day grace period, and the vaccine was given 4 days after.  There were no adverse reactions for this vaccine.
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient's pertinent medical history included smoking. Drug reactions/allergies were reported as none. On 26-JUL-2016, the patient was vaccinated with ZOSTAVAX (lot # M009773, expiry date 17-MAY-2017) subcutaneously (strength, dosing details, anatomical location were unknown). Then on the same date the patient received PNEUMOVAX 23 on the opposite arm. On an unspecified time after vaccination (on an unknown date in JUL-2016), the patient developed a red welt, on the injection site. The patient returned to the pharmacy on 27-JUL-2016, the show the welt. She sought medical attention by speaking with the pharmacist. No treatment was given for the adverse event. No lab diagnostic tests were performed. The outcome of the event was not known. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
This spontaneous report concerning a 81 year old female patient was received from the patient herself. The patient's medical history included cancer. The patient did not had drug reactions or allergies. Concomitant therapies included gabapentin. On an unknown date in 2007, the patient was vaccinated with ZOSTAVAX) 1 time vaccine in the arm (dose, route, lot number and expiration date were not reported) to prevent the shingles. The patient reported that in 2013, she got the shingles. An now, she had post herpetic neuralgia because of the shingles she had. Additionally, despite the fact that the patient in the past had cancer, she received ZOSTAVAX (product use issue). The patient seek for medical attention and received treatment for the events. Every year she had blood tests performed (results not provided). The outcome of post herpetic neuralgia and herpes zoster was not reported. No product quality complain was reported. The causal relationship between the events and the suspect therapy ZOSTAVAX was not provided.    Additional information has been requested.
It has been reported that the pt experienced severe arthralgia after the first dose then pain decreased. After the 2nd dose the pt experienced more pain.
This case was reported by a physician and described the occurrence of autoimmune sensorineural hearing loss in a 54 year old male pt who received Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. In March 2002 the pt received the 2nd dose of LYMErix. Approximately 3 weeks post-immunization, the pt experienced sudden hearing loss. The pt was evaluated at a tertiary care center. The physicians at the tertiary care center could not find "any other good explanation" for the haring loss, "except a possible autoimmune response" to LYMErix, and a diagnosis of autoimmune sensorineural hearing loss was made. The autoimmune sensorineural hearing loss was treated with prednisone. The event persisted as of 7/24/03. Sensorineural hearing loss is considered by manufacturer to be medically serious (OMIC). The follow up received on 8/14/03 states the sensorineural hearing loss had improved. The physician considered the event to be medically serious. He indicated that the event was possibly related to LYMErix administration, or to a "possible viral syndrome at about the time of hearing loss." The LYMErix immunization series was discontinued.
COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4499921-00 (AbbVie).  A 39-year-old female patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 11Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 11Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 38 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The action taken for adalimumab was unknown. Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of COVID was not provided. Causality: COVID-19 vaccine: Causality as per reporter (Drug/Vaccine): Possible.  The reporter considered "covid" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Initial report was received from a health care professional on 11 January 2012. A patient (gender, age and date of birth not reported) had received an injection of ADACEL, sanofi pasteur Ltd. lot number C2998BA (route and site of administration not reported) on 09 September 2008. On an unspecified date, the patient later developed coughing. It was suspected the patient had pertussis. The patient had enzyme-linked immunosorbent assay (ELISA) testing performed. The anti-PT IgA results were below the threshold for seropositivity and the anti-PT IgG were slightly above the threshold for seropositivity. The patient possibly received a Td or Tdap vaccine (manufacturer not reported) six years earlier. Past medical history and concomitant medications were not reported. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
My arm is still red and itches a lot; My arm is still red and itches a lot; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 13Jan2021, and since an unspecified date in Jan2021 she had some reaction to it: her arm was still red and itched a lot. Patient asked if she should take the second shot. Final outcome of the events was reported as unknown.Information on the batch number has been requested.
Cellulitis around injection site and entire upper arm. Developed late in the day shots were administered. Patient was seen 9/1/12 and prescribed Cephalexin for infection.
I got the shot around 10:15 in the morning, by 4 o?clock that afternoon I felt like very sluggish, fatigue, and I couldn?t keep my eyes open. By 3 o?clock the next morning I felt like I had fallen off a roof my whole body just ache and then I woke up and then having a migraine since December 28 of 2021 as of today I still have migraines when I wake up in the morning I have taken Tylenol and it just does not help
Information has been received from a physician concerning an 18 year old female who on 28-FEB-2008 was vaccinated with the first dose of GARDASIL (lot reported as "0724U"). Concomitant suspect therapy included VARIVAX (Oka/Merck) (MSD). Other concomitant therapy included MENACTRA (Sanofi Pasteur), hepatitis A virus vaccine (unspecified) and tuberculin purified protein derivative. Per the reporter, after receiving the first dose of GARDASIL, the patient's eyes instantly rolled into the back of her head and she fainted. The patient was "administered alcohol" and she recovered. No additional information was provided regarding this adverse experience. Additional information has been requested.
heart palpitations; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration at the left arm on 14Jan2021 at a single dose for COVID-19 immunization. The vaccine was administered in a Nursing Home/Senior Living Facility. The patient had no medical history. The patient had not received other vaccine in four weeks. Concomitant medication included erythromycin eye ointment. On the 17Jan2021 4PM, 3 days after being vaccinated the patient got heart palpitations and shortness of breath. This continued until the 23Jan2021 when he stopped having the heart palpitations. However, the shortness of breath has continued. It started out as light shortness of breath and has evolved into moderate. He was not gasping for air but it was uncomfortable enough where he has had to take time off of work. He was seen by a doctor on 27Jan2021. The patient did not receive any treatment for the event. The patient had Nasal swab/ SARs CoV-2 RNA Real time RT PCR on 25Jan2021, and the result was negative. The outcome of the event heart palpitations was recovered on 23Jan2021 and shortness of breath was not recovered.  Information on lot number/batch number has been requested.
Headache, chills, fever, body headache, rigors, fatigue, malaise, through the vaccination night. Since vacation has continuous fatigue and headache. 4/12/21 right side neck/face pain and headache on right side.-worsening 4/16/21-went to walk in clinic. 4/17/21 headache/neck pain extreme went to ED. Continues to have neck/face and headache.
Intense dermatographia started 11 days after COVID-19 booster. Was initially treated for hives with a 6 day corse of prednisone and antihistamines with no relief. Was then diagnosed with vaccine related dermatographia which is still on going! I am taking 40mg Zyrtec daily, and Benadryl at HS. I have also tried Hydroxyzine, Allegra, Pepcid, and topical creams with no relief! I am awaiting a allergy referral.
I have pictures.  Arm within 3 hours became red, hot, swollen,  itching,extremely painful. Can't stand anything touching it. Not even sleeve on shirt.  In less than 24 hours developed cellulitis on arm at site. Terrible headache and nauseated. First vaccine arm hurt, red, swollen but not this bad and lasted 2 days and went away. Also had headache  with first shot.
1) Throat got tight 2) numb around my mouth 3) felt like i had nauseating, water in my mouth 4) tingly all over my face
Bilateral Kidney pain started 49 hours after the injection. Kidney pain increased to severe level (7.5 out of 10) and patient was admitted to the ER 61 hours after the injection. Tests indicate that there was no blood in the urine which ruled out the likelyhood of kidney stones. tests also indicated there was no evidence of kidney infection. Tests did indicate dehydration. Two tylenol and IV fluids were administered. The kidney pain did not increase. Patient was released. The pain subsided over the next three days.
Arm presents with red welts and swelling in the upper arm area from the vaccination area to the elbow. Strong pain in the whole arm and itching in the area of the welts.
I woke up on 06-Feb-2021 and noticed that there are two large welts on my left arm where I received my vaccination on 01-Jan-2021.
The Patient received a pediatric dose (0.2ml) of Pfizer which was not diluted.
VACCINE WAS KEPT AT ROOM TEMPERATURE FOR MORE THAN 2 HOURS; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with mrna 1273 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-JUN-2021, the subject experienced vaccine was kept at room temperature for more than 2 hours. On 12-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was kept at room temperature for more than 2 hours and poor quality vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210648291 and 20210417942.
Pt was given PROQUAD instead of regular MMR. The patient did not have any adverse reactions.
Chicken pox started appearing on feet, then right arm, ankles, legs and rest of body.