chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated against flu three times / In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza)/Suspected vaccination failure; In each of those years / had at least one really bad cold with a high fever (can't tell if it was influenza); Really bad cold; High fever; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of vaccination failure (also experienced influenza and bad cold with a high fever after receiving on an unknown date, refer case US2021AMR117937) and Flu vaccine with an associated reaction of vaccination failure (also experienced influenza and bad cold with a high fever after receiving on an unknown date, refer case US2021AMR118022).   On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza, cold and fever. Rechallenge with Flu vaccine was positive. On an unknown date, the outcome of the vaccination failure, influenza, cold and fever were unknown.   It was unknown if the reporter considered the vaccination failure, influenza, cold and fever to be related to Flu vaccine.  Additional details were reported as follows: This case was reported by patient himself. The age at vaccination was not reported. The patient got vaccinated against flu and in that year after that he had one really bad cold with a high fever and stated he could not tell if it was influenza. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming influenza were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case is one of 3 cases, reported by the same reporter. Note: As the patient was not sure for influenza, hence considering the worst case approach captured influenza along with vaccination failure as event. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR118022:Same reporter. US-GLAXOSMITHKLINE-US2021AMR117937:Same reporter.
I'm home with covid on my 9th day so I look like a failed vaccine case; I'm home with covid on my 9th day so I look like a failed vaccine case/ sick/ cold; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "I'm home with covid on my 9th day so I look like a failed vaccine case"; SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "I'm home with covid on my 9th day so I look like a failed vaccine case/ sick/ cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown result, notes: Patient sent PCR swab. Clinical course: patient was in home with COVID on her 9th day (onset date Jan2022) so she looked like a failed vaccine. Patient was heavily exposed that she ended up getting sick. And to that point, COVID had been like a cold.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200239527 same reporter/SD/AE, different patient;US-PFIZER INC-202200239526 same reporter/SD/AE, different patient;US-PFIZER INC-202200239528 same reporter/SD/AE, different patient
female patient received the vaccine which started leaking down her arm/ NO AE; female patient received the vaccine which started leaking down her arm/ NO AE; Initial information received on 10-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves female patient (age not reported) who received vaccine 0.5 mL INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT MULTIDOSE] (batch number, expiry date, route and site of administration not reported) which started leaking down her arm (exposure via skin contact and underdose) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to exposure via skin contact and vaccine underdose (latency: same day).  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.  There will be no information available on the batch number for this case.
12/25/2021 I woke to swelling and pain in my left hand and a week later the right swelled but went back down. The left kept on hurting but right was back and forth with arthritic pain across the last few months. Last Friday, 3/25/2022, I had a rheumatoid test done and just today on 3/29/2022 I discussed the negative results and was told there was an arthritis that wouldn't show up on this test. So the doc offered to go ahead to try and treat it as if it was positive. If no help through this then my doctor will know it will be the new type and treat it as such.
This spontaneous report as received from a physician via a company representative refers to an 85 year old female patient of unknown demographics. Patient's current condition and medical history was not reported. On an unknown date in 2010, the patient was vaccinated with ZOSTAVAX (dose, unit, route not reported). No concomitant medication was reported. On an unknown date in 2014 (four years after receiving ZOSTAVAX), the patient was diagnosed with disseminated zoster (life threatening, hospitalization). The patient was hospitalized for ten days and received unspecified treatments. There was no product quality complaint involved. The outcome of disseminated zoster was reported as recovered. Causality between the event and ZOSTAVAX was not reported. Causality between the event and ZOSTAVAX was not reported. The reporter considered the event to be life threatening. Additional information is not expected as the reporting physician cannot be contacted.
I received the Moderna Vaccine on March 11, 2021. Ten days later, on March 21, i noticed the first hives on my legs. By March 23, the hives had spread across my body and the injection site on my left arm was inflamed. I went to the doctor's office and the prescribed Benadryl and Hydrocortosone cream. Five days later, the hives were still active and my upper lip swelled up. I contacted my doctor's office via a tele-medical call and they prescribed Allegra and Zyrtec also. By April 5, the swelling of my upper lip had gone down and my injection site was better, but the hives were still all over my body. I went back to the doctor's office and they precscribed Prednizone  as well. After taking prednizone  for 5 days and other medication for seven days I was able to stop all medications without the return of the hives.
Within 10 days of first covid vaccine, pt developed urticaria that has persisted x5 weeks and may go on to chronic urticaria. No angioedema, bruising or systemic symptoms. Likely idiopathic but due to time frame of vaccine, we considered it worthwhile to report it, as the vaccine continues to be studied.
PERSISTENT HEADACHE IN THE REAR PART OF HEAD; This spontaneous report received from a patient concerned a 28 year old male. The patient's weight was 185 pounds, and height was 73 inches. The patient's concurrent conditions included: no alcohol user, smoker, and sulfur allergy, and other pre-existing medical conditions included: Patient never had headache before and no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211021A, expiry: unknown) dose was not reported, administered on 15-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-DEC-2021, the patient experienced persistent headache in the rear part of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache in the rear part of head. This report was non-serious.
Started having Hip pain approx. 9 days after receiving the shot, started seeing a chiropractor the first week of June, pain got worse shortly thereafter, then started to get pins and needles in my feet and hands, then my legs started aching really bad making walking difficult, and ended up in emergency room at Hospital on July 4th as I could not longer walk. They did multiply test and then did a spinal tap, where they diagnosed me with GPS -Guillain-Barre Syndrome. I was admitted at that time and spent a week in the hospital before regaining enough feeling to be released to start Physical therapy at home. I am able to walk but still have numbness in the feet and hand making everyday task difficult.
After receiving vaccine, student stated he "couldn't feel" his (L) arm and (L) hand. Able to raise (L) arm to chest level when asked, grasp was weak. BP 98/60 P 60. Incident occurred approx 1/2 hour after shot given. After another 30 minutes pt stated he had some feeling back in hand and arm. Parent took him to MD around 2pm. At this point he had recovered feeling/sensations in (L) arm and (L) hand. No further incidents reported from pt at this time.
Developed chest pain, shortness of breath, nausea, vomiting within 24 hours of vaccine. Evaluated in the ER- lab work up, CXR, CT PE negative. Symptoms resolved prior to ER discharge.
Onset 9:15-9:30 AM redness, induration and hot to touch at immunization site (right thigh).
Pt. developed zoster (shingles) on10/03/01 after receiving varicella vaccine 9/25/01
My arm at injection developed a rash, was hot and tender to touch, itchy - this developed 9 days after the vaccine.
Ulcers on tongue; administration date: 12May2021, dose 2; administration date: 28Apr2021, dose 1.; This is a spontaneous report from a contactable consumer (patient). A 17-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown), via an unspecified route of administration, administered in the left arm on 12May2021 at 08:00 (at the age of 17-year-old), as dose 2, single for COVID-19 immunization. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Lot Number: unknown), via an unspecified route of administration, administered in the left arm on 28Apr2021 at 16:00 (at the age of 17-year-old), as dose 1, single for COVID-19 immunization. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 08:00, the patient experienced administration date: 12May2021, dose 2; administration date: 28Apr2021, dose 1. On 13May2021, the patient experienced ulcers on tongue. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with Ibuprofen and cold liquids. The clinical outcome of the event ulcers on tongue was not recovered at the time of this report and outcome of another event was unknown.   The lot number for the vaccine (BNT162b2) was not provided and will be requested during follow up.  Follow-up attempts are completed. No further information is expected.
Loss of hair, smell, taste, depression, anxiety, panic attacks, water/wind sound lingering in right ear.  Treatments: therapist. Mood stabilizers. Over the counter meds for loss of hair. Ongoing.
Left side of face tender and swelling; Left side of face tender and swelling; This is a spontaneous report received from a contactable consumer, the patient. A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202), via an unspecified route of administration in the left arm on 12Mar2021 at 08:30 (at the age of 58-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 18Mar2021 at 08:00, the patients left side of face was tender and had swelling. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event left side of face tender and swelling. The clinical outcomes of the events tenderness and swelling face were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain in the injection site), ARTHRALGIA (pain in the joints of his whole body), HEADACHE (Strong headache) and PYREXIA (High fever) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 19-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE PAIN (Pain in the injection site), ARTHRALGIA (pain in the joints of his whole body), HEADACHE (Strong headache) and PYREXIA (High fever). At the time of the report, INJECTION SITE PAIN (Pain in the injection site), ARTHRALGIA (pain in the joints of his whole body), HEADACHE (Strong headache) and PYREXIA (High fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included Advil. Reporter did not allow further contact
fever, muscle aches, headache, chills Had a fever of 100.5 this morning. Still has all other symptoms
swollen red large circle of inflammation that lasted 6 days. Went back to pharmacy and they said it looked like a bad reaction. If lasted more than 7 days, was told to go to urgent care.
R deltoid warm, swollen, red, itches, afebrile. Tx: Keflex 250/5 one tsp tid x 10 days Motrin. Significant reduded s/s post 24 hrs.
Beginning at around 2:30 am 3/9/21 (about 12 hours after receiving vaccine), I got the chills/was shivering uncontrollably for about 2 hours.  Beginning around 8:30 pm 3/9/21, I experienced fatigue much earlier than normal and ended up going to bed for the night around 9:30 pm (about 2.5 to 3 hours earlier than normal)
Muscle pains, EXTREME vomiting and nausea, light headed, feverish
Asthma flares.    Was very bad . Followed by by COVID swabbing by primary office.  Then treated for asthmatic bronchitis- nebulaizing treatments and solutions merril dose pack.  Felt a bit better.  Once steroid stopped 2 days later much worse.  Low grade temperatures and coughing.  Diagnosed now with pneumonia.  On Zpack antibiotics.  Tapered  prednisone dosing and long acting albuterol inhailers.
Evening of vaccine receipt had local arm pain.  Followed by fever and chills and arm pain for 3 days.  Followed by eczematous rash on medial upper arms bilaterally lasting now for 4 days and progressing.  Only systemic symptom is fatigue.  Fevers resolved.  No rash other than on medial aspect of both arms.
High pitched crying, fever, large lymphnodes appearance x 5 days, not able to eat because of crying so much; lasted a period of days; pt taken to MD & told nothing was wrong, sx still occured & worsened; irritable behavior, jump in sleep;
Fever 101 beginning day after immunizations. Large area of redness surrounding injection site, worsening. General malaise and myalgias. Area about 11 cm x 8 cm erythema/induration (L) deltoid. Tx: Omnicef 600mg po q day x 10 days. Follow up in 3 days.
This spontaneous report as received from a nurse refers to a male patient of unknown age. No medical history and current conditions were reported. On unspecified dates in 2011 the patient received the first 2 doses of the GARDASIL (dose, route and lot # was unknown). On 10-MAR-2015 (reported as presently), the patient was in the office to receive his third dose (inappropriate schedule of drug administration). No adverse effects were reported. No product quality complaint was involved. The outcome of the event was unknown. No further information was provided. Additional information has been requested.
recently started having suicidal thoghts; has been in great pain for over a year; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suicidal ideation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced suicidal ideation (serious criteria GSK medically significant), pain and shingles. On an unknown date, the outcome of the suicidal ideation and shingles were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the suicidal ideation, pain and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's friend. The age at vaccination was not reported. The reporter reported that the patient got shingles shortly after the vaccination. The reporter also reported that the patient had been in great pain for over a year and had recently started having suicidal thoughts. The follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR006235, reported by same reporter.
Swollen lymph node in neck on left side; Swallowing painful; Breathing slightly strained; Headache; Fluctuating body temperature; Had expected amount of soreness on day 2.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 29Mar2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included allergies to opioids and unbromated corn. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. Concomitant medications included a herbal allergy tincture by Allertonic. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced an expected amount of soreness. On 31Mar2021 at 14:00 the patient experienced swollen lymph node in neck on left side (same side as shot) that was extreme enough to make swallowing painful and breathing slightly strained, accompanied by headache and fluctuating body temperature. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for adverse events. The clinical outcome of the event swollen lymph node in neck on left side, swallowing painful, breathing slightly strained, headache and fluctuating body temperature was recovered on 03Apr2021.   No follow-up attempts are needed. No further information is expected.
patient received pfizer vaccine on 4/22/01 and then janssen vaccine on 7/13/21 for unknown reason.
Information has been received from a pharmacist concerning an approximately 60 year old female consumer with no known allergies or pertinent medical history who on 10-APR-2008 was vaccinated SQ with a first dose of zoster vaccine live (Oka/Merck). There was no concomitant medication. On approximately 11-APR-2008, the patient developed pain and swelling at the injection site. On 16-APR-2008, the patient called and reported the symptoms to the pharmacist. There were no lab studies performed. The patient reported that the pain and swelling seemed to get better during the day but got worse at night. At the time of the report the patient had not recovered. There was no product quality complaint involved. Additional information has been requested.
Injection site reaction, pruritus. It was reported that a male pt received vax on 09/16/1999. Reportedly sometime after the vax, the pt experienced a red raised bump at the injection site accompanied by itching and tenderness. From additional information received on 09/20/99, it was reported that the pt recovered from this experience.
Within five minutes of receiving the first dose of the Moderna vaccine,  I started to feel slight pain in the injection site (my arm) reminiscent of a bruise. An hour later, I started to feel tired and weak, and the soreness in my arm worsened slightly. The pain on a scale of 1-10 was a 3.  45 minutes later, I experienced stiffness in my neck and upper back, though that isn't unusual for me. I also started to feel nauseous and cold at that time, but the nausea subsided within an hour.  The severity of these symptoms stayed the same the rest of the evening. I went to bed at midnight, and woke the next morning at 8am. My arm where I had received the shot felt much more sore and painful, especially when I move it, and mainly when any pressure is applied to the area. I was woken by pain in my arm when I payed on that side of my body. The pain is now a 4, but a 7 when pressure is applied. It is now 12:30 pm.
Vaccine mixed with incorrect diluent (sterile water instead of normal saline). Pt informed of error and offered revaccination. Pt reports sore arm at injection site for a couple of days after vaccination; no further s/s noted.
Vaccines on 5/22/02 in left arm-DTaP #5, IPV #4 SQ. 24 hrs later-noticed redness, swelling, pain arm injection site. Seen in office 5/24/02, 81/2 X 7 1/2 cm area redness, swelling, induration. From .2 + (?). Treated with Benadryl and Motrin.
patient stated she felt really bad. It began 3 days after immunization and pt went to her doctor. she said that she did nothing different and took nothing different than normal. pt claimed dr said it was probably bad reaction to the flu shot.