chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the second dose of the shingles vaccine: I experienced vomiting 7 hours later, went to bed and slept for the night and woke up sweating, a high temperature, chills, headache, nausea, muscle aches, feeling depressed, lethargic for the entire day. I know these reactions (side-effects) are listed in the brochure that was provided to me at the pharmacy but the severity of the side-effects makes me question whether it is safe to administer this vaccine to the age group it is intended...I continued to experience side-effects: esp. headache, muscle aches for several days after the vaccination. It was a good thing my husband was here to manage all my chores for me. I experienced some of these same symptoms after the first shot but not to the extent of the second shot. (A prescribed vaccine...second shot).
Rash on the left shoulder at the injection site, went down to the elbow, was on the back of his hands and slightly down the back of his left leg.; Blisters; Itching; Spent two sleepless nights; Rash was red; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on the left shoulder at the injection site, went down to the elbow, was on the back of his hands and slightly down the back of his left leg.), BLISTER (Blisters), PRURITUS (Itching), INSOMNIA (Spent two sleepless nights) and RASH ERYTHEMATOUS (Rash was red) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced RASH (Rash on the left shoulder at the injection site, went down to the elbow, was on the back of his hands and slightly down the back of his left leg.), BLISTER (Blisters), PRURITUS (Itching), INSOMNIA (Spent two sleepless nights) and RASH ERYTHEMATOUS (Rash was red). On 11-Feb-2021, BLISTER (Blisters) outcome was unknown. At the time of the report, RASH (Rash on the left shoulder at the injection site, went down to the elbow, was on the back of his hands and slightly down the back of his left leg.), PRURITUS (Itching), INSOMNIA (Spent two sleepless nights) and RASH ERYTHEMATOUS (Rash was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Onset of mild - mod fever, nausea, severe pain at injection site evening of 3/16/09. Onset of itching + mild rash over body 3/17/2009.
A spontaneous report has been received from a Health professional concerning a 11 year old male patient of unknown ethnicity. The relevant history and concomitant disease of the patient were not reported. The concomitant medications of the patient were not provided. It was reported that the patient received FLUMIST QUADRIVALENT (intranasal) on 27-OCt-2014 at that office, and he came back on 31-Oct-2014 due to flu-like symptoms. Patient tested positive for Influenza A. Action taken was not applicable for FLUMIST QUADRIVALENT. The outcome of the events of tested positive for influenza A and flu-like symptoms was unknown. The events tested positive for influenza A and flu-like symptoms were considered to be non serious by the reporter.
Patient has local redness and rash at injection sites as well as rash on back of the neck. Patient's nurse said she can take benadryl if needed.
COVID Vaccine   Erythema at injection site, Injection site pain, Pruritis, Swelling at injection site >100 mm or > 10 cm erythema  and swelling
patient hasn't really done very well after the first dose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "some allergic reactions to other medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "patient hasn't really done very well after the first dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, Fever, Nausea, leg Cramps/Aches, pain in the injection site
One week later (on a Wednesday morning after receiving the vaccine the previous Wednesday afternoon) I had the onset of a headache, body aches, chills and extreme fatigue making it impossible to work. Slept most of the day.  Next couple days with less severe symptoms and mostly resolved this morning (Saturday) aside from some fatigue.  ALSO the site of the injection became red, tender, warm, swollen and slightly itchy with the onset of these symptoms after a milder injection reaction had resolved for several days.  This  makes me question if this is a late reaction to the vaccine and hence reportable as I have not read about this possibility
Patient reported with pain at the site, a rash greater than 10 cm and numbness with tingling of the arm.
When shot was administered it felt different from other flu shots I previous had. Felt the vaccine enter the arm and it was sore immediately following shot. Over the course of several days the soreness increased until I was unable to raise or lower my arm without severe pain. Went to see my doctor on 11-3-14. He prescribed prednisone. There was relief within 48 hours but after the final dose on the 5th day the pain returned daily increasing over the course of about two weeks to just about the same level. I called my doctor again and he prescribed another round of prednisone which I started on 12-4-14. Again within 48 hours there was some relief but the pain is now returning again but not yet to the same level as the week after the shot.
Moderna shot on February 5th. Because we had 4 weeks of travel planned we got a Pfizer shot on September 1st; Moderna shot on February 5th. Because we had 4 weeks of travel planned we got a Pfizer shot on September 1st; Small reaction; This is a spontaneous report from a contactable consumer. A contactable male consumer (patient) reported for himself that who received bnt162b2 (BNT162B2) formulation solution for injection, dose 3 (Lot number and expiry date was not reported) via an unspecified route of administration on 01Sep2021 as dose 3 booster single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine dose 1 Moderna formulation solution for injection, (Lot number and expiry date was not reported) via an unspecified route of administration on an unspecified date as first dose single for COVID-19 immunisation, historical Vaccine dose 2 formulation solution for injection, (Lot number and expiry date was not reported) via an unspecified route of administration on 05Feb2021 as second dose single dose for COVID-19 immunisation. His wife and he received our 2nd Moderna shot on 05Feb. Because they had 4 weeks of travel planned, we got a Pfizer shot on 01Sep. They had very small reaction. He feels that the mixture may give more immunity, (Interchange of vaccine products, Off label use). Outcome of the events was unknown.    The lot number for [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101300168 Different patient, same drug and event
Leukemia; This spontaneous case was reported by a consumer and describes the occurrence of LEUKAEMIA (Leukemia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LEUKAEMIA (Leukemia) (seriousness criterion medically significant). At the time of the report, LEUKAEMIA (Leukemia) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. The patient experienced Leukemia month after 2nd Moderna.  Company comment-This spontaneous case concerns a male patient of unknown age  with no medical history reported, who experienced the unexpected serious (medically significant) event of Leukaemia on unknown date approximately one month after second dose of mRNA-1273 vaccination. No further information on risk factors, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a male patient of unknown age  with no medical history reported, who experienced the unexpected serious (medically significant) event of Leukaemia on unknown date approximately one month after second dose of mRNA-1273 vaccination. No further information on risk factors, detailed clinical course, investigations, treatment of the event was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
In October the month after my vaccination I started to have skin disturbances and was diagnosed with Lichen Sclerosis, I then saw a dentist and stated that I may have lichen planus. I then saw an ENT who stated I may have Lichen Planus. I started to have more disturbances in Oct and in December it got even worse. I went to Urgent care for the rash and bumps. I went to then a dermatologist again that had diagnosed me with Lichen Planus. Clobetasol steroid for treatment that does help with it however the bumps will continue to come up and spread. I apply it on irritated spots and there is a small risk of skin cancer due to these pustules that form.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2020 at 09:00 as dose 1, single (Lot number: FL1284), in right arm, on 13Jan2021 at 09:15 as dose 2, single (Lot number: FT1686), in right arm, on 20Aug2021 at 13:00 as dose 3 (booster), single (Lot number: FD8448), in right arm and on 02Jun2022 at 15:15 as dose 4 (booster), single (Lot number: FM9992) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease" (unspecified if ongoing), notes: Crohn's Disease; "Arrhythmia (PVC)" (unspecified if ongoing), notes: Arrhythmia (PVC),; "Previous COVID infection", start date: Jun2020 (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: tested positive for COVID again; (26Jun2022) Positive, notes: Symptoms returned on 26Jun and I tested positive for COVID again at that time. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Symptoms returned on 26Jun and I tested positive for COVID again at that time.  No follow-up attempts are possible. No further information is expected.; Sender's Comments:  The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
After first 7 days I developed a rash at site that was itchy and swollen. Couple days and that went away. Week 2 experienced pain from upper arm shoulder neck area. Lasted about 3 days and then I couldn't lift my arm on my own. No pain and it seems to be located just in the shoulder area that I can't extend it out but can move the rest of arm fine.  Went to family doctor who ordered an cervical xray which showed arthritis and enlargement. They were to refer me to an orthopedic Dr but hasn't yet. Reading on my own I found PTS, and excess of motor cells in neck area as options.  I'm just trying to figure out what to do. Do I get my second shot? Do I get it in the arm that's already affected? Or do I risk the other arm? It's been over a week now and movement has not improved.
I felt like I had COVID-19 and pt. said he just felt like he had a cold.
Expired Menveo administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 69-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA641A, expiry date 31st October 2022) for prophylaxis.   On 28th November 2022, the patient received Menveo. On 28th November 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 6-Jan-2023 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Menveo, which led to expired vaccine used.
Normal VS. PT with reproducable pain over the left anterior chest wall and left arm. Pain is superficial and reproducable.     PT given Naproxen 500mg and Lidoderm 5%
This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNTBNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiration date not reported), via an unspecified route of administration, on Aug 19, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient experienced dizziness on an unspecified date. Patient wanted to know more about the side effects of the Pfizer COVID-19 vaccine. Her second dose is scheduled on Sep 9, 2021. The outcome of the events: unknown. The lot number for the vaccine, (BNT162B2), not provided and will be requested during follow-up. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.
It was a real bad burning in my nose and nasal congestion. I thought it was a sinus infection because I get those frequently. I also had chills and a fever, and a headache. My blood pressure was also up. I took an at home COVID-19 test and it came back positive. I went to the doctor the next day and took another COVID-19 test which also came back positive. I was given PAXLOVID. It was also noted after the COVID-19 infection that I had some hypertension. I was told to take zinc and vitamin C, and I was put on low dose amlodipine.
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-MAY-2003 and 22-NOV-2006, the patient was vaccinated with first and second dose of M-M-R II (Lot # and expiry date was not reported) for prophylaxis. On 12-FEB-2018, the patient inadvertently received a third dose of with M-M-R II recombinant human albumin (rHA) 0.5 ml, subcutaneous (lot # N010495, Expiry date :31-MAR-2019) for prophylaxis. It was reconstituted with sterile diluent (Manufacturer Unknown) (Lot # N015479, Expiry date : 23-JUL-2019). The physician assistant reported that the patient was supposed to receive a dose of VARIVAX on 12-FEB-2018, but instead received the third dose of M-M-R II. Physician assistant reported the error occurred because of human error and that she "just grabbed the wrong vaccine" (wrong drug administered). No symptoms reported. There was no product quality compliant involved.
Minor was administered IPV on 9/22/2023, no sign nor symptoms at the moment. Minor is 4 weeks pregnant estimated delivery date is 05/31/2024 no birth weight available at the moment.
PT. WAS GIVEN DTAP AND IPV IM TO LEFT LEG, FLU AND MMR TO RIGHT LEGON 02 FEB 04. SWELLING WAS NOTED TO LEFT LEG, MOTHER OF PATIENT BROUGHT PATIENT TO ER ON 03 FEB 04. PT HAD FOLLOW UP VISIT WITH PRIMARY DOCTOR ON 04 FEB 04 AND WAS DIAGNOSED WITH CELLULITIS TO LEFT LEG.
Vaccine received on 17th.  Terrible joint pains and body aches from a hour after for another 2 days.  Perfectly fine until the night of the 22nd when chest pains began.  I experienced chest pains through the night and they worsened the next day.  I scheduled an appointment with a cardiologist where all results came back normal from blood pressure to EKG.  I was advised to get blood drawn rapidly from quest diagnosis but the pain was unbearable and the results wouldnt come back quickly enough so I was advised to meet cardiologist at ER.  Pain continued throughout entire 5 hour visit and went from a pain level of 10 down to a 3/4 IMMEDIATELY around 9pm.  Minor chest pain lingered for 7 days and I felt fatigued, joint pains and body aches for 14 days after.  I was released from ER after multiple tests.  It was determined that my white blood cell count was elevated causing inflammation, which I was told was a marker for pain.  I was also give medicine to treat for early onset pneumonia as a precaution.
I could not  bear the light  coming  in my room; I could not stand and I had to close curtains and I stayed in the suite of secluded darkness for a couple of hours.; My neuropathic facial pain that for some strange reason flared up; My neuropathic facial pain that for some strange reason flared up; This is a spontaneous report from a contactable consumer. An elderly patient of unspecified age ("by the way in my 80's") and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation and gabapentin 2100 mg daily , route of administration, start and stop date, batch/lot number were not reported for an unspecified indication.  Medical history included ongoing trigeminal neuralgia, ongoing neuralgia, ongoing hypoacusis. The patient's concomitant medications were not reported.  Approximatively one hour after vaccination, when at home, patient experienced could not  bear the light  coming  in my room , could not stand and  had to close curtains and stayed in the suite of secluded darkness for a couple of hours, neuropathic facial pain that for some strange reason flared up.  The action taken in response to the event(s) for bnt162b2 was not applicable , for gabapentin was unknown. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : PFIZER INC-2021299378 similar report from same reporter
Right arm reddened, swollen and "felt some hard" 3/4 of below injection site per mom. Able to move arm and fingers, good sensation.  No fever.  Mom had been applying heat to reduce swelling and called HD 4/20 as did not have MD.  Instructed to give Children's Motrin per instructions on box, elevate arm and apply cool compresses. She did so and stated she continues to do so this morning with reduced swelling and redness "It looks much better." Has my cell# and I will check again tomorrow.  Instructed to go to ER if becomes worse or does not continue to improve, and she expressed understanding. In process of recovery at this time will monitor.
Maybe be completely insignificant...one week after I received the vaccine, my left shoulder in which I received the vaccine started itching and itched for 24-30 hours.  I believe it  itched enough to disturb my sleep moderately.  The next morning I took a single zyrtec and either due to time or the effects of the antihistamine, my shoulder stopped itching.  My shoulder did NOT become red or show a rash. It is probably insignificant and may be normal for the general population but of all the shots I can remember and I receive a flu vaccine every year, I never had my arm itch significantly near the shot date or after.  It  was not a significant event, but I report it just in case this is unusual.
I became very tired after receiving the injection, followed by severe chills that evening, started running a fever during the night. I believe it got up to 100.9. The next day (Sunday) I slept a lot while continuing with the chills and fever. Monday was better, just very weak, temp was about 99.5. Today was good. No fever, a little sluggish, but much better.
On 4/5/21, I woke up in the middle of the night, and my heart was racing, I felt confused and disoriented and it felt like I was about to go unconscious. I also had extreme panic. I felt this way for about 4 hours. Then, for about 3 months, I would get bouts of extreme anxiety, brain fog, confusion and immense fatigue that would seem to come out of nowhere. Currently, I still have moments of intense anxiety (I had not had panic attacks or immense anxiety prior to receiving the COVID vaccine) and brain fog that will last for about 2 hrs at a time, and they come on about 3 times per week.
4 hours post injection patient developed x 4-5 blanchable mildly erythematous and edematous irregular - shaped wheals surrounding injection site w/o over lying skin color changes, warmth, or ITP. Rash was pruritic. PO Antihistamine given and sxs resolved.
Headache, muscle pain, and rash at the site of injection. Did not seek medical care. Rash is still there but other symptoms have gone away.
I felt really tired and fatigued on Monday night, 05/02/2022. So I took a COVID-19 test and it came back negative. The next morning on Tuesday, I had a bad headache and sore throat so I decided to take another test. This time, it came back positive. I contacted my physician and scheduled a telehealth virtual appointment, told her my symptoms, and she prescribed me Paxlovid. I went to the pharmacy the next day to pick it up and have been taking it ever since. This morning (05/09/2022) I took my last dose and feel way better than I was last week.
Vial was punctured at 9:05 AM, vaccine was stored in fridge and labeled with a "beyond use date/time" of 5/5/21 at 3:05 PM.  Vaccine was administered to patient at 3:57 PM (52 minutes beyond expiration time). Pharmacy tried to contact patient but no answer, voicemail left.
Information has been received from a registered nurse concerning a 42 year old female, was vaccinated with a 1st, 2nd, and 3rd dose of Hepatitis B vaccine on 05/28/99, 06/28/99, and 01/19/00 respectively. After the 1st and 2nd dose, the patient "felt funny". Prior to receiving her 3rd dose, the patient was seen by her physician as she had recently recovered from bronchitis. The patient was advised to receive the 3rd dose, and at 9 AM on 01/19/00, she was administered the vaccine. Two hours after the 3rd dose, the patient "felt funny". By 5 PM, the patient had developed a more "significant" reaction than after the previous two vaccinations and reported extreme tightening in the chest and sore throat. By 7 AM on 01/20/00, the patient had developed difficulty breathing and went to her physician where the doctor administered Benadryl and Prednisone. The patient's experiences of difficulty breathing, sore throat, and tightening in the chest were considered to be other important medical events. The patient recovered and has not had any problems since. Additional info not expected.