chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the shot, I went home and felt fine.  I did some housework (cleaning) for about thirty minutes, then sat to rest .  Shortly thereafter, I began feeling pain in my left arm.  The pain became more severe as the day progressed until it was very severe and movement of my arm was limited.  The pain progressed throughout the night and also moved into my shoulder.  I got very little sleep even after taking Tylenol and trying heat and  ice applications.  Now, on the third day I am still having pain and am unable to lift my arm or move it outward without severe pain.  I am definitely hindered in my movement and use of left arm.  This is disturbing as I am an artist and need both arms to do my work.
I have a very itchy rash on my stomach and legs; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration at right arm on 17Mar2021 at 17:00 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included high blood pressure. The patient's concomitant medications included valsartan(MANUFACTURER UNKNOWN), buproprion(MANUFACTURER UNKNOWN), metropolol(MANUFACTURER UNKNOWN) and thyroid(NP THYROID), all from an unknown date for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration and anatomical site on an unknown date as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. She did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 18Mar2021the patient experienced very itchy rash on her stomach and legs. Therapeutic measures were taken as a result of the events was unknown. The clinical outcome of the event very itchy rash on stomach and legs was not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
redness and swelling at both injection sites. later patient went to ED for evaluation and at that point patient was lethargic, dragging left leg, hives, and facial swelling
dizzy, heart palpitations, disoriented,   then a day later flu, sore throat, swollen glands, diaahria, don't know temp
6hr p/vax pt lt arm became swollen & red;also had diarrhea which started the next morning accompanied by low grade fever;
I started having a skin reaction on head and neck and down my back along my spin. I would say the reaction originated at a brain surgery scar. It was just very inflamed and hot. My joints began to be really hot and swollen. Mainly both knees, hips, and my lower back and neck. Became hot and swollen and painful to which I was worked up for inflammatory diseases and autoimmune diseases. Nothing which came back abnormal other than elevated inflammation in my body somewhere. Those signs and symptoms pretty much dissipated over the course of the year. When I received my third vaccine, they flared up again. My joints become sore and painful to the point where I couldn't walk. I had the skin reaction all over again. I have a higher amount of arthritis in my knees than I did a year ago. But the skin inflammation is still present but not as severe. I tried antihistamine, antiparasitic, antifungal, antibiotics, and no improvement on anything. They just dissipated over time. The areas that were most inflamed or affected were areas where I previously had surgeries or incidents it was like it inflamed areas that were already affected. I didn't put this together until I received the 3rd vaccine and I didn't realize until the symptoms came back. Also received flu shot the same day of 3rd vaccine.
This spontaneous report as received from the consumer's mother refers to a 16 year old female patient with medical history of café au lait spots and strabismus. There were no drug reactions or allergies. On 12-JUL-2013, the patient was vaccinated with GARDASIL, first dose, route reported as injections (lot and dose not reported). Concomitant therapies included Tramadol started approximately on 04-OCT-2013 (reported as 2 weeks ago). On 12-JUL-2013, after the patient received GARDASIL she started immediately having adverse experiences, the patient had dizzy spells and throws up every week or two at random. The patient also tore out her meniscus and needed to have surgery in the future. The patient sought for medical attention (called the office). No treatment given for the events. No lab diagnostics performed. The reporter (patient's mother) did not plan on continuing with the treatment since the patient is about 5 weeks late for the second dose. The reporter also did not know how having the late dose two of GARDASIL would react with the patient having surgery. Therapy with GARDASIL was discontinued. The outcome of the events was reported as not recovered. Additional information has been requested.
On 1/19/00, the pt developed a few spots which were described as rounded papules on the left chest, 4-5 in a line above underarms. The pt was afebrile with no other symptoms. The pt sought unspecified medical treatment. On an unspecified date, the pt recovered. No further information is available.
headaches for 3-4 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches for 3-4 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-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 HEADACHE (headaches for 3-4 days). At the time of the report, HEADACHE (headaches for 3-4 days) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant medications were provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2021: Additional information added on 08-Feb-2021 does not contain any new information. On 22-Apr-2021: Follow up received on 22-Apr-2021 had updated contact information of reporter.
Information has been received from a physician concerning a female patient who on approximately 12-AUG-2009, "three weeks ago", was vaccinated intramuscularly into the deltoid with a dose of GARDASIL. The next morning after vaccination, on approximately 13-AUG-2009, the patient had experienced headaches and dizziness every day for the last three weeks. The patient also had not been able to concentrate in school. The patient sought medical attention by an office visit. The patient recovered from all symptoms on 02-SEP-2009. Follow up information was received from the physician who reported that the 14 year old patient on 18-AUG-2009 was vaccinated with her first dose of GARDASIL (Lot No. 663452/0671Y). On 19-AUG-2009, the patient experienced severe headache and dizziness. The patient was prescribed ANTIVERT for the treatment of dizziness. Although the patient was going to school, she was very tired and had difficulty concentrating. The patient sought unspecified medical attention. At the time of the report, the patient had recovered from all symptoms. The patient's headache, dizziness, disturbance in attention, and fatigue were considered to be other important medical events by the reporter. No further information is available.  11/2/09 Medical records received for date 9/2/09. DX: Adverse rx to vaccine. Presenting SX: c/o severe HA, dizziness x3wks. Pt states began after first vax of gardasil.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. The patient's pertinent medical history was not reported. On 13-JAN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # and expiration date were not provided) 2 ml, oral. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 as dose 1, single (Lot number: Er8737) and on 21Apr2021 as dose 2, single (Lot number: Ew0171) at the age of 38 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Lot number: 034f21a), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CLARITINE, start date: 01Jan2020; FLONASE [FLUTICASONE PROPIONATE], start date: 01Jan2020; CALCIUM GUMMY, start date: 01Jan2020. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Patient came in for a ppd test.  We believe Decavac was administered b/c Decavac was found dated and in the ppd cup holder.  This occurred on 09/24/07 in the afternoon.  She came back in for the ppd to be read and there was redness measuring 4 1/2cm x 5 cm and a 2cmx2cm induration. Patient was rechecked on 09/28/07 and the site had redness only at the induration site and patient stated it felt alot better.
Febrile seizure approximately 24-28 hours after vaccines were administered. Child was seen at ER - T104. Seizure lasted approximately 5 minutes. No adverse sequelae.
Patient reports abnormal (extreme) soreness in her arm where she cannot even lay on the right side. It was warm to the touch yesterday but that has subsided a bit. Red welts started appearing today (11/29).
1/24/2020 @ 11:35 am - Administered 7 vaccines to client.  Upon placing sharps into sharps container, the client slid off of chair and fell onto floor.  Awakened client and directed him to sit on chair.  Client alert, sat on chair, and stated he felt dizzy.  Nurses, RN, RN, and NP provided support.  Client drank water, juice, and ate crackers.  Cold compresses applied to right upper front part of face.  Girlfriend was allowed to be present with client's permission.  Waited 15 minutes.  Advised if headache, pressure in head and/or vomiting developed to go to Emergency Room immediately.
Four days post second Covid-19 Moderna Vaccine patient started to have some "tightness" in bilateral lower legs. This continued to get worse as the days went on. She visited with her PCP Dr., who suggested a couple days of alternating Tylenol and Ibuprofen. She did this but did not get relief. Around the first week of November she also started to develop some "tingles and burning" in her arms as well. The tightness in her legs also changed to "tingles and burning". The most severe location is her left arm. She feels some weakness as well in her left arm. She also saw a chiropractor  to see if this could be nerve related. She did not receive any relief from that. She continues to have severe burning and tingles in bilateral arms and legs without any explanation.
Fever, treatment Rocephin 500 mg 10/23/06. Frequent urination on 11/5/06. Sore throat and fever on 12/1/06. Fever on 12/3/06 and 12/4/06.
pt recv vax 18APR97 & 25APR97 pt devel a mild erythematous maculopapular rash on trunk;pt was tugging on ears, devel loss of balance, & exp high fever of 101-103;
got the vaccine and still got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. As per the patient even if you got the Shingles vaccine you could still get the shingles not as severe. The patient got the Shingles vaccine and still got the shingles. The follow up would not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Maculopapular rash, facial swelling, eyes swollen skin very dry & itchy. MMR given 14JAN; sx started 16JAN tired, h/a then worse 17JAN. tx Benadryl. sx better in 4 days.
Arthralgia, CoughWheeze, Fatigue, Sweating, Runny Nose, Congestion  Narrative: No further details given
4am next morning: restless and crying, started with jerking movements, non responsive. Lasted after 4 minutes. To ER for evaluation. Had 1 similar episode June 25, 2004.
red, warm and tender left arm in a swath pattern from injection site. itchy and slightly raised
This spontaneous report received from a consumer via social media via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced suffering with joint pain. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of suffering with joint pain was not reported. This report was non-serious.
This spontaneous report was received from registered nurse regarding a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-JAN-2015 12:30 PM, the patient was vaccinated with a dose of improperly stored GARDASIL (lot # K004205, expiry: 12-JAN-2017) dose 2, intramuscularly in the left arm (left deltoid). No concomitant medications were reported. No adverse events were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications was not reported. On 20-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016 (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion for 24 hours in which the lowest recorded temperature was 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal), 0.2 milliliters, unknown. FLUMIST quadrivalent started during Jan-2015. The patient experienced the pediatric practice manager reported that 40 doses of the FLUMIST were given through the month of Jan 2015 despite temperature excursions, and possible expired vaccine which started during Jan-2015. FLUMIST quadrivalent was continued. The outcome of the event of the pediatric practice manager reported that 40 doses of the FLUMIST were given through the month of Jan 2015 despite temperature excursions, and possible expired vaccine is unknown. The report was considered to be non-serious by the company physician.
a lump in her right breast/ they said the results came back as cancer; This is a spontaneous report from a contactable other-HCP. This 48-year-old female other-HCP (patient) reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose at left arm for COVID-19 immunisation on 14May2021. Relevant history included Internal Uterus Bleeding and COVID-19 since 11Mar2021 per PRL COVID 19 (Nasal Swab). Relevant concomitant drug included VITAMIN D NOS. The patient received the first dose of BNT162B2 for COVID-19 immunisation on 23Apr2021 (48-years old at the time of vaccination). The patient was not pregnant.  The patient had PRL COVID 19 (Nasal Swab) on 01Apr2021 with negative result. The patient felt a lump in her right breast since 26May2021 at 10:00 PM. She went to her primary doctor. They told her to do a mammogram. The patient did one in Jul2021. Then she saw a breast specialist. And then she did an ultra-sonogram. They told her the lump was looking big so they told her to do a biopsy. After she took the biopsy they said the results came back as cancer. At the reporting time the patient was in treatment. The patient would receive chemotherapy. The outcome of event was not resolved. The vent was reported as serious due to Medically significant.        The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event of breast cancer and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   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 adverse events. 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.
Severe Dizziness; nausea; body pain; It felt heavy and temporary unable to raise; Severe chills (felt like all my internal organs are frozen cold); heartbeat sounded strong beats (can feel the pump); Body weakness; muscle weakness; It felt heavy and temporary unable to raise; This is a spontaneous report from a contactable consumer reported for herself. This 55-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), via an unspecified route of administration at left arm on 14Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient experienced severe dizziness (BP normal at 120/80), nausea, body pain, while sideways lying down: unable to raise right foot or raise her foot. It felt heavy and temporary unable to raise for two days, severe chills (felt like all my internal organs are frozen cold), heartbeat sounded strong beats (can feel the pump) for at least 2 days, body weakness or muscle weakness.Start date for all events were 14Jan2021. Meclizine 25mg was received as treatment. The patient had no Covid tested post vaccination. The patient was not pregnant. The patient had no other vaccine in four weeks or other medications in two weeks. The patient had no known allergies. The patient had all normal from blood glucose of 109 and bp 120/80 on 14Jan2021, day of vaccine was a perfect day. Outcome of all events was recovering.   No follow-up attempts are possible. No further information is expected.
Received flu vaccine 3-16-11. Began experiencing muscle weakness and lack of coordination in both legs. This increased and then could not stand or walk. This began on 5-11-11. Diagnosed with Guillain-Barre syndrome in E.R. Admitted to hospital and received treatment for 5 days.
Pt states after receiving GARDASIL, has had pains to feet.  Persistent nausea.  Abdominal pains.
Suspected Vaccination Failure; My friend got after the vax; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-FEB-2023 Reporter's Comment: This case was reported by the consumer via interactive digital media. The reporter reported that he/she was still mad because his/her friend got it after the vaccination. The reporter reported that crimes against humanity. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding primary schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Pt reported shortness of breath and wheezing after returning home.  Pt sought medical attention from an ER.
Fever of 103, lasted 4 hours with fluctuation, down to no fever after 8 hours. Treated with Tylenol. Associated with joint aches and headache
Fever of 103 approx 48 hours post vaccination and scattered patches of erythroderma (legs, buttocks, cheeks). Treated with Tylenol, Motrin and Benadryl.
On 02/05 I had sniffles and I took a COVID test and it was negative. Sunday I felt fine. Monday morning 02/07 I purchased another COVID test at the pharmacy. My test came back positive. I had congestion and fatigue. I never had a fever or aches and pains. It didn't go into my lungs or chest. I did a telehealth visit, doctor said to just stay home and rest. I took over the counter medication.
Approximately 15mm sl. erythema at site.  Twenty minutes after leaving facility, mother phoned stating area was 25 cents size red and uncomfortable.   01/25/2006 Patient returns for PPD reading above site of error - approximately 35mm, sl. erythema and raised - "states doesn't bother me."  Advised may persist several weeks, review as needed.
Moderna COVID-19 Vaccine EUA;  Red circular area where shot was given, bumpy (rashy), itchy
I had my first vaccine on January 18 2021 and my left arm still hurts. I have been moving it and putting heat/ice packs on it. I called my doctor last week  March 2 2021 and they said to wait a couple of more weeks to come in.  Is this normal after the first vaccine or has any one else had a similar issue from the first one?