chrisvoncsefalvay/vaers-outcomes huggingface dataset:
red, painful and itchy rash size of the fist on the upper arm away from injection site, rash very warm to touch whole left hand was achy took Tylenol for pain relief  it lasted for three days, now it reduced to light brown patch, feels arm little weak and sometimes itchy
From telephone correspondence received at manufacturer on 11/13/02, it was reported that a 60 year old adult female received Fluzone SV 2002-2003 USP (Lot # U0930FA) on 11/06/02.  The following morning the pt broke out in hives and a generalized rash, and experienced swollen lips and itchy eyes.  There was no reported difficulty with breathing. She was administered Allegra 10mg and Benadryl.  Pt had received Fluzone for the past 5 years with no history of allergic reactions or egg allergies.  It was not reported whether the pt recovered.
Pt received the Janssen Covid-19 vaccine. Pt started to feel numbness and tingling in his left hand (vaccinated arm) 15 minutes following the immunization. Pt stated that he felt fine other than his left hand experiencing numbness and tingling, specifically in his fingertips. Pt had no other adverse symptoms. I asked the pt to remain seated for an additional 15 minutes. He stated that he was ok but I convinced him to remain in his seat so we could continue to evaluate him. After a total of 45 minutes of evaluation, pt stated that the feeling of numbness and tingling was gone. Once again, I verified with the pt that he was feeling ok, with no additional adverse feeling or symptoms. Pt stated that he felt fine now and only felt a little soreness at the injection site.
Patient called today 10/7 to say she was C/O pain and had swelling on arm to collar bone and back to shoulder blade. Also said very painful. I recommended a walk in clinic visit.
Red, swollen and hard area where my vaccine was administered. It is also itchy and hot to the touch. Area about the size of a softball in diameter.
redness at the injection site; warmth at the injection site; swelling at the injection site; throbbing pain in that area; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd June 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced injection site erythema, injection site warmth, injection site swelling and injection site pain. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling and injection site pain to be related to Shingrix.  Additional details were reported as follows: The age group was not reported but was selected as adult as per vaccine indication. The patient received Shingrix and experienced the typical side effects of redness, warmth, and swelling at the vaccination site this lasted about 5 days.  The patient experienced deep throbbing pain in that area.  It was not constant but more still b.
A health professional form was received on 11/29/01 concerning a female patient who was inadvertently administered Fluvirin SC instead of IM in October 2001. In October 2001, the patient received a SC administration of Fluvirin vaccine and did not complain of any adverse effects at time of administration. The reporter assessed the causality to be unclassifiable.
Chest Pain; Back Pain; fever; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198), dose 2 intramuscular, administered in Arm Right on 07Mar2021 12:00 (the day of vaccination) (at the age of 74 years) as single dose for covid-19 immunisation. Medical history included sleep apnoea (ongoing) from Apr2014 and C-PAP Machine, breast cancer (Mastectomy Radiation) (ongoing) from 05Dec2020 and ongoing Mastectomy Radiation, Shingles, thyroid, blood pressure, Gastroesophageal reflux disease (GERD), Bladder disorder. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EM9808) and experienced Chills, Headache, Cough, Sneezing, Difficulty lifting right arm. Concomitant medication(s) included gabapentin (NEURONTIN) taken for herpes zoster; levothyroxine (SYNTHROID) taken for thyroid disorder; lisinopril (ZESTORETIC) taken for blood pressure abnormal; lovastatin (MEVACOR) taken for blood cholesterol; omeprazole (PRILOSEC) taken for gastroesophageal reflux disease (GERD), oxybutynin (DITROPAN) taken for bladder disorder. On 09Mar2021 01:00, the patient experienced chest pain, back pain, On 08Mar2021, fever, fatigue. Therapeutic measures were taken as a result of chest pain, back pain, fever, fatigue as paracetamol (TYLENOL). The patient had no relevant lab test 2week before COVID vaccine. The outcome of event were recovered on 2021.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's medical history included: history of being immunocompromised. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802072, and expiry: unknown) dose was not reported,  frequency time was 1 total administered on 08-MAR-2021 to left deltoid as prophylactic vaccination. No concomitant medications were reported.  On 09-APR-2021, the patient had confirmed immunological vaccine failure (did not developed antibodies) and laboratory data included (NR: not provided): antibody test showed no antibodies toward Covid-19. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210815255-Covid-19 vaccine ad26.cov2.s -confirmed immunological vaccine failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, SPECIAL SITUATIONS
patient came in for 2nd dose of moderna vaccine  and stated that about 10-14 days after first dose her knee became swollen. She states she had knee surgery on that knee about a year ago.  She had a tissue expander put in. She states the knee is getting worse.  She says it feels tight like there is fluid inside.  I did inspect the knee and it was swollen around the knee cap and above the knee. Visibly more swollen than other knee. I told her to contact her knee doctor for further guidance.
1st message from pt:  Patient called and said she had a reaction to the shingles shot and pnemonia shot. Whole shoulder turned bright red, fever of 102, sore all over, itchy, left work early on Friday because of the reaction. Is scheduled to come back in on Jan 29 for her second shingles shot. Did not go to the er, urgent care. Should patient move this apt because of the reaction or is there something patient can take before hand. Patient is afraid this may happen again at 2nd shot. Arm is still red.  2nd message from pt:  Patient called and said she had a reaction to the shingles shot and pnemonia shot. Whole shoulder turned bright red, fever of 102, sore all over, itchy, left work early on Friday because of the reaction. Is scheduled to come back in on Jan 29 for her second shingles shot. Did not go to the er, urgent care. Should patient move this apt because of the reaction or is there something patient can take before hand. Patient is afraid this may happen again at 2nd shot. Arm is still red.   Nurses note:  Checked with Dr, she said that the pt should not get the 2nd shingles shot.  She can take tylenol, ibuprofen, and/or benadryl as needed.  Called pt, relayed this info.  She confirmed what was in the 2 messages.  She said that she wasn't short of breath but felt like she didn't have enough room for air.  That is gone now.  Told her not to take benadryl while working, driving, or if needing to be awake since it causes drowsiness.  She verbalizes understanding. She said that it's been getting a little better each day.  Told her to call us back in a couple of days if she doesn't continue getting better each day.  She verbalizes understanding.
Patient received vaccine on Wed pm. Friday broke out in red, itchy, raised blotches on upper torso-front, inside to front of thighs and on inner aspects of arms. Reported a headache at the same time as rash appeared.
Supraclavicular and axillary lymphadema; tenderness only in side where shot was given; This is a spontaneous report from a contactable nurse (patient). A 31-year-old female patient received single dose of BNT162B2 (Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 21Jan2021 10:15 for COVID-19 immunization. Age at vaccination: 31-year-old. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included asthma. The patient had no known allergies. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications within 2 weeks of vaccination. On 23Jan2021 07:00, the patient experienced supraclavicular and axillary lymphedema; and tenderness only in side where shot was given. No treatment was given for the events. The events were considered non-serious by the reporter. Since the vaccination, the patient had not been tested for COVID-19. The patient was recovering from the events at the time of reporting.  Information on the lot/batch number has been requested
The whole body turned white, lips turned gray, her pupils were dialated, she lost her vision and her hands were numb. All symptoms lasted for 5 minutes, then everything went back to normal
This spontaneous report as received from a  Licensed Vocational Nurse (LVN) refers to a multiple unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. In unspecified dates during July 2015, the patients were vaccinated with doses of improperly stored (Oka/Merck) VARIVAX (dose and route were not reported), lot # L009203 expiry date 17-MAR-2017, L007225 expiry date 03-MAR-2017. There was no concomitant medication provided. No adverse effects reported. This is one of two reports received from the same reporter. Additional information has been requested.
Thursday: day of vaccine began to feel a knot/ball in the middle of my stomach underneath my belly button. Took a Tylenol to relieve the pain and took a nap, the stomach cramp pain woke me up and I once again took a Tylenol and went to bed because I felt sick, tired and week. On Friday and Saturday, I still had the stomach cramp, difficulty time breathing, I had a hard time getting out of bed because my waist was hurting, my legs felt heavy and I had a hard time walking. The stomach cramping, leg heaviness, tingling, inflammation, numbing, and back pain got more intense and I had a difficult time moving and breathing. I would get winded walking from one room to another. I spent most of my afternoon sitting down or laying down to rest because I felt sick, tired and very weak, I took Tylenols during the day to see if the pain would go away. By the end of the day, I was having more cramping, difficulty breathing, my legs felt very heavy, numbed, tingling, inflammation and my feet felt as if I was walking on jelly. I had to get help to stand up and walking. On Sunday, the stomach cramp went away, I still would loose my breath when I would walk from one room to another, the tingling, numbness, inflammation, leg and feet heaviness was worse. On Monday, I called clinic and talked to an advice nurse and told her my symptoms and she urged my to go to the nearest ER. I went to the closest ER, where the nurses had to come out to help me walk inside the hospital, because they had no available wheelchairs and I was not able to walk in. I was admitted and they did blood tests (all came out normal, an CT Scan of my head and the ER doctor tried to do a Spinal tap. I was in the ER for a day and then transferred by ambulance to another hospital. Once at hospital they did a MRI of my spine, Ultra Sound to check for any blood clots, blood tests (all came out normal), was in the hospital for a week
Grandmother stated that pt developed a rash over his chest, tummy and back several hours after immunizations given. They took him to the ER. He was given Benadryl and Atarax in ER and a prescription for Atarax and Prednisone. Low grade fever and no rash noted to face and arms or legs per grandmother. No problems at injection sites per grandmother.
For the first two days a had pain in my left arm but it went away. Around 2pm on that following Sunday (4 days after) I suddenly come down with a fever and headache. I felt so tired, but I took Tylenol and I felt better through the following day. Now, on Tuesday almost a whole week after my shot I get this itching on my chest and arms. Turned out that I got hives, I am not aware of any allergies and I have only broken out into hives one other time in my life and it was 8 years ago and I still do not know the cause. It is now Thursday and the hives have somewhat gone down but I still feel the itchiness around my body. Also to note that the itches are almost about my waist (arms, chest, stomach, back, and neck) I also used the itching cream to relive the itching but I am so tired of the feeling on my body.
Reported "small knot" and inflammation now at injection site on left arm. Has noted "knot" since injection. Inflammation for the past 3 days. Area at measures 8mm.
didn't feel well for 3 days/kicked his/her butt big time; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Linked case(s) involving the same patient:US2022AMR121789   Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, shingles vaccine kicked his/her butt big time.  The patient had every side effects you could have and didn't feel well for 3 days.  The side effects were nothing compared to what her husband had endured after having shingles.  The reporter stated that, take care and he/she would hope your second would not as bad. Additional Supportive Information: The follow up would not possible as no contact details were available. For tolerance of 2nd dose, refer case US2022AMR121789; Sender's Comments:  US-GSK-US2022AMR121789:Second dose case/Same reporter
Day after the vaccine, I started experiencing throbbing pain on shoulder/arm opposite to the vaccinated arm. Pain became more intense at night and after 48 hours, started experiencing decreased range; Day after the vaccine, I started experiencing throbbing pain on shoulder/arm opposite to the vaccinated arm. Pain became more intense at night and after 48 hours, started experiencing decreased range; decreased range of motion; heaviness on shoulder/arm area all the way to the elbow; This is a spontaneous report from a contactable pharmacist (patient).  A 51-years-old non-pregnant female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number=EK5730, intramuscular in left arm on 17Dec2020 at 17:15 (at the age of 51 years-old) as a single dose for COVID-19 immunization. The patient received the vaccine in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19 nor was tested.  There were no other vaccines within four weeks. Medical history included: hypothyroid, endometriosis, low blood pressure history, anxiety and H pylori. Concomitant medication included sarecycline (SARECYCLINE) for acne, take for 3 days levothyroxine (LEVOTHYROXINE), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), colecalciferol (VITAMIN D [COLECALCIFEROL]), ginkgo biloba (GINGKO BILOBA), and camellia sinensis extract (GREEN TEA [CAMELLIA SINENSIS EXTRACT]).  On 18Dec2020 at 0700, the patient experience throbbing pain on shoulder/arm opposite to the vaccinated arm. The clinical course as follows: At 0700, the day after receiving the vaccine, she started experiencing throbbing pain on shoulder/arm opposite to the vaccinated arm. The pain became more intense at night and after 48 hours, started experiencing decreased range of motion and heaviness on shoulder/arm area all the way to the elbow. The patient was not hospitalized for the events. The patient was treated with OTC obuprofen 400 mg and acetaminophen (TYLENOL). The clinical outcomes of throbbing pain on shoulder/arm opposite to the vaccinated are, decreased range of motion and heaviness on shoulder/arm area all the way to the elbow was not recovered.
This spontaneous report was received from a physician via a company representative and refers to a male child patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. Approximately in 1997 (reported as "about 20 years"), the patient was vaccinated with a dose of M-M-R II frequency reported as "one injection", parenteral route reported as "injection" (anatomical place of vaccination was not provided), for Measles, Mumps, and Rubella  prophylaxis. Approximately in 1997 (reported as "two weeks after the vaccine was administered"), the patient experienced seizures and for an unspecified reason and the child passed away (death), subsequently on an unspecified date, the child passed away for an unspecified reason. At the time of reporting, the outcome of seizure was unknown. The reporter did not provide a causality assessment between M-M-R II, seizures and death. Upon internal review, seizures and the death were determined to be medically significant. Additional information is not expected, as the reporter did not provide consent to follow up.
(L) arm red, and swollen, hot to the touch swelling in neck, next AM. Went to E.R. as per health dept said. M.D. prescribed doxycycline 100mg x 7 days.
This spontaneous report as received from a registered nurse refers to a patient of an unknown age and gender. On 02-FEB-2001, the patient was vaccinated with the first dose of RECOMBIVAX HB. On 02-MAR-2001, the patient was vaccinated with the second dose of RECOMBIVAX HB and on 27-APR-2001, the patient was vaccinated with the third dose of RECOMBIVAX HB. On 27-APR-2001, as the third dose for this patient was administered 2 months after the first one. The outcome of as the third dose for this patient was administered 2 months after the first one was unknown. Additional information has been requested.
Muscle pain after first vaccine; Increased pain of her fibromyalgia after the first vaccine; having issues with her nerves; having issues with her muscles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) at the age of 46 years 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: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain after first vaccine"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Increased pain of her fibromyalgia after the first vaccine"; NERVE INJURY (non-serious) with onset 2021, outcome "unknown", described as "having issues with her nerves"; MUSCLE DISORDER (non-serious) with onset 2021, outcome "unknown", described as "having issues with her muscles". Additional information: The patient stated that she got her first Covid 19 vaccine almost 5.5 weeks prior to the report. Her doctor told her not to get the second dose. She stated that she wanted to get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, fever, myalgias 12 hours after receiving Td.  Then weakness of muscles in thighs and shoulders, numbness in little and ring fingers of hands and medial surfaces of forearms. Referred to neuro.
Information has been received from a registered nurse concerning an approximate 9-year-old patient who on 20-SEP-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). In January 2008, the patient developed chickenpox and presented with a low grade fever. The rash was mild, lasting for 3-4 days. No lab work was available. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
Rash all over body. Started on stomach - is still spreading 5 days later. On most of body at this point, except face, hands, feet.
Inter alia, burning at injection site and later at back, chills/shaking, later fever, gout attack at right elbow area, nightmares, head sensations and continuing to today: palpitation, sweating, hot flashes, night sweats, insomnia, and interrupted sleep (notwithstanding any answer to item 21, which is required and has limited, preset choices: not sure, at this time, if there is any permanent damage).
1 wk p/shots devel enlarged glands & fever of 101-102; no rash, but did vomit twice;
Unusual leg pain upper thigh back of thigh prolonged  Standing makes worse, did not happen 1st dose. No treatment necessary just taken ibuprofen.
Generalize rash from neck to groin; This spontaneous case was reported by a physician and describes the occurrence of RASH (Generalize rash from neck to groin) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Generalize rash from neck to groin). The patient was treated with CORTISONE on 03-Feb-2021 for Rash, at a dose of 1 dosage form. At the time of the report, RASH (Generalize rash from neck to groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication were not reported.
Symptoms began 10 days after vaccination and lasted 5 days: Fever > 102; chills, rigor, rash, all over.
Severe headache, severe arm, neck, armpit and shoulder pain with numbness, swelling and tingling
Fever 103 Chills Sweats Shaking Headache Full body aches
General malaise, h/a, dizziness, 15 min p/administration of MMR; advised APAP pain & discomfort;
Redness,swelling and tenderness 12x11cm on LD assessed by RN.Patient advised to place ice pack and motrin for pain.