chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Joint pain; Fatigue; Headache; Pain and swelling at injection site; Pain and swelling at injection site; makes me feel sick/ malaise; Muscle pain; Nausea; Fever; This is a spontaneous report from a non-contactable nurse reporting for herself. A female patient of unspecified age received the second dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 19Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient experienced the following on an unspecified date in Jan2021 after her 2nd dose of COVID 19 vaccine: "This Covid 19 vaccine makes me feel sick. Experiencing the following after my second dose: Pain and swelling at injection site, Fatigue/ malaise, Headache, Muscle pain/ Joint pain, Fever, and Nausea." Outcome of the events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Nausea, vomiting, diarrhea,  fever, sweats, body aches, swollen lymph nodes.
Information has been received from a physician concerning himself, a 60 year old male with no pertinent medical history and no drug reactions or allergies who on 26-SEP-2008 was vaccinated intramuscularly with PNEUMOVAX 23 (lot # not reported). Concomitant therapy included influenza virus vaccine (unspecified) which was administered in the same arm at the same office visit. On 26-SEP-2008 the patient developed fever, chills, and a sore arm 8-9 hours after receiving the PNEUMOVAX 23 vaccine. The patient's fever (unspecified as low-grade fever) and chills lasted 48 hours. At the time of the report the arm pain was resolving. The physician reported that he took ALEVE and TYLENOL for the symptoms. No other symptoms or treatment reported. No other information was available. Additional information has been requested.
Swollen, painful,  and red site of about 2? diameter.  Shivering fever of up to 101 degree. Taken at the same time with flu shot.  Tylenol 1000mg every 6 hours and bed rest.
79-year-old female with history of COPD presents the emergency department in mild distress secondary to dyspnea by EMS from home.  She is been sick for the past 5 days and states is gotten worse.  Her daughter states she called EMS when her oxygen dropped to 80% and her temperature was 102 degrees.  She has had Covid exposures.  She does not complain of chest pain.  She states she does feel very weak.  She is fully vaccinated against Covid.  She states she has not lost her sense of taste or smell. Patient is Covid positive.  She does fit criteria for Sirs and sepsis and will be given IV fluid.  She was started on Rocephin and azithromycin.  Now that her Covid is positive she will be given 10 mg of Decadron as well.  She is on high flow oxygen and her O2 saturation is 96 to 97%.  She does not appear to be in any acute distress.  She will be admitted hospital.  Labs are pending. The patient is receiving IV fluids and per her ideal body weight should receive 1700 cc.  She will be given 2 L.  She has been having diarrhea as well. 0150 patient is on 13 L high flow oxygen.  Saturation is 94 to 95%.  Her heart rate has improved and her IV fluid bolus is in progress.  Her sodium is 128.  Remaining labs are nonconcerning with negative cardiac enzymes.  Chest x-ray does show patchy bilateral infiltrates.  She will be admitted  to the ICU.
Initial case received from a consumer on 08 August 2011. It involves a case of overdose. A female patient, with a history of cat bite, received one dose of IMMUNOGLOBULIN HUMAN ANTIRABIES (total of 5 injections) and one dose of RABIES VACCINE on 26 July 2011; manufacturers and lot numbers were not reported. On 28 July 2011, she received another dose of IMMUNOGLOBULIN HUMAN ANTIRABIES (total of 4 injections) instead of a second dose of RABIES VACCINE. On 02 August 2011 she received a third dose of IMMUNOGLOBULIN HUMAN ANTIRABIES (total of 4 injections) in error, in addition to a second dose of RABIES VACCINE. On 04 August 2011, she received a third dose of RABIES VACCINE. The patient was unable to provide exact amount of vaccine received, however she reported that she had received three full doses of IMMUNOGLOBULIN HUMAN ANTIRABIES. Following the second dose of  IMMUNOGLOBULIN HUMAN ANTIRABIES, the patient developed chest pain, head pressure, fatigue, nausea, lymph node swelling, and breast soreness. At the time of the report, the events were ongoing. Documents held by sender: None.
It was reported in a published article, that up to 215 patient developed Guillian-Barre syndrome (GBS) after vaccination with a dose of RECOMBIVAX HB. There were 215 cases (mean age 31.15 + 19.67 years) of GBS reported after RECOMBIVAX HB vaccine vaccination from 1990 to 2009. Among the vaccinated patients, 161 (74.9%) developed GBS within 6 weeks, 28 (13.0%) after 6 weeks, and for the remaining 26 patients (12.1 %) the time between vaccination and developing GBS was unknown. The distribution of GBS within the first 6 weeks after vaccination was unbalanced: 97 (51 %) of GBS cases were reported within the first two weeks with a peak in the first week after vaccination. Hospitalization and disability were reported in 170 (79.1%) and 45 (20.9%) cases, respectively. GBS occurred in 134 cases (62.3%) with RECOMBIVAX administrated as a single vaccine and in 81 cases (37.7%) when it was combined with other vaccines. At the time of the report the patient's statuses were unknown. OBJECTIVE: To determine the rates and characteristics of Gullian-Barre syndrome (GBS) after administration of RECOMBIVAX HB. BACKGROUND: There are isolated reports of GBS after RECOMBIVAX HB vaccination DESIGN/METHODS: We used data from the vaccine Adverse Event Reporting System supplemented by data from the center for biologics and research under the freedom of information act. RESULTS: There were 215 cases (mean age 31.15 + 19.67 years of GBS reported after RECOMBIVAX HB vaccination from 1990 to 2009. Among the vaccinated patients, 161 (74.9%) developed GBS within 6 weeks, 28 (13.0%) after 6 weeks, and for the remaining 26 patients (12.1 %) the time between vaccination and developing GBS was unknown. The distribution of GBS within the first 6 weeks after vaccination was unbalanced: 97 (51 %) of GBS cases were reported within the first two weeks with a peak In the first week after vaccination. Hospitalization and disability were reported in 170 (79.1%) and 45 (20.9%) cases, respectively. GBS occurred in 134 cases (62.3%) with RECOMBIVAX HB administrated as a single vaccine and in 81 cases (37.7%) when it was combined with other vaccines. Based on the data obtained from the National Health Interview Survey from 2000 to 2005, it is estimated that an average of 54 millions of patients are vaccinated with influenza vaccine each year. The reporting rate of post- hepatitis vaccine GBS is 4.5 cases per million vaccinations, which is in the range expected for the general population. CONCLUSIONS/RELEVANCE: Although our results suggest that the reporting rate of GBS post- RECOMBIVAX HB overlaps with the incidence of GBS in the general population, the unbalanced distribution of reported cases in the first 6 weeks after vaccination suggest that some cases of GBS are caused by RECOMBIVAX HB. These results warrant continuous and careful analysis of GBS after RECOMBIVAX HB vaccination. Follow up information has been received from a physician who reported that he did not have patient identifiers. The physician reported that they used a database and the Freedom of Information act in researching the article. No further information is available.
Patient had redness, discomfort and mild swelling at injection site. Swelling improved and nearly resolved while examined in clinic. Redness and discomfort with palpation still present during examination. Pt given oral BENADRYL and instructed to cotinue with oral BENADRYL as prescribed and apply ice.
Developed tinnitus the day after receiving the second dose of the Pfizer vaccine. The ringing in ears is prominent and is still present 7 months after the second dose of the vaccine. Have visited physician and ENT specialist. All have downplayed the tinnitus and have denied it could be linked to vaccine.
Fever, decreased ROM; chills; malaise and achiness that prevented her from getting out of bed x 24 hours; Red; itchy; painful vaccine site.
Patient's left arm was erythemic, swollen, and warm.  The patient comlained of slight pain and tenderness in the area.  The affected area covered the top part of her arm.  Patient has taken Tavist and is using Benadryl cream.
Full Body Itching (Uriticaria), with dermatographia and hives, severe and worse at night, starting 2.5 weeks after Moderna Booster.  Symptoms still ongoing now, 4.5 weeks later, similar severity.  Helped only by Zyrtec.
Fell out of bed while sister changing sheets (After second vaccine); This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell out of bed while sister changing sheets (After second vaccine)) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Stroke (in early April) in April 2021.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced FALL (Fell out of bed while sister changing sheets (After second vaccine)) (seriousness criterion hospitalization). At the time of the report, FALL (Fell out of bed while sister changing sheets (After second vaccine)) outcome was unknown.            It was stated that the rehab center has the records for the first vaccine but they could not find records of the second vaccine. Reporter stated that she was trying to change her sister's sheets and her sister fell out of bed. When emergency medical services  was taking her to the hospital, they her vaccination card. The reporter stated that her sister did not have any side effects after vaccination and the fall had nothing to do with the vaccine.   Concomitant medications were not reported . Treatment information was not provided.  Company comment Based on reporter's causality and the fact that patient fall out of bed during change of bedsheets, and patient did not experience any adverse reaction after vaccination, the event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on reporter's causality and the fact that patient fall out of bed during change of bedsheets, and patient did not experience any adverse reaction after vaccination, the event is assessed as unlikely related to mRNA-1273.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with none drug reactions/allergies. On an unknown date the patient was vaccinated with VARIVAX (merck) (strength, dose and frequency were not provided) for vaccination. On an unknown date the patient developed a severe reaction of a large bubble with pus in at the injection site after receiving a dose of VARIVAX (merck). The outcome of event was reported as recovered/resolved. The pharmacist reported that because of the patient's age, she was unsure if the patient actually received VARIVAX (merck) in the past. Additional information has been requested.
This spontaneous report has been received from a nurse and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M038856, expiration date 14-SEP-2018; lot # M043305, expiration date 26-OCT-2018, lot # M042496, expiration date 19-OCT-2018 and lot # M045204, expiration date 11-NOV-2018 (doses and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion between 6 to 14 degrees Fahrenheit for 3 hours and 49 minutes. Digital data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information is not expected because there was no consent to contact the reporter. Sender's Comments: US-009507513-1706USA000988:
About 45 minutes after injection felt slight swelling of my throat (anaphylaxis).  Swelling subsided after about 45 more minutes.  It was not necessary for me to take Benadryl or use my Epi-pen.
CHILLS; FEVER; HEADACHE; MUSCLE ACHE; NAUSEA; This spontaneous report received from a consumer concerned a 20 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On APR-2021, treatment medications included: paracetamol. On 07-APR-2021, the subject experienced chills. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. On 07-APR-2021, the subject experienced muscle ache. On 07-APR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 104 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, and had not recovered from chills, headache, muscle ache, and nausea. This report was non-serious.
Eye felt irritated, rubbed eye, cornea abrasion developed, developed pain went to eye dr ,  found to have shingles  ulcers  on the inside of eye lid.
He received the MMR Vaccine on January 29th. On Tuesday, February 6th he developed a 101 degree fever which did not let up until middle of the night on Thursday February 8th. Then on the morning of February 8th, he developed a rash that has now covered his entire body. It started out light and has gotten worse. They are measle like bumps all over. I did speak to our doctor and he did reassure us that this was a side effect. I am not sure how long this will take to subside but hopefully not long. His behavior for the most part is normal, he is just itchy.
The patient received Kinrix for his third dose of DTaP and IPV. The patient did not have any adverse reactions or outcomes as he has had doses of DTaP and IPV in the past.
A day after the vaccine I had ringing in my left ear which lasted for two days and then went away. Today, about ten days after receiving my second vaccine, I started experiencing cramps and vaginal spotting about five days before my next scheduled period, which is normally very regular.
sensitive skin; psoriasis; colitis; full body rash two days after shot; This is a spontaneous report received from a contactable consumer, the patient. A 58-years-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) via an unspecified route of administration in left arm on 08Mar2021 at 10:00 (at the age of 58 years) as a single dose, for COVID-19 immunisation. Medical history of the patient included colitis, psoriasis and allergies to pecans. Patient previously took immune suppressing drug mercaptopurine, monitored with blood draws, white cell count normal. The patient was not diagnosed with COVID-19 prior to the vaccination and was not tested for COVID-19 since the vaccination. Concomitant medication included unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced full body rash two days after shot, sensitive skin, psoriasis and colitis on 10Mar2021 at 700. Event full body rash two days after shot had resulted in doctor visit on 22Mar2021. Patient took prescription unspecified cream and Benadryl as treatment for reported events. The clinical outcome of events full body rash, sensitive skin, psoriasis and colitis was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected
RUNNY NOSE, FATIGUE, SORE THROAT, HEADACHE,COUGHING, DIARRHEA
She has numbness and tingling in hands and feet and this moves into calves. It is constant in the hands and fairly constant in the feet, but it gets better when running. In the face and the calves it is transient.  Some weakness in the hands, she drops thinks that she would not normally drop.   Had EMG, cervical MRI, all negative.
Localized adverse reaction to TDAP vaccine. Hives across upper back & chest area. Swollen injection site & reddened. Pt. denies any shortness of breath.
Left arm/nerve pain radiating down arm  for 2 weeks. 1st week she could not lift arm at all.
Mom stated site discomfort day of vaccinations but she noticed the next morning 4/26/12 site redness and patient cried when anyone touched it. No heat or swelling noted. Gave cold compress with Tylenol instructions.  I told mother this was caused by combining the Prevnar and flu in the same arm and since she will not be getting any more Prevnar, this reaction should not reoccur with her next flu vaccine.
Patient received Shingles vaccine on 5/21/08 - lot # 0295X, exp 7/25/09. Patient presented to hospital on 6/4/08 with 1 week history of progressive numbness and weakness. Exam notable for significant facial weakness, dysarthria proximal>distal weakness in an asymmetric pattern, areflexia and stocking glove sensory loss. Patient thought to have Guillain Barre syndrome. Subsequently noted to have autonomic dysfunction with labile BP - syncope X2, pulse and profuse diaphoresis. LP was done which showed cytoalbuminologic dissociation, confirming the diagnosis of GBS. Titers for other infectious causes pending but no history of recent illness. The presentation is quite consistent with a vaccine induced GBS. Patient is currently receiving IVIG, tolerating well with questionable improvement after 4th infusion. 7/30/08-records received for DOS 6/4-6/17/08-DC DX:Guillain-Barr syndrome. Presented with C/O 7 day history of numbness in hands, arms, feet, legs and tongue. Day after onset of symptoms felt better and played golf. Symptoms began 1 week after vaccine. PE: decreased temperature sensation cranial nerve 7 inability to close eyes.Positive Romberg decreased strength in extremities. Wide-based gait. No reflexes in upper or lower extremities. Treated with IVIG. Syncope.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: shortness of breath, drop in oxygen level, worsening of fibromyalgia
Light headed immediately after Vaccine, 2-4-2021 the following morning severe joint pain in all fingers,Abdominal pain, nausea and very sore arm at injection site took Ibuprofen which helped the following day I couldn?t tell I was good as new
Developed rash at injection site about a week after vaccination then turned red and warm. Very mild itching. Fades for a bit but is then comes back, no itching just a pale redness and rashiness. Still there today. About 4 inches long and 3 inches wide.
first dose of Shingrix vaccine from expired supply; This case was reported by a pharmacist and described the occurrence of expired vaccine used in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 10th September 2021) for prophylaxis.   On 15th September 2021, the patient received the 1st dose of Shingrix. On 15th September 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The pharmacist reported that, the patient was inadvertently administered first dose of Shingrix vaccine from expired supply, which led to expired vaccine used. The reporter consented to follow up. This case was linked with cases US2021197373, US2021197372, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021197373:same reporter US-GLAXOSMITHKLINE-US2021197372:Same reporter
Fever started on 4-27-11, rash appreared on 4-29-11.  Fussy past 2-3 days.
A large knot formed in my arm and it was very red and sore with severe itching.  It is still sore with a medium knot in my arm and very itchy as of 7/2/2022.
Fussiness with new attitude towards her normal routine. Not wanting to sleep alone, and she normally doesnt like to be near anyone while sleeping. A new cry. Slept much longer periods and didnt eat at her normal times. Went nearly 8 hours before eating and slept for 16 hours; 7:00 PM to 11:00 AM.
Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches). At the time of the report, HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Received a call from client today.  He was following up to see if we had received any feedback from a VAERs on his adverse reaction.  I am not sure if I previously submitted a VAERs report, so I let him know that I would submit a new one just in case.  He reported that following his 2nd vaccine his tinnitus got progressively more severe.
Starting 02/10/2022 upon awakening, I was unable to move my arm. The pain was severe (radiating from the injection site to the underarm area and to the right under arm area) and I had a "plum size" swelling underneath my arm. It was itchy, burning and warm to the touch. All day it was painful and very weak. On Friday (02/11/2022), I went to see NP and she prescribed me 600mg of Motrin (which I am sensitive to due to my asthma); however, the swelling/pain was bad enough that I needed it. Also, she prescribed me a steroid cream to use 3x daily, which significantly helped. By Sunday, the Motrin kicked in and the cream definitely helped with the pain and itching to the point that I started feeling significant relief. I have hidradenitis suppurativa stage 2 bilaterally under my arms and had surgery in 2019 to remove it. Therefore, its a sensitive area and I believe that made the area more susceptible to complications.
Swelling in both legs below knee- 24 hrs after receiving Measles vaccine with pain, bruising on knees and upper legs.
This spontaneous prospective pregnancy report was received from a physician refers to a 22 year old female patient with penicillin (unspecified) allergy and percocet (unspecified) allergy. The patient's medical history included depression, suicide attempts and high risk HPV on PAP smears. On 08-AUG-2013, the patient was vaccinated with GARDASIL (lot # reported as H02108, expiry: 13-AUG-2015) dose 2, 0.5 ml, intramuscular route prior to learning of pregnancy. The patient received the first dose of GARDASIL on 12-AUG-2012. Patient was seen in unspecified emergency room for spotting on 16-AUG-2013 and then was seen in physician's office 20-AUG-2013 for pregnancy. The patient became pregnant with LMP on 01-JUL-2013 and EDD of 07-APR-2014. The pregnancy outcome was outcome pending. On an unknown date the patient experienced seen in physician office on 20-AUG-2013 for pregnancy. No treatment was given for spotting. The outcome of spotting was unknown. Additional information has been requested.