chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial case was retrieved from a search of the scientific literature on 10 September 2012. The following is verbatim from the article: "A 33-year-old female with no significant past medical history was referred to the rheumatology clinic in May 2010 by her primary care physician for having pain and swelling in multiple joints since November 2009. Patient received a seasonal flu shot in October and a week later, she noted some joint pain and aches in hands, wrists, and knees, which resolved within a few days and patient became asymptomatic. A month later, she received H1N1 vaccine and a week after started experiencing joint pain, swelling, and stiffness in hand, wrist, elbow, shoulder, and knee joints. She also complained of significant morning stiffness that last for more than one hour. On physical examination she had bilateral synovitis in fourth and fifth metacarpophalangeal (MCP), second, and third proximal interphalangeal (PIP) joints, with prominent left ulnar styloid. She fulfilled most of the criteria for classification of RA based on College of Rheumatology (CR) guidelines. Laboratory findings initially included an erythrocyte sedimentation rate (ESR) of 24 mm/hr, rheumatoid factor (RF) of 26 IU/mL, C-reactive protein (CRP) of 1.3mg/dL, cyclic citrullinated peptide (CCP) IgG of 212. Her basic chemistry, liver function tests, hemoglobin, and complement levels were essentially within normal limits. Serological tests were positive for antinuclear antibody (ANA), RF, anticyclic citrullinated peptide (anti-CCP) and negative for SSA, SSB, hepatitis C virus, parvovirus B19 and being immunized for hepatitis B. Her radiological findings were negative for any joint effusion or destruction. On initial presentation to her PCP, she was given a 10-day course of prednisone 40mg daily, which partially helped with symptoms in the beginning with eventual relapse of symptoms. Later she was started on methotrexate 7.5 mg weekly along with a short duration (3 weeks) of low-dose prednisone with daily folic acid and calcium/vitamin D supplementation. During her follow-up visit about 2 months later, her disease activity score (DAS) were 4.83 and number of tender joints was 7 and number of swollen joints were 5, with significant improvement in morning stiffness which lasted for 5-10 minutes. However, her pain was controlled only while she was on steroid therapy for 3 weeks and had returned thereafter. Later she was switched to golimumab (TNF-a inhibitor) 50mg once monthly subcutaneously. Her methotrexate dose was also increased to 12.5mg weekly. At her third visit her symptoms were much improved and her ESR and CRP were also within normal limits. In conclusion, a causal relationship has not been confirmed between swine-flu vaccine and onset of RA, but there is a temporal connection between the two based on our case report." The patient's outcome was not reported. Documents held by sender: None.
(R) upper arm pain. Tdap given April 11, 2013 - fever, body aches within 6 hrs. Worsening dyspnea over next week, finally admitted to hospital with worsening COPD, O2 dependent, continues to smoke. End stage COPD.
Flare up of arm; felt bad; 7 patients late second dose of Shingrix over 6 months, with one of those patient being due today; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced rash, feeling bad and incomplete course of vaccination. On an unknown date, the outcome of the rash, feeling bad and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the rash and feeling bad to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient flare up of the arm and felt bad after the 1st dose of Shingrix and late for second dose of Shingrix over 6 months, which led to incomplete course of vaccination.  HCP unable to provide full patient details. The reporter did not consented to follow up.  This was 1 of 7 cases, reported by the same reported.
Chills, Headache, Body Aches, Runny nose, congestion, dizzy , nausea
Booster after 2nd shot in April- left arm red & swollen. Eye gland swollen, face swollen & itchy. Second dose ?Covid Arm? was much worse? but no eye or face issues
pneumonia; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Three weeks after the first vaccination, the patient experienced pneumonia on an unspecified date. The outcome of event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Received Hep A vaccine (R) arm 6/24/11. 6/25 noticed few red spots on arm & by 6/26 had spread up & down arm individual red, raised, bumps with central white spot or sab.
About 14 hours after receiving the injection, I started to have some minor chills. After 24 hours of receiving the injection I also developed a fever of 100.4, felt slightly achy, and had a headache. My symptoms lasted for about 36 hours total. I drank a lot of water, had a normal appetite, and took some Tylenol.
Fever 102 Vomiting Muscle aches Fatigue Blurry vision
She has a discoloration at the injection site of the first dose and can still feel the first shot, is this normal? It is brown in color, like a bruise; can still feel the first shot/ still has pain at the injection site of the first dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (She has a discoloration at the injection site of the first dose and can still feel the first shot, is this normal? It is brown in color, like a bruise) and VACCINATION SITE PAIN (can still feel the first shot/ still has pain at the injection site of the first dose.) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE BRUISING (She has a discoloration at the injection site of the first dose and can still feel the first shot, is this normal? It is brown in color, like a bruise) and VACCINATION SITE PAIN (can still feel the first shot/ still has pain at the injection site of the first dose.). At the time of the report, VACCINATION SITE BRUISING (She has a discoloration at the injection site of the first dose and can still feel the first shot, is this normal? It is brown in color, like a bruise) and VACCINATION SITE PAIN (can still feel the first shot/ still has pain at the injection site of the first dose.) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-352988 (Patient Link).
hurting; itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash), PAIN (hurting) and PRURITUS (itchy) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for an unknown indication.     The patient's past medical history included No adverse event.    On 11-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 RASH (Rash), PAIN (hurting) and PRURITUS (itchy). At the time of the report, RASH (Rash), PAIN (hurting) and PRURITUS (itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient did not have any concomitant therapies, pertinent medical history or known drug reactions or allergies. In approximately July 2016 (reported as "sometime last week"), the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml, intramuscularly, lot # M003659 with expiration date 20-SEP-2017. On the same day, she was also vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L001456 with expiration date 22-OCT-2016 (dose and route of administration were not reported). Administered doses of vaccines experienced a temperature excursion of 25 degrees Fahrenheit for 7 days. There were no previous temperature excursions. Data logger was involved. In approximately 2016, the patient experienced sore arm. The patient did not seek medical attention and did not receive any treatment. There were no lab diagnostic studies performed. The outcome of the sore arm and the relatedness between the event and the suspect drugs were not reported. This is one of several reports received from the same reporter. Additional information has been requested.
1st / dose on December 2019 / COVID pandemic / 2nd dose / August 3rd, 2021; 24 hours later / I had "stinging; 24 hours later / I had itching; It "looked like a pimple"; This case was reported by a consumer via call center representative and described the occurrence of stinging in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   On 3rd August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 3rd August 2021, unknown after receiving Shingrix, the patient experienced social problem. In August 2021, the patient experienced stinging, pruritus and pimples. On an unknown date, the outcome of the stinging, pruritus, pimples and social problem were unknown.   It was unknown if the reporter considered the stinging, pruritus and pimples to be related to Shingrix.  Additional details were provided are as follows: The case was reported by patient himself. The age at vaccination was not reported. The patient received 2nd dose of Shingrix, 20 months after receiving 1st dose because of COVID pandemic. 24 hours after vaccination, the patient experienced stinging and itching on the right side of back and his spouse indicated that it was looked like a pimple. Not all information was available. Lot and expiry date were not provided. The reporter did not want to provide demographics. The reporter consented to follow-up.
COVID-19 Vaccine  Pt received vaccine 1/7/2021 and discharged to home. Pt endorsed one day of nausea, headache, fatigue, and chills following vaccination. On Monday 1/11/21, pt woke up to a large, red, discolored, warm, grapefruit-sized lump on her arm at site of injection. PA at clinic she worked with was curbsided, who said it might be cellulitis. Pt called her PCP who issued prescription for cephalexin 500 mg cap PO TID x 10 days on 1/11/2021. After 2 days of therapy, pt reports lump is still red, discolored, and grapefruit-sized, but is no longer warm.  2/2/21: Pt received 2nd dose of COVID vaccine without issue.
Her sister was diagnosed with covid today 27Jan2021/Positive with covid after the first dose; Positive with covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable nurse (patient's sister). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on unknown date in Jan2021 at single dose on right arm for preventative.  Medical history and concomitant medications were not reported.  Reporter's sister had gotten COVID in between the two vaccine doses. She clarified that her sister only had the first dose of the vaccine. Her sister was diagnosed with COVID today 27Jan2021. Lab data included SARS-CoV-2 test positive on 27Jan2021. Her sister will be done with quarantine the day before she gets her second dose. She was calling to ask if her sister can get the second dose. She read all the information and she thought it should be ok for her sister to get the second dose. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Information has been received from a physician concerning a 24 month old female patient with no illness at time of vaccination and no drug reactions or allergies, who on 02-MAR-2011 at 11:00 was vaccinated with a second dose of VAQTA (Lot # 669749/1628Z) in the left upper thigh and a first dose of MMR II (Lot # 668234/0830Z) in the left lower thigh. On 02-MAR-2011 at 11:00 the patient passed out during 2-3 minutes after receiving shots. It was not related to crying or breath holding. The patient's blood pressure was normal after some oral fluids. The patient was fine and was sent home. On 02-MAR-2011, the patient was recovered. Additional information has been requested.
Lost control of legs/ couldn't get back up off the ground until the next morning; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ATAXIA (Lost control of legs/ couldn't get back up off the ground until the next morning) and CHILLS (Chills) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CETIRIZINE (ALLERTEC [CETIRIZINE]) from 01-Jan-2015 to an unknown date for Allergy, ALLOPURINOL from 01-Jan-2015 to an unknown date for Blood uric acid, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) from 01-Jan-2020 to an unknown date for Vitamin supplementation.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced ATAXIA (Lost control of legs/ couldn't get back up off the ground until the next morning) and CHILLS (Chills). On 12-Mar-2021, ATAXIA (Lost control of legs/ couldn't get back up off the ground until the next morning) had resolved. On 13-Mar-2021, CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-080283 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Added concomitant medications, updated patient demographics and event outcome.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080283:second dose
Dizzy for a few seconds after injection, just as I was sitting down in waiting area. As driving away, slight nausea for about 20 min.  Also, weird feeling above lips, which lasted about an hour.  Later that evening a muscle that's been bothering me for a while in lower back near pelvic bone suddenly became kind of inflamed feeling and itchy on the inside.  Lasted overnight and into mid morning.  Then, suddenly went away. On day 10, after vaccination, I developed a rash at the injection site, which I still have slightly today.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who was administered dose of GARDASIL (dose and route unknown) on 25-JUN-2013, lot # H021608, Expiration Date: 13-AUG-2015). No adverse event was reported. This is one of the report from the same source. Additional information is not expected.
HAVE BALD SPOT ON THE BACK OF MY SCALP THAT I BELIEVE IS DUE TO COVID VACCINE.  Have never had a bald spot nor any family history of alopecia.  Read online that others have reported the same (reported bald spot appearing 2-6 weeks after covid vaccine).
1wk p/vax pt devel post nasal drip, cough & chills;seen by Md who dx a sinus infect & prescribed unspecified meds;
Patient developed a rash and itching about 15 minutes after receiving the Moderna vaccine.  Patient was given 25 mg of Diphenhydramine HCI
Left upper arm red & swollen (shots given on 4-24-04). Mom took son to doctor on 4-26-04. Instructed to give Benadryl- spoke to mom on 4-27-04- she stated swelling is resolving.
5 min change in consciousness (unresponsive) with stiffening body then 1-2 hours of less responsiveness afterward.
the patient "had low titers and didn't know if she was ever vaccinated with MMR II; patient received a dose of MMR II (Lot#Unknown/Exp:Unknown) by the intramuscular route rather than the subcutaneous route; Information has been received from a pharmacist referring to a 58 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose detail, lot # and expiration date were unknown) by the intramuscular route rather than the subcutaneous route for low titers (incorrect route of product administration).        The patient had low titiers and did not know if she was ever vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The outcome of the event was unknown. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
next day extremely tired. Slept in car during work lunch break, then straight home went to bed at 5 pm and got up the next morning.
Pt suffered near syncopal event. Pt was lethargic, diaphoretic, hypotensive and bradycardic.
Some pain in the arm where I received the shot but not at the injection site, more generalized upper arm soreness; I realized the area directly under my left armpit was swollen and tender.; I realized the area directly under my left armpit was swollen and tender.; After second dose on June 5th I experienced fatigue and spent June 6th in bed.; After second dose on June 5th I experienced fatigue and spent June 6th in bed.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in the left arm on 05Jun2021 at 10:45 (at the age of 52-year-old) as single dose for COVID-19 immunisation. Medical history included asthma and allergies indoor or outdoor. Concomitant medication included cetirizine hydrochloride (ZYRTEC), naproxen sodium (NAPROXIN) and esomeprazole magnesium (NEXIUM) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route the left arm on an unknown date in May2021 (at the age of 52-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jun2021, after the second dose the patient experienced fatigue and spent June 6th in bed. The patient also had some pain in the arm where she received the shot but not at the injection site, more generalized upper arm soreness which she just included as fatigue symptom. By Monday, 06Jun2021 at 10:00, the patient noticed increasing soreness in the same arm but this time when she raised the arm up to stretch in case, she slept on it funny. The patient realized the area directly under the left armpit was swollen and tender. When compared it to the other armpit, the patient realized it was only the left side. On the day of the report, it was still tender and swollen so the patient went online and found this survey. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue, spent June 6th in bed, some pain in the arm where she received the shot but not at the injection site, more generalized upper arm soreness, area directly under left armpit was swollen and tender were not recovered at the time of this report.  The lot numbers for, BNT162b2, were not provided and will be requested during follow up.
patient received expired dose of IPOL vaccine/No AE; Initial information was received on 26-Jun-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 11-month-old male patient who received an expired o.5ml dose of IPV (VERO) [IPOL] [lot P1A46, expiry date: 03-May-2020] via an intramuscular route at the left thigh on 25-Jun-2020 for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.   On 25-Jun-2020, the patient received concomitant medication included HEPATITIS B VACCINE for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used. The patient received expired vaccine which was expired on 03-May-2020 (expired product administered).   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
A report has been received from a Health Professional concerning a 1 year old, female subject, who had been receiving FLUMIST. FLUMIST started on 05-Oct-2013. The Nurse Practitioner reported that they had inadvertently given FLUMIST to a 23 month old patient on 05-Oct-2013. No symptoms and side effects were observed after administration. The patient recovered from the event of we inadvertently gave FLUMIST to a 23 month old on an unspecified date. The report was considered to be non-serious.
Local 4x4 cm reaction, upper right arm and neck muscle painful. Fever 103.
Mast Cell Attack; severe pressure headache; pain in left ear; burning eyes; runny nose; sore muscle at injection site, upper right arm; Sore tongue w/ 2 ulcers; sore throat; partial loss of smell and taste.