chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The certified medical assistant reported that the patients were administered doses of RECOMBIVAX HB that were improperly stored (dose, route and lot number not provided) (dates unspecified). No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Medical Assistant brought it to my attention that she gave a expired vaccine to a patient. The above name vaccine was given on 1/27/2017, provider was made aware and I was made aware. Patient's parent stated patient had a mild temp of 99.0 F, and the child was a bit fastidious but is not active. Vaccine had expired 12/03/2016. It was overlooked by both LVN during monthly check and MA prior to be given.
Initial report received from a health care professional (nurse) on 20 Jul 2010: This patient received an intramuscular injection of only the lyophilized Men A powder of MENVEO (batch number: 029011), (dose: unknown) that was reconstituted with sterile water for injection rather than with the Men CWY conjugate component on 15 Jul 2010. No adverse events were noted following this administration. Follow up nurse report received on 02 Aug 2010: It was reported that the patient had medical history of acne and adolescent postural kyphosis. Patient's demographic was updated. No other information was reported.
4/21/2021 2:05 pm: Injection given, 2:35 pm: rash/hives developed on patients neck on the left side (same side as injection). 2:40 pm: patient given Benadryl 75mg by mouth (3 capsules x 25 mg each), 2:55pm: Rash/hives continues to spread to chest and back. Patient decides to go to Emergency Room. 3:10 pm: Pharmacist called and confirmed patient's successful arrival to Emergency Room.
This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 64-year-old female patient who received SHINGRIX. Concurrent medical conditions included multiple sclerosis (Diagnosed prior to receiving the vaccine), supraventricular tachycardia (Diagnosed prior to receiving the vaccine), osteoporosis (diagnosed prior to receiving the vaccine) and bladder infection (Diagnosed prior to receiving the vaccine). Concomitant products included atenolol, gabapentin, trimethoprim, Vitamin B12, vitamin d, ZYRTEC, Calcium Plus S, CELEXA, Cranberry, ESTRACE cream, Glucosamine and chondroitin, Preservision, PROLIA, Red yeast rice and XANAX. On 24th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema, injection site bruising, vaccine administered at inappropriate site, leg pain, injection site pain, swelling, injection site wheal and skin warm. On an unknown date, the outcome of the localized erythema, injection site bruising, vaccine administered at inappropriate site, swelling, injection site wheal and skin warm were unknown and the outcome of the leg pain and injection site pain were recovering/resolving. It was unknown if the reporter considered the localized erythema, injection site bruising, leg pain, injection site pain, swelling, injection site wheal and skin warm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received OCREVUS infusion as concomitant medication. The patient received SHINGRIX on right buttock due to MS and past injections. The consumer reported that as soon a s she got home, she experienced red, raised spot larger than a silver dollar with a deep bruise as well. The patient had a really huge welt at the injection site that was about the size of a moon pie and it really, really hurt. The patient stated that when she rolled over, her leg on that same side would ache as well. The patient stated that the redness and heat started going away and at the date of reporting it was flat and pink, but there was still a bruise about the size of a silver dollar. The caller had reaction to vaccine at injection site.
Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2017, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In February 2017, the patient was treated by a physician at a family medicine for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
My arm became red, itchy, and swollen on 2 days after the vaccine. The swelling , itching, and redness, went down 2 days later, however, it later returned 2 days later and I am in day 9 and my arm is still itchy, red, and swollen.
Pt received FLUZONE at 12pm on 9/28/13. At 1045pm started have pitting edema bilateral both calf. 9/30/13 edema decreased to 1 (+) pitting.
10ARP92 t101.4 x 3 days;  11APR92 rash trunk & arms & face x 3 days;
Fever one week after vaccine, maximum 102 degrees of 3 days duration followed by macular red rash on torso and face
tested positive for Covid; Initial information was received on 11-Dec-2020 regarding an unsolicited valid non-serious case from a non-health care professional/consumer (patient) via social media.  This case involves a patient of unknown age who tested positive for covid (sars-cov-2 test positive), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient tested positive for covid (sars-cov-2 test positive).  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Approximately 3 hours after injection: Slight  headache, body aches, ?punky? feeling.  Approximately at 7:00pm same day, noted diffuse rash on legs- thighs and back of calves. Next day noted a little more on bilateral arms, back and neck. Some burning feeling as if razor burn (had not shaved) and itching.
Prior to getting my vaccine I had consistently low blood pressure and no heart palpatations. After getting my vaccines I devleoped very high blood pressure and it has gone up steadily. I now require medications.
Inflammation for over 2 months in both shoulders and arms from shoulder to elbow, inflammation in palms of both hands for 1 month and inflammation in both legs - back side only- from knee to buttocks
Terrible sore arm for over a year, hard to lift my arm. Soreness every night. Decreased ability to use arm
Mother called - shots (MENACTRA and Varicella) were given on 8/01/14 in (L) arm. Mother states redness and swelling "(L) arm up to (L) shoulder that took 5 days to go away", mother states no fever or any other reaction - mother called PCP - instructed to give BENADRYL or CLARITIN. She gave CLARITIN.
dose of Shingrix about 4 years ago and never received a second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about 4 years ago ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: dose of Shingrix about 4 years ago and never received a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The patient never received a second dose of Shingrix. The reporter did not have exact DOB (date of birth) or initials at time of chat. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Soreness at vaccine site, low grade fever, body aches, fatigue   Improvement with Ibuprofen
Joint pain and cracking at shoulder lasting a whole week now. After receiving my injection, I noticed that it was given very high up on my arm, just barely 1 finger width's away from my shoulder joint. As a healthcare provider myself, I know to be aware not to administer too high as this can result in shoulder injury. I unfortunately seem to have encountered this firsthand myself. I wanted to wait a week hoping the pain would go away, but it is still there even after a week. It was severe pain starting about 36 hours after receiving the shot, then for two more days, the pain was about 8/10. The pain has become less severe over time, but I am unable to use my left arm to the same capacity anymore due to this constant shoulder joint pain. Prior to this, I have never had any shoulder pain.
Starting 01-19-2022 I have had sensitivity to the skin of my upper back associated with a rash, the sensitivity feels like pins and needles and is sensitive to touch and movement. It is not an itchy rash, or a raised and red or blistered rash. Looks mostly like try skin. The sensitively has lasted two days and does not seem to be getting worse but also is not getting better.
Woke up in middle of night with fever and chills and body aches.  Arm very sore and hard to lift.  Tylenol taken with not too much relief. Slept most of the day. Second day arm is much better and can move more. Body is still achey.
27DEC96 pt presented to clinic w/moderate amount of red, raised spots, non-vesicle;no treatment-observe;
My son was given a duplicate injection of a vaccine which was already given previous in the same year.  The two medical offices did not share information from previous records.
Child became very irritable with excessive crying 2days after vaccination. Parent gave Tylenol the following day and child improved.Parent also complained of raised bumps at the sites of injections. Resolved.
EXTREMELY PAIN AT INJECTION SITE. INJECTION SITE RED AND SWOLLEN AND HOT TO THE TOUCH PAIN RADIATING DOWN ARM TO HAND AND UP SHOULDER. FEVER. MALAISE. FLU LIKE SYMPTOMS.
I received the shot and went back out to sit down. I started feeling really sweaty to the point that I had to fan myself.  My husband went to get me a bottle of water and my daughter was talking to me and while she was midsentence , everything went black, then all went back to normal but she was done speaking so I think I blacked out. This happened 3 times. No issues breathing. Just hot and dizzy. We went home and I took a nap as I was feeling fatigued and woke up about 3-4 hours later. Sore arm the rest of the day and I got up the next day feeling ok.  Just more tired than usual since.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: injection site is warm to touch and tender to touch.  advised pt to draw a surrounding line and monitor and take benadryl.  If not better see doctor
patient got Gillian Barre and about died; Initial information regarding an unsolicited valid serious case received from a consumer/ non-healthcare professional (patient's daughter in law) via social media on 07-Dec-2020.  This case involves a female patient of unknown age who got Gillian Barre (Guillain-Barre syndrome), while she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date (latency unknown) the patient got Gillian Barre (Guillain-Barre syndrome) following administration of INFLUENZA VACCINE. The event Guillain-Barre syndrome was considered medically significant. Reporter stated that patient was about to die.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for Guillain-Barre syndrome.  Information on the batch number was requested.; Sender's Comments: This case concerns a female patient who was presented with Guillain-Barre syndrome after vaccination with non-company suspect Influenza Vaccine. The time to onset was uknown. However, patient's medical condition, concomitant medication and laboratory tests ruling out alternate etiologies were not reported. Moreover, one vaccination preceded the events. Based upon the reported information, the role of an individual vaccine cannot be assessed
sore arm that is painful, making arms and hands weak and limiting day to day activities; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm that is painful, making arms and hands weak and limiting day to day activities) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included GLIPIZIDE, TRIAMTERENE, POTASSIUM, ATORVASTATIN and LISINOPRIL for an unknown indication.   On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE PAIN (sore arm that is painful, making arms and hands weak and limiting day to day activities). At the time of the report, VACCINATION SITE PAIN (sore arm that is painful, making arms and hands weak and limiting day to day activities) had not resolved.        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.   Treatment medications was not provided.
Existing mild case of vitiligo which I had for decades with no change (only a few small patches of depigmented skin-verified by a doctor), became widespread on my entire body. Got progressively worse over the past 2 1/2 years.  I have had  a total of 7 covid shots including initial shot on 3/15/2021.
Patient's husband called 1PM, 11/6 said patient developed nausea & vomiting at 5PM (2hrs after shot) frothy vomit, trouble breathing, trouble sleeping, hallucinations. Felt fine morning of 11/6/10.
ON my right armpit, I developed a tingling sensation (like a cold sore) that turned into a stinging sensation. It was red and liquid filled bumps appeared on my skin (under the same armpit). Went to a dermatologist and diagnosed it as shingles
This is not a patient adverse reaction.  This is an administration error/ concern.  While injecting the vaccine, a significant amount of the vaccine squirted from the hub of the syringe.  There was no indication prior to or at the time of the injection, that there was any issue with the needle.  Following the injection and spillage, there was resistance when attempting to engage the needle safety device.  The BD retracting syringe was being used. The patient is aware of the event.
This spontaneous report as received from a other health professional refers to a patient of unknown demographics. On 25-SEP-2014 the patient was vaccinated with PNEUMOVAX 23 lot # J007059; expiry: 31-JUL-2014 (dose regimen unspecified). On 25-SEP-2014, the patient received an expired dose of PNEUMOVAX 23. No adverse effect has been reported. The outcome of received an expired dose and no adverse effects reported is unknown. There was no product quality complaint involved. Additional information is not expected.
Pfizer Bivalent dose given for 1st primary dose, instead of the Pfizer monovalent dose.
Covid arm morning after vaccine, chills, fever, muscle aches, headache, loss of appetite, felt like worse flu for 1.5 days after onset of symptoms.  First symptom hit approx 7 hours after vaccine and lasted 1.5-2 days.   Also had covid arm 9 days after first vaccine but it was worse after second vaccine.
Right upper arm became very swollen, hard, and painful to the point that I could not raise my arm or touch the spot.  I also had a fever and headache.
Cellulitis; Fatigue; Minor headache; Methicillin resistant Staphylococcus aureus infection; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4246636-00 (AbbVie).  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 18Oct2021 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for colitis ulcerative. Relevant medical history included: "DEEP VEIN THROMBOSIS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 17Mar2021, when the patient was 48 years old, for Covid-19 Immunization; Bnt162b2 (Dose:2), administration date: 07Apr2021, when the patient was 48 years old, for Covid-19 Immunization.Concomitant drugs were not reported. Irregular labs were reported.  The following information was reported: CELLULITIS (medically significant), outcome "unknown", described as "Cellulitis"; FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Minor headache"; STAPHYLOCOCCAL INFECTION (non-serious), outcome "unknown", described as "Methicillin resistant Staphylococcus aureus infection". The action taken for adalimumab was unknown.  Causality for HUMIRA(ADALIMUMAB):The reporter's causality for the event(s) of FATIGUE AFTER COVID VACCINE, CELLULITIS, MINOR HEADACHE AFTER COVID VACCINE and METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS was not reported.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) (TOZINAMERAN:The reporter's causality for the event(s) of FATIGUE AFTER COVID VACCINE, CELLULITIS, MINOR HEADACHE AFTER COVID VACCINE and METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS was not reported.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Shot was given Wed 10/6/10. Arm became red, painful, swollen, developed chills & itching locally.
02/24/1997 Fever 100, vomiting, stomach ache. 02/26/1997 clinic visit, temp of 100.8, left otitis media. Prescribed Amoxicillin then Septra. 03/05/1997, ENT - bilateral, otitis media, significant bilateral hearing loss. PEETS. Hearing has returned to normal in the right ear. Left - severe sensory neural hearing loss at certain frequencies.
Information has been received from a female pharmacist of unknown age via a company representative referring to herself. Pertinent medical history and drug reactions/allergies were not reported. In December 2015 the patient was vaccinated with ZOSTAVAX (route, dose, lot# and expiration date were not reported). Concomitant drug was not reported. Following the vaccination, on an unknown date the patient experienced a little rash at the injection site. The patient did not seek medical attention. The patient recovered on an unknown date. The causality was not reported. Additional information has been requested.
Chills; fevers; Injection site arm ached; Body aches; Was in bed for 2 days; Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Was in bed for 2 days), PRURITUS (Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.), CHILLS (Chills), PYREXIA (fevers) and VACCINATION SITE PAIN (Injection site arm ached) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis and Allergy (Patient takes Loratadine 10mg daily for allergy issues.). Concomitant products included LORATADINE for Allergy, PREDNISONE for Rheumatoid arthritis, OXYCODONE, VENLAFAXINE, EZETIMIBE (ZETIA), VITAMIN D NOS, POLYCARBOPHIL CALCIUM (FIBER), D-MANNOSE and ZOLEDRONIC ACID for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced CHILLS (Chills). In 2021, the patient experienced BEDRIDDEN (Was in bed for 2 days), PRURITUS (Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.), PYREXIA (fevers), VACCINATION SITE PAIN (Injection site arm ached) and MYALGIA (Body aches). At the time of the report, BEDRIDDEN (Was in bed for 2 days), PRURITUS (Scalp itching started sometime after the patient received both Moderna Covid-19 vaccinations.), CHILLS (Chills), PYREXIA (fevers), VACCINATION SITE PAIN (Injection site arm ached) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes vitamins used for unknown indication.  No treatment information was reported by the reporter.   This case was linked to MOD-2021-364248 (Patient Link).