chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; Sickness; Fever; Stress/STRESS OUT; Elevated sedimentation rate/HIGH SEDIMENTATION RATE.; Limb hyperextension/HYPEREXTENSION OF FINGERS; SKIN BOIL BREAKOUTS IN INNER THIGHS WHEN STRESSED OUT; RHEUMATOID ARTHRITIS FLARE IN RIGHT HAND; This case was reported by a consumer and described the occurrence of rheumatoid arthritis flare up in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included adalimumab (Humira) solution for injection in pre-filled pen for rheumatoid arthritis.   Concurrent medical conditions included rheumatoid arthritis.   On an unknown date, the patient received Shingrix and Humira (subcutaneous) at an unknown dose and frequency. In July 2020, unknown after receiving Shingrix, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant). On an unknown date, the patient experienced injection site pain, sickness, fever, stress, elevated sedimentation rate, limb hyperextension and boil. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim). Humira was continued with no change. On an unknown date, the outcome of the rheumatoid arthritis flare up, injection site pain, sickness, fever, stress, elevated sedimentation rate, limb hyperextension and boil were unknown.   It was unknown if the reporter considered the rheumatoid arthritis flare up, injection site pain, sickness, fever, stress, elevated sedimentation rate, limb hyperextension and boil to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient taking the Humria, CF 40 mg once in 2 week via subcutenous route, for Rheumatoid arthritis flare in right hand. The patien received Shingrix vaccine and expereienced injection site pain, sick, fever. On unknown date, the patient expereinced skin boil breakouts in inner thigh, when stressed out, hyperextension of fingers. In 2020, the patient exerienced high sedimentation rate. The patient was treated with bactrim. The patient had relevant laboratory of bool work: sedimentation rate was slightly high (35 verses 28). It was unknown if the reporter considered Rheumatoid arthritis flare up, injection site pain, sick, fever, skin boil breakouts in inner thigh, stress, hyperextension of fingers and high sedimentation rate to be related to Humira product.
Full body hives that would not calm down with Benadryl and Claritin combination. Nothing else in environment or diet was new or different.  Duration of 7-8 days.
on day 8 developed a red rash, itchy and warm to touch. Picture of arm was taken.
did not get the full dose added that there was 0.3 mL of the vaccine left in the syringe with no reported adverse event; Initial information received on 15-Oct-2023 regarding an unsolicited valid non-serious case received from a Pharmacist.  This case involves a 3 years old female patient who did not get the full dose added that there was 0.3 ml of the influenza quadrival a-b vaccine [Fluzone qiv] left in the syringe with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect influenza quadrival a-b vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, strength, and expiration date: not provided) for Immunisation (incorrect dose administered) (latency- same day). Information on the batch number was requested.  Action taken- Not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
pt fainted shortly after vaccination (within 5 minutes). Pt regained consciousness within few seconds. Pt lied down with feet higher on a chair. Pt was monitored for 30 minutes and recovered fully.
This spontaneous report has received from a medical assistant, referring to a 22 year old patient (gender unknown). No information was provided regarding the patient's medical history, concurrent conditions, drug, allergy history or concomitant medications. On 17-JUL-2017, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB, lot # M029233, expiration date 09-AUG-2018, (dose and strength were not provided) for prophylaxis.
aching all over; sore arm; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aching all over), PAIN IN EXTREMITY (sore arm) and VOMITING (vomiting) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (aching all over), PAIN IN EXTREMITY (sore arm) and VOMITING (vomiting). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (aching all over), PAIN IN EXTREMITY (sore arm) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were provided as antidepressant medication.
Sore arms and hands. Sore stomach muscles........during the night after the shot ....by morning all aches were gone
I experienced irregular period afterwards my first dose; after I received that dose in the month of November, I did not have a menstrual cycle; my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine; my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 (Lot number: FF2589) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE taken for asthma; CHELATED IRON taken for anaemia. The following information was reported: MENSTRUATION IRREGULAR (non-serious) with onset 2021, outcome "unknown", described as "I experienced irregular period afterwards my first dose; after I received that dose in the month of November, I did not have a menstrual cycle"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 2021, outcome "unknown" and all described as "my cycles are irregular, I have more bleeding and more cramping, more pain than I did before the vaccine". Therapeutic measures were not taken as a result of menstruation irregular, heavy menstrual bleeding, dysmenorrhoea.  Additional information: No Prior Vaccination.  No follow-up attempts are possible. No further information is expected.
6 pm day of vaccine dizzy poor hearing rt. ear felt dull in front of head.
Pt. states that after receiving the 2nd dose of Moderna 09/07/2021, started experiencing symptoms 09/27/2021 of loss of hair (thinning) and  fatigue.  No noted Primary visit/communications. Still continuing to experience symptoms.
4" red patch showed up on arm eleven days after first vaccine shot. Got some fluid filled bumps on my chin, kind of like cystic acne, but not painful.  The bumps seemed to be filled with pus or water. Both the patch and the bumps subsided after four days. I have never had dermal fillers. I have had acne cysts injected with cortisone over the years, but not recently and one of the bumps seemed to be where I had had a cyst in the past.
The pt became irritable, appetite decreased, had fever of 101.4, mild redness at injection site.
A little over 2 weeks following my first vaccine i started to have numbness and tingling in my legs that spread to my arms. I made an appointment with my primary care physician who recommended i follow up with a neurologist. I scheduled a neurologist appointment for a month later but went to the ER three times with symptoms worsening feeling weak and like I was going to pass out. I was initially told by my primary care physician and ER physician that this was not a side effect of the vaccine so i received my second dose. My heartrates have not been able to be controlled since going up to the 190's when i stand.
Flashing lightening bolt, left peripheral vision.  Referred to retinologist. No retinal tear.  Detaching vitreous humour
Low grade temp 99 F on 12/30/20 1:12 s/p COVID-19 vaccine [Moderna] received on 12/28 @13:08. Acetaminophen 650mg administered once on 12/30 2:09 with resolution of symptoms.
Arm began to hurt Thursday, 5 pm. Then, got fever and body aches. All night Thursday and through Friday had headache. Missed work Friday. Still have sore arm Sunday. It has a knot at injection site and is not to touch.
Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; Experiencing sever cramps in her legs and thighs/cramps in my legs are horrendous they hurt so bad that I'm screaming they hurt so bad; caused her to go into the flare; Muscle joints pain; Extremely tired; Muscle joints pain; Experiencing flu like symptoms; Body ache; Headache; sick; feeling bad; The initial case was missing the following minimum criteria: specific product. Upon receipt of follow-up information on 01Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (BNT162B2 also reported as Covid 19 vaccine; unknown lot number and expiration date), via an unspecified route of administration on 17Dec2020 at a single dose for covid-19 vaccination. Medical history included having something called Adult Still's which is bad Rheumatoid Arthritis. The patient's concomitant medications were not reported. The patient reported that she got the vaccine and was experiencing sever cramps in her legs and thighs, and muscle joints pain. She mentioned on a scale of 1-10 it is 20. The patient also experienced flu like symptoms which were body ache and extremely tired. The patient reported that she called because she received her first Covid shot on 17Dec2020 and she was really sick from then, she was talking like super sick. In Dec2020, she had muscle cramps, headache, no fever but like she had the flu. She has something called Adult Still's which is bad Rheumatoid Arthritis, so it caused her to go into the flare but she was still sick. She was still feeling bad. She was still having muscle pains in her leg. The patient mentioned that she had to go to the emergency room because she could barely move her leg. They told her that it was a combination of Adult still's and her Covid 19 shot, so they gave her some medications. They gave her Lyrica 75 mg, twice a day and it messed me up that she couldn't even function. So, now she had to come home from work and now she was still having the leg cramps and just not feeling well so what can she do to feel myself better. The outcome of the event cramps in legs was not recovered while the outcome of the other events was unknown.  Information on the batch/lot number has been requested.
Throat began to become scratchy, and tongue felt swollen. Difficulty breathing. Chills, and severe shaking.
This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested positive for covid-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced COVID-19 (Tested positive for covid-19). At the time of the report, COVID-19 (Tested positive for covid-19) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: Positive. 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.
Started at 5:30 to 5:45 with sore joints and fever and continued at 4 a.m. with extreme dizziness and sweating. At this point, patient sought medical attention.
Pt vaccinated with DTP developed uncontrollable screaming, whimpering, facial grimmace, stare into space, loose bladder control when scream, not remember - then all of a sudden OK - last for hrs all sx gone. Dilantin begun 11DEC90.
Patient received Pfizer vaccine with 1st dose on 03/25/2021 and 2nd dose on 04/17/2021. Patient Covid + on 10/05/2021 and hospitalized Per ED note: The patient presents emergency department after experiencing multiple falls over the past 1 week.  She states that over the past 1 month she has been supposed to be using a walker at home although she really is not using the walker at home.  She reports that throughout the last week with these falls she has not been using the walker as she is still "getting used to it".  The patient is alert oriented answering my questions appropriately and denies any specific pain anywhere.  She denies any blood thinners at home and denies any particular pain.  The patient was laying on the floor but she is unsure of how long she was on the floor for.  She denies any fevers or chills, she does report a mild dry cough.  She denies vomiting or diarrhea.
Initial and follow up literature case received on 28 Sep 2010 and 11 Oct 2010: This child with an unknown medical history was vaccinated with H1N1 (manufacturer unknown, batch number unknown) on unknown date. The patient was hospitalized one week after vaccination on unknown date with H1N1 infection. The outcome was not reported.
Vaccine was administered to patient but she did not meet age criteria. Patient is 17 years old and 10 months.
Pain in lower right arm/forearm (not injection site). Feel like I slept wrong on my arm, but with more pain. It feel like I have been hit by a blunt object on forearm
Baseball sized erythema and warmth.  Dx iatrogenic vs allergic reaction.  Treated with Keflex po.
contracted covid after receiving the 1st vaccine dose; contracted covid after receiving the 1st vaccine dose; This is Spontaneous report from a contactable nurse. This nurse reported similar events for 6 patients. This is the 3rd of 6 reports.   A patient of unspecified age and gender received the first dose of bnt162b2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient contracted COVID after receiving the 1st vaccine dose on an unspecified date. The outcome of the events 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.,Linked Report(s) : US-PFIZER INC-2021035078 same reporter/product/event, different patient;US-PFIZER INC-2021035069 Same reporter/drug, different patient/ event
Stiff neck; pain in back; shortness of breath; sore arm; pain in right side of entire body/pain; I am still weak/ Minimal energy level; fatigue; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiff neck), BACK PAIN (pain in back), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm) and PAIN (pain in right side of entire body/pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-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 MUSCULOSKELETAL STIFFNESS (Stiff neck), BACK PAIN (pain in back), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (sore arm), PAIN (pain in right side of entire body/pain), ASTHENIA (I am still weak/ Minimal energy level), FATIGUE (fatigue), CHILLS (chills) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiff neck), BACK PAIN (pain in back), PAIN IN EXTREMITY (sore arm), PAIN (pain in right side of entire body/pain), ASTHENIA (I am still weak/ Minimal energy level), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown and DYSPNOEA (shortness of breath) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: Follow up received contains added New Events(Musculoskeletal Stiffness, Back pain, Dyspnoea, pain) and  Outcome of the Event Headache changed to Not recovered. On 12-Jul-2021: Follow-up received Contains New event Asthenia added and for events dyspnea and headache outcome updated to not resolved.
24 hours later - chills and arm achiness 30 hours later lymph node in arm pit swollen and tender as of 12/26/2021 the node is still swollen and tender but has gone down some
48 hours after 3rd dose of moderna vaccine patient arm of injection began to hurt and was unable to use her arm or hold anything. Patient is currently pregnant.
Initial report was received on 07 October 2011 from another manufacturer (service request number 1-4524616947), who received the report from a health care professional. An 8-year-old female patient had received a TETANUS TOXOID vaccine (manufacturer unknown, lot number, route, site and date of administration not reported) and an unspecified amount of time later, she experienced an anaphylactic reaction. Outcome was not reported. The patient's current age was 65 years of age. No additional information was provided at the time of the report. Documents held by sender: None.
Patient was administered the Pfizer Covid-19 5-11 year old but should have received Pfizer Covid-19 for 12 year olds.
Reaction to first Shingrix shot; rash on both legs/rash on feet; This case was reported by a consumer via call center representative and described the occurrence of nonspecific reaction in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of months after receiving Shingrix, the patient experienced nonspecific reaction and rash. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the nonspecific reaction was unknown and the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the nonspecific reaction and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A couple of months before the time of reporting, after receiving the Shingrix vaccine, the patient developed a rash on both legs and feet, he took antibiotics and it cleared up. The reporter would liked to knew whether his status as genetic biomarker HLA-B27 positive makes that an autoimmune response to Shingrix. The reporter wanted to knew whether he would get the second shot. The reporter denied consent to follow-up.
Menstrual change.  Menstruation started much earlier than typical (22 day cycle), followed by 2 months of late beginnings (38 day cycles). Regular menstruation resumed after 3 cycles.
weakness-so severe pt could only ambulate w/help-total lethargy, amorphous anxiety later; proven to be blood sugars 19-50;6-8wk bedridden;other pt known to have same rxn;extreme weight loss;blood sugars problem;
Starting in July of 2022 I started having excessive menstrual bleeding that could not be controlled by medication. As of March 13, 2023, they located a baseball size in my uterus. I was also having pain that would not stop. The doctor tried 3 birth control medication which did not help. I have a follow up MRI on April 10, 2023. I am also scheduled to have a hysterectomy on April 28, 2023. My Ob-Gyn discovered the mass. I am still having the issue and awaiting surgery. I had dose 6 of the Pfizer Bivalent vaccine on November 4, 2022. This did not change the issue.
Tasted metal 15 minutes after injection, 25 minutes after injection left eyelid felt heavy and appeared droopy, could not lift my left eyebrow, forehead and check feel tight. 22hrs later my forehead and left check feel tight and eye still droopy. Eyebrow can move more normally
Chills; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 30-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 at 09:30 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included allergy to arthropod sting. Concomitant medications included fluticasone propionate (FLONAZE) and loratadine (LORATADINE). The patient took dose 1 of bnt162b2 on 26JAN2021 at 09:30 AM for COVID-19 immunization (lot number:EL3247, Vaccine location: Left arm). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced chills, nausea and headache on 15Feb2021 at 20:00. No treatment was received for the events. Outcome of the events chills was recovered on 15FEB2021 (Chills lasted approximately 3 hours), Nausea was recovered on an unknown date in FEB2021, Headache was recovered on 16FEB2021 (lasted until 12:00 PM of the next day).  Follow-up (25Feb2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Raw sensation on tongue - progressively worse, roof mouth felt burnt, tongue red, gums, teeth sensitive to brushing, sensitive to acidic/spicy/carbonation.