chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose of the vaccine was brownish color in the syringe and darker; A spontaneous report was received from a consumer who was also a female patient of unreported age, who received Moderna's COVID-19 vaccine (mRNA-1273) and states that her first dose of the vaccine was white/off white in color and the second dose was brownish and darker/product color variation.   The patient's medical history was not provided.  Products known to have been used by the patient were not provided.  On an unreported date, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  Patient reports the liquid in the syringe was white to off-white.  Upon receiving the second dose, on  another unknown date, the patient received the second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   The patient noticed that the second dose of the vaccine was brownish and darker in the syringe than the first dose.  Consent to contact was denied.  Treatment information was not provided.   Action taken with mRNA-1273 was not applicable.  The outcome of the events, the second dose was brownish and darker/produce color variation, was considered resolved.; Reporter's Comments: This report refers to a case of product color issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
A fib that has worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "A fib that has worsened". Clinical course: The patient had the Pfizer COVID-19 vaccine on schedule as recommended by the CDC. The patient has had heart issues after receiving the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recvd 1st dose of vax w/no noted problem; 2nd dose of vax recvd 18AUG92 w/in an hr following the vax, pt exp sore arm w/pain @ inject site; sx resolved w/in 24 hrs; No further details were provided;
I was  forced to take this vaccine in order to keep my job.   This was suppose to prevent covid.   It did not.   I was diagnosed with CoV-19 on 01/10/2022 and again on 6/11/2022.    Our plant is covered up with covid cases and they?re all vaccinated.   So much for safe and effective.
missed the second dose of Shingrix; This case was reported by a pharmacist 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 on June 2020.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follow: The age at vaccination was not applicable for this report. The patient missed to receive 2nd dose at appropriate time. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reported VAREs details pertains to 1st dose of Shingrix. The reporter consented to follow up.
PATIENT WAS VERY ANXIOUS AT THE TIME OF THE INJECTION.  INMEDIATELY AFTER THE FACT PATIENT FELT STINGING PAIN AT THE INJECTION AREA AND  FELT LIKE A BRACHIAL PLEXUS LESION .  HE was unable to fully close his hand for a few hours.  WE CONTACTED HIM THE DAY AFTER AND HE IS FEELING WELL. PATIENT PUT ICE ON THE HAND.
Patient is a COVID-19 vaccine breakthrough case who was hospitalized on 4/15/2021 due to COVID Pneumonia.
From initial report received on 1/8/01, it was reported that an 18 month old male was given TriHibit (a combination of Act-Hib and Tripedia) and IPOL vaccines on 1/5/01. Pt reportedly, experienced "within 24 hours" a 5cm X 8cm red area at the injection site radiating to inner thigh. From additional correspondence received on 2/21/01, additional pt, vaccine, vaccine administration and responsible physician information was provided.
mom stated pt cried constantly all day 20MAR96;refused food & was unconsolable
No adverse event noted. Person pre-registered via online registration with incorrect birthdate. Minor inadvertently received first dose of Moderna vaccine on 4/2/2021.
extreme fever; chills; shortness of breath; This is a spontaneous report from a contactable Physician via Pfizer Sales Representative. A 6 decades male patient (reported as in his 50's) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. the patient experienced extreme fever, chills, shortness of breath after receiving the vaccine. Outcome of events was unknown.   Information about lot/batch number has been requested.
"very severe psychotic thoughts"; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOTIC DISORDER ("very severe psychotic thoughts") in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PSYCHOTIC DISORDER ("very severe psychotic thoughts") (seriousness criterion medically significant). On 20-Mar-2021, PSYCHOTIC DISORDER ("very severe psychotic thoughts") had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products included High blood pressure medication and type 2 diabetes medication.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe headache, Tingling numbness in arms hands and feet, swelling of the face around eyes, dizzy and confused.
Patient was vaccinated in infancy for smallpox with slight reaction and almost no scar. He was re-vaccinated as a condition of entering country rail port of entry in August 1961. The vaccine used was a paste resembling beeswax and packaged in a small tin for multiple uses. It was applied using a tool resembling a dental amalgam applicator.     The 1961 vaccination might relate to a dysplastic nevus which developed at the site of the second smallpox inoculation. The nevus was surrounded with small, thin melanoma lesions. It was diagnosed by MD and removed by MD ca. 2014.
Received vaccine on March 18th.  Was very tired that day. March 19th slept most of day, had muscle aches.  Saturday, March 20th had fever, muscle aches, headache, fatigue.  March 21 had all the above but short of breath.  March 22, in the hospital with fluid in the lungs, very high blood pressure, short of breath, on oxygen.
2 days after immunization, pt experienced palpitations intermittently. Saw physician assistant 1 time, then MD again 11/8. Rx'd atenolol. P 100, BP 190+/100 when she checked during episodes. Peak of symptoms on 11/8, no episodes today.
other zoster-related conditions; shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions or concomitant medications was provided. On 25-SEP-2012, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On unknown dates, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by healthcare providers, including but not limited to a physician, for shingles, and other zoster-related conditions. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered/not resolved. The reporter considered the events of shingles, and other zoster-related conditions to be related to zoster vaccine live (ZOSTAVAX).
Fridge temp went out of range by 4 degrees overnight sunday due to storm, Agency closed on 1/17. Vaccines were administered to patients in the morning
Started symptoms post immunization: Headache about eyes, Back neck sore, tired, not sleep well, shoulder and hips ache, decreased appetite, nausea with out vomiting, sweating.
After I got the vaccine I felt pretty tired, and around Sunday at midnight I start getting chills, and I wasn't running a fever at this point. I started to use the bathroom around 4 in morning and I felt very nausea and I passed out. When I pass out I have seizures, so I had a seizure; during the seizure I fell over on my partner and he called 911. I was then taking to the hospital by the paramedics.  I was sent home for the hospital and then I ran a fever for about three days.  I also had swollen lymph nodes for about a couple of days, and my injection site was swollen.
throbbing pain; started having pain in the right arm; arm started swelling; sore; swelled around the injection site; hurt from all the way down from shoulder to elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (throbbing pain), PAIN IN EXTREMITY (started having pain in the right arm), PERIPHERAL SWELLING (arm started swelling), PAIN (sore) and INJECTION SITE SWELLING (swelled around the injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced PAIN (throbbing pain), PAIN IN EXTREMITY (started having pain in the right arm), PERIPHERAL SWELLING (arm started swelling), PAIN (sore), INJECTION SITE SWELLING (swelled around the injection site) and ARTHRALGIA (hurt from all the way down from shoulder to elbow). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN (throbbing pain), PAIN IN EXTREMITY (started having pain in the right arm), PERIPHERAL SWELLING (arm started swelling), PAIN (sore) and INJECTION SITE SWELLING (swelled around the injection site) had not resolved and ARTHRALGIA (hurt from all the way down from shoulder to elbow) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up was received and event outcome was updated to recovered/resolved.
5 PM following flu shot on 12/10/10 8:45AM pt had -> vomiting, T 100.3 -> midnt multiple V T 103 parent phoned us 12/13/10 to report this -> next am (12/11/10) he fine no fever no V.
has fever in it/it lasted over 2 weeks; vaccination site reaction (Moderna arm); redness, big round bull size; A spontaneous report was received from a Consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events covid arm, redness, big round bull size, has fever in it, it lasted over 2 weeks.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced the events covid arm. redness, big round bull size, has fever in it, it lasted over 2 weeks.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events, covid arm, On an unknown date the outcome of events, redness, On an unknown date the outcome of events, big round bull size, On an unknown date the outcome of events, has fever in it, On an unknown date the outcome of events, it lasted over 2 weeks was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Individual was to receive first dose of Covid Pfizer vaccine for 5-12 year olds. This individual received the the Bivalent Covid Pfizer Vaccine for 5-12 year olds instead of the monovalent dose. No signs or symptoms, no adverse reactions. No concerns at this time.
Fast heart rate, blood pressure of 180/98, dry mouth, weird taste,  weakness, chest pains, chest pressure.
10 minutes of Pt first dose Pfizer vaccine, pt complained of nausea and hot flash. Pt stated she hasn't had any food since yesterday. Water was provided as well as a cooling pack and emesis bag. Vitals were obtained: 138/84, 99% r/a, 62, 20, pt was observed until she felt better and discharged at 17:00
severe neck pain; left arm hurts when she tries to move it; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (severe neck pain) and PAIN IN EXTREMITY (left arm hurts when she tries to move it) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced NECK PAIN (severe neck pain) and PAIN IN EXTREMITY (left arm hurts when she tries to move it). At the time of the report, NECK PAIN (severe neck pain) and PAIN IN EXTREMITY (left arm hurts when she tries to move it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: No specific follow-up information recorded.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 88-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin) and paracetamol (Tylenol). On 13th March 2019, the patient received the 1st dose of SHINGRIX. On 13th March 2019, less than a day after receiving SHINGRIX, the patient experienced shivering (serious criteria hospitalization), fatigue (serious criteria hospitalization), fever (serious criteria hospitalization), chills (serious criteria hospitalization), headache (serious criteria hospitalization) and eye pain (serious criteria hospitalization). On an unknown date, the outcome of the shivering, fever, chills, headache and eye pain were recovered/resolved and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the shivering, fatigue, fever, chills, headache and eye pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she went to the emergency room on 13th March 2019, was hospitalized, and was discharged home on 14th March 2019. The patient reported that, the severe shivering that she experienced went to the core of her body. In March 2019, shivering, fever, chills, headache and eye pain were resolved. The patient planned to continue follow-up with her physician on an unknown date.
pt recv vax & post vax exp stiffness & pain in the joints of the fingers of lt hand;tx advil;sx lasted for approx 3 wk to 1month;
Fever as high as 101.5F  and chills starting since 1am, lasting until 10pm. Extreme body and muscle aches. headache that was not alleviated with tylenol or advil.
First presented with aches and pains in joints at 11:30, then severe chills. Temperature at 12:30 was 102.3, 15 minutes later 103.2, 15 minutes later 104.4. She had vomiting several times and diarrhea. At noon, she took 3 ibuprofen to little effect.  At 3 we tried Tylenol (2), but she threw them up. At 3:15 her temp started going down and at 3:45 was 100.5. She also presented with bleeding at the site of the injection.
Patient reports that approximately 24-48 hours after receiving 3 vaccines (Hepatitis B, Tdap & Typhoid) that she began feeling numbness/tingling/cramping in right arm and right foot for which she believe is attributable to the hepatitis B vaccine.  She also received a 2nd booster/4th dose of Covid-19 Vaccine (Pfizer lot#GL0087) on 4/13/2023 at the Health Department. Symptoms did not progress any further and have since resolved over the past 1 month.  However, they were great enough to cause her to visit her primary care physician for further follow-up.  Her PCP ordered a MRI and bloodwork (CBC with Auto Differential, vitamin B12, CMP Comprehensive, Assay Magnesium).  All testing came back normal per PCP.    On 5/22/2023, she had her 2nd dose of Hepatitis B for which she has experienced the same symptoms to her left arm and left foot.  After discussion with her PCP he encouraged her to let us know she was having symptoms.  As of today, 5/24/2023, she feels the symptoms are starting to resolve.  No further testing for this incident has been done at this time beyond reporting and will continue to monitor for complete resolution of symptoms.
had pink cheeks and tired, a week later woke up with chills and shivering, had heart palpitations, and tightness in upper chest
Fever; chills; body aches; headache; fatigue; This is a spontaneous report from a contactable Other Health Professional (patient). A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EH9899) intramuscular at arm Left on 18Dec2020 15:45 at single dose for covid-19 immunization. Medical history included seasonal allergies, eczema, and diagnosed with COVID-19 prior vaccination. Concomitant medication included fluoxetine hydrochloride (Generic Prozac), krill oil, bifidobacterium lactis (PROBIOTIC), sambucus nigra (ELDERBERRY) and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fever, chills, body aches, headache, fatigue on 19Dec2020 12:00 PM, no treatment received for the events. COVID was not tested post vaccination. The outcome of the events was not recovered.
Severe overall body pain and enhanced migraine. Pain level (1-10) 8 lasting so far into 1/20/23. So loss of balance.  Intense back and shoulder ache. Somewhat controlled but not completely by APAP. Fatigue, minor muscle cramping, chills, shivering.
PT was given the vaccine 9 days after the beyond use date. The clinic is currently working on establishing guidelines and processes for this not to happen again.
Bad reaction to anthrax vaccine; On 27SEP2021, a spontaneous report was received from a consumer via another pharmaceutical company.  On 16SEP2021, a female consumer of unknown age called a pharmaceutical company inquiring about a vaccine and stated that after receiving the "anthrax vaccine," BioThrax (anthrax vaccine adsorbed) she experienced a "bad reaction (PT: Adverse event)." On 29SEP2021, a follow-up was received from the reporter stating that there was no additional information available with regards to this event. The outcome of the event is unknown.  The patient's medical history and concomitant medication use was not reported.  No additional information was provided.  Company Comment:  The company considers the event is not assessable, there is not enough information to assess.; Sender's Comments: The company considers the event is not assessable, there is not enough information to assess.
3/17/09 Received PC from Pt states LA started itching and swelling this weekend. Tdap was given on 1-28-09 states applied soaks to LA area. On 3/16/09 area started draining called HD 3/17/09 advise see PMD. Saw PMD 3/17/09 was given antibiotic to take.
This medically confirmed spontaneous report (initial receipt 13-Dec-2011) concerns a 1-year old female patient, who had no pertinent medical history, drug reactions / allergies or taking any concomitant medication. On 30-Nov-2007 the patient received flu vaccine. On the same day she also received dose 1 of VARIVAX injection and dose 1 of MMR. Ten days later, the patient was unable to walk and had 'pinpointing'. She developed cerebella ataxia and was taken to an ER (Emergency Room) with no significant finding. The ataxia resolved within 5 to 7 days after onset. The event outcome was recovered. The patient has since received a second MMR on 06-Dec-2011 with no problems to report. The reporter considered events to be serious as the events caused significant disability / incapacity.
Severe shoulder pain. Treated with oral steroids followed by physical therapy, a second round of physical therapy (ending in mid January 2020). Pain improved but did not go away. Referred to Doctor (ortho physician) at end of January but COVID delayed appointment until June 2020. MRI ordered (delayed until mid August 2020). Xray guided steroid injection into shoulder September 2020. Pain and shoulder functionality issues resolved until mid November 2020 when all pain returned and continues to worsen.
Following 2nd dose, pt. experienced sudden onset of fatigue, headache, SOB, rash, joint pain and swelling at injection site.  BP elevated and having random muscle contractions in legs.  Symptoms ongoing without meaningful resolution.  Was seen by provider with diagnosis of serum sickness - started on steroid taper with no improvement.  Labs, EKG and chest x-ray normal.
Woke with intense pain in left thumb, left breast(cancer surgery 2011) incision site, left hip, left knee, arch in left foot. This pain continued for 10 days but slowly got better. I was extremely tired for this period and although I still worked, I shouldn't  have but have no sick time. I now have tenderness and a scab on my left areola which I must see the doctor about since prior breast cancer. I didn't see the doctor for this problem but had a prior telehealth appointment scheduled on Nov 4 and discussed my symptoms  resulting from this flu shot. I still have some transient pain in all areas listed above. I had no fever or pain on right side except my right arm where the vaccine was administered (due to prior ca in left breast).