chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Great big round ball on her arm of the size of a tangerine, swollen; Hot; Big red circle on her arm; Sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), HEADACHE (headache), INJECTION SITE SWELLING (Great big round ball on her arm of the size of a tangerine, swollen), INJECTION SITE WARMTH (Hot) and INFUSION SITE ERYTHEMA (Big red circle on her arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache). On 20-Jan-2021, the patient experienced INJECTION SITE SWELLING (Great big round ball on her arm of the size of a tangerine, swollen), INJECTION SITE WARMTH (Hot) and INFUSION SITE ERYTHEMA (Big red circle on her arm). On 19-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), INJECTION SITE SWELLING (Great big round ball on her arm of the size of a tangerine, swollen), INJECTION SITE WARMTH (Hot) and INFUSION SITE ERYTHEMA (Big red circle on her arm) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications included sleeping pill and blood pressure medication.  Event treatment: Tylenol (acetaminophen) for headache.
Arm soreness at injections site, 2nd dose; Fatigue/very tired; achy all over the body; hard to raise her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 09:30 (Lot number: EW0171) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis in her knees" (unspecified if ongoing), notes: Diagnosed about 5 years ago.; "migraines" (unspecified if ongoing). Concomitant medication(s) included: ALEVE taken for headache. Vaccination history included: Bnt162b2 (LOT: EW0150, Dose: 1, Anatomical location: left arm), administration date: 06Apr2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Arm soreness at injections site, 1st dose". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (29Apr2021), described as "Arm soreness at injections site, 2nd dose"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (29Apr2021), described as "Fatigue/very tired"; PAIN (non-serious) with onset Apr2021, outcome "recovered" (29Apr2021), described as "achy all over the body"; MOBILITY DECREASED (non-serious) with onset Apr2021, outcome "recovered" (29Apr2021), described as "hard to raise her arm". Therapeutic measures were taken as a result of vaccination site pain, fatigue, pain, mobility decreased.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not had vaccines before but, she was not sure if they were Pfizer. Mild side effects right after the vaccine: The patient experienced fatigue, all over body aches, very tired and was hard to raise her arm but, it did not last but, 24 hours maybe. It started in the evening of day of the vaccine and she felt achy the next day after. It was gone on 29Apr2021. She reports she was able to work through it, she works from home. Caller reports the arm soreness was to be expected and went away a few days after getting the shot. The soreness was in the arm is to be expected, she was assuming, right.   No follow-up attempts are possible. No further information is expected.
pt recv vax 5DEC95 & 9SEP97 pt exp a very mild breakthrough case of chickenpox;
14  year old came in for her booster vaccine. Patient was given Moderna Booster  0.25 ml  (instead of Pfizer booster)
8/22/07 Received Varicella in right upper arm. 8/23/07 Patient noticed "bump on right arm at noon; told her mom about 6:30pm area red and warm, slight itch. Mother gave patient, Ibuprofen, Benadryl and ice pack. Measured 6cm height x 6cm width at 9:30 pm. 8/24/07 Area of firmness 3cm height x 6cm width and redness and warmth noted.
I started having some joint pain in my knees and a little in my fingers and then got back spasms.  Back spasms may have been a result of the joint pains.  On a pain scale of 1-10 with 10 being severe, I'd say it was a 4 although the back spasms were much higher.  Just wanted to document this.
Patient received vaccination on 1/15/2021. Hemorrhagic Stroke on 1/20 , then diagnosed with complicated idiopathic coagulopathy
Five weeks post vax, the pt experienced severe joint pain in his hands, wrists, feet, knees, and shoulders. Additionally, he had a temperature of 102. He was considered by the reporter to be disabled and was admitted to the hospital. He was treated with Daypro and with prednisone on a tapering schedule.
Woke up with severe left eye pain and migraine  01/20/2021.  I ended up with papilledema in my left eye and posterior scleritis in my right eye.  I have not had one day since then without a migraine or eye pain.  Joints got worse.  Intestines switched from costipation my whole life to diarrhea for six years.
I do not have the information regarding the manufacturer, or lot number. The nurse at my employer's clinic said it was a FLUZONE QUADRIVALENT preservative free flu shot.  She said some were with the preservative. By 7pm on the day I got the vaccine, I had severe pain in my entire left arm. I alternated TYLENOL and ibuprofen and used a heating pad to help soothe the pain. I vomited at midnight and 3am. I had full body aches and nausea all day on Saturday, 10/6. On Sunday, 10/7, I felt better but still couldn't eat much and was dehydrated. I also felt like I broke a fever Saturday night, although I never took my temperature prior to that.
Diffuse urticarial rash and fever 100.2 began 2 1/2 hrs after Pediarix, HIB, Prevnar were given. Pt was irritable with joint pain, large and small urticarial plaques with blueish hues, almost target lesions from head to toe but mostly seen on lower extremities. Pt treated with Zyrtec and Tylenol. Rash and symptoms gone 6/30/2005 in AM.
Initial report received from a non-healthcare professional (patient's mother) on 05 September 2013. A female patient had received a dose of DTaP (manufacturer unknown, batch number was unknown, dose in series, route and site of administration were not reported) on an unspecified date in 1988. The patient's pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at time of vaccination was unknown. The patient's concomitant medications were not reported. On an unspecified date after vaccination the patient developed fever and swelling at injection site. Laboratory investigations and corrective treatment were not reported. On an unspecified date, the patient had recovered from events. Documents held by sender: none.
She was gray, but she had a little color in her lips; Toes were tingling; Woke up and passed out/when she got up, she passed out a little in her bed; Arm is numb/Leg on the left side is numb; Arm obviously hurts; Is weak, too weak to walk on her own; is weak, too weak to walk on her own; This is a spontaneous report from a contactable consumer. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0185) dose 1 via an unspecified route of administration in Arm Left on 24May2021 16:30   (at the age of 16 years old) as single for COVID-19 immunisation at pharmacy. Patient's medical history (including any illness at time of vaccination) was none. The patient's concomitant medications were not reported. The patient was taking Pfizer Covid Vaccine so hopefully the patient doesn't get COVID and can be a global citizen, to keep everyone safe. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none, caller confirms it was patient's first dose of the Pfizer Covid vaccine. Prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. Adverse events following prior vaccinations was none. The patient experienced as, arm is numb/leg on the left side is numb on 24May2021, woke up and passed out/when she got up, she passed out a little in her bed, she was gray, but she had a little color in her lips, toes were tingling on 25May2021, arm obviously hurts, is weak, too weak to walk on her own on an unspecified date on May2021. Reported as, Caller states she has a foreign exchange student living with her, she's 16. Caller states the patient got her first shot yesterday, and this morning she woke up and passed out. Caller states the patient's arm obviously hurts, but her biggest complaint is that her arm is numb and also her leg on that left side, the left arm, and left leg have been numb until this morning and then she passed out. Caller states the patient tried to get up to go to bathroom this morning and when she got up, she passed out a little in her bed, then she got up and tried to make it to the bathroom. Caller states when the patient came in her room, she was gray, but she had a little color in her lips, then passed out. Caller states the patient didn't stay passed out, but she was limp. Caller reports the patient never lost consciousness. The caller states the patient has stated her toes were tingling also. Caller reports the patients tingling in her toes, and the passing out began 25May2021. Caller reports the patient's numbness in her limbs were immediate and began 24May2021. Caller states the patient is still not feeling well and is weak, too weak to walk on her own. Caller initially confirms the patient has recovered completely from her symptoms but then confirms that she is getting better and has improved for all symptoms reported. Outcome of all the events were recovering.  Follow-up attempts are needed. Further information is requested.
10 years of age patient received a dose of Kinrix on July 5th 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2TP74, expiry date 10-JUN-2024) for prophylaxis.   Previously administered products included dTap (received 4 doses of dTap vaccine on an unknown date) and IPV (received 3 doses of IPV vaccine on an unknown date).   On 05-JUL-2023, the patient received Kinrix. On 05-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 10 years of age patient received a dose of Kinrix on July 5th 2023). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Nov-2023 The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received a dose of Kinrix at an inappropriate age, which led to inappropriate age at vaccine administration.
My Mom had headache, body pain, chills and fever  and very weak on the 29, and 30 of April. On May the 3,2021 I found my Mom Dead in Bed. My Mom was a very active lady for her age.
PT did not have a reaction to vaccine Pt was given vaccine after beyond refrigeration date. Lot number was not expired yet.
three patients received a expire vaccine, with no AE reported; Initial information received on 21-Oct-2021 regarding an unsolicited valid non-serious case from a other health professional via consumer/non-Healthcare Professional via Medical Information (Reference number- 00822925).  This case involves a three unknown demographics patients who was vaccinated with the expired dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On 15-Oct-2021, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  It was reported "she just got this nurse manager job and that there had been rotating nurses before and the new shipment was mixed in the refrigerator with the old shipment and she doesn't know how to proceed and she feels awful about it. She states that she wanted to repeat the vaccines and she is calling us today without the knowledge of others at her practice. She states that they have a very fragile population in particular that is immunocompromised and she has to protect them. She states that the literature I have e-mailed her is pertinent because she doesn't want the patients to be afraid because they are getting another vaccination and this way she has something to present to them.."  At time of reporting, 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 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.  There will be no information available on the batch number for this case.
Massive chest pain that seemed to originate in the lungs. Worse with each inhale. Began about 12 hours after the injection and lasted about 2 hours.  Also severe headache, beginning hours after injection, that lasted about 48 hours. Could not attend classes the next day. These symptoms were accompanied by high fever, chills, body aches, which began with the headache and did not dissipate for about 48 hours.
At site of DTaP, patient developed redness, swelling and induration (5 x 5.5 cm.)  Mom scheduled office visit.
LMP was 12/15/2020. Vaccine given on 12/22/2020. 3 positive pregnancy tests on 01/16/2021. Miscarried on 01/20/2021 as confirmed by serial quantitative hcg testing. Estimated 4-5WGA. Expectant management at home only
Pulmonary embolism diagnosed following CT scan on 4/9/2021. Noticed pain in right lung a few days previous (4/7/2021). Prescribed Xarelto.
Rash on abdomen and back of neck, ("red dots") Fever of 100.5. Same rash as when child took amoxcil.
According to the family, he had symptoms of weakness, nausea, headache, difficulty breathing beginning May 15, 2021.  They spoke with him on Sunday, May 16, 2021 and he was continuing to have symptoms.  On Monday, May 17, he called one of his daughters, but she missed the call.  The family tried to call him on May 18- and May 19, but they couldn't reach him.  A welfare check was initiated on May 20; however, the police didn't enter the residence.  He was found dead in his bed on May 21, 2021, with changes of decomposition.
VACCINE GIVEN ON THURSDAY, JUNE 4, 2009.  SUNDAY A.M. WHEN I AWAKENED MY BODY WAS HURTING ALL OVER, AND MY SKIN HURT!! I WAS WEAK. I TOOK 2 EXTRA STRENGTH TYLENOL AND RESTED & SLEPT THE ENTIRE DAY.  SINCE IT WAS SUNDAY I DID NOT SEEK MEDICAL HELP OR NOTIFY THE PHARMACIST.
Severe local reaction measuring 2.5 inches in diameter of induration.  Prescription for Pramoxine-Hydrocortisone 2.5-1% cream prescribed.
Patient had no adverse event or outcome. After administration, was discovered that vaccine refrigerator was out of temperature range. Patient is notified and offered re-vaccination. Patient had TDap on 9/21/2021, also in vaccine refrigerator when out of range. Patient also had no adverse event or outcome from that immunization. Also notified and offered re-vaccination.
I have depression I can pit the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (I have depression I can pit the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Depression.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (I have depression I can pit the vaccine). At the time of the report, DEPRESSION (I have depression I can pit the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: follow up was received on 26-may-2021 and contain no significant information
a little bit of cold; a slight rise of temperature; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (a little bit of cold) and PYREXIA (a slight rise of temperature) 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-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced NASOPHARYNGITIS (a little bit of cold) and PYREXIA (a slight rise of temperature). At the time of the report, NASOPHARYNGITIS (a little bit of cold) and PYREXIA (a slight rise of temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Reporter did not allow further contact
COVID 19 Treatment; COVID 19 Treatment; Pfizer/ BioNTech Dose number 1, Dose number 2/ Pfizer / Moderna Dose number 3/ BioNTech Dose number 4; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 31Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 03Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Asthma until early 20s. I am 32. Anxiety.; "Asthma" (unspecified if ongoing), notes: Asthma until early 20s. I am 32. Anxiety. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Jan2022, outcome "not recovered", described as "Pfizer/ BioNTech Dose number 1, Dose number 2/ Pfizer / Moderna Dose number 3/ BioNTech Dose number 4"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jul2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2023) Negative, notes: Negative PCR test 05Jul2023; (08Jul2023) Positive, notes: It is my first. Positive test 08Jul2023; (19Jul2023) Positive, notes: 19Jul2023: Symptoms return (runny nose, mild cough) Positive antigen test nasal swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patients current age is 32 years. The patient does not have any Known allergies.  Adverse event: Jul2023 First symptoms: Tuesday 4 or Wednesday 5. The patient does not remember. Negative PCR test 05Jul2023. The patient tested because her sister had symptoms but was testing negative with nasal antigen. She still never tested positive on nasal antigen. This is her 3rd time with COVID. It is the patient first. Positive test 08Jul2023. No tests were taken between these dates. Paxlovid started Sunday the 9th, no doses were missed. Anti-viral details: Product: COVID 19 Treatment, brand: Paxlovid, Treatment start date: 09Jul2023, Treatment stop date: 13Jul2023, indication: Treatment of COVID-19. 19Jul2023: Symptoms return (runny nose, mild cough) Positive antigen test nasal swab.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information, a possible contributory role of the suspect product cannot be completely excluded for the reported events 'vaccination failure' and 'Covid-19' due to a plausible temporal association. Interchange of vaccine products might have played a causal role in the reported events.
Decrease  O2  Increased blood sugar Increased b/p Increased short. Of breath
Felt lightheaded after vaccination. Had pruritis over arms bilaterally. Had two urticarial lesions over back.   SBP 144. The patient was provided with water and asked to lie down. The patient felt better and able to ambulate. Pruritis resolved without intervention. Urticaria almost completely faded.   No SOB, GI distress, mucosal involvement, difficulty swallowing.
Arthralgias post AVA #6 with later development of sleep disturbance, chronic fatigue, impaired memory and concentration, and possible post exertional malaise.  Symptoms: Fatigue, Malaise >60 Days, Insomnia, Cognitive deficiency, Joint Pain, multiple joints.
Arm soreness 12/03/2021 around 24 hrs after injection, headache and fatigue 12/03/2021 - 12/06/2021.
Swelling, redness, rash (L) arm & shoulder; mild fever (antibiotics) PO BID x 10 days.
My arm began to get sore at the injection site on the evening of my injection.  The next day I developed a golf ball sized, red bump.  I iced it and took Ibuprofen for a couple of days.  It resolved by day 5.  On day 6, a small donut sized, red, sore and itchy spot appeared.  I called my doctor and she told me to put ice on it and take Tylenol.  I just put ice on it.  It was gone by day 11.  On day 12 I have a red ring around my injection site with other red patches beneath.  I am reporting this issues on day 13.
Numbness in arm at 11:02 am  V/S  109/61  p. 64 at 11:10 am  V/S  128/66 p. 68
Client received his first Pfizer COVID-19 vaccine dose at 2:54pm. At 3:07pm,  client raised his hand in the Vaccine Site Observation Area and was assisted by EMT on call. Client  stated he felt "dizzy and lightheaded".  EMT escorted client to a zero gravity chair and assessed his symptoms while a second EMT checked his vitals every 5 minutes. Vitals were within normal range. Client alert & oriented x4. Denied nausea or shortness of breath.  Last intake at 12pm. Client stated he got his blood drawn at 1:30pm and had felt dizzy when he got his blood drawn as well.  Client was given a bottle of water. At 3:14pm, client stated the dizziness had resolved. At 3:21pm, client stated he felt "completely normal" and walked with steady gait out of facility. Client stated he would be driven home by his sister.  Information on V-Safe given.