chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The injection site became swollen, sore and itchy.  I also had a rash on my left hand and sharp pains in my fingers.  A few hours later, the swelling went down and the rash was less intense.  I did not seek medical attention, as I did not feel the symptoms warranted an emergency room visit. I  thought this was odd that it occurred a week after I was given the vaccine, but it was obviously due to the vaccine.  I am wondering if it is safe for me to receive the 2nd dose?  I had a severe reaction( dizziness, headache, severe vomiting and diarrhea) to a flu vaccine in 1987 and I have not received a vaccine of any kind since.
Sudden infant death; Taken to hosp by ambulance; Assessment: critically ill child w/significant metabolic acidosis due to some unk event; Most likely aspiration which caused cardiopulmonary arest;
Felt dizzy at work the next day after the second shot. Passed out and then was sitting down and I felt nauseous. I threw up 5 times and my arms started to get numb. I had a fever when I got home and I couldn?t move because my body hurt so badly. Migraine and dizziness has been persistent ever since and is interfering with my daily life. Been treating with tylenol which helps a little but not completely. As soon as I stand up and move I feel like I?m going to pass out.
I have only had the first Moderna dose. I did not have any immediate reaction to it other than some soreness at the injection site.  One week after receiving my first vaccine dose, I noticed a red, hot, itchy circular area around the injection site (about 2 inches in diameter).  I notified my doctor. I am taking 2 benadryl at night, and Allegra during the day.  Reddish area grew slightly in size over the next 2 days, then started to diminish.  It is still slightly pink, but improving.
Patient hasn't received her 2nd dose yet; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received her 2nd dose yet) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received her 2nd dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received her 2nd dose yet) outcome was unknown.        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.   No relevant concomitant medications were reported. No treatment information was provided.
Had no pain in arm or redness for the first 10 days. Developed severe pain in my arm  from the injection sight up to my ear and neck. The pain in my neck stayed for 9 days with pain to my arm that was terribly painfull. Now I still have an ache in my neck and arm that is mild but also feels very tired like if you had a neck injury from nerve pain
This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of VAQTA injection 9strength, dose, route of administration, indication, lot # and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Paxlovid treatment from 30Nov2022 to 05Dec2022; Paxlovid treatment from 30Nov2022 to 05Dec2022; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Batch/Lot number: unknown), on 17Mar2021 as dose 2, single (Batch/Lot number: unknown), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "Type 2 diabetes mellitus" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Restless leg syndrome" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; LISINOPRIL; AMLODIPINE; LEVOTHYROXINE; TRAMADOL; GABAPENTIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Paxlovid treatment from 30Nov2022 to 05Dec2022". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
6 y.o. boy inadvertantly given Td because DOB on IZ card was incorrect.  Error noticed in immediately, and patient immunized with DTaP same day.  Mom made aware of mistake.
Vaccine administered 07/09/2003; Febrile Seizure 07/13/2003; Diagnosis of Pneumonia 07/13/2003; Child recovered well without symptoms of illness.
32 hrs after Flu vaccination a large deep red area about 2 1/2 inches below the injection spot. Spot was slightly swollen and warm to the touch. 6 hours spot started to bruise.
arm was itching; swelling there's a liquid, red, hot, and now it has travelled all over his elbow to his wrist; Vaccination site erythema; hot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Feb-2021 and was forwarded to Moderna on 07-Feb-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (arm was itching), SWELLING (swelling there's a liquid, red, hot, and now it has travelled all over his elbow to his wrist), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and INJECTION SITE WARMTH (hot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047620A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (arm was itching), SWELLING (swelling there's a liquid, red, hot, and now it has travelled all over his elbow to his wrist), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and INJECTION SITE WARMTH (hot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, PRURITUS (arm was itching), SWELLING (swelling there's a liquid, red, hot, and now it has travelled all over his elbow to his wrist), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and INJECTION SITE WARMTH (hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
No initial symptoms other than a sore arm when i got my second shot on 1/8. On 1/21/21 started with hives, uticaria, and mild angioedema that has not yet subsided despite having received treatment. was told it could be a late reaction and that i should report it.
This is a request to ask the FDA to encourage the scientific community to pursue an ETHICAL Covid-19 vaccine that does NOT use the fetal line of aborted children in either the production or testing of a vaccine!! Many of us have a conscientious objection to the use of aborted children in this manner and will not participate in this unethical use of human beings.
Blurry vision, high BP, high pulse, and nausea occurring approx. 2-3 hours after vaccination.
I was tired and slept a lot other than that I had a cough and that was it. I did have extreme tiredness.  I slept for eighteen hours.
Persistent soreness that lasted over 1 week with some redness that travels down the arm. Patient was advised to use cold compress and option to take tylenol or ibuprofen (with food) for comfort if soreness and redness persist.
Patient received 2nd dose of the Johnson and Johnson Covid-19 vaccination.  First dose on 3/10/21 and on 4/7/21.  Patient is aware of this mistake.  She has not had any complications or health concerns following the vaccines.
LARGE AREA OF REDNESS, TIGHTNESS, WARM TO TOUCH WITH BLISTERING OF RIGHT UPPER DELTOID AREA.  PATIENT AFEBRILE, AND FEELING FINE.
Dose given Friday morning. Chills, followed by fever and severe tremors began Friday late evening. Shaking was violent and uncontrolled, but patient retained gross motor function. Shaking so severe that anything other than lying in bed posed a threat. Tremors lasted roughly six hours, then quickly subsided and did not return. Roughly 48 hours of severe headache, mild light sensitivity, and severe fatigue characterized by nearly 30 hours of sleep between Saturday morning and Sunday evening.
Chills, aching, flu like symptoms, swollen, red and rash at injection site, inflamed, itching and sore to the touch.
Information has been received from a physician via a company representative referring to a currently 20 year old female patient. The patient was not pregnant. The patient's medical history and drug reactions/allergies were not reported. Concomitant medication included (unspecified) TDAP and MENACTRA. In approximately 2007, when she was 11 year old, the patient was vaccinated with GARDASIL (lot # and expiration date were unknown, 0.5 ml) intramuscular. It was unknown whether the patient had received her first, second or final dose of the GARDASIL series when she received the dose referenced in this report. After getting the vaccine shot, the patient developed a medical condition called "Postural Orthostatic Tachycardia Syndrome" (date unspecified). Initially, the patient had her follow up visits when she was younger with her primary care physician (the reporter) who was evaluating her symptoms after she had received the shot. After she was officially diagnosed with Postural Orthostatic Tachycardia Syndrome, she began seeing an unknown cardiologist. It was unknown if treatment was given for the event. The outcome of the event was not recovered. The causality was not reported. Additional information has been requested.
Patient complained of local itching around injection site approximately 15 minutes after vaccination. Patient had history of allergies to other meds and pharmacist administered diphenhydramine by mouth to patient. Patient said itching went away within a few minutes of taking diphenhydramine. Pharmacist continued to monitor for an additional 45 minutes. Patient had no further complaints
I felt extreme fatigue & headache from 2am until 10pm on Thirsday. I went to work but could not drive. I missed 4 hours of work and came home to sleep. I could not lift my arm Thursday but that went away by Froday morning. On Friday I had fever and chills.
Recurrent diarrhea; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and DIARRHOEA (Recurrent diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced DIARRHOEA (diarrhea). On 14-Apr-2021, the patient experienced DIARRHOEA (Recurrent diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. On 21-Mar-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, DIARRHOEA (Recurrent diarrhea) had not resolved.            No concomitant medications were reported.
One episode of bloody stool and decreased formula intake (drank two ounces during day).  Was sent to ED at Hospital.  In ED they did an ultrasound and patient was found to have an intussusception and required surgery.
MMR vaccine was given in the incorrect route. Vaccine was given IM instead of SQ.   No adverse reactions at the time of the event.
No additional adverse events reported.; administration of PROQUAD to an 14 year old Patient; This spontaneous report was received from a physician and refers to a 14-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 22-AUG-2022, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin [rHA]) (PROQUAD) subcutaneous injection, 0.5 ml, lot # W012741, expiration date 16-OCT-2023, for prophylaxis (route of administration and anatomical site were not provided) (product administered to patient of inappropriate age). No additional adverse events were reported (no adverse event).
Patient developed area of erythema and increased warmth approximately 4 cm x 3 cm, 8 cm distal to injection sites and associated with pruritus. Seen at urgent care center on 02/07/18, and diagnosed with local allergic reaction per patient; no discharge papers available. Advised to take diphenhydramine and return if symptoms increased or failed to resolve. Had only local reaction; no periorbital or circumoral edema, no SOB/DOE, no N/V/D. Patient was referred to allergist on 02/08/18 after she related this diagnosis.
No clinical symptoms and side effects. No additional AE/PQC; she received first dose of GARDASIL 9 series over a year ago approximately, and then received 3 additional doses for a total of 4 doses of GARDASIL 9; This spontaneous report was received from a Pharmacist and refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant therapies were not provided.  On an unknown date in 2022 (over a year ago approximately), the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (anatomical location, strength, lot #, expiry date, and route of administration were not provided). Then, the patient received 3 additional doses for a total of 4 doses of suspect therapy (extra dose administered). No clinical symptoms and side effects. No additional adverse events.
post-herpetic neuralgia; The vaccine did not prevent shingles as intended; shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient of unknown age. Information about concurrent condition, medical history and concomitant therapy was not reported. In 2011, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date not reported) at a Pharmacy, as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 15-DEC-2011, the patient was treated by a physician, for the onset of a severe vesicular rash, which was diagnosed as shingles. The patient was prescribed amitriptyline (ELAVIL) for management of her painful symptoms and chronic pain. On or about 31-JAN-2012, the patient sought subsequent from the physician, for the diagnosis of post-herpetic neuralgia, a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed amitriptyline pregabalin (LYRICA) for management of her painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events post-herpetic neuralgia, herpes zoster and vaccination failure was not reported. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
On 11/18/2022 begin with abdominal pain; heartburn; abdominal pain lasted through the 11/20/2022; heart burn continued until doctors office visit on 11/22/2022; prescribed PRILOSEC, symptoms subsided shortly after.
Received vaccines on 4/6/12. On 4/11/12 reported via phone conversation that on night of 4/9/12 he developed a rash with hives on lower legs and trunk. 4/13/12 Patient saw his PCP & reports rash/hives.
This spontaneous report was received from a physician via company representative, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 03-APR-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 Single dose 0.5mLVls 10SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration unknown), which was stored at 34 Fahrenheit (F) Degrees (1.111111111 Celsius) for a total of 144 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Irritable bowel syndrome; Vaccination adverse reaction; Hives; Pinched nerve; Hip replacement; 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-163-4236033-00 (Abbvie).  A 55 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 08May2021 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single and intramuscular, administration date 18Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HIP ARTHROPLASTY (medically significant) with onset 12Aug2021, outcome "recovering", described as "Hip replacement"; IRRITABLE BOWEL SYNDROME (medically significant), outcome "unknown", described as "Irritable bowel syndrome"; VACCINATION COMPLICATION (medically significant), outcome "recovering", described as "Vaccination adverse reaction"; URTICARIA (medically significant), outcome "unknown", described as "Hives"; NERVE COMPRESSION (medically significant), outcome "unknown", described as "Pinched nerve". The action taken for adalimumab was unknown.  The reporter considered "hip replacement", "irritable bowel syndrome", "vaccination adverse reaction", "hives" and "pinched nerve" related to bnt162b2.  Causality for Humira (Adalimumab):  The reporter's causality for the event(s) of left hip replaced, irritable bowel syndrome, side effects from covid shots and booster, hives off and on possibly caused heat and pinched nerve in back with Humira (Adalimumab) was no reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of left hip replaced, irritable bowel syndrome, side effects from covid shots and booster, hives off and on possibly caused heat and pinched nerve in back are related to humira (Adalimumab). Causality as per reporter for Pfizer BioNTech Covid-19 Vaccine (Tozinameran) for events hip replacement, Irritable bowel syndrome, Vaccination adverse reaction, Hives, Pinched nerve 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: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Next day, arm very sore, red area about 3 inches by 3 inches around injections site.  Red area also very hard and swollen.
Parent called and reported child was having strange head movements, jerking head around and around for about 15-20 min. Took to ER - no temperature, no labs or images taken. Pt had since stopped seizure like movements when got to ER.
pt had high fever & began twitching & jerking motions of hands, feet, & head 7-8 hrs p/vax; pt also fussy & didn't feed as well;
NO DISTRESS NOTED AT THE TIME OF OR AFTER ADMIN HEP B VACCINE.  *ER NOTES, MOTHER STATED THAT 15 MINS AFTER CHILD REC'D HEP B VACCINE, SHE COMPLAINED OF HEADACHE, SHORTNESS OF BREATH AND FACE BECAME RED.  *ER NOTES AND REVIEW OF SYSTEM HEENT: COMPLAINS OF A DIFFUSE HEADACHE. DENIES BLURRY VISION, DOUBLE VISION, OR SORE THROAT. CHEST:DENIES SHORTNESS OF BREATH CURRENTLY. CARDIAC:DENIES PALPATIONS OR IRREG HEART BEAT. ABDOMEN:DENIES ABD.PAIN OR CHANGE IN BOWL HABITS. EXTREMITIES:DENIES WEAKNESS OR CHANGE IN SENSATION.  PAST MEDICAL HISTORY: NONE. MEDICATIONS: NONE. ALLERGIES: TETANUS.  VITAL SIGNS: TEMP 97.7, RESP. 12-14, PULSE 98, B/P 143/85
A week after the 2nd dose, I started to feel my right arm achy. It was pink in color. I could feel it spreading and not getting better. It was about 5X9 raised area inches down to my elbow. I used ice pack. It did not burn or itch, just painful. My muscle was swollen and bulging out towards the bottom of 5X9 raised area. My doctor was unaware of the condition so I used ice pack and anti inflammatory medication. Around the end of April 2021, I felt pain around the right shoulder. It felt like my shoulder was dislocated. I did go see a chiropractor and did physical therapy treatment. The chiropractor said it was muscular inflammation and a reaction to the vaccine. It took 4 months for the COVID arm to resolve. My shoulder pain is still ongoing.