chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Very very full/Very stuffed; Not feeling the greatest; 8-10 trips to void the food; Vomiting; Fatigue; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (Very very full/Very stuffed), FEELING ABNORMAL (Not feeling the greatest), FREQUENT BOWEL MOVEMENTS (8-10 trips to void the food), VOMITING (Vomiting) and FATIGUE (Fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bypass surgery (5 bypass surgeries) in 2018. Concomitant products included VITAMINS NOS for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced ABDOMINAL DISTENSION (Very very full/Very stuffed), FEELING ABNORMAL (Not feeling the greatest), FREQUENT BOWEL MOVEMENTS (8-10 trips to void the food), VOMITING (Vomiting), FATIGUE (Fatigue) and HEADACHE (Mild headache). At the time of the report, ABDOMINAL DISTENSION (Very very full/Very stuffed), FEELING ABNORMAL (Not feeling the greatest), FREQUENT BOWEL MOVEMENTS (8-10 trips to void the food), VOMITING (Vomiting), FATIGUE (Fatigue) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
DOWN FOR 2 TO 3 DAYS AFTER VACCINATION; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse event following covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced down for 2 to 3 days after vaccination and the patient was dread of receiving the third dose although patient knew it would be helpful (dose number in series 2). The reporter stated that "yeah I'm down for 2 t 3 days after I take it, dread getting there 3rd. Although I know it helpful." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of down for 2 to 3 days after vaccination was not reported. This report was non-serious.
cannot eat anything; Can not go to work; diarrhea; Rash on the arm at the injection site; fatigue; muscle pain; chills; Rash is swollen on the arm at the injection site; Rash is red on the arm at the injection site; Rash is itchy on the arm at the injection site; Rash is painful on the arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), VACCINATION SITE SWELLING (Rash is swollen on the arm at the injection site) and VACCINATION SITE ERYTHEMA (Rash is red on the arm at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), VACCINATION SITE SWELLING (Rash is swollen on the arm at the injection site), VACCINATION SITE ERYTHEMA (Rash is red on the arm at the injection site), VACCINATION SITE PRURITUS (Rash is itchy on the arm at the injection site), VACCINATION SITE PAIN (Rash is painful on the arm at the injection site) and VACCINATION SITE RASH (Rash on the arm at the injection site). On 17-Apr-2021, the patient experienced DIARRHOEA (diarrhea) and IMPAIRED WORK ABILITY (Can not go to work). On an unknown date, the patient experienced DECREASED APPETITE (cannot eat anything). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), VACCINATION SITE SWELLING (Rash is swollen on the arm at the injection site), VACCINATION SITE ERYTHEMA (Rash is red on the arm at the injection site), VACCINATION SITE PRURITUS (Rash is itchy on the arm at the injection site), VACCINATION SITE PAIN (Rash is painful on the arm at the injection site), DIARRHOEA (diarrhea), DECREASED APPETITE (cannot eat anything), IMPAIRED WORK ABILITY (Can not go to work) and VACCINATION SITE RASH (Rash on the arm at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product usage were not provided. Treatment details were not provided.
Pt. describes soreness within 2 hrs. and pain at site. Next day c/o swelling and difficulty moving arm. 9-10-12 ER visit with diagnosis of cellulitis - IV antibiotics and sent home with steroid pack and BENADRYL. Began PT to prevent frozen shoulder 10-10-12.
Redness right atm at inj site 1/2 dollar sized no fever no streaking. Swelling.
Patient received an undiluted 0.3mL of the pediatric COVID-19 vaccine(Orange Cap). Patient did not have any side effects immediately following the administration of the vaccine. Any adverse events from patient after leaving the pharmacy are unknown
pt recvd vax 8APR93 approx 1400 had urticaria all over w/some facial edema; sent to ER;
first racing heart, chills, aching muscles, headaches, nausea, vomiting, feaver
Light headed, dizzy,neck pain, tiredness, blood pressure high, nausea   Thought I was having a heart attack.
Received vaccines DTAP #5 and IPV #4 on 01/18/2005, on 01/19/2005 left deltoid area with erythema 4x3 CM light pink and streaks.  Warm compress, pain control, observe.
This case was reported by a nurse and described the occurrence of lump injection site in a 4-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) plus a separate injection of Haemophilus influenzae type b conjugate vaccine (Hib vaccine, unknown noon manufacturer). On 17 March 2006 the subject received 2nd dose of Pediarix in an unspecified thigh (lot number not provided) and an unspecified dose of Hib vaccine "in the same thigh". On 17 March 2006, the subject also received 7-valent pneumococcal conjugate vaccine (Prevnar) "in the other thigh". On 17 March 2006, less than one day after vaccination with Pediarix and Hib vaccine at an unspecified time after vaccination with Pediarix and Hib vaccine, the subject experienced redness and swelling at the injection site and a small lump under the skin at the injection site of Pediarix and Hib vaccine. At the time of initial reporting, 27 March 2006, the swelling injection site had resolved, the redness injection site had improved and the lump under the skin at the injection site was ongoing. The nurse considered the events to possibly be related to vaccination with Pediarix and Hib vaccine. Follow-up will not be available.
sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On 8th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the dose of Shingrix  and experienced sore arm which led to pan in arm. The patient states that she does not have fever. The reporter did not consented to follow up.
Day 1: Jittery after coffee (unusual. Lasted for 1 month). Fatigue for approx 1 week. Day 2: Very sleepy.  Day 5: Menstrual - very heavy for 3 days. Day 6: Very sleepy. Pain in buttocks & pelvic area lots of pressure. Stomach problems. Still very sleepy. Left wrist pain started (sharp, achy, constant).  Pain similar to doing too many handstands. Day 7: Wrist pain progressively worse. Has not done anything to aggravate arm. Day 8: Pain in wrist now has traveled to elbow. Day 15: Pain in left arm is now from elbow to fingers. Not swollen. Pain pretty constant. Day 16: Pain in arm = level 8. Day 24: Wrist sensitivity lingers. Can't put pressure on arm. Bowel movement irregular (not solid, color off) - lasted for at least 1 month. 2 Months: Menstrual heavy w/ clumps. Sore throat. Low-grade fever. 1 week later - dry cough. 3 Months: Tired & dizzy. No appetite.   Painful bumps appeared in vaginal area as had previously appeared after 1st vaccine dose. Painful to touch. Low-grade fever with sore throat. Sore neck.
On L arm where DTAP and Hib were administered, there is redness, induration and is warm to the touch.
Imm on 4/29 - macro-vesicular rash inside ( L ) elbow- 4/2-spread to rash - also spread to inside ( R ) knee 5/6/10 & ( R ) cheek today.
Entire body is covered in huge hives and rashes/hives and rashes were all over my thighs, hips, stomach, back, legs, arms, neck; Entire body is covered in huge hives and rashes/hives and rashes were all over my thighs, hips, stomach, back, legs, arms, neck; Feel extremely hot; Had trouble sleeping; itchy on her head/itchiness spread throughout my body/itchy on my head, neck and ears; Feel feverish; This is a spontaneous report from a contactable consumer (patient herself). A non-pregnant 30-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in left arm, at age 30-years, on 27May2021 18:30 (Batch/Lot Number: EW0185) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Medical history included herpes simplex virus 1, beta thalassemia, allergy to green onion, white onion, leeks, garlic, wheat, mangoes and chemical sunscreens. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient historically received first dose of BNT162B2 (Batch/lot number: EW0172), on the left arm at age 30 years on 06May2021 06:30 PM for COVID-19 immunisation. On Friday 28May2021, patient started to feel feverish around 11AM and that last until Saturday evening. Saturday night 29May2021 23:45, patient began to feel extremely hot and itchy on her head, neck and ears. She also had trouble sleeping because the itchiness spread throughout her body. She woke up Sunday morning 30May2021 and discovered that her entire body was covered in huge hives and rashes. The hives and rashes were all over her thighs, hips, stomach, back, legs, arms, neck. She tried taking BENADRYL all day Sunday but on Monday evening, 31May2021 the hives started spreading more to new places: a huge circle patch in between her chest, on the sides of her ribs,  under her armpits, the size of a pancake-shaped hive on her neck and collarbone, pancake-shaped hive on the back of her tail bone, on her  buttocks, as well as hives spreading down to the right arm and hand. This Tuesday morning 01Jun2021, patient woke up and find the hives were in new places on her body: many large hives splotches on her shins and calves. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. The outcome of the event feel feverish was recovered on 29May2021, while for the other events, it was not recovered.
Got a fungal infection / after first vaccine; Im falling apart; No social life again, look like a swamp thing; Herpes went away after Shingrix 1st dose; trying to Kill me; Mental and physical abuse; Mental and physical abuse; Inappropriate age at vaccine administration; DOB 2/11/1983 / had herpes and took Shingrix; This case was reported by a consumer and described the occurrence of fungal infection in a 36-year-old male patient who received Herpes zoster (Shingrix) (batch number 2AH5M, expiry date 18th May 2021) for prophylaxis.   The patient's past medical history included herpes virus infection. Previously administered products included Flulaval trivalent (received Flulaval trivalent vaccine on 15th October 2015), Flu Quad (received on 15th October 2015, in right deltoid,batch number:H33J2, expiry date: 31st May 2016), Flu Quad (received on 4th December 2014, 0.5 ml in left deltoid,batch number:UI173AB, expiry date: 30 June 2015) and Tdap (received on 11th February 2012).   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th April 2019, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration and drug use for unapproved indication. On an unknown date, the patient experienced fungal infection, emotional disorder, social withdrawal, unexpected therapeutic effect, feeling abnormal, physical abuse and mental distress. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the fungal infection, emotional disorder, social withdrawal, unexpected therapeutic effect, feeling abnormal, physical abuse, mental distress, inappropriate age at vaccine administration and drug use for unapproved indication were unknown.   It was unknown if the reporter considered the fungal infection, emotional disorder, social withdrawal, unexpected therapeutic effect, feeling abnormal, physical abuse and mental distress to be related to Shingrix.  Additional details were provided as follows: The patient stated that he had herpes and took the Shingrix vaccine and the herpes went away, but he developed a fungal infection after the first vaccine and the fungal infection was now all over his body.  The patient stated that he had no herpes on his private parts, but had a fungal infection that progresses to get worse and worse.  The physician continued to give steroid cream that causes it to spread all over body. The patient stated that vaccine was trying to kill him. The patient was not even going to start talking about the issue. The patient would never having the opportunity to have a social life again. The patient was suffering from mental, and physical abuse. The vaccine was making him look like a swamp thing, spreading rumors around and about him. Locking him up in every year. The patient was falling apart, and GSK company was to blame.  The reporter was consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021183425:Same reporter.
pt recv vax & exp lt upper arm red & tender;no fever;no APAP;tender to palpate;lt arm 8x12 cm red area tender;negative swollen;negative ax or supra clavicular LN;infect r/o cellulitis p/DPT;tx APAP for pain, DPH, ATB;
48 hrs after the first Moderna shot, I got hives pretty bad over four days. I took benadryl, took oatmeal baths and used cold compresses to help alleviate the symptoms.
Within 5 minutes after injection I felt nauseated and had a metallic taste in my mouth.  Both continued for the rest of the day(Thursday 4-8-21). In the evening my body began to ache intensely.  Tossed and turned all night feeling ill with chills and feverish.  Second day (Friday 4-9-21) nausea subsided and body aches were intense followed by headache.  By the evening of the second day I noticed a rash on my left clavicle an inch away from my neck as well as a large raised cyst like shape.  By morning today (Saturday 4-10-21) the rash was gone but the cyst has remained and is more tender to the touch.
Ongoing tingling to left side of face from forehead down to chin. Does not cross the midline. 1/16 at 3 am started with headache off and on, overall not feeling 100%. Rested and drinking fluids, without resolving completely.
Facial flushing; Weakness; Fatigue; This is a spontaneous report from a non-contactable pharmacist. A 52-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an intramuscular route of administration in the left arm on 21Apr2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. On an unknown date in Apr2021, the patient had facial flushing, weakness and fatigue, monitored for 2 hours before leaving. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events facial flushing, weakness and fatigue was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
First three days was just muscle soreness and fatigue.  On day 4 I started having tight chest and SOB while snowshoeing, which I did not have the day before on same activity.  That night I woke up with SOB and tightness in my chest and severe pain in area of my heart.  I could not lay on my left side.  It seemed like I was having heart attack symptoms.  Barley slept but upon waking my heart rate was 94 and the pain remained in LT Axilla area.  Took it easy for day and that night again had trouble sleeping, SOB but not as bad.  Woke up with excrutiating pain radiating up the base of my RT skull.  Was concerned about blood clot potential??  Had SOB when walking up stairs.  My throat hurt when bending over, as if my esophagus was crushing.  Friends said my face looked puffy and I felt bloated.  Landed up reporting to ER at the Hospital on Monday, Feb. 1st as directed by my PCP.  Hospital was told I had just had 2nd dose of vaccine, but did not think it was related.  I will mention all tests below, but upon arriving home on Feb. 2nd, I discovered a rash breaking out on underside of my LT upper arm, LT inner thigh and LT lower leg.
Pt. with shaking, fever, lethargy, runny nose. Seen at emergency department.
Rectal bleeding; This is a spontaneous report from a contactable Pharmacist. An adult female Pharmacist (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on 23Aug2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. In Aug2021, the patient experiencing rectal bleeding (medically significant). The outcome of event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Rectal Bleeding. 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.
On Friday it started with pain in my leg and it moved up my leg to a rash on my bottom and pain in my ribcage on the same side of my leg. It was shingles. On Sunday I went to the hospital, they did an EKG, chest x-ray, blood work, ultrasound, which all came back normal. Then they diagnosed me with shingles.
Vaccine given subcutaneously; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine given subcutaneously) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 23-Mar-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine given subcutaneously). On 23-Mar-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine given subcutaneously) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.       Concomitant medications were not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received on 28-JUN-2021 included no new information.
2:37 she received 1st dose of Moderna vaccine 2: 50 Patient c/o itching at insertion site ; itching spread to her hands and feet. Lung sounds clear ,  room air sat was 97% 2:54 Benadryl 25 mg given PO x 1 dose and continued to monitor pt. Her BP was 147/97. Pt was having some anxiety due to  itching. 03:15 patient states itching is better. Lung sounds remain clear, Denies any itching on her throat. Voice is clear; no changes to voice changes.  Pt advised to report any additional side effects to VESAFE app. Will follow up  1/28/2021
Approximately 5-10 minutes after receiving vaccines, mom states child sneezed & started "whining" & scratching all over". She noticed he was breaking out in hives then he started coughing. She took him directly to the emergency room at the hospital where he was given epinephrine.
; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (  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 09-Mar-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 TINNITUS (). At the time of the report, TINNITUS  outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
rash; Initial information received on 28-Aug-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to case 2023SA265322(CLUSTER).  This case involves a patient of an unknown age and gender who experienced rash after receiving Meningococcal A-C-Y-W135 (T Conj) Vaccine [Menquadfi].  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 unknown dose of suspect Meningococcal A-C-Y-W135 (T Conj) Vaccine solution for injection (strength, expiry date and lot number not reported) via unknown route in unknown administration site for immunization.  On an unknown date, the patient developed a rash (unknown latency).  Information on the batch number was requested.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (rash).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event.