chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swell up 3 inches lower the injection site; heat around the injection site; arm pain; Itching around the injection site; Tiredness; redness; swollen arm; body aches; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness), VACCINATION SITE SWELLING (swollen arm), PAIN (body aches), PERIPHERAL SWELLING (swell up 3 inches lower the injection site) and VACCINATION SITE WARMTH (heat around the injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No medical history was provided by reporter.  Concomitant products included LISINOPRIL for Blood pressure management.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced ERYTHEMA (redness), VACCINATION SITE SWELLING (swollen arm), PAIN (body aches), VACCINATION SITE PAIN (arm pain), VACCINATION SITE PRURITUS (Itching around the injection site) and FATIGUE (Tiredness). On 24-May-2021, the patient experienced PERIPHERAL SWELLING (swell up 3 inches lower the injection site) and VACCINATION SITE WARMTH (heat around the injection site). The patient was treated with IBUPROFEN for Pain, at a dose of 200 mg. At the time of the report, ERYTHEMA (redness), VACCINATION SITE SWELLING (swollen arm), PAIN (body aches), PERIPHERAL SWELLING (swell up 3 inches lower the injection site), VACCINATION SITE WARMTH (heat around the injection site), VACCINATION SITE PAIN (arm pain), VACCINATION SITE PRURITUS (Itching around the injection site) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient started to feel arm pain, redness, swollen, itching all in the injected arm, also she states start feeling some tiredness and body aches. Patient toke some Ibuprofen 200Mg for two days and the pain had an improvement, but on 24May2021 she starts feeling pain again, itchiness and started to swell up again the arm, but about 2 or 3 inches lower than the injection site. Patient stated that feel heat on the read area of her arm, and that she's applying cold paths to relief malaise.   Patient applying cold paths to relief malaise.
Patient had bilateral calf muscle aches, watery eyes, low grade fever and general malaise 12- 24 hours after her first flu shot. The symptoms were severe enough that she came to the clinic crying. Influenza A and B swabs were negative and exclude a concommitant influenza infection. Treatment: oral ibuprofen with good relief at the clinic. Informational sheets regarding adverse effects of flu shots given to mother.
Limp; altered state of consciousness, not responsive to interactions with parents. In another place and fever and rash. Lasted 24 hours after immunizations.
BODY ACHES; HEADACHE; EXTREME FATIGUE; This spontaneous report received from a consumer (company representative) concerned a 27 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, headache, and extreme fatigue on MAR-2021. This report was non-serious.
Swelling, redness and warm to touch at injection site - progressively worsening over week time course. Patient was given BENADRYL as treatment by physician.
Within an hour of vaccine, I experienced fatigue and muscle aches and a headache all within that first hour. Also, redness and swelling at injection site and some heat. And all of the symptoms lasted and didn't dissipate for several days. The headache was debilitating to the point that I didn't want to let wait it out and I called the hospital line and got a recommendation for ibuprofen. I took ibuprofen.  I never got a fever. I think the headache probably resolved within 3 or 4 days; muscle aches 4-5 days and I was fatigued for a week to 10 days. I was worried about my second dose and I had very few reactions to my second dose.
Information has been received from a nurse concerning unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of ROTATEQ (dose, strength, frequency, lot # and expiration date were unknown) were orally administered to the unspecified patients for prophylaxis. The ROTATEQ were exposed to following temperatures: from 35 Fahrenheit to 49 Fahrenheit, 32 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit, 35 Fahrenheit and 35 Fahrenheit for a time frame of 24 hours respectively. No adverse effects were reported. Data logger was involved, but no previous temperature excursion was reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA003579: US-009507513-1612USA003952: US-009507513-1612USA003950.
JOINT ACHES,NECK PAIN,HEADACHE,SEVERE CHILLING,SOME ABDOMINAL CRAMPING
A report has been received from a Health Professional concerning a 12 year old, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 30-Dec-2013. It was reported by health professional that four patients were inadvertently administered expired FLUMIST QUADRIVALENT which started on 30-Dec-2013. The outcome of the event expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
At first I did not associate the rash to the COVID vaccine but have been hearing others reporting rash similar to mine.  It has been ongoing to quite some time now and it seems to be spreading.  I have a rash in my armpits and upper arms, on my trunk-back and front and on my Right forearm.  I am also noticing small bruises under my breast which occurred first and bumps on the sides of my breasts.
Dizziness on 09/29/2011. Diarrhea and nausea on 09/30/2011. Increase fluids, rest, BRAT diet.
Fever of 102.5, muscle cramps, loss of balance, weakness, tiredness and blurred vision
Employee started having a fluttering feeling in her chest and felt like her heart rate was fast along with difficulty taking a deep breath due to pain on the left side of chest. She was seen in the ER and diagnosed with PVC's. She is currently still having symptoms and is to follow up with Cardiology. Potassium and fluids given in ER.
Patient received KINRIX IM (L) AT about 1610. About 5-10 mins later (while still in office) mom noticed that pt had redness/hives of cheeks & upper (L) arm along with itching, doctor did note a rash on trunk during exam prior to vaccine administration. Gave 12.5 mg of BENADRYL and observed pt. x 40 mins with resolution of sx's no difficulty breathing or swelling of mouth/tongue/lips.
Patient was found with no pulse no heart rate by a staff member around 11 pm.  Earlier that day seen by myself for fatigue, sorethroat, nausea.
Mother came in with documentation stating took to ER on 12-2-07.  Bottom of child's feet itched & spots but the spots came & went.  No allergies to eggs.  No problems with previous immunizations.  Immunizations done on 11-29-07.
Client was only given partial dose of MENVEO as the vaccine was mixed with sterile saline dilutant instead of conjugate. No adverse reaction occured.
He was very ill with nausea, vomiting, headache and fatigue requiring ER admission. This patient is a 72 y.o. male with history of partial parathyroidectomy in 2017, GERD, and HLD who presents with several days of worsening nausea, emesis, and pressure HA that developed after this Moderna COVID booster shot (third dose) last week. His symptoms started several days after the booster. HA is worsening and preventing the patient from sleeping.Took Tylenol, Sudafed, DayQuil, and ibuprofen with minimal relief. Has chronic sinus issues and reports no recent changes. No fever, chills, sore throat, abdominal pain, diarrhea, or urinary complaints. No known sick exposures. PCP is Dr.
Snycopal Episode.  BP was taken.  Gave juice and rest, recovered quickly.  Did not eat prior to coming in for visit.
Left arm sore and swollen, itching, at and around injection site. Induration of about 6 - 10 cm diameter.
Any moving to my arm towards the back, it like a slotting pain for 30 seconds. I cannot move my Left arm to the back at all. I cannot lay on my left side for any period. I have very limited monition toward the back. I went to see the doctor about this. He referred me to a physical therapist. They are unsure what is causing this.
She returned to the pharmacy 11/2/10 stating that her arm was swollen and hurting. It was red from her injection site all the way down to her elbow, warm to the touch, and slightly swollen. She said the swelling was better today than it was last night.
This spontaneous report as received from a medical assistant refers to an infant female patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013  the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknown) (lot # H018691 exp. date 07-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921, 1309USA012210, 1309USA012211, 1309USA012212, 1309USA012213, 1309USA012214, 1309USA012215, 1309USA012216, 1309USA012217, 1309USA012218, 1309USA012219, 1309USA012220, 1309USA012221, 1309USA012222, 1309USA012223, 1309USA012225, 1309USA012226, 1309USA012227, 1309USA012228, 1309USA012229, 1309USA012230, 1309USA012231, 1309USA012232. Additional information is not expected.
PATIENT RECIEVED 2 VACCINES FIRST THE PFIZER BIVALENT 30MCG/0.3ML FOLLOWED BY A FLUARIX FLU SHOT. Less than 2 minutes later the patient felt faint and lost vision.  the patient appeared to very pale and I had her immediately put her head between her legs. After a few seconds color returned to her ears and face. She stated she felt much better after doing that. I had her maintain the position until she felt comfortable. She was provided drinking water. About 15 minutes later i checked her blood pressure (109/70) and hr (65) pt stated they felt much better and were okay to leave.
Fever, Influenza A, acute suppurative OM. AUGMENTIN ES 600 mg/5mls 3.5mls po bid x 10 d, TAMIFLU 6mg/mL 5 m bid x 5 d. 2 yrs old vaccinated now with fever. Patient had red throat and runny nose. Parents concern about vaccine reaction to flu. Most like causes for fever is viral not related to vaccination. But will test for strep. Considering issue of possible reaction to flu vaccine will do nasal swab for influenza and RSV. Flu swab came back positive spoke with mom will start pt, mom and dad on TAMIFLU.
flu like symptoms; congestion in her nose; a low grade fever of 99.3; cold and flu like symptoms; eyes very watery; chill; throat is itchy; just a little tired; shoulder was sore; This is a spontaneous report received from a contactable consumer(Patient). This consumer (patient) reported for herself that the 54-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer- Biontech COVID-19 Vaccine, Batch/lot number : ER8722 or 8732) via an unspecified route of administration, administered in Arm Left on 27Mar2021 at single dose for covid-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing (knee surgery), pain from an unknown date and unknown if ongoing, hypersensitivity from an unknown date and unknown if ongoing (sometimes she has allergy symptoms). Concomitant medication(s) included paracetamol (TYLENOL) taken for arthritis, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported; fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6) taken for an unspecified indication, start and stop date were not reported; glucosamine sulfate (COSAMINE [GLUCOSAMINE SULFATE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced shoulder was sore on 27Mar2021 with outcome of recovered on 30Mar2021, just a little tired on 28Mar2021 with outcome of recovered on 30Mar2021, nose is full on 05Apr2021 with outcome of not recovered, cold like symptoms on an unspecified date with outcome of unknown , congestion in her nose (nose is full and eyes very watery) on 05Apr2021 with outcome of not recovered, a low grade fever of 99.3 (fever, not high, 99.3) on 05Apr2021 with outcome of not recovered, throat is itchy on 03Apr2021 with outcome of not recovered, chill on 04Apr2021 with outcome of not recovered, eyes very watery on 05Apr2021 with outcome of not recovered. The patient underwent lab tests and procedures which included pyrexia: 99.3 on 05Apr2021.   The clinical course was reported as follows: "Caller received the first dose of the Covid vaccine on March 27th. Caller reports doing well only having a sore shoulder and was tired for a few days. Caller states a week later, she started experiencing cold and flu like symptoms that consisted of a sore throat, congestion in her nose, a low grade fever of 99.3. Caller asked if this is side effects of the vaccine? Can I experience side effects a week later? Caller asked if she does get better, should she keep her original appointment or schedule for a later date?"     No follow-up attempts are needed. No further information is expected.
Hands, arms itchy-raised hives hands, neck itchy, resp difficulty. 10:15 Mom notified of transport. Transported via rescue.
Fever of 101, shortness of breath, treated on 09/15/2014 for a UTI. Condition worse, admitted to hospital with atrial fib, developed pneumonia, pleural effusion, and pericardial effusion. In hosp. 12 days.
My Cortisol levels have dropped to extremely low levels leaving me tired all the time! 2.5. I have little energy during the day even though I am sleeping soundly eight hours a night with a 45 minute nap each day.  I have also started burping every 15 minutes with no known cause.  I have had multiple tests run with nothing coming back abnormal including an upper endoscopy.  I do not suffer from reflux or any indigestion problems.  I have a weird pain in the joints of my middle finger on one hand alone.  I have had brain fog and basic lethargy.
Head pain, Vision Issues, Memory issues which eventually lead to losing consciousness, stopped breathing had multiple seziures and was eventually diagnosed with Encephalitis and / or Meningitis
Patient given 0.5ml dose of covid-19 vaccine by Janssen. Patient stated was scared of needles. He immediately stated he thought he was going to pass out. Patient passed for approximately 30 seconds and jerked/like a seizure then came back but still felt dizzy, passed out again and jerked came back but still felt bad, Patient stated he did not feel right was hot wanted to lie down on floor. 911 was called made patient comfortable until EMT's arrived and patient was taken to ambulance and released.
No adverse event; My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (My vaccine box did not have a expiry date. When we try to enter it says the expiration was around 14 days back .).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 3rd patient out of 4 pediatric patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-712814, US-MODERNATX, INC.-MOD-2023-712819, US-MODERNATX, INC.-MOD-2023-712822 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-712814:Patient 1 US-MODERNATX, INC.-MOD-2023-712819:Patient 2 US-MODERNATX, INC.-MOD-2023-712822:Patient 4
received Moderna COVID-19 booster on 11/23/2021 at 4:15 pm.  At about 5:00 pm I lost vision in my right eye.  I called Eye Institute immediately.  I talked with my doctor.  She set up appointment with Dr. for late the next morning (11/24/2021).  Dr. siagnosed a central retinal occlusion.  She sent to the ER at Medical Center..  I was admitted and given a number od\f tests including blood work, MRI, CT scan and others.  I was discharged mid day (11/25/2021).
8:26am Client complaint of dizziness and anxiety.  Client evaluate by EMS onsite.  BP 65/34, P 34, O2Sat99%.  8:37am EMS onsite started IV on client's right arm.   Client reported feeling better.  8:46am client was transported to  Hospital.  BP 74/30, P 69, O2Sat 98%
first dose was administered on 09Nov2019 / second has not been administered; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th November 2019).   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 follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
About 30 mins after my vaccine I felt dizzyness, with chills and I felt very very cold I went to the ER and they gave me antibiotics for my UTI,  The next day I had body aches joint aches headaches, I also broke out in hives all over my body
Vaccination administered at 5PM (4:45 appointment) Patient has history of fainting with injections. Patient asked to lie on gurney for vaccination in Medical tent B.  Immediately post vaccination eyes rolled back in head. Brief tonic seizure lasting 1-1.5 minutes. Patient unresponsive @ 40 seconds then eyes open and responsive to voice. Vitals stable during episode. BP 135/77 P 103-82 R 14-16 O2 sat 94% on room air improving to 99% after 1 minute. Vital signs repeated at 17:10 and 17:25 (stable). Patient asked to remain supine on gurney for 30 minutes post injection. Patient conversing with staff 2-3 minutes post incident. Patient able to drink juice and light snack prior to DC. DC home with mother after 35 minute observation. Patient assisted to schedule next appointment. Patient asked to request to lie on medical gurney in medical tent for second injection.
Patient received the incorrect booster. Patient should have received the Pfizer 5-11 yr (orange top) for her booster
SWEATS; SORENESS; FLU-LIKE; TIREDNESS/FATIGUE; FEVER; This spontaneous report received from a consumer concerned a 6 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. 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 sweats, soreness, flu-like, tiredness/fatigue, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, sweats, soreness, tiredness/fatigue and flu-like was not reported. This report was non-serious. This case, from the same reporter is linked to 20211164631.
Blood pressure went up; Heart Rate exceeded 100 beats a minute five minutes after the injection; This is a spontaneous report from a contactable other hcp (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthmatic from an unknown date and unknown if ongoing. The patient don't have heart problems or blood pressure problems. The patient's concomitant medications were not reported.  The patient experienced heart rate exceeded 100 beats a minute five minutes after the injection and blood pressure went up on an unspecified date in Mar2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized for 1 day due to the events. Therapeutic measures were taken as a result of the events which included Heart monitor/ IV for flushing. The patient did not recover from the events.  Information about lot/batch has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events "Blood pressure went up" and "Heart Rate exceeded 100 beats a minute five minutes after the injection" cannot be completely excluded based on temporal association.  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 identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
I had a sore arm the first day and felt tired. The second day I had a stuffy and runny nose, my muscles were sore especially around trapezoids. Around 3 pm the second day I felt queasy and had diarrhea. I was lethargic the second day. The 3rd day had minor diarrhea and was a bit tired. Diarrhea stopped by 2pm and muscles felt better.
Mild nose bleed occurred after vaccination.    Other side effects were same as listed but the nose bleed was unexpected and not listed on my insert.
Breakthrough case admission after 2 vaccines Pfizer 8/17/21 lot# EW0186;  Pfizer 10/9/21 lot# 30155BA
pruritic rash on extremities (especially lower legs);no systemic sx;devel w/in 24hr of vax;tx w/antihistamines;