chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received her Moderna COVID Vaccine.  While in the Observation Unit patient reported to the observation RN that her throat felt tight and itchy.  The RN supervisor was notified, and patient was moved to  extended observation room.  Vital signs were within normal limits.  Patient remained alert with clear and appropriate speech and without shortness of breath or difficulty breathing.  Dr.  was notified, and he came to bedside.  At this time patient stated her lips and tongue felt numb.  Benadryl 25mg PO administered.  Patient was observed by RN for 30+ minutes more after receiving Benadryl.  After this time, patient reported throat tightness decreased and numbness was gone.  Patient was re-evaluated by Dr. and released to home with her mental health care home staff member just over 1 hour  after vaccine was administered.
thigh swollen-red-hot; sl fever 99.3; mom called MD who told her by phone that pt had cellulitis & ordered ATB;
This spontaneous report as received from a physician refers to a patient of unknown age and gender, who on 16-FEB-2013, was vaccinated with a dose of GARDASIL (dose and route were not reported) (lot number reported as 1167Z) (expiration date: 08-DEC-2012). No adverse effects reported. Additional information has been requested.
Swelling under armpit. Pain in fingers,toes abdomen on the right side and horrible pain in the left end of collar bone. Pain in toes comes and goes. Pain in right abdomen lasted two days. The pain in my collar bone is continuous and tender to the touch.
left deltoid with red, raised area approx 7 cm in diameter. Hot to touch and painful c/o shortness of breath more than usual. Pt is 1PPD smoker.
For several days after the Roto virus vax my son was vomiting, refusing to nurse or eat, has loose, mucousy stools, a red raw anus, diaper rash and general fussiness.
Diarrhea x 3 days, fever x 12 hours, arm pit swelling, energetic.
Uncontollable Chills, Paralysis, Chest Pains, Trauma, Muscle Aches, Headaches; 2 a.m.- 12:00 p.m. 03/22/21; Headaches lasted for 5 days until 03/27/21. Chills, Paralysis, Chest Pains, Trauma, Muscle Aches, Headaches; 3 a.m. - 10 a.m. 04/19/21; 2nd round not as severe as first round
After my third shot on 10/11/2021, I began developing a fever and fatigue around 7pm that evening that lasted until 4pm on 10/12/2021. I woke up on 10/13/2021 and felt good enough to go for a 3 mile run. I had higher heart rate during the run than usual and increased sweating. I had to stop multiple times due to the rapid heart rate. In the shower after the run, I felt light headed and had to sit down to avoid passing out. These symptoms occurred again the next day on 10/14/2021 when I went for another 3 mile run. These symptoms are abnormal because I run 3-5 miles in the morning, 5 days a week.
DAPTACEL was inadvertently given instead of Adacel with no reported adverse event; DAPTACEL was inadvertently given instead of Adacel with no adverse event; Initial information received on 28-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional via Media Information (under reference 00833274).  This case involves an 11 year old female patient who was inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) [wrong product administered and product administered to patient of inappropriate age].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other concomitant vaccines.  28-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Total, lot 65829BA and expiration date: 01-Mar-2022) via unknown route in an unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (same day latency).  At time of reporting, no adverse event 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.
Patient states that at approximately 2230 on 10/9/2020 she started to experience numbness and tingling in her hands and feet. Client states that she also experienced a headache and pain on the left side of her neck. Client states that she was concerned that it was Guillen-Barre Syndrome so she went to the emergency department. The ED diagnosed her with peripheral neuropathy.
vaccine administered after beeing in the fridge for 40 days; Sore arm; Headache; vaccine was given to patients, it had been stored in the fridge for 40 days so 10 days over our recommended storage; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (vaccine was given to patients, it had been stored in the fridge for 40 days so 10 days over our recommended storage), EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 004M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine was given to patients, it had been stored in the fridge for 40 days so 10 days over our recommended storage). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). On 31-Aug-2021, PRODUCT STORAGE ERROR (vaccine was given to patients, it had been stored in the fridge for 40 days so 10 days over our recommended storage) had resolved. At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered after beeing in the fridge for 40 days) had resolved and PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported that from 1 vial 10 doses taken and the vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° C to 25°C or 46°F to 77° F), went over in a vaccine cooler, stated that the most would be 3 hours (start and end of the vaccination clinic)  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-304531, MOD-2021-304556 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up received contains updated information on patient characteristics, batch no of vaccine doses 1 and 2 and events after booster dose (Third dose)
a week after receiving the vaccine I started feeling shortness of breath. It progressively got worse and on April 23, 21 was admitted into Hospital with blood clots to the left leg and to my lungs.
Pt said her arm was very sore, almost to the point she couldn't move it. Also red at the site and slightly warm to the touch.
Bruising, feeling of heat, redness overlapping bruised area and present in non-bruised area, no systemic sx.
Child given the COVID-19 Pfizer bivalent dose for 12+ in error, should have received the 5-11 dose.
This spontaneous report as received from a Doctor of pharmacy refers to a 71 years old female patient with penicillin allergy. The patient's medical history included breast cancer in 2002. The patient was vaccinated with a dose of ZOSTAVAX (Lot # H011427, expiration date 12-SEP-2013) SQ in the left arm on 11-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 11-OCT-2012, immediately after withdrawing the needle, the patient developed a hardened bubble at the injection site. The bubble enlarged but subsequently stabilized. The injection site bled for a short time then resolved. On 12-OCT-2012, the pharmacist called the patient, the bubble had resolved and there was a quarter sized blue area at the injection site and the patient was recovering. The patient did not receive treatment for the adverse events. There were no lab diagnosis or studies performed. Additional information has been requested.
My 2nd Moderna vaccine was on March 14th, and by March 18th I had a red and itchy rash with hives on both sides of my neck, more on the left side to start, and up a little into my hair.  I took Benedryl (1 pill doses) and after a few days it seemed to subside, so I stopped taking Benedryl.  It came back with a vengeance on the morning of March 26th -- more red, more itchy, and raised patches in some areas.  I took Benedryl (1 pill doses).  By the morning of the 27th, the itchy red grew from the sides of my neck to also being in the center front of my neck, and up behind my ears.   Then I saw redness on my inner thighs, at my ankles, and some red patches on/by my knees, though those did not itch.  Sometimes I'd feel like a wave of heat and then feel more of the rash and itch move up under my chin, up the sides of my face, on my forehead, and up the sides of my head higher into my hair.  After a shower, the patches of red really stand out.  Since March 27th, I've been taking Benedryl as 2 pill doses every 4-6 hours, and putting a Cortizone cream on my neck 3 times a day.  The first uses of the Cortizone cream made it worse before it made it better.  I considered calling my general doctor, but it seemed to have reached its peak.  Today is the 31st, I still have it in all of those same areas, I can see it on my neck, inner thighs, and face, but it's better, not as red, and my neck only itches a little now and then.  I'm not letting my guard down this time though, I will continue taking Benedryl and using the Cortizone cream for a while.    I should add, on the day of my 2nd vaccine, March 14th, that afternoon my right arm was really sore and raised at the injection site and it hurt down a few inches from the site on that arm.  Later, my left arm hurt in the same areas.  That night, I had extremely intense chills from about 10:15 to 11:30 PM when I fell asleep.  The next morning,  March 15th, I woke with a terrible headache, a fever of 100.9, and awful muscle aches behind my neck, throughout my upper back, and on my shoulders. I took Advil then and I went back to sleep for most of the morning.  By noon, I was at 98.8 and I worked (at home).  For the next few days, the muscle aches slowly went away, but once in a while I'd feel a wave of mild headache and dizziness.   I also want to add, when I had my first Moderna vaccine in my right arm on February 14th at 11:00 AM, that afternoon my right arm was really sore and raised at the injection site and it hurt down a few inches, and later my left arm also  in the same areas.  I was really tired that evening and went to bed really early.  About a week after my vaccine, I noticed a reddness on the top of my forearms, I didn't think it was itchy in the daytime, but it must have been overnight because in the mornings I'd see marks where I had scratched at it.  It started worse on my left arm, but was on both arms, it was red and areas looked like a heat rash.  I took Benedryl (1 pill doses) for about a week, till it subsided and went away.
This spontaneous report was received from a licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. The nurse reported that the patients received improperly stored (temperature excursion: 20 C, time frame: 24 hours) doses of VARIVAX of lot/batch # L034370 with expiry date 08-SEP-2017 and lot/batch # L042265 with expiry date 26-OCT-2017 (Dose, strength, dose number, vaccination site and route of administration not provided) on unspecified dates. Concomitant therapies were not reported. The previous temperature excursion was reported as 8.2 C for 13 hours. No adverse effects were reported. Product quality complaint (PQC) was not involved. No further information was provided. This is one of two reports from same reporter link. Additional information has been requested.
Red, swollen, welted, difficult to move arm, itching - Noticed pain the same night vaccine was administered, swelling - Patient felt pain as soon as the needle retracted - All symptoms in left arm (Pneumovax vaccine)
I had a fever, body aches, chills and joint pain that lasted only 24 hrs.  My estimated date of delivery is June 14, 2021
coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (Radiation treatment caused burns on her bladder). Concurrent medical conditions included Seizures, COPD, Hypertension, Diabetes, Allergy and Restless leg syndrome.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced COUGH (coughing). At the time of the report, COUGH (coughing) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD21-076194, US-MODERNATX, INC.-MOD-2021-078417 (E2B Linked Report).; Sender's Comments:  MOD21-076194:Cross-linked case US-MODERNATX, INC.-MOD-2021-078417:
Patient had red, swollen, warm to touch, itchy area about 2 to 3 inches below injection site on the day after injection.  Injection site was not involved.
pt recvd vax & w/in 1 wk exp a nose bleed which was described as uncontrollable & lasted for 7 minutes; then exp a 2nd less serious nose bleed; Lab eval showed thrombocytopenia; No further details were provided;
Left upper arm shows redness approx. 5 inches in diameter surrounding injection site.  No induration. Area warm to touch.
In evening p/vax given mom took pt to ER because rt leg red, swollen, & spasming; mom told to give APAP;
Information has been received from a consumer concerning her daughter, a 16 year old female who on unspecified dates was vaccinated with a first and second dose of GARDASIL (lot # not reported), respectively.  It was reported that the patient experienced a "little more pain during her 2nd vaccination than her 1st vaccination".  The pain was during the injection while at the physician's office.  The patient recovered on the "day of vaccination".  Additional information is not expected.
Information has been received from a physician concerning a male who was vaccinated PO with a 2.0 ml dose of ROTATEQ (date not reported).  It was reported that the patient was taken to the hospital due to a case of intussusception after vaccination (date not reported).  The course of treatment and the outcome were not reported.  The reporter felt that the intussusception was life-threatening.  A product quality complaint was not involved.  Additional information has been requested.
I waited the 15 minutes. I walked to my car and drove to work. Got very busy with work, coughed here and there. Noticed my tongue felt swollen and tried to swallow some water and had difficulty, realized I was having a little  anaphalxsis   reaction. It started approximately it 12pm, maybe earlier, I was busy.
104.9 temp for 1 day following 103.9 temp weakness,very lightheaded dizziness I was feeling like if I was waking from anesthesia aanesthesia very tire vertigo headaches severe body aches was not able to lift my head or move my body
Information has been received from a consumer concerning her 2 month old child who was vaccinated PO with a 2.0 ml dose of ROTATEQ. The patient experienced "bloody stools" 4 days after receiving the vaccine. She also stated "they changed from yellow to a little green with some blood." It was unknown whether medical attention was sought. The outcome was unknown. There was no product quality complaint. Upon internal review, bloody stool was considered to be an other important medical event. Additional information has been requested.
Acute annular, polycyclic erythematous wheals with central duskiness on face and extremities that flared and resolved within <24 hours.
3 - 5 cm raised red area. Pt treated with Diphenhydramine 25mg Hydrocortisone 1% cream.
This spontaneous report as received from a pharmacist refers to a 65 year old female patient. On 03-NOV-2014, the patient was vaccinated with ZOSTAVAX vaccine vial, with lot number J008528 and expiry date 19-OCT-2014 (dosage information and route not reported). No concomitant medication was reported. On 03-NOV-2014, a nurse vaccinated the patient with expired ZOSTAVAX vaccine. No adverse effects were reported. The outcome of the events were unknown. A product quality complaint (PQC) was not filed. Additional information has been requested.
Patient Received 1st Dose of Heplisav-B , and 2nd Dose 5 months Later; Initial Report Received on 10-OCT-2022   This is a spontaneous report received from a pharmacist regarding a patient who received HEPLISAV-B for hepatitis B immunisation.    There was no medical history reported for the patient.    Concomitant medications were not reported.   On 20-APR-2022, dose 1 of HEPLISAV B (Lot # not reported, expiration date not reported, NDC # not reported), was administered for hepatitis B immunisation.     On 08-SEP-2022, 142 days after having been vaccinated with HEPLISAV B, the patient received her second dose of HEPLISAV B.   The outcome of the adverse event was not reported.   No further information was available at the time of the report.   Company comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Initial report received from a nurse on 02 April 2007. A 2 month old, male patient developed a fever of 100.2 F axillary, was fussy and had redness around the left eye after he received ActHIB (reported lot number UF071AA, corresponding lot number Z1094-2) intramuscularly in the left thigh; IPOL (lot number Z0457) intramuscularly in the right thigh; Tripedia (lot number U1751BA) intramuscularly in the left thigh and Prevnar (lot number B08646A) intramuscularly in the right thigh, on 01 March 2007. He had a temperature of 101.4F axillary at the office. Both of his legs have induration, no warmth, tenderness or erythema. Tylenol was given before the vaccinations, it was also given after - 0.8 ml po every 4 hours. He had no illness at the time of the vaccinations - well child visit. It was reported the patient recovered. Follow-up information received on 19 June 2007 from a health care professional. The case was reviewed, and there was no additional information at this time. Same reporter as cases 2007-01010, 2007-01012, 2007-01013, 2007-01014, 2007-01015.
VARIVAX administered on 06/25/2018. On 7/9/18, Patient contacted the Clinic with complaint of pain and redness at injection site post-injection. Patient is concerned at duration of pain and redness. Initially arm movement aggravated pain but this is no longer the case. Patient noticed pain and lump in left axilla on 7/3/18. At rest, pain is 3-4/10. With direct pressure in axilla, pain increases to 7. No fever or discharge at injection site. Non-tender. Upon exam, at injection site posterior left upper arm with patchy redness and increased warmth (approx. 3 cm diameter) are noted. No redness or skin changes or visible mass in left axilla.
Fever 100, body aches, severe headache, nausea, earache, soreness in arm
has Leukemia CLL and she got both doses of Covid vaccine; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), first and second dose, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that the patient has Leukemia CLL and she got both doses of covid vaccine on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient contracted COVID after being fully vaccinated Couth, Sore throat, congestion, headache, nausea
Slight swelling, redness and tenderness at the site of injection; Slight swelling, redness and tenderness at the site of injection; Slight swelling, redness and tenderness at the site of injection; This spontaneous report was received from the patient' mother who was a creative services company representative  regarding her daughter, a 15-month-old female. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient experienced slight swelling, redness and tenderness at the site of injection (Vaccination site swelling) (Vaccination site erythema) (Vaccination site tenderness). Therefore, the patient's mother called her pediatrician and alerted her, but was told that these were common side effects of this vaccination  (also reported as post-vaccination reaction), so she kept monitoring the patient in order to document new events and or her recovery. Furthermore, the mother stated that the patient's symptoms resolved within two days on an unspecified date.   The causal relationship between all the events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not reported.
patient reported a swollen vaccine site after the vaccination. thought it was normal. it still persists after 1 week. it is itchy, moderately swoller, hot. patient also reports light pain and hardening  around the area.
Fever, fatigue, headache, muscle pain, chills, joint pain, swollen lymph nodes, persistent stomach pain, chest pain, dizzy, faint, spreading rash from upper back, upper arms, neck & face. COVID arm on 1st vaccine for 16 days. 2nd vaccine: No COVID arm, but...all of the above +  faint within 1st hour, then again on the following Friday... on the floor.
Patient received his first dose of Pfizer vaccine and waited 15 minutes in the observation area. Upon rising from chair, patient reported feeling dizzy and faint. Patient called for assistance. Patient reported feeling hot and sweaty and being unable to hear and see correctly. Pulse and SpO2 were taken, Pulse was initially 54 bpm and rose to 68 bpm after drinking water. SpO2 was 94-95% RA. Patient refused EMS. Patient reported feeling better after about 20 minutes. Hearing and vision improved. Patient remained in observation area for another 20 minutes before leaving in stable condition.
This spontaneous report as received from a licensed practitioner nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with improperly stored ROTATEQ, oral, (lot#, strength, dose and frequency unspecified). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.