chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Fever; Nausea; near syncope; This case was reported by a physician via sales rep and described the occurrence of chills in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, fever, nausea and presyncope. On an unknown date, the outcome of the chills, fever, nausea and presyncope were recovered/resolved.   It was unknown if the reporter considered the chills, fever, nausea and presyncope to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced chills, fever, nausea and presyncope. The reporter did not agree to be followed up from GlaxoSmithKline.
pt recv vax 22APR97, 25APR97, 29APR97, 6MAY97, 21MAY97 & exp episode of lethargy, hypersomnolence, hives, angioedema, nausea, vomiting, dyspnea;pt followed up w/MD & was treated w/med;
I noticed that my esophagus would go numb.  It doesn't happen all the time, but when I does, I can't feel anything in my throat from the base of my head down to the top of my chest.  I can breath and swallow fine, but, for instance, if I'm drinking something, I feel it enter my mouth and start down my throat, but then it disappears until it hits my chest area.  It also always feels like there is a lump in my throat right where you start to swallow.  That's been pretty common and it makes me want to cough all the time.  Again, I've never had trouble breathing or eating.
Inappropriate schedule of vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On an unknown date, the patient received the 2nd dose of Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate schedule of vaccine).  The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-SEP-2023 The reporter unable to provide any vaccine or patient details. The patient received the 2nd dose of Bexsero early at 25 days instead of at a month, which lead to shortening of vaccine schedule. Health care professional (HCP) did not consent to follow-up from safety.
Rhythmic myoclonic jerks for 30 mins starting 1 hr after vaccines given; fussiness for 7 more days. Myoclonci jerks of both arms while sleeping, every 1-2 minutes for 30 minutes total, onset 90 minutes after vaccinations. (Not reported to MD until 10/17/2006)
PT REPORTED LOCALIZED RAISED AREA LARGE WELT PUFFY HOT AND SWOLLEN WITH MARGIN FEW DAYS AFTER SHINGRIX.. I CALLED DR WHO PUT PT ON CEPHALEXIN WHICH CLEARED SKIN REACTION. PT CLEARED FOR SECOND SHOT
Information has been received from a pharmaceutical company as part of a business agreement (manufacturer report number 080118-0000044) and a pharmacist concerning a 19 year old female, who, on an unspecified date, was vaccinated with a dose of Gardasil.  Concomitant suspect therapy included CHEMET.  On 18-JAN-2008 the patient experienced throat swelling, swelling of face, swelling of lips, and a drug interaction.  The duration between the administration of the vaccine and the onset of the symptoms was unknown.  The patient temporarily discontinued CHEMET for 3 to 4 weeks.  When the patient resumed treatment with CHEMET she experienced the same events.  Subsequently, the CHEMET was permanently discontinued.  The Gardasil was considered a co-suspect drug.  The reporter considered the events to be possibly related.  Additional information is not expected.
10/10/14 call from patient to MD to report pain and decreased RDM left arm. Pt stated her arm has felt this way since receiving Flu vaccine 9/30/14. MD advised office visit. 10/13/14 Pt saw MD states cont pain, little relief with ADVIL, cannot raise arm over head. Pt describes "weird sensation from Left shoulder to hand. 11/13/14 - MD visit by patient complains of cont. Left arm pain." Weakness. Pain decreased. Physical Tx ordered.
I got covid on March 31st, 2022, tested positive on June 1st.
the patient was administered a dose of PNEUMOV AX 23 and within 20 minutes of administration the patient had flushing of her face, pain in her face which then turned into itching of her face and lip swelling; the patient was administered a dose of PNEUMOV AX 23 and within 20 minutes of administration the patient had flushing of her face, pain in her face which then turned into itching of her face and lip swelling; the patient was administered a dose of PNEUMOV AX 23 and within 20 minutes of administration the patient had flushing of her face, pain in her face which then turned into itching of her face and lip swelling; the patient was administered a dose of PNEUMOV AX 23 and within 20 minutes of administration the patient had flushing of her face, pain in her face which then turned into itching of her face and lip swelling; This spontaneous report has been received from a pharmacist concerning a 73-year-old female patient.  The patient's concurrent conditions included an allergy to sulfonamide (reported as "Sulfa") and an allergy to lidocaine (LIDODERM).  Her medical history included red bumps (rash papular). The patient did not have any concomitant therapies.   On 06-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) one dosage form via subcutaneous, for prophylaxis (reported as routine vaccination) (concentration, frequency of vaccination scheme and anatomical location of vaccination were not reported). Lot Number S0009945 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), expiration date not reported, but upon internal validation, it was established as 10-AUG-2020.  Twenty minutes after vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23), the patient experienced flushing of her face, pain in her face which then turned into itching of her face (pruritus) and lip swelling. As the reaction occurred at the physician's office, the patient was treated immediately with dexamethasone (DECADRON) 8 milligram (mg) and diphenhydramine (BENADRYL) 25 mg.   The pharmacist confirmed that the event was not cancer or a congenital anomaly and that the patient did not die, nor she was hospitalized. The pharmacist also informed that the event was not life-threatening, did not cause significant disability or incapacity and that the patient did not overdose.   At the time of reporting, the patient was not recovered from the events.    The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) vaccination and the patient's events was not reported.
The patient developed erythema with induratum at the left thigh in an area 4 1/2cm x 2cm. The patient had multiple erythematous papules and vesicles. The left thigh had an edematous base with papular lesions scattered over the trunk and arms.
This spontaneous report was received from medical assistant, referring to a 2 month old patient of unknown gender. The patient's medical history, concomitant therapy, drug and allergy history were not provided. On 05-OCT-2017, the patient was vaccinated with VAQTA injection, 25/0.5 (units were not provided), lot number N020950, expiration date 17-OCT-2018, for prophylaxis (dose, frequency, dose number and administration route were not reported); which was reported as outside of the prescribing information. No adverse effects were reported.
Rash at injection site began 5/13/21; going to take Benadryl and call my doctor.
Not only am I expiriencing sweats,chills, nausea, headaches/migranes, blurred vision but as of December 9th I began to have very bad irritability followed by a very bad depression with slight suicidal thoughts and they have not gone away. I do Have a history of mental illness in my past but it?s been gone for about 10 years
Shingles diagnosis Left shoulder; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 07Feb2021 11:15 (Batch/Lot Number: EM9810) as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included omeprazole, and lisinopril. No other vaccines received within 4 weeks. The patient experienced shingles diagnosis left shoulder on 26Feb2021 17:00. Event resulted in physician's clinic visit and was given VALTREX as treatment. Outcome of the event was recovering. Patient was not diagnosed with COVID prior to vaccination and had not been tested post-vaccination. The second dose was received on 28Feb2021 (lot number: EN6202) on the left arm.
Massive Pulmonary Embolism of the right lung, small PE in the Left lung, and DVT of the right femoral the week of November 8-12, being hospitalized on the 12th of November 2021.  Resulting in Thrombolectomy and anticoagulated
pt admitted to hospital with SOB; found to be positive for COVID; acute respiratory failure secondary to COVID; given steroids, zinc, Vitamin C, Remdesivir, ABX; O2 supplementation - BiPAP; pt's condition continued to worsen despite aggressive measures; pt passed away in the hospital
Information has been received from a health professional concerning a 12 month old male birth twin with no other medical history who on 09/23/2004 (previously reported as 09/24/2004) at 3:30PM was vaccinated subcutaneously in his left arm with a first dose of varicella virus vaccine live (Oka/Merck) (Lot # 646674/0709N).  There was no illness at the time of vaccination.  On 09/26/2004 (previously reported as 09/27/2004) at 6:00pm, the patient reported to the office with mild varicella all over his body (face, torso, legs).  The patient was being treated with hydroxyzine hydrochloride (ATARAX) and oatmeal baths.  The outcome was reported as not recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  Follow up information from the health professional indicated that the lesions lasted 4-5 days and the patient was now recovered.  No further information is available.  The reporter also indicated that the patient's twin sister developed mild varicella after vaccination (WAES #0409USA02454).
pt recvd vax;3-4 days p/dose 1,exp generalized malaise,lasted x 2 days;3-4 days p/ dose2,exp malaise,lasted x 2 days;7 days later,exp welts which subsided in dec93;tx seldane;
LARGE AREA OF REDNESS W/ WITH WARM AND SWELLING 4 INCHES x 3 INCHES.  SOME ITCHINESS.
100°temp; This case was reported by a consumer and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was selected as adult as per the vaccine indication. The patient received 2nd dose of Shingrix and got 100 degree F body temperature. The patient was asking how long will the fever last.
An hour later I fell down in house hit my head on coffee table, muscle gave out nad I rode to the Hospital in an ambulance. They admitted me , I could not walk. I had a bad reaction with my MS, and my gallbladder needed to be drain. I was in the hospital for 30 days then they shipped me to rehab for another 30 days.
This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 23Mar2021 as dose 2, single (Lot number: EL3247) and on 05Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 50 years, all intramuscular for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "home Ag 22May2022 Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: Nasal Swab. Investigational report conclusion: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for 'Lack of Effect' of the Pfizer BioNTech Covid-19 vaccine lot FF2589, EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2589, EL3247  fill lot FF2558, EL3230 and the bulk formulated drug product lot FE5318. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.
Enlarged lymph node left arm; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 25-May-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Enlarged lymph node left arm) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (Poison ivy).   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced LYMPHADENOPATHY (Enlarged lymph node left arm). At the time of the report, LYMPHADENOPATHY (Enlarged lymph node left arm) 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.   Patient was not diagnosed/tested positive for COVID-19. No concomitant medication was reported No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: significant Follow-up received on 26-jul-2021, updated patient allergic condition, and suspect drug batch number
Severe bloodshot left eye -- I do have a picture if helpful to you Minor nasal congestion Slight headache 1 day prior to the bloodshot eye - relieved by Tylenol
Patient called this morning and said the right arm where she got the prevnar vaccination has turned bright red and swelled up. She said after the vaccination her muscle hurt like normal but now all of a sudden she was experiencing this. Advised the patient to contact her doctor to report in case needed followup and to monitor reaction for worsening symptoms. Will follow up with patient to see if symptoms resolved or if she saw her doctor.
Rash the size of my hand around the vaccination area and hot.   This is the 5th day and the symptoms are starting to subside
Patient reported having chest pain for a few hours in the evening (around 7pm) after getting a shingles vaccine earlier in the day (3:54pm). She said her arm soreness set in. Then it radiated to her neck, other arm and chest. She had swollen lymph nodes. Her blood pressure went up to around 150/80 but it was fine the next morning. She said it was mild pain that resolved within a few hours.
Vaccine administered approximately 5 pm on 7/12/2021 in left arm.  Felt left arm tingle right after injection, within 24 hours throat and epiglottis areas felt swollen and had red and white blotches/sores in throat, around uvula, tonsils and surrounding tissues in mouth. Lips a bit tingly as well.  Felt very fatigued. As days passed, throat sores increased and migrated on roof of mouth  and towards lip region and inside of upper lip had red sores that looked bloody and lips with some swelling and tingling.  today, 7/19/21, one week after vaccine was given, throat and lips are almost back to normal, but not quite-still with some mild upper lip irritation, swelling and redness and mild throat irritation and blotches but to a much lesser degree.  Did some warm water salt rinses throughout the week, rested, took Advil or tylenol.  I did not go to the doctor's office.
Headache, Myalgia, Fever, FATIGUE Narrative:  Other Relevant History:
Needle-like pain in left chest.  Happened 3-4 times over the span of 2 days following the booster shot (3rd shot).  Each occurrence lasted for several seconds.  At least two occurrences happened while standing up.    The booster shot (3rd shot) is Moderna.  The first 2 shots were Moderna as well.  No chest pain after the first two shots, only after the 3rd shot.
PATIENT REPORTED NO ISSUES AT TIME OF VACCINE ADMINISTRATION ON 3/19/2021. PRESENTED TO LOCAL ER WITH HIGH BLOOD PRESSURE ABSNORMAL TO PATIENT ON 3/30/21.
On 03/15/2022 I had a lot of pain, a few weeks before that I has some pain, but just ignored it. This pain I had was unbearable and I could not lay down. So I Googled it and pleurisy came up so I went to an urgent care clinic. They did an X-ray, EKG and a CAT scan. The doctor was very straight forward with the seriousness of this and called the pharmacy and put me on Eliquis for 3 months. That will be up in the middle of June. So far I have no pain currently. The day I started the medication I went to bed in a recliner, woke up with no pain so I was able to go to bed.
Severe respiratory distress, diaphoresis, drop in O2 sat. Required EPIPEN and EMS transport.
I started feeling sick right away with body aches and feeling chilled. I felt like I had COVID all over again. A while later I noticed that my arm was itching where they had injected me and when I looked, I saw a big red blotch. It was itchy, burning and painful to the touch. I believe I called the doctor and I don't remember if we met in person or spoke over the phone but the issue lasted a few days and eventually it went away on it's own.
Fatigue, Body aches, Muscle aches,  Fever, Back pain, Dry Mouth, Sore Throat
Site: Pain at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Abdominal Pain-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Lymph Node Swelling-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Weakness-Severe, Additional Details: severe heavy mensustral bleeding
This spontaneous report was received from a pharmacist who reported that five infant patients between 2 and 10 months of age (gender not provided) were inadvertently administered a third dose of PEDVAX HIB (dose, route, frequency and lot# not provided) two months after a second dose. No adverse effects were reported. Follow up information was received from the pharmacist. Patient identifiers (initials and birth dates) were provided. Lot numbers and expiration dates were unavailable at this time. This is one of several reports received from the same source. Additional information has been requested.
Admitted to hospital on 6/25/22 for NSTEMI and Covid. Symptoms included shortness of breath and cough. Not hypoxic so no breathing tx, steroids, ordered. Pt discharged on 6/28. Readmitted on 6/30/22 for chest pain and shortness of breath. Discharged on 7/2/22. Has prior history of HTN, CABG, obesity, COPD, CAD
Cellulitis at injection site. Erythema, warm, painful.  Small red bump noted day after vaccine. Cellulitis worsened over the week.
Reported approx 30 hrs after vaccination developed large painful approximately 4in swelling at corner of left jaw with swelling up into the parotid gland area and pressure sensation in ear.  Treated on 10/21/2019 with 10 days of cipro and clinda prescribed per Clinic and seen for first visit at our clinic on 10/25/2018 with pain and swelling improving and 3.5cm lymph node palpable at angle of left side of mandible.
Developed 13cm x 13cm erythematous, warm to touch area below injection site that she noticed this morning. Arm tender to touch. No fever or chills. Stopped by office at 1 pm to have staff check it. Cold compress, BENADRYL, and TYLENOL. Patient advised to monitor for increase pain, swelling, or redness.
Erythematous, tender, warm area on (L) arm lower vaccine (9 x 4.5 cm) (PPV23) site of onset 12 hrs after injection; promptly resolved within 36 hrs upon onset of Prednisone.
I had covid following the booster vaccine. I believe my husband gave it to me. However, I had no reaction to any of the three vaccines themselves. I wonder if I didn't build up the right antibodies because of some of my chronic conditions. I have had to have my MMR vaccine 4 times and I am still not immune. My COVID symptoms were watery eyes, stuffy nose, scratchy throat, and body aches. I don't remember having a temperature. I got a COVID test on 10/ 21/2021 and it was positive. I received 4 antibody shots that same day. I called my doctor and was advised to increase vitamin C and some other meds. Overall, my symptoms weren't very severe. However, I still have a residual chest tightness and slight wheezing. I did have the flu after COVID so it could be from that too.
1 hour after vaccine administration, developed burning of hands, especially back of hands and fingers, somewhat warm to touch.  No itching.  Hands were bright red in color, worse on back of hands, somewhat red on palms.  Did not extend past wrists.  Grandmother called emergency room:  "the doctor didn't think it was from the vaccine because it was too soon."  Hands were still red through the night, patient was able to sleep.  Morning of 12/11/2009, hands were a little less red.  Hand lotion "maybe helped." Patient went to school.  Around 1 pm, redness flared up.  Father took patient to Hospital walk-in clinic. Two doctors looked at her.  One doctor stated it was not from the vaccine, the other doctor was undecided but instructed the father to report it.  Saturday night, December 12th, hands were still burning.  Redness starting to fade.  Cold water and ice pack were applied to hands which helped allow patient to sleep through the night.  On Sunday, December 13th, patient did not complain about hands burning, hands looked normal.  On Monday, December 14th, hands still looked normal.  Instructed to call HD prn more problems.
About one week after receiving 4th dose of vaccine symptoms of Fibromyalgia began getting much worse. Currently in constant pain.
After patient received Janssen vaccine patient felt dizzy, stated he had a needle phobia. Informed site lead of situation. Instructed patient to remain seated. Water was given to patient. Instructed patient to lie down on floor with legs elevated, applied cold pack to forehead. Patient stated he felt better, but advised patient to remain lying down for the full 15 minutes of observation. After 15 minutes, patient sat up slowly, then stood up and stated he felt fine and no longer dizzy. Patient walking normally, no signs or symptoms of dizziness or fainting. Patient left accompanied by his wife and child.
Took the Vaccine with the Flu shot at the same time.  Exhaustion, the sore arm that became painful, significant chills, body ache, and not wanting to move.  Still really sore, with body aches and chills now once in a while.  So symptoms subsiding.