chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PARALYZED; MUSCLE SWELLING; This spontaneous report received from a social media through a patient via a company representative concerned patient of an unspecified age, and sex. 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 (series 1) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose,01 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Reporter stated that, "My son-in-laws friend has been paralyzed for a week from J and J vaccine. The doctors are saying it is muscle swelling. They refuse to admit it is from the vaccine." On an unspecified date, the patient experienced paralyzed, and muscle swelling. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the paralyzed and muscle swelling was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211223119.; Sender's Comments: V0:20211223490-COVID-19 VACCINE AD26.COV2.S-Paralyzed. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Evening of vaccine (Thursday night): chills, headache, aches and pains First day after vaccine  (Friday April 2): chills, sweats, dizziness and fuzzy thinking, extreme fatigue, headache, joint pain Second day  (Sat April 3):  fatigue, headache, aches and pains Evening of the second day (Sat April 3): fatigue, acute pain in my left armpit/swollen glands in my armpit/breast/neck Third day (Sunday April 4): fatigue, headache, armpit pain and swelling radiating to the entire upper left side of my body Fourth day (Monday April 5): fatigue, headache, armpit pain slightly abated Fifth day (Tuesday April 6): fatigue, armpit pain slightly abated Sixth day (Wednesday April 7): neck still stiff, left armpit still very tender Seventh day (Thursday April 8): left armpit tender 8th day (Friday April 9) until now:  still tender/sore in and around left armpit, still a bit stiff in the neck
pt recv vax 16SEP98 410PM parent called hlth dept 18SEP98 about child leg;child brought into clinic rt thigh swollen, red & sl bruising;feverish to touch;edema in rt leg 2x's size of nl lt leg;edema all around upper thigh;itching;
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On unspecified dates the unspecified patients was vaccinated with doses of improperly stored GARDASIL 9 (lot # L013429, expiration date 21-JUL-2017) (dosage, strength and route were not reported). There was no concomitant medication reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was due for a Pfizer second dose, but Medical Assistant gave a moderna booster instead.
This case was reported by a physician and described the occurrence of allergic skin reaction in a 35 year old female subject who was vaccinated with Twinrix for prophylaxis. The reporting physician is an allergist. The subject's medical history included depression, herpes simplex infection, migraine, mitral valve prolapse and sulfa allergy. Concurrent medications included Lexapro, Wellbutrin, and Acyclovir. On 16 February 2006 at 9:00am, the subject received 1st dose of Twinrix in the right arm. On 16 February 2006 at 9:00am, the subject also received an injection of tetanus toxoid (Aventis Pasteur) in the left arm. On 16 February 2006, at 10:15am approximately 75 minutes after vaccination with Twinrix, the subject experienced injection site hives on the right arm, at the site of the Twinrix injection. The hives,  "then spread" to a cutaneous systemic allergic reactionon 16 February 2006. The subject was seen at an allergist's office and was treated with adrenalline (Epinephrine) and steroid (Steroids). The immunization series with Twinrix was discontinued. At the time of initial reporting, 17 February 2006, the events were improved. The reporting physician stated that she, "thinks (the events) were probably with Twinrix since the tetanus vaccine was in the left arm and the reaction started in the right arm."
After the 4th of July I developed COVID-19 and was mildly sick, and did run a 101-103 degree fever for about a day or so. About 6 months later I started throwing up and developed a fever. I went to the ER and tested positive for both Flu A and Flu B, and they also informed me I was diabetic at that time. They could not rule out that I may have had a heart attack or stroke, and I was also very dehydrated. They gave me two different IV bags and possibly some probiotics. I feel like because of the vaccination and getting COVID-19 so close together it decreased my defenses against disease. I do remember having a pain in my arm on the same side as the vaccination that seemed to last a little longer than previous vaccines. I'm very weak, I just feel different. My back hurts for the last six months, and I just feel weak and tired all the time.
Information has been received from a consumer concerning her 22 year old daughter with an allergy to AVALOX who in December 2006 and February 2007 was vaccinated with a 0.5 ml first and second dose of Gardasil.  Concomitant therapy included iron (unspecified).  The patient's mother reported that sometime in May 2007, the patient was experiencing pain in her wrist and hand associated with rheumatoid arthritis since receiving Gardasil.  The patient also had been diagnosed with Sjogren's syndrome.  The patient sought unspecified medical attention.  Unspecified blood work and manual tests were performed.  At the time of this report, the patient had not recovered.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Additional information has been received from a nurse practioner. The nurse reported that the patient "doing fine". The nurse stated that the patient had signs and symptoms (dry eyes and dry mouth) of SJOGREN's syndrome prior to the vacciantion with GADASIL. The patient was not diagnosed with rheumatoid arthritis. The patient's SED rate was reprotedly high at 69 and the RA factor was less than 20, which was reportedly within normal limits. No additional ifnormation is expected.
tested positive for covid; tested positive for covid; This is a spontaneous report from a contactable Pharmacist.  A male patient of an unspecified age (Age: 38; Unit: Unknown) receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for covid after the first dose of the covid 19. Caller wanted to know if the patient needed to wait to get the second dose. The outcome of the event was unknown. Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  However, no complete effect of the suspect vaccine could be reasonably achieved from first dose to protect from the targeted infection.  Further information like COVID infection date needed for a full meaningful medical assessment.
Patient administered dose from a vial 12 hours post puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a vial 12 hours post puncture.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 002A21A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, ENALAPRIL and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a vial 12 hours post puncture.). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a vial 12 hours post puncture.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug details was reported.  Vial taken out from freezer on 6-dec-2021 and first punctured on 6-dec-2021 and placed in refrigerator on 6-12-2021.   This case was linked to MOD-2021-407042, MOD-2021-407056, MOD-2021-407134 (Patient Link).
Pt reported very sore L arm a few days after vaccine  administration. He notes the pain was constant since vax admin.  Rates pain as between 3 - 7 out of 10 (depending on movement and time of day).  Can sleep on left side. Pain worse when reaching across his body and with abduction of arm (particularly if lifting something).
3rd dose 4 weeks after the 2nd dose; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a infant male patient who received DTPa-HBV-IPV (Pediarix) (batch number B4722, expiry date 17th February 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and PEDIARIX for prophylaxis.   On an unknown date, the patient received the 3rd dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 2nd dose of PEDIARIX. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device and an unknown time after receiving PEDIARIX, the patient experienced drug dose administration interval too short. On an unknown date, 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-Jul-2022 Reporter's Comments: The patient received the Pediarix 3rd dose 4 weeks after the 2nd dose. No reactions reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive Information: The patient received the Pediarix 3rd dose before recommended interval, which leads to shortening of vaccination schedule.
breaking out into sweats; breaking out into sweats and fevers; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 09:30 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; MAGNESIUM; VITAMIN B12 [VITAMIN B12 NOS]; ZINC. Vaccination history included: Bnt162b2 (product: COVID 19, lot unknown: True, lot unknown reason: Misplaced/discarded, administration date: 23Aug2021, administration time: 11:30 AM, dose number: 1, vaccine location: Left arm), administration date: 23Aug2021, when the patient was 29 years old, for covid 19 immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset 14Sep2021 01:00, outcome "not recovered", described as "breaking out into sweats"; PYREXIA (non-serious) with onset 14Sep2021 01:00, outcome "not recovered", described as "breaking out into sweats and fevers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hyperhidrosis, pyrexia.  Additional information: The patient was on day 4 and still breaking out into sweats and fevers every couple of hours. the patient did not tested covid post vaccination and covid prior vaccination was no.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient stated that developed itching at injection site, she scratched site and then site became numb.
2hrs p/vax severe crying when woke up from nap-leg swelling from hip joint area to ankle, red, hot also fever up to 102, crying lasted approx 6hrs;
Varicella Information has been received from a physician concerning a healthy female patient who in 1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). "Earlier this year", in 2005, the patient experienced full blown chicken pox. Subsequently, the patient recovered from chicken pox. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Difficulty breathing, chest tightness, fever, joint pain, dizziness five hours after receiving annual influenza vaccination.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case was linked to cases 2018SA298695, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA298495, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298701 and 2018SA298649 (same reporter). This case involves a patient (age and gender unspecified) who received previously frozen vaccine, FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered with the FLUZONE HIGH DOSE. On an unknown date (in between 01-Oct-2018 to 08-Oct-2018), the patient received a single dose (also reported as 5 mls) of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1995AB (20-Jun-2019) via intramuscular route in unknown administration site (either the left arm or right arm). It was a case of actual medication error due to incorrect product storage and overdose. It was reported that there was a possible temperature excursion of vaccine when it was known that the temperature report from the refrigerator showed that the FLUZONE HD was already frozen previously. The reporter also stated the patient was called and scheduled to be re-injected. It was unknown if the patient experienced any adverse event. 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 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.
Redness & tenderness to right forearm p/receiving immun 27JAN92; tx for cellulitis w/ATB, moist heat, subsequently resolved;
Itching at injection site; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       On 22-Jan-2021, the patient experienced redness at the injection site that ended on 26-Jan-2021. On 29-Jan-2021, the patient reported that the injection site redness has came back.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Narrative: Headache, Arthralgia, CoughWheeze, Fatigue, Chills, Injection site pain and swelling
MA gave patient extra dose of the flu vaccine by mistake; instead of the HPV vaccine. MA advised patient grandma, Dr., and supervisors. Also MA talked to MA at agency to ask about any adverse reactions patient might have. MA advised that it will just be an invalid dose for the patient since he had already received  his flu vaccine for the season. MA then gave patient the correct immunization the same day.  MA advised grandma that it would just be an invalid dose that it would count against him.
Pt recvd Engerix-B vax 09MAY91; Soon p/exp palpitations, resting tachycardia & PVC's; As of 20MAY91 no tx had been given; sx are now subsiding & are intermittent;
Information has been received from a registered nurse concerning a 21 year old female with lactose intolerance and a history of viral hepatitis C who "while she was in high school" was vaccinated with the first and second doses of GARDASIL (dose, route and lot# not reported). Concomitant therapy included oral birth control. The nurse stated that the patient was in the office today (29-NOV-2010) requesting the third dose. The nurse also mentioned that in the patient's chart it was indicated that the patient had a history of HPV infection but was not certain if this infection occurred before or after the patient received either dose of GARDASIL. Nurse did not know if the patient received any treatment for the HPV infection. The patient had had Pap smears on 04-AUG-2009 and 02-AUG-2010 which were normal, and HPV testing was not performed, "based on the cytology". The patient recovered from the HPV infection on an unknown date. This is an amended report. Upon review of the file, another AE code "HPV infection" was added. Additional information has been requested.
COLD; RUNNY NOSE; CHILLS; FEVER; HEADACHE; INJECTION SITE REDNESS; This spontaneous report received from a patient concerned a 65 year old female. 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced injection site redness. On 29-MAR-2021, the subject experienced cold. On 29-MAR-2021, the subject experienced runny nose. On 29-MAR-2021, the subject experienced chills. On 29-MAR-2021, the subject experienced fever. On 29-MAR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold, runny nose, chills, fever, and headache on 30-MAR-2021, and injection site redness on 10-MAR-2021. This report was non-serious.
ITCH BEGAN EVENING OF VACCINE ADMINISTRATION; USUAL SITE, ARM RED, SORE, GEN MALAISE NEXT 2-3 DAYS THEN RESOLVED; ITCHING INTENSIFIED DAILY ? WHEALS ? WHEEZING; NO RELIEF WITH BENADRYL; GIVEN MEDROL DOSE PAK, CLARITIN;
achenes; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   On 1st November 2022, the patient received Shingles vaccine and Flu vaccine. In November 2022, less than a week after receiving Shingles vaccine and Flu vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine and Flu vaccine.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that had shingles shot and flu vaccine the day prior to the reporting. The patient asked can patient take Advil for ache.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. On 10-JUN-2015, the patient was vaccinated with second dose of M-M-R II (lot# J006140 and expiry date: 17-APR-2015) subcutaneously which was expired. On an unknown date, the patient was vaccinated with first dose of M-M-R II which was not expired. No adverse effects were reported. No product quality complaint was reported for M-M-R II. Additional information has been requested.
Information has been received from a physician via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history or concomitant medications were not reported. On 24-JUN-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 single DS, 0.5 mL VIs 10SDV, (lot number L035882, with expiration date of 19-APR-2017) (route and anatomical location were not reported) that was improperly stored. On an unspecified date, the PNEUMVOAX 23 vaccine had a temperature excursion. The lowest temperature excursion was of 34 Fahrenheit (F), (1.111111111 Celsius degrees) for a total of 176 hours. No adverse effects were reported. The vaccine storage criteria and the type of the excursion were reported as refrigerator (R), and the vaccine status was reported as "in excursion". Furthermore, no product quality complaint was involved. This is one of several cases from same reporter. Additional information has been requested.
04/26/2022 I started with chills and headache. I took a home test that was negative. Then I had headache and fatigue. I took another test that night and it was positive. The next day I had congestion and fatigue. It got worse after that. I got really bad fatigue, shortness of breath, a headache, cough, aches and pains and sore throat. I still have fatigue and headache.