chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received Td vaccine on Friday 12/19/08 in her left vastus lateralis muscle. She had just received several allergy injections in both of her deltoids 1 day prior. To minimize irritation, her Td injection was given in her thigh. Patient states her thigh became edematous, reddened, and pruritic by Saturday, 12/20/08 night. She was self administering NSAIDS with GI protection and Anti-histamines as recommended. She spoke with the on -call provider on Saturday who suggested she continue with the above medication regimen, and return to the clinic on Monday for a visual assessment. On Monday, 12/22/08, patient was seen by RN + MD. A 3X2 inch inundated area surrounded a 1 inch reddened area in the mid left vastus lateralis mm area. Her left groin lymph node was also tender and edematous. She was afebrile. the area was warm, reddened and tender to the touch. She was prescribed Keflex 500 mgs p.o. 4 X's daily X 7 days, and was told to return to the clinic in 24-48 hrs if no decrease of symptoms.Her only know allergies is to Latex and Vicodin which produce pruritis.
Pt recvd 3 doses of Engerix-B & did not respond; 8JAN92 recvd 4th dose of Engerix-B; remained neg & was given 5th dose on 17FEB92;
Information has been received from a mother concerning her 3 year old son, with no known pertinent medical history and no known drug reaction/allergies reported, who in approximately in May 2003 was vaccinated with a dose of varicella virus vaccine live.  There was no concomitant medication.  On 03/14/2005 the patient experienced possible breakthrough case of chickenpox.  Unspecified medical attention was sought.  No lab diagnostics studies were performed.  At the time of the report the reporter indicated that she does not know if it is chickenpox or not sit is difficult to determine if the AE has improved.  The report indicates patient status as not recovering and that therapy was not discontinued.  There was no product quality complaint involved.  Additional information has been requested.
He woke with a fever of 101.5.  Then at approx. 8:10 AM he had a seizure that lasted approx. 5 min. followed by a period of total unresponsiveness of about 20 min.  He has no history of or prior seizures.
Frequent and recurring hives, appearing throughout body, not just at injection site. They come and go rapidly and seem to be more frequent at night and early morning, but do come less severely throughout the day. Intensely itchy and warm when an outbreak occurs. Appearing on neck, arms, trunk, legs. Had a doctors appointment the night before filling out this form, and will attempt high dose antihistamines and pepcid, per doctor's recommendation, and if not improved after a few weeks, will start on steroids. Doctor thinks hives could have been triggered by vaccine, as no other changes in environment have occurred. No history of allergies other than occasional mild seasonal allergies.
Information has been received from a physician concerning a 2.5 month old female patient who on 1JUN2004 was vaccinated with a dose of hepatitis b virus vaccine + Hib conj vaccine. The physician reported that redness and swelling appeared at the injection site after being vaccinated. No treatment was required. It was noted that the bump still remains. There was no product quality complaint reported. At the time of the report no other information was available. Unspecified medical attention was sought. Additional information has been requested. The physician also mentioned that a 15 month old male patient developed redness and swelling immediately after injection with hepatitis b virus vaccine + Hib conj vaccine.
This spontaneous report was received from a physician referring to a 12 month old female patient. The patient's concurrent conditions and medical history were not provided. On 23-JAN-2017 at 11:20 hours, the patient was vaccinated with a extra dose of VARIVAX Lot # reported as M004662, at the same time, she was vaccinated with influenza virus vaccine inactivated (6-35 months) Lot # M60994 both in the right lateral thigh, besides, she received M-M-R II (lot # reported as M007464) and PCV-13 (lot # M60994); both in the left lateral thigh (strength, dose and expiration date were not reported for any vaccine) the indication for all the vaccines was prophylaxis. The patient did not have any illness at the time of vaccination. The patient's parents were called and made aware that the patient had been received an extra dose VARIVAX. The patient's parents verified that the patient showed no adverse reactions. Additional information is not expected as all relevant information has already been received.
This spontaneous report was received from a female consumer of "just over 50 years old", via company representative, referring to herself. The patient's medical history included varicella. The patient's concurrent condition, drug and allergy history was not reported. On 14-APR-2017 the patient was vaccinated with ZOSTAVAX (dose, strength, route of administration, lot number and expiration date were not reported) for prophylaxis. The patient's concomitant medication was not reported. The reporter stated that, on 15-APR-2017, the day after receiving the vaccine the patient experienced redness and swelling in the arm, lymph nodes under the arm, and into the breast area. In addition it was reported that the physician/employer looked at the patient's arm and "offered no treatment, but directed the patient that she would be all right". The outcome of the events were reported as resolved, on an unspecified date in 2017. The causality assessment between ZOSTAVAX and the adverse events was unknown at the time of reporting. Additional information is not expected, because physician refused additional contact.
Systemic: Seizure-Severe, Additional Details: Patient had Grand Mal Seizure approximately 2 minutes after injection. She does have a history of seizures.
I experienced SEVERE abdominal pain, directly in my stomach followed by extreme nausea and dizziness. This continued for 3 days until I had diarrhea beginning Sunday at midnight, non stop for over 48 hours. The pain in my stomach continues to affect me, it?s been 6 days.
Sore arm, fatigue, body aches, swollen painful lymph nodes on my left side. Most bothersome lymph nodes under my armpit and near my collar bone and neck.  I?m at day 9 since I had my vaccine and they are still swollen and sore.
injection site red; injection site started itching; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PRURITUS (injection site started itching) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PRURITUS (injection site started itching). At the time of the report, INJECTION SITE ERYTHEMA (injection site red) and INJECTION SITE PRURITUS (injection site started itching) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No relevant concomitant medications were reported.  No treatment information was provided.
I had a rash within 24-48 hours of both injections. I didn't report the first because I had done yard work following the first dose and assumed it was due to something like poison ivy. After the second dose, I stayed home for the next couple days, and I noticed that I got the same rash (both times mostly on my left hand and forearm). Rash seems harmless - no pain, etc, though it itched the first time. Went away after a week or so. The second dose rash, I didn't feel or notice until yesterday afternoon (48 hours post vaccination), and it does not itch this time. Rash is small pinpoint red spots. Some were raised the first time, but none appear to be so this time.
Patient was supposed to get the Pfizer Bivalent and got the Pfizer monovalent- patient has been notified
Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from an Office Manager of pediatric practice. This case was linked with case 2018SA177896 (same reporter). This case involves a four months old patient (gender not reported) who experienced generalized rash all over without other adverse effect, while he/she received vaccines ACT-HIB and IPOL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included DTAP (Manufacturer: GSK); PREVENAR and ROTAVIRUS VACCINE. On 12-Jun-2018, the patient received a dose of suspect IPV (VERO) (Lot number: N1G51, expiry date: 02-Aug-2019, dose in series was not known) via intramuscular route in the right thigh. On 12-Jun-2018, the patient received a dose of suspect HIB (PRP/T) VACCINE (Lot number: UI917A, expiry date: 09-Oct-2019, dose in series was not known) via intramuscular route in the right thigh. On an unknown date, the patient developed a non-serious generalized rash all over without other adverse effect (rash generalized following the administration of IPV (VERO) and HIB (PRP/T) VACCINE. (Other relevant tests included No lab test reported). Final diagnosis was generalized rash all over without other adverse effect. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for generalized rash all over without other adverse effect. List of documents held by sender: none.
Non pruritic rash surrounding injection site, no swelling, no pain, stable and not progressing.
extreme pain/Left arm injection site was sore; arm still swollen/Left arm injection site hard and swollen; arm still warm/Left arm injection site hot; sore; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (extreme pain/Left arm injection site was sore), VACCINATION SITE SWELLING (arm still swollen/Left arm injection site hard and swollen), VACCINATION SITE WARMTH (arm still warm/Left arm injection site hot), MYALGIA (sore) and INJECTION SITE ERYTHEMA (Injection site red) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K0A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE PAIN (extreme pain/Left arm injection site was sore), VACCINATION SITE SWELLING (arm still swollen/Left arm injection site hard and swollen), VACCINATION SITE WARMTH (arm still warm/Left arm injection site hot), MYALGIA (sore) and INJECTION SITE ERYTHEMA (Injection site red). At the time of the report, VACCINATION SITE PAIN (extreme pain/Left arm injection site was sore), VACCINATION SITE SWELLING (arm still swollen/Left arm injection site hard and swollen), VACCINATION SITE WARMTH (arm still warm/Left arm injection site hot), MYALGIA (sore) and INJECTION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-Feb-2021: No specific follow-up information recorded.
Patient received 0.3ml of undiluted Pfizer product approximately 5x dose. Patient experienced no adverse effects for about 4-5 hours. Around 7 hours post dose, patient reported a tingling, pins & needles sensation similar to a pinched nerve experience 10-11 years ago. About 28 hours post injection, patient reported soreness at injection site, fever (unknown reading), myalgia and GI distress. Patient sounded tired, understandably,  but not in distress.
Tdap administered IM into (L) deltoid. Less than 12 hrs. after vaccination admin. Pt C/O discomfort, swelling, redness and heat at injection site. C/O similar SX when received Dtap at age 4.
Approximately 4 hrs. after the injections started to get chills and a fever that went up 102.9. This lasted approximately 5 hours.
My husband also had the same vaccine at the same time but did not experience my symptoms as described below: Vaccination was given very high on the should blade instead of upper arm of left arm. After the injection on 2/27/21 arm was mildly sore, but on the third day, there was more pain. On March 3, the pain was worse, very painful to lift or bend left arm, constant throbbing pain, there is no inflammation on the injection site but whole left arm especially the injection site is very very painful. To this day, March 5, 2021 the pain and throbbing persists, It is very painful to lift or bend the left arm. Will start take OTC CVS Ibuprofen 200 mg every 6 hours to ease the pain.
Headache, first occurred during sleep night after injection; awakened at 3:30 AM- pain on-and-off all day. Intensified at 1PM next day. Moderate Muscle soreness at injection site (Left arm).
medication error due to temperature excursion product administered to patient with no reported AE; medication error due to temperature excursion product administered to patient with no reported AE; Initial information received  on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case involves a 59 years old of an unknown gender patient who was administered vaccines post medication error due to temperature excursion with no reporter adverse event , after receiving vaccine INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2022, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED( lot UJ899AA and expiration date:30-Jun-2023) at an unknown dose via unknown route in unknown administration site as prophylactic vaccination.  On 26-Sep-2022 ,the patient developed a non-serious  event of medication error due to temperature excursion product administered to patient with no reported ae (poor quality product administered) (latency: same day)(Product storage error )(Latency: Unknown).   Action taken :not applicable  It was not reported if the patient received a corrective treatment for the events.   Outcome: Unknown for both events   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. and unknown gender patient who experienced medication error due to temperature excursion product administered to patient with no reported ae and medication error due to temperature excursion product administered to patient with no reported ae while receiving vaccine
Swelling on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling on the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling on the injection site). At the time of the report, VACCINATION SITE SWELLING (Swelling on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided Treatment Ice pack
This spontaneous report as received from a medical assistant refers to a 63 year old male patient. Pertinent medical history, drug reactions or allergies were not reported. Additional information is not expected because reporter refused additional contact.
Headache, chills, fatigue, aches and pains in arm and legs, feel feverish but no fever
numbness and tingling in upper and lower extremities/bilateral upper and lower extremity changes, strength and dexterity changes; numbness and tingling in upper and lower extremities; dexterity issues/bilateral upper and lower extremity changes, strength and dexterity changes; intermittent dull occipital headaches; This is a spontaneous report from a contactable Nurse (patient)  This 36-year-old female patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 07Jan2021 at single dose for covid-19 immunization .The patient medical history was not reported.  The patient's concomitant medications were not reported.  She received the first dose of the Pfizer vaccine on 7th Jan and after 2 weeks, she started experiencing numbness and tingling in upper and lower extremities and dexterity issues, caller stated its progressive issue to the point that its interfering with her daily actives.On 21Jan she recognized bilateral upper and lower extremity changes, strength and dexterity changes, intermittent dull occipital headaches. She Wanted to know if those symptoms are in line for reported symptoms with part one. Is scheduled for her second one today and was unable to get appointment with her doctor until tomorrow. Stated that she has reservations about having the second one.The events were reported as non serious.Outcome of the event was unkown
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4147796.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Batch/Lot number: unknown), on 15Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, all intramuscular for suspected covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1164825), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "SUSPECTED COVID-19". The action taken for adalimumab was unknown.  The reporter considered "suspected covid-19" related to BNT162b2.  The reporter's causality for the event of COVID with Adalimumab Solution for Injection was reasonable possibility. The reporter's causality for the event of COVID with Pfizer BioNTech SUSPECTED COVID-19 vaccine (Tozinameran) was Reasonable Possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Swollen lymph node left arm; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 21Aug2021 at 14:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. On 26Aug2021 at 14:00, the patient experienced swollen lymph node left arm. The event swollen lymph node left arm did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node left arm was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning her daughter who had been vaccinated with three doses of GARDASIL and after the second dose began experiencing headaches. The patient was not hospitalized. The patient was seeing a rheumatologist. Follow-up information was received from a 23 year old female patient. She reported she in June 2007, August 2007 and December 2007 was vaccinated with the first, second and third dose of GARDASIL (lot numbers not reported) respectively. There was no illness at time of vaccination and there was no pre-existing allergies, birth defects or medical conditions either and "she was never a sick child or a sick adult". On 01-OCT-2007 morning the patient started to experience migraines. The patient reported she had constant migraine since then. She had seen a neurologist multiple times. She had an MRI, and MRV and and MRA done in late 2007 and they all showed no complications. She had been prescribed amitriptyline hydrochloride, ZOMIG, FROVA, FIORICET, TOPAMAX, INDERAL, lisinopril among others, not one of these medications helped her migraines. she saw her original primary care doctor and now being followed by her new primary care physician. She had multiple infections, many times getting tested for Lyme disease (negative) and other blood tests (negative). She was in constant crippling pain from her migraines, as well as muscle joint pain and weakness, and frequently getting infections. She had been bruising especially easily since October 2007 also. She was tested for VON WILLEBRAND'S Disease, but results were negative here as well. Her new primary doctor had recently diagnosed her with chronic fatigue and referred her to a Rheumatologist, which she had scheduled an appointment. The patient strongly believe her symptoms are side effects caused by the GARDASIL vaccine. She reported she had none of these symptoms prior to receiving the vaccine, and there was no medical explanation to her symptoms as of yet. The patient was not recovered. The patient's events were considered to be disabling. Additional information has been requested.
SORE ARM; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on unknown date, refer case US2021AMR025848).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had sore arm.  The doses received 6 months apart and got it late in 2019 and so far so good. The patient also got the Pfizer 3 weeks apart.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR025848:same reporter
09/09/22 presents to Cardiology for "cardiac cath". PMHx of "HTN HLD"
PATIENT RECEIVED COVID VACCINATION THAT WAS PAST THE BEYOND USE DATE. NO ADVERSE REACTIONS NOTED.