chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from an RN concerning a 23 year old black female pt who was vaccinated with a 1st and 2nd dose of Hep-B vaccine recombinant on 4/20/99 and 5/17/99, respectively. Approximately 1 hour, post vax, the pt experienced nausea, weakness, emesis and light-headedness. There was no evidence of a local reaction at the injection site. The pt was given a cold compress. It was reported that other members of the pt's family had the flu during this time. Follow-up information from an RN, reported that the pt returned to work 1 day, post-onset, and reported resolution of symptoms within 24 hours of onset.
After 8 hours, then chills, extreme fatigue, nausea and all over soreness for 3-4 days.
Nausea, horrible headache, chills, weakness turning to severe weakness, shortness of breath, fatigue, heart beating very hard.  Today is 3rd day of symptoms.  Still experiencing fatigue, headache, fatigue.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 15Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "high cholestoral" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) unknown results, notes: Treatment of COVID-19; (26Jun2022) Negative; (27Jun2022) Positive, notes: COVID Rebound - tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient stated that no known allergies he knew of. The patient took COVID 19 treatment with Paxlovid (treatment start date: 20Jun2022, treatment stop date: 24Jun2022, lot number: FW4118, indication: Treatment of COVID-19). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Red break outs on the arm, where injection was given, from wrist to shoulder. There was 4 and they were red circles that turned into bullseyes.
ALLERGIC REACTION, INIT 4/8/2023 CHEST PAIN ALLERGIC REACTION, INIT 4/8/2023 OSTEOARTHRITIS OF RIGHT HIP
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manger and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 04-SEP-2020, the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot #S022584, expiration date: 31-OCT-2020, dose: 1 injection (exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis.  The temperature excursion took place on 04-AUG-2020 and was as follows: below 2 Celsius degree (C) (1.1 C) for 27 hours and 45 minutes and above 9 Celsius degrees (9 C) for 1 hour and 15 minutes. There were no previous excursions reported. The digital data logger was involved. No further adverse events (AE) or product quality complain (PQC) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
lip and nose numbness; nose numbness; This case was reported by a consumer via call center representative and described the occurrence of numb lips in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 30th July 2020, 5 min after receiving Shingrix, the patient experienced numb lips and intranasal numbness. The patient was treated with benadryl (nos) (Benadryl) and medication unknown (Inhaler (Nos)). On 30th July 2020, the outcome of the numb lips and intranasal numbness were recovered/resolved.   It was unknown if the reporter considered the numb lips and intranasal numbness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced lip and nose numbness. She took Benadryl and her inhaler as a precautionary measure.  The sensation lasted 6 to 8 hours and resolved.  She was considering whether to get the 2nd dose or not.  She reported this event online to Medwatch. The reporter consent to follow up.
Pt recv vax on 8/12/98; on same day pt exp itching x 10 hr; on10/15/98 pt exp headache; 8/16/98 pt exp nausea & diarrhea
Patient received vaccination, became anxious and lightheaded. lost control of her bladder. opened an ammonia inhalant and patient felt better.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 62-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Total of 173 doses/vials were given for LOT  070H21A. The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information
The patient stated that this morning (04/08, the morning after her immunization the evening prior) she felt malaise, nauseous, and had diarrhea.
I?m a healthcare provider and received the Moderna COVID-19 vaccine in January.  For the past 7 months, if I do any sort of physical activity or get excited, I get a very debilitating brain fog and headache.  It?s adversely effecting my work and can be dangerous at times.  I?ve had to pull my car off the road on several occasions because the symptoms were so severe.  I?m learning how to cope with the triggers but has definitely decreased my quality of life.  I?m unable to exercise and have to be very careful when doing household chores.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2021-395985.
Severe local reaction to the INFANRIX. Some limitation of arm movement (L) - no compromise of use of hand.
Reporting MD indicated had seen rise in core Hep B antibodies following hepatitis vax;
Headache, Myalgia, Fever, Chills, Fatigue, Injection site pain, Swelling at injection site
Headache, NauseaVomiting, Severe HA, nausea, chills
This spontaneous report was received from a nurse concerning to a 4 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 05-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Six hours after receiving vaccine felt very tired.  Next morning body aches, moderate headache, very tired and chills.  Fever off and on with chills.  50 hours after vaccine felt fine and continued with normal life. One week (7 days) after vaccine experiencing chills, body tingling and arm and leg numbness.  Severe headache and nausea.  This has been going on for over 24 hours now.
feeling bad 4 days after 1st dose, with sinus, and headaches, allergies, cold,     later shoulder would start hurting coming and going . after 2nd dose moving and laying down in shoulder and then in hands became worse . severe joint pain
This spontaneous report as received from a physician refers to a 84 year old female patient with drug reactions/allergies to erythromycin, sulfa, iodine and quinolones, and no medical history. On 10-JUN-2014 the patient was vaccinated with a dose of ZOSTAVAX for preventative ( lot#, dosage and route not reported). On 12-JUN-2014, "2 days later" after vaccination, the patient developed "eruptions or blisters" on both of her forearms. The patient went to the emergency room on an unspecified date regarding the reaction. The physician stated the patient was given ATARAX (ALPRAZOLAM) at the hospital but "she's not taking it right now" by the time of this report. The physician stated the patient was not admitted to the hospital. The physician stated the patient was seen in his office on 16-JUN-2014, and was taking BENADRYL for the reaction by the time of this report. When asked the patient's present status the physician stated "it's already subsiding" by the reporting time. The causal relationship was not reported. Additional information has been requested.
I discovered through neurologist lab work. Pancreas enlarged with a mass. I went to my primary care physician, and they sent me for an ultrasound, and it also showed a mass. I went in for an MRI on January 20, 2023. The recommendation was to monitor it. I went to my gastroenterologist, and they will complete an endoscopy on April 06, 2023. I have diarrhea off and on but no other symptoms.
forgot to get my 2 year old the second dose of Bexsero/ 1st dose received by patient; This case was reported by a consumer via interactive digital media and described the occurrence of inappropriate age at vaccine administration in a 2-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 details were provided as follows: The reporter was the patient's parent. The age at vaccination was not reported. The patient received 1st dose of Bexsero before recommended age, which led to inappropriate age at vaccine administration. The reporter stated that he/she forgot to get 2-year-old patient the 2nd dose of Bexsero. The reporter asked, should start again with 2 doses. The follow-up would not possible as no contact details were available.
pt recv vax & had an unspecified rxn following vax w/MMR; No further details were provided;
Right hand pain in center of palm.  Started the very next day of vaccine.  First three days was very painful and radiated up to just past the wrist.  Now its just sore.
Jan. 21-Jan. 24:  In bed: fatigue, dizzy, nausea, body aches, headaches Jan. 24- present day:  Fatigue, brain fog, headaches
S.L. STATED THAT HE WAS "NERVOUS" BEFORE VACCINE ADMINISTRATION.  HE STATED THAT HE FELT "LIGHT-HEADED" ABOUT 2 MINUTES POST-VACCINE.  HE PUT HIS FEET UP AND HAD SOME COLD WATER TO DRINK.  ABOUT 2 MINUTES LATER, HE SAID HE FELT "NAUSEATED" AND PROCEEDED TO THROW UP IN THE PHARMACY.  AFTER THROWING UP, HE STATED THAT HE FELT BETTER.
chest pain; General fatigue; Itchy at the injection site; Redness on the injection site; "area felt warm"; Severe pain in arm; Slight head ache; general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), VACCINATION SITE WARMTH ("area felt warm"), PAIN IN EXTREMITY (Severe pain in arm), HEADACHE (Slight head ache) and FATIGUE (general fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma, Hyperthyroidism and Birth control.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in arm), HEADACHE (Slight head ache) and FATIGUE (general fatigue). On 25-Apr-2021, the patient experienced VACCINATION SITE WARMTH ("area felt warm"), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Redness on the injection site). On 26-Apr-2021, the patient experienced CHEST PAIN (chest pain) and FATIGUE (General fatigue). At the time of the report, CHEST PAIN (chest pain), VACCINATION SITE WARMTH ("area felt warm"), PAIN IN EXTREMITY (Severe pain in arm), HEADACHE (Slight head ache), FATIGUE (general fatigue), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Redness on the injection site) and FATIGUE (General fatigue) 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.   Treatment Ibuprofen
failure to warn that it could happen again,and so it did with second booster; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (failure to warn that it could happen again,and so it did with second booster) in a  patient of an unknown age and gender 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (failure to warn that it could happen again,and so it did with second booster). At the time of the report, IMMUNISATION REACTION (failure to warn that it could happen again,and so it did with second booster) outcome was unknown.            No concomitant and treatment medication were reported.   This case was linked to MOD-2022-563602 (Patient Link).
ABOUT FOUR days after I got the vaccine I got a rash on my lower left arm that continued to itch for several days. After online appt I called a urgent care nurse. Hives spread from arm to all over to chest and across face and neck. Took Zyrtec, Benadryl. Hives were worsening after about two weeks I was seen in person. F/u with dermatologist and allergist. Allergist increase the Zyrtec and Pepcid dosage up to 4 a day along with other medication for hives and rash. subsides after 4 months
Case number PHEH2014US004461, is an initial spontaneous report from a consumer (physician himself) received on 03 Mar 2014. This report refers to a 34-year-old male patient. Past medical history and concomitant medications were not reported. He was administered only MenA powder component of MENVEO (batch number: not provided) reconstituted with sterile water instead of Men-CYW-135, intramuscularly on 26 Feb 2014. He did not complain any adverse reaction following the administration error (wrong solution used in drug reconstitution).
Mom reports that after receiving immunizations and leaving the clinic that baby had bumps over both legs from thighs to feet. She call the after hours triage nurse who told her to go the ED if rash got worse.  Mom reports rash improved, but appeared again in the am, at which time she took the baby to the ED. No fever, no cough, no wheezing noted. Taking good p.o feeds.
patient given an expired dose of Tenivac, no AE; Initial information received on 01-Dec-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (unknown demographics) who was vaccinated with an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  Patient did not received other vaccines.  On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U610AA and expiry date: 23-Oct-2020) via an intramuscular route in the left arm for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  Reporter relationship: HCP (health care professional)  At the time of report, no adverse event was 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 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.
Waited 30 mins, Tounge tingly, no SOB or Tachycarida, clear speech
Patient fell out of chair while waiting 15 minutes for monitoring after vaccination.  He was unconscious for less than a minute.  I checked for pulse which was present along with breathe sounds.  He proceeded to gain consciousness and sat in a chair.  He was coherent but tired and started sweating.  We called EMS who checked him out and stated he had vasovagal syncope.  The patient left on his accord after EMS left.
2 hrs after vaccination developed body aches, 100 fever. Woke during night with feeling that throat was swelling. Was breathing normally. When woke in the morning, chest felt tight.
Vaccine extremely painful; Normal swelling at site; Headache; Arm  is painful; Numbness and tingling to my finger tips; Tingling to my finger tips; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd October 2019, the patient received the 1st dose of Shingrix. On 2nd October 2019, immediately after receiving Shingrix, the patient experienced injection site pain and injection site swelling. In October 2019, the patient experienced headache, pain in arm, numbness in fingers and tingling of extremity. On an unknown date, the outcome of the injection site pain, pain in arm, numbness in fingers and tingling of extremity were not recovered/not resolved and the outcome of the injection site swelling and headache were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, headache, pain in arm, numbness in fingers and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The vaccine was extremely painful to the patient. Soon after, the patient experienced normal swelling at site and headache an hour later. Less than a week after receiving the Shingrix, the patients arm was painful and experiencing numbness and tingling to finger tips. At the evening of reporting date, the patient was still experiencing numb, tingling and pain.
Patient states left hand has been having intermittent throbbing pain up to wrist starting 2 days after receiving second Moderna dose.
Muscle aches whole body, headaches, a 101-degree fever, fatigue, weakness and extreme fatigue
Began to passout, vasovagal response, laid on floor, ambulance was called, and they came and took her BP, and said it was still low. She sat outside in ambulance, until her husband came to pick her up, then she went home and laid on couch. After 1st injection patient then explained that she has vasovagal responses to injections.
2 of which made him ill for 2/3 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "2 of which made him ill for 2/3 days".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
APPROX 3 INCH ARE OF REDNESS AND SWELLING AT SITE, RASH AROUND UPPER ARM/SHOULDER.   STARTING 6-6-22 TREATMENT OF COOL COMPRESSES, ORAL TYLENOL AND BENADRYL FOR 24-48 HOURS.  LASTED UNTIL 6-7-22, THEN IMPROVED WITH NO ISSUES.
Chills, muscle ache (severe), headache ( moderate), extremely overheated over time.  Aches the worse