chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of headache in a 60-year-old female patient who received SHINGRIX (batch number 5544H, expiry date 15th May 2021) for prophylaxis. On 21st February 2019, the patient received SHINGRIX. On 21st February 2019, less than a day after receiving SHINGRIX, the patient experienced headache, nausea, tachycardia, hypertension and tremor. The patient was treated with BENADRYL (NOS) and SOLUMEDROL. On an unknown date, the outcome of the headache, nausea, tachycardia, hypertension and tremor were unknown. It was unknown if the reporter considered the headache, nausea, tachycardia, hypertension and tremor to be related to SHINGRIX. Additional details were reported as follows: The registered nurse reported that they gave a patient SHINGRIX, in the morning and the patient went back in complaining of a severe headache, nausea, tachycardia, hypertension and tremors. The patient had no rash and no closing of the throat. The patient received BENADRYL and SOLUMEDROL. The full safety report was not completed at this time.
Client requested MMR currently taking birth control pills. Client finds out later that she was 4 weeks pregnant at time of vaccination.
developed hives of the upper extremities and groin five hours after the injection.  Treated with topical and oral steroids.
This spontaneous report as received from a physician refers to a 11 year old patient. On 13-MAY-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (route of administration, lot # and dose were not reported). Concomitant therapies included unspecified LIQUID PEDVAXHIB. On 15-MAY-2014, the patient experienced positive Tuberculosis Skin Test (PPD). Another two PPD tests were performed on (13-MAY-2014 and 20-AUG-2014) but results were not reported. No treatment was given for adverse event. Patient sought medical attention on follow-up visit. The outcome of the event was unknown. Relatedness between event and vaccination was not reported. Additional information has been requested.
Information has been received from a pharmacist concerning a patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX (Lot # 664653/1337Y). Subsequently the patient experienced rash. At the time of this report, the patient's outcome was unknown. Follow-up information has been received from a pharmacist who reported that the 80 year old female patient with hypertension (HTN), morbid obesity, cardiac failure congestive (CHF) and no known drug allergies on 16-OCT-2010 was vaccinated into the left deltoid with a dose of PNEUMOVAX. The patient had received a dose of influenza virus split virion 3v vaccine inactivated (manufacturer unknown) on 12-OCT-2010. The pharmacist also reported that on 17-OCT-2010, the patient had a localized rash, afebrile. On an unspecified date the patient recovered. A standard lot check investigation has been finalized. All in-process quality checks for the lot number 664653/1337Y were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specification. The lot met the requirements of the Center and Research and was released. follow-up information has been received. It was reported that the patient with hypertension (HTN), morbid obesity, cardiac failure congestive (CHF) and gastrooesophageal reflux disease and left knee pain at the time of the vaccination, on 16-OCT-2010 was vaccinated in the left deltoid with the first dose of PNEUMOVAX. On 17-OCT-2010 at 9:00, the patient experienced a localized reaction to the left deltoid: swollen, redness and track down deltoid. At the time of the report, the patient had recovered. A complete blood cell count was performed (no results provided). Localized reaction to the left deltoid swollen, redness and track down deltoid were considered to be other important medical events by the reporter because it was reported that the event requited medical/surgical intervention. This is one of several reports received from the same source. No further information is available.
Stiff neck/fever sores in mouth, worsening asthma, diarrhea.
pt recvd vax & devel n; h; malaise; & broke out fine papular rash on neck & abdo;
Leg pain, Tingling in hands, weakness, weird sensations like things crawl out of legs.
Breakthrough COVID infection requiring hospitalization reported per EUA requirements. Patient received Pfizer COVID vaccine dose #1 on 3/23 and dose #2 on 4/13/21.   Patient admitted from 7/9 to 7/13/21 for acute hypoxic respiratory failure in setting of COVID19 PNA. Received nebs PRN, HFNC weaned to NC 2L. Prescribed dexamethasone for total of 10 days.
My wife is having side effects after the booster dose; Did not use typical syringe or needle equipment to inject the dose/jet inject/ jet stream device to inject the dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (My wife is having side effects after the booster dose) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Did not use typical syringe or needle equipment to inject the dose/jet inject/ jet stream device to inject the dose) in a female patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (My wife is having side effects after the booster dose) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Did not use typical syringe or needle equipment to inject the dose/jet inject/ jet stream device to inject the dose). At the time of the report, VACCINATION COMPLICATION (My wife is having side effects after the booster dose) outcome was unknown and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Did not use typical syringe or needle equipment to inject the dose/jet inject/ jet stream device to inject the dose) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that the pharmacy used a jet injection for giving the vaccine instead of typical syringe.   Reporter did not allow further contact
A few hours after vaccination, patient states she had extreme soreness in the upper arm and it  started to turn very red and hot. When she presented back to the Pharmacy 3 days later, the redness and edema was still present on her entire upper arm from the top of deltoid, down to the elbow and on the under side of the arm as well. She was counseled to take Benadryl and to seek medical attention if the swelling did not go down some in the morning or spread further. I asked her to mark the area so she could compare in the morning.
Case number PHEH2015US005313, is an initial spontaneous report from a consumer (patient) received on 17 Mar 2015 and with follow up information received from the quality assurance department (QA reference number: 358730) on 20 Mar 2015 and a follow up received from nurse on 20 Mar 2015, with the follow-up information received from Quality Assurance Department (reference number: 358730) on 26 Mar 2015. This report refers to a 29 years old female pregnant patient. Past medical history included Graves' disease. Concomitant medications included propylthiouracil and prenatal vitamins. The patient was vaccinated with BEXSERO (batch number: unknown) on 24 Feb 2015. On 04 Mar 2015, the patient underwent blood test which confirmed non-viable (not further specified). The patient's pregnancy was confirmed by quantitative lab work (possible chemical pregnancy). However, no ultrasound was done to confirm the pregnancy. The patient's last menstrual period (LMP) was on 28 Jan 2015 and expected date of delivery (EDD) was 04 Nov 2015. On 08 Mar 2015, the patient had a miscarriage. The patient's pregnancy was not associated with any contraception failure and the patient did not discontinue any drugs due to the pregnancy. The patient had now recovered and was now having regular menses. Seriousness and causality of the events was not reported. Seriousness assessment of miscarriage was upgraded based on the NVS-IMS list. On the basis of the review performed it is possible to confirm that BEXSERO manufacturing process is under control. From a technical and quality point of view, neither any objection nor discrepancy has been identified nor was any cause identified for the reported adverse event. Non-significant follow up information received from the quality assurance department (QA reference number: 358730) on 20 Mar 2015: Updated QA reference number. Follow up received from nurse on 20 Mar 2015: updated patient demographics, medical history, concomitant medications, LMP, EDD and other clinically relevant information in the narrative. Follow-up information received from the Quality Assurance Department (reference number: 358730) on 26 Mar 2015: Updated BEXSERO batch review report.
There was no adverse event, reporting is done due to vaccine error. Error was noted on 5/12/23. no reports from parents on adverse events after immunizations administered.
swelling of left arm and then swelling in left leg; painful; unable to bend; bedridden for 4 days; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 59 years old female patient who experienced swelling of left arm and then swelling in left leg (swelling), painful (pain),unable to bend (mobility decreased) and bedridden for 4 days (bedridden), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1938 (Expiry date 30-Jun-2020) via intramuscular route in unknown administration site.  On an unknown date, the patient developed a non-serious swelling of left arm and then swelling in left leg (swelling), painful (pain),unable to bend (mobility decreased) and bedridden for 4 days (bedridden) (Unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.   (Other relevant tests included no lab data.) Final diagnosis was bedridden for 4 days, unable to bend, painful and swelling of left arm and then swelling in left leg.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for all the events.
Initial report received from a pharmacist on15 Jan 2010: This patient was vaccinated with S-OIV FLUVIRIN of an unknown batch number, 0.5 ml on unknown date which was stored at temperatures as low as 34F and 35 F. No adverse event was reported.
RECEIVED VACCINE ON 2/9.  FELT QUEASY BUT NOT BAD ON TUES PM AND WED.  THEN FINE WED 2/10 NITE. ON THURSDAY 2/11 RASH STARTED ON LEFT ARM NEAR INJECTION SITE.  TOOK OTC BENADRYL .  STARTED SPREADING TO WHOLE ARM AND UPPER CHEST AND HEAD AND NECK.  SEVERE SHEDDING OF SKIN.  PAINFUL AND ITCHING.  ON SUNDAY 2/14 WENT TO EMERGENCY ROOM AND WAS ADMITTED OVERNIGHT OBSERVATION.  RECEIVED IV LIBRIUM, DIPHENHYDRAMINE, FAMOTIDINE, OLORAZEPAM, METHYLPREDNISOLONE SOD SUC (PF).
Swelling on my left side next to the collar bone and neck,  tender and pain between shoulder and color bone. Fever of 102, chills, body ache and headache, weakness, and fatigue.
a lymph node in her neck; a swollen lymph node under her right armpit; Headache; her face felt funny on the right side; like her cheek was very heavy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), INDIFFERENCE (her face felt funny on the right side), SWELLING FACE (like her cheek was very heavy), LYMPHADENOPATHY (a lymph node in her neck) and LYMPHADENOPATHY (a swollen lymph node under her right armpit) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HEADACHE (Headache), INDIFFERENCE (her face felt funny on the right side) and SWELLING FACE (like her cheek was very heavy). On 12-Feb-2021, the patient experienced LYMPHADENOPATHY (a lymph node in her neck) and LYMPHADENOPATHY (a swollen lymph node under her right armpit). On 11-Feb-2021, HEADACHE (Headache), INDIFFERENCE (her face felt funny on the right side) and SWELLING FACE (like her cheek was very heavy) had resolved. At the time of the report, LYMPHADENOPATHY (a lymph node in her neck) and LYMPHADENOPATHY (a swollen lymph node under her right armpit) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications included heart pill and birth control pill for PCOS.  Treatment has not been specified.
On evening following injection patient with swelling of left upper extremity, sweling progressed overnight with increasing swelling, erythema and induration requiring IV antibiotics.
fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and CHILLS (chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 23-Mar-2021, PYREXIA (fever) and CHILLS (chills) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were provided   This case was linked to MOD-2021-039179 (Linked Report). This case was linked to MOD21-086779, MOD-2021-039179 (Patient Link).; Sender's Comments:  MOD-2021-039179:1st Dose
Rash entire body with itching.  11/16/09:  Prenatal records received for date of service 11/12/09.  Dx:  Hives. Assessment:  Hives on arms, legs and back.  Itchy.  Took Benadryl with no relief.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2014, the patient was administered the ZOSTAVAX vaccine by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On or about 07-AUG-2014, the patient was treated by a healthcare provider for the following injury resulting from the patient's ZOSTAVAX use: Shingles. The patient claimed damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
side effects/they went away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects/they went away) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects/they went away). At the time of the report, VACCINATION COMPLICATION (side effects/they went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Complaining of itching at site, lower left arm and face, 5 minutes, post vax. Given Benadryl 25mg po and repeated, 1 hour later. She went to see her doctor. Her husband picked her up from work and took her to the doctor.
3 Days after receiving the 2nd dose of the vacinne, my mild tinnitus has gone from barely noticable(2 out of 10) to a (10 out of 10) 24 hours a day. I feel like I have moderate to severe inflamation in my inner ears.
Fever developed the night of the vaccine and continues for three days. On the third day after the vaccine, the fever stopped and a rash appeared. Clinically this is consistent with a viral infection (roseola) and likely not related to vaccine.   However, given temporal relationship to vaccine administration, report made
Mild body aches, feverish, temp 98.3, felt like sore throat coming, head cold. Mild discomfort at injection site.
VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 52 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 20-MAR-2022) dose was not reported, 1 total administered to left arm on 08-SEP-2021 for prophylactic vaccination and the patient experienced administration of refrozen vaccine following vaccination with first dose of covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 212A21A, and expiry: 20-MAY-2022) dose was not reported, 1 total administered to left arm on 25-JAN-2022 for prophylactic vaccination. Age at time of vaccination 52 years old. No concomitant medications were reported. On an unspecified date, the vaccine was refrozen (Dose number in series 2) and on 25-JAN-2022, the patient experienced administration of refrozen vaccine (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, involving the same patient is linked to 20220537688. This case, from the same reporter is linked to 20220538238, 20220537548, 20220537683, 20220538428, 20220538297, 20220538573, 20220538480, 20220538149, 20220537688, 20220538627, 20220537341, 20220537444, 20220538292, 20220538411, 20220537356, 20220538693, 20220539045, 20220537532, 20220538146, 20220538316, 20220538210, 20220538758, 20220538437, 20220538425, 20220540435, 20220537507, 20220540853, 20220540611, 20220541180, 20220540524, 20220540570, 20220540688, 20220540474, 20220540765, 20220540420, 20220540814, 20220541085 and 2005084289.
I received the Vaccine around 11:14 a.m.  At around 4:30 my lips started feeling tingling and the roof of my mounth was feeling the same.  I did notice that my lips were swollen and my face was swollen slightly.  I continued to drink fluids.  I did take 50 mg of Benedryl hoping that the tingling and swollen lips would go away.  It took almost three (3) hours for my lips to go down a little.  I did not take anymore Benedryl.  I alerted Pharmacy regarding my symptoms and Dr. via telephone call.  I do not plan to take the second dose.
There was severe shaking, tingling and numbness in my left foot, the effect was more severe in the toe region. This effect persisted over a long time, I never had such adverse effect in my body. Currently, the effect has reduced, but not completely waned. I also felt lack of flow of blood when I sat for some longer time, needed to shake my leg to start walking. Apart from these, I had fever, body pain and lack of breathing after vaccination which persisted for first few days.
This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Lump in his throat), RASH PRURITIC (Rash itches a little bit) and RASH (Rash on his torso(ribs, stomach, and lower spine on his back)) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 043B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced PHARYNGEAL SWELLING (Lump in his throat), RASH PRURITIC (Rash itches a little bit) and RASH (Rash on his torso(ribs, stomach, and lower spine on his back)). At the time of the report, PHARYNGEAL SWELLING (Lump in his throat), RASH PRURITIC (Rash itches a little bit) and RASH (Rash on his torso(ribs, stomach, and lower spine on his back)) outcome was unknown. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Mild, Systemic: Chills-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Systemic: Headache-Mild, Systemic: Joint Pain-Medium, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Unable to Sleep-Mild, Additional Details: patient has pacemaker.
pt recvd vax;w/in 24 hrs p/ vax, exp unconsolable crying for 1 hr; recovered; reported to ped at ofc visit mar94
Didn't get the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported. No Treatment information was reported.  Reporter said that patient received the first dose of the Moderna COVID-19 on the first week of June and "life got in the way", the patient never received the second dose. When asked for clarification the caller said that the patient did not get the second dose because of work.  Upon follow up, the patient reported that the patient was doing fine, had received the second dose and the patient declined for follow up.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: attached : narrative updated, Medication error ticked