chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed a fever of 39 C; swelling at the injection site; redness at the injection site; pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (developed a fever of 39 C), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062H21A) for COVID-19 prophylaxis.     The patient had possibly copd.  Concurrent medical conditions included Fibromyalgia and Asthma.    On 21-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (developed a fever of 39 C), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, PYREXIA (developed a fever of 39 C), VACCINATION SITE SWELLING (swelling at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 39 degree Celsius.         No concomitant medication was provided by reporter. On 21-Dec-2021, the patient received first booster dose. The patient developed a fever of 39 C and had swelling, redness and pain at the injection site.  No treatment information was provided by reporter.
Anaphylaxis; This case was reported by a pharmacist via call center representative and described the occurrence of anaphylaxis in a female patient who received Rabies NVS (Rabies Vaccine (Chicken Embryo Cell) for Human Use) for prophylaxis.   On an unknown date, the patient received Rabies Vaccine (Chicken Embryo Cell) for Human. On an unknown date, unknown after receiving Rabies Vaccine (Chicken Embryo Cell) for Human Use, the patient experienced anaphylaxis (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylaxis was unknown.   It was unknown if the reporter considered the anaphylaxis to be related to Rabies Vaccine (Chicken Embryo Cell) for Human Use.  Additional details were provided as follows: The age at vaccination was not reported. The reporter did not specify brand name of rabies vaccine. No lot number, expiration date, or full patient demographics was provided. The reporter noted that, the reaction took place when the patient was in junior high.
Information has been received from a pharmacist via a company representative referring to an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were unknown) for prophylaxis. On an unspecified time after receiving ZOSTAVAX, the patient got sick, she developed the flu. The outcome of the events was unknown. Causality was not provided.     Additional information is not expected as follow up with the pharmacist is not permitted.
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 66-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 medications were reported.  Date the vial was initially stored in the refrigerator reported as unknown. Vaccine was expired on 07-APR-2022.  The vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non significant information.
Fell out of chair, seizure, pinpoint pupils. Noted patient laying on floor with open eyes. Pt is breathing comfortably. Pt was then transported via wheelchair to a bed. Pt reports that has history of psychogenic non-epileptic seizure due to history of abuse (pt will not further disclose her medical condition) that has recently been happening more frequently, and pt receives care . Pt also reported that did not drink enough water and did not have anything prior to visit. Pt was given cracker and juice. Pt was observed till 17:15 and was stable at discharge - discharged at 17:15. Pt declined transport via wheelchair and pt's friend picked up patient. Pt was advised to follow up with PCP. VS: BP: 110/64, HR: 64, R: 16 and O2 sat: 100% room air.
EXTREMELY HEAVY PERIODS WITH CLOTS STARTED AFTER THE 1ST SHOTS. THE HEAVIEST FLOW EVER EXPERIENCED. I HAVE TO USE AN 8 HOUR PAD AS A PANTI LINER NOW, AND I CAN SOAK THROUGH A SUPER PLUS TAMPON IN AN HOUR.  THIS HAS BEEN THE CASE FOR SIX MONTHS NOW, ALWAYS ON DAYS 1 AND 2 OF MY CYCLE. HUGE CLOTS WILL COME OUT OF ME AND GO INTO THE TOILET WHEN I GO TO THE BATHROOM.
Patient presented to clinic twice for eval of rash. Dx'd 4-24-15 with (R) upper thoracic shingles.
The evening after DTAP and influenza shot "lethargic that night" "like he was unplugged stopped talking. Parents reported this on 2/18/14; vaccines administered 11/21/13. Did not call office.
On 25 Feb she received the Tdap, HPV, MCV4P Immunizations. A week later she developed 3-4 pruritic, mildly painful, papules around anus. They were small, the size of the opening of a retractable pin. Her mother questioned her closely about sexual abuse and there seemed to be none. She was treated with warm compresses and Vaseline topical with relief after 3 days or so. She had HPV Dose #2 on 25 April 2014 and on 6 May developed one similar lesion.
ARM SORE SWOLLEN AND RED FROM UPPER ARM DOWN TO ELOW WITH OUT CROSS OF JOINT
After the shot was given, he seemed nervous and I asked if he was okay and he said yes. So I turned around to get a bandaid and he fell off the chair. He was conscious the whole time but didn't remember if he got the shot. 911 was called and I observed him while we waited for them to get here, he was never taken to the hospital. Paramedics observed and released him . Patient said he always gets nervous when he gets any type of shot or blood drawn and this type of situation has happened in the past. This was unknown to us when administering the vaccine.
Entire upper arm swelled to twice normal size (according to patient)starting 2 hours after vaccine administered.  Very painful.
Hives generalized, chills, mucus secretions, peripheral cyanosis. Treatment: Prelone, Benadryl, Epipen times 2, ER management.
RIGHT ARM- SWOLLEN AND HAS A RASH OF ABOUT 2" WIDE AND 3" LENGTH. CHILD WAS TAKEN TO THE EMERGENCY ROOM FOR FOLLOW-UP.
20 weeks pregnant after 2nd dose; Hives all over her body after 2nd dose; Red rash all over her body after 2nd dose / Quit antihistamine rash comes back; Itchy all over her body after 2nd dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over her body after 2nd dose), RASH ERYTHEMATOUS (Red rash all over her body after 2nd dose / Quit antihistamine rash comes back), PRURITUS (Itchy all over her body after 2nd dose) and MATERNAL EXPOSURE BEFORE PREGNANCY (20 weeks pregnant after 2nd dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 011J209) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 15-Dec-2021. On 12-Feb-2021, the patient experienced URTICARIA (Hives all over her body after 2nd dose), RASH ERYTHEMATOUS (Red rash all over her body after 2nd dose / Quit antihistamine rash comes back) and PRURITUS (Itchy all over her body after 2nd dose). On 25-Aug-2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (20 weeks pregnant after 2nd dose). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Rash, Hives and Pruritus, at a dose of 1 dosage form and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at a dose of 1 dosage form. On 25-Aug-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (20 weeks pregnant after 2nd dose) had resolved. At the time of the report, URTICARIA (Hives all over her body after 2nd dose), RASH ERYTHEMATOUS (Red rash all over her body after 2nd dose / Quit antihistamine rash comes back) and PRURITUS (Itchy all over her body after 2nd dose) outcome was unknown.            Concomitant medication details were not reported by the reporter.   Patient stated that as long as she took Zyrtec the rash goes away, but when she stops taking Zyrtec the rash came back. The doctor also prescribed one week Steroid Medrol dose pack which she finished taking. Patient  was thinking about getting a booster shot. The LMP of the patient was reported as 08-MAR-2021.; 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.  This is a case of maternal exposure before pregnancy.
Chills, Fever, Pain around injection site, red swollen upper arm with raised welts.
Information has been received from a 20 year old female healthcare student who on 6-FEB-2009 was vaccinated with a first dose of GARDASIL. On 6-FEB-2009 the patient reported she felt like she had the flu, was achy and had a fever. The patient was off work for about two days. The patient recovered on approximately 11-FEB-2009. The patient sought unspecified medical attention. No further information is available.
Pain from neck to arm; Changes in hearing; Blood pressure elevation of 150/90/blood pressure 140/80; Swollen face; Injection site pain; Rash down the arm; pain through out body/Muscle pain; Joint pain; fever on and off; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face) and INJECTION SITE PAIN (Injection site pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma (asthma). Concurrent medical conditions included Allergy (allergies).    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face), INJECTION SITE PAIN (Injection site pain), VACCINATION SITE RASH (Rash down the arm), MYALGIA (pain through out body/Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (fever on and off). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Sleep disorder, at an unspecified dose and frequency; METHYLPREDNISOLONE ACEPONATE (ADERVAN) for Sleep disorder, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF) at an unspecified dose and frequency. On 09-Mar-2021, VACCINATION SITE RASH (Rash down the arm) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain from neck to arm), HYPOACUSIS (Changes in hearing), HYPERTENSION (Blood pressure elevation of 150/90/blood pressure 140/80), SWELLING FACE (Swollen face), INJECTION SITE PAIN (Injection site pain), MYALGIA (pain through out body/Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (fever on and off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood grouping: ab negative (Inconclusive) AB negative. On an unknown date, Blood pressure measurement: 150/90 (High) 150/90 then went back down to 140/80.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
She has had trouble with her bowels, she's "pretty constipated"; She felt "lightheaded" the day after the second dose; This is a spontaneous report from a non-contactable consumer (patient herself). A female patient of unspecified age received BNT162b2 (COMIRNATY, Formulation: solution for injection, Batch/lot number: not reported, Expiry date: Not reported), via an unspecified route of administration on 15Feb2021 as dose 2, single for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Patient had no known allergies. The patient previously received first dose of BNT162b2 (COMIRNATY, Formulation: solution for injection, Batch/lot number: not reported, Expiry date: Not reported), via an unspecified route of administration on 25Jan2021 as dose 1, single for COVID-19 immunisation. Patient felt "lightheaded" the day after the second dose. She has had trouble with her bowels, she's "pretty constipated", so her doctor relayed to her that she could use the laxative Miralax, she already took it. She also mentioned she is taking all her other medicines, did not specify which. She stated that her symptoms were not related to the vaccine, she has always had them, and she just wanted to know if she could take a laxative. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Upon reviewing skilled nursing facility's chart, it appears his temperature was normal the day of vaccination, and the day after vaccination. On 12/24/21, however, his temperature increased to 100.9 degrees. It came down later that day and started between 97.1 and 99.8 in the days following. Nursing notes state that patient was noted to have reduced appetite and difficulty breathing. On 12/28/21, an XRay was ordered due to difficulty breathing and loratadine 10mg daily was started "for congestion". The XRay findings report that there was a slight right lower lobe infiltrate. Left side appeared clear and heart unremarkable. Doxycycline 100mg BID started in response. On 12/31/21, at approximately 7pm, patient called nursing and asked for the doctor to be contacted because he was having an extremely difficult time breathing. Nursing noted he was using his accessory muscles to breath and his oxygen sats were 70-73% on room air. Nurse applied oxygen 3L and it did not increase O2 sats. Breathing treatment administered and MD contacted. Orders to go to ER were given. EMS arrived and upon repositioning / transferring patient, the patient became unresponsive. CPR was initiated but patient was never able to regain a sustained heartbeat. Per facility staff, family denies having given authorization for COVID booster to be given and believes that booster was cause of death.
Presented w/AMS, fever, chills. Admit for COVID PNA. Hx of lymphoma, HTN. Tx w/abx, steroid, remdesivir, O2. At time of review pt on RA.  Doing well, transport delayed until this am. To SNU today
red spots and little bumps below the injection site; red spots and little bumps below the injection site; red spots and little bumps below the injection site; a lot of pain; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spots and little bumps below the injection site), PAIN (a lot of pain), VACCINATION SITE MASS (red spots and little bumps below the injection site), VACCINATION SITE ERYTHEMA (red spots and little bumps below the injection site) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, the patient experienced PAIN (a lot of pain), PYREXIA (fever) and CHILLS (chills). On 05-May-2021, the patient experienced RASH MACULAR (red spots and little bumps below the injection site), VACCINATION SITE MASS (red spots and little bumps below the injection site) and VACCINATION SITE ERYTHEMA (red spots and little bumps below the injection site). At the time of the report, RASH MACULAR (red spots and little bumps below the injection site), PAIN (a lot of pain), PYREXIA (fever) and CHILLS (chills) outcome was unknown and VACCINATION SITE MASS (red spots and little bumps below the injection site) and VACCINATION SITE ERYTHEMA (red spots and little bumps below the injection site) had not resolved.            No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Follow-up received on 05-JUN-2021, no new information was updated.
increased pins and needles feeling; increased pain in her right hand and right foot; preventing her from walking comfortably; This case was reported by a consumer via call center representative and described the occurrence of pins and needles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included stroke (about 6 years ago had a right sided thalamic stroke). Concurrent medical conditions included central pain syndrome (had pain in the right side of her body).   On 19th September 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pins and needles, pain in hand and walking difficulty. On an unknown date, the outcome of the pins and needles, pain in hand and walking difficulty were unknown.   It was unknown if the reporter considered the pins and needles, pain in hand and walking difficulty to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and about a week or two ago noticed that was increased pain in her right hand and right foot with increased pins and needles feeling which was so bad that it was preventing her from walking comfortably. The reporter consented to follow up and did not know the lot no.
SEIZURE; This spontaneous report received from a patient via social media via a company representative, concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received additional dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) was not reported, 1 total, administered on an unspecified date  for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced seizure. Reporter stated that "Patient my sil had a seizure hours after a covid booster. First one ever" (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220636274-covid-19 vaccine ad26.cov2.s-seizure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Information was received from a physician via an Internet article regarding cases in litigation concerning 789 females of unknown age, who were vaccinated with GARDASIL (lot numbers, dates, dosages, and routes of administration not reported). Between May 2009 and September 2010, there were 789 reports of "serious" adverse reactions (not further specified) that occurred after GARDASIL vaccinations. The outcome of the "serious" adverse reactions was not reported. Upon internal review, 789 reports of "serious" adverse reactions was determined to be medically significant. This is one of several reports from the same source. Additional information is not expected.
Flu like symptoms, body ache, fatigue, headache, persistent right deltoid pain.
COVID-19 Vaccine Moderna EUA. Vaccine administered 2-3 inches below deltoid. No redness or swelling noted immediately after vaccine administration. Patient denies pain related to placement of vaccine.
DIED; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis.  It was unknown if patient experienced any adverse event after covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed (dose number in series 2). It was reported that "we will not know how many have died...the vaccines are making way too much money. My niece died shortly after taking her second shot. There is know proof it will never be released if there was proof. Too much money being made." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220909775-COVID-19 VACCINE AD26.COV2.S- Died. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH