chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day following the immunization, patient states she saw a small hard bump at the injection site. Then she started noticing a pea sized amount of redness which has now grown to a golf ball size. The area is still itchy, she hasn't been scratching for fear of further irritating the area but she rubs her hand over the area to relieve the irritation. Patient denies any pain. She states her first SHINGRIX dose did not have any reactions. I advised her to continue monitoring the area, to try ice packs to relieve the swelling and in the event the irritation continues to see her PCP .
3 partial Anaphylactic reaction; Face was swollen; Nose was swollen; Lips were swollen; bad reaction to the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (3 partial Anaphylactic reaction) in a male 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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION COMPLICATION (bad reaction to the vaccine). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (3 partial Anaphylactic reaction) (seriousness criterion medically significant), SWELLING FACE (Face was swollen), SWELLING (Nose was swollen) and LIP SWELLING (Lips were swollen). At the time of the report, ANAPHYLACTIC REACTION (3 partial Anaphylactic reaction), VACCINATION COMPLICATION (bad reaction to the vaccine), SWELLING FACE (Face was swollen), SWELLING (Nose was swollen) and LIP SWELLING (Lips were swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant product use was not provided. Treatment information included steroids.   Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Case upgraded to serious as "3 partial anaphylactic reactions " events added. Patient's contact information updated for further follow-up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient died in her sleep the night after receiving the vaccine. 2/21/06 Received medical records from PCP/ss 2/23/06 Received medical records from new PCP who provided vaccine/ss
TC from pt. to report reaction to ZOSTAVAX vaccine. Received the vaccine 5-10-11, in the afternoon, 5-11-11 at 2 AM was awakened with itching, generalized body aches and fever of 101.9. No evidence of rash. Pt. reports feeling much better today, just wanted PCP to be aware and document the reaction. Instructed may use OTC antihistamines for generalized itching if needed. Pt. verbalized understanding.
body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Aug-2021, the patient experienced MYALGIA (body aches). At the time of the report, MYALGIA (body aches) outcome was unknown.            No concomitant medications were reported by the reporter.  No Treatment information was provided by the reporter.   This case was linked to MOD-2021-286769 (Patient Link).   Reporter did not allow further contact
Pain in both legs, more severe in right leg; Pain and throbbing both ears, more sever in right ear; Off and on abdominal pain. These have been continuous from around March 22nd to today.
Patient was given his four year old vaccines yesterday on 5/2/23 and returned today 5/3/23 with an 10-12cm red and swollen reaction after having quadracel administered into the right arm. Patient skin was hot to touch.
Began with rash on arms and legs, palms and soles. Mild itch. Felt a little ill right before rash started.  All started on 10-22-10.
Cardiac flutter; This spontaneous case was reported by a non-health professional and describes the occurrence of CARDIAC FLUTTER (Cardiac flutter) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (Cardiac flutter) (seriousness criterion medically significant). At the time of the report, CARDIAC FLUTTER (Cardiac flutter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  The patient did not receive any treatment. Lab details were not provided.  No treatment information was provided.  This case concerns an adult female with a serious unexpected event of cardiac flutter. Event onset with unknown latency after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-219960 (Patient Link).; Sender's Comments: This case concerns an adult female with a serious unexpected event of cardiac flutter. Event onset with unknown latency after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient received HPV (#3) injection 3-6-11. Patient came to office 4-7-11. C/O pain at injection site. No redness. No swelling. No fever.
Patient called the pharmacy on 01/21/2022 to report her on going symptoms since receiving her Covid Moderna booster. She described her symptoms of heart pounding out of her chest and elevated BP.  She said immediately, she had a hot sensation around her heart that radiated to her middle back and neck. She said this felt different than an anxiety attack. She was treated with ice pack and water and left the waiting area before a final check and did not report her symptoms again until 1/21/2022 by phone.  She has been to the ER three times and was followed up by her PCP and cardiologist. BP medications were started after the first ER visit and then increased by cardiologist. EKG was reported as normal. Pt said she did not have any heart issues prior to the booster shot. Each ER visit she was dismissed as anxiety. The most recent visit her BP was 211/114 on 1/20/22 and was taken by ambulance to ER. Again BP was resolved and she was sent home stating she was having white coat syndrome and anxiety.   As we talked on the phone, I had her take her BP at home after 5 minutes of silence and reviewing BP monitoring technique.  Her BP was 222/120 with pulse of 104. I recommended to call ER or if she didn't want to go to her, get ahold of her PCP or cardiologist ASAP as this is a crisis.
I experienced a breakthrough case of COVID-19 with being diagnosed with tinnitus with a hissing sound in my ear, it stops and then comes back and if it is not the hissing noise it is a chirping noise in my ear, the EMT doctor said it may or may not ever go away. I also am experiencing hearing loss.
foggy headed; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 27Mar2021 at 00:45 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to something that starts with p that prevents itching, but it was unspecified. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), bupropion (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and b. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the left arm on 06Mar2021 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 29Mar2021 at 15:30, the patient felt extremely foggy-headed all day. It was like her brain was in the off-position. The patient needed to drop-off her GPS at a store five miles away to have it updated. While driving there, she completely forgot where she was going four times, & it took a while for it to come back to her. The patient couldn't think at all, she just had to wait for it to come to her, and she was calmly driving down a 2-lane road the first time, the patient knew she was going in the right direction, but couldn't remember where she was supposed to end up. That happened twice on that one & a half mile stretch of road. Then while her brain was working, the patient got on a major highway and did that two more times, she completely forgot where the heck she was going (not a clue). The patient just kept driving, calmly, and finally, the business popped into her brain, and she was satisfied, and she just kept going till she got to her exit then she got off the highway and found the business. The patient had forgotten where she was going before, but never 4 times in one trip. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event foggy feeling in head was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Headaches began day after and continue to today- 5 days later; Next morning grapefruit size hot tender knot at injection site; Next morning grapefruit size hot tender knot at injection site; Next morning grapefruit size hot tender knot at injection site; Immediate swelling at site; Severe fatigue for 3 days after, moderate today; Muscle, body and neck aches continuing; Muscle, body and neck aches continuing; Muscle, body and neck aches continuing; GI upset with diarrhea x 3 days; GI upset with diarrhea x 3 days; Lymph node swelling underarm on side of injection; This is a spontaneous report from a contactable nurse, the patient. A 55-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 03Sep2021 at 12:30 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications. On 03Sep2021 at 17:30, the patient experienced immediate swelling at site. On 04Sep2021, the next morning, patient experienced grapefruit size hot tender knot at injection site. On 05Sep201, the patient had headaches which began day after and continued to current day, 5 days later. The patient had severe fatigue for 3 days after, moderate the current day and muscle, body and neck aches which were continuing. The patient also had gastrointestinal upset (GI upset) with diarrhea for three days and lymph node swelling in underarm on side of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events immediate swelling at site, next morning grapefruit size hot tender knot at injection site, headaches began day after and continue to today- 5 days later, severe fatigue for 3 days after, moderate today, muscle, body and neck aches continuing, lymph node swelling underarm on side of injection was not recovered at the time of this report and of GI upset with diarrhea x 3 days was recovered on an unknown date of Sep2021.
Spoke with client's mom today 8/24/2021 at 9:40am, she states that the client developed a rash shortly after receiving vaccines from me yesterday.  It was red and itchy from the belly button to his groin area.  She put an antibiotic cream on the affected area and the rash appeared to go away.  This morning when the client woke up, he had a rash covering his back and the client states that his body is broken because both of his legs hurt.  I advised mom to call his pediatrician and let him know what is going on and whether he will be able to receive future doses of these vaccines.  I also told mom she could try Benedryl on his rash to see if that helps.  Mom states that otherwise the client feels fine- no fever or anaphylaxis.
flu; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender who experienced flu after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any concomitant disease or risk factor.  On an unknown date in 2009, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient developed flu (influenza) (unknown latency).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
within first few moments after injection- arm/hand numbness .  the following day- lightheadedness and severe headache
Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medication was not provided. Treatment medication was not provided   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Pt was given the Pfizer 5-11 bivalent booster but should have been given the Pfizer 12+ bivalent.
SkinRash small hive to arm. day after vaccination swelling to right upper lip Narrative:
fever; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), PAIN (achy) and FATIGUE (tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), PAIN (achy) and FATIGUE (tired). At the time of the report, PYREXIA (fever), PAIN (achy) and FATIGUE (tired) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.4 (High) 100.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was available. No Treatment Medication was available.
Near end of patient's 15 minute post-vaccine wait period, patient reported feeling slightly dizzy. Patient was seated then stood to notice. Patient took own BG with own meter, documented WNL for patient.(122g/dL). Patient was then instructed to be seated with feet elevated to monitor. Patient took own pulse, reported at 70bpm., WNL for patient fitness level.  During continued time seated, about 15 more minutes, patient reported that her throat "felt funny" or tingling. Patient was then given 37.5mg liquid diphenhydramine and driven to nearest healthcare facility with NP/MD- Urgent Care(7 miles away). Once there, patient seen by NP on duty, assessed( BP taken140/80), monitored, and released without further concern. No treatment given at UC. Patient not required to resume work same day, so was driven home by family member. Follow up: reported to work without concern next AM.
Information has been received from an office manager concerning a 17 year old male patient who on 04-MAY-2010 was vaccinated with a fourth dose of RECOMBIVAX HB (lot number not available). The office manager reported that after the patient was vaccinated with the three doses of RECOMBIVAX HB, all blood work (hepatitis B surface antibody) came back negative (less than 5), "not immune", requiring a fourth dose of RECOMBIVAX HB. The patient did not develop hepatitis B. No other adverse events were reported. At the time of the report the patient had not had follow up laboratories. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information received via medical records indicated that the patient was a non smoker male. The patient's past drug therapy included first doses of IPV (unspecified), DPT and Hib conj vaccine (unspecified carrier) on 02-SEP-1992. On 11-JUL-1992 the patient received a first dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown); on 05-AUG-1992 the patient received a second dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown) and on 03-JAN-1993 the patient received a third dose of hepatitis B virus vaccine (unspecified) (manufacturer unknown). On 23-APR-2010 the patient had an anti-HBs titer (less than 5); it was reported that the patient did not have immunity to hepatitis B virus. On the same date a Varicella zoster virus IGG AB indicated that the presence of IgG VZV antibody was consistent with immunity. On 04-MAY-2010 the patient was vaccinated with a fourth dose of RECOMVIBAX HB (manufacturer unknown) (lot # AHBVB7URAA). On 24-JUL-2010 the patient had another anti-HBs titer which showed that the patient had immunity to hepatitis B virus (145 mIU/mL). This is one of several reports received from the same source. No further information is available.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left 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: "Obesity" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing). Concomitant medication(s) included: BUPROPION; PHENTERMINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid from 04Jul2022 to 08Jul2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report was received from a physician assistant and refers to a 43 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 08-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 38 degrees Fahrenheit for 1224 hours (51 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
Initial information received on 14-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 6 months old patient of unknown gender who was administered the diluent (dtap/IPV) portion from vaccine PENTACEL (lot C5593AA, expiry date 27-Oct-2019) via unknown route in the right thigh on 28-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR; and ROTATEQ. It was a case of actual medication error due to inappropriate reconstitution technique staff member only administered the diluent (Dtap/IPV) portion from PENTACEL. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.