chrisvoncsefalvay/vaers-outcomes huggingface dataset:
AWAKENED FROM SLEEP BY AN EXTREMELY LOUD SIREN IN HEAD / TINNITUS; This spontaneous report received from a patient via a company representative concerned a 71 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was very good health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-AUG-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-AUG-2021, the patient experienced awakened from sleep by an extremely loud siren in head/tinnitus. Laboratory data (dates unspecified) included: Laboratory test Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from awakened from sleep by an extremely loud siren in head / tinnitus. This report was non-serious.
Patient's wife stated that on Sunday he was feeling weak most the day. She took his blood oxygen because he is on oxygen for COPD and it was lower than normal. She turned his oxygen up to 5%, then took his blood pressure. His blood pressure was 256/136, so she called the ambulance. When he was brought into the hospital they put him on a ventilator.  He is still on a ventilator as of 5/8/2021. The hospital staff said he had double pneumonia and they plan on trying to take him off the ventilator on 5/10/2021.
LAST NIGHT RASH APPEARED CHEEKS AND EYELIDS FIRST THEN SPREAD TO CHEST AND BELLY.  iNCREASED FUSSINESS, DECREASED APPETITE NO FEVER, LAST WEEK RHINORRHEA, CLEARED UP AFTER 2 DAYS, NO VOMITING OR DIARRHEA, DECREASED ENERGY BUT NOT LETHARGIC, RUBBING EYES NO KNOWN EXPOSURE OTHER THAN IMMUNIZATION. NO CHANGE IN PERSONAL CARE PRODUCTS.
Left arm began hurting at the injection site less than 24 hours after receiving the shot. It was very painful to lift my arm; especially when putting on and taking off clothing.  More than 30 days after receiving the injection my left arm still hurts at the injection site. It isn't nearly the pain that I felt 24 hours after the injection,  but there is still a mild amount of pain at the injection site.
A report has been received from a Health Professional concerning an 11 year old, female subject, who had been receiving nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The patient moved and only half of the dose went into one nostril which started on 31-Oct-2014 and also reported that the patient did not stay to receive the second half of the dose. The outcome of the event of patient moved and only half of the dose went into one nostril is unknown. The report was considered to be non-serious.
Patient was questioned about receiving a previous dose of covid-19 vaccination and she stated she did not and that it was an error on the state reporting form. We administered the pfizer covid-19 vaccine. When the technician called the other pharmacy to have the state registry entry corrected they stated she did get the shot and they had signatures on file. When re-questioned, the patient stated she had gaps in her memory due to a recent panic attack and may have gotten it but did not have any memory of it.
Patient received vaccineation in L arm, then developed tingling on right cheek and side of tongue.  Seen in ED and told to followup with Primary Care Provider
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Pt almost fainted, states vision narrowed and he felt like he was going to pass out. But then as quick as it come on it subsided and he was fine. -Severe, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: visual changes=narrowed vision that corrected within less than 5 minutes
Very minor temporary muscle soreness at the upper arm area of the second shot; This is a spontaneous report from a contactable consumer (patient). A 74-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 74-year-old), dose 2 via an unspecified route of administration, administered in Arm on 28Feb2021 as dose 2, single for covid-19 immunisation. Medical history included asthma (I have asthma (well controlled), in overall very good health). The concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 07Feb2021 for covid-19 immunization and No reaction on previous exposure to vaccine. The patient reported, very minor temporary muscle soreness at the upper arm area of the second shot (in the opposite arm of the first shot) on an unspecified date in 2021. Wished to participate in Covid-19 booster shot trial if/when it may occur. Outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Increased weakness and lethargy observed day following booster. This has continued past 7 days now.
Big red welts and hives on left arm near injection site, redness, warmth, swelling, burning sensation,  chills, nausea, headache, and my left ear is red, swollen, and itchy . This started on 1-7-22.
10 cm indurated area; erythematous area at right upper arm; pain 1 day post injection; This case was reported by a nurse via other manufacturer and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2019, the patient received the 1st dose of Shingrix. On 27th June 2019, 1 days after receiving Shingrix, the patient experienced pain. On 28th June 2019, the patient experienced erythema. On an unknown date, the patient experienced induration. On an unknown date, the outcome of the pain, erythema and induration were unknown.   It was unknown if the reporter considered the pain, erythema and induration to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The nurse reported that she developed pain and erythematous at right upper arm and 10 cm indurated area after vaccination. No further information were reported.
8 year old male received 2nd doe of VZV on 02/10/09 at around 0830. Starting at 2100 on the same day the child exhibited erythema, edema in the left arm. The left arm was also hot to the touch. At 0630 on 02/11/09, eruption of cluster of blisters/vesicles of varicella. The school nurse may have applied hydrocortisone cream to the area and marked the area of induration. The mother and child came to the Health Department for assessment at about 1530 on 02/12/08. Mom was instructed to not give patient ASA, to seek help if area of induration enlarges, if fever or general malaise worsens. The patient was told to not put hydrocortisone or any other topical products on the area. Advised to drink increase fluid intake, stay home from school until lesions are dry and scabbed. Asked parent to call the Health Department on Tuesday, 02/17/09 to report on condition of arm.
Case number PHHY2012US013372 is an initial literature report received on 14 Feb 2012. Authors published the adverse events following administration of H1N1 vaccine to pregnant women that were reported to Vaccine Adverse Event Reporting System. This case refers to a 23-year-old female patient. She was vaccinated with H1N1 (manufacturer and batch number: unknown) between 01 Oct 2009 and 28 Feb 2010. She was pregnant and was at 19 weeks of gestation at the time of vaccination. The cleft lip was first detected during a prenatal ultrasound examination at 22 weeks gestation. On an unspecified date she delivered a baby with a congenital anomaly of cleft lip (see linked case: PHHY2012US013388). The author's stated that, because cleft lip is embryologically determined during the first trimester of pregnancy, it is implausible to consider vaccination at 19 weeks gestation as a possible causative agent. Authors concluded that the pregnant women who were vaccinated with H1N1 vaccination with inactivated and live vaccines did not show unusual pattern of maternal or fetal outcomes. The most common pregnancy specific adverse event was spontaneous abortion (SAB) and stillbirth, and more than a third of women who experienced SAB had at least one risk factor (advance maternal age). Seventy two percent of women who had stillbirth had at least one risk factor or had a pathological finding in the fetus or placenta, suggesting factor other than vaccination that may be contributed to the fetal demise. This suggested that women with higher risk were overrepresented in VAERS database.
Joint pain; A spontaneous report was received on 25-Jan-2021 from a  healthcare professional concerning a unknown aged male patient who received Moderna's COVID-19(mRNA-1273) vaccine and developed joint pain.  The Patient medical history was  not provided. No concomitant medications was reported.  On 28-Dec-2021, prior to the onset of events, patient received  mRNA-1273(Batch: unknown) route of administration unknown  for the prophylaxis of covid-19 infection.  On unknown date, patient experienced joint pain.  No laboratory information was provided.  Treatment information includes Ibuprofen.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was recovered/resolved.
Approx 4 hours post vaccine patient reports coughing for 30-60 minutes followed by a sore throat and mouth that lasted for approx 3-4 hours. Was not bad enough to keep her from falling asleep that night. By the next morning all signs and symptoms had fully resolved.
Severe fatigue. Dysarthria. TIA like symptoms. Panic attack like experience. Death like experience with the feeling of impending doom. Difficulty understanding other people or interpreting what I see. Fell in the airport and canceled my flight
Vaccinee rec'd a first vax on 17JUL90 events occurred 4 days pos vax & resolved, w/out treatment; had onset of low grade fever, malaise, arthralgia on 18JUL90, day p/ rec'd 1st vax & not 4 days post vax;
Large area of induration, erythema, tenderness, encompassing entire deltoid to elbow. pain (L) neck/ribs
Arm in the injection site is feeling sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm in the injection site is feeling sore) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm in the injection site is feeling sore). At the time of the report, VACCINATION SITE PAIN (Arm in the injection site is feeling sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   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.; 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.
pt had a gen erythematous, blanchable, confluent rash on back & face that started the same noc p/vax;pt given med;
Patient said he experienced vomitting, diarrhea, sweating, weakness, bloating, he had shortness of breath and difficulty breathing.
Mother case. Case number PHEH2014US022267 is an initial spontaneous report from the pharmacist received on NOV 2014. This  report refers to a 37-yaar-old female pregnant patient. This pregnant patient's last menstrual date was not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 03 OCT 2014. On the same date, after vaccination she experienced pain in the arm at the injection site which has continued for 30 days. It was reported that she was still reporting pain in her arm. The seriousness and causality of the event were not reported.
Pt stated Right arm was extremely sore, red and swollen. Soreness was finally almost gone on 11/16/18 but still red and swollen.
Patient received third dose early.  Second dose was November 2021.  Patient aware of early dose. No adverse effects.
Patient was given a Booster dose of Moderna instead of the Booster of Pfizer.
Information has been received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date, the patient was vaccinated with one dose of improperly stored RECOMBIVAX HB 2.5/0.5 unit not provided (lot # L033343, expiration date 13-SEP-2017; dose and route were unknown). No adverse effect was reported. The storage details for this RECOMBIVAX HB were 0.6 Celsius degree for 3 hours 41 minutes, 0.5 Celsius degree for 8 hours 4 minutes, and 0.9 Celsius degree for 2 hours 14 minutes. Additional information had been requested.
Started with pain in the back of his head and started to itch approximately 25 minutes after vaccination. Tylenol administered per individual and his employer. Health facility administered Benadryl at 5:30pm when itching started. At 5:40pm stated he was feeling better, but warm and his pain was gone. At 5:43pm stated he was feeling better and went back to work on his own.
Narrative: Patient was symptomatic (felt like he had a "head cold" and states he was lethargic and had foul taste in his moth) therefore had COVID test performed at hospital, which was positive. Patient went home and did nor require hospitalization.
Swelling, redness, hot to touch, pain to touch at injection site.  This did not occur after the first vaccination or the second two booster shots. Aches and pain throughout body and tiredness per usual All symptoms lasting over 3 days.
Patient was in today for her 1st dose Pfizer.  Approx 5 minutes after injection, patient felt weak and hot and brought herself to the floor.  No LOC, pt did not hit her head.   Patient was evaluated by Dr, given water and cool compress. No SOB.   No other complaints,  Pt waited an additional 25 min. Vital signs upon discharge WNL BP 92-57, Pulse 84, O2 100%
local redness and swelling, cellulitis, no antibiotics required, left thigh, lateral aspect 10 x 7 cm.
Fatigue; High fever for 9 hrs, low grade fever for 24 hrs; Vomiting; Diarrhea; Mild pain around abdomen; This non-serious case was reported by a consumer and described the occurrence of abdominal pain in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 577BF, expiry date SEP-2023) for prophylaxis.   On 17-APR-2023, the patient received Shingrix .5 ml. In APR-2023, an unknown time after receiving Shingrix, the patient experienced abdominal pain (Verbatim: Mild pain around abdomen). On 17-APR-2023, the patient experienced fatigue (Verbatim: Fatigue), fever (Verbatim: High fever for 9 hrs, low grade fever for 24 hrs), vomiting (Verbatim: Vomiting) and diarrhea (Verbatim: Diarrhea). On 19-APR-2023, the outcome of the fatigue, fever, vomiting and diarrhea were resolved (duration 2 days). The outcome of the abdominal pain was not reported.   It was unknown if the reporter considered the abdominal pain, fatigue, fever, vomiting and diarrhea to be related to Shingrix.     It was unknown if the company considered the abdominal pain, fatigue, fever, vomiting and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-APR-2023 The patient had an additional side effect was mild pain around the abdomen. Also experienced fatigue, high fever for 9 hours, low grade fever for 24 hours, vomiting, and diarrhea. The symptoms were not treated.
medication error due to temperature excursion that exceeded the stability data, Fluzone Quadrivalent multidose vial was administered to patient, with no reported adverse event; medication error due to temperature excursion that exceeded the stability data, Fluzone Quadrivalent multidose vial was administered to patient, with no reported adverse event; Initial information received on 12-Oct-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves a 56-year-old (unknown gender) patient, reported a medication error due to temperature excursion that exceeded the stability data and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] multidose vial was administered to patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Sep-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE (strength, formulation, dose , route: unknown) (lot number: UJ899AA and expiry date: 30-Jun-2023) in unknown administration site for Immunization and on the same day fluzone quadrivalent multidose vial was administered to patient, with no reported adverse event (poor quality product administered) and medication error due to temperature excursion that exceeded the stability data, with no reported adverse event (product storage error) (unknown latency).  This situation is reported as a medication error due to temperature excursion that exceeded the stability data documented in the local labelling and additional supporting stability data.  Action taken with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED was not applicable for both events.  At time of reporting, the outcome was Unknown for both events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Runny Nose; Feels Run Down; Body Aches; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Apr-2021 and was forwarded to Moderna on 22-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny Nose), CHILLS (Chills), FATIGUE (Feels Run Down) and MYALGIA (Body Aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Arthritis.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced CHILLS (Chills) and MYALGIA (Body Aches). On 22-Apr-2021, the patient experienced RHINORRHOEA (Runny Nose) and FATIGUE (Feels Run Down). On 11-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, RHINORRHOEA (Runny Nose), FATIGUE (Feels Run Down) and MYALGIA (Body Aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information included Advil tablets by mouth.
Arm swelling, itching, burning, hot to touch, and redness that began a few days after injection. These began at the inkection site and have spread from upper arm to elbow amd now to forearm as of today. I have a few other raised burning itching areas on my ipper body that are smaller amd less intense.
Pt developed pinpoint rash on fingers, arms, trunk/back, legs, feet on 5/29/13 a.m. (some rash on feet/ankles raised); no fever, no cold symptoms, non-pruritic, tried several different sunscreens in past 5 days. Vaccines administered 1 d before rash.
She got the vaccine, went home and noticed soreness in her arm and rash.  During the night she had chills and fever, hard to breath as if she had the flu.  She did not take anything as she is allergic to too many things.  She is still having the rash on her arms, it is not sore anymore, but is going to contact her doctor.
Pt called to inform she had a red itchy rash around her 2nd covid injection site (left deltoid)approx 24 hours after her shot on March 11. Stated the rash was also present on her chest and "felt like it was on my back but I didnt see it", also on top of right foot. Reported taking benadryl March 12th (when she noticed the rash). Denied SOB or difficulty breathing. Rash resolving now. Pt did not feel she needed to be seen however wanted us to be aware in the event it need to be reported. Instructed pt to continue to observe rash, call clinic if needed
redness; injection site rash; injection site itch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (injection site rash), VACCINATION SITE PRURITUS (injection site itch) and VACCINATION SITE ERYTHEMA (redness) 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 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE RASH (injection site rash) and VACCINATION SITE PRURITUS (injection site itch). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (redness). On 01-Feb-2021, VACCINATION SITE RASH (injection site rash) and VACCINATION SITE PRURITUS (injection site itch) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-033833 (Patient Link).   Reporter did not allow further contact
20 minutes after injection, I experienced a significant increase in blood pressure (177/103), dizziness and headache. As of 12 hours later, symptoms have not resolved.
Case number PHEH2013US005286, is an initial spontaneous report received from a nurse on 04 Mar 2013. This report refers to a 13-year-old female patient. Her medical history and concomitant medications was not reported. She was vaccinated with MenCYW-135 liquid component of MENVEO (batch number: X11082) on 03 Mar 2013 and did not receive MenA lyophilized conjugate. No adverse event was reported following this administration error.
Patient exhibited symptoms of a seizure that lasted about 1-2 seconds.  She came out of it right away, drank some water, rested for 15 minutes then felt fine and was able to go home with her grandmother.  She said she felt light-headed after her shot.  She didn't seem to remember what happened though.  She wasn't too talkative to tell us more about how she felt.
Experienced chills, fever, fatigue, numbness of hands and legs (right), no appetite, no sense of taste, jittery, weakness, no bowel or bladder control.  From 3/3 - 3/19 (16 days).  Currently, fingertips are still numb.