chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis; chest pain; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022c21a and 006b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant), CHEST PAIN (chest pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, MYOCARDITIS (Myocarditis) and CHEST PAIN (chest pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot#022c21A with AEs of Myocarditis and chest pain. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273, lot#022c21A with AEs of Myocarditis and chest pain. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Had small maculopapular rash all over hisbody coughing and congestion and drowsiness.
Patient came in wanting to get a flu shot and was accidentally administered a shot of the Pfizer COVID 19 vaccine. The patient had received two shots prior to this one with the second being approximately 3-4 months ago.
This spontaneous report as received from a registered nurse refers to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On an unknown date the patients were inadvertently administered with unknown number of doses of improperly stored PNEUMOVAX23 (dose strength, route unspecified). No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. This is one of the several reports from the same source. Additional information has been requested.
Pt should have received a Fluzone immunization. Instead, he inadvertently was given a Flublok immunization.  No treatment.  No adverse outcome.  No symptoms observed while in clinic room.
Approximately 5 days after administration; this patient a woke 5 AM with "hive and welts" allover her body, from her neck down. She took a Benadryl later dissipated. Occurred again on 09/04 and 09/05 AM. Each time "hives and welts" on her legs each time took Benadryl. No SOB, tongue numbness, swelling, itch.
After receiving the injection in the left deltoid itching and rash appeared within 10 minutes traveling down the arm and across the chest to the mid sternum throat became itchy and heart rate increased to the 120s. Rather than wait for urgent care availability to administer Benadryl I drove down the hill to pharmacy and administer 50 mg PO Benadryl. I then returned home where are my husband could monitor my symptoms. By 10:06 AM symptoms had mostly resolved and only a small 10 cm x 10 cm rash remained. By 11 am all symptoms had resolved with exception to new onset fatigue most likely a side effect of the Benadryl. The following day mild to moderate fatigue, vertigo and intermittent nausea presented resolving by 8/31/2021.
Shot reaction at DTaP left arm injection site, Left upper arm with redness / induration 3.5 X  4.5, Benadryl, Motrin, cool compresses.
Inflamed area about 3 inches long and 1.5 inches wide at injection site. Area is warm to the touch,slightly raised and sore to the touch.  Symptoms still present as of 12/11/2009 at 1:08 PM. No treatment sought to date.
given a 0.25ml of the Moderna Covid-19 vaccine for his 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (given a 0.25ml of the Moderna Covid-19 vaccine for his 1st dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 13-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a 0.25ml of the Moderna Covid-19 vaccine for his 1st dose). On 13-Jan-2022, ACCIDENTAL UNDERDOSE (given a 0.25ml of the Moderna Covid-19 vaccine for his 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information provided.
Staff member reported symptoms started 5 hours after receiving her vaccination on 1/19/2021. She reported fever 102.1F took 1,000mg Tylenol and temperate went down 99F. Currently 98F without medication. She also headache, body aches and chills and continues to feel symptoms but headache is improved.
Received Moderna COVID vaccine 2nd dose to left deltoid at 10:00 am.  Approx 5mis later she stated she was feeling light headed, dizzy and sweating.  Also stated she felt nauseated and might throw up.  She remained in the facilty for and additional 30 mins with the nurse.  Stated her symptoms seemed to be improving but she still felt nauseated.  Encourage to eat some peanut butter crackers.  This made her nausea subside.  Her husband came to drive her home.  She stated she felt well enough to drive home with him following in his car.
Received Rotateq and turned blue and stopped breathing. Required bag mask ventilation and chest compressions x 3 minutes before pinking up and crying. Transported to hospital by EMS.
Severe  pain in groin area; Ligament inflamed; Hurts when she walks; Severe pain in hips; This spontaneous case was reported by a consumer and describes the occurrence of GROIN PAIN (Severe  pain in groin area), LIGAMENTITIS (Ligament inflamed), GAIT DISTURBANCE (Hurts when she walks) and ARTHRALGIA (Severe pain in hips) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced GROIN PAIN (Severe  pain in groin area), LIGAMENTITIS (Ligament inflamed), GAIT DISTURBANCE (Hurts when she walks) and ARTHRALGIA (Severe pain in hips). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, GROIN PAIN (Severe  pain in groin area), LIGAMENTITIS (Ligament inflamed), GAIT DISTURBANCE (Hurts when she walks) and ARTHRALGIA (Severe pain in hips) outcome was unknown.            No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Description to be coded was updated as per the description as reported.
The day of the shot I felt a lot of chills , cold and after taking a hot shower I felt better.  The next day I woke up with pain in my entire body, a pain that I have never felt and it lasted for two days.  On Thursday the pain was gone and started feeling sore, no energy and no strength.  On Friday 3/12/21 I started with a cough and has not gone away.  It has been a week since I received the COVID vaccine and I still feel tried, week, no energy and no strength.  At this point I'm not sure if I should schedule a doctor's appointment.
Vaccine administered in right thigh. Next day, area was warm, red, swollen and tender approximately 4 cm in diameter.
Information has been received from a nurse concerning a 50 year old female who on 05-NOV-2008 was vaccinated with dose of PNEUMOVAX (lot number 661065/1021X) (injection site and route not reported).  Subsequently the patient had a red raised spot around the injection site and experienced fever.  Unspecified medical attention was sought.  The outcome of the patient's experience was unknown.  This is one of several reports from the same source.  No further information is available.
Got my 2nd Moderna Shot on 2/4/2021 my 1st one was on 1/7/2021 so 2 months after getting my 2nd shot my primary doctor and I decided to run the Covid 19 Antibodies test on me to make sure I am protected since I am Immunocompromised and at high risk. My test results came back the next day from Quest and said I was Negative for the Antibodies, Any input on this please?
her son already received a shot before but still had COVID; her son already received a shot before but still had COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "her son already received a shot before but still had COVID". The clinical course was reported as follows: Caller, (Name withheld) was calling about the COVID-19 Vaccine, she mentioned that her son already received a shot before but still had COVID. She is asking if they still need to get another shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
No additional AE; The HCP had administered expired ROTATEQ; This spontaneous report was received from a pediatric nurse practitioner (PNP) concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, historical drug, concomitant therapies were not provided.  On 27-JUL-2020, the patient was vaccinated with an expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dosage regimen was not provided) lot # R033251, expiration date 29-JUN-2020, taken orally, as prophylaxis. No additional adverse event was reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EN9581), in left arm, on 16Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "Breast cancer Survivor" (unspecified if ongoing), notes: Breast cancer Survivor; "Removal of Gall Bladder" (unspecified if ongoing), notes: Removal of Gall Bladder; "known allergies: Sulfa" (unspecified if ongoing), notes: known allergies: SULFA. Concomitant medication(s) included: TAMOXIFEN, start date: Sep2015; HYDROXYCHLOROQUIN, start date: May2016; VITAMIN D3, start date: Mar2013; VITAMIN B12 [CYANOCOBALAMIN], start date: Mar2013; VITAMIN E [TOCOPHEROL], start date: May2016; COLACE, start date: Sep2015. Past drug history included: Codeine, reaction(s): "known allergies: codiene", notes: known allergies: codeine; Percocet, reaction(s): "known allergies: Percocet", notes: known allergies: Percocet; Evista, reaction(s): "known allergies: Evista", notes: known allergies: Evista; Aromasin, reaction(s): "known allergies: Aromasin", notes: known allergies: Aromasin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
The vaccines were sitting out at room temperature in the heat as it was a warm day; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (The vaccines were sitting out at room temperature in the heat as it was a warm day) 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 PRODUCT STORAGE ERROR (The vaccines were sitting out at room temperature in the heat as it was a warm day). At the time of the report, PRODUCT STORAGE ERROR (The vaccines were sitting out at room temperature in the heat as it was a warm day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's concomitant medications were not reported.   No treatment information was provided by the reporter.
site hard itchy-day later circle red closer to elbow than shoulder no pain - scratchy;
There was no adverse event.  Adult dose administered to 11 1/2 year old.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE PULMONARY EMBOLISM 2/1/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Patient passed out for a few seconds twice. Had patient lay down. Called EMS. She started feeling better but blood pressure was very low so EMS took her hospital to be checked out.
Information has been received from a licensed practical nurse concerning a 4-year-old Caucasian female with no pertinent medical history or allergies who on 07-JAN-2008 was vaccinated with the first dose 0.5 ml dose of PROQUAD (lot # 657300/0545U) SQ in the right thigh.  There was no illness at the time of vaccination.  There were no concomitant medications.  On 13-JAN-2008 the patient developed a red, itchy induration at the injection site of the right thigh.  The nurse described the red area as 14 x 22 mm red area on right thigh where the PROQUAD was given.  The patient was examined in the office on 14-JAN-2008 and was prescribed diphenhydramine hydrochloride (BENADRYL).  No diagnostic labs were performed.  The patient had previously been administered PROQUAD on 29-SEP-2004.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Additional information has been requested. This is a follow-up to report (s) previously submitted on 4/4/2008.  Information has been received from a licensed practical nurse concerning a 4-year-old female with no pertinent medical history or allergies who on 07-JAN-2008 was vaccinated with the first dose 0.5 ml dose of PROQUAD (lot # 657300/0545U) SQ in the right thigh.  There was no illness at the time of vaccination.  There were no concomitant medications.  On 13-JAN-2008 the patient developed a red, itchy induration at the injection site of the right thigh.  The nurse described the red are as 14 x 22 mm red area on right thigh where the PROQUAD was given.  The patient was examined in the office on 14-JAN-2008 and was prescribed BENADRYL.  No diagnostic labs were performed.  The patient had previously been  administered PROQUAD on 29-SEP-2004.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No additional information is expected.
aching in the arm for a week; Injecting the vaccine too high and it's like so much into the shoulder; Poor administration, too high up on the shoulder instead of down in the muscle; This is a spontaneous report from a contactable nurse via Pfizer-sponsored program named Pfizer. A 63-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Apr2021 (Lot Number: ER8734) as single dose for covid-19 immunisation  .  Medical history included hyperthyroidism and Pott's disease. Concomitant medication included carvedilol.  The patient experienced aching in the arm for a week, injecting the vaccine too high and it's like so much into the shoulder; it has to be do with poor administration too high up on the shoulder instead of down in the muscle. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
L shoulder has ongoing sorenesss since flu shot..no signs of infection, no redness, no swelling, no warmth..just general achiness.
Approximately 15 mins post-vaccination, patient c/o burning sensation in left arm around site of injection.  Burning sensation was proximal to injection site and extending to left shoulder and neck. No dermatological changes, itchiness, edema, or warmth.   At 12:04 PM, VITALS: HR 90, RR 16, BP 122/80, Temp 98.9, O2 97%, Lungs CTAB, A& O x 4. NAD  Patient advised to monitor symptoms and elected to leave site at 12:20 PM as symptoms did not progress but never fully resolved
Information was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's concurrent condition and medical history were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, lot# and route unknown), influenza virus vaccine (manufacturer unknown) (dose, lot# and route unknown) and pertussis vaccine (manufacturer unknown) (dose, lot# and route unknown). Concomitant therapy was not reported. Four to five days after the vaccination, the patient developed fever, chills, redness at injection site on an unknown date. The patient sought medical attention by contacting the pharmacist. The outcome of the events was unknown. Additional information has been requested.
Admit for COVID-19 infection. On day of arrival had only received one vaccine, had planned to get the second that day. O2, zinc, steroids, rocephin, Zithromax, vancomycin. Oxygen requirements increased steadily to 100% BiPap by 8/31. She will be discharged today to inpatient hospice GIP at local location. Discharge Condition: Unimproved.
Symptoms appeared on 12/31/20 with a sore arm, redness, warmth, and swelling at injection site.  The reaction began to spread for the next 5 days.  Throughout this time I was putting ice on it, taking Motrin, Benadryl, and applying hydrocortisone cream.  The reaction went away for 2 days (1/5/21 and 1/6/21).  The reaction then came back on 1/7/21.   I went and saw my healthcare provider on 1/7/21, and was told it was a localized reaction and to continue to monitor it.  I still have this reaction to this day, 1/10/21.
numbness, starting from day 1 getting worse on day 5. Woke up day 6 with racing heart. Went to ER, heart rate was 170. It calmed down after 20 min. I am still experiencing numbness and it is getting worse.
Symptoms started around hour 2 with nausea, injection sight was not sore but had some discomfort below injection site. Continued to have nausea. Had chills in the middle of the night, chills started around 1-2 am and was gone by morning. Woke up with body aches and very tired/fatigued. By hour 18 had diarrhea. Still having fatigue and body aches.
On June 7,2022 , I noted a rash on my left side that was burning in nature.  I was examined by my physician on June 8th.  He believed this rash was consistent with a mild case of Shingles and prescribed a course of valacyclovir which I started that day.  The rash resolved over the next 3 days and was essentially resolved by June 10-11th.
Herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 56-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in 2015 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for Herpes Zoster resulting from the use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of Herpes Zoster was unknown. The reporter considered Herpes Zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Severe pain in center chest.  Felt as if my chest/breastbone was being hit repeatedly with a ball hammer.  10 days after vaccine I had 4 episodes of extreme tightness/pain in chest & right side of lower abdomen.  Walking dog when I experienced episode #2.  Did not think I would able able to  walk home 1 block away.  Got on knees and vomited (in neighbors yard!).  Got home tried to vomit again (nothing came up)  So sever I almost went to ER but episodes dissipated.    Experiences 2 more episodes on 3/24.  Experienced 1 more episode during night of 3/24.  Went to DR. on 3/25 early AM.   Have not had any additional episodes!!
found unresponsive by co-workers, eyelid fluttering, eyes crossed, difficulty breathing
Approximately the day after receiving the second dose of Shingrix, the patient began to experience eye pain and low grade fever. Upon being evaluated by their eye health provider, they were treated with a steroid eye drop. Vision and eye discomfort was fully resolved within a few days of treatment.
This spontaneous report was received from a Licensed Practical Nurse refers to 5 patients of unknown age and gender. Since 13-DEC-2012, the patients were inadvertently vaccinated intramuscularly with a 0.5 ml dose of GARDASIL (lot# not reported) that had been improperly stored. No adverse effects reported. No concomitant medications were reported. Additional information is not expected.
Patient Vaqta today for second dose in Hep A series however should have received Havrix due to age.
Woke up this morning and was very dizzy and weak.  Mom encouraged fluids, still dizzy and weak, but improving.
This patient had a warm, painful, swollen, red spot right at the injection site about an inch in diameter, no where else on body, left a bruise after a week of symptoms.
On July 22nd I gave her a bath as usual and when I pulled her out of bath she was shivering which was odd. Saturday morning about 5:00AM she woke up crying which was unusual. She woke up again at 6:00AM and she was super hot and she had a fever of 101.4. I gave her TYLENOL. She was cranky all day. We thought it was due to teething. She was tired and irritable. Saturday night we thought she was getting better but she didn't want to eat. Saturday night she didn't sleep hardly at all. Sunday morning she was still hot with fever. I found a blister below her lip on her chin. She still wouldn't eat and would only drink her milk. Also, Sunday morning her mouth smelled horrible. She finally ate a little bit but still not feeling well all day Sunday. Later that day she had more rash/blisters below and above her lip area. We called urgent care on Monday morning. Triage nurse noted it may be Hand/Mouth/Foot. We took her to her pediatrician on Monday and she was diagnosed with HMF. Treatment included alternating MOTRIN/TYLENOL. As of today she is still sick. Fever is gone but she has mouth sores and rash. She is starting to eat a little bit. Blisters/rash is right outside her lips and under her lips and she has blisters inside her mouth as well. There is a possibility she picked this up from our community pool.