chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NAUSEOUS; TOOK TWO DOSES IN A ROW; This spontaneous case report was received from a pharmacist (PVX2019-541) on 28-Feb-2019. The report describes a female consumer who felt nauseous following the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis. The consumer also "took two doses in a row".  It was reported that the consumer took Vivotif doses as an inappropriate way. The doses were taken on day 1, 3, 5, and 6. She took the fourth dose today (28-Feb-2019) after which she was very nauseous. She took Emetrol (phosphorated carbohydrate) to treat nausea.  The action taken with Vivotif with respect to the events nauseous and "took two doses in a row" was not applicable.  The clinical outcome of the events nauseous and "took two doses in a row" was unknown.  Company's Comment: In this case, it was reported that a female consumer experienced "nausea" following the intake of oral Vivotif. There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took two doses in a row" was considered as not applicable. ; Sender's Comments: Company's Comment: In this case, it was reported that a female consumer experienced "nausea" following the intake of oral Vivotif . There seems to be a temporal association between the intake of the vaccine and the event. Also, nausea is labelled as per CCDS. Hence, the causality of the event with Vivotif is assessed as possible. The causality of the event "took two doses in a row" was considered as not applicable.
Information has been received from a nurse referring to two patients of unknown age and gender.   On 31-JUL-2017, the patients were vaccinated with improperly stored ROTATEQ (lot # M038728, expiration date 28-APR-2018; dose was unknown) orally for prophylaxis. Both doses of ROTATEQ administered after prior excursion but before current excursion. No adverse effects were reported.  Date logger was involved. The previous temperature excursion was 47 Fahrenheit degree to 77 Fahrenheit degree for 2 hours 10 minutes. Temperature excursion was 47 Fahrenheit degree to 77 Fahrenheit degree for 35 hours.
No additional adverse effect reported.; Caller reported that PROQUAD that went out of range was administered.; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 25-FEB-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) as prophylaxis (concentration, number of administered dose, dosage, vaccination scheme frequency, route of administration and anatomical location were not reported; lot number T027115 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported as 07-FEB-2022). No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was -10 degrees Celsius to 8 degrees Celsius (-3.7 degrees Celsius) for a time frame of 22 hours on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger.
heart strain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that an 82-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced heart strain on an unspecified date. It was reported that the patient was supposed to take the second shot tomorrow, however the patient is experiencing heart strain. Wanted to know if taking aspirin is fine or if we have a protocol in taking medicine in between doses. The outcome of the event was unknown.  No follow-up attempts are needed; information about batch/ lot number cannot be obtained.
COVID vaccine breakthrough case, Moderna 3/2/21 025A21A, 3/30/21 013B21A and 12/6/21 045F21A
I had heart problems resulting in a trip to the ER, my Troponin number was 8 and stayed there.  I was sent home and followed up with Doctor a cardiology.  After all the testing, I have a-fib and am now on 5mg twice a day of Eliquis.
2 weeks after vaccination had fever, chills, neck stiffness. Never reported at that time. Then soon after that developed red vesicular rash over scalp, forehead, arms, chest and trunk. Now the neck stiffness, fever and chills have disappeared but rash still persists. Denies any shortness of breath or chest pain or choking sensation or mental confusion. Still recovering.
Just wanted to let you know that I still have a lot of pain in my left arm from the flu shot.  There are some days when I have trouble lifting things.  Hurts when I lift my arm up high.  I've been taking Motrin as needed but it's been 2 weeks since the shot.  I'll go see my doctor in a few days if needed.  Thank you for your attention to this matter.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient received flulaval on Monday, November 7 at a flu clinic at her place of employment.  She reported to the Employers nurse on site that she was having a local injection site reaction to the shot. Nurse reported red, tender, sore, hot, horizonatal 1" by 3" raised red area on deltoid area of arm, with some localized itch.  The nurse on site gave her an ice pack for about 20 minutes, ibuprofen, benadryl, and a topical pain/hydrocortisone cream.
MMR & VARIVAX given 11/30/10. On morning of 12/1/10, awoke with hive-like rash on face, right arm and left leg. Resolved after dose of BENADRYL. On 12/4/10, presented to Emergency Room with enlarged inguinal lymph node on left. Evaluated by ER doctor and pediatric surgeon.
pt recvd vax & 3 hrs later began high pitch inconsolable cry; pt v at 11pm; MD notified & advised apap;
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for the long-term prevention of shingles and zoster-related conditions as prescribed and/or administered by a pharmacist. Subsequent to the patient zoster vaccine live (ZOSTAVAX) inoculation, pt was treated by a healthcare provider in a hospital for shingles (herpes zoster). As a direct and proximate result of Plaintiff's use of the zoster vaccine live (ZOSTAVAX) vaccine, plaintiff had and would continue suffer ongoing injuries, including but no limited to: mental and physical pain and suffering; medical care and treatment for this injury; significant medical and related expenses as a result of these injuries. The outcome of the event was considered not recovered. The event was considered related to zoster vaccine live (ZOSTAVAX).
Mostly mild sore throat, coughing, fatigue, body aches, no fever, no vomiting, runny nose, mild headaches on and off.  I treated with Tylenol, cough drops and lot of liquids.  I tested positive on 10/22/2022 and I was able to have the antibody infusion on 10/24/2022. As of today, I feel somewhat better, I am easily fatigued, mild sore throat and runny nose.
Rash, Facial swelling, tongue and lip tingling and swelling, palpitations and shortness of breath, Patient given Decadron 10 mg IM on 08/06/2021 @ 11:45 am, Famotidine 20 mg qd, claritin 10mg qd on 08/07/2021 Decadron 10mg  IM, claritin 10 mg qd and Famotidine 20 my qd
Fever     pt does not have thermometer at home to take temp, reports "mild temp" o Headache     pt reports headache for 3 days.  Pt reports rest of family is covid positive.  o Cough
Moderna arm (injection site red rash), chills, fatigue, fever, body aches, migraine, nausea, shortness of breath, injection site pain, and swollen lymph nodes. Fever, shortness of breath, swollen lymph nodes, and moderna arm still persists. All other side effects started to go away after 24 hours.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on face\ stomach\ arm) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced URTICARIA (Hives on face\ stomach\ arm). At the time of the report, URTICARIA (Hives on face\ stomach\ arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Mild, short term memory loss, can't remeber what he said; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Mild, short term memory loss, can't remeber what he said), PYREXIA (Fever) and CHILLS (Chills) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Smoker.    On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AMNESIA (Mild, short term memory loss, can't remeber what he said), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, AMNESIA (Mild, short term memory loss, can't remeber what he said), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-143933 (Patient Link).
Gave undiluted COVID 19 vaccine,  Parent notified, PCP notified, no s/s of adverse reaction noted
12 hours post immunization, I got to go to toilet and felt dizziness, I started talking loudly to people who were not present.iI got up x3 to use toilet and around 0430 fell against night stand and twisted my back. My husband took me to toilet. I had a headache and felt very confused. Around 0545, I got up and fell  down near toilet.  I became anxious and stayed in bed unless I had him to walk me. I fell asleep and had dreams I didn't understand and heard people talking to me.  Husband found a  walker in our attic and I used it all day. I was less cognitively impaired but still felt dizzy.
Patient began experiencing night terrors on a nightly basis starting on Dec 1, 2021.   Intensity of the night terrors appear to be diminishing.  He has no prior history of having night terrors and as always slept soundly throughout the night.
I started getting symptoms of hoarseness and lost my voice. I had lots of drainage and congested. I had diarrhea and headaches. I thought it was a sinus infection. I was in another state and got back. I could not breath good, then I developed a fever. I went to my doctor and took a COVID-19 test that was positive. I was prescribed PAXLOVID for 5 days. I did feel better and was functioning. I still feel tired, fatigued, and some congestion. I did also lose my taste or smell so I lost my appetite. I am eating better today.
tongue tingling, bilateral sides of mouth, back of tongue and back of throat.  Chest warmth and tightness
Pt states he felt sinus congruent with sore throat, muscle aches allover, Temp, congestion (sinus), general malaise swollen lymph Glands @ neck.
Patient become symptomatic on 11-10-2021 of a DVT in distal left lower extremity.  confirmed by Ultrasound on 11-15-21.
First two doses of pfizer vaccine, 3rd dose of moderna vaccine; First two doses of pfizer vaccine, 3rd dose of moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of OVERDOSE (First two doses of pfizer vaccine, 3rd dose of moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (First two doses of pfizer vaccine, 3rd dose of moderna vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced OVERDOSE (First two doses of pfizer vaccine, 3rd dose of moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (First two doses of pfizer vaccine, 3rd dose of moderna vaccine). At the time of the report, OVERDOSE (First two doses of pfizer vaccine, 3rd dose of moderna vaccine) and INTERCHANGE OF VACCINE PRODUCTS (First two doses of pfizer vaccine, 3rd dose of moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication was reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: TCR added-NNI. Reporter stated that all of the forms have already been completed and sent in. There is no need for further follow-up.
Vaccine was administered on 10/19/11. Patient presented with 5 cm diameter ecchymosis in right deltoid injection site on 10/24/11. Physician was notified.
Neck muscles soreness one week after vaccine Headache,sore throat, runny nose nine days after vaccine. persistent headache  eleven to twelve days after vaccine.
Pt states her right arm is still very sore and hurts to even use it sometimes. It's now been almost 4 mo. since she received the inj. No treatment given at this time.
get the flu right after they get the shot; Initial information received on 06-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).   This case involved an adult patient of an unknown age and gender who get the flu right after they get the shot(Influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient had flu right after they get the shot year after year (Influenza).   No relevant laboratory details were provided. It was not reported if the patient received a corrective treatment.  Outcome of the events were reported as unknown. It was not reported if the patient received a corrective treatment.  There will be no information available on the batch number for this case.
within 24 hours had diarrhea, vomiting, and chills lasting approx. 24 hours.
pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) 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 (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator 23-Dec-2022 and dose was administered after BUD).    It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medications were reported.  Total 42 Dose were administered after 30-day Use By Date. Vaccine was administrated on 26-Jan-2023, 27-Jan-2023, 30-Jan2023, 31-Jan2023, 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. Vial size was reported as 0.4 ml per vial. Vial did not undergone any temperature excursions.  No treatment information was provided.  This case was reported for patient 28 out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:(Patient 1)
Day 8 following vaccine started with hives surrounding the injection site- swelling, itching etc. Subsided within 3 days. Hydrocortisone helped with the itching
Information has been received from a physician concerning a 4 month old male who on 14-OCT-2008 at 09:00, was vaccinated with his second dose of 2 ml oral ROTATEQ.  Concomitant therapy included poliovirus vaccine, PREVNAR, and hepatitis B virus vaccine (unspecified).  Around 4 that day, the patients mother reported that that patient had diarrhea with blood and the child was irritable and had been crying.  They were sent to the ER and a barium enema was performed and ruled out intussusception.  It was determined to be severe gastroenteritis.  The event of severe gastroenteritis improved after stopping therapy.  The patient was considered to be recovering.  The patient sought unspecified medical attention.  There was no product quality complaint.  Additional information was received from the physician who reported that on 13-OCT-2008 at 10:00 (previously reported as 14-OCT-2008 at 09:00), the patient was vaccinated with the second dose of oral ROTATEQ (Lot # 660877/0305X), the second dose of IM IPOL (SANOFI PASTEUR, Lot # A0490-2) (site left), the second dose of IM PREVNAR (WYETH, Lot # C86141) (site right), the second dose of IM ACTHIB (SANOFI PASTEUR, Lot # UF259AA) (site right) and  the second dose of DAPTACEL (SANOFI PASTEUR, Lot # C2935AA) (site left).  On 13-OCT-2008 at 16:00, the patient's mother called and stated that the patient started with diarrhea 1-2 hours prior and now cries a lot and has bloody stool.  The patient was seen immediately.  The patient was fussy and had a tender abdomen and documented blood in stool.  There was visual blood in the stool as well as occult blood in the stool.  The patient was seen at the emergency room.  A barium enema was negative.  The patient was considered to be recovered on 15-OCT-2008.  Severe gastroenteritis and bloody stool were considered to be immediately life-threatening, and other important medical events.  Additional information has been requested.
Information was received from a physician via an internet article regarding cases in litigation concerning female patients of unknown age, who were vaccinated with GARDASIL (lot numbers, dates, dosages, and routes of administration not reported). Between May 2009 and September 2010 (exact dates not provided), there were reported to be 25 cases of Guillain-Barre Syndrome that occurred after GARDASIL vaccination. The outcome of the 25 cases of Guillain-Barre Syndrome was not provided. Upon internal review, 25 cases of Guillain-Barre Syndrome was determined to be medically significant. This is one of several reports from the same reporter. Additional information is not expected.
Had a lump; It swelled up; Red; Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE NODULE (Had a lump), VACCINATION SITE SWELLING (It swelled up), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Covid arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On an unknown date, the patient experienced INJECTION SITE NODULE (Had a lump), VACCINATION SITE SWELLING (It swelled up), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Covid arm).   At the time of the report, INJECTION SITE NODULE (Had a lump), VACCINATION SITE SWELLING (It swelled up), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE PAIN (Covid arm) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sudden hearing loss, left ear - Z-PACK - decongestant - steroid nose spray (NASONEX) (1 week) Prednisone (2 weeks). Tube in ear for (5 steroid treatments in ear).
I noticed hours later as my left arm was tight? it was swollen from the injection site up to my shoulder and down to my wrist, my left breast was enlarged with a rash under neath, my left leg enlarged down to my calf.  My back  and entire body was itching. I had hives on my left arm up to my shoulder. I have photos and showed to several nurses who objected to giving me a 2nd dose due to the severe reaction. An Infectious Disease Physician stated I will need to be hospitalized to get a 2nd vaccine. My employer requested medical clearance but it was DENIED. I am still seeking medical attention - covid test and antibody test .
Body ache, chills, skin feels like pins and needles, headache, fatigue, redness/small rash near injection site, soreness at injection site, nausea. No fever or loss of appetite.  Slowly feeling better but still feel tired and achy more than a day later. Chills and nausea are gone. Redness /rash around injection site is new.