chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received the new Bivalent and were given 0.25 mL dose instead of the 0.5mL; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (received the new Bivalent and were given 0.25 mL dose instead of the 0.5mL) and NO ADVERSE EVENT (No adverse event) in a 69-year-old 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) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (received the new Bivalent and were given 0.25 mL dose instead of the 0.5mL) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received the new Bivalent and were given 0.25 mL dose instead of the 0.5mL) 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 assessment was provided for ACCIDENTAL UNDERDOSE (received the new Bivalent and were given 0.25 mL dose instead of the 0.5mL).    Concomitant product use was not provided by the reporter. Treatment information was not provided.   Reporter did not allow further contact
This spontaneous prospective pregnancy report was received form a 23 year old female patient (also nurse) reporting on herself. On 26-AUG-2014 the patient splashed less than 0.1ml of M-M-R II in her face and possibly her eyes when drawing up the vaccine. The patient/nurse immediately washed her face and flushed her eyes with sterile saline. She was concerned since she was pregnant with 28 weeks of gestation. The patient's last menstrual period (LMP) was 11-FEB-2014 with estimated date of delivery (EDD) of 18-NOV-2014. The pregnancy outcome was outcome pending. Patient contacted her OB/GYN physician. No adverse effects reported. Additional information has been requested.
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent and reported for a 27-year-old patient (reporter's daughter).  A 27 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm".  Additional Information: My mom age 92 and brother got both doses of the Pfizer; none of them have allergies. My older daughter got both doses. My other daughter age: 27 received the first dose of the Pfizer got a sore arm. I was hesitant due to my allergies.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 5/7/99, the pt developed varicella and sought unspecified medical attention. No further information is available.
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 concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014, the patient was treated by a physician for a vesicular outbreak, which were diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX vaccine for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Chest Congestion; Skin pain on his back; Low grade fever of 100; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY CONGESTION (Chest Congestion) 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 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PULMONARY CONGESTION (Chest Congestion) (seriousness criterion medically significant), PAIN OF SKIN (Skin pain on his back) and PYREXIA (Low grade fever of 100). At the time of the report, PULMONARY CONGESTION (Chest Congestion), PAIN OF SKIN (Skin pain on his back) and PYREXIA (Low grade fever of 100) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Body temperature: 100 low grade fever.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. The patient had seen his doctor who told him to call Moderna for answers. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Upon landing took rapid test at airport on Jul 30 and tested postiive ; Upon landing took rapid test at airport on Jul 30 and tested postiive ; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single and on an unspecified date (Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient been tested for COVID-19 since the vaccination. The patient took polymerase chain reaction (PCR) test nasal swab on 28Jul2021 prior to boarding flight  and received the result as positive upon landing on 30Jul2021. Upon landing took rapid test (nasal swab) at airport on 30Jul2021 and tested positive was quarantined. The patient was not hospitalized and did not receive any treatment. The outcome of the events was recovered on an unspecified date in 2021.  The lot number for BNT162B2, was not provided and will be requested during follow up.
During bedtime while sleeping with  sore arm and fatigue, my whole body, even the scalp itches so much.  I thought it was just winter dry skin, but the next day when it still itch, I took an aller-clear med and it eased.  I also experience chills and felt feverish but no fever, some tiredness. On the third day, I experience  diarrhea twice.  In the afternoon, everything seemed back to normal, feeling fine.
Left arm became gradually sore and stiff and painful over a period of a month when I went to see an orthopedic doctor who told me I had a frozen arm. He gave me a prescription for steroids which help relieve some of my symptoms.
Rapid heart rate bursts occurred at random intervals starting several hours after the shot and continued through Saturday.  Could not breath or move during each incident.  Fainted on at least one occasion during heart rate burst. If sleeping, was woken up during the event. Swelling pressure inside of left side of chest, extending into left shoulder began Friday morning.  Could not lay down without pressure pain from inside chest.  Had to sleep sitting up.  Unusually fatigued all day.  Swollen lymph nodes in neck began Sunday morning.  Sought acupuncture treatment for relief Tuesday evening.  Swelling pressure inside of chest and shoulder decreased during treatment. Swollen lymph nodes in neck still present. But am able to lay down without pain after treatment.   Will be returning for another acupuncture treatment as my chosen form of recovery.
Pt received vaccine & got chills a 7PM, went to bed a muscle spasm in leg, severe headache, and wheezing. Pt took ALLEGRA 180 & sx went away.
Pain in leg; Fever; Nights sweats; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Mar-2021 and was forwarded to Moderna on 12-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Nights sweats), PAIN IN EXTREMITY (Pain in leg) and PYREXIA (Fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 01L20A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESOMEPRAZOLE and ATORVASTATIN for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced NIGHT SWEATS (Nights sweats) and PYREXIA (Fever). In March 2021, the patient experienced PAIN IN EXTREMITY (Pain in leg). At the time of the report, NIGHT SWEATS (Nights sweats), PAIN IN EXTREMITY (Pain in leg) and PYREXIA (Fever) outcome was unknown.            The action taken with mRNA-1273( Moderna COVID-19 vaccine) was not applicable. No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Followup received on 23-06-2021 and contains no significant information.
Employee received Pfizer Covid19 vaccine on 2/3/2021  at 8:30 am and at 12:30 pm she began having intermittent palpitations and "flushed" feeling in her chest.
Fatigue (2+ days) Slight headache Slight nausea Soreness at site of injection (more than expected)
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Additional Details: Patient complains of red, and itchy rashes on his left arm extending above and below is elbow. Patient states that the rashes appeared 2 days after Moderna booster was administered and has not gone away. I counseled patient to take OTC antihistamine and topical steroid (hydrocortisone) and to refer to doctor if symptoms don't improve in the next couple days.
Patient was administered the second booster of Moderna on 4/5/22 but the vial had expired on 4/4/22. Incident was reported to Moderna and a lot analysis was completed. Results showed the vaccine "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration".
his heart rate it was just like 130 so it's bit elevated; he have been checking his temperature and its low grade; he is just feeling cold; he is kind of really warm; kind of red just like red; like blushing earlier; I have my son earlier get his first dose of the COVID vaccine. He is only seven; This is a spontaneous report from a contactable consumer (parent). A 7-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FK5127, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced his heart rate it was just like 130 so it's bit elevated, he have been checking his temperature and its low grade, he is just feeling cold, he is kind of really warm, kind of red just like red, like blushing earlier, and I have my son earlier get his first dose of the COVID vaccine. He is only seven. The reporter just wanted to check with them to know because the reporter has his son earlier got his first dose of the COVID vaccine. He was only seven so that was around 11'o clock that morning and right then it was 7 or almost 8'o clock, then few hours he had been checking his temperature and it was low grade like 98.8 is the higher, 99.6, 99.5 but he kept on complaining that he was just feeling cold like that was like two blanket like it was cold there where they were at (City name) he took blankets and he stated he was kind of really warm and kind of red like blushing earlier just like red. Although the reporter thought it was maybe because he just feeling warm inside but he just feeling cold. The reporter questioned was that normal. When paraphrased the concern. The reporter stated the patient temperature about 99.8 was the highest, 99.6, 99.5 but kind of like low grade the reporter meant it did even reach 100 so far but he should complain for cold like really cold. Yes, and it was kind of reddish earlier but it kind of disappeared, but the reporter does not know it was just because of the reaction or and his heart rate it was just like 130. It was supposed to be like 110 Right? Normal 70 to 110. So, it was bit elevated. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 99.8, body temperature: 99.6, body temperature :100, body temperature: 98.8, body temperature: 99.5, and heart rate: 130: elevated. The outcome for all the reported event was unknown.   No follow-up attempts are needed. No further information is expected.
Myalgia, Arthralgia, Fever, ARM PAIN, CHILLS, NECK AND SHOULDER PAIN Narrative:
Patient's representative requested RSV vaccine (Abrysvo). After administration it was reported that she had already received RSV Arexvy on 9/23/23.
Information has been received from a physician concerning a 17 year old female who on 28-NOV-2007 was vaccinated with a first dose of Gardasil (lot # not reported) and the patient turned pale and experienced low blood pressure after the dose. Subsequently, the patient recovered from turning pale and low blood pressure. The patient sought unspecified medical attention. No product quality complaint was involved. Additional information has been requested.
Light headed,  Nausea, Vomiting and Diarrhea. It happened 40 minutes after vaccination.
hallucinations; extreme confusion; This case was reported by a other health professional via call center representative and described the occurrence of hallucination in a patient who received Rabies NVS (Rabies Vaccine (Potential Marburg)) for prophylaxis.   Co-suspect products included immunoglobulin human anti-rabies (Rabies Immunoglobulin) for product used for unknown indication.   On an unknown date, the patient received Rabies Vaccine (Potential Marburg) at an unknown dose and Rabies Immunoglobulin at an unknown dose and frequency. On an unknown date, unknown after receiving Rabies Vaccine (Potential Marburg), the patient experienced hallucination (serious criteria GSK medically significant) and confusion. The action taken with Rabies Vaccine (Potential Marburg) was unknown. The action taken with Rabies Immunoglobulin was unknown. On an unknown date, the outcome of the hallucination and confusion were unknown.   It was unknown if the reporter considered the hallucination and confusion to be related to Rabies Vaccine (Potential Marburg).  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced extreme confusion and hallucinations. The reporter consented to follow up. It was unknown if the reporter considered the hallucination and confusion to be related to Rabies immunoglobulin.
Office drew up all doses from vial w/o a double check and entered NDC, lot number and expiration date from a sticky note posted next to refrigerator. At some point staff realized that at least some of the time, they had pulled monovalent vials out and administered instead of bivalent as inteded
Two days post vax, the pt developed an injection site reaction characterized by pain and swelling. She also developed swollen glands under the left arm and experienced irritability.
Information has been received from a nurse for the pregnancy registry for HPV vaccine concerning a 16 year old female who on 20-AUG-2007 was vaccinated with the first dose of GARDASIL vaccine (yeast), 0.5 ml intramuscularly. Concomitant vaccination included meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA). On 14-APR-2008 the patient was vaccinated with the second dose of GARDASIL vaccine (yeast), 0.5 ml intramuscularly. The nurse reported that the patient is now pregnant, on an unspecified date a pregnancy test was done. It was noted that the patient tested positive for HPV during routine PAP test. The patient is not experiencing any known symptoms. The patient's LMP was 01-APR-2008 and EDD 06-JAN-2009. The patient sought medical attention and was seen by the physician. Additional information has been requested.
Diarrhea  Fever = 102.9 Intense muscle and jaw pain Intense headache Loss of smell Heart felt enlarged
Patient called to complain that she had been expressing pain in her muscle close to her left shoulder since 10/14/2017 when she received a flushot along with her husband. She reported that her husband experienced 2 days of pain that had since resolved. Patient described the pain as radiating down her arm when she moves it, and her arm feels weak with straining. Patient states that there is no discoloration in the area, but there is heat. Patient had flushots in the past with no problem. I have not been able to reach her primary care physician.
Patient called to report that she has had pain in her left shoulder blade and it hurts when she moves her arm above her head since receiving the vaccine last Wednesday.  Also states that at one point last week after receiving vaccine pain was going down left arm and into hand. She has not seen anyone about the pain.
Intense headache, numbness on the left side of the face, constant left eye pain, chest fatigue.
Felt nausea, dizziness, Felt something in throat, after couple of minutes, At mention of throat 911 was called, EMS arrived less than 5 minutes, observed, took blood pressure, checked pulse, blood oxygen checked.  Ems said he looked pale, continued to observe patient for about 30minutes, Mention of patient possibly experiencing panic attack, had history of in past. He was feeling fine by then, no need to go to hospital. Police followed him home. I called patient at 3:33PM he was home, said throat was fine, he just felt tired, He said he was o k .
down for the count for 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (down for the count for 24 hours) 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEPRESSED MOOD (down for the count for 24 hours). At the time of the report, DEPRESSED MOOD (down for the count for 24 hours) had resolved.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-411607 (Patient Link).
This is an 89-year-old Caucasian gentleman who is fully vaccinated against  COVID-19 and has multiple medical problems, including hypertension,  hyperlipidemia, AFib on Xarelto, hard of hearing, who was sent in from home  because of generalized muscle aches and pains and generalized weakness.  Found  to have a UTI and also tested positive for COVID-19; he was sat 90% on RA, but he was  hypoxemic with his pO2 being 67.7 on room air.  The patient got Regeneron and  was supposed to be discharged home, but then he was complaining of weakness,  and the family said they could not take him home since he was too weak.  Also,  he was found to be in AFib with RVR. received ceftriaxone, dexamethasone, and vancomycin. Discharged on 12/24/21
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 17Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Known allergies: Mangos" (unspecified if ongoing); "PTSD" (unspecified if ongoing), notes: Post-traumatic stress disorder (PTSD). Concomitant medication(s) included: SERTRALINE, stop date: 23Jun2022; WEGOVY; METFORMIN; VYVANSE.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Reported that For COVID 19 Treatment, Brand Paxlovid, Treatment start date 24Jun2022, Treatment stop date 26Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Erythema of 5x8cm. Lump, mild warmth and swelling developed in R upper arm at site of flu vaccine.
05/04/14 - 05/11/14 - Fever of 102-103 05/07/14(AM) - 05/13/14 - Rash (started with legs around injection site, spread over entire body, including face) 05/07/14(PM) - 05/13/14 - Swelling of Hands & Feet
The next morning there was nausea, dizziness, extreme fatigue and chills. I had to spend the day in bed under an electric blanket. I was unable to do anything. Miraculously, the next morning I was fine except for a sore arm.
Pins and needles sensation in L foot began 10 minutes after injection and is still occurring intermittently at this time.  Lowe left leg numbness occurring 45 minutes after injection and still occurring infrequently.  Pins and needles sensation to left hand and numbness occurring to posterior left forearm 45 minutes after injection and still occurring infrequently.