chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain in stomach; Vomited once; extreme pain from diaphragm to waist.; extreme pain in torso area, from diaphragm to waist,front to back, all areas including stomach; This is a spontaneous report received from a contactable consumer, the patient. A 69-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the left arm on 15Mar2021 at 09:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN). The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route in the left arm on 22Feb2021 at 09:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 16Mar2021 at 00:30, the patient experienced extreme pain in torso area, from diaphragm to waist, front to back all areas including stomach and vomited once. The patient felt pain and discomfort mostly at night. It was painful to lay down and to sit. The pain continued for one week. On 29Mar2021, the patient started to feel like the pain and discomfort was beginning to subside. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of events pain in torso area, from diaphragm to waist, front to back, all areas including stomach and vomiting were recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Case number PHEH2014US019262, is an initial spontaneous report received from a pharmacist on 24 Sep 2014. This report refers to an unknown age and gender patient. Past medical history and concomitant medication were not reported. The patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: M13066), intramuscularly without being reconstituted with Men A lyophilized conjugate component on an unknown date. No adverse event was reported following this administration error.
COVID arm; Both arms hurt / Especially right arm / Right arm is hurting more; Neck to shoulder hurts; Crying; Spine was hurting; severe body aches after second dose; Red rash on right arm / Rash on my arm / rash on her arm for a week; Burning arm of injection / Right arm still burns sometimes / Both her arms hurt, especially her right arm./The right arm is hurting more; all red / Red rash on right arm; Left shoulder was hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), PAIN IN EXTREMITY (Both arms hurt / Especially right arm / Right arm is hurting more), NECK PAIN (Neck to shoulder hurts), CRYING (Crying) and SPINAL PAIN (Spine was hurting) in a 42-year-old female patient 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 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 VACCINATION SITE REACTION (COVID arm), PAIN IN EXTREMITY (Both arms hurt / Especially right arm / Right arm is hurting more), NECK PAIN (Neck to shoulder hurts), CRYING (Crying), SPINAL PAIN (Spine was hurting), MYALGIA (severe body aches after second dose), VACCINATION SITE RASH (Red rash on right arm / Rash on my arm / rash on her arm for a week), VACCINATION SITE PAIN (Burning arm of injection / Right arm still burns sometimes / Both her arms hurt, especially her right arm./The right arm is hurting more), VACCINATION SITE ERYTHEMA (all red / Red rash on right arm) and ARTHRALGIA (Left shoulder was hurting). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Burning sensation, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (COVID arm), PAIN IN EXTREMITY (Both arms hurt / Especially right arm / Right arm is hurting more), NECK PAIN (Neck to shoulder hurts), CRYING (Crying), SPINAL PAIN (Spine was hurting), MYALGIA (severe body aches after second dose) and VACCINATION SITE ERYTHEMA (all red / Red rash on right arm) outcome was unknown, VACCINATION SITE RASH (Red rash on right arm / Rash on my arm / rash on her arm for a week) and ARTHRALGIA (Left shoulder was hurting) had resolved and VACCINATION SITE PAIN (Burning arm of injection / Right arm still burns sometimes / Both her arms hurt, especially her right arm./The right arm is hurting more) had not resolved.            No concomitant medications were provided.   This case was linked to MOD-2022-472568 (Patient Link).
Sore arm, site tender and warm to the touch. All over body aches and chills beginning 16 hours post injection and lasting about 24 hours.
Pt did not respond to the Engerix-B vax series; 21JAN92 neg HBSAB; pt recvd 3 booster doses of Engerix-B; subsequent titers 11JUL91 & 23OCT91 all neg;
Patient received the Moderna Bivalent Booster vaccine for 6mon-5yrs as the second dose of her primary COVID vaccine series.  The dose of this vaccine is lower than the recommended Moderna Bivalent Vaccine for 6mon and older for Primary series.  So patient received a lower dose than recommended for dose 2 of her primary COVID Vaccine series.
Day 14 after vaccination, noticed gum bleeding and skin rash for petechia. I had 3 nose bleeds a week prior at different days.
Admitted to Hospital on date of adverse event for treatment of COVID-19 (positive) following completion of COVID-19 vaccine series.
pt recvd vax & pt exp pain @ the site of inject; pt has recvd medical attention & the sx still have not subsided;
got extremely sick after each of the original 2 shots/could not get out of bed; dizzy; didnt know who was in the room; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "dizzy", "got extremely sick after each of the original 2 shots", "could not get out of bed Activities of daily living impaired", "didnt know who was in the room". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got extremely sick after each of the original 2 shots/could not get out of bed"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "didnt know who was in the room". The events "got extremely sick after each of the original 2 shots/could not get out of bed", "dizzy" and "didnt know who was in the room" required emergency room visit.  Additional information: the patient was taken to the ER even though she was in good health.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201283469 same patient/drug/events, different dose;US-PFIZER INC-PV202200098797 same patient/drug/events, different dose;
Janssen COVID-19 Vaccine EUA Headache, fever, chills, fatigue
pt devel Herpes Simplex Type I in the mouth & lips starting 3 days p/vax administered; no hx of prev Herpes infect;
Patient reports having flu-like symptoms ever since he received the vaccination. The patient received a prescription for Ciprofloxacin after visiting his PCP.
Patient reports he was otherwise in a normal state of health until this afternoon when he suddenly developed diffuse body aches, 1 episode of vomiting, and subjective fever around 1 hour after receiving his pneumococcal vaccine at a routine PCP visit. Says the afternoon was a "blur" for the most part but specifically denies feeling dyspneic during this time period. Also denies associated cough, chest pain, or pleuritic pain. He
The child was at sitter's house when left thigh started swelling and turning hot and red. Parents took child to ER. Received antibiotics at the ER and to take home. Possible DX of staph or strep. Parents took child home. On 8/18/2010 dad called health department to report event. He stated that the leg was still quite swollen, but they took child to the sitters house. Is currently on antibiotics.
This is a non serious spontaneous case from a consumer in the USA, involving dizziness. The reporter causality is not provided. This case is submitted according to the VAERS agreement for FluMist. An adult male reported experiencing dizziness, tiredness, stomach upset, poor appetite and difficulty in sleeping, several hours after receiving FluMist administered in a clinic at his workplace on 01/05/05. The patient did not take any medications nor did he call or visit his primary physician. On 01/06/05, he went back to the clinic and informed the nurse who administered the FluMist of his symptoms. The nurse indicated that about 130 other employees took the FluMist and he is the second person who had reported having reactions after receiving it. The patient stated that he has been receiving the flu shot for the past several years but that he had never experienced any similar reactions. On 01/07/05, he decided to stay home and voluntarily "quarantined" himself from his wife and 2 little children as he thought he might be contagious. The patient has not yet recovered. The reporter did not assess relationship between events and FluMist vaccination. Information from missing data report states unable to reach the reporter. No further information is available.
around 2 weeks p/vax, lost eye sight in rt eye (never got it back fully);h/a, mood swings;sore joints, back pain; weight gain;
left arm: pain, swelling, redness, warmth, itching: after 5 days: still a  bump at injection site (but smaller than in previous days), still warmth (but  less than in previous days), redness has become pinkness in a smaller area, also less itching, minor pain at touch  puffy eyelids and inflammation but this may have been blepharitis which I have had in the past
No additional adverse effect; the patient was inadvertently administered the third dose of ROTATEQ at age 36 week; This spontaneous report was received from a nurse referring to a 36-weeks-old patient of unknown gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On 08-JAN-2020, the patient was inadvertently vaccinated with the third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally as prophylaxis (concentration, vaccination scheme frequency were not reported; lot number S000945 has been verified to be a valid, expiration date reported and validated as 13-JUL-2020) at age 36 weeks (inappropriate schedule of product administration).  No additional adverse effects were reported.
deep pain in his upper arm at the injection site that radiated down to forearm, upper arm was still very sore and feels tender to the touch; deep pain in his upper arm at the injection site that radiated down to forearm, upper arm was still very sore and feels tender to the touch; Initial information received on 23-Oct-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional  This case involves a 42 years old female patient who experienced deep pain in his upper arm at the injection site that radiated down to forearm, upper arm was still very sore and feels tender to the touch (pain and vaccination site reaction), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Oct-2019 at around 2:30 pm, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route in the right arm.  On an unknown date, the patient developed a deep pain in his upper arm at the injection site that radiated down to forearm, upper arm was still very sore and feels tender to the touch (pain and vaccination site reaction) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Other relevant tests not reported.      Final diagnosis was pain and vaccination site reaction.  It was not reported if the patient received a corrective treatment.  The patient was recovering from the events.
Patient became nauseated and then fainted approximately 3-5 minutes after receiving the immunization
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of MMR II 0.5 ml injection (lot# L026553, expiration date was not reported) (route and site of administration were not reported). Concomitant therapies were not provided. According to the reporter, the vaccine was stored at a temperature of 11.1 Celsius degree for 1 hour and 36 minutes and also at a temperature of -12.3 Celsius degree for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, Headache, NauseaVomiting, CHILLS, BOTH ARMS SORE Narrative:
inadvertent administration of PROQUAD to a 14-year-old patient who was scheduled to receive only MMR-II; administration of PROQUAD to a 14-year-old; No additional AE; This spontaneous report was received from a nurse, referring to 14-year-old male patient. Information regarding the patient's historical condition, concurrent condition and concomitant medication was not provided. Patient's historical vaccines included varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II).  On 13-NOV-2023, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection (exact dose, lot #, expiration date, route of administration and anatomical location were not provided) instead of M-M-R II for prophylaxis (Wrong vaccine used, Inappropriate age at vaccine administration). No additional adverse event (AE)/product quality complaint (PQC).
Client had chicken pox with blisters, itching, rash, low grade fever at age 12.
This case was reported by a nurse and described the occurrence of a bleeding bowel in her 18 year old daughter who received hepatitis B vaccine recombinant. The patient's past medical history was notable for irritable bowel syndrome which was diagnosed in March 1999. On 1/19/00, the patient received the first dose of Engerix B. At an unspecified time following the administration of the first dose of Engerix B on an unspecified date in 2000, the patient experienced a bleeding bowel and alopecia of the scalp. The patient was seen at a physician's office. On 3/13/00, the patient received the second dose of Engerix B. This represents a schedule of two months between the first and second doses of Engerix B which is longer than the recommended interval of one month between the first and second doses. On 7/17/00, the patient received the third dose of Engerix B. As of May 2004, the events were unresolved. Comment: Bleeding bowel (intestinal hemorrhage) was assessed as medically serious (OMIC).
patient was given pfizer vaccine and was sitting in the chair for post vaccination waiting for about 5 minutes.  Suddenly I looked up, I noticed her body stiffened and her eyes closed. she tumbled to the floor and hit her head on the ground. Paramedics were dispatched immediately.  patient woke up right away, we checked her pulse, forehead for fever, and back of her head for any possible bleeding.  She answered all questions that we asked of her correctly (such as her name, her age, etc.) Paramedics arrived, took her blood pressure, oxygen level (both normal), blood sugar (normal). Parents decided to take her to hospital for further evaluation.  I called and spoke to Dad 5 hours later, dad stated that she is doing fine.
Patient felt pain and couldn't lift arms for days afterward. Patient had doctor visit and physical exam. Dr. concluded that patient has axillary nerve damage. Patient has been going to physical therapy for the last month which helped but has not completely.
Information has been received from a county health registered nurse concerning a 9 year old female who on 17-JUL-2000 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-FEB-2007, the patient developed varicella, < 50 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
Pt came back to pharmacy on 10/10/11 and asked if the pharmacist about side effects of the vaccine. Upon further discussion, the pt reported that the dose she received seemed to "stay in arm" and was "lumpy". She also reported soreness at the injection site. As of today (10/10/11), the symptoms had resolved. Also, of note, patient received a seasonal flu vaccine IM in the deltoid of the opposite arm at the same time.
After few minutes of vaccine administration  (DTaP, Hib, Hep B, IPV, MMR). Pt developed maculopapular lesion with itching. She was treated with epinephrine pex. IM and Benadryl IM. She recovered without complications.
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), in Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive on home antigen test on Day 2; Negative, notes: Tested negative on home test on Day 9; Positive, notes: test positive again Day 11, 12, 13,14, 15; Positive, notes: test positive again Day 11, 12, 13,14, 15; Positive, notes: test positive again Day 11, 12, 13,14, 15; Positive, notes: test positive again Day 11, 12, 13,14, 15; Positive, notes: test positive again Day 11, 12, 13,14, 15. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was treated with Paxlovid from 27Mar2023 till 30Mar2023. Currently symptomatic with swollen glands, nasal congestion, sore throat, intermittent cough. Hoping this passes in day or two. Patient had no known allergies.  The information on the batch/lot number for BNT162B2 NOS has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148452 same patient, different drug/event;
no additional AEs; MMR II that underwent multiple temperature excursions were administered; This spontaneous report was received from a physician referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 03-JUN-2021, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) recombinant Human albumin (rHA)(strength, dose and route were not reported, lot # S020162, expiration date: 30-JUN-2021) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to temperatures of minus 58 Fahrenheit (F) to 46 F for a 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds; 47.8 F 0 hours 5 minutes 0 seconds, as recorded by the digital data logger. Previous excursions included 57 F for 1 hour 53 minutes 0 seconds; 56.3 F for 0 hours 48 minutes 0 seconds; 47.8 F for 0 hours 11 minutes 0 seconds. No additional adverse event (AE) information was provided.   This is one of the multiple reports reported by the same reporter.; Sender's Comments:  US-009507513-2106USA007355:
Day # 2: pain at injection site 2-21: itchy throat with cough (mostly dry with lite phlegm) hacking and severe choking at times 2-21: shortness of breath, at times complete loss when coughing/choking 3-7: malaise, sleepy 3-7: muscle aches, especially legs with calve spasms 7-21: sinusitis 7-21: upset stomach, gassy, gurgling, loose stools, heartburn 8-12: losing sense of taste 12-16: complete loss of taste 16-21: taste returning, but still "off"
Approximately 2 hours after receiving vaccine, I experienced an episode of dizziness, to the point that I needed to sit down to avoid falling.  After sitting for about 15-20 minutes I was able to get up and walk back to my office.  For the next few hours though, I continued to feel a little disoriented or "loopy" for the lack of a better word. Went home about 4 hours later and seemed to be fine, just a little more tired than usual.  Doing just fine now.  PS. I am employed at a hospital and received the vaccine as part of being a healthcare worker.
First some pain in left arm at injection site...... after a few hours my all m y joints started to hurt really bad. Especially my left knee backside and my right ankle. Both had been injured in the past. the pain was so bad that I was limping while walking. that lasted for three days then the intensity of the pain abated still noticeable in all the joint till about 1.5 weeks after the injection. Still now almost 4 weeks after injection I still feel the injection site in my left arm. A noticeable light pain and itching.
Systemic: Nausea-Medium, Systemic: Vomiting-Mild
Rash and redness appeared 11 days after the shot. Mostly itchy. Patient is about to take Benadryl and will see a Dr
Pt recvd 2nd dose of Hep B vax (Recomb) & lab eval revealed SGPT 144; no further details were provided;