chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense Headache 7-10 of 10; Low grade fever 100.4; Significant bodyaches; cold sweats; This is a spontaneous report from a contactable other health care professional (Patient, self-reported). A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in arm left on 27Jan2021 07:30AM, as second dose, single, dose 1, (Batch/Lot Number: EJ1686), via an unspecified route of administration, administered in Arm Left on 06Jan2021 07:30AM, as first dose, single for covid-19 immunization. Reportedly other medical history was none. Patient did not have allergies to medications, food, or other products/known allergies. Concomitant medication included paracetamol (TYLENOL) and ibuprofen (MOTRIN [IBUPROFEN]) received in two weeks of vaccinations. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19 prior vaccination. Patient has not been tested for COVID-19, post vaccination. On 28Jan2021 02:45AM, the patient experienced intense headache 7-10 of 10, low grade fever 100.4, significant body aches and cold sweats. The patient underwent lab tests and procedures which included pain assessment: 7-10 of 10 and pyrexia: 100.4 on 28Jan2021. Treatment was not received for adverse events. Outcome of the events was recovering.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
OFF LABEL USE; VACCINE USED IN INAPPROPRIATE AGE GROUP; This spontaneous report received from a health care professional concerned a 17 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included hydrocephalus and has a shunt, and cerebral palsy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 11-APR-2021, the subject experienced off label use. On 11-APR-2021, the subject experienced vaccine used in inappropriate age group. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine used in inappropriate age group and off label use was not reported. This report was non-serious.
Patient was fine during the injection, during the observation period that patient became dizzy and diaphoretic.  His O2 sat was 98% on room air, 76 HR, 16 resp.  He was fine after a couple of minutes and no intervention was needed.
Hives on legs about 3 hours after the shot. Itch back of Right knee, red spot appeared on Right knee. 5 Red spots appeared on Left knee. She had no temperature.
Patient experienced vasovagal reaction post-Pfizer #1. Per parent, patient was "fine" for the first 10 minutes, then started c/o symptoms. EMS assessment at 1259: initial BP 71/33, HR 45, RR 20, SPO2 97%, BSG 109. EKG indicated bardycardia, then sinus arrythmia. Final assessment before transport to hospital: BP 100/61, HR 85, RR 15, PSO2 98%.   Parent was counseled by a health department RN to discuss the reaction with pediatrician prior to receiving the second vaccine.
This is a spontaneous report from a noncontactable nurse (patient). A 51-year-old (non-pregnant) female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), at the age of 51, via an unspecified route of administration, in the left arm, on Mar 8, 2021, at 12:00, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. The patient has no known allergies to medications, food or other products. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. On Mar 9, 2021, patient experienced arm pain and round area of swelling at injection site. No therapeutic measures taken as a result of the reported events. Since the vaccination, patient has not tested for COVID-19. The outcome of arm pain and round area of swelling at injection site: recovering (at the time of this report). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Pt received MMR 7/29. 8/5/16 presented to ER in asystole.
Two weeks after first vaccine i developed a rash on my belly.  It was very itchy.  after 2nd dose on March 6, rash got worse.  Physician says it may be shingles. Wondering if vaccine lowered my resistance to get shingles or if is a rash from the vaccine
Menstruation was due 1/10/21 (2 days after vaccine). I am typically very regular. Period did not start until 1/24/21 and as of today (2/9/21) has not ended (17 days long so far).  VERY heavy flow with A LOT of clotting.  Additionally, on Day 8 after vaccination, injection site became red, hot, and itchy with a hard knot at injection site.  This lasted for 2 days then went away.
Nausea followed by  incoherence/fainting, rapid breathing, sweating, chills and and diarrhea.
Use of Moderna vaccination is contraindicated for use in persons under 18 years old, this patient is 16 years old and received the 1st dose of the Moderna vaccination erroneously.  No adverse events, s/sx, negative outcome reported by the parent.
1st dose given on 1/12/2022 and 2nd dose given on 2/2/2022, 3 weeks apart NOT 4 weeks apart like how Moderna is supposed to be given - no adverse reactions
Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 as dose 1, 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: HEADACHE (non-serious) with onset Oct2023, outcome "recovered" (Oct2023).  Additional information: Reporter stated her daughter was vaccinated on Saturday 14Oct2023. During report while doing supplemental form caller stated she stayed home with headache. Caller's sister also. After about a day went away. Caller's sister had headache on 1st day.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334595 same reporter/drug, different patient/AE.;US-PFIZER INC-202300333483 same reporter/drug, different patient/AE.;
sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE and INJECTION SITE PAIN in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia. Concomitant products included ATORVASTATIN for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE. On an unknown date, the patient experienced INJECTION SITE PAIN. The patient was treated with ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, HEADACHE and INJECTION SITE PAIN (arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-097682.
Information has been received from a consumer concerning a 20 week old female with no drug allergies, who on 04-DEC-2007 was vaccinated with a first dose of PedvaxHIB. Concomitant suspect vaccinations included Comvax vaccine. On 04-DEC-2007 the patient developed a huge blister at the injection site, cold sweat, red face, loss of appetite, and decreased urination. The patient sought unspecified medical attention. No laboratory diagnostics were performed. At the time of the report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
No symptoms after the vaccine. The next day I had slight headache, in August I tested positive, after having a COVID-19 home test, I had cough, headache, and tiny little fever. I went to immediate care on the 15th and got a positive test again. They gave me an injection. They told me to take over the vitamin's supplements, I took them for 2 months. By Oct 10th, 2022, all the symptoms were gone. On Dec 29th I had severe cough, wet cough, a lot of congestion, fever for one day, very fatigue, I stayed 3 days in bed, I went to the doctor and got antibiotics, I think it was bronchitis or flu (at the same time).
pain to the injection site and feeling of needles poking around injection site; feeling of needles poking around injection site; This is a spontaneous report from a contactable consumer (patient herself). A 56-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 56-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. On an unknown date, the patient reported "pain to the injection site and feeling of needles poking around injection site (vaccination site discomfort) was a side effect. The patient reported that ever since receiving the second dose of the Pfizer COVID vaccine almost 5 weeks ago, she had pain to the injection arms, but only at the injection site. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Information has been received from a pharmacist, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of ZOSTAVAX (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) for prophylaxis or with doses of VARIVAX (strength, dose, anatomical location, administration route, lot number and expiration date were not reported) also for prophylaxis. On unspecified dates, the patients experienced an unspecified "swollen arm". The outcome of the swollen arm was unknown and the causality between the vaccination with ZOSTAVAX or with VARIVAX regarding the event was not reported. This is one of several reports received from the same source.; Sender's Comments:  US-009507513-1709USA005581: US-009507513-1709USA008138:
COVID(+) WITH SYMPTOMS NASAL CONGESTION, COUGH NO SMELL OR TASTE Narrative:
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Severe
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II (dosing regimen and frequency unknown) (lot number and expiry date unknown). No concomitant medications were reported. On an unknown date the patients experienced mumps outbreak at an unspecified college. It was also reported that the nurse was unsure of how many patients developed the mumps or how many patients have received M-M-R II prior to getting the mumps. The outcome of mumps outbreak was unknown. The action taken with the therapy with M-M-R II was unknown. The relatedness of the events to the therapy with M-M-R II was unknown. No product quality issue was reported. Additional information has been requested.
5 days going to 6 of on and off fever, throat swelling, lip swelling, body aches, nausea.
C/O pain in left upper arm since flu shot, and lateral aspect of left shoulder. Pain with ROM in left shoulder. NO redness, no swelling, no effusion of (L) shoulder and no ecchymosis noted. Tx: Alternate hot and cold compress, soak in warm tub. Tylenol #3 for pain. Follow-up as needed.
Pt seated on exam table, witnessed to have eyes deviate (R) w/LOC and < 5 sec shaking, felt to be vasovagal/syncope, No sz. Alert after approximately 15 sec, clammy, emesis x 1, BP 86/54, glu 99, HR 30's Sent via EMS to local ED, monitored, N EKG. d/c to home.
Full body Hives, itchy, redness, pain when itching. Acute Urticaria. No new detergents, foods, body care items.
AFTER RECEIVING THE VACCINE SHE COMPLAINED OF AN ALLERGIC REACTION. ONSITE EMS AND PHYSICIAN RESPONDED.  HER BP 138/78 HR 104/100% O2 ON ROOM AIR. PATIENT REFUSED ADDITIONAL EVALUATION AND WENT HOME AGAINST MEDICAL ADVISE.
11 & 12MAy noted to have rash on buttocks-vesicular pustular lesions as described by mom;15MAY97 began w/fever 101.2, restless prev noc;rash noted to be scattered w/few on legs, abd back, face-maculopapular lesions;
Breakthrough case admission after three vaccines Pfizer 2/22/21 Lot# EN6200;  Pfizer 3/15/21 Lot# EN6207;  Pfizer 10/1/21 Lot# FC3183
About 25 minutes after receiving injection the left side of my face began tingling and feeling numb (sort of like numbing at the dentist). 5 1/2 hours later (8:45 PM) the left side still feels numb. Felt like a beginning of a headache at the top of my head - has not progressed further than that. With home equipment:  oxygen level 98, pulse 82.  BP 154/78 (usually about 146/70
Hot Flashes; Feeling Tired; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (Hot Flashes) and FATIGUE (Feeling Tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032D21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included LAVANDULA ANGUSTIFOLIA ESSENTIAL OIL (LAVELA WS 1265) for Anxiety.(homeopathic)   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced FATIGUE (Feeling Tired). On an unknown date, the patient experienced HOT FLUSH (Hot Flashes). On 14-Apr-2021, FATIGUE (Feeling Tired) had resolved. At the time of the report, HOT FLUSH (Hot Flashes) outcome was unknown.            The patient did not take any medication to help with the symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up received on 21 Jul 2021. contains non significant information.
Swelling and redness at injection site right leg, firm to touch.  Fever of 101 F x2 days when redness appeared. Seen by MD on 01/20/04.  Put on Augmenting three times a day for 7 days.
FLARE UP; PAIN; This spontaneous report received from a health care professional concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient was treated with golimumab (solution for injection, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 19-MAR-2021, the patient experienced flare up. On 19-MAR-2021, the patient experienced pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with golimumab was not reported. The outcome of the flare up and pain was not reported. This report was non-serious.
multiple unspecified patients were administered improperly stored RECOMBIVAX HB; No adverse effects reported; Information has been received from a pharmacist referring to multiple unspecified patients of unknown age and gender. Information about concurrent conditions, concomitant medications and medical history was not provided.   On unknown dates, the patients received improperly stored doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (lot # R012001 and expiration date 06-NOV-2020) (dose and route of administration were not reported), for prophylaxis. The vaccines were exposed to a temperature excursion of 18.6 Celsius degrees (°C) (9 °C to 25 °C) during a time frame of 96 minutes which was detected by a digital data logger. There was a previous temperature excursion of 9 °C to 25 °C during 167 minutes. No adverse effects were reported.     This report was a non-valid case as there was no information about the patients' identification.  As of 03-JUL-2019, all telephone attempts to obtain follow-up information have been unsuccessful.
Sick; She stated that they had flu; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Sick) and INFLUENZA (She stated that they had flu) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and 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 ILLNESS (Sick) and INFLUENZA (She stated that they had flu). At the time of the report, ILLNESS (Sick) and INFLUENZA (She stated that they had flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Influenza virus test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test positive: negative (Negative) Negative.         No concomitant information was reported. It was stated that patient had had lot of problems in the family and and said that the grandson may had brought the cold viruses home. No treatment information was provided.   This case was linked to MOD-2022-596889, MOD-2022-596523, MOD-2022-597292 (Patient Link).   Reporter did not allow further contact
10 minutes post vaccination, patient had a syncopal event. Vitals: 133/83, 66, 100%. Patient stable and released to his mother. Patient walked to exit w/RN. Declined wheelchair. Patient had steady gait and left in stable condition at 20:21.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patient so unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was reported. On an unknown date, the patients were vaccinated with PEDVAXHIB lot # L035880, expiration date: 11-AUG-2018 (dose, route of administration and anatomical location were not reported) that was improperly stored. No adverse events were reported. Additional information is not expected as the reporter did not wish to be contacted.
Red, macular, papular rash over head, face, truck, upper arms. Noticed on 1-15 (24 days after receiving MMR vaccine). Per follow-up: Not life threatening illness per reporter. None - Pt recovered and having no symptoms.
1 day later began with decreased appetite, headache, dizziness and low grade fevers. Fevers persisted for 3 days. Headaches, paleness and decreased appetite for 10 days Bizarre behaviors and emotional dysregulation for 10 days.
2nd sz @ 10PM on 16MAR95, noc following DTP/HIB vax earlier this day;
Within days of receiving vaccine started feeling mild discomfort on right side of lower abdomen while doing light abdominal exercises. This continued for about 10 days and then flu-like symptoms started - bloating, continual abdominal discomfort, back pain, lack of appetite for 3 days.  On Friday, April 16, I went to doctor who sent me to the ER for further tests which showed appendicitis resulting an appendectomy on Saturday, April 17 at 7:30 AM.
Blood in stool four day after vaccination with no rash, irritability, vomiting or abdominal distension.
A few hours after the vaccine, patient began feeling nauseous, dizzy, vomiting, muscle cramping, and chills. Patient was seen in the ED and was sent home.
Immediate localized reaction, 2 days later went to emergency room with swelling in arm and general malaise, diagnosed with cellulitis and put on antibiotic for 10 days.
Woke up two days removed from second shot and I had a swollen lymph node on my left armpit, which was the same side I received the second Pfizer shot, left arm.
Metallic smells and tastes.  Most foods have a sour metal taste or after taste.  I did lose my smell when I had covid in December for many weeks but it had returned.  I am now two weeks last my first dose of pfizer and am tasting metal in the back of my throat for the last 3 days.
Major pain in both legs and knees starting in May and still continues. It was very difficult to bend down or stand up. Presently I have a swollen left knee for several weeks.  In October I started having allergic reactions to spices in foods. I've  never had allergies. I would get Swollen lips and a few hives. I was given Benedryl, Pepcid, and Predisone. I still continue to have allergic reactions, but now I have much more large hives that itch and look like Chronic Spontaneous Urticaria. I take Benedryl and Zyrtec to relieve symptoms, but they come back.  I took a blood test on 10/15 and was tested negative for Rheumatoid arthritis. I went an Allergist on 11/6, and the Dr. couldn't determine the cause. I took a blood test on 12/16, and it came back positive for Lupus. I've never had any of these issues before taken the vaccine. I'm very upset about my diagnosis and, I'm worried about taking the Booster. I need answers. Please help me find out why I may have Lupus as per blood results.
Patient received a second dose of the bivalent covid booster .no adverse event reported .previous dose was back in November
Day after shots threw up 1 time, had a fever of 99.2 . Day 2 after shots began to get hives. Day 3 after shots has thrown up 2 times and is very sleepy. Decreased appetite.
The patient was given the first dose of the Pfizer Covid vaccine. He was instructed to sit in a chair in the waiting area in front of the pharmacy for 15 minutes. Within minutes, one of the technicians alerted us that he was having some problems, and when I came out of the pharmacy, his head was slumped to the side. By the time I reached him, he was sitting up and talking to me. His wife came up and said he has had issues passing out after vaccines and having blood drawn before. My pharmacy manager went to get him something to drink hoping that would help him. He was sweating. He then lost consciousness again, and I called 911. I sent a technician after an employee that works on our front end that is a paramedic/fireman. He came and checked him out until the ambulance got here. They took to hospital via ambulance.