chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1049: CG called OH and advised she received the COVID19 vaccine yesterday and woke up this morning at 0630 with a rash to her right chest and right hand, and complains of fatigue. CG denies any SOB or any other symptoms at this time. CG advised she has a history of COPD, Asthma, and granuloma disease. Advised she spoke with her Oncologist about receibving the vaccine who did not have any concerns but also voiced that she did not speak to her PCP. Occ. Health advised CG that she be seen by urgent care or PCP for current symptoms and to go to the ER if symptoms worsen or she becomes SOB.  1106: Called CG to see if she was able to touch base with PCP, advised that she has a call out to her and messaged her PCP. CG states that the rash has remained the same since this morning and that it does not itch anymore. Again advised CG if worsens to go to Urgent care or ER. CG verbalizes understanding. Will follow-up with CG later today. 1448: Called CG states the hives are mostly gone, she took some benadryl and feels back to her normal self, just has some scabs from where she scratched herself. CG states her PCP responded back to you that if she felt necessary should go to the urgent care or do a virtual appointment. Cargiver declined and states she is feeling a lot better. Advised CG to call OH with any changes and to go to the ER or Urgent care for any emergency symptoms. CG verbalized understanding.
Pain and swelling at the injection site, severe pressure in head, body aches, cold and flu symptoms, temp of 104, Symptoms come and go.
Rash, pain, and swelling on injected limb.  Pt given Benadryl by mother with symptoms improved.  Still pain in limb with significant decrease in rash.
pt was inadvertently given a second high dose flue shot on 10/13/23. they had received their inital one on 9/1/23
Chills, Body aches, headache, sore/red throat. Lasted 24 hours.
9/21/03 unusual behavior around 9pm. 9/22/03 unusual behavior, fever 1:00pm 102 degrees, dizzy, lethargic, pale, vomiting, weakness. 9/23/03 fever 102 deg, unusual behavior, lethargy, dizzy, weakness, cough pm. 9/24/03 fever 104 deg, vomiting, dizzy, weak, unusual behavior, doctor appt. 9/25/03 fever 102 deg, vomiting, dizzy, weak, lethargy, unusual behavior, paleness, cough. 9/26/03 difficulty breathing, fast heartbeat, dizzy, weak, pale, fever 102, dizzy, unusual eye twitching. Doctor visit-nebulizer with Albuterol for wheezing and difficulty breathing-pneumonia L lung. Rx: Amox 250mg 2 tsp 2x1day for 10 days. 9/27/03 difficulty breathing, fast heartbeat, dizziness, weakness, paleness, ususual behavior-doctor visit. 10/8/03 dizziness and eye twitching still remains occasionally 1x1 day. The 60 day follow up received on 1/13/04 states pt has had constant respiraotyr and eye infections since the vaccine and occasionally still has dizzy spells and eye twitching. Also his breathing always seems more laborred than it ever was.
COVID 19 Treatment; COVID 19 Treatment; Pfizer/BioNTech Dose Number: 4 / Moderna Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 38 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 20May2022 as dose 3 (booster), single (Lot number: 038A22A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraines" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Oct2022, outcome "unknown", described as "Pfizer/BioNTech Dose Number: 4 / Moderna Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (29Mar2023) Negative, notes: testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE), COVID-19 and Interchange of vaccine products cannot be ruled out.
chills; sweating; felt like she was not having a lot of energy; body aches; fever; feel really hot; mild headache; soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), HYPERHIDROSIS (sweating), ASTHENIA (felt like she was not having a lot of energy), PAIN (body aches) and PYREXIA (fever) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (chills), HYPERHIDROSIS (sweating), ASTHENIA (felt like she was not having a lot of energy), PAIN (body aches), PYREXIA (fever), VACCINATION SITE WARMTH (feel really hot), HEADACHE (mild headache) and VACCINATION SITE PAIN (soreness at the injection site). The patient was treated with IBUPROFEN ongoing since an unknown date for Headache, at a dose of 800 mg. At the time of the report, CHILLS (chills), HYPERHIDROSIS (sweating), ASTHENIA (felt like she was not having a lot of energy), PAIN (body aches), PYREXIA (fever), VACCINATION SITE WARMTH (feel really hot), HEADACHE (mild headache) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.        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 provided
soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 23-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness in her arm).   At the time of the report, VACCINATION SITE PAIN (soreness in her arm) outcome was unknown.      Concomitant product use was not provided by the reporter. No treatment information was provided.
After 1 week patient said she is still in pain. After 17 days, patient has pain the backs of the legs and has difficulty walking. She shivers and has the chills. Her hands and feet are swollen. It hurts for her to bend over. She has dizziness when she wakes up in the morning.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation; coviD-19 vaccine mRNA (mRNA 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown). The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing); "Dose 1 and 2: Pfizer/ dose 3: Moderna" (unspecified if ongoing), notes: Dose 1 and 2: Pfizer/ dose 3: Moderna. Concomitant medication(s) included: Duloxetine; Naltrexone. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Apr2022, outcome "unknown", COVID-19 (medically significant) with onset Apr2022, outcome "not recovered" and all described as "Still testing positive on day 13". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Positive, notes: Still testing positive on day 13. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt was hospitalized Jan 18, 2021 after he had fallen outside overnight and lay there approximately 12 hours until he was found. Hypothermic & rhabdomyolis diagnosis. Gradually improved w/ strength & mental status - was in swing bed @ hospital. He got his first Covid 19 shot on 2-8-21. Was fine @ 0300 on 2-9-21 and @ 0430 he was found unresponsive. Dx: probable arrythmia & pronounced dead @ 0454. Noted on pain scale @ 2/8/21 @ 21:11, clients pain was a 7/10 They offered pain med & he refused They repositioned & distracted him @ 2047 on 2/8/21 Pain had decreased to 3/10 and nothing given. Then @ 0300 check he was sleeping and @ 0430 unresponsive.
PATIENT COMPLAINED OF FACIAL TINGLING AFTER 15 MINUTES OF RECEIVING THE VACCINE. 25 MG OF DIPHENHYDRAMINE WAS GIVING ORALLY. PATIENT USED THE RESTROOM AND THEN LEFT AT 2:10PM STATING "SHE IS FINE"
Pain around injection site; stiff shoulder; left muscle sore; This is a spontaneous report from a contactable consumer (patient himself). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: en6198), via an unspecified route of administration in the left arm on 23Mar2021 at 14:00 (at the age of 64-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient previously received bnt162b2 (lot number: er2613) on 22Mar2021 administration on left arm as dose 1, single for COVID-19 immunisation. The patient received other medications within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. 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 vaccination. On 23Mar2021, 08:00 AM, the patient experienced pain around injection site, stiff shoulder, left muscle sore. The patient did not receive any treatment for the events. The outcome of the events was reported as recovering.  No follow-up attempts are needed. No further information is expected.
pt recvd vax & 24 hrs later exp rash on stomach, back rt thigh along w/urticaria; pt was not seen by MD; tx w/DPH event resolved;
I had a mild headache for 2 days; sore arm.; Had some fatigue for 2 days.; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Lot number: EL3248, Expiry date: unknown) via an unspecified route of administration on right arm on 23Jan2021 at 08:45 AM at single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, Sjogren's syndrome, fibromyalgia and hypothyroidism. The patient has no Allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Concomitant medications included methotrexate, atorvastatin and levothyroxine. The patient stated she had a mild headache for 2 days, sore arm and had some fatigue for 2 days on 23Jan2021 at 18:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and also since the vaccination, the patient was not been tested for COVID-19. Therapeutic measures were taken as a result of the events had a mild headache for 2 days, sore arm and had some fatigue for 2 days which was Tylenol and rest. The outcome of the events headache and fatigue was resolved on 25Jan2021 while outcome for sore arm was resolved on an unspecified date in Jan2021.
Patient unable to raise left arm above head and left arm was swollen. Per Nurse practioner  patient was told to contact primary physician on monday and get ultrasound done.
Swollen node at the injection site; Glands under the arm has swollen; This is a spontaneous report from a contactable consumer. A 24-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 29Jun2021 at 18:30 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an intramuscular route of administration in the left arm on 08Jun2021 at 17:30 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. On 30Jun2021, the patient had a larger swollen node at the injection site and glands under the arm had swollen as well. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events larger swollen node at the injection site and glands under the arm had swollen were not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient received 1st dose of Pfizer vaccine and returned for 2nd dose in 28 days and received 2nd dose Moderna vaccine.
The patient developed a rash on her chest and armpits. It has happened in the past in the winter season, but it worsened after the vaccination.
Headache, rash on stomach, itching, skin peeling from the roof of the mouth.
Expected reaction; She felt like she got the cold or flu; She felt like she got the cold or flu; Achy; Little bit fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Expected reaction), NASOPHARYNGITIS (She felt like she got the cold or flu), INFLUENZA (She felt like she got the cold or flu), PAIN (Achy) and PYREXIA (Little bit fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Expected reaction), NASOPHARYNGITIS (She felt like she got the cold or flu), INFLUENZA (She felt like she got the cold or flu), PAIN (Achy) and PYREXIA (Little bit fever). In 2021, PAIN (Achy) and PYREXIA (Little bit fever) had resolved. At the time of the report, VACCINATION COMPLICATION (Expected reaction), NASOPHARYNGITIS (She felt like she got the cold or flu) and INFLUENZA (She felt like she got the cold or flu) outcome was unknown.            No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2022-439044, MOD-2022-440881 (Patient Link).
Moderna COVID-19 vaccine EUA About 10 hrs after receiving vaccine (2nd dose)  I became very anxious/ jittery I took my BP and it was extremely high 194/ 92  ( normal pressure for me averages 118/ 70.  Went to bed and tried to relax and rest. Did not see anyone other then telling spouse. (I am a nurse)
Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 84 and admitted on 2/21/21 with sepsis, pneumonia, and altered mental status which were the eventual causes of death.
This spontaneous report as received from a licensed vocational nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL  (exact dose, dose number and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 21.04 degrees Celsius for 36 hours and 25 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
It woke me up at 5am and I was having a difficult time breathing there was air blowing everywhere but not going in my lungs I was dizzy numb and thought I was going to pass out lets felt heavy and felt like I had ankle weights on.  Took vitals an ½ hour later BP 156/75 Pulse 82, Blood sugar 202, 10am took vitals again 136/74 pulse 80 BS 119.
On July 1st 2021 I noticed a dark spot on my right cheek about an inch away from my nose round, a 1/4 inch in diameter and hard underneath. It is also raised at the surface. It has not changed since I noticed it. I saw my Dermatologist 07/28/2021 and she wanted to watch it to see if it might heal on its own. She told me to use Neosporin every night; I did for a about a month and it didn't change anything. I have another appointment again for her to check it on 04/21/2022.
CLIENT PRESENTED HIMSELF AT A COMMUNITY OUTREACH  FOR VACCINATION STARTING THAT HE HAS NOT RECEIVED ANY COVID19 VACCINE. CLIENT RECEIVED COVID19 MODRNA VACCINE. A CHECK IN THE SYSTEM LATTER FOUND THAT HE HAD RECEIVED J&J
Got vaccine at 3p, by 9p had chest pain and palpitations. Day 7 developed round rash around site, increased chest pain and palpitations and shortness of breath. Holter monitor showed PVCs and PACs. Have had high BP and PVCs since.
sinus migraine; a lingering headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6199) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TOPIRAMATE; ADVIL [IBUPROFEN]. Past drug history included: Motrin, reaction(s): "known allergies: Motrin". Vaccination history included: Bnt162b2 (Dose 1, Lot number=EN6201, Administration time=02:15 PM, Vaccine Location=Right arm), administration date: 17Feb2021, when the patient was 58 old, for Covid-19 immunisation. The following information was reported: MIGRAINE (non-serious), outcome "recovered", described as "sinus migraine"; HEADACHE (non-serious), outcome "recovered", described as "a lingering headache". The events "sinus migraine" and "a lingering headache" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine, headache.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 24 hours after first dose I was teaching online and got a sudden pain in my chest that quickly intensified. I was in severe pain and had my husband take me to the EMT station a few doors down from my home. The pain began to radiate down my sides and into my stomach. The EMT did an EKG and determined it was not a heart attack and helped me calm down. I was then in panic mode. The chest pains lasted the rest of the night off and on but less intense. I also had a painful sinus infection feeling/migraine for 3 days with a lingering headache for 2 more days. My second vaccine left me with the same sinus migraine but only for 1 day with a lingering headache for 3 days. No chest pains with second dose. Doctor or other healthcare professional office/clinic visit Emergency room/department or urgent care. The treatment medications inculded Imetrix, lots of fluids and lots of sleep.  No follow-up attempts are possible. No further information is expected.
Low grade fever; joint pain; muscle pain/soreness; injection site pain, swelling, and redness; loss of appetite resulting in weight loss of 5 pounds in one week; nausea; abdominal cramping; severe constipation; acid reflux; tinnitus; inability to regulate body temperature/profuse sweating
broke out in hives; This case was reported by a nurse via sales rep and described the occurrence of hives in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. In October 2022, immediately after receiving Shingrix, the patient experienced hives. The patient was treated with allergy medication {nos} (Allergy Medication). On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.     Additional Information: GSK Receipt Date: 08 DEC 2022 Reporter's comment: The reporter stated that the patient was administered the first dose of Shingrix 2 months ago from reporting and broke out hives shortly thereafter. The patient continues to experience hives 2 months after receiving Shingrix and the hives were only controlled with daily allergy medication. The reporter consented to follow up
Narrative:  patient return to clinic not feeling well, after evaluation by provider on site patient was transferred to ER via ACLS for further evaluation
Itchy red rash body, arms and legs. Treatment: ATARAX 25 mg 1 po
1/5/2021 vaccination. Similar to first vaccine reaction. 'Worst body chills'. Seven hours; feverish. TYLENOL, ADVIL. 1/6 morning - feverish, body aches. No new lesions.
Mother called on-call provider on 10/5/14 - pt had fever, not walking, crying about leg pain. Went to ED.
Pt recvd DTP/OPV devel fever by afternoon; temp to 105 during noc; pt had high pitched cry; pt was adm to hosp through ER 19SEP; Pt had no convuls & was not in any distress; pt monitored closely; devel fever;