chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 at 04:00 as dose 1, single (Lot number: EL9262), in left arm, on 11Feb2021 at 03:00 as dose 2, single (Lot number: EM9810), in left arm, on 01Sep2021 at 09:00 as dose 3 (booster), single (Lot number: EW0186), in left arm and on 13May2022 at 09:00 as dose 4 (booster), single (Lot number: Fj4991) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Recurring indigestion" (unspecified if ongoing), notes: Recurring indigestion; "Have taken medication for cholesterol previously but discontinued over 6 months ago." (unspecified if ongoing), notes: Have taken medication for cholesterol previously but discontinued over 6 months ago.; "Have taken medication for cholesterol previously but discontinued over 6 months ago." (unspecified if ongoing), notes: Have taken medication for cholesterol previously but discontinued over 6 months ago. Concomitant medication(s) included: OMEPRAZOLE, start date: 14Jul2021. Past drug history included: Formaldehyde, reaction(s): "Known allergies: Formaldehyde", notes: Known allergies: Formaldehyde. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (2022) Normal temperature, notes: Normal temperature both instances; SARS-CoV-2 test: (2022) positive; (24Jun2022) positive; (29Jun2022) Negative; (04Jul2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Addition information: Start date of treatment for COVID-19 was 24Jun2022. Stop date of treatment for COVID-19 was 29Jun2022. After testing positive for COVID 24Jun2022 began Paxlovid immediately for 5 days. Symptoms were very mild. Tested negative 29Jun. On 04Jul2022 I tested positive again for COVID. Started with very runny nose which I thought was allergies, next day chest had mild congestion which caused me to test that afternoon. Normal temperature both instances. Second time I'm feeling more congestion and coughing with sneezing. Second day i'm still testing positive. Normal temp.
per lit ref pt recv vax 6wk a/hosp adm;postmortem histological exam of lung showed a severe, diffuse, intra-alveolar giant cell pneumonia;typical multinucleated giant cells of the warthin-Finkeldey type w/prominent inclusions seen;
9 hours after vaccine:  Unable to lift arm more than 30 degrees up. 12 hours after vaccine:  fatigue 15 hours after vaccine:  fever 100.3-100.6.  severe body aches.  chills.  elevated heart rate (100bpm),  extreme fatigue.  arm pain.  unable to sleep 24 hours after vaccine:  body aches, fatigue, skin did not want anything on it. general feeling unwell 36 hours after vaccine: fatigue 48 hours after vaccine: no symtoms
Itchy welts; Rash across her chest wall, abdomen, back and groin area; Allergic reaction; pinching in her breast area; This case was reported by a other health professional via call center representative and described the occurrence of urticaria in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 454S2, expiry date 5th November 2021) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 15th August 2019, 1 days after receiving Shingrix, the patient experienced urticaria, rash, allergic reaction and paresthesia. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the urticaria, rash, allergic reaction and paresthesia were not recovered/not resolved.   It was unknown if the reporter considered the urticaria, rash, allergic reaction and paresthesia to be related to Shingrix.  Additional details were provided as follows: The medical assistant reported that the patient received Shingrix and the following day she experienced an allergic reaction which included itchy welts with a rash across her chest wall, abdomen, back and groin area.   She had a mammogram on the same day as the vaccine and she felt some pinching in her breast area the next day and initially thought it was related to the mammogram.   Her physician started the patient on the Medrol pack and her symptoms are still unresolved. The reporter consented to follow up. There is discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Patient states a few hours after , both eyes were swollen. Had Left arm pain all down to palm of his hands, up to head briefly.  Had rash and bumps forming.  He went to  ER  due to swollen eyes and pain.  Noticed on 11/6,  more bumps start occurring but eyes were not swollen. He went back to ER with Right shoulder and arm pain that was very severe.
On day 11 after booster, I broke out in hives all over my body. I was put on prednisone and antihistamine.
A non-serious spontaneous report of inadvertently given half dose of H1N1 LAIV was received from a nurse/health professional concerning a 30-year-old female. The patient's medical history and concomitant medications was not reported. On 27-Oct-2009, the patient was inadvertently given half dose (0.1ml) of H1N1, Intranasal. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Child developed swelling in left armpit after vaccination with pain. Was seen in 02/26 and had ultrasound 02/28 which showed prominent axillary lymph nodes. Follow up phone call 03/01 mother stated pain had resolved and swelling was improved but still present.
pt says that she woke up that night w/ chills.  She got up next morning w/ 101.5 fever, chills, fatigued, and body aches.  These symptoms lasted 2 days.
she was experiencing arthritic pain and discomfort; Inappropriate schedule of vaccine administered; she was experiencing arthritic pain and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (she was experiencing arthritic pain and discomfort), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ARTHRALGIA (she was experiencing arthritic pain and discomfort) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004c21a) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (Johnson and Johnsons COVID-19 Vaccine (1st dose)) on 29-Mar-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE NRVV AD26 (JNJ 78436735). Concurrent medical conditions included Pain (had problems with her right hip). Concomitant products included IBUPROFEN for Hip discomfort.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced DISCOMFORT (she was experiencing arthritic pain and discomfort), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and ARTHRALGIA (she was experiencing arthritic pain and discomfort). On 10-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, DISCOMFORT (she was experiencing arthritic pain and discomfort) and ARTHRALGIA (she was experiencing arthritic pain and discomfort) outcome was unknown.            No treatment medication was given.  Patient is taking booster dose of Moderna COVID-19 Vaccine. Patient had arthritic pain 3 and half hours after vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Follow up received on 10-Nov-2021, contains no new information.
After getting last vaccine, (Varicella) pt stated feeling sick and hot. BP 83/38. Pt laid on floor with legs propped at 45 degrees. Stated felt better after 5 mins. BP 115/63. Pt able to sit in chair after 10 mins. she was able to walk out of clinic. Stated feeling fine. Mom states has been having freq fainting episodes lately.
This spontaneous report received from parent via social media via a company representative concerned a female of unspecified age. Initial information was processed along with additional information received from central complaint vigilance on 17-JUN-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported, 1 total administered 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 an unspecified date, the patient contracted COVID-19 infection (coded as suspected COVID-19 infection and suspected clinical vaccination failure). The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint 90000183041.; Sender's Comments: V0: 20210634766-COVID-19 VACCINE AD26.COV2.S- suspected covid-19 infection and suspected clinical vaccination failure. These events are considered not related. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a nurse (immunization official) concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates (from 01-MAR-2016 to an unspecified date), the patients were vaccinated with improperly stored doses (incorrect product storage ) of GARDASIL 9 lot # L043213, (the expiration date, dose and route were not reported) for prophylaxis.. No adverse events reported at this time. The call was made by the data logger with a registered temperature of 10.3 °C during 107 hours and 30 minutes and there was no previous temperature excursion registered. This is one of three reports from the same reporter. Additional information has been requested.
Legs went numb at 10 am by 6:30 PM paralysis up to stomach.  Responded to Medical Center diagnosed with Guillain-Barre treated for 6 days in ICU with ? Globulin IV still affected.
Patient had rash start to right arm evening of 11/15 then became hot to touch, painful and itchy. Came to clinic 11/17 was given Rocephin 1gm IM and started on Keflex 500mg every 10 hours for 10 days.
Head Ache, Nausea, abdominal stomach pain, flu like symptoms, Chills and fever, night sweats. Motrin was given to treat symptoms also Ultram and Tylenol.
Admitted to the hospital because of chest pain and persistent sinus tachycardia and diagnosed with mild Myocarditis.  Visit ER earlier that morning because of severe chest pain.
Patient got his second dose of the Pfizer Covid vaccine at ~1300 on 3/5/21.  On 3/6/21, he developed fever, dizziness, temp up to 101.  He experienced dizzy spells especially when he got up.  He is able to walk with help.  He took tylenol 1000 mg morning and evening on 3/6/21.   Patient stated the worst symptom is the dizziness.   On 3/7, patient had a temp of 100.2.  He had pain and swelling in axilla where he got second vaccine and along his side. Patient reported the dizziness is getting a little better and is not constant. In the afternoon, his temperature went up to 102.9 F.  Patient's PCP recommended that he be evaluated in the emergency department.   Patient was evaluated in the emergency department.   He received a liter of normal saline and was subsequently discharged.
100 degree fever for 24 hours , vomiting, chills, bone pain extremely intense, chest pressure , numbness of right hand, swollen lymph node in right arm pit , extreme exhaustion, dizziness
Headache, NauseaVomiting, fatigue, soreness at injection site Narrative:
The patient have seasonal allergies and she already took Benadryl at night.  She developed throat feeling itchy about 30 minutes past vaccine administration. The patient  drunk water ,ate crackers and offered to take another dose of Benadryl. She was unable to swallow the Benadryl for the first attempt then second attempt successfully swollen. At 12:00 she was feeling better and symptoms improved. Discharged to go home.
No adverse effect reported; The patient was vaccinated with improperly stored doses of GARDASIL 9; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. No information was provided regarding the patient's concomitant medications, pertinent medical history, drug reactions or allergies.  On 30-JUL-2019, the patient was vaccinated with improperly stored doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot number R029117, with expiration date: 10-JUL-2021 for prophylaxis. No adverse effects were reported.  The doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) underwent temperature excursions of 47.5 degrees Fahrenheit (°F) for a time frame of 2 hours and 45 minutes, which was called by the digital data. There were no previous temperature excursions reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA001263:
This spontaneous report as received from a registered nurse refers to a 2 year old patient (gender was not reported). On 31-AUG-2015, the patient was vaccinated with a dose of improperly stored (Oka-Merck) PROQUAD lot # K020754 (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Pt. states that after receiving both doses of Phizer 03/25/2021, tested Positive for Covid-19 08/26/2021 ,
Shortly after my first vaccine I began experiencing left shoulder, arm and hand tingling and cramping/spasming lasting 10-15 seconds each time. This is ongoing and occurs 3-4 per hour.
Sick for 24h; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick for 24h). The outcome of the sickness was recovered/resolved (duration 24 hrs).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.   It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient had his/her first shingles shot, next month he/she would get his/her next one, was paying for it.  The reporter stated that it did make him/her sick for 24 hours. The follow up would not possible as no contact details were available.
Information has been received from a registered nurse (R.N.) referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with GARDASIL (lot # K004205, expiration date 12-JAN-2017, lot# K005881, 14-JAN-2017; dose and route not reported) that had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Developed COVID-19 positive 01/08/2021 with symptoms beginning 01/07/2021
Infant given DTP/HIB/OPV; sl elv fever & irritability that PM, then infant died in sleep during nap the next day; (SIDS); 0 sz or other activity noted;
pt c/o pain to lt deltoid area 28OCT98 @ noc then on 29OCT98 pt noticed swelling, itching & redness;was seen @ clinic & tx w/med;
some left arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (some left arm pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001B21A) for COVID-19 vaccination.     The patient's past medical history included Heart valve regurgitation and Dry eyes. Concurrent medical conditions included Depression, Anxiety, Narcolepsy (diagnosed 2000), Low blood pressure and COPD. Concomitant products included DILTIAZEM HYDROCHLORIDE (CARDIZEM CD), PHENELZINE SULFATE (NARDIL), CLONAZEPAM, GLYCEROL, PROPYLENE GLYCOL (SOOTHE [GLYCEROL;PROPYLENE GLYCOL]) and MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (some left arm pain). At the time of the report, PAIN IN EXTREMITY (some left arm pain) outcome was unknown.            Treatment details included acetaminophen. Event outcome details were not reported.   This case was linked to MOD-2021-047854 (Patient Link).
Pt came to ER c/o headache, sore throat, fever, elevated HR, and chest pain.  Symptoms started same day.
Wide awake, overly alert. Woke up at 1a after 4.5 hours of sleep and wide awake for the next 15 hours. Difficulty falling and staying asleep next two nights also. Not typical for him. Restless, and then developed a runny nose with clear discharge, and a barky cough within a week of receiving vaccine. Missed 3 days of school.
soreness, redness, warmth, and swelling at injection site.  jaw soreness, jaw locking, abdominal muscle spasm, on/off left lower leg pain and numbness
Information has been received from a nurse practitioner concerning a 69 year old female patient with hypertension, sleeping dysfunction, asthma, arthritis and allergic reaction to codeine, sulfa drugs, BUSPAR, AUGMENTIN, NORCO who on 05-MAY-2010 was vaccinated with a 0.5mL dose of PNEUMOVAX 23 (lot# 663888/0627Y, expiration date: 10-NOV-2010) IM. Concomitant therapy included lisinopril-HCTZ (MSD), WELLBUTRIN, omeprazole (MSD) and AMBIEN. On 05-MAY-2010 the patient experienced redness, pain, swelling and warmth of the arm, starting about one inch below the injection site after receiving the vaccine. The patient sought medical attention via office visit and was treated with BENADRYL and KEFLEX. No laboratory diagnostic tests were performed. At the time of the report, the patient's outcome was unknown. The nurse practitioner requested a lot check. Follow-up information has been received from a family nurse practitioner concerning the female patient with no illness at the time of vaccination who on 05-MAY-2010 was vaccinated IM with the first dose of PNEUMOVAX 23 (lot# 66388/0627Y). On 05-MAY-2010 AM the patient was seen in the doctor's office complaining of left arm pain, erythema and swelling 2.5cm below the puncture site (conflicting information reported as injection given in the right deltoid). Swelling and erythema noted down to the elbow. The patient had no axillary adenopathy. The patient complained of severe pain down to hand. No laboratory diagnostic tests were performed. At the time of the report, the patient's outcome was unknown. Injection site erythema, pain, swelling and erythema, pain in arm and swelling arm were considered to be other important medical events by the reporter. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
Arm sore, tired, muscle ache lasting 1 1/2 weeks.  No treatment.
Several minutes after the patientgot the vaccine, she fainted. Then her face and arms were red. After she regained consciousness I gave her 2 teaspoonsful of  diphenhydramine liquid then her redness slowly went away. She was breathing fine but was very pale. EMT then came and checked up on her.
I stay at my parents the night before work because their home is located much closer to work--my fiance and I live much farther away.   I received the vaccination around 10AM Sunday morning.  Sunday night I went to bed around 8:30PM and experienced severe chills throughout the night.  I awoke around 12AM and got up to get a drink.  I got a drink of water and checked my temperature, temp was 100.7.  I felt yucky but not horrible.  I walked back to my parents' room to tell them I would be staying home from work.  As I got to their room and began to speak, I began to feel nauseous and weak and suddenly collapsed.  My dad leaped up and helped me stand up so I could get to the restroom.  I walked a few steps and then collapsed again and lost complete consciousness--I do not recall collapsing again or what happened shortly after.  Per my dad, I was unresponsive, and he drug my limp body from his bedroom to the bathroom.  My mom called 911.  After several minutes, I regained consciousness and was leaning against my dad in the bathroom.  I felt my fever break and was sweating profusely.  EMS arrived at my home and checked vitals--everything was stable.  I was A&O x3 and was able to drink water.   I declined being transported to the hospital.  I felt the loss of consciousness was likely due to dehydration or fever (although my fever really wasn't that high).
1) 8 hrs after flu shot, sudden chills and racing pulse lasting 2 hrs.  2)next day,exhaustion, falling asleep, difficult to stand, weakness, sweating; fast pulse 3)sense of throat closing (took inhaler) or swelling 4) coughing, sore throat, hoarseness 5)sinus liquid running freely from the nose, dripping into throat 6)anti-biotics started with immediate curative effects.  I consulted with two doctors: "it's just the symptoms, not the flu" to "it's just a coincidence, so it must be the flu"