chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pain and tenderness in the left armpit; pain and tenderness in the left armpit; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 13-years-old male patient received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: FA7485, Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in arm left on 08Aug2021 at 14:45 (age at vaccination 13-years-old) as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine included bnt162b2 (BNT162B2, Formulation: solution for injection, Lot Number: FA7484, Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in arm left on 18Jul2021 at 02:00 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seasonal allergy (Known allergies: seasonal allergens) and autism from an unknown date and unknown if ongoing. Concomitant medications included that the patient received within 2 weeks of vaccination included clonidine, wellbutrin, abilify and sertraline taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Aug2021 at 10:00 AM, the patient experienced pain and tenderness in the left armpit. Treatment received for the adverse events reported as unknown. The outcome of events was unknown. The events were reported as non serious.  Follow-up attempts are completed. No further information is expected.
Swelling, redness about 8 inches in diameter, pain, soreness. I recommended pt to take ibuprofen and apply ice or a cold compress to arm. Pt contacted the next day and said her symptoms improved. Called pt and she said she was better.
PAIN IN BOTH ARMS, HANDS, LEGS AND FEET; SORENESS AT ADMINISTRATION SITE MOMENTARILY; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: antibiotics allergy, latex allergy, alcohol user, non smoker, and type 2 diabetes, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included metformin for type 2 diabetes. On 07-APR-2021, the patient experienced soreness at administration site momentarily. On 15-APR-2021, the patient experienced pain in both arms, hands, legs and feet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at administration site momentarily on 07-APR-2021, and had not recovered from pain in both arms, hands, legs and feet. This report was non-serious.
tachycardia; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  A 35-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: TACHYCARDIA (non-serious), outcome "unknown". The event "tachycardia" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient also physician, no cardiac history developed tachycardia several weeks after Pfizer Covid 19 vaccine Seemed better then had Moderna booster and Covid symptoms returned. No better. Patient saw cardiologist the tachycardia was documented on electrocardiogram and halter monitors. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a licensed practical nurse and refers to a 17 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 09-NOV-2015, the patient was vaccinated with a dose of GARDASIL 9 (lot # L007560, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Travelled to and back home at beginning of May. On 5/7 I began feeling cold-like symptoms w/ a productive cough. I tested positive on 5/9 and contacted my Dr and got Paxlovid and took it for 5 days. I was sick up until 5/14. I re-tested on 5/18 and was negative.
Runny nose/ sniffling nose; Swollen arm; Sneezing; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose/ sniffling nose), PERIPHERAL SWELLING (Swollen arm) and SNEEZING (Sneezing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported. On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced RHINORRHOEA (Runny nose/ sniffling nose), PERIPHERAL SWELLING (Swollen arm) and SNEEZING (Sneezing). At the time of the report, RHINORRHOEA (Runny nose/ sniffling nose), PERIPHERAL SWELLING (Swollen arm) and SNEEZING (Sneezing) outcome was unknown.    No concomitant medications were provided. No treatment medications were reported. Reporter did not allow further contact.
Administered vaccine IM in right deltoid. Immediately developed one large hive around the administration site the size of a quarter.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 60 year old female. The patient's weight, height, and medical history were not reported.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose, start therapy date were not reported for prophylactic vaccination. Batch number is not reported but a follow-up will be requested. Concomitant medications included Prednisone for drug used for unknown indication.  On an unspecified date, the subject experienced confirmed immunological vaccine failure. The patient called the physician to inform that she did not have any issues in tolerating the vaccine but was concerned that the immunization did not happen. She also mentioned that she did couple of antibody tests after 6 weeks from the day of vaccination and found out that the results were negative. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Results were negative. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of confirmed immunological vaccine failure was unknown. This report is serious (confirmed immunological vaccine failure). This report was associated with product quality complaint: 90000179026; Sender's Comments: V0;20210518327-covid-19 vaccine ad26.cov2.-confirmed immunological vaccine failure. This events is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Pt came down with severe headache on 4/15, started vomiting, complaining of "worst headache of his life, very lethargic, can't stay awake." Sent to ED on 4/21.  Diagnosed with subdural hematoma with midline shift and hypertensive emergency and admitted to the ICU. Emergent craniotomy with hematoma evacuation with subgaleal and subdural drains placed on 4/21
Temp elevation of 102.6 on 18FEB91, dec appetite & urine output; Taken to MD mom states told baby had an ear infect;
8 days after injection,  experienced itchy, red, warm rash tender to touch around the injection site.
Onset of fatigue, night sweats/fever, headache, myalgias in 2010. Diagnosis of neutropenia, unknown cause. Concerned that anthrax and yellow fever immunizations received in 2003, 2004 may have caused illness. Causality assessment provided. Causality "unrelated".
Moderna COVID Vaccine was drawn on 08/24/21 @ 12:41pm and was given outside the 12 hour period recommended by manufacture.  Vaccine was given on 08/25/21 @ 12:40.
MEDICAL ASSISTANT INJECTED VACCINE IN THE LEFT ARM. AFTER ADMINISTRATION MEDICAL ASSISTANT FOLLOWED UP WITH DOCUMENTATION AND NOTICED THAT THE VACCINE WAS EXPIRED. SHE QUICKLY LET PROVIDER KNOW, PATIENT WAS INSTRUCTED TO STAY FOR OBSERVATION FOR 15 MIN. AFTER 15 MIN PT DID NOT REPORT/EXPRESS ANY SYMPTOMS OR RACTION TO THE VACCINE.
Developed fever to 102, inject site - light red, swollen & tender & screaming episode for more than 4 hrs day following DTP/OPV, became increasingly irritable, also had diarrhea, hospitalized for 2 days. Duration of illness 4 days.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.), PRODUCT STORAGE ERROR (11JAN2023 was beyond use date, administered on 14JAN2023) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (11JAN2023 was beyond use date, administered on 14JAN2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.), PRODUCT STORAGE ERROR (11JAN2023 was beyond use date, administered on 14JAN2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Concomitant medication was not reported.  Patient received Moderna bivalent 6m-5y of age dose after the beyond use date. 11-Jan-2023 was beyond use date and product was administered on 14-Jan-2023.  This case contains information for the 2nd of 3 child patients described by the reporter.
As nurse was administering vaccine, vaccine syringe (prefilled) seemed to work fine, however once nurse withdrew needle and safety mechanism was activated the prefilled syringe snapped at the luer-lock hub leaving the child unharmed in the process
I had immediate soreness after the vaccine does. Then at 7pm of the evening after getting my vaccine, I began to feel weak, get chills, and run a low grade fever. At midnight, my fever had increased to 101 and I began taking Tylenol (recommended by Pharmacy). I had sever body aches, muscle fatigue, joint paint, chills and nausea through the night and the next day. In the morning, I had excruciating pain in my abdomen and began vomitting. Later that  day, my fever increased to 102.7 (with Tylenol) and I called my regular doctor. She told me to continue to monitor and if my fever did not decrease by 7pm to go the hospital. Finally, my fever decreased to 101, muscle aches, chills and joint pain continued. I began vomitting uncontrollably for a short period of time. I was very dizzy and weak the remainder of the day. Saturday, my fever finally broke (I sweated all day) but my body was still weak and sore. I also had dizzy spells on and off. Sunday, I felt much better but was still very tired compared to my normal self. I had abdomen pain and burning on and off. I also got hive on my hands Sunday afternoon. After Benadryl, the hives went away but I still felt itchy all over.  Today (Monday), I still don't feel like myself, but it is the best I have felt since receiving the vaccine. I have never experienced anything like this and was miserable Thursday night, Friday and some of Saturday. It truly was a terrible experience.
Fever up to 105.5 with ear pain, difficulty sleeping, jerking awake from sleep.  Put on Cefdinir.
Note: My sister in-law visited on Nov 10, left Nov 13. They tested Covid positive that evening.  I tested positive for Covid on Nov 15, and again Nov 17, Nov 20,  Nov 22 (so far).  Symptoms Nov 15-18 moderately severe cold symptoms, sinus, and lung congestion, fatigue.  Started improving Nov 18.
Nausea, lightheaded, heart palpitations, stomach and chest pain, face tingling, hot face arms tingling , sharp back pain
Received the high dose flu shot on 9/20/22. Within a few hours I started getting body aches and was notably tired. By the next morning, I was extremely congested, still achy, and still tired. This went on for 2 more days, but then the coughing started on the evening of 9/22/22. And as my wife types this for me, it has now been 5 days and the coughing and congestion continue. I feel as though I had (have) the flu. The only symptom I didn't get was a fever, although my wife insists that first night I 'felt' warm (but I did take my temp on 9/21 and it was normal).
elevated temp 102, crying, wouldn't stand up, dec appetite;Ibuprofen, DPH;
This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with dose 2, 1 DF PNEUMOVAX 23 on 28-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule of drug administration. No treatment information was reported. The outcome of inappropriate schedule of drug administration was reported as not recovered/not resolved. Inappropriate schedule of drug administration is not related to PNEUMOVAX 23. {Additional information has been requested. Additional information is not expected.}
Patient received PREVENAR-13 in left deltoid on Wednesday. She developed itchy rash on Sunday, 4 days after vac. Pt called the pharmacy on Monday and got instructions to see MD if rash not resolved. Pt saw PCP on Tuesday and received diag: -local injection reaction, no infection. Medications: ZYRTEC tbl., BENADRYL tbl. and Fluocinonide cream.
pt recv vax 28DEC95 & on 31DEC98 broke out w/about a dozen lesions;very mild case of chickenpox-2wk later sibling broke out w/mild case of chickenpox-both children had vaccine same day;verified by MD that pt had chickenpox;
Muscle soreness at injection site; fatigue on the day of the vaccine administration; This is a spontaneous report from a non-contactable pharmacist, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Mar2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 08Mar2021, the patient experienced muscle soreness at injection site and fatigue on the day of the vaccine administration. 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 muscle soreness at injection site and fatigue on the day of the vaccine administration was resolved on an unknown date in Mar2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 11/18/97; on 11/24/97 pt exp visual disturbances (green spots).
On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 9 week old female patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 15-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ((dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.   Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.  This is one of several reports received from the same reporter.  This is an amended report. The reference "US-009507513-1903USA013366" was captured as E2B Linked Report.; Sender's Comments:  US-009507513-1903USA013366:
12/22/2021- Flu-like symptoms; stuffy nose, persistent cough, sore throat, persistent sneezing (NO FEVER)
On day 9 I started getting an itchy big toe. On day 10 that continued and I started getting welts on the top sides on both legs. It was like a vascular rash like welts not like hives. The next morning I went to Employee clinic and showed them, they told me they didn't know go to my PCP. The welts continued to spread to all my joints. It was very itchy it went behind my knees, hands and ankles. I did not get any welts on my torso front or back. I went to my PCP, said I have "Covid toe" and she did a Covid test and that came back negative. She sent me to a Dermatologist, they said it was definitely a Covid rash and from the vaccine.  The rash happened like if I was shedding the virus.  She said the rash was very vascular. She said it's not an allergic reaction but they did prescribe me a prednisone and topical cortisone cream, Benadryl and Pepcid.  This happened 10 days after with the second dose and used my prescriptions and never got back like before.
The pt developed Guillain Barre on 12/10. Was admitted to the hospital and remains hospitalized. On 1/23/01 the prognosis for a full recovery in 2 years. Was transferred to a rehab unit on 1/16/01. Also diagnosed with sleep apnea.  Follow up on 07/09/2001: "Chronic illness before includes chronic heart disease, sleep apnea, atrial fib.  "
AREXVY vaccination was given to a pregnant 36 year old woman; Inappropriate age / 36 year old woman; This non-serious prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 36-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number L7HN5) for prophylaxis.   Concurrent medical conditions included pregnancy.   On 17-OCT-2023, the patient received Arexvy. On 17-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Inappropriate age / 36 year old woman). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: AREXVY vaccination was given to a pregnant 36 year old woman). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): Trimester unknown Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 17-OCT-2023  The reporter stated that the Arexvy vaccination was given to a pregnant 36-year-old woman (patient), which led to inappropriate age at vaccine administration. Gestational age of fetus was not available. The reporter consented to follow up.
8:30- I received booster COVID-19 vaccine; 8:45- after post vaccine wait- felt wobbly legged and faint as she stood to exit clinic; 9am- after 15 more minutes of waiting still felt light headed. BP taken was 110/46; 9:15- was able to go to restroom and felt better, was allowed to return to her work department. 9:15- upon arriving back to work dept. she sat down and coworker noticed she was pale and asked her if she felt ok, stated she was lightheaded and dizzy and felt faint. BP was taken 58/41; pulse 163. Supervisor took her to the ED. There she was worked up and at 9pm was admitted to ICU. Had Atrial flutter and on an adenosine drip, alter amiodarone and Cardizem drip. No cardio version occurred and by 8:30am 2/10 was in a normal sinus rhythm. Was discharged to home 2/10 after 5pm. Started on 2 new meds- Cardizem 120 ER daily and Eliquis twice daily.
Information has been received from a certified medical assistant concerning a 4 year old male with no allergies, who on 11-Aug-2006 was vaccinated IM into the right thigh with a third 0.5ml dose of hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) (lot# 653774/0010F). On the morning of 12 Aug 2006, the patient experienced a 14 by 16 cm red, warm, raised, painful, induration at site of the injeciton. It was noted that the patient was not in any respiratory distress. The patient was treated with over the counter antihistamines. No diagnostic laboratory studies were performed. At the time of this report, the patient was recovering. No product  quality complaint was involved. Additional information has been requested.
Pt states that the next day he had a dull ache and rash on his right shoulder, and over the last couple of days it has spread to the front of his chest; it is itchy and red.  Pt has tried hydrocortisone cream but it hasn't provided long term relief and rash seems to be getting worse.  Pt advised to seek out a doctor visit for possible steroid treatment.
pt stated flu like symptoms fever chills, then swelling in neck near lymph nodes, referred to MD, nurse stated normal for the swelling.  Not to worry (3:30 pm 12.10.19)
Felt like I had a lump in my throat 45 minutes after shot, then 2 hours later patch of Hives broke out on left thigh
This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, chills and feeling unwell. On an unknown date, the outcome of the influenza-like symptoms, fever, chills and feeling unwell were unknown. It was unknown if the reporter considered the influenza-like symptoms, fever, chills and feeling unwell to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient presented with flu like symptoms, fever, chills and did not feel well following a dose of SHINGRIX. The patient was out of commission for 1 to 2 days. The lot number and expiration date, date of administration and date of birth were not available at the time of reporting. The injection site and route of administration could not be confirmed.