chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had an anxiety attack and this is why she missed her dose; I missed my 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (She had an anxiety attack and this is why she missed her dose) and PRODUCT DOSE OMISSION ISSUE (I missed my 2nd dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (She had an anxiety attack and this is why she missed her dose) and PRODUCT DOSE OMISSION ISSUE (I missed my 2nd dose). At the time of the report, ANXIETY (She had an anxiety attack and this is why she missed her dose) and PRODUCT DOSE OMISSION ISSUE (I missed my 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow-up received on 1-July-2021.TCR added, contain No New Information
This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult patient who received SHINGRIX for prophylaxis. On 30th July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, between 1 and 2 months after receiving SHINGRIX, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site itching to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. A week before the reporting date, the patient started getting an itching sensation at the location of the shot. The patient asked if this was normal and if the patient should take any action. The patient was waiting for response.
Patient said he started having symptoms beginning of October, including sneezing, congestion, fever, and loss of smell.  Tested positive for Covid 19 on 10/03/2021.  Patient was getting antibody infusion at outside facility when he was noted to be hypoxic and brought to ED.  In ED revealed Covid PNA and placed on 4 LNC.  Developed acute hypoxic respiratory failure secondary to Covid PNA, intubated on 10/17/21.  Started on Lovenox, delivered decadron and remdesivir, and baricitinib.  Patient continued to decline despite full treatment.  Patient was too unstable to be transferred for CRRT.  He was made DNR and patient expired on 10/24/2021
He had tinnitus after the 1st shot which got a little worse after the 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (He had tinnitus after the 1st shot which got a little worse after the 2nd shot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (He had tinnitus after the 1st shot which got a little worse after the 2nd shot). At the time of the report, TINNITUS (He had tinnitus after the 1st shot which got a little worse after the 2nd shot) outcome was unknown.            no concomitant medications were reported treatment information was not provided. Patient has tinnitus every day to varying degrees.  It's more prominent when he's idle and it's quiet and less noticeable when he's busy or in conversation.   This case was linked to MOD-2021-287633 (Patient Link).
Patient reported a raised bump on left arm a half inch- 1 inch from injection site. Patient reported this happened 4 days after the vaccination and the bump was about 2-3 inches wide. Patient states they went to the ER and received KEFLEX and ibuprofen but states it does not hurt. Patient states it was itching mildly.
when pt came into office for DTP; mom states that p/3rd DTP pt had fever of 104 for 24 hrs; pt was very irritable & restless; APAP given; had local reaction;
One large raised bump on left arm - about 2inches diameter.  One smaller raised bump about 1" diameter.  Red, painful like a bruise - not itchy.  Not sure if either bump is directly on the injection spot, but in the general area of injection.  Noticed it on April 6th. The one larger bump has increased in radius. It has been 3 days so far.  Pain is not as bad as day one.  No treatment except advil for pain.
Extreme headache and chills, temp of 101.5 at 12 hrs post.  Nausea Then Low grade fever for the next 48 hours. Arm pain at injection site as anticipated.  Fatigued and generally achy for five days after. Arm swelling, redness and itching presented at 60 hours post and 72 hours. Back to feeling normal after one week.
ITCHINESS; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068 expiry: UNKNOWN) .5 ml, administered on 07-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-MAR-2021, the subject experienced itchiness. On 07-MAR-2021, the subject experienced headache. On 07-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 09-MAR-2021, and nausea on 07-MAR-2021, and had not recovered from itchiness. This report was non-serious.
03/03/2021 (0720-0735) Immediately following vaccination I experienced 2/10 sharp, constant substernal chest pain lasting for approximately 15 minutes.  03/04/2021 (0200-0400) Awoke with subjective feeling of fever, full-body muscle cramping, and uncontrollable, mild, full-body convulsions without loss of consciousness (not true seizure-like activity). These were not the typical "shivering" symptoms typically experienced by patients with high fever.  All other symptoms experienced following severe symptoms more closely resembling flu-like symptoms that are to be expected following second vaccine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 5 (booster), single (Lot number: GJ3275) at the age of 29 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pituitary surgeries" (not ongoing); "hypopituitarism" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Cefepime, reaction(s): "ALLERGY TO CEFEPIME". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2023) Negative, notes: Rebound / return of symptoms after testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment as Paxlovid with start date 05Jul2023 and stop date 10Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300250720 same reporter/patient, different drug/event;
Positive COVID-19 test/had my booster on Sunday and today I tested positive for Covid; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID-19 test/had my booster on Sunday and today I tested positive for Covid) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: two doses were Pfizer (2 doses). Past adverse reactions to the above products included No adverse event with two doses were Pfizer.    On 05-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19 test/had my booster on Sunday and today I tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID-19 test/had my booster on Sunday and today I tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.  This is a spontaneous case concerning a 51-year-old, female patient, who received the first two doses of  another brand of COVID-19 vaccine (Pfizer). The patient received booster dose of mRNA-1723 vaccine and two days later was positively tested for COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Follow up received contains - Reporter occupation and reporter type updated, updated event verbatim.; Sender's Comments: This is a spontaneous case concerning a 51-year-old, female patient, who received the first two doses of  another brand of COVID-19 vaccine (Pfizer). The patient received booster dose of mRNA-1723 vaccine and two days later was positively tested for COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Rash, swelling, itching (site) (expected), left eye had blurred vision and some pain for about 24 hrs (not expected).
Patient has been vaccinated with a booster dose Pfizer vaccine , with the lot # FG3527 expiration date 02/2022 from a vial that was stored in the fridge and should have been used until 12/12/2021 and patient received vaccine on 12/13/2021 , which resulted in an expired vaccine for one day. Patient di not have any side effects.
Above I put 2 unknown only cause he had Hep A and Influenza but I'm not sure what types. 21 days after his shots he developed swollen lymph nodes (paranoid) and 5 weeks after had to have surgery because they became swollen so badly and developed a staph infection.
This spontaneous report was received from the consumer's husband referring to an 84 year old female patient. The patient presented allergies to sulfa drugs, but his pertinent medical history was unspecified. On 16-APR-2009, the patient was vaccinated with ZOSTAVAX vial, 0.65 ml, single dose subcutaneous (lot number was not reported). Concomitant medication reported as many by unspecified. On 19-OCT_2015, the patient experienced shingles and the husband added that she had shingle rash on her scalp, forehead and in her left eye. The wife stated also that shingles were very painful and very itchy. Patient sought medical attention via doctor office visit and received treatment with VALTREX for 7 days and an unspecified eye drops. No lab diagnostics studies were performed and no hospitalization was required. The outcome of herpes zoster and ophthalmic herpes zoster was reported as not recovered. Additional information has been requested.
1307- I heard a car horn, located the patient in the driver's seat, put the car in park. Pt was completely passed out. He regained conciousness after approximately one minute after contact. Pulse weak at 68, I laid the seat back. Paramedics took over care. Unknown disposition by nurse, to her knowledge ambulance was not called. - RN
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 54-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). Concomitant products included amlodipine, atorvastatin, ibuprofen, metformin and sertraline. On 6th April 2018, the patient received SHINGRIX (intramuscular). On 6th April 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On 7th April 2018, the patient experienced injection site induration, injection site erythema and injection site swelling. On 11th April 2018, the patient experienced injection site itching. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were recovering/resolving and the outcome of the injection site itching was not recovered/not resolved and the outcome of the injection site induration was unchanged. The reporter considered the injection site pain, injection site itching, injection site induration, injection site erythema and injection site swelling to be almost certainly related to SHINGRIX. Additional information was received as follows: On the next day after vaccination, the patient experienced swelling and redness at the injection site, which had spread from the arm to the armpit. The patient also experienced some hardness at the injection site.
The resident developed Bullous Pemphigoid that has spread on her skin. Blisters and rash has not been healed by any treatments since onset in June of 2021.
I tested positive; I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 28Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 30Sep2022, outcome "recovered" (01Oct2022) and all described as "I tested positive". The patient was hospitalized for drug ineffective, covid-19 (start date: 30Sep2022, discharge date: 01Oct2022, hospitalization duration: 1 day(s)). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Sep2022) Positive, notes: I received my fourth Covid vaccine on 28Sep. Due to a hospital visit two days later, I tested positive; (01Oct2022) Negative, notes: the next day before I was released, I tested negative.  Clinical course: Patient received fourth Covid vaccine on 28Sep. Due to a hospital visit two days later, patient tested positive. However, the next day before release, patient tested negative. Inquired if positive due to the recent vaccine shot.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
WITHIN TWO HOURS OF VACCINATIONS PATIENT BECAME RED BEGINNING ON THE EARS SPREADING TO ALL EXTREMITIES AND ONE SPOT ON HER BACK. PATIENT BECAME FUSSY & CRYING. RETURN TO PHYSICIAN'S OFFICE @ 1:15P.M. WHERE PATIENT WAS GIVEN BENADRYL & TOLD MOTHER TO FOLLOW UP ON MONDAY. INSTRUCTED TO GO TO NEAREST ER WITH CHANGES IN BREATHING &/OR JOINT SWELLING.
I began having a mild headache, body aches, and fatigue on the evening of my shot. That night my headache became extremely painful and the headache and fatigue continued to last through the following day. Then by the next day (48 hrs post vaccine) I felt fine again. In the afternoon, I started to develop a plugged duct in my right breast (I am nursing). And by that night I had developed a low grade fever and severe body aches. These have lasted into this morning (now  almost 72 hours post vaccine).
A spontaneous report has been received from a Health Professional via Medical Representative concerning a 10 year old, male patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received nasal FLUMIST QUADRIVALENT (intranasal) on 09-Oct-2013. Nurse reported concerning her son testing positive for influenza A. The patient was administered FLUMIST QUADRIVALENT on 09-Oct-2013. On 21-Dec-2013, the patient was diagnosed with a sinus infection and was given Amoxil for ten days. On 30-Dec-2013, he developed a fever which lasted for 3 days, runny nose, cough and body aches. He recovered from the flu. The outcome of the event of sinus infection was unknown. The reporter considered the event to be non-serious. Corrected report 06-May-2014: The case has been updated with full data due to KUR term additions for FLUMIST/Q/Laiv.
Really short pain on her left leg and thigh.; Really short pain on her left leg and thigh.; She has fever all day yesterday.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Lot number: FF8841) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), administration date: 14Sep2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Really short pain on her left leg and thigh."; PYREXIA (non-serious) with onset 06Oct2021, outcome "unknown", described as "She has fever all day yesterday.". Therapeutic measures were taken as a result of pyrexia.  Additional information: Reporter calling because my daughter she is 16 (Further clarifications unknown hence not captured in tab) and she just have the Pfizer vaccine on Tuesday at 6PM and since right after the vaccine he is having a really short pain on her left leg and thigh and she has fever all day yesterday and kind of runaway this morning and I am just concerned that if it should be something then I need to take it to hospital. "When paraphrased the concern and Vaccine name as Pfizer COVID-19 Vaccine : Reporter stated, "Correct or is it a normal side effect?". Reporter was informed about Pfizer Medical Information department and Reporter was also informed about the role Pfizer drug safety department. LOT#: Reporter stated, "I need to go down stairs and get it, I don't have it with me right now, Well I need to go down stairs would you want to you wait you can transfer me. "Treatment: Reporter stated, "I am getting the card, For the fever, Tylenol for fever."Height and weight: Reporter stated, "4'11 no I am sorry 5'1 and it's 112 I think." (Not clarified hence not captured in tab) Reporter stated, "So I have the card now. So on the first dosage it is FC3183 and on the second dose FF8841, that's the number?" (Not clarified hence not captured in tab) When paraphrased the date of second shot as 05Oct2021: Reporter stated, "Yes."Date of first dose of vaccine: Reporter stated, "14Sep2021"(Clarified as 14Sep2021). Site of administration: Reporter stated, "(pharmacy name). In the left. "When paraphrased the Facility name as (Pharmacy): Reporter stated, "Yes". Mailing address: Reporter stated, "(Address Withheld) (Not clarified hence not captured in tab). Reporter was informed about the Pfizer Medical Information Department, and provided with the number as ## and requested to dial the option 3 and informed about timings as 8AM to 8PM as per EST. Further probing was not done hence limited information was available over the call. QR comment: Reporter Type not probed over the call hence by default Reporter type captured as Consumer or other non health professional.  No follow-up attempts are possible. No further information is expected.
6 days after receiving the shot I had significant pain in my left side around around mid-rib and at the top of my left shoulder.  the significant pain last for at least 72 hours.  I took  Tylenol, which helped, but never completely relieved the pain. The pain moved at times to other areas, including my neck and back and right side of my chest.  I also had shortness of breath, which continues to this day. 9 days after the shot I noticed  redness at the site of the shot.
Pt stated to be a bit nervous about receiving his initial vaccine for covid. He said he sat down  at 2:51. He said he did not recall passing out just waking up. Vital signs were taken to know pt baseline. All vital signes were wthin norma limits. He stated to feel a little sweaty and hands be a bit cool. He became more talkative with staff and more contrfitriblwe.  Pt left after feeling better and safe to drive home. He was encouraged to bring someone else with him next time.
The patient was vaccinated on an unspecified date. On approximately 08/12/2000, the patient developed a full-blown case of chickenpox. The patient sought unspecified medical attention. Additional information has been requested.
pt recvd vax & exp redness, pain & swelling which extended from the inject site to neck, & fever; pt spoke to MD who asked to come to the office but declined to do so since sx subsided the next day;
got up twice during the middle of the night and fell twice; flu like symptoms; body aches; joint pain; headache; stinging; swelling; redness at injection site; tiredness; This is a spontaneous report from a contactable nurse (patient). A 52-year-old female patient who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration in right arm on 08Feb2021 at 19:30 at a single dose for covid-19 immunization at Hospital. The patient's medical history and concomitant medications were not reported. NDC number of COVID-19 vaccine was unknown. On 08Feb2021, the patient experienced stinging, swelling, tiredness and redness at injection site. The tiredness started last night at 9pm. She had been sleeping on and off ever since. She took Benadryl at 08 p.m. last night and it went away. On 09Feb2021, she had body aches, headache and joint pain. She has had flu like symptoms since. She has had body aches and tiredness. She hasn't had a high fever. She was in bed. She got up twice during the middle of the night and fell twice because of the joint aches. She lost her balance. Her joints just gave out. She was steady on her feet. She was just slow. She was not taking Benadryl now. She just had ice on the back of her neck, and it was working. The headache was manageable without medication and ice. Therapeutic measures were taken as a result of stinging, swelling, and redness at injection site. The reporter classified the events as non-serious and assessed the causality between the event and the vaccines as related. The outcome of events stinging, swelling, tiredness and redness at injection site was recovered on 08Feb2021, outcome of body aches was recovering and outcome of other events was not recovered.
Anxiety with panic attack, no vertigo,  Face flushed, HR rapid,   brought to first aid room and after lying down for a few minutes felt better.  HR 88, Resp 16   B/P  128/90
Covid monitoring documentation. PT admitted 12/6/21 documented to have positive covid. PT received Janssen 7/28/21 Lot 205A21A for dose 1.