chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FEVER OF 102-107F; SHAKINESS; VOMITING; SENSATION OF COLD; CHILLS AND SHIVERING; HALLUCINATIONS; WEIRD TASTE IN MOUTH; This spontaneous report received from a patient concerned male. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, acid reflux, and heat burn. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021  around 1-1:20 pm to the left arm for prophylactic vaccination. Concomitant medications include blood thinners, medication for heart burn and acid reflux. Patient did not take his medicines on the day of his vaccination and few days after the vaccination. On 01-APR-2021 23:00, the patient experienced chills and shivering, fever of 102-107F, sensation of cold, vomiting and shakiness. Patient had not contacted his MD and had not taken any medications to manage those symptoms. At the time of calling (on the day of reporting), patient was feeling better but was having weird taste in mouth. On the same night of the vaccination (01-APR-2021), patient started experiencing hallucinations. The person who took this report on call recommended patient seeing his doctor regarding hallucinations. There were no hallucinations at the time of reporting. Laboratory data included: Body temperature (NR: not provided) 102-107 F.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hallucinations, shakiness, sensation of cold, chills and shivering, and fever of 102-107f on APR-2021, had not recovered from weird taste in mouth, and the outcome of vomiting was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210406953-COVID-19 VACCINE AD26.COV2.S-hallucination. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 2021040695300-COVID-19 VACCINE AD26.COV2.S-fever. This event is labeled per RSI and is therefore considered potentially related.
the patient bad not reported any adverse effects from Intramuscular administration; MMR ll vaccine intramuscularly instead of subcutaneously; This spontaneous report was received from a pharmacist referring to a 64 years old female patient. The patient's concomitant medication, pertinent medical history and drug allergies and reactions were not provided.      On 04-DEC-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength and dose were not provided; lot # was S032826 and expiration date was 16-OCT-2021) intramuscularly for prophylaxis (incorrect route of product administration). At the time of this report, the patient bad not reported any adverse effects from intramuscular administration but the patient also had not been notified she received the vaccine intramuscularly instead of subcutaneously.
2 days after vaccination, she notes tender axillary lymphadenopathy in left arm.
Patient arrived in the ER today, 10/13, post-Janssen vaccination. This individual arrived feeling very flushed after being vaccinated. They presented with tachycardia and hypertension post-vaccination and ER doctor diagnosed an allergic reaction due to the Janssen COVID-19 vaccination.   Treatment:  Famotidine 40mg/20mL X1 IV Methylprednisone 125mg/2mL x1 IV Vital Signs Monitoring Q30min  Individual will be discharged from our care.
Started with cough, the next morning was coughing up gobs of phlegm, since then cough and phlegm have gotten progressively worse, also having some trouble regulating body temperature in the early morning hours, slight headache, minor ear and throat pain.
Information has been received from a registered pharmacist concerning a 42 year old female with no known allergies who on 10/29/02 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot # 643782/0675M). Concomitant therapy that day included a dose of influenza vaccine. On 10/30/02 the patient developed a 6 inch induration, tingling in the arm and difficulty using the arm. The patient sought unspecified medical attention. Additional information has been requested.
Within 10 min of receiving vaccines, child became unresponsive to mom, eyes rolled back, muscle tone decreased, BP 82/48, P 100, R 26 x easy, non reactive to stimuli. Epinephrine 1:1000 .1cc given SUBQ. Child became more responsive, recovered 35-45 min.
08/26/22 presents to EC ED for "SVD (spontaneous vaginal delivery)". PMHx of "fibromyalgia and fatigue"
1st dose at the end of OCT 2021 has not received his 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received at the end of October 2021, exact date was not known).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: This case was reported by the patient. The patient had not received his second dose of Shingrix to the date. The patient was provided medical advice disclaimer and referred to healthcare professional. The patient was provided Centers for disease control guidance per content on alternative dosing schedules. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This spontaneous report as received from a pharmacist refers to a 69 years old male patient. No medical history or concurrent conditions were reported. On 28-DEC-2012, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously in the left deltoid. Lot number was reported as H013014 with an expiration date of 03-OCT-2013. No other co-suspects were reported. Concomitant medications included unspecified cholesterol and blood pressure medication. After the patient was administered with the vaccine, he reported that he felt dizzy. The patient's episode of dizziness resolved "within about 2 minutes, and the he felt fine". The injection site did not demonstrate any redness or swelling. The pharmacist states that he will follow-up with the patient later "today" to verify that he has recovered, but at the present time, the pharmacist stated that he believes the patient is fully recovered. The reporter relatedness for felt dizzy is unknown for ZOSTAVAX. No additional information is currently available. Additional information has been requested.
had a shot yesterday for the vaccine and I'm having chest pains; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (had a shot yesterday for the vaccine and I'm having chest pains) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE.    On 05-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced CHEST PAIN (had a shot yesterday for the vaccine and I'm having chest pains). At the time of the report, CHEST PAIN (had a shot yesterday for the vaccine and I'm having chest pains) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication not reported.   Dosage text for suspect product was given as Unknown,  Treatment medication not reported.
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; Patient received expired vaccine that was administered on 15-March-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    Concomitant medication use information was not provided by reporter.  Individual vials or intact cartons was unknown. Vial size was reported as 10 dose vial. Date the vial was initially stored in the refrigerator was reported as 14 March 2023. The vial did not undergo any temperature excursions.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
fever; This case was reported by a consumer via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever of 102 degree F for 3 days. The reporter did not consented to follow up. This case has been linked with US2019197505, for unspecified number of patients.
I haven?t gone to a doctor. Before any news came out about heart inflammation, I felt my heart beating really fast after this vaccine. Now it?s been 2 months and I still feel like my heart is ?inflamed?. I?m a big believer in science, and I stand by the vaccine, but literally my heart has been hurting a lot more (IT LITERALLY NEVER HURT) before the vaccine. I really hope I didn?t just mess up my body somehow with this. Legitimately the pain is not bad at all (maybe a 2 out of ten) but it has not gone down since I got the vaccine. I notice when I do physical activity I also get tired faster. I run, I?m a relatively healthy person but I?m experiencing some mild heart inflammation after this shot. Please take note. I still stand beside the vaccine, I?m just explaining what symptoms I?m feeling. And of course idk if it?s from the vaccine, but I?ve never had this feeling in my heart before having this vaccine. I hope it goes away.
Arm swollen (shoulder to mid forearm); Swelling was red; Swelling was hot to touch; This case was reported by a nurse via sales rep and described the occurrence of extensive swelling of vaccinated limb in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2022, the patient received the 1st dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. In September 2022, less than 2 weeks after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site warmth were recovered/resolved.   The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site warmth to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The reporter was a licensed practical nurse. The reporter said that a patient received Bexsero in left arm deltoid muscle approximately 2 weeks ago from reporting date.  The patients arm from shoulder to mid forearm swelled.  The swelling was red and hot to touch.  The practice saw patient and treated successfully. The swelling, redness, and hot to touch symptoms all had subsided.  The practice believed this AE (Adverse events) was related to product. The reporter stated that this event was already reported to VAERS. The reporter did not agree to follow up from GSK.
Post menopausal for 2 1/2 years.  Began having a period/spotting right after the first dose of the vaccine.  Having a regular period each month. Date of last period 5/27/21 - 5/30/21.
MOTHER STATES RIGHT ARM EXTREMELY SWOLLEN AND RED FROM SHOULDER TO ELBOW WITH WHITE SPOTS.  CHILD HAD TEMP OF 103 AND WAS VERY SLEEPY. WAS TAKEN TO ER AND DIAGNOSED WITH AN ALLERGIC REACTION.
Onset of Pigmented Purpura reported in patient's left leg from ankle to mid thigh.  Unresolved at this time.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date of 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Oka/Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from a physician concerning a patient (age range reported as 2-5, units not reported) of unknown gender. On 15-OCT-2014, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Was in reception area immediately after injection of Gardasil and fell to floor and had full body twitching for 5 to 10 seconds.  Was not observed falling.  Mother had back to her while paying receptionist.  No complete loss of consciousness noted.  Has redness on right side of face and c/o of pain in right temple area.  PERL. Pale. Skin warm and dry.  Not involuntary of bodily functions.  Full ROM and good grasp and answers commands appropriately.  No prior Hx of medical conditions except anemia when younger.  BP130/90. Pulse 88reg. Happened at 9:50am and ambulance arrived to take her to ER at 9:57am.  Phone call from mother stating she was discharged to go home at  11:20am.
Vaccine was administered in the right upper Gluteus Muscle.  The recommended site for Covid -19 vaccination is intramuscular in the deltoid muscle of the arm or alternatively the anterolateral thigh.
little bit of soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   An 83-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient received his first dose of the vaccine on Friday and that he was "doing well" with a "little bit of soreness" and knows "that was normal". He also said his wife received both vaccines and is doing well. He commented that they are both trying their best to protect themselves and that he was thankful for the opportunity to have the vaccine. Caller asked what the dosage of the vaccine was, if the dose was the same for someone who was 12 years old as for himself, and what the dose for the second shot was the same as the first. The clinical outcome of the events was reported as unknown.  Information about Lot/batch number has been requested.
First symptom was  tightening of throat on 2/18/2021 not closing nor sore just tightening.  That lasted 48 hours.  Joint pain started after throat dissipated on Friday 2/19/21.  Joint pain was progressive from shoulders for several days, then  knees for a day, then tops of one foot for one night, then it moved to my hands.  I had swelling where I could not close my hands. I had severe and exstremely painful joint pain in  both hands that kept me up at night and unable to pick up things or close my hands.  I used ice packs for some relief. It would sometimes calm down somewhat for hours and I would think it was over and then it would come back . The hand symptoms lasted from 2/23/21  through 3/5/21 when pain began to slowly calm down.  I had one hand that would not close into a fist for one day 3/6/21 when pain was much less. By Sunday 3/7/21 most symtoms were much less with symptoms dissipating all together.  I have had no recurrence since the weekend of 3/6/21 of any symptoms.
Information has been received from a physician concerning a female patient between the age of 8-12 years old who on unspecified dates was vaccinated with two doses of VARIVAX (Merck) (lot#s not reported). On an unspecified date in 2004 the patient came down with full blown chickenpox. Unspecified medical attention was sought. At the time of this report, the patient had recovered. This is one of several reports from the same source. Additional information has been requested.
Initial report received from a pharmacist on 15 Jan 2010: This patient, with an unknown medical history, was vaccinated with one dose of FLUVIRIN (batch no. 104045P1), 0.5 ml, intramuscularly, on an unspecified date. The FLUVIRIN vaccine had been stored at temperatures as low as 34 degrees Fahrenheit and 35 degrees Fahrenheit. No adverse event was reported. No further information was provided.
Janssen COVID-19 Vaccine EUA 10Pm Night of Vaccine:  Extreme chills - shivering and teeth chattering , fever of 101.7 degrees, weakness, lower back and body muscle aches, headache, dizziness and spinning sensation   Morning After Vaccine: Fatigue, nausea, loss of appetite, headache, fever of 100.3 degrees
Rash to right thigh - indurated. Noted on 5-12-14. Seen by doctor 5/13. Supportive care, TYLENOL/MOTRIN PRN.
Contracting COVID; Contracting COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4399548-00.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Batch/Lot number: unknown), on 04Jan2021 as dose 2, single (Batch/Lot number: unknown) and on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years, all intramuscular for COVID-19 immunization; adalimumab (HUMIRA), first regimen (Lot number: 1160362) and second regimen since Apr2022 (Lot number: 1160362), all subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Contracting COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter considered "Contracting COVID" related to BNT162b2 while the reporter's causality for the event(s) Contracting COVID was not provided for Humira (Adalimumab).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
This case was reported by a consumer via call center representative and described the occurrence of nausea in a adult male patient who received SHINGRIX for prophylaxis. On 25th September 2018, the patient received the 1st dose of SHINGRIX. On 26th September 2018, 1 days after receiving SHINGRIX, the patient experienced nausea, vomiting, general body pain and fever. On 28th September 2018, the outcome of the nausea, vomiting, general body pain and fever were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting, general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. The patient received SHINGRIX in an unknown deltoid. The reporter gave consent to follow up. This case has been linked to the case US2019007963, reported by the same reporter.
I received the first Pfizer injection Tuesday, April 13th.  I had signed up for the 12:15 slot, but when I arrived it was like a cattle call.  I arrived in time for what I thought was a 12:15 appointment but ended up standing in line for an hour before actually getting the shot.  I was fine the rest of that day aside from developing soreness in the muscles of my right arm.  The following morning, Wednesday, April 14th,  I was awakened to very noticeable soreness in both arms and the back of my neck. As the morning progressed, I developed flu-like symptoms, complete body aches, chills, fever, slight nausea, blurred vision, mild diarrhea.