chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Extremely sick; Vomiting; Diarrhea; Sweat; Chest hurting; Stomach burning; I need to get up which is really difficulty right now; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number, and expiration date were not reported), via an unspecified route of administration on an unspecified date, as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced extremely sick, vomiting, diarrhea, sweat, chest hurting, stomach burning, and I need to get up which is really difficulty right now on an unspecified date. Patient inquired whether he/she needs to go to the emergency room, because he/she have been extremely sick, all night vomiting, diarrhea, sweat, his/her chest hurting, his/her stomach burning. Patient needed to know on what needs to be done right now. Patient also stated he/she needs to get up and go to get a pen which is really difficulty right now, so he/she is going to get a hold of somebody right away. When confirmed if the patient got the side effects from Pfizer COVID Vaccine, patient stated that no, he/she just had the vaccine on Tuesday, Tuesday night. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
vaccines experienced multiple excursions, vaccine stored at temperature outside the recommended range was administered to patient; vaccine expired on 19-Nov-2018 was administerd to patient on 15-Mar-2019; Initial information received on 02-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA125041, 2019SA125047, 2019SA125008, 2019SA125033, 2019SA125087, 2019SA125072, 2019SA125066 and 2019SA125054 same reporter.  This case involves a 4 years old female patient who received vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and TUBERCULIN PPD (TUBERCULIN PPD) for Tuberculin test received on 15-Mar-2019.  On 15-Mar-2019, the patient received a 0.5 mL dose of suspect IPV (VERO) lot N1K931M, expiry date- 19-NOV-2018 via intramuscular route in the deltoid nos.  On 15-Mar-2019, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to incorrect product storage and expired vaccine used.  This was reported to the MIA- Fluzone Quadrivalent, Daptacel, ActHIB, Pentecel, IPOL, Adacel, Menactra. The vaccines experienced multiple excursions. 1st excursion excursion: 13Feb2019-14Feb2019 was out of range for 8 hours and 45 mins was at 1.56 degrees C. for the Fluzone Quad, Daptacel and ActHIB. 2nd excursion: 13Feb2019 9 hours 15 mins 1.56 degrees C. 3rd Excursion: 15Feb2019-22Feb2019 was out of range for 9 hours 30 mins at 1.56 degrees C. 4th excursion: 13Feb2019-22Feb2019 was out of range for 13 hours at a temperature of 1.18 degrees C for the Daptacel, Menactra and Adacel 5th excursion 13Feb2019-25Feb2019 were out of range for 24 hours and 15 mins at a temperature of 1.18 degrees C. Fluzone Quad and Pentacel 6th excursion 22Feb2019-26Feb2019 out of range for 23 hours 45 mins at 1.18 degrees C. Fluzone Quad, Pentacel and Daptacel 7th excursion: 13Feb2019-26feb2019 out of range for 33 hours and 4 mins at 1.18 degrees C for Adacel, Menactra, Ipol, ActHIB, Dapatacel, Pentacel and Fluzone Quad  It was unknown if any adverse event was occurred.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  Documents held by sender: none.
Pronounced edema, redness and itching at injection site on right arm. Ice applied. Refused antihistamine. Arm checked in 30 minutes; at 45 minutes had swelling of right eye. Chlo-Amine tablets (4) given. Arm slowly improved. Continued with ice. Instructed to take Benadryl at home and call MD if condition worsens. At 16:00, arm checked and was much improved.
Extremely intense and debilitating neck pain with nausea - lasted one evening, 4 days after injection
Fever of 105.7 rectally and irritability approximately 8 hours after vaccines given.
Frequent sensation of hot water or hot air pouring down right lower leg.  Not a burning or pain sensation, but "hot".  Symptoms last about 30 seconds, but the frequency is increasing rather than decreasing.  Current sensations are about 1-2 times per hour, intermittently
On April 15, I had aches and pains and was very tired. On April 16th, I developed a tennis ball-sized lump under the arm I received the shot in. It is still there to date but has shrunk to the size of a golf ball. On April 30th, I developed a sore throat. May 1st, I threw up several times. I stayed in bed feeling weak with a low-grade fever on and off. I also developed a deep productive cough followed by wheezing on my exhale. It is now May 4th. I am still coughing and have a lot of mucous production. Fever comes and goes. I had a telephone "visit" with my PCP on May 3rd  because both his office and urgent care would not allow me to come in person with possible COVID symptoms. My PCP prescribed an antibiotic, an inhaler and a cough medicine.
The day after the shot about 10:30 AM, started to feel very fatigued. Lasted throughout the day. on the second day after the shot around noon, started to have a pins and needles sensation in my ear and nose. Over the course of 2 hours, that sensation would stop and move to a different part of my body (fingers, arms, toes, back, hamstring, calves, etc). it would last for a while and show up elsewhere.  Went to ER after it persisted for 2 hours. Total event lasted about 4 hours. On third day, woke up with slight tingling in toes but after moving around for a few minutes, that sensation went away. At the time of this report, i feel no tingling and no fatigue. Note: i marked unknown to whether i have recovered from averse event as the ER doctor told me this could come back over the next few days and that we needed to let the vaccination process run through its course.
1/24/2021 - 6 days after receiving vaccine developed red, hot, swollen circular itchy area at injection site 4 cm radius. Also reports nausea - Had vaccine @ Hospital.
Very early menstrual cycle- came at 21 days, 3 days after 2nd vaccine. I have never ever had a cycle that short before.
Varicella vaccine given on 4/22/14. On 5/10/14 patient presented to office with "rash". Rash started around 5/8/14. First on face around mouth/nose, then spread almost everywhere. On exam - scattered papulovesicular rash - some in clusters - nose, mouth, torso, extremities, lesions in different stages of disease. Some scabbed.
Left arm muscle very sore. Application of heat and deep muscle massage provide temporary relief, but still painful to this day.
(L) upper post. arm with 17 cm x 13 cm area of redness warmth to touch, tender, 6 cm x 6 cm induration. Mild (L) axillary tenderness. DTR's intact in (L) arm. NL ROM. Chest = clear. Ht = RRR without M RG.
On 2/17/2023, my girlfriend told me she had a sore throat. I then decided to take a home antigen test, and I got a positive result. I couldn't believe it, so I tested myself five times over 2/17/2023 and 2/18/2023. I had varying results; three were positive and two were negative. I later noticed that the two negative tests were from the same company, had the same lot number, and were due to expire in a couple of days. During this time, I had no symptoms. On the afternoon of 2/19/2023, I began to develop a sore throat and a general malaise. On 2/20/2023, my symptoms worsened, and I had a temperature of 100.6. On 2/21/2023, I was prescribed PAXLOVID, which I began taking that day at noon. This was the worst day as far as symptoms go, because my throat was so sore that I couldn't swallow. It felt like there was a painful lump in my throat. My temperature that day was 102. Later that day, I coughed my pill up when I took my second dose of the PAXLOVID. It was like there was an obstruction in my esophagus, and I repeatedly had to try swallowing the pill. Also, when I drank water, it didn't seem to go down. It just sat, and I would cough it up. The following days were a little better. By the time 2/25/2023 rolled around, I finished my last dose of PAXLOVID. By 2/27/2023, I felt much better, so I decided to test myself. I tested myself on 2/27/2023 and, and I got a positive result. On 3/1/2023, I tested myself again and got a positive result. On 3/10/2023, I finally got a negative result for the first time. I tested again on 3/12/2023, I tested and got a positive result. I then tested again on 3/14/2023 and got a negative result. At the time of this writing, I have a minor residual cough. Other than that, I feel fine.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: PATIENT STATED HE'S AFRAID OF NEEDLES.
On 1st day, he proceeded on his own to give 0.5ml adult tetanus/ID/LFA. When the pt arrived, requesting a TB test, provider was completely unaware that this occurred until after the pt had left the clinic. Pt immediately called; has so far been seen on day 2, 4 and returning today. Forearm on 1/11/03 with 10cm X 7cm, redness, hyperemia, central induration. Pt advised to use cool packs, Benadryl, Keflex, ranitidine BID and consult with MD.
On September 27, 2021 I started to have rash that was red and swelling on my left arm. I called health clinic and I explained to them the symptoms and I went in the same day on September 27, 2021. When I arrived they checked my vitals. No fever and my blood pressure was fine. The doctor examined my left arm where the rash was located. The urgent care Dr. prescribed me some pills but I forgot the name of the pills. The urgent care doctor contacted my PCP about my symptoms and on October My PCP prescribed me ointment Diclofenac for the rash.
Fever low grade x 2 days then spiked t103 on 18SEP91; rash covering face & body 19SEP91;
Initial report received by a health care professional on 25 June 2010. A 14-year-old female patient, with no medical history and no illness at the time of vaccination, received on 22 June 2010 a left deltoid intramuscular injection of TYPHIM VI, lot number E0213-1 and developed "night tremors" after the vaccine during the night. The outcome was reported as unknown. Follow-up information received from a health care professional on 23 July 2010. The patient was not seen by a physician and did not require treatment and "according to her Mother, she is absolutely fine". The patient's mother suspected this was an anxiety reaction due to the patient never having been out of the country and what she had heard about her destination". No further information was provided and no additional information is requested. Documents held by sender: None.
Rash on legs and tops of feet that ended up in broken blood vessels (on tops of feet) .  Thought it might be related to sun exposure, but went to specialty doctor who recommended blood work done. When that came back as normal, doctor said it may be due to reaction from vaccine. Took antihistamine for several days and the rash and itching has gotten better.  The doctor thought it could possibly be a reaction to the second dose of vaccine and urged us to report it.
Shot given 9-10...experienced flu like symptoms on 9-11.  Beginn 9-12 in the morning injection site became warm, red, and swollen (about 3 inch in diameter).  Patient is putting ice on it.  Patient was referred to contact MD
PATIENT EXPERIENCED VASOVAGAL SYMPTOMS, PRINCIPALLY THAT OF VERTIGO, NAUSEA, & HEADACHE.
Suboptimal dose given < 0.5cc. Error due to incorrect dosing when drawing up. Unclear if pt got a full dose. In concern and in an abundance of caution, advise will need to revaccinate, explain at lengths that he is not fully vaccinated and VE may be less and she would be at risk. Discussed options at length along with risk and consequences. Pt questions answered, will decide after to get re-vaccinated. No concerning sx when discussed on phone. Only sx is having flu like sx.
Patient was given Johnson& Johnson vaccine around 2:30PM  and was advised to wait 15 minutes to observe any possible reaction. She left the pharmacy without any symptoms. An hour and a half later, she came back with rash on her face, none on the body, no fever, no headache, no sign of difficulty breathing. Pharmacist recommended her to take 2 capules of 25mg of Benadryl and wait at the pharmacy for 15 minutes. Pharmacist also recommended her to go to ER if she develops worsening symptoms within a few hours.
Information was received from a medical assistant via a company representative referring to two female patients of unknown age. The patients' medical history, concurrent condition and concomitant therapy were unknown. On unknown dates, the patients received an unspecified dose of series with GARDASIL 9 injection (lot#, expired date, dose, dose number and route unknown) as recommended vaccine for their age. On unknown dates, the patients were both passed out within a couple of minutes of receiving GARDASIL 9. It was unspecified that if the treatment was given for the patient or how long it took for either patient to regain consciousness. The patients sought medical attention via speaking with the physician. The causality assessment between the event and GARDASIL 9 was not reported. Upon internal review, passed out was determined to be medically significant event. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 12-APR-2018, the patient was vaccinated with an expired dose of VAQTA injection 25/0.5 (unspecified units) lot # N012324 (expired date: 05-APR-2018), intramuscularly (dose not reported) for prophylaxis. No adverse effect reported. No product quality complaint (PQC) was involved.
Pt. reports that a few hours after the vaccine, he felt that his throat and chest were tight and uncomfortable and then he developed fever, chills, myalgias after vaccination that resolved after about 48 hours.  Last documented fever was Tuesday (7/6) morning.  In general, he has been feeling tired with decreased appetite but maintained adequate hydration and has had normal urine output.  Over the past 24 hours, he has developed chest discomfort that has progressed to chest pain; it peaked this morning (7/8) when he woke up and he woke his parents up because the pain was so bad.  Due to chest pain, he presented to the ED for evaluation where he was found to have non-specific ST segment changes on his EKG, elevated troponin to 5.69. He was admitted to the hospital and treated with NSAIDs where he has been improving.
sore arm; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included motion sickness. Concomitant products included paracetamol (Tylenol).   In January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced pain in arm, chills and fever. On an unknown date, the outcome of the pain in arm, chills and fever were recovered/resolved.   It was unknown if the reporter considered the pain in arm, chills and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR130000   Additional Information: GSK Receipt Date: 6-SEP-2022 Reporter's Comments: The patient self-reported this case.  The reporter stated taking Tylenol and an unspecified OTC (over the counter) motion sickness medication. The patient received her 1st dose of Shingrix and experienced a sore arm, chills, and fever which resolved in a few days.  The reporter did not give consent to follow-up. Additional Supportive Information: For tolerance of 2nd dose refer case US2022AMR130000, reported by same reporter; Sender's Comments:  US-GSK-US2022AMR130000:Same patient
I got very cold and felt real weak.  Chills, no fever.  I drank lots of water (my wife thought I may be getting dehydrated).  All I wanted to do was sleep sitting up with blankets around me. In the morning I felt much better and ate good the entire day.
Constant Ringing in the ears, hissing, high pitched Humming, sounds like a ?Cicada? chirping in my ears all the time.
Vaccine on 01/26/06 MMR, developed a rash and fever within a few days, was given on 2/6/06 for the rash that had been there x 1 week, decreased appetite, itching diagnosis by doctor as an aerobic infection. On 1/26/06 well visit child was walking, climbing, pointing, follows commands. 4/14/06 Assessment: speech delay/strabismus.
Unrelenting headache, chills, nausea, body aches, fever of 101.3F. Onset 14 hours after vaccine. Fever 20 hours after. Relieved with Tylenol and Motrin, ice packs.
Dose administered after 30-day Use By Date or after manufacturer date of expiry-day; Dose administered after 30-day Use By Date or after manufacturer date of expiry-day; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry-day) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry-day) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    On 24-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry-day). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry-day). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry-day) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry-day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   5 doses were administered after 30 day use by date. On 21-Jan-2022, the vial was initially stored in the refrigerator. It was administered on 24 or 25-Feb-2022 and also on 28-Feb. The vial did not undergo any temperature excursions.  No concomitant medications were reported.  No treatment information was reported.  Patent reported- influenza quadrivalent vaccine given on the same vaccination day. 30-day thawed expiration on 2/20/22.   Most recent FOLLOW-UP information incorporated above includes: On 07-Mar-2022: Significant Follow Up received: Added patient information, vaccination date, concomitant vaccine  (Influenza vaccine), event onset date.
No adverse event; vaccines administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 08-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (vaccines administered past the expiration date).    No concomitant medication information was provided.   It was reported that the vaccines were stored in a standard freezer (15 degree Celsius to -25 degree Celsius). Their temperatures were Max -24C and Min -23C The following doses/Lot numbers were also impacted, Moderna COVID-19 Vaccine Lot: 037A22B Received: 19May2022 CDC expiration 31Oct2022, Date of administration 15Nov2022, Moderna COVID-19 Vaccine Lot 060H21A received: 27Dec2020 CDC expiration 28Mar2022, Administration 11Apr2022, Moderna COVID-19 Vaccine Lot: 083B22A received: 15Nov2022 CDC expiration: 28Feb2023, administration date:5Apr2023  HCP doesn´t had any patient identifiers.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728242 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728242:Same reporter (Lot number 083B22A)
Myalgia, Arthralgia & Fever Narrative:  Fever 100.2, myalgia, arthralgia; took tylenol  Other Relevant History:
Urticarial reaction at injection site 4 x 3 cm, + erythema + edema, TX BENADRYL, ice and CLARITAN.
At 2:03 p.m, we received information that patient "passed out" in the parking garage.  Patient brought back to Vaccine clinical area  - unresponsive, cold and clammy.  911 called   At 2:06  BP 12/33; HR 45, R 20 and O2 sats 100%, T 97.3.   BG 161 Patient then opened eye after sternal rub and responded to name.  HR and Pulse continue to decline. 911 arrived and take patien to hospital.
Moderna vaccine was given on 14 days after first dose was given. After speaking to patient, it is verified that we did indeed write down the correct date for the second dose, however; patient confusion led to him thinking he had to come in for his second dose when he received reminder email for second dose. First dose administered May 14, reminder on card for June 11. Second dose actually administered on May 28 as a walk up. Pharmacy should have done more thorough job of vetting and recognizing that vaccine is too early to administer. Patient was called and counseled on incident. Patient was notified that there is currently limited info on effectiveness of receiving 2nd dose too early and that he does not need to redo his doses. Patient states he is doing fine and does not have any severe adverse reactions.
pt recv 2 doses of vax on 7JUN95 & 11AUG95 but has neg titer
Fever, chills, body aches, headaches, lightheadedness, Pneumovax injection site on Left arm with redness, swelling, warm to touch, cellulitis like, mild to moderate pain