chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Stomach cramp; Nausea; Soreness and pain at the injection site; This spontaneous case was reported by a health care professional and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach cramp), NAUSEA (Nausea) and VACCINATION SITE PAIN (Soreness and pain at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramp), NAUSEA (Nausea) and VACCINATION SITE PAIN (Soreness and pain at the injection site). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (Stomach cramp) and NAUSEA (Nausea) had resolved and VACCINATION SITE PAIN (Soreness and pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.
Fever, runny nose, coughing Dx 6/1/09 with pneumonia Rx  AMOXICILLIN.
Case number PHEH2014US024361, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to an 84 years old male patient. His medical history and concomitant medications were not reported. He had tolerated vaccines (no further details provided) well in the past. He was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 07 Nov 2014. It was reported that the patient received FLUVIRIN PFS that was stored at 49 degree F for 1 hour 15 minutes. No adverse event was reported following this maladministration. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
Diarrhea, Nausea Vomiting, Angina, MYALGIAS Employee stated she experienced the following with COVID 19 Moderna, dose 2 nausea, vomitting, chest pains, myalgias, back pain, shoulder pain-was evaluated in private ED and admitted for evaluation for chest pain, also had GI eval
pt recvd MMR vax when 5-5 1/2 mon pregnant & exp diarrhea, vomiting, dizziness, shaking, pain in legs, & lack of appetite, h/a;when baby was born exp szs, vomiting, diarrhea, cold like sxs, high fever, blood in stool
Shingrix put my bf in a wheel chair for months; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of wheelchair user in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wheelchair user (Verbatim: Shingrix put my bf in a wheel chair for months). The outcome of the wheelchair user was not reported.   It was unknown if the reporter considered the wheelchair user to be related to Shingrix.     It was unknown if the company considered the wheelchair user to be related to Shingrix.   Additional Information: GSK receipt date: 31-March-2023 This case was reported by a patient via interactive digital media. The reporter's best friend received the Shingrix and put in a wheel chair for months. The patient had right after first and only dose of this poison. The follow up would not possible, as no contact, details were available.
Subsequent to receiving varicella virus vaccine live the pt developed chickenpox that consisted of high fever, trouble sleeping, and approximately 300 lesions. The pt was treated with acyclovir and Tylenol with codeine.
Fever 101. Lasting for 4 days. Loss of appetite. Swelling and bruising at injection site; hard finger shaped lump formed diagonally from injection site to front of arm. Approx. 2 inches in length.
PATIENT RECEIVED SECOND DOSE OF JANSSEN VACCINE AFTER 21 DAYS OF PFIZER VACCINE FIRST DOSE (ADMINISTRATION ERROR); OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 62 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on 15-SEP-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 15-SEP-2021, the patient experienced patient received second dose of janssen vaccine after 21 days of pfizer vaccine first dose (administration error). On 15-SEP-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received second dose of janssen vaccine after 21 days of pfizer vaccine first dose (administration error) and off label use was not reported. This report was non-serious.
Within a day or two / pain; restricted the range of motion in left arm; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th November 2020, the patient received the 1st dose of Shingrix. In November 2020, less than a week after receiving Shingrix, the patient experienced pain in arm and joint range of motion decreased. On an unknown date, the outcome of the pain in arm and joint range of motion decreased were recovered/resolved.   It was unknown if the reporter considered the pain in arm and joint range of motion decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but captured adult as per vaccine indication. The patient received the first Shingrix vaccination and within a day or two the pain restricted the range of motion in left arm by about 90 percent. This lasted for approximately 4 months. The patient asked if this could have been an allergic reaction.
Within 24 hours of vaccination, patient started to develop pain and limited range of motion. She also had a bruise that lasted for 2 weeks. Her initial symptoms have improved, but she still says that she is experiencing a deep throbbing pain. She has been using massage, ibuprofen, and hot tub to relieve symptoms.
Information has been received from a healthcare worker concerning an unspecified number of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (dose, unit and route not reported, lot # L042846 with expiration date 15-SEP-2017 and lot # L029631 with expiration date 14-AUG-2017). The vaccines were exposed to 34 F for 30 minutes, previous temperature excursion included 55 F for 16 hours and 34 F for 2 hours. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Shingrix reconstituted with sterile water; Shingrix reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The reporter was Pharmacist. Age at vaccination was not reported. The reporter did not have available information related to the patient neither lot number and expiration date. Pharmacist called to report that a patient received a dose of Shingrix that was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was same as primary reporter. The reporter did not consent to follow up.
ADACEL that were administered in August were administered in error again yesterday with no reported adverse event; Initial information received on 13-Dec-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-health care professional.  This case is linked to case 2022SA507244(CLUSTER).  This case involves a 13 years old male patient who experienced adacel that were administered in august were administered in error again yesterday with no reported adverse event after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE,HEPATITIS B VACCINE (and VARICELLA ZOSTER VACCINE for Prophylactic vaccination.  On 16-Aug-2022 he also received a (series-1)dose of the suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE(Dose-0.5mL)(Frequency-Total)( Strength = STANDARD) (Batch/lot number-U7283AA) via intramuscular route in the right deltoid for Immunization.  On 12-Dec-2022, the patient received a (series-2)dose of Same suspect(Dose-0.5mL)(Frequency-Total)(Strength = STANDARD) via intramuscular route in right deltoid for Immunization  (Batch Number/Lot Number, Expiry date: Unknown)  On 12-DEC-2022 the patient developed a non-serious event Adacel that were administered in august were administered in error again yesterday with no reported adverse event (inappropriate schedule of product administration)(Latency- 3 months 27 days) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action Taken : Not applicable.  At time of reporting, the outcome was Unknown for the event     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 the 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.
Accidentally administered 0.1 of moderna vaccine intradermally instead of tubersol for TB skin test. Patient reported that arm was itching where bleb was formed. Patient with known history of anxiety began to feel strange. heart rate went up to 130, but quickly returned to 80s after deep breathing and parent came to bedside for comfort. Patient's BP was in  130s/80s. No airway compromise or difficulty breathing, sats 99-100%. Patient was observed for 1 hour, given 25 mg of benadryl, and left with father. Given ED precautions.
vaccine 12:30 PM 8:30PM felt very cold. Soaked in hot bath for awhile, went to bed. Sometime later very had high fever that lasted for hours and was accompanied by high heart rate and aches. After I had cooled a bit I took my temperature--103. Heart rate over 100, maybe up to 120 my resting pulse is typically in the l 50s )Suspect fever at peak was over 104. Fever and elevated heart rate lasted for hours. . At 2:30 AM took 3 ibuprofen, returned to bed and drifted off. An hour or two later woke up completely drenched and dripping with sweat but no longer feverish. Drifted back to sleep. By 9 AM felt almost normal, but (not surprisingly) a bit wrung out.
I have good and bad side effects, first of all I have trouble, pain in my knees and today I relieved from much pain in knees,; Pain in the arm; Headache; Diarrhea; started with a feel and now it was more, it was a pain, it was like a crack in her abdominal; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 08:15 at single dose for COVID-19 immunization. The relevant medical history included thyroid disease and arthritis (have problem with her knees and they said it arthritis). Concomitant medications included vitamin c, vitamin d3 and vitamin e, all from an unspecified date for thyroid disease. The patient stated that first moment it was okay, not feeling much just the pain in the arm on 17Dec2020 and in the next day she had good and bad side effects, first of all she had trouble, pain in her knees on 18Dec2020 and at the time of the report she relieved much from pain in knees, they came back but that was okay. She had a little headache, not much on 17Dec2020. But at the time of the report like an hour prior to the report she started with diarrhea in Dec2020. Diarrhea was getting worse, it started with a feel and now it was more, it was a pain, it was like a crack in her abdominal, she had gone to the bathroom few minutes prior to the report and almost she felt like she had to go again. The patient did not ask the dose and stated that they were supposed to give her a one dose, it was her first dose, her second dose coming on 07Jan. The outcome of the event pain in the arm was unknown, for event arthralgia was recovering, while the other events were not recovered.  Information about Lot/Batch number has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored dose of VAQTA which had the lot # M017982, expiry date: 13-SEP-2017 (route, dose and anatomical place of vaccination were not provided). No adverse effects were reported. The vaccine was exposed to temperature of 34.2 Fahrenheit 24 hours and 34.5 Fahrenheit 12 hours. No previous temperature excursion was reported. The temperature excursions were detected by a data logger. No product quality complaint (PQC) involved and no further information provided. Additional information has been requested.
Jittery and ?head feels different/weird? on 11/13/2021 about 6 hours after vaccine. Woke up complaining of headaches next day. Pt started having uncontrolled head movements and jerks along with facial twitches. It started only when brain was at rest like watching TV or listening in class. Now, it?s happening constantly during conversations, eating, reading and writing. Continued daily and teachers noticed head bobbing and twitching. She also looks unfocused when looking at teachers.
103 temp, weak, achy, nauseated, 101 temp for @ least 4 days;bad cough 99 to 100 temp
patient came down with COVID; patient came down with COVID; This is a spontaneous report received from a non-contactable consumer from a Pfizer-sponsored program, regulatory authority. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot numbers and expiry dates were reported) dose 1, single and dose 2, single; both via unspecified routes of administration, on unknown dates, for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was trying to make booster shot appointment, but the patient came down with COVID on an unspecified date. The outcome of the events was unknown at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202101368205 same reporter, same drug, same events, different patients
Severe bone, muscle, joint, nerve pain (pain level 10) for three days after vaccine. Shoulder swelled and ached in shoulder joint (pain level 10) also for 3 days. Chest pain and palpitations for two days. Symptoms that began on day of vaccine and are still severe today: headache, dizziness, sinus pain and drainage, sore throat, runny nose, sneezing, cough and extreme fatigue.
Moderate dizzyness, starting 04:00 am 09/14 and ending 10:00 am 09/14. Balance issues (see below), vision feeling "one inch in front of eyes", brain fog (see below), difficulty judging distances. Moderate balance issues, starting 04:00 am 09/14 and ending 02:00 pm 09/14. Swaying, increased need to sit. Moderate brain fog, starting 06:00 am 09/14, decreasing to light symptoms at 01:00 pm, ending at 08:30 pm 09/14. Difficulty concentrating and remembering fine details. Moderate full body chills and aches, starting 08:00 pm 09/13, ending 04:00 pm 09/14.
nausea and vomiting, diarrhea, fever, and chills. No treatment - sleep/time.
increased floaters in eyes, extreme blurriness in both eyes and peripheral vision light flashes in both eyes.
mom said next day was limp off & on staring spells fussy but consolable, not responding;was fine & back to usual next day;
Swelling, redness, pain worsening for 1 week - (6 days). Pt. prescribed antibiotic as treatment. Suspect also due to very poorly controlled diabetes.
red itchy clusters on the left arm on the opposite side of elbow around 2 weeks; Itchy; clusters developed as little bumps; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (red itchy clusters on the left arm on the opposite side of elbow around 2 weeks), PRURITUS (Itchy) and SWELLING (clusters developed as little bumps) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 025B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE and METOPROLOL for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-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 ERYTHEMA (red itchy clusters on the left arm on the opposite side of elbow around 2 weeks) and SWELLING (clusters developed as little bumps). an unknown date, the patient experienced PRURITUS (Itchy). The patient was treated with MOMETASONE FUROATE at an unspecified dose and frequency. At the time of the report, ERYTHEMA (red itchy clusters on the left arm on the opposite side of elbow around 2 weeks), PRURITUS (Itchy) and SWELLING (clusters developed as little bumps) outcome was unknown. Not Provided
After receiving the vaccine ZOSTAVAX, I had redness, itching, and warmth at the injection sight for approximately 1 week.
Vomiting with no warning, almost call it projectile, never had this in my life before, severe muscle ache, tightness in ribcage, couldn't sleep hurt too much in right side of chest, diarrhea.
She reports that the first 2 days after her vaccine her arm was red, swollen and sore then resolved.  She now reports that starting  around 6-7 days after the vaccine she developed redness, itchy, swelling and soreness at the site.  She also has body aches at this time
Sub-q PNEUMOVAX given in left arm. Arm swelled and was inflamed. Pt went to doctor and received an Rx fro KEFLEX 500mg qid x 7d
A report was received from a health care professional on 12/3/03 concerning a 30 year old female vaccinee who inadvertently received expired Fluvirin vaccine on 12/3/03. On 12/3/03 the vaccinee was administered 2002-2003 Fluvirin. No adverse events were reported at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
On 10/20/21 patient received first dose of Pfizer COVID-19 vaccine. 5 minutes after administration, patient informed pharmacy team that he "did not feel good, felt light-headed" and that his vision seemed dim and obscured. He looked pale and was sweating. We asked him to sit down on the floor and to keep his back against the wall. We called 911 and his family member also arrived at the store. Patient claimed to have felt anxious prior to the vaccine. We gave him water to sip on.  Ambulatory services arrived and checked his vitals. He started feeling better and a trip to the ER was deemed unnecessary . After 35 minutes his family member took him home. I called him the next day and he reported feeling fine.
She got her vaccine, 20 minutes after that she was driving home, and felt the pain in her arm.  A second later she had a pounding headache in the front of her forehead.  The rest of the evening it was just terrible pain in her arm and the headache.  On Friday morning she had slight flu symptoms, and each hour they increased rapidly.  By 10:00 AM she had full flu symptoms with her rib hurting, chills, hot and cold, felt like full blown flu.  By 2:00 PM her teeth were chattering she was so cold.  She was taking her temperature throughout the day, she normally is in the low 96/97 range, was 98.4 to 98.5 which for her is a fever.  She didn't think to take anything as she has had health issues for years.  At 5:00 PM she took an Ibuprofen and the chills went away, and the arm stopped hurting.  On Friday evening she had a choking cough, kept coughing and did that for an hour or so.  Put in a cough drop and did it again with a coughing spell/choking cough.  All day Saturday she was fine, then Sunday she started feeling bad again, not severe but had flu again on Sunday and half of Monday.  She is still not feeling like before the vaccine, kind of like she still had flu like symptoms lingering.    She had four previous COVID vaccines and on the 1st and 2nd doses for 24 hours she had slight flu-like symptoms.  The extra and the first booster she had no reactions.    She did have a Zoom APT with insurance and the lady was surprised that she had the symptoms and gave her VAERS phone #.
DTAP in left arm muscle, had swelling of entire left arm extending to anterior left chest within 24 hours of shot. Treated with Augmentin for possible cellulitis. Resolved within 5 days.
Information has been received from a health professional concerning a six year old male pt with no allergies and no pertinent medical history, who on 08Sep00 was vaccinated SC with 0.5mL varicella virus vaccine live. There was no concomitant medication. On 21Dec05 the pt experienced breakthrough varicella. There were no lab studies performed. The adverse event did not improve and the pt's outcome is not recovered. There was no product quality complaint reported. The pt sought unspecified medical attention. Additional information has been requested.
sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st shot received on an unknown date).   On 6th April 2021, the patient received the 2nd dose of Shingrix. On 6th April 2021, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. On the day of reporting, the patient got 2nd shot of Shingles and experienced sore arm. The patient asked, if he/she could take Advil or Tylenol for a sore arm.