chrisvoncsefalvay/vaers-outcomes huggingface dataset:
?Moderna arm?-swelling, itchiness, rash, and redness next to/at injection site. Redness, swelling, and rash lasted 6 days. Itchiness has lessened, but still there. Additionally, breast soreness, tenderness, and swelling in both breast but that extended only into the left armpit.
pt recvd shot on 12JAN93; MD prescribed some tablets for strep throat; during this period pt began to have minor memory loss, mode swings, loss of appetite, stomach problems on 28JAN93 blacked out & was hospitalized;
Floeing day: Headache, fatigue, arm pain followed by pressure and mild pain in lower right leg (this started 3 days after vaccine).  Headache and fatigue resolved after 5 days with rest/ibuprofen. Leg pressure/cramps is ongoing. I will be contacting my doctor for guidance.
Patient said she was having pain from a Pneumonia shot she received quite some time ago.  She stated after getting the shot she had pain for over 2 weeks and could not lift her arm above her head.  Area is still irritated and painful 3 months later.
This spontaneous report was received from a nurse concerning to a 3 months old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 16-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # K023534, expiration date: 22-MAY-2016) (strength and dose were unspecified), the route was defaulted to oral. No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified group patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. The nurse reported a group of patients received unspecified doses of PNEUMOVAX 23 lot # L029306, expiration date 26-MAR-2017 (dose, route of administration were not reported), on dates in the last 2 weeks (reported as late May to early June 2017). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004082: Original Case: 1706USA004082.
Fatigue, headache, shortness of breath, chest pain, lightheadedness, heart palpitations, brain fog,
40 minutes after vaccine on 12/19 heart racing and trouble breathing.  Light headed.  went for treatment received epi pen and transported to hospital.  Received no more treatment after Epi pen at hospital.    Never had reaction to a vaccine.  Never had any allergic reaction.
It was reported that a 19 year old male pt received a Menomune vaccination on 02/06/2001 at 2:30pm. Reportedly by 6:30pm that same day the pt developed soreness of his left arm and difficulty swallowing. The physician stated that the pt was engage din a sproting activity the entire day and soreness may be attributed to this activity. From follow-up info received on 03/27/2001, pt info was updated. Follow-up info stated, "Please disregare: pt later treated (the following day) for Tonsillitis caused by Strep. (It is obvious it was a mere coincidence) Thank you."
The whole list you gave: Tiredness, muscle pain, headache, shivering, stomach pain, nausea.  It began nearly 2 hours after the shot, with tiredness, feeling fuzzy, and a headache.  I had stomach pains about 8 hours after the shot, shivering about 10 hours after the shot.  I felt better the next morning, but I had muscle pains for the rest of Day 2.   The muscle pains felt like my muscles were all too short for my bones.   Tiredness continued on Day 3, but was mild.
patient experienced dizziness and light headed as well as sweating. patient was seated. blood pressure checked and monitored. breathing and heart rate were normal. resolved within 10 minutes.
Case developed cough on 3/25/10 which worsened to a paroxsysmal cough on 3/31/10.  Doctor prescribed Azithromycin po x5 days.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 1:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 1:40 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.47.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 PM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer or refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
Narrative: COVID infection following COVID vaccine series 04/07, Moderna, dose #1 05/03, Moderna, dose #2 08/07 pt cc: fever, rhinorrhea, sore throat exposure: boyfriend 08/12 COVID swab, result; detected 08/08- 08/16 symptoms continue 08/12 SARS-COV-2 LINEAGE B.1.617.2 08/12 SARS-COV-2 CLADE 21A DELTA
Patient was on a catch-up schedule for vaccine, and I was unaware as a result the child was given 4-year-old vaccines, this resulted in patient receiving and extra DTAP AND VARICELLA. Child was observed for 15 minutes after vaccines given per protocol, no adverse reaction noted.
INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF-LABEL USE; This spontaneous report received from a physician concerned a 15 year old male. 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: 201A21A and expiry: 23-JUN-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced inappropriate age at vaccine administration. On 02-JUN-2021, the subject experienced off-label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off-label use was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
4 month old had been given .5ml of Fluzone Quad; Upon second medical examination of the case during internal review, a significant correction was performed on 12-Jun-2019 to remove the classification "non-case".   Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 04 months old male patient who was given single 0.5ml of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 15-Oct-2018 (lot number: UT6301MA, expiry date: 30-Jun-2019) via intramuscular route in the left thigh.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Immunisation and Rhodo virus vaccinations.  It was of actual medication error case due to inappropriate age at vaccine administration..  It was not reported if patient experienced any adverse 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 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.  List of documents held by sender: none.  Addendum on 15-Oct-2018: Upon second medical examination of the case during internal review, a significant correction was performed on 12-Jun-2019 to remove the classification "non-case".
1/22/21-1600 left arm became swollen, red, and itchy-size of half dollar which became bigger. Pt. took Benadryl same day with little improvement. Today on 1/25/21 pt. noticed slight improvement in size  and hardness of left arm, and left arm is no longer itchy.
After much research I believe I have Chronic Spontaneous Urticaria Following Pfizer-BioNTech Coronavirus Disease 2019 Messenger RNA Vaccination.   Not exactly sure when it started because I didn't record the exact date, but I had the first shot on 3-29-21 and the second on 4-19-21 and the booster on 12-22-21.   When my body warms up, I get waves of pins and needles all over my body.   There is no area that does not get it.   I never had this before.  I have always exercised and been an avid walker for 30 years.   I am now 56 and every time I exercise or get hot for some other reason it always hits me.   I do not get hives, just the overwhelming pins and needles.
Body aches, chills, and fever of 100.6. Took a Tylenol and will monitor throughout the evening.
rash spread to his entire body and face on 4/5/2020; The patient "developed a rash on the back and stomach on 4/4/2020; This spontaneous report was received from a consumer referring to his 12 months old son. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 25-MAR-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route, batch/lot# and expiration date were unknown) for prophylaxis; varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route, batch/lot# and expiration date were unknown) for prophylaxis and hepatitis a vaccine, inactivated (manufacturer unknown) (strength, dose, frequency, route, batch/lot# and expiration date were unknown) for prophylaxis.  On 04-APR-2020, the patient developed a rash on the back and stomach. On 05-APR-2020, rash spread to the patient's entire body and face. A phone call had been placed to the physician to seek medical attention. The outcome of the events was not recovered. The causality assessment was not provided.
Patient came to clinic yesterday, June 1, 2021. Stated she had a itchy rash to her arms, chest, abdomen, and inner thighs that started the night she received the COVID 19 J&J vaccine. She received the vaccine on 4/8/2021, but did not report the rash until yesterday. She had no other symptoms -  No throat tightening, dysphagia, hives, SOB, chest pain, or flushing. On exam she has a dark pink/red, maculopapular, excoriated rash to both forearms, right side of abdomen, and inner thighs.  Rash is resolving but has been there for 2 months. She had no PMH and is not taking any prescription or OTC medications.
"Patient was brought to triage area for hx of presyncopal episodes with immunizations/injections.   Patient was accompanied by wife. Pfizer vaccine administered in left upper arm. Approximately 5 minutes after vaccine pt c/o dizziness. Pt A/Ox4. Layin,g dow, 1110: Blood pressure: 105/49., 62, 99% RA (1 bottle water given), Symptoms resolved. Remained A/Ox4.  Instructed to follow up with PCP for additional testing and further evaluation for orthostatic hypotension. Verbalized understanding. No questions or concerns.  "
rechecked my antibody levels after my second dose and they are the lowest they have been yet at 0.7; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL1283), via an unspecified route of administration on 08Jan2021 at a single dose for COVID-19 immunization. Medical history included covid-19 from May2020. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EH9899, expiry: unknown) on 18Dec2020 for COVID-19 immunization. The patient had Covid back in May2020 and she had her antibodies checked all along since having Covid. Her antibody levels on a graph show that they decreased a little each time, but she rechecked her antibody levels after her second dose and they are the lowest they have been yet at 0.7 (Jan2021). The outcome of the event was unknown.
Later in the evening after receiving the vaccine, I experienced a very strong and pounding headache. I took some Ibuprofens and went to sleep around 9pm and the headache was resolved around 11:30pm. However, later during the night the headache came back. Also, my body aches all over and just generally uncomfortable feelings. The injection site felt warm to the touch and sore.
received his first dose of Pfizer on 8/11/21 and was schedule for his second dose on 8/25/21. arrived to the clinical on 8/25/21, and was administered the second dose of Pfizer. The medication administration error occurred as the patient received his second dose 14 days apart instead of 21 days. The patient remained asymptomatic during is observation. Patient informed of the mistake and advised to monitor for signs and symptoms. Patient denies any symptoms and stated he "felt fine". Provided patient with the Pfizer fact sheet and a contact number.
covid positive after 4 doses of the Pfizer covid 19 vaccine; covid positive after 4 doses of the Pfizer covid 19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (172086). The reporter is the patient.  A 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; BNT162b2 (BNT162B2), 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 included: "high blood pressure", start date: 2005 (unspecified if ongoing), notes: high blood pressure diagnosed in 2005 after she had a stroke.; "she had a stroke" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL oral taken for hypertension; HYDROCHLOROTHIAZIDE oral taken for hypertension. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25Dec2022, outcome "not recovered" and all described as "covid positive after 4 doses of the Pfizer covid 19 vaccine". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Over the weekend she had a negative test; (25Dec2022) Positive, notes: Result: positive; Unit: Not Provided; (03Jan2023) Positive, notes: She tested last night and it was a very faint positive for covid; (04Jan2023) Positive, notes: Today she tested a very bold positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Concomitant products included lisinopril taking for years, has been as high as 40mg in the past, currently taking 10mg (10mg tablet once a day by mouth); hydrochlorothiazide taking for years, 25mg tablet once a day by mouth. She had all the Pfizer covid 19 vaccines including the bivalent booster, clarifies she has had four doses. Her 4th dose was the bivalent booster and it was administered in Nov2022. She is 69 years old. She tested positive for covid on and started taking Paxlovid on Monday 26Dec2022, then tested negative this past weekend on Saturday. Then yesterday she started having a tickle on her throat and started having cold symptoms again. She tested last night and it was a very faint positive for covid. She tested a very bold positive. She knows what she read is that there can be false negative but unlikely to get a false positive.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Localized erythematous area 6cmx6cm on right arm at site of injection.
Knot in arm 2 inches below injection site: 5/28/2021-5/29/2021 pain at injection site: 5/28/2021-5/29/2021 diarrhea: 5/28/2021 throughout the day nausea: 5/28/2021-5/30/2021 intermittently throughout the day extreme fatigue: 5/28/2021-5/31/2021 all day everyday extreme dizziness: 5/28/2021-5/31/2021 intermittently throughout the day; not as much on 5/29/2021, but the worst on 5/30/2021 menthol metallic taste in mouth and throat: 5/28/2021-5/31/2021 intermittently throughout the day slight tingle and swelling of tongue: 5/28/2021 intermittently throughout the day red face: 5/28/2021-5/29/2021 throughout the days whenever walking hot and sweaty then followed by fully body chills: 5/28/2021 intermittently throughout the day chills: 5/28/2021-5/30/2021 intermittently throughout the day
Child had inconsolable, high pitch cry for nearly 24 hours. Spiked fever of 104.9 for 48 hours with Tylenol give every 4-6 hours. Child appeared extremely irritable with any stimulation or movement regardless of where she was touched.
got skin rashes all over the body; This is a spontaneous report from a contactable consumer. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0175) via an unspecified route of administration in the left arm  on 23Apr2021 at 11:15 at the age of 51-years-old as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included VITAMIN D, TRIVORA, and Multivitamins, all taken for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021, the day after the first shot, the patient experienced skin rashes all over the body except the face that looked like chicken pox not itchy though. She had chicken pox, when she was under 6-year-old and never been vaccinated for it. The patient had no fever and was less active on second day, but still there and less visible with no blood or scar. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event  got skin rashes all over the body was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Headache, chills,dizzy , vaccination side sore, I feel cold but at the same time I'm feeling warm from the inside, I also feel like when you suffer from sinus pain around my eyes
Developed joint pain fingers, wrists, hips, knees, elbows, shoulders, neck; could not get warm/shivering. Lasted approximately 18 hours.
Information has been received from a certified medical assistant referring to unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with doses of improperly stored COMVAX (dose, route, lot# were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
aches and pains in all muscles and joints, cold sweats, tiredness, anxiety, depression, fever, lack of appetite.  Ibuprofen for pain.  Valium for anxiety and depression.
itchy rash small red bumps on chest arms and legs,  Took an allergy anti -histamine pill and put anti itch lotion.
Patient reports experiencing tachycardia approximately 2 weeks after receiving Moderna COVID-19 Vaccine booster dose.   She reports her resting heart rate was approximately 150.  The patient consulted with her healthcare provider and had additional testing.  No further details about tests or results are available to pharmacist.
About 15 hours after vaccine, developed increased (L) arm pain, headache, photophobia, fatigue, fever 102, decreased appetite, malaise, neck pain. Symptoms present for 24 hours then began to decrease. Noted to have large amt (12x4cm + 11.5 x 10cm) erythema, tenderness to (L) arm and (L) axillae 40 hours after injections. Resolved completely on its own by 96 hours after injection.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with HAVRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of HAVRIX (details unknown). Between 20 minutes and 18 hours after vaccination with HAVRIX, the subject experienced rash and hives. At the time of reporting the outcome of the events was unspecified. This case involves a pharmaceutical product complaint. The healthcare professional reported that there had been 3 incidents of rash and hives following vaccination with HAVRIX within the time frame of 20 minutes to 18 hours following the administration. This is case 3 of 3 (see case IDs A0878214A and A0878505A for the other reports). Follow-up received on 09 September 2010: QA analysis revealed the complaint to be unsubstantiated.
Allergic reaction; injection site became swollen and indurated, excessive sweating in hands, red rash spots on both arms, dizziness, nausea, breathing difficulty. Result: Mild relieve of symptoms.
Enlarged pupil - 3 days after  Vision can?t go from bright to dark room  Neurological sensations in face two days after Geographical tongue two days after