chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Body aches; Chills; Little fever; quite a bit discomfort; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), DISCOMFORT (quite a bit discomfort), CHILLS (Chills) and PYREXIA (Little fever) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer vaccine (Patient the first dose of the Pfizer vaccine on 15Feb2021 Lot EL9266.) on 15-Feb-2021 and Pfizer vaccine (Patient the second dose of the Pfizer vaccine on 18Mar 2021 Lot EN6204) on 18-Mar-2021. Concurrent medical conditions included Cholesterol.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced DISCOMFORT (quite a bit discomfort). On 10-Nov-2021, the patient experienced PAIN (Body aches), CHILLS (Chills) and PYREXIA (Little fever). At the time of the report, PAIN (Body aches), DISCOMFORT (quite a bit discomfort), CHILLS (Chills) and PYREXIA (Little fever) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.  This case was created for booster dose. Patient wanted to know if she could take any Aspirin product or Excedrin   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: Significant followup received on 10-NOV-2021 contains historical vaccine added, event coding updated. On 10-Nov-2021: Followup received on 10-NOV-2021 contains Non-Significant  information.
Fever; Achiness; fatigue; malaise; swollen left armpit lymph node; This is a spontaneous report from a contactable consumer. A 27-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 05Feb2021 at 09:15 (at the age of 27-year-old) as 2nd dose, single dose in left arm for COVID-19 immunisation at Workplace clinic. The patient's medical history included PCOS (Polycystic ovarian syndrome). Patient had no allergies. Concomitant medications include Wellbutrin XL, Aldactone, Vit D, Zyrtec, Turmeric. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 15Jan2021 at 09:15 as single dose in left arm for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Feb2021 Friday night at 21:00, 12 hours after the second dose of vaccine, the patient experienced fever, which peaked at 101.6 around 03:00 AM on Saturday and stayed a little above 100 most of Saturday. On 05Feb2021 at 21:00, 12 hours after the second dose of vaccine, the patient also experienced achiness, fatigue, malaise, swollen left armpit lymph node. There was no treatment received for the adverse events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 101.6 on 06Feb2021, fever peaked at 101.6 around 3 AM , body temperature: little above 100 on 06Feb2021, stayed a little above 100. The clinical outcome of the events was recovered on 07Feb2021.  Follow-up attempts are completed. No further information is expected.
4 hours after vaccination pt had some chest heaviness, SOB, abd upset, sore throat, lethargy.
2 weeks after injection, still has an abscess - Tx - cold compresses and keeping an eye on it for now.
pt stated she woke up with a sore arm and it remained sore for 2 weeks
Got Pfizer as her first dose on 29Jan2021, had an allergic reaction to it.; Then got Moderna COVID-19 vaccine as her second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2, Solution for injection), administration date 29Jan2021 (Batch/Lot number: unknown) at the age of 74 years as dose 1, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administered in arm left, administration date 03Nov2021 (Lot number: 071F21A) as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 03Nov2021, outcome "unknown", described as "Then got Moderna COVID-19 vaccine as her second dose"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Got Pfizer as her first dose on 29Jan2021, had an allergic reaction to it.".  Clinical information: Patients stated that she got pfizer as her 1st dose on 29Jan2021 had an allergic reaction to it. The got the Moderna Covid-19 Vaccine as her 2nd dose (lot # 071F21A) on 03Nov2021 in her left arm she said that she just got a pain in her left arm after the 2nd dose.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a registered nurse refers to a 5 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (Merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
INTERMITTENT UTERAL CRAMPING; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: 07-AUG-2021) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAY-2021, the subject experienced intermittent uteral cramping. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from intermittent uteral cramping on 16-MAY-2021. This report was non-serious.
LMP: 20 Jul 10, Vaccinated 02 Aug 10. Positive preg test 23 Aug 10. Miscarriage 28 Aug 20.
Developed hives; Extremely itchy; It worsened and spread over the entire body; Rash on the shoulder near the injection site; Anaphylactic reaction; Red Bumps; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced RASH MACULAR (Red Bumps). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), URTICARIA (Developed hives), PRURITUS (Extremely itchy), RASH (It worsened and spread over the entire body) and VACCINATION SITE RASH (Rash on the shoulder near the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red blotches, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), RASH MACULAR (Red Bumps), URTICARIA (Developed hives), PRURITUS (Extremely itchy), RASH (It worsened and spread over the entire body) and VACCINATION SITE RASH (Rash on the shoulder near the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       According to the report it started as a rash on the shoulder near the injection site in the evening of the 1st dose. There were tiny dots which were extremely itchy. Skin like scabs would fall away on scratching them. The next day, it worsened and spread over the entire body. Patient called an ER doctor and he was told that he was having an anaphylactic reaction to the propylene glycol component of the vaccine. He then visited a dermatologist and received a steroid shot and he was put into an oral steroid regimen where the dose tapers every day. These calmed the symptoms down but by the 10th day though they were still visible. It took several months for the events to resolve. He was advised not to take the 2nd dose of any COVID-19 vaccine.   No relevant concomitant medication information provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up information was received on 14 Jul 2021 as a Telephone Contact Report wherein events anaphylactic reaction, pruritic, injection site rash, urticaria, rash were added. Event outcome updated as recovered. Action taken updated to withdrawn. This case was upgraded to serious as event anaphylactic reaction was added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
nausea; chills; This is a spontaneous report from a Pfizer-sponsored program a contactable consumer (patient).  This female patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route od administration, on 19Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. She's experiencing symptoms like nausea and chills. She wants to know how long the symptoms will be. Outcome was unknown. Information on the lot/batch number has been requested.
This spontaneous report was received from a nurse and refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 15-MAY-2017, the patient was vaccinated with an improperly stored dose of PROQUAD injection, lot # M044018 with expiration date 01-MAY-2018 (strength, dose and route of administration were not reported). The vaccine experienced temperature excursion of 30 degrees Fahrenheit for 64 hours. Digital data logger was involved and there were no previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved in this case. Additional information has been requested.
Breakthrough COVID case. The evening after receiving my booster vaccine, I started feeling very sore, tired, fever over 100 and fatigue. I felt extremely tired for about 2 weeks I was given 2 COVID 19 test and tested negative both times. I thought it was a cold or allergies and went back to urgent care because I still had COVID symptoms. I was fine Jan - March. March I started experiencing blue fingers for 7 or 8 hours along with chest pain, diarrhea, chest tightness and migraines. Tested positive for COVID in March. I am still experiencing chest pain ever so often.
My arm felt very sore at the site of injection for around 3 days from the day of injection, like I had worked out really hard and it hurt to lift it.  Unexpectedly about 9 days after the shot, the site of injection was itchy, red and hot. There was also a lump about the size of an almond. It all resolved on its own in about 4 days.
Blinding headache, nausea, disorientation, dizzy, fatigue, minor arm pain. This lasted for 24 hours. Couldn't move, tried to sleep, but too much head pain.
the patient was 17 years old and 11 months when given the vaccine. this vaccine is approved for 18 years old and above. she did not have an adverse reaction.
Initial unsolicited report received a consumer on 15 SEP 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS TOXOID) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date, following vaccination, patient developed allergies include tetanus toxoid. Lab tests and corrective treatment were not reported. Outcome of event was not reported. List of documents held by sender: none.
Rash, itchy around neck, hot, weak, drowsy, evaluated by EMS-transported to nearest ER
Pt nasally congested 8/17.  Had vaccinations 8/18 at 3:30pm.  Congestion worsened that evening.  Fever in am of 101 degrees core.  At noon dad noticed anterior fontanelle bulging.  Child alert but slightly more fussy than usual.  Eating fair but improving by this afternoon. 10/1/08 Reviewed hospital medical records of 8/19-8/21/2008. FINAL DX: viral syndrome; meningitis ruled out; pre-existing diaper dermatitis Records reveal patient experienced fever & bulging fontanel day after vaccinations. Had rhinorrhea, mild thrombocytosis & decreased abs neutros.  Tx w/IV antibiotics & antivirals.  Improved & d/c to home.
Influenza vaccine given 9/24/15. Admitted to hospital 9/26/15. Eventually diagnosed with transverse myelitis with marked neurological impairment.
Extremely sharp pain in jaw (r) commenced within 48-60 hours of injection; is ongoing without relief.
2:00 PM gave Menactra and Tdap (R) arm; felt fine, no problems. Gave Gardasil (L) arm, felt pain at site, felt light headed. Stomach hurt, leaned back then eyes crossed, became stiff (body) and shook body for about 1 min then sat up asking - what is going on, then felt lightheaded and laid down on exam table. 2:04 PM 98/60, pulse 58. 2:13 Pulse Ox 99%. 2:20 PM 108/64, 71, Pulse Ox 99%, still feels nauseous. 2:28 PM Stated better, minor queasiness, feels tired. 2:30 PM C/O pain in tummy, leaned back, laid down. 2:44 PM Headache. 2:52 PM She got up and felt better, left office.
Pt came in for routine care 4/3/08.  Was given two vaccines MCV4 and Varicella.  Woke in AM w/ severe localized reaction.  Checked by Dr in office.  No fever, sl. induration, od itching.  Benadryl Q4 hrs. Call if increase size or fever.  The reaction was to Varivax.
This spontaneous report as received from a physician in the format of a medical record refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant medications were reported. Reportedly, GARDASIL 9 was inferred to have experienced the following temperature excursions: 36.9 F for 10 minutes on 24-DEC-2016, at 00:31 hours; and 38.6 F for 20 minutes on 27-DEC-2016, at 07:51 hours. They were called out because of a digital data logger. On 27-DEC-2016, at 14:13 hours, the patient was vaccinated with the first, improperly stored, 0.5 ml dose of this vaccine (which had a lot # of M021407 with an expiration date of 30-APR-2018), intramuscularly, in the left deltoid, for prophylaxis. Despite this, no adverse symptoms were reported. All available medical records will be provided upon request. This is one of the several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002579: US-009507513-1703USA011160: US-009507513-1703USA010731: US-009507513-1703USA011162: US-009507513-1703USA011158: US-009507513-1703USA011159.
Varicella vaccine administered on 10/1/04. 4 days prior to the visit parents noted red area around site that became scaly. On OR today crusted lesion (serious) at injection site.
Patient recieved DTAP, Hep A, and Prevnar vaccines on 12/13/06 was seen on 12/19/2006 for a body rash.  Provider unsure if rash resulted from immunizations or antibiotic.
Vaccine leaked from the injection site and not all of the vaccine was administered. No adverse event or injury occured. The dose was reattempted and was successful.
Right arm swelled from elbow to shoulder and was red and warm. Hospital gave me intravenous with BENADRYL, PEPCID and SOLUMEDROL (steroid), ZYRTEC (5 daysx1 day).
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date from 17-NOV2016 to 15-DEC-2016, unspecified number of patients were vaccinated with improperly stored GARDASIL (lot # K010215 and expiry date 30-MAY-2017) for prophylaxis. The vaccines were exposed to a temperature of 2.5 C for 1 hour and 10 mins. No adverse effects were reported. The call was because of digital data logger. There was no previous exposure. Additional information has been requested. Sender's Comments: US-009507513-1612USA013519: US-009507513-1612USA010663: US-009507513-1612USA013518: US-009507513-1612USA013520.
Unusual menstruation: while I still occasionally get my period, it is only ever very light and short. One week after my booster, however, I had an unusually long and heavy cycle. I have not bled so much in years.
Information has been received from an investigator concerning a 5 yr old female with acute lymphocytic leukaemia in remission who entered a study, title as stated above. On 04Jun93 the pt was vaccinated SC with a first 0.5ml dose of varicella virus vaccine live (lot CW591). Concomitant therapy included chemotherapy and steroid therapy. On 16Jul93 a culture taken from the broviac catheter exit site was positive for pseudomonas. The pt was placed on a 10 day course of ciprofloxacin and scheduled for catheter removal on 13Aug93. On 12Aug93 the pt presented with fever of 102.5 and neutropenia ANC 42. The pt was hospitalized and treated with vancomycin, ceftazidime and tobramycin. On 16Aug93 the pt was discharged, cultures were negative and the pt was placed on cephalexin (Keflex) 250mg TID for 4 days. The pt SC recovered. The reporting investigator felt that neutropenia was severe and was possibly related to varicella virus vaccine live. No further information is available. The serious adverse experience for this report occurred outside the protocol specified time frame for collection of safety information.
3am-heart racing, restlessness, lips slightly swollen,  Lethargy, back and legs ached with shooting pains, chills 2/26-excruciating chest pains around 4 pm, restlessness continued, swollen at site of injection as big round about size of baseball, slept 17 hours
No adverse event.  I'm reporting a vaccine administration error.  Immediately after withdrawing the needle from my arm, the vaccinator squirted a stream of vaccine onto the floor. Therefore, I don' t know whether I received a full dose (or any dose at all).
felt bad for a few hours and was okay; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad for a few hours and was okay) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029421A) for COVID-19 vaccination.     Concurrent medical conditions included Depression, Anxiety disorder and Blood pressure high. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) for Anxiety, LORAZEPAM for Anxiety disorder, AMLODIPINE BESILATE (NORVASC) for Blood pressure high, BUPROPION HYDROCHLORIDE (WELLBUTRIN) and DESVENLAFAXINE SUCCINATE (PRISTIQ) for Depression, NIACIN for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced FEELING ABNORMAL (felt bad for a few hours and was okay). On 01-Mar-2021, FEELING ABNORMAL (felt bad for a few hours and was okay) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported.   This case was linked to MOD-2021-074953 (Patient Link).
A report has been received from a Health Professional concerning a patient. Male subject, who had been receiving FLUMIST (Intranasal). The patient's concurrent disease(s) included hypogammaglobulinemia. Concomitant medications included immunoglobulin human normal. FLUMIST (Intranasal) started on 11-Oct-2013. It was reported that a child with hypogammaglobulinemia accidentally received FLUMIST on the morning of 11-Oct-2013. The outcome of the event of a child with hypogammaglobulinemia accidentally received FLUMIST this morning is unknown. The report was considered to be non-serious.
My lower left leg swelled up to double the size and was seeping through the skin. It was seeping out at the foot and ankle. I have had some blood tests and a CT scan looking for vascular issues and they found none. I have had 3 doses of Antibiotics. First, I had Cephalexin, then Bactrim, and then Doxycycline. I am still dealing with this at this time. I have also started taking a blood pressure medication Hydrochlorothiazide.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 06-FEB-2019, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R019391 with expiration date 05-JUL-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
First night, pain at sight. 2nd day, pain at sight, sore muscles, headache, upset stomach, tiredness, insomnia - took Tylenol and nap, didn't eat much. 3rd day, pain at sight, extremely sore muscles,  could barely move neck and shoulders, upset stomach, took Tylenol & Tramdol. 4th day, pain at sight, muscle pain in neck and shoulder was less extreme - took Tylenol.