chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine at 930am on 10/11/13. She noticed tingling in her lips at 1:30pm. She notified me (LPN) and my nursing supervisor (RN) at 220pm of this symptom and now they were numb. She was given a BENDARYL 25mg PO at 230pm. Re-evaluated at 3pm and now has a sore throat, red itchy eyes and some blurred vision. Supervisor spoke with a doctor and agreed she should be evaluated before leaving work. She was seen by Dr at 315pm. Another BENADRYL 25mg was given to her orally at 345pm. Her temp was 98.4 when she was roomed for that appt. No labs checked and she was told by the doctor to remain at work for 1 hr if she didn't have anyone at home and to take BENADRYL 25mg every 6 hrs for the next 48 hours. She did stay at the clinic (clinic employee - lab) for 1 hr and during that time, approx 330pm, she had the chills. Her temp was now 99.4. She was re-evaluated at 415pm after taking the 2nd BENDARYL and she had feeling back in her lips. She felt very chilled and tired. Her temp was checked before leaving for home and it was up to 99.8. She left for home at 430pm and another co-worker was following her to her house. She was going to go sleep and someone was going to check on her at 6pm. Told to follow up or call 911 if she had shortness of breath, throat swelling, hives or any other major reactions. She stated she understood. Incident was also reported to Employee Health to make a note in her employee file.
Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report  was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021. Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
This spontaneous report as received from a pharmacist refers to a 78 year old male patient. No patient's concurrent conditions, medical history or concomitant medications were reported. On an unspecified date in 2000, the patient was vaccinated with a dose of ZOSTAVAX (strength, route, site of administration, Lot#, expiry date were not reported). On an unknown date in 2015, reported as "a few months ago", the patient developed shingles. The outcome of shingles was unknown. The causality assessment between the event and suspect therapy was not provided. Additional information has been requested.
15 year old male had just received his first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old male had just received his first dose) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 20210625) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old male had just received his first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old male had just received his first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
administered improperly stored VARlVAX; This spontaneous report was received from a medical assistant referring to a 12-month-old male patient. Information about concomitant medication, pertinent medical history, drug reactions or allergies was unknown.  On 28-AUG-2020, the patient received improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (also reported as therapy start date unknown) (lot # S038701, expiration date: 01-DEC-2021, dose was not reported, subcutaneous) for prophylaxis (reported as "well check") (product storage error). The varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The vaccine was exposed to temperature from minus 9 Celsius degree to 8 Celsius degree (also reported as minus 6.1 Celsius degree) (multiple excursions). The time frame was unknown by reporter. No previous temperature excursion. Another varicella virus vaccine live (Oka/Merck) (VARIVAX) vaccine (lot# S032355, expiration date: 14-OCT-2021, dose was not reported, subcutaneous) was involved. The vaccine was exposed to temperature from minus 14 Celsius degree to minus 10 Celsius degree for 116 hours and from minus 9 Celsius degree to 8 Celsius degree for 13 hours. Time frame was reported as 129 hours. No previous temperature excursion. Data logger was involved for both vaccines.
10 minutes after receiving immunization delivered pruritic maculo-papular rash on arms that spread to face back and chest, no other   symptoms.   No respiratory compromise, stable vital signs.  61 pulse, 129/80 BP, 36.5 C Temp.  After 30  minutes patient received benadryl  im. for pruritus and was transfered to Emergency room for further observation and evaluation.
severe vertigo and nausea lasting one and half weeks. subsided to left eye struggling to focus with distance while moving, brain fog
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with improper stored PROQUAD (lot # R015739, expiration date: 02-DEC-2019; lot # R011216, expiration date: 15-OCT-2019, strength, dose, frequency and route were unknown) for prophylaxis reconstituted with well stored sterile diluent. The vaccines had temperature excursion of 15 degree F to 46 degree F (18.9F) for 7 hours 18 minutes. Previous temperature excursion was 15 degree F to 46 degree F (14.5 F) for 48 minutes. The call was due to the digital data logger. No adverse event was reported. No product quality complaint involved.
pt recv vax 12JUN96 & 9JUL96 pt returned to MD w/a large area of petechiae;initially MD questioned muscular atrophy/urticaria;on f/u MD stated that pt had local erythema w/bruising & dimpling @ inj site;MD states pt had muscle atrophy;
Vaccine administered in physician's office yesterday and later in day complained of left arm, site of administration, redness, swelling, pain, and itch.
Noticed hives - neck/arm/legs about 30 minutes after vaccination. Benadryl OTC 50mg 6PM, resolves 24 hours later, no trouble breathing. Irritation, left arm ache - resolved.
Within the first hour, developed headache and neck ache  (back of neck where neck meets head) and arm ache all on right side of body, same side as injection. Also developed a slightly chemical taste in my mouth, which lasted 36 hours. Within 5 hours, headache, neck ache, arm ache significantly painful; applied gel ice packs to head and right arm; went to bed early. Awoke at midnight with entire right arm, down to hand, feeling like it was in a steel-toothed trap; pain was excruciating, and while I was able to rotate arm and flex hand, pain level was very high. At same time, neck ache was very high, felt like a boulder was sitting on it. At same time, had blistering migraine with runny nose and eye. Called family doctor's office at 8am next day to ask whether I could take migraine medication (elatriptan or sumatriptan) after vaccine; office closed but nurse in call center told me to go to ER; I suggested the side effects were very painful but listed as possible, and didn't knwo that they warranted ER, and just wanted to know whether I could take triptan for agonizing migraine; nurse didn't really know how to respond. I went back to bed with ice. A few hours later, a family member called their doctor's office and was told yes, I could safely take triptan. Took sumatriptan at 1pm and it cut the migraine way back, to a manageable level. Over the course of the first 24 hours after vaccine, also felt lightheaded, woozy, nauseous, hot, cold sweats, digestive upset and loose stool, diminished appetite. Checked temperature a few times, but it was normal. At 5pm of second day, took 2 Tylenol, which helped pain. Waited 24 hours before taking 2 more Tylenol. By end of second full day after vaccine, feeling better, but like I had a bad head cold with mild headache.
Patient received her first dose of the pfizer vaccine and then went on to wait in the waiting area for 15 minutes. During that time, she began to feel light headed and dizzy. I went out to the waiting area to check on her and it appeared she was very lightheaded. She was responding to her father and I by nodding, I lifted her legs on the chair and gave her water. She began to feel better after drinking water. I called 611 to inform them while the patient's father called 911 from his cell phone. Patient started to verbally respond and said she was feeling better and was just dizzy and light headed. EMS did come and they checked her blood pressure which they confirmed to me was borderline low and they said her sugar levels were normal. By this time, patient was able to talk and stand and said she felt a lot better and EMS said that there is no need to transport her to the hospital.
Tired; Low grade fever; This is a spontaneous report from a contactable consumer (patients daughter). A female patient of an unspecified age received bnt162b2 (Solution for injection, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1 single and on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got the Pfizer COVID 19 vaccine and had 2 doses. The patient experienced normal side effects and now has none. Reporter did not remember the side effects, but said her mother was tired and had low grade fever but did not experienced joint pain. On unknown date the patient was tired and experienced low-grade fever. Outcome of the events were recovered on unknown date.  Information about lot/batch number cannot be obtained. No further information is expected.
FULLNESS; OXYGEN LEVEL NOT GREAT; TROUBLE BREATHING; NOT SLEEPING WELL; FELT WORSE; RASPING; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd, cigarette smoking, thyroid disorder, hip replacement, brain tumor, high cholesterol, alcohol user, dry mouth, anaphylactic reaction from carboplatin, drugged feeling like floating at full strength, and exhaustion, and other pre-existing medical conditions included no thyroid but takes thyroid replacement. The patient experienced drug allergy when treated with moxifloxacin hydrochloride for drug use for unknown indication, and drug allergy when treated with venlafaxine hydrochloride. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 at right arm for prophylactic vaccination.  Concomitant medications included salbutamol for copd. On MAR-2021, the subject experienced rasping. On 10-MAR-2021, the subject experienced trouble breathing. On 10-MAR-2021, the subject experienced not sleeping well. On 10-MAR-2021, the subject experienced felt worse. On 15-MAR-2021, the subject experienced oxygen level not great.  Laboratory data included: Chest X-ray (NR: not provided) clear, and Oxygen saturation decreased (NR: not provided) not great. Treatment medications included: erythromycin, and fluticasone propionate. On an unspecified date, the subject experienced fullness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing on 18-MAR-2021, and not sleeping well, felt worse, and rasping on 15-MAR-2021, and the outcome of fullness and oxygen level not great was not reported. This report was non-serious.
A non-serious spontaneous report of administration of expired product was received from a father/consumer concerning a six-year-old female child. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 28-Mar-2010. On 08-May-2010, the patient received expired H1N1, Intranasal, for unknown indication. There was no adverse event associated with this medication error therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved.
This spontaneous report was received from a Medical Assistant concerning a 30 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 26-APR-2017, the patient was vaccinated with PROQUAD (dose, route, lot number and expiration date were not reported) for prophylaxis, reconstituted with sterile diluent (dose, route, lot number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Swollen glands under left arm for four days then after 6 days swelling of glands in both armpits and under jaw.  Has not improved in almost 2 months.
Information has been received from a nurse practitioner concerning her 13-year-old son who in approximately 1996 was vaccinated with a 0.5 ml dose of MMR. Subsequently, in approximately 1998, the patient experienced breakthrough measles when he was "three to five years old," and was "covered from head to toe with 300 to 500 vesicles with a fever." Unspecified medical attention was sought. The patient recovered from breakthrough measles. No additional information to report. There was no product quality complaint. Additional information has been requested.
PATIENT RECEIVED VACCINE THAT EXPERIENCED A TEMPERATURE EXCURSION, VACCINE WAS KEPT IN THE REFRIGERATOR FOR MORE THAN 30 DAYS. NO SIDE EFFECTS
10 month old received Kinrix; Received Kinrix instead of 3rd DTap-IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-month-old male patient who received DTPa-IPV (Kinrix) (batch number 25zh4, expiry date 27-OCT-2024) for prophylaxis.   On 20-APR-2023, the patient received Kinrix. On 20-APR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 10 month old received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: Received Kinrix instead of 3rd DTap-IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-APR-2023 The nurse stated that a patient inadvertently received Kinrix for their third dose of DTaP and IPV.  The reporter consented to follow up via email. The 10 month old patient received Kinrix instead of third dose of DTaP and IPV, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
OFF LABEL USE; DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 17 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, and batch number: 1821286 expiry: 06-SEP-2021) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 22-JUL-2021, the subject experienced off label use. On 22-JUL-2021, the subject experienced drug administered to subject of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and drug administered to patient of inappropriate age was not reported. This report was non-serious.
devel chickenpox;vax given 23OCT95;rash 5SEP98;
The vaccine was administered subcutaneous routine instead of intramuscular.  There were no signs of any immediate reaction.
pt recv vax & devel severe tenderness, redness & warmth @ the inj site;MD dx cellulitis & prescribed an ATB;
a little bit of headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (a little bit of headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (a little bit of headache). At the time of the report, HEADACHE (a little bit of headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment medications were not provided The caller also said his son and his son's wife also got Moderna, and they were happy with that. His son had a little bit of headache after that, but upon clarification, caller said that's nothing with the shot.   This case was linked to MOD-2022-472171 (Patient Link).
Pt recv vax on 10/20/98; on 10/25/98 pt exp sore throat,weakness,fever,hoarseness,mucous in throat, &headache.
This spontaneous report was received from a licensed practical nurse referring to a 27 year old patient (gender unknown). The patient's pertinent medical history, current conditions and concomitant medications were not reported. On 20-OCT-2016, the patient was vaccinated with improperly stored dose of VAQTA (dose and route were not reported) lot #M012261 and expiry date: 01-FEB-2018 (volume/dose reported as 1), for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA004376: US-009507513-1610USA003097: US-009507513-1610USA004377.
Burning in chest and throat. And weird taste along with it. As if after getting and iodine shot for a cat scan.. the same metallic taste.
Patient received Pfizer COVID vaccines on 12/28/20 and 1/19/21. Had exposure to COVID, tested positive for COVID-19 by PCR on 3/10/21. Patient was asymptomatic.
16m. old boy come for 3 shots: Flulaval (R thigh) & DTaP & Pedvax Hib (L thigh). Developing hives (1 lesion) mild, check 5 minutes after given shots, no other local Reaction or systemic Reaction. Given Benadryl & Ibuprofen, pt vomited right away. Redo Benadryl, pt's Rash improved after 30 minutes Here for 15 month exam.Mother concerns about allergies due to cough and runny nose also eczema concerns -ma Dental referral list given to call and schedule appointment. Patient presents today for routine health maintenance with his mother.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that an unspecified patient received a dose of M-M-R II (dose, route and lot number were not reported) yesterday, 11-AUG-2014, that was exposed to temperatures outside of the proper storage range. No adverse effect reported. Additional information has been requested.
sick for week and half with flu like symptoms. RA symptoms worsens until present. Feel like my meds are not working now to control RA. lots of swelling and stiffness and pain. Now have thrush in mouth and throat.
About two months after receiving the Moderna Bivalent Booster, I tested positive for Covid-19. My husband had it first, but by the time we quarantined away from each other, I already had it. I experienced symptoms of a sore throat, lack of energy, congestion and a cough. I contacted my PCP and I was prescribed Paxlovid. I feel that Paxlovid helped with my symptoms. As of today, I feel like all of my symptoms have finally resolved.
Patient received 0.5 ml of Pfizer covid 19 vaccine for their first booster. Patient is not experiencing any side effects at the moment the phone call was made but was instructed to monitor any unusual side effects/symptoms for the next week.
Pt recvd vax 28JUL92 & 3 hrs later devel rash on neck & other body parts;