chrisvoncsefalvay/vaers-outcomes huggingface dataset:
high blood pressure; hit in the neck area, then went to the both sides of her face and then went up to the head; severe headache; muscle ache; severe reaction before left the vaccination site; difficulty breathing; chills; severe fatigue; nausea; fast heartbeat; weakness; dizzies; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (severe reaction before left the vaccination site), DYSPNOEA (difficulty breathing), BLOOD PRESSURE INCREASED (high blood pressure), HEART RATE INCREASED (fast heartbeat) and ASTHENIA (weakness) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included MESALAZINE (50 xerollic) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE REACTION (severe reaction before left the vaccination site), DYSPNOEA (difficulty breathing), HEART RATE INCREASED (fast heartbeat), ASTHENIA (weakness), DIZZINESS (dizzies), CHILLS (chills), FATIGUE (severe fatigue) and NAUSEA (nausea). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (high blood pressure), PAIN (hit in the neck area, then went to the both sides of her face and then went up to the head), HEADACHE (severe headache) and MYALGIA (muscle ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (severe reaction before left the vaccination site), DYSPNOEA (difficulty breathing), BLOOD PRESSURE INCREASED (high blood pressure), HEART RATE INCREASED (fast heartbeat), ASTHENIA (weakness), DIZZINESS (dizzies), PAIN (hit in the neck area, then went to the both sides of her face and then went up to the head), CHILLS (chills), FATIGUE (severe fatigue), NAUSEA (nausea), HEADACHE (severe headache) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High. On an unknown date, Heart rate: increased (High) Increased.     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.
Became weak and fatigued 18 hours after receiving 2nd Moderna vaccine. Around 24 hours later got dizzy. The dizziness has not subsided. I feel it thoughout the day on and off.  Nothing is helping
(L) upper arm swollen, inflamed at deltoid muscle, decreased tenderness & swelling since day after injections given on 7/6/11.
Patient reports a swollen gland in her neck 3 days after Tdap injection. Reassured of minor reaction.
get the flu everytime I get the shot; Based on information received on 14-Dewc-2020 case updated as valid case.  Initial information received on 09-Oct-2020 regarding an unsolicited non-serious non-case received from a consumer(Patient) via social media.  This case involves a patient of unknown demography who got the flu everytime (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), past vaccination, family history and concomitant medication was not reported.  On an unknown date, the patient received a dose of INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (unknown latency), the patient received INFLUENZA VACCINE and got the flu everytime (influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.  Additional information received on 14-Dec-2020 regarding an unsolicited non-serious case received from a consumer(Patient) via social media.  Event (influenza) was added; Corresponding fields and narrative updated accordingly.
This spontaneous prospective pregnancy report has been received from a 21 years old, female consumer with no pertinent medical history and no drug reactions/allergies who was referring to herself. It was reported that on 13-SEP-2013 the patient was vaccinated with the first dose of VARIVAX (Merck) for prevention of varicella (dose and frequency not reported). No concomitant drugs were reported. On an unknown date in 2013 reported as prior to receiving her first dose of VARIVAX (Merck) (lot # not reported) on 13-SEP-2013, she took a home pregnancy test which showed that she was not pregnant, on 19-SEP-2013 the patient realized that her period was late and took another home pregnancy test which showed what she was pregnant. No adverse effects were reported. The patient became pregnant with last menstrual period (LMP) estimated as 2013. Estimated date of delivery (EDD) was not reported. The pregnancy outcome was pending. The outcome of the event was unknown. No treatment was given for the adverse event. The patient did not see medical attention. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
flu-like synd w/fatigue;lymphadenopathy, sore throat, dizziness, sneezing, coughing, nausea, post nasal drip
Fainted/Collapsed- Was out for 20-25 seconds, nurses picked-up in hall and brought her back to room and gave her oj to drink once she was able to sit up.
Effects of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Effects of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Effects of the Moderna vaccine). At the time of the report, IMMUNISATION REACTION (Effects of the Moderna vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2023: Non-significant follow-up appended
Severe vertigo, nausea, vomiting, tinnitus, ear fullness for several hours followed by more than 10 moths and still ongoing daily symptoms including but not limited to intermittent vertigo, visual disturbance, double vision, headache, hyperacusis, constant sensation of rocking, bobbing, swaying, lightheadedness, fatigue, insomnia, weight loss from nausea and discomfort. Evaluated by pcp several times, ophthalmology, Neuro-otology with repeat labs, audiograms, MRI brain and multiple visits to these providers. Suspected menieres exscerbstion vestibular neuritis vs chronic  vestibular migraine with only minimal relief over the months following from use of prn medications. Started vestibular migraine diet and nortriptyline with no benefit as of the date of this writing. Continued daily symptoms and poor quality of life.
C/O wheezing, chest congestion x 2 days 11/9 seen in ER Dx: with Bronchitis, given breathing tx and Z-PAK. Followed up with MD 11/10. Still c/o discomfort. Pt recovered some.
Redness/swelling without itching/pain or systemic symptoms on L thigh about 18 hours after injection was administered.
Fatigue; headache; severe migraine; This is a spontaneous report from a contactable other HCP. A 25-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 10:00 at single dose for covid-19 immunisation. Medical history included hypothyroidism. No known allergies. Historical vaccine included bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:00 at single dose for covid-19 immunisation. Concomitant medication(s) in two weeks included levothyroxine sodium and drospirenone, ethinylestradiol betadex clathrate (YAZ) and daily womens vitamin. On 17Feb2021 06:00, the patient reported, fatigue and headache on day 1 after vaccine, day 2 fatigue and severe migraine. The patient did not receive any treatment for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Since the vaccination, the patient not been tested for COVID-19. The seriousness was reported as non-serious. The outcome of events was recovering.  Information about lot/ batch number has been requested.
VARICELLA vaccine # 2 given 11-24-09 with site redness/swelling. 11-25-09 onset "irregular heart rate", fatigue; 11-28-09 presents to ER c/o: irregular heart rate. Diagnosed with participation - probably due to immune response from work- related immunizations. 12-3-09 presents to ER again with same complaint.   12/11/09 & 12/15/09:  ED and Hospital Records and follow up consult for dates of service 12/7/09  Dx:  Palpitations, symptomatic PVC's.  Presents with c/o irregular heart beart, missing beats x 1 day after second varicella vaccine, anxious, exertional dyspnea, chest heaviness.  Discharged in good condition.
(None Noted - adverse reaction). MMR vaccine expired 6/18/2011 but administered on 06/20/2011.
Chest pain post SPV- pos enzymes, post EKG. No robust take. Vaccinated 24 Apr. 06 May awoke with pressure in center of chest. No rad, no SOB, diaphoresis, dizziness or palpitations. Never had pain like this before. Went to ED. Transferred underwent heart cath. Results below. Symptoms: CHEST PAIN, UNSPECIFIED(R079).
ringing in ears; fullness in her head; ears pop; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears), HEAD DISCOMFORT (fullness in her head) and EAR DISCOMFORT (ears pop) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 30L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (ringing in ears), HEAD DISCOMFORT (fullness in her head) and EAR DISCOMFORT (ears pop). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; VITAMIN B12 NOS at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency. At the time of the report, TINNITUS (ringing in ears), HEAD DISCOMFORT (fullness in her head) and EAR DISCOMFORT (ears pop) outcome was unknown. Not Provided          No concomitant medications reported. The patient was treated with antihistamine.   This case was linked to US-MODERNATX, INC.-MOD-2021-089224 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089224:1st Dose
Patient said they had an itchy arm the first they had the Moderna vaccine, as well as general itchiness. After she received the 2nd dose on 5/4, about 15-20 minutes later she complained on itchiness around the area as well as a dry and itchy throat. Patient did not have any difficulty breathing but was uncomfortable and anxious. Patient was given intramuscular Benadryl and the itchiness subsidized. 9-1-1 was called and patient refused to go with them and was picked up by her daughter.
fever up to 39,  continue to have fever for 2 days.   acetaminophen is good to relieve but can't eliminate. start to have chest pain under breast when heavily breathing in after 48hrs.
2nd moderna vaccine given 7/12, that night developed some mild low back pain. The next morning the pain was more severe and associated with left leg pain (throbbing). He developed a rash as well (purpura with some bulla) on the buttocks which then traveled down his leg and into the left foot (not painful/pruritic). No fever, chills or other adverse SE.
Urinary Tract Infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary Tract Infection) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced URINARY TRACT INFECTION (Urinary Tract Infection). At the time of the report, URINARY TRACT INFECTION (Urinary Tract Infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant information  provided. Treatment included AZO and waiting for doctor to give antibiotic.
CERVARIX was given to a male patoent while this vaccine should be given to female patients only.
Patient reported to pharmacy on 11/7/13 with a raised red rash on both arms and legs. Patient was treated with ZYRTEC 10 mg tablets one daily after being evaluated by his primary care physician.
PATIENT CALLED AND STATED AFTER A COUPLE OF DAYS SHE NOTICED A HIVE LIKE AREA ON HER ARM AND OTHER PLACES ON BODY, STATED SHE HAD ALSO WORKED OUTSIDE IN A BARN RIGHT AFTER. PT WAS TOLD TO GO SEE A DOCTOR.
Patient described having a red, raised rash at the injection site that is warm to the touch. Two days after beginning of reaction, patient had encircled the original affected area and the next day it had slightly grown past the marking. Patient also states she experienced chills, aches, headache and mild nausea. Patient was advised to use cold packs, ibuprofen and diphenhydramine to help with symptoms until they are able to get ahold of their primary physician.
Dose administered after manufacturer date of expiry; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry).    No concomitant medications were reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The vaccine had been frozen with no known temperature excursion before being thawed today for administration.   The vial was initially stored in the refrigerator on 27-Feb-2023 .  The vial did not undergo any temperature excursions.  No treatment medications were reported.
swollen arm; Redness; Hot to touch; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), ERYTHEMA (Redness), FEELING HOT (Hot to touch) and PRURITUS (Itchy) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZ0A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), ERYTHEMA (Redness), FEELING HOT (Hot to touch) and PRURITUS (Itchy). On 25-Jan-2021, PERIPHERAL SWELLING (swollen arm), ERYTHEMA (Redness), FEELING HOT (Hot to touch) and PRURITUS (Itchy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information provided. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
Moderate sore arm by injection site about 12 hours after receiving shot and lasted only about 24 hours; fatigue and mild body aches around 24 hours after shot that lasted about 12 hours
pt recv vax 21APR95 & had a peculiar feeling in both arms on 22APR95;24APR95 pt had severe hypoglycemia;pt feels that vax was the cause of hypoglycemia;
VARICELLA 1: 6-02-2003; VARICELLA 2: 5-18-2007
Redness and swelling at site of SQ injection (MMR-V) on date of administration (6/25). On 6/27, redness increased and spreading second rim of pinkness. Area of reaction outlined. Parents advised to start cephalexin if redness spreads out of marked areas and/or fever.
pt exp redness & hardness 6 inches around the inj site, soreness & edema around the inj site, numb & tingling fingers, sore breast, sore wrist & nausea;also dysphagia 3hrs p/vax
pt stated that 10 minutes after receiving the covid vax her throat started closing so she went to the ER.  She had hives, chest tightness, and unable to breath.  They injected epi-pen and administered steroids, Pepcid and Benadryl.  She was released to go home after 5 hours.  The next day she had really bad sternum chest pain, back pain, neck pain and fatigue so she went back to the ER.  They did chest XRAY that came back clear, did an EKG w/ normal results, and blood work w/ high white blood count.  New RX for Naproxen 500mg, lidocaine patches, Zofran and has an EPI pen on order. Pt states since leaving the ER she still has fatigue, pain in neck, arm, back, and now in the face. She states her face is numb and has bad pain and blurred vision in both eyes, more so on the right side.  The ER told her to come back if she needed to FU.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 16-JUN-2009, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a different physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
mom reported t105 for 3 days p/DTP given 14AUG92; took to ER on 3rd day of t105;
This spontaneous report was received from a register nurse concerning a 60 year old female patient with high cholesterol, amoxicillin allergy and sulfa allergy. The patient's medical history included shingles in February 2012. On an unknown day, in September 2012 (one week ago) the patient was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). Concomitant medications included: ESTRACE. On 27-SEP-2012, the patient developed an outbreak of shingles on her arm at the ZOSTAVAX injection site. The patient received VALTREX as treatment for the event. At the time of the report, the patient had not recovered from the event. Additional information has been requested.
can't hardly walk/can't hardly move my legs; I'm terrible. I feel spacey; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received firs dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: not provided), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her COVID shot yesterday (18Jan2021) and stated "Today, I'm terrible. I feel spacey, can't hardly walk, I'm walking with a cane and I never walked that like that before. Just as soon as I got the first shot, I can't hardly move my leg". The patient asked if this will go away and what was the problem. Outcome of the events was unknown.  Information about lot/batch number has been requested.
Patient was administered a booster dose that may have been administered outside of the room temperature window. Janssen is good for 2 hours at room temperature.  Vial was out of the refrigerator for longer than 2 hours time.
Patient presented to ER severely hypothermic, and disoriented and what appeared to be sepsis with a leukocytosis.  Workup was negative for any cause of infection and was even seen by infectious disease. Patient had received his first Moderna vaccine that morning, and had no prior exposure to Covid 19 virus.