chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TERRIBLE BODY ACHES; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced terrible body aches, fever, and headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible body aches, fever, and headache. This report was non-serious. This parent/child case is linked to 20210439367.
Patient left work early due to heart fluttering and pain behind eyes.  He went home and tried to rest, but ended up feeling worse and went to Emergency Room.
Patient presented to ED @1500  with complaints of substernal chest pressure/pain.  Pain did not resolve and became increasingly more uncomfortable.  No recent medication changes or other concerning symptoms.  VSS stable and labs unremarkable except elevated troponin.   Admitted to hospital for further work-up. Cardiology consulted with recs for possible myocarditis treatment with high dose steroids and serial troponin monitoring.
Patient was given the vaccine and shortly after passed out, she was passed out for approximately 5-10 seconds before waking up and being responsive. Emergency was notified as soon as possible and EMS was sent to the pharmacy. While waiting to EMS, Patient was responsive stating she was nauseous and was given a plastic bag and a water from the store. As time went on she was more responsive and talking a bit more. Store pharmacist and store manager stood with patient and boyfriend waiting for EMS. EMS showed up approximately 10 minutes after phone call and assessed patients vital signs and did their eval. She was taken by EMS out to the ambulance for further evaluation.
Moderna COVID?19 Vaccine EUA: Injection site pain began within a few hours on Friday. Mild underarm pain began around 12:20 a.m. Saturday as I was getting to sleep, about 11.5 hours after the shot. It was uncomfortable raising my left hand over my head in the morning, about 8 a.m. Sunday. When going to sleep around 11 p.m. Sunday, the pain had worsened, making sleep uncomfortable. Around 2 a.m. Monday (today), I touched my underarm and it was painful to the touch.
I still have a bruise where I got the a shot; My arm still hurts bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site bruising in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of illness (1st dose January, reference case US2023AMR044368).   On 05-APR-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced injection site bruising (Verbatim: I still have a bruise where I got the a shot) and pain in arm (Verbatim: My arm still hurts bad). The outcome of the injection site bruising and pain in arm were not resolved.   It was unknown if the reporter considered the injection site bruising and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the injection site bruising and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-Jul-2023 This case was reported the patient via interactive digital media. The patient got the 2nd shot and still his or her arm hurt very bad. The patient still had a bruise where got the shot. Follow-up not possible as no contact details provided. For tolerance of 1st dose refer case US2023AMR044368, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR044368:Same patient, different dose
pt recv vax & approx 15min later exp dizziness/flushing/shaky feeling;BP 128/82, HR 84;tx w/epi;layed down approx 30min;
Initial and follow-up information has been received through the Merck pregnancy registry from a nurse practitioner concerning a 16 year old female who on 07-SEP-2007 was vaccinated with her first dose of GARDASIL IM. On 17-OCT-2007 a positive urine pregnancy test determined patient was pregnant (LMP = 14-AUG-2007). The patient also had prenatal blood work performed. The patient sought medical attention with an exam in the office. The patient's outcome is unknown. Follow-up indicated that the patient had a scheduled caesarean section at term, secondary to a decreased amniotic fluid index. It was reported that the patient "opted" for a caesarean section. The patient delivered a healthy infant with no anomalies and there were no complications. Upon internal review the decreased amniotic fluid index - resulting in a C-section was considered to be an other important medical event. Additional information has been requested.
2 days after vaccine was give on 5/20/21 around 430 she complained of chest pain that was sharp and pressure and that it was hard to breath.  She was taken to the ED for evaluation.  At the time of exam she was feeling better in her chest and complained that the pain had moved to her upper abdomen.  There were no findings on physical exam or heart monitor.  Her heart rate was elevated mostly in the 90's and low 100's.  No further complaints of chest pain, but continues to be achy 1 week post vaccine especially in her knees.
Took the vaccine and had a reaction to it; A spontaneous report was received from a consumer, regarding a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a reaction.  The patient medical history was not reported. Concomitant medications were not provided.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in unknown for prophylaxis of COVID-19 infection.  On 19-Jan-2021, after vaccine administration, the patient experienced reactio.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the events took the vaccine and had a reaction to it was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Pt recvd vax & was noted to be fussy & irritable; exp epileptic? attack--spasms w/lt hand & arm stiff; parents were unable to bend this arm; trembling; colic; throat irritation; dx meningitis/encephalitis; t106; ear infect, feel bad;
Information has been received from a nurse practitioner concerning unspecified number of patients of unknown age an gender. Patients' medical history and concurrent conditions were not reported. Between 06-APR-2015 and 30-APR-2015, unspecified number of patients were vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (dose, lot # and route were not reported). No adverse effects were reported. Follow up information has been received from a receptionist during a phone call on 02-JUN-2015. The reporter could not supply patient identifiers, lot numbers or dates of vaccination. Follow up information was received on 15-JUN-2015 from a nurse practitioner. The reporter provided the names, dates and lot numbers with expiration dates of the patients who received (Oka/Merck) VARIVAX which was incorrectly stored. A total of 22 patients received the improperly stored vaccine between the date of 06-APR-2015 and 30-APR-2015. On 17-APR-2015, a male patient of unknown age received (Oka/Merck) VARIVAX (lot number K021936, expiration date 10-NOV-2016. The vaccine was reported as improperly stored. No adverse event was reported. Follow up information was received on 16-JUN-2015 from a nurse practitioner. Multiple patients received the (Oka/Merck) VARIVAX which was exposed to higher than normal temperature. All vaccines were completed before the date required by the manufacturer. As of 16-JUN-2015, no vaccines were left from the event. Additional information has been requested.
My episode started with my mind racing with thoughts. Random and terrifying so much that these episodes became a concern and I sought advice. This all started with what happened after my 1st dose and it was like my nerves in my body was going haywire. Not so much tremors as maybe misfires and vibrations. Had some medical test leading up to my mental issue in relation to my body's nerves going off involuntarily. But when I got my booster, all of that stopped and my mental anguish began. My PCP referred me to a therapist and was advised on my current prescription Buspirone. The mental issues subsided after a few days. It currently seems I am episode free. May follow up in a few months or if new episodes occur update with my PCP.
EXPERIENCED ITCHING AND HIVES ALL OVER FACE AFTER LESS THAN AN HOUR OF RECIEVEING THE MODERNA VACCINE. I TOOK BENADRYL AND HIVES SLOWLY WENT AWAY BUT THE ITCHING SYMPTOMS REMAINED.
Mom said about 48 hours after shot, within 15 minutes, upper body waist broke out in very red and irritating hives. Mom gave her BENADRYL and hydrocortisone topical. Mom called Dr next day 11/16 to inform that blisters were almost completely dry. Doing better.
Child given vaccine that may have had temperature excursion (data logger failure) with stable fridge temps before & after. DOH determine the vaccine to be at risk & advised reporting & revaccination  Child had no ill effects thus far
Site:Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chills-Medium, Systemic: Dizziness/Lightheadness-Medium, Systemic: Flushed/Sweating-Medium, Systemic:Nausea-Medium, Additional Details: Patient had vasovagal response from vaccination and was sweating, dizzy, nauseaous about 1 minute after administration. Immediately after administration, noted swelling and some minor bleeding at injection site. Instructed pt to lie on ground on back with feet elevated for 15 mins and gave full water bottle and some ritz crackers. Pt improved at 15 mins and was monitored for another 15 minutes for total monitoring time of 30 minutes after administration. Patient was feeling well when he left.
This case was reported by a healthcare professional and described the occurrence of burning in a male subject of unspecified age who was vaccinated with HEPATITIS A vaccine, (manufacturer unspecified).  On an unspecified date the subject received unspecified dose of HEPATITIS A vaccine.  At an unspecified amount of time following injection with HEPATITIS A vaccine, the subject experienced burning and tingling.  The burning and tingling worked it's way down the arm.  The reporter stated that the events only last 2 to 5 minutes and then seem to be fine.  Resolution was not specifically stated.  The reported felt that this was not occurring say 6 months ago.  These events occurred in a number of different subjects from the same source, but with different contacts.  Linked cases included A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515, A732528A, A0732533A, A0732539A, A0732540A, A0732936A, and A0732944A.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided Treatment medications were not provided
Eyelids swelled shut bilaterally for 18 hours, treated with Benadryl. Myalgias, arthralgias for 72 hours. Local injection site pain 96 hours.
Approximately 10 minutes after vaccination the patient reported feeling "hot" and appeared lethargic. She lost consciousness, had mild full body tremors, and was unresponsive sliding down in her chair. She was pale and clammy. This lasted approximately 30 seconds. During this event she had urinary incontinence. She was assisted to a private area where she was given oral fluids and a snack. She was  observed for more than one hour. During this time her VS's were WNL. The provider attending her stated the patient became anxious when the subject of leaving was brought up. She reported having anxiety with shots.
Hot arm to touch; pain at injection site; sore to lift/move arm;  exhaustion
This spontaneous report as received from a public health, healthcare professional refers to unspecified patients of unknown age and gender. On an unknown date the unspecified patients might had vaccinated with improperly stored M-M-R II (lot#, dose, frequency and route unspecified), which were exposed to 53F for 12 hours and exposed to 54F for five hours. No adverse effects reported. Follow up information has been received from an office manager concerning 2 patients. On 19-SEP-2013 the two patients were vaccinated with improperly stored M-M-R II (H018181, exp. 05-OCT-2014), which were exposed to 54F for 5 hours (date excursion ended 06-SEP-2013). This is one of several reports received from the same source (linked MARRS#: 1311USA007619, 1311USA011609, 1311USA011610, 1311USA011611, 1311USA011612, 1311USA011613, 1311USA011614, 1311USA011615, 1311USA011617, 1311USA011618, 1311USA011619). Additional information has been received.
I just started to get freezing cold. No matter what I did, I was cold all of the time. Towards the end of the summer my blood pressure starting going up. Went to the ER for the high blood pressure. Prescribed medication for hypertension. I have been experiencing more shortness breath after the 2nd shot. I had a lung scan 1/3/2022 and they found enlarged nodes. I am a smoker.
Patient presented with swollen red, hot, itchy left upper arm (front and back, shoulder to elbow) on 7/29/2019 Advised her to go to doctor. I notified doctor. She wanted to wait and "watch it". I will follow up daily with her until it resolves
pt recv vax & devel mumps & was hospitalized following vax w/MMR; addtl details are being requested;
Sore in shoulder when I got the shot Skin turned red and was painful down to the armpit. Took 4 days to clear up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 26-MAR-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (dose, lot number, expiration date were not reported). No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a physician via company representative concerning a 11 year old male patient. The patient's concurrent conditions was not provided and his medical history was reported as none. On 11-OCT-2016, the patient was vaccine with the first dose of GARDASIL 9 0.5 ml, intramuscularly, lot # L040054 with expired date of 26-OCT-2017 (strength was not provided). Other suspect therapies administered concomitantly with GARDASIL 9 included meningococcal vaccine (manufacturer unknown) (start date, dose, strength, route of administration, lot number and expiration date were not provided) and tetanus toxoid (manufacturer unknown) (start date, dose, strength, route of administration, lot number and expiration date were not provided). At the time of the report the patient was taking Albuterol HFA 90 mcg as concomitant medication. The physician stated that about 5 minutes after getting vaccinated the patient was trembling. The medical attention and treatment were lay him down for 15 minutes and gave him cheese and crackers. At the time of the report, it was not known if the patient would complete the series of GARDASIL 9. At the time of the report the patient was recovered on unspecified date in October 2016. The causal relationship between the event and GARDASIL 9 was unknown. There was not intervention to prevent serious criteria and product quality complaint (PQC) involved. Additional information has been requested.
Case number PHEH2014US025143, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 75 year old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was in between 46 to 49 degree F during excursion. No adverse events reported after the maladministration (incorrect storage of drug).
Client complained of feeling nauseous. Client given bucket if needed and she requested water and felt better after having some..  She waited an extra 10 minutes and left facility with friend.
Patient reported "burning" sensation in R arm about - min. after inj. Skin on right arm patchy & mildly erythematous. She reported feeling less burning after 10 min cold application & erythema resolved after 20 min.
Right arm twitching; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Aug-2021 and was forwarded to Moderna on 09-Aug-2021.    This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (Right arm twitching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 MUSCLE TWITCHING (Right arm twitching). At the time of the report, MUSCLE TWITCHING (Right arm twitching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No information on concomitant medications were reported. No information on treatment medication was reported.   Reporter did not allow further contact
Red area became bigger; Arm felt hot; Itchy; Small, red ball with pimples; Felt kind of weird; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), ACNE (Small, red ball with pimples), FEELING ABNORMAL (Felt kind of weird), ERYTHEMA (Red area became bigger) and FEELING HOT (Arm felt hot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (Itchy), ACNE (Small, red ball with pimples) and FEELING ABNORMAL (Felt kind of weird). On 02-Feb-2021, the patient experienced ERYTHEMA (Red area became bigger) and FEELING HOT (Arm felt hot). At the time of the report, PRURITUS (Itchy), ACNE (Small, red ball with pimples), FEELING ABNORMAL (Felt kind of weird), ERYTHEMA (Red area became bigger) and FEELING HOT (Arm felt hot) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Treatment for the event included ice.
12 month old child was inadvertently given a Typhim vaccine / no AE; Initial information received on 08-Jan-2020 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 months old female patient who received 0.5 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM] (lot number-RZA301M and Expiry date- 31-May-2021) via unknown route in right vastus lateralis on 07-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included YELLOW FEVER VACCINE (YELLOW FEVER VACCINE),INFLUENZA VACCINE (INFLUENZA VACCINE), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN); VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) and HEPATITIS A VACCINE (HEPATITIS A VACCINE).  It was an actual medication error case due to inappropriate age at vaccine administration.   At a time of reporting no adverse event was reported.  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.
little body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (little body aches). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PAIN (little body aches) was resolving.            No concomitant medication details was provided.
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of SHINGRIX in left arm a little over 1 month before the date of reporting. The patient developed a rash at the injection site. The rash lasted for approximately 1 week, then went away. The reporter did not consent to follow-up.
Airway constricted, filled. Wheezing, coughing. Heart rate increased. Overall- an asthma attack, which I haven't had in over 20 years. Treated with vaporizer, relaxation techniques, and Vicks Vaporub. Difficulty breathing continued, but lessened as the night wore on (completely clear by morning)- the most severe lasted approximately 30-45 minutes.
patient reported tingling and spasms in left face , was referred to pcp or ER . pending outcome from medical expert.
5 days after covid vaccine, my R ankle became red, hot, swollen and painful to walk on. Saw PCP 2days later who referred me to ortho who thought it was some type of inflammatory condition. Told me to wear brace or boot- could not tolerate either due to pain, edema. Ankle got worse- could not walk on it at all and I became febrile. Ortho told me to go to ER to R/O a blood clot or septic arthritis.
+11 hours- chills &body aches (ongoing) +15.5 hours- fever 101 +17 hours- fever 100.5, headache, nausea (ongoing)
Pt. c/o bilateral knee swelling & pain beginning 10d after receiving several vaccines.