chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My first dose of Moderna had little to no symptoms. My 2nd dose of Moderna (administered 04/13/2021) came with heavy side-effects, which included about 48 hours of fever, body aches, and chills.  Following the clearing of the fever, I experienced gross hematuria which lasted about 5 days.  Very dark brown to red urine, but with no pain.  This was treated as a UTI through my local urgent care.  On 11/17/2021, I received my booster shot of Moderna and experienced the same symptoms with similar severity for about 48 hours.  Following the clearance of the fever and chills, I again experienced the gross hematuria.
24hr post vax pt devel soreness & redness @ site;poss temp;2x3cm spot on arm;sore & tender to touch;rxn treated for cellulitis;warm compress;
20 minutes after vaccination patient started to to feel mild fullness sensation on throat (similar feeling to banana allergy).  Self resolved after 5 minutes
approx 5hr p/vax pt devel an inj site rxn characterized by an 80mm by 90mm area of erythema, induration & pruritus;pt applied ice to the area & recovered p/5 days;this is 1 of 9 pt from this facility to devel an inj site rxn p/flu vax;
I will say my last couple bouts were less painful at least.; got vaccines after shingles; I will say my last couple bouts were less painful at least.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles about 10 times). Previously administered products included Antiviral. Concurrent medical conditions included cancer, nerve pain, blistery rash (had the itchy rash of blisters) and pruritus (had the itchy rash of blisters).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: I will say my last couple bouts were less painful at least.), product use in unapproved indication (Verbatim: got vaccines after shingles) and unexpected therapeutic effect (Verbatim: I will say my last couple bouts were less painful at least.).  The outcome of the pain was not reported and the outcome of the product use in unapproved indication and unexpected therapeutic effect were unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-MAR-2023. This case was reported by a patient via interactive digital media. The patient had it about 10 times and it was excruciating.  The nerve pain was relentless, itchy rash of blisters and it lasted several weeks each time and it was debilitating.  The patient got the vaccine after had Shingles a couple times. The patient say that conditioned last couple bouts were less painful at least.  The patient stated that everyone should get the Shingrix vaccines.  The patient become chronic but it was a bit less painful since the vaccines. The patient had to take antivirals during cancer treatments last year so did not got a breakout.  The patient stated that it was a horrid virus. The patient received Shingrix after having shingles which was less painful after vaccination which led to unexpected therapeutic effect and drug use for unapproved indication. The follow-up could not be possible as no contact details were available.
Patient received a flu vaccine during a community based vaccination clinic. Approximately 5-10 minutes after receiving the vaccine, the patient complained that her tongue was swollen and she felt like she had a rash on her trunk. No rash was observed, but patient's tongue was visibly swollen and speech was garbled. BP 160/90, HR 90. 911 was called. While assessing the patient, the tongue swelling and garbled speech resolved on its own. Patient stated she felt better. EMS arrived and assessed patient who remained asymptomatic. Patient was transported to ER for further evaluation. Patient did report a past history of GI symptoms after her first flu vaccination, but stated she had received other flu vaccines without any side effects or adverse reactions.
Pain in left shoulder joint (severe), dry eyes, low grade temp, body aches, itchy throat.
Narrative:  Patient presented to ER 10/31/2021, 11/1/2021, 11/3/2021, 11/4/2021, 11/6/2021 with same complaints of rapid heart rate, palpitations, chest pressure, shortness of breath, generalized pain. It doesn't appear when patient was ER these were documented occurring when present. Patient explained around 11/10/2021 symptoms seemed improved.
Severe headache, body aches, elevated blood pressure, sweats, weakness x48 hrs. followed by fatigue, intermittent HA, and joint pain, ear pain, lack of appetite, cough x5days total
Information has been received from a healthcare worker concerning multiple unspecified patients of unknown age and gender. Patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were administered with doses of improperly stored M-M-R II (strength, unit, frequency and route not reported, lot # L020188 with Exp. date 03-JUN-2017 and therapy type rHA). The vaccines were exposed to 1.6 degree for 5 hours and 51 minutes, and -8.6 degree for 4 hours and 46 minutes (two different days in February 2016), there was a previous temperature excursion with 4.1 degree and 20.1 degree for a total time frame out of range of 15 minutes in January 2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Weak; Loss of appetite; Fever; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), VOMITING (Vomiting) and FATIGUE (Fatigue) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced ASTHENIA (Weak), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), VOMITING (Vomiting) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (Weak), DECREASED APPETITE (Loss of appetite), PYREXIA (Fever), VOMITING (Vomiting) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up information received on 09-JUL-2021 contains no newinformation.
Information was received on 28-JUN-2017 from a registered nurse who reported that a 66 year old male patient received one dose of ZOSTAVAX intramuscularly (IM) (dosage not reported) on 28-JUN-2017 for routine vaccination. The patient has no past medical history, concomitant medications or past drug history. There were no labs run for the event. On 28-JUN-2017, the patient received the ZOSTAVAX vaccine that had expired the day before on 27-JUN-2017. The lot# is M024698. The physician's office will monitor the patient. As of 28-JUN-2017, the patient only received one dose of expired ZOSTAVAX and the outcome of administration of an expired vaccine was unknown. Reporter wanted to know if the dose needed to be repeated and was to be contacted if the patient needed to be revaccinated. Additional information has been requested.
Received Moderna vaccine through employer  Developed headaches and hot flashes ~24 hours after vaccination. Evaluated by me on 2/2/21.
This spontaneous report has been received from a medical assistant referring to an adult patient of unknown age and gender. The patient's pertinent medical history, concurrent condition, concomitant medication and drug reactions/allergies were not reported. On 28-NOV-2018 the patient was vaccinated with a pediatric dose of VAQTA 25/0.5 (1 dosage form; lot # R010368, expiration date 25-MAR-2019) via intramuscular for prophylaxis (inappropriate dose of vaccine administered). No adverse effects were reported in the patient.
Spoke with pt this morning. She got her 1st Covid vaccine at 10:15. She left at 10:25, said room was crowded and she had her  2 year old with her.    She reported feeling dry mouth and clammy at 1035.  Called Triage at 1109,(copied from Triage note):  Pt states that she received her first vaccine this am, about 45 minutes ago. States that she is having trouble swallowing, dry mouth, pressure in throat area, hands are clammy, feeling hot. All started just a couple minutes ago, got dizzy and lightheaded.   Pt has never had reactions to any other vaccines in her past. As she is talking, she is feeling worse. Taking benadryl now as we speak.  RN, 4/28/2021 11:10:16 AM > Pt is going straight to urgent care now, husband is driving. She has taken benadryl. Aware to call 911 if trouble breathing prior to arriving to urgent care. Will be calling pt back to check on her later today.    Pt did not go to  Urgent care as instructed, she went home and started to drive to Hospital.  She reported being a mile away from her house and felt her tongue swelling and poor vision. She called 911, was given epinephrine in car, prednisone and benedryl. Transported to Hospital and was observed for 4 hrs. Pt asking if okay to take Prednisone, trying to concieve and should she get 2nd vaccine? MD, 4/29/2021 11:19:40 AM > Should not get second vaccine.  Ok to take the prednisone taper as rx'd.
Nausea onset 10 hours after vaccine followed by repeated vomiting (approximately 7 times over 8 hours) and diarrhea (lasting 48 hours).
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Severe, Systemic: Lymph Node Swelling-Medium, Additional Details: patient states on her drive home her arms was "unbearably" painful and the next day was swollen, tender and warm to touch. thinks may have been in lymph nodes because she also experienced pain under breast and joint pain
PATIENT PRESENTED INFLAMED, REDNESS, AND MODERATE TO SEVERE URTICARIA AT THE SITE OF IMMUNIZATION. PATIENT WAS MANAGED WITH A COURSE OF DIPHENHYDRAMINE 50 MG.
Could not sleep last night; Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm; Red Injection site (2 quarters size); Swelling on the injection site; Itchiness on the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep last night), VACCINATION SITE PRURITUS (Itchiness on the Injection site), VACCINATION SITE PAIN (Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm), VACCINATION SITE ERYTHEMA (Red Injection site (2 quarters size)) and VACCINATION SITE SWELLING (Swelling on the injection site) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness on the Injection site). On 17-Sep-2021, the patient experienced INSOMNIA (Could not sleep last night), VACCINATION SITE PAIN (Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm), VACCINATION SITE ERYTHEMA (Red Injection site (2 quarters size)) and VACCINATION SITE SWELLING (Swelling on the injection site). The patient was treated with PARACETAMOL (TYLENOL) on 17-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA (Could not sleep last night), VACCINATION SITE PRURITUS (Itchiness on the Injection site), VACCINATION SITE PAIN (Pain on the Injection site/the pain is getting worst/Can not pick up her baby using her left arm), VACCINATION SITE ERYTHEMA (Red Injection site (2 quarters size)) and VACCINATION SITE SWELLING (Swelling on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient states that she could not sleep last night from the pain and she can not pick up her baby using her left arm.  No concomitant medication details were reported.
L arm redness 7x6cm, swelling 45rcm. DTaP #5 and IPV #4 given on 3/5/03.
This spontaneous report as received from a pharmacist refers to a female patient with no pertinent medical history. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (manufacture unknown) (lot # not reported). It was reported that on an unknown date the patient was allergic to PNEUMOVAX 23. The outcome of the event was unknown. The relatedness for the event was unknown for PNEUMOVAX 23 (manufacture unknown). This is one of several reports received from the same patient. Additional information has been requested.
Pt. briefly pale, weak & lightheaded after vaccine being given. Very nervous prior to injection. Laid down on exam table from few minutes. Drank cool water & had lollipop. Sat up & continued to wait for sisters appt. x 30 min.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.
1st dose of shingrix on AUG 2020,  2nd dose was given June 16th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number 34L52, expiry date 6th July 2023) for prophylaxis.   Previously administered products included Shingrix (patient got 1st dose of Shingrix in August 2020).   On 16th June 2022, the patient received the 2nd dose of Shingrix. On 16th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comment: The patient details were not available. The reporter consented to follow up. No email provided. Additional Supportive Information: The patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
swollen, tender left shoulder, nausea, vomiting, syncope referred to primary provider if symptoms worsen
My first dose I had a dead arm of 2 days? meaning I had reduced ROM and couldn?t lift my arm above my head with assistance of using my right arm. General soreness to injection site. I slept 14 hours the day after my injection and had no appetite for a few days. Fatigue and these onset of symptoms occurred 12 hours after my shot.  My 2nd dose similar symptoms.. not as sore or dead of an arm  as the first dose. Again general malaise that lasted a few days. Fatigue, Foggy and didn?t drive or even go on a walk as I was too weak and couldn?t think straight. My husband had to make me meals and I stayed in bed for a few days. Thankfully I didn?t have to work.  My booster shot was on a Wednesday. Again sore arm and fatigue. No appetite. My symptom hit me hard on that Friday when I was at work and had to leave early from my shift. I had worsening of these intermittent irregular heart rate and rhythm. Foggy, couldn?t tolerate bright lights, nervousness, diarrhea. A new symptom was this burning sensation at the base of my skull in my cervical spine. It was warm and aching. My spine ached. I felt out of control and couldn?t get comfortable. I bathed and put pajamas on and went to bed. I had chills. I slept?  I had to call off of work for that Saturday 10/13 and 10/14 because I was so weak. I had no appetite. I made myself eat and hydrate. My heart just kept acting up.
insidious onset lateral right foot pain at fibularis tendons from lateral malleolus to the base of 5th metatarsal
Patient received first dose of Moderna vaccine 1.5 months prior to turning 18 months of age.
Severe headache, body aches and sinus congestion with nasal pain. Took three days to recover with school time lost. Very severe headache for 29 hours.
Cellulitis of (R) arm, redness, swelling, warm to the touch.
Throat itchy, chest and back itchy, ears itchy, post nasal drip and cough.  Three days later, upper body including arms very itchy, throat itchy, post nasal drip and cough.
Patient received the first dose of Moderna vaccination on 3/26/2021. Patient states that the next day she started to develop mild chest pain that would come and go. Saw a medical provider on 4/5/2021 for sinus infection and was prescribed Augmentin. Patient states that soon after starting medication she started to develop a bumpy rash on her back and chest. Medication was changed to Zpack on 4/14. Rash continued. Patient received her second dose of Moderna vaccination on 4/23/2021. Patient states that chest pain has progressively worsened since 2nd dose. Was evaluated by provider on 4/27/2021 and prescribed Indomethacin for diagnosis of Pericarditis. Patient continues to have rash on chest and back.
I do not know, I was not the one the pt. reported to. I was advised by my supervisor to fill this out.
Headache, Diarrhea & NauseaVomiting Narrative: a few hours after the injection, he developed diarrhea, nausea, vomit once, and headache. The diarrhea, vomit and nausea resolved by the next AM, but the headache continued for 2 days.
This case was reported by a consumer and described the occurrence of oral thrush in a 14 day old male pt who received Hepatitis B vaccine. A physician or other health care professional has not verified this report. On an unspecified date in 2004, the pt received the 1st dose of Hepatitis B vaccine. At an unspecified time following administration of vaccine in 2004, the pt experienced oral thrush. The pt was seen at a physician's office. The event resolved on an unspecified date.
Patient's daughter called on her behalf to translate from Spanish. She reported that her mother was having "flu-like" symptoms approximately 3 weeks after receiving the J&J vaccine. She also mentioned that she was having a headache in the back of her head and neck which are known to be possible indication of a cerebral venous sinus thrombosis which has been rarely associated with the J&J vaccine. I advised the daughter to take the mother to the emergency department for further evaluation and she agreed that she would take her right away.
Felt hyper as if he took some cold medication; Positive benefit after first dose, lungs felt so good that he did not need to take any asthma medications, asthma complications (cough and phlegm) easily decreased by 75%; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (Felt hyper as if he took some cold medication) and POSITIVE DOSE RESPONSE RELATIONSHIP (Positive benefit after first dose, lungs felt so good that he did not need to take any asthma medications, asthma complications (cough and phlegm) easily decreased by 75%) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included LISINOPRIL for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PSYCHOMOTOR HYPERACTIVITY (Felt hyper as if he took some cold medication) and POSITIVE DOSE RESPONSE RELATIONSHIP (Positive benefit after first dose, lungs felt so good that he did not need to take any asthma medications, asthma complications (cough and phlegm) easily decreased by 75%). On 17-Mar-2021, PSYCHOMOTOR HYPERACTIVITY (Felt hyper as if he took some cold medication) and POSITIVE DOSE RESPONSE RELATIONSHIP (Positive benefit after first dose, lungs felt so good that he did not need to take any asthma medications, asthma complications (cough and phlegm) easily decreased by 75%) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was key'd up and ready to go (only lasted for a day).  No treatment information was provided.
Flu flu vaccine was not administered correctly. The dose was not injected into the muscle of the arm as recommended.
Heart palpitations, very cold feeling, chills. Wore full winter clothing in my house and while sleeping with blankets and a space heater
had screaming fit (shrill scream) for 45 mins; uncontrollable 4 hrs p/1st DTP; had low grade fever through noc & into next day; severe local rxn @ inject site-red, hot induration fifty cents piece size;
On the same day in afternoon, My left arm was 2 X2 inches and it was hot. that night 4 inch . The next am was 5 inches  like an extra muscle, big red and hard and hot for abt 2 months. In June2021. I couldn't reach my back it is painful. I couldn't move my right arm under that arm itself. I did go for physical therapy for 4 weeks. The arm from the shoulder hurt on the right side. Doctor - routine check in on 15JUN2021 . Physical Therapy on 25 jun2021 for 4 weeks.
On multiple unspecified dates, multiple unspecified patientes received improperly stored vaccine; No adverse effect; This spontaneous report has been received from a medical assistant, concerning a 9-week-old male patient.   The patient's concurrent conditions, historical conditions, previous drug reactions, or allergies and concomitant medication were not reported.  On 18-APR-2019, the patient was vaccinated with improper stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (dose, frequency, route of administration unknown) Lot#R016790 and expiration date 20-APR-2020 for prophylaxis. No adverse effects reported.  Additionally, temperature for vaccines were total time and highest temperature above 9°C (9.9 C); time frame: 4 hours; with no previous temperature excursion. The error was identified via a data logger.  This is one of several reports received from the same reporter.  This is an amended report. The reference "US-009507513-1903USA013366" was captured as E2B Linked Report; Sender's Comments:  US-009507513-1903USA013366:
A 61 year old male was exposed to a flying bat in the house while sleeping on 8/11/02. He had received post-exposure therapy following exposure to rabies. Following doses of Imovax and RabAvert, he experienced mediastinum pain and ache (pericarditis) after each dose of vaccine (Imovax and RabAvert). He had already received 4 doses of rabies vaccine. He is 12 years post atrial septal defect repair. Further information is pending. Additional information received on 9/17/02: The patient had used the word pericarditis for chest discomfort. This was not the diagnosis of the treating physician. There was no evidence of pericarditis as per this physician.
Multiple episodes of Atrial Fibrillation - Diagnosed at Emergency Room, March 2021 and at  Emergency Room on 28 March 2021.
Vaccinated with IPV and DTAP from health department on 05/12/04.  Mother brought pt into our office on 05/14/04 with complaints of increased edema, increased redness, increased warm to touch-gradually getting worse (+) fever up to 101F.