chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a healthcare worker concerning a 21 year old female with no medical history and drug allergies who on 11-MAR-2009 was vaccinated intramuscularly with her second 0.5 ml dose of GARDASIL (660616/0570X). There was no concomitant medication. On 13-MAR-2009 the patient developed groin pain and a lump in her groin. The side of the groin that is affected was unspecified. The patient was seen in the physician's office. Sexually transmitted disease cultures were collected at the same visit that the second dose of vaccine was given. At the time of reporting (16-MAR-2009) the patient was not recovered. The patient was vaccinated intramuscularly with her first 0.5 ml dose of vaccine on 04-DEC-2008 (660616/0570X). This is one of several reports from the same source. Additional information has been requested.
Intermittent episodes of  double vision:  - February 2021  - April 2021  - June 2021 -   - August 2021  - October 8, 2021  - November 5, 2021  - December 5, 2021
Rash (about the size of a dollar bill and below injection site), Fever, Chills, painful shoulder and arm. Difficulty lifting arm, and fatigue.
12-6-14 All day tired and sleeping on the couch.  No appetite.  Not eating more than a half cup of soup. 12-6-14 Very bad rash all over both arms, rash also under breasts and on her back. Upper arm where injection was administered was swollen, red and very sore. 12-11-14 2:00 AM, Very dizzy, threw up, called 911 for ambulance. Had a silent heart attack according to doctor's report.
Information has been received from a physician concerning a female patient who was vaccinated with her second dose of Gardasil and developed hives all over her body. The hives were not concentrated to one specific area of the body. Medical attention was sought. The patient's outcome was not reported. Additional information has been requested.
Moderna COVID-19 Vaccine EUA Persistent sore throat rash/swelling around injection site , over a week after receiving.
A report has been received from a Health Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMISTS started on 03-Jan-2013. It was reported that patient experienced inadvertent administration of expired FLUMIST which started on 09-Jan-2013. The outcome of th event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious. Summary of insignificant follow-up information received 26-Feb-2013 from Health Professional: Form completed date has been updated Mar-2013. Name of manufacturer added, vaccinated at and purchased at has been added. Suspect drug start date and event start date added.
After 5 minutes received Pfizer bivalent covid vaccine, patient claimed dizziness, headache, nausea, no SOB or chest pain. Rph called 911 and paramedic checked her BG 93 & BP 99/60.
REDNESS, SWELLING AND PAIN IN RIGHT ARM; NAUSEA; PALPITATIONS; DIFFICULTY BREATHING.
extreme fatigue; sinus infections; bronchitis; achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, With the first dose I was fine. Zero side effects.), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "recovered", described as "achy"; FATIGUE (non-serious), outcome "not recovered", described as "extreme fatigue"; SINUSITIS (non-serious), outcome "not recovered", described as "sinus infections"; BRONCHITIS (non-serious), outcome "not recovered".  Additional Information: just wanted to take a moment to provide you with feedback regarding your COVID vaccine. I had both of my shots last Mar2021 and Apr2021. With the first dose I was fine. Zero side effects. With the 2nd dose I was run down, extreme fatigue and achy. That lasted 3 days. Before the vaccine I never got sick. I work in a school and had a great immune system. Since the vaccine I have had extreme fatigue, sinus infections and bronchitis. I have not had COVID. so bravo on that note.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dose / reconstituted with sterile water instead of the supplied adjuvant; Dose / reconstituted with sterile water instead of the supplied adjuvant; This case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 52-year-old male patient who received Herpes zoster (Shingrix) (batch number F4234, expiry date 3rd April 2022) for prophylaxis.   On 8th July 2021, the patient received the 1st dose of Shingrix. On 8th July 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The patient was administered a first dose of shingrix that was reconstituted with sterile water instead of the supplied adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The nurse gave permission for follow-up. This case had been linked with US2021151600, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151600:Same reporter.
Hives and angioedema beginning 8 days post-vaccination. Controlled short term with prednisone, hydroxyzine, Claritin, controlled long term with Claritin. Residual symptoms include rash, itching, dermographia. Symptoms have continued for 6+ weeks.
Pt devel hives surrounding the inject site 6 days p/recvd acellular pertussis vax; Hives resolved in 2 days w/DPH;
Yesterday evening patient reported hoarseness. Patient told by on-call MD to take BENADRYL which relieved pt's hoarseness.
arm was a little bit sore; vomiting; nausea; Neck pain; severe headache; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Neck pain), PAIN IN EXTREMITY (arm was a little bit sore), HEADACHE (severe headache), CHILLS (chills) and PYREXIA (fever) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058856) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023 at 8:00 PM, the patient experienced NECK PAIN (Neck pain), HEADACHE (severe headache), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, NECK PAIN (Neck pain), PAIN IN EXTREMITY (arm was a little bit sore), HEADACHE (severe headache), CHILLS (chills) and PYREXIA (fever) had not resolved and VOMITING (vomiting) and NAUSEA (nausea) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient's vaccinations details were as follows: Moderna COVID-19 vaccine on: Dose 1 1MAR2021, 002A21A, Dose 2 30MAR2021, 028A21A, Dose 3 28OCT2021, 076C21A, Dose 4 10JUN2022, 054A22A.  The patient's arm was a little bit sore and had some neck pain. Around 8:00 PM the patient had a severe headache, severe neck ache, chills, fever. Sick all night and couldn't take care of her animals. Also had vomiting, nausea. These symptoms lasted 24 hours before resolving. Patient used a heating pad on head, but had no medications to help with her symptoms.
It was discovered at teh end of the day on 12/12/2022 that the pfizer bivalent vaccine that was given was taken out of the fridge on 12/8/2022 at 8:55 AM. Vaccine was given on 12/12/2022 at 12:40PM. This was beyond the 12 hours that the vaccine was good for. Patient did not have a reaction at the time vaccine was given or 15 minutes following administration and has not reported reaction to the vaccine that was given.
Felt lousy; GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he or she received both doses of Shingles vaccine close together and felt lousy. The patient stated that he or she did not have issue, he or she may never gotten but was proactive. The patient stated that anything that gave you an edge is worth doing. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR052754:Same reporter, 1st dose
knife come up under her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (knife come up under her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (NO RELEVANT HISTORY PROVIDED.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (knife come up under her arm). At the time of the report, PAIN IN EXTREMITY (knife come up under her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
pt recvd vax;exp syncope sxs;became dizzy,stumbled to floor;momentary disorientation;color pale;BP & P nl;observed in hlth dept x 20-30mins;left hlth dept alert & oriented;BP 90/60;no further probs;
Large circular rash (larger than a typical cell phone in size) around injection site appearing 2 weeks after first dose.  Rash is slightly itchy, but not painful.
2-3 minutes after patient received immunization, she was seated and began to feel nauseous and dizzy/lightheaded. She reports that she then started trembling slightly and dropped her phone. Her mother was close by and saw her looking pale and starting to slump over in her seat so she went and caught her as she briefly lost consciousness (<30 seconds). The patient did not hit her head or fall onto the ground as she was being held by her mother seated next to her. Patient regained consciousness and it was noted that her lips were void of color. She stated that she still felt a little dizzy but was able to drank a mini water bottle and a bottle of orange juice, and  eat a granola bar. EMS arrive and evaluated her. She was found to have normal pulse ox and normal finger stick glucose level with all vital signs stable. She and her mother declined transport to ED and left for home. Patient reported that she has a history of anxiety surrounding needles, but this has not happened to her before.
Given 9/21/12 @ 445 pm, employee reports that on about 1 hour 5:45 she developed 5-6 round raised rash, each area size of a dime. They itched. No SOB, no other symptoms 9/24/12 I observed 2 area that remained. Raised plaques approx. 2 cm/1 cm wide. 10/1/12 areas flat, fading away.
Nausea, vomiting, stomach ache, headache, migraine, sore arm,  numb arm, fever
Pain in both biceps & pectoral muscles mainly at night. Severe enough to cause awakening from sleep. This level of pain lasted about 5 days. Still get some pain in biceps on excersion.
Patient was given an expired Hep B vaccination on 1-10-2022, by the medical assistant. The Hep B vaccine expired on 1-03-2022. Patient notified by this  Registered Nurse, that she would need to return to clinic for another Hep B vaccination. No adverse reactions. Pt. was understanding and states she will return to clinic.
Chest pain; Arm pit was burning; Felt tingling; Sweaty; Color of face went white; When lying down BP was higher than standing up; panic attack; Breast feeding; This spontaneous case was reported by a health care professional and describes the occurrence of CHEST PAIN (Chest pain), BURNING SENSATION (Arm pit was burning), PARAESTHESIA (Felt tingling), HYPERHIDROSIS (Sweaty) and PALLOR (Color of face went white) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included DULOXETINE from 06-Jan-2021 to an unknown date for Depression.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced CHEST PAIN (Chest pain), BURNING SENSATION (Arm pit was burning), PARAESTHESIA (Felt tingling), HYPERHIDROSIS (Sweaty), PALLOR (Color of face went white), BLOOD PRESSURE FLUCTUATION (When lying down BP was higher than standing up), PANIC ATTACK (panic attack) and BREAST FEEDING (Breast feeding). At the time of the report, CHEST PAIN (Chest pain), BURNING SENSATION (Arm pit was burning), PARAESTHESIA (Felt tingling), HYPERHIDROSIS (Sweaty), PALLOR (Color of face went white), BLOOD PRESSURE FLUCTUATION (When lying down BP was higher than standing up), PANIC ATTACK (panic attack) and BREAST FEEDING (Breast feeding) outcome was unknown.        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.   No treatment information provided.
pt recvd vax & 10 days following vax, devel full blown measles; was admitted to hosp x 3 days;
Bad diarrhea; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of   in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L2O4) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.  Treatment information was not provided/unknown.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
2 hour fever, chills, & injection site reaction (soreness, redness, and swelling).
S/p vaccination reports feeling weak, lightheaded w/associated nausea  Vitals assessed/ wnl; BP 125/85 P 66  O2 sat 98% RA Monitor x 30 minutes, po hydration, rest Expresses "feels better" Released from facility to home w/ wife
GAVE AN 18 YEAR OLD MALE HIS 1ST PFIZER COVID-19 VACCINE AND HAD HIM SIT DOWN FOR 15 MINUTES. ALMOST 5 MINUTES AFTER THE VACCINATION, THE PATIENT WAS SLOUCHED IN HIS CHAIR, SWEATING, LOOKING PALE, AND COMPLAINING THAT HIS BODY WAS HURTING ALL OVER. I RAN OVER TO THE PATIENT AND ASKED IF HE WAS HAVING TROUBLE BREATHING, TO WHICH HE DENIED. I BEGAN TO ASK HIM WHERE EXACTLY DOES IT HURT TO WHICH HE MENTIONED HIS LEGS AND BODY.  SINCE HIS BREATHING WAS FINE, I SUSPECTED IT WAS JUST A PANIC ATTACK BUT NONETHELESS I PROVIDED HIM AN ICE PACK AND WATER. WE ALSO MOVED HIM TO A MORE PRIVATE AREA TO ELEVATE HIS LEGS. I OFFERED TO CALL 911, BUT HE DENIED. WE KEPT HIM FOR 30 MORE MINUTES WATCHING OVER HIM TO SEE HOW HE PROGRESSED. HE FELT MUCH BETTER TOWARDS THE END. THE PATIENT ADMITTED HE WAS HAVING A PANIC ATTACK. MY TECHNICIAN OFFERED TO CALL A FAMILY MEMBER TO COME GET HIM, BUT HE DENIED AND SAID HE WAS OKAY TO DRIVE HIMSELF HOME.
Pt received Pfizer 2nd dose (LOT#: EW0187) at 1249 on 6/29/21. Patient alerted EMT at 1300 and stated that she felt dizzy during her vaccination and after receiving the vaccine. Patient was placed on anti-gavity chair by EMT at 1301. Patient was given juice at 1302. EMT took patients vitals signs at 1305. BP: 112/80, HR: 80, O2: 98%. Patient stated that she is allergic to onion and shrimp and she is currently not taking any prescription medications. EM reassessed and retook patient vital signs. BP: 114/78, HR: 84, O2: 98%. Patient stated that she was feeling normal and she no longer feels dizzy. Patient stated that she felt calm and relaxed. Patient state that she no longer felt dizzy or anxious. Patient left vaccination site at 1336 unassisted and with a steady gait.
Chills, nausea, intense headache, 39.45 Celsius fever, it started at 4 and didn?t go away until I took ibuprofen at 10pm and eventually fell as sleep at 11
Initial unsolicited report received from nurse (NP) on 25 February 2015. A 05-year-old male patient, whose concomitant medications were not reported, had received a fifth intramuscular dose of DAPTACEL (batch number- C4709AA) and intramuscular and third intramuscular dose of IPOL (batch number- K1649-1) (site of administration was left deltoid for both vaccines) on 24 February 2015. The patient had medical history of no know allergy. And had no illness at the time of vaccination. On 24 February 2015 same day after vaccination, the patient's left arm at injection was OK and experienced indurated and warm just below the injection site to a few inches below the elbow. The patient required ER/doctor visit. Laboratory investigations and corrective treatment were not reported. At the time of report outcome of events were not reported. List of Documents held by sender: None. Follow-up report received from a nurse on 10 April 2015. Patient was prescribed to take BENADRYL. On an unspecified date, patient had swelling. It was reported that patient was further needed testing and treatment. At the time of this report the outcome of the event swelling was reported as resolved and the outcome for other events were reported as unknown. List of Documents held by sender: None.
Swelling at injection site, headache, fatigue. nausea, fever, rigors.
Im not feeling good / something running around at my back and tummy; not feeling well; felt heat inside my body; headache; heavy on my chest; pain in arms; Feelings of weakness; side effects; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache) and CHEST DISCOMFORT (heavy on my chest) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache), CHEST DISCOMFORT (heavy on my chest), PAIN IN EXTREMITY (pain in arms), ASTHENIA (Feelings of weakness) and VACCINATION COMPLICATION (side effects). At the time of the report, FEELING ABNORMAL (Im not feeling good / something running around at my back and tummy), MALAISE (not feeling well), FEELING HOT (felt heat inside my body), HEADACHE (headache), CHEST DISCOMFORT (heavy on my chest), PAIN IN EXTREMITY (pain in arms), ASTHENIA (Feelings of weakness) and VACCINATION COMPLICATION (side effects) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: The follow-up information received contain significant information- New events added.
Moderna vaccine inadvertently administered to person under 18 years of age at nursing home vaccination clinic for residents and staff.  Administration error/deviation from EUA caught on review of consent forms by pharmacist overseeing vaccination clinic.  Nursing home administrator contacted by pharmacist on 11/22/21 (several hours after vaccination) who contacted mother & involved employee regarding error deviation & what potential ADR's to monitor for.  Followed up on 11/24/21 & 12/2/21.   No adverse reactions noted per mother & recipient as of 12/1/21 (both employees of nursing home).  Mother & recipient advised would have to receive Pfizer COVID-19 vaccination from local pharmacy that carries it for 2nd dose of series  28 days after first dose.
Fever to 101F, nausea, dizziness and muscle ache at site of injection with some fine rash. Reaction started 10/6/00.
1-25-2019 Client presented to health department today with Mother. She reports that client developed significant swelling at top of right thigh after vaccinations given on 1-15-2019. She reports that the swelling has gone away but that area has gotten red. Mom concerned. Assessed area on client's leg. Child has 3.5cm reddened area on right upper thigh at sight of varicella injection given on 1-15-19. Area is warm to touch. No swelling, knot, pustule, or drainage noted.  Area at injection site slightly darker in color than surrounding redness. Discussed with Mom appears to be local reaction to varicella but to seek medical care with any concerns.
This spontaneous report was received from a medical assistant and refers to a 35 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 30-APR-2018 the patient was vaccinated with M-M-R II (lot # N013279, expiry date: 28-APR-2019) (dose, strength and frequency were unknown) intramuscularly instead of the recommended subcutaneous route for prophylaxis. M-M-R II reconstituted with sterile diluent (MRK) (lot# N015479, expiry date: 23-JUL-2019). No adverse effects were reported. No product quality complaint was involved. It was reported that, no prescription drug treatment was required for the event. This is one of two reports received from the same reporter.
Patient presented to our hospital 6/29/21 with x 3-4 weeks of progressive dyspnea on exertion and dry cough. She was subsequently found to have a pericardial effusion s/p pericardiocentesis and drain placement on 6/30. Fluid analysis was not indicative of bacterial pericarditis and blood+pericardial fluid cultures are no growth (fluid 37% neutrophils, 54% monos, 5% lymphs, normal glucose. Reportedly 750 mL of straw colored fluid was removed during the pericardiocentesis. The pericardial drain was left in place. RPR is negative. Path report from 6/30 pericardial fluid indicated no malignant cells seen, "by immunochemistry the epithelial cells are positive for cytokeratin 7, calretinin and WT-1, and negative for estrogen receptor, GATA-3, BerEP4, CDX-2, PAX-8, Claudin-4, TTF-1, p40, and keratin 20. Reactive mesothelial cells are favored." Unfortunately she did have subsequent reaccumulation of her pericardial fluid s/p redrain and growing Proteus on 7/8, now being treated as a suppurative pericarditis. Thought is that she did not initially present with bacterial infection, but subsequently developed Proteus infection  from drains and surgical exposures. No history of trauma nor immune disease.  She reports no history of imbedded ticks nor erythema migrans, but we are sending for Lyme serologies. We are also sending for galactomannan and enterovirus PCR.