chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included sterile diluent lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the sterile diluent used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old male patient. The patient administered the vaccine on 20-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014064: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
p/vax pt exp swelling in arm from deltoid down to wrist;pt sought unspecified medical attention;
Reported nausea/dizziness/SOB. Called over EMT for eval.  BP and HR normal. Pt reports feeling better. EKG normal.
Swelling and bruising 6 to 8 hours after injection. On 12/10 was instructed to see MD and MD suggested possible infection and blood vessel hit.
No adverse symptoms reported; Inadvertently received an expired dose of VAQTA; Information has been received from a physician concerning to a patient (age and gender not reported). No medical history, concomitant medications nor concurrent conditions were reported. On 27-SEP-2019,  the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (Lot No. R021233, exp. date 05-SEP-2019) for prophylaxis. No adverse symptoms were reported.
washed out feeling; Felt worse; Headache; Felt terrible; Achy; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt terrible), PAIN (Achy), MALAISE (Felt worse), HEADACHE (Headache) and FATIGUE (washed out feeling) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 0131L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced FEELING ABNORMAL (Felt terrible), PAIN (Achy) and HEADACHE (Headache). On 27-Feb-2021, the patient experienced MALAISE (Felt worse). On 02-Mar-2021, the patient experienced FATIGUE (washed out feeling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Felt terrible), PAIN (Achy), MALAISE (Felt worse), HEADACHE (Headache) and FATIGUE (washed out feeling) outcome was unknown.            Patient  reported that she took two Tylenol. On 27 Feb 2021, she stated that she "felt worse" and took two additional Tylenol.  Action taken with mRNA-1273 in response to events was not applicable.
Intense painful chest pains. At one point I collapsed onto the ground and could not breath it hurt so bad, it felt like my heart was being squeezed and then my arm started to hurt. I thought I was having  a heart attack. After a few minutes I could breath again but that was one of the scariest experiences of my life. The chest pains continued for months after the vaccine. None of them where as intense as the time I collapsed but they still hurt and have not subsided. I have never had chest pains before until I took the vaccine. I have never experienced chest pain like it even when running 26 mile marathons. Three days after taking the vaccine my left eye watered and cried constantly. I have always had perfect vision and never had watering or randomized crying in one of my eyes before. It has not stopped and has proceeded since taking the vaccine. In fact my vision sometimes gets blurry in that eye now.
pt rcvd vax; pt's arm was warm,itchy,swollen; pt tx w/ APAP; in eve pt devel chills & t 100;pt tx benadryl cream;
Diarrhea and rectal bleeding; slight on day of vaccine; increasing to very bad at two weeks post
lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "lymphadenopathy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
red, swell, increased urticaria and under arm warm to touch. (R) Deltoid area No adverse rxn reported from any previous vaccination.
Patient was educated one on one on Moderna vaccine, a nurse and a dialysis tech read the health questions which patient answered. Patient signed consent to receive Moderna vaccine. It was administered intramuscularly by an RN one hour after initial dialysis treatment per policy. Patient was observed for 15 minutes, no adverse reaction was noted. Her dialysis treatment went well. When she came out of treatment area, she handed the vaccination card to her husband. Her husband told the technician who assisted her that she had her first dose already at external location. He did not have the card available at the time but he brought at the next treatment. Her 1st dose was given on 3/3/21 at clinic. The staff reported the incident to Clinical Services. Clinical Services advised staff to follow up with patient, call patient if she is feeling adverse symptoms. Patient was called on 3/9 , she reported no unusual symptoms. She said she feels fine. She came for dialysis treatment on 3/11, 3/13, and 3/16 and 3/18. She denies any unusual symptoms reports that she's ok. She was seen during monthly rounds today by Dr.
Initial report received on 30 June 2009 from a health care professional. A 47-year-old female patient, who has a history of migraine headaches and allergies to aspirin and antihistamines, had received a dose of ADACEL (lot number, route and site of administration not reported) on 30 June 2009 at 09:30 am. Approximately six hours after vaccination around 16:00 pm the same day, the patient had a feeling of nausea and dizziness, and her chest was feeling warm and it was hard to breath. The patient presented to an urgent care facility as advised by her health care provided and was evaluated by a physician. Treatments received were not reported. No diagnostic tests or laboratory data were reported. At the time of this report, it was unknown whether the patient had recovered. Documents held by sender: None.
48 HOURS AFTER RECEIVING JAPANESE ENCEPHALITIS VACCINE, PT PRESENTED TO CLINIC WITH RASH ON TRUNK, NECK AND FACE. SAW PHYSICIAN ON 6-5-08 AND WAS RX'ED BENADRYL,AND HCT CREAM.
Shingles. Eye on right side, eyelid, right forehead, up into hair on right side into crown of head on right side.
No adverse event. Patient received injection of FluBlok outside the recommendation of 18 years. To date (12/11/2020) patient has not had any adverse events.
10/17/2017 - Called c/o  H/A photophobia since vaccine. Fever x 1 day with bodyaches. 11/21/17 called to report she was seen by Dr. for continued issues including cognitive problems x 1 month. Weakness to right side of body (slowly improving) had N/V. 4 days after vaccine all symptoms started.
General itchy rash on arms, legs, and trunk. Short term blisters on skin lasting approximately 1 hour each.
Tinnitus and whooshing sound , stuffiness in both ears and feeling of ears being blocked , bilateral hearing loss,  symptoms more severe in left ear since last week of February. It took me a few weeks to get an ENT appointment scheduled. ENT surgeon consulted  , Bilateral hearing loss as evidenced by  two audiograms,  ENT surgeon advised more tests including  another audiogram.   Saw ENT on March 24 ,2021, next appointment scheduled for April 9th No history of any hearing problems before this event started, no history of any health problems , no chronic diseases or on any medication.
Incorrect vaccination given. Patient did not have any symptoms. correct vaccine was given in opposite arm as outcome
Within one and one-half hours after flu vaccine random hives developed, then followed by a very bumpy and itchy rash; throat and roof of mouth felt scratchy; tongue felt tingly; took Benadryl and symptoms became less; continues to take Benadryl approximately every 4 hours since after event and today it is 10/13/23 and will continue to take until symptoms go away.
IMMUNOCOMPROMISED PATIENT WAS GIVEN 0.5ML DOSE FOR 4TH COVID SHOT INSTEAD OF 0.25ML PATIENT HAS NOT EXPERIENCED ANY PROBLEMS AND NO TREATMENT WAS NEEDED.
Approximately 3? round rash/discoloration at injection site accompanied by small bumps and itching, some aching. Occurred about 10 days after vaccine. Treatment by dermatologist: Betamethasone cream to be applied for two weeks. Started improving within two days and is almost gone now (02/08/2021). However, arm still has minor, deep muscle aching, especially when lifting arm.
I did the vaccine got so sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK receipt date: 24-AUG-2022 Reporters comment: This case was reported from the patient via interactive digital media. The patient stated that he/she received the vaccine got so sick. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Soreness in vaccination sight. Tightness in muscle. Restricted movement with the left arm. Slight shortness of breath.  Low-grade fever (99.6 F).  General joint discomfort.  Flu-like  symptoms. Fatigue.
Received vaccine, 3.5 min later fainted, hitting head. Regain consciousness, reported nausea, vomited. Ambulance called, vitals stable. IV started, pt transported to hospital. CT revealed a sub cranial bleed, craniotomy performed at hospital.
This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of RECOMBIVAX HB (Lot # not provided) which were exposed a supported temperature excursion, continued to be administered to unspecified patients on unspecified dates since 07-AUG-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
Felt lightheaded about 1 hr after vaccination, symptoms continued into the evening. Body aches, headache, fatigue started that evening lasting about x2 days. Intermittent fever & chills began last night 2/28/2021, again today. Took tylenol, which helped with fever. Contacted her PCP who has scheduled a virtual visit with her for Wednesday 3/3; also has scheduled a covid test today. No other symptoms at this time.
11/03/2021 29 yo male presents to clinic for bilateral shoulder pain and weakness, experiencing numbness and tingling in fingers, more the right, and bilateral shoulder pain. States symptoms began 10/29/2021 Also has red spots down both arms and palms. Has not had this happen before. Noted numbness and tingling of his r arm and itchy hives on his right forearm which migrated to his chest, left arm, then diffusely. Ordered, ibuprofren, CBC/CMP/TSH at that time was normal 11/12/2021 pt was prescribed prednisone 40mg x 5 days by provider which pt states helped but after stopping experienced rebound urticaria  Seen in the ER on 11/17/2021 for ongoing rash, Right eye swollen shut. Rash noted to neck and chest. States that he feels like throat getting tight. SOB, mouth edema, severe allergic reaction  ER Meds:  Medication Dose Route sodium chloride 0.9% (normal saline bolus) 1000 mL IV Piggyback (Intravenous) EPINEPHrine (EpiPen Auto-Injector) 0.3 mg IntraMuscular methylPREDNISolone 125 mg IV Push (Intravenous) diphenhydrAMINE (Benadryl) 25 mg IV Push (Intravenous)  Seen by PCM on 11/19/2021 for third week of urticarial ordered Zyrtec 10-40mg daily- Pepcid 20mg BID  cetirizine, 1 tab(s), Oral, BID, PRN allergy symptoms,  11/04/2021 09:00 PDT   WBC 7.8 (4.5 - 13.0)  12/02/2021 08:25 PST   WBC 16.8 (H) (4.5 - 13.0)   12/17/2021 11:37 PST   WBC 6.6 (4.5 - 13.0)  12/02/2021 pt is now on the threshold of chronic urticaria with intractable symptoms we initiating Xolair (omalizumab), to control symptoms, an anti-IgE monoclonal antibody that is FDA-approved for chronic idiopathic urticaria and adults and adolescents 12 years of age and older who remains symptomatic despite H1 antihistamine treatment. Ordered to continue high dose antihistamines and Pepcid- Xolair 300mg q 4 weeks 12/07/2021 Spoke with pt states hives are well controlled, has residual itchiness for which he continues to take high dose antihistamines.  Pt took his last dose of prednisone 10mg yesterday.
Patient presented to the ED on 3/2/22 for chest pain. Patient presented to the ED and was subsequently hospitalized on 3/8/22 for severe sepsis, acute hypoxemic respiratory failure. These visits are within 6 weeks of receiving covid vaccination.
face swollen (described as skin hanging over eye, big pocket of skin under both eyes); skin hanging over eye,big pocket of skin under both eyes; both eyes were puffy and itchy; both eyes were puffy and itchy; left eye was irritated; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EYE IRRITATION (left eye was irritated), PERIORBITAL SWELLING (both eyes were puffy and itchy), SWELLING FACE (face swollen (described as skin hanging over eye, big pocket of skin under both eyes)), EYE SWELLING (skin hanging over eye,big pocket of skin under both eyes) and EYE PRURITUS (both eyes were puffy and itchy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 04-May-2021, the patient experienced EYE IRRITATION (left eye was irritated). On 05-May-2021, the patient experienced PERIORBITAL SWELLING (both eyes were puffy and itchy). 05-May-2021, the patient experienced EYE PRURITUS (both eyes were puffy and itchy). On 07-May-2021, the patient experienced SWELLING FACE (face swollen (described as skin hanging over eye, big pocket of skin under both eyes)) and EYE SWELLING (skin hanging over eye,big pocket of skin under both eyes). The patient was treated with TOBRAMYCIN on 05-May-2021 at an unspecified dose and frequency; OFLOXACIN on 06-May-2021 at a dose of 0.3 % and FLUOROMETHOLONE on 07-May-2021 at a dose of 0.1 %. At the time of the report, EYE IRRITATION (left eye was irritated), PERIORBITAL SWELLING (both eyes were puffy and itchy), SWELLING FACE (face swollen (described as skin hanging over eye, big pocket of skin under both eyes)), EYE SWELLING (skin hanging over eye,big pocket of skin under both eyes) and EYE PRURITUS (both eyes were puffy and itchy) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-193722 (Patient Link).
only the liquid portion was administered; only the liquid portion was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA728A, expiry date 30th September 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Feb-2023 Reporter's comment: The nurse told that this event was discovered because a vial of Menveo was left alone in the fridge, so they were not sure about when this dose was administered, or to whom it was administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient inadvertently administered only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Employee/patient reports that the injection was given high in her upper arm,  superior to the usual deltoid placement, nearly at the acromion process.  She felt pain almost immediately following the injection. Throughout the evening, her arm became more stiff and she had difficulty moving it in any direction.  Range of motion improved some over the past couple of weeks, but she continues to have pain with certain movements of her left arm.  She denies any associated redness or swelling. She denies associated numbness or tingling. She denies any fever or chills.
Redness and swelling to left thigh. Clindamycin Palmitate 7 mL, 3 times a day x 10 days.
Starting on 11/01/2022, I had a sore throat, cough, fatigue, slight fever, and congestion with a runny nose that lasted two to three days. I treated my symptoms with some ZYRTEC before calling the advice nurse. She advised that I speak with a physician. The physician advised that I take MUCINEX DM. I have been taking that for around three days and it seems to have helped. I no longer have a sore throat but do still have a bit of fatigue and congestion. However, it is not keeping me from my everyday activities.
Patient's arm progressively lost range of motion through the day and he described shooting pain down his arm. After school (15:00), he could extend his arm minimally, he could not lift his arm over his head, and  said it was not like the usual pain after other shots he's had in the past. I looked at his shoulder and realized the injection site was very high on his shoulder and not consistent with landmarks for IM injections for the deltoid. I called pediatrician, who said to ice the shoulder and give ibuprofen. We gave the ibuprofen two days and he still has problems with range of motion.
Bleeding from mouth/lip.  Took 45 minutes to stop bleeding.  Significant amount of bleeding soaked through a hand towel.  In addition, noticed bruising on right hand and arms and legs.  Also noticed pin point red dots on body.    No treatment received.  Bleeding from mouth finally stopped after 30-45 minutes.
Patient states she had redness, hard swelling, pain and a rash at the injection site. She also stated that the rash extended across her back and shoulders. She applied hydrocortisone cream to the affected area.
This spontaneous report was received from a registered nurse, concerning a female patient of unknown age. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 23-MAY-2018, the patient was vaccinated with the first dose of GARDASIL 9 (lot number N010497 with expiration date on 15-JAN-2020) (strength and anatomical location were not provided), administered intramuscularly for prophylaxis. After vaccination, she had a pregnancy test which showed that she was pregnant. No adverse effect was reported. Her last menstrual period (LMP), estimated date of delivery (EDD), gestational age and trimester of exposure were not provided. At the time of this report, the pregnancy outcome was pending.
15SEP93 well child check-recvd vax & later pt choked, turned blue was stimulated by nurse & started to breathe again; dx taken to hosp adm/monitored w/o further problems;
I woke up on Saturday 3/13 and noticed that my vision on my left eye was very fuzzy and stayed that way for a few days. I made an appointment to see my optometrist on Wednesday 3/18 and he referred me to a retina specialist Dr. I saw Dr on Friday 3/19. He ran tests and diagnosed me with branch retinal vein occlusion in my left eye. This is typically caused by a blood clot in the eye. The occlusion caused swelling in my retina and macula which caused my vision loss. I was treated with an injection of Eylea (anti-VEGF) to reduce the swelling on my retina/macula. I will need to have these injections every 4 weeks to maintain my sight.
Patient received SHINGRIX in the right deltoid and AFLURIA in the left deltoid on 10/1/2018. Per 10/2/2018 Primary Care note, patient reported generalized myalgias and dizziness 6 hours after receiving vaccines. Also has bilateral erythema and possible early cellulitis at both upper arms R greater that L. Given push fluids, Tylenol PRN fever, and Z-Pak.
Initial information received on 20-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female patient of unknown age who couldn't lift up her arm, after she received vaccine TETANUS TOXOID. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On 21-Nov-2018, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in the shoulder nos. On an unknown date, The patient couldn't lift up her arm following the administration of TETANUS TOXOID. No lab test reported. Final diagnosis was mobility decreased. It was not reported if the patient received a corrective treatment. Outcome of the event was not reported.
Went for an afternoon walk and experienced previously ankle injury agitation. Started on right ankle then progressed upwards with joint pain. Also had some nausea and headache. Experienced frequent urination throughout the night.