chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient given 0.5 ml of Moderna 6 mo-5 yrs vaccine instead of 0.25 ml
1st dose - 25Jan2021; 2nd dose 04Mar2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25Jan2021; 2nd dose 04Mar2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 030L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Influenza vaccine (flu vaccine) in September 2021. Past adverse reactions to the above products included No adverse effect with Influenza vaccine. Concurrent medical conditions included Atrial fibrillation (she takes unspecified medications.).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25Jan2021; 2nd dose 04Mar2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 25Jan2021; 2nd dose 04Mar2021) outcome was unknown.      No concomitant medications were reported.  Patient did not had Covid-19 diagnosis prior to or after getting the vaccine.  Patient had no history of allergies.  No treatment medications were reported.   This case was linked to MOD-2022-530257 (Patient Link).
Fever, Diarrhea, FEVER TO 101 F, CHILLS DIARRHEA 3 DAYS- LOST 2 DAYS OF WORK, USED TYLENOL
Severe injection site reaction including pain, swelling, redness, and warmth approximately 8 hours after administration.
12jun90 pt vax 3rd hepta B. pt devel swelling at inject site 2 3/4 by 2 1/2 inches.  27jun90 swelling subsided and left a hard sudcutaneous nodule.
Golf ball size swelling of left axillary lymph node with tenderness and  left arm numbness as if ?a tourniquet was placed on the upper arm.? This appeared on the second day after second dose of vaccine lasting about 48 hours. Swelling, tenderness and numbness started to resolve after 48 hours.
At 0600 on 23 Feb I woke up with a temp of 101.9 (normally, I am at 97.4) headache, stuffy head, body ache and a sore arm at the injection site.  I had elevated temperatures for the next 24 hours.  Headaches also lasted 24 hours.  Also, this was accompanied by fatigue.  Even the slightest exertion winded me.
Pt received her Pfizer vaccine. During post vaccine monitoring she began to complain of not feeling well. Pt complained of lightheaded/dizziness, headache, and weakness and transferred to wheelchair. Vital signs monitored (148/77, spo2 100%). Patient stated this is above her baseline and not usual. Patient began to complain of chest pressure and was transferred to EMS stretcher to continue to monitor and transferred to hospital.
6-2-17 4:00 P rectal temp to 103.4 vomited x 1. 6-3-17 5:00 am rectal temp to 104.6 vomited TYLENOL. Sent to ED and had neg work up for flu, neg U/A. Traveling and got MMR 5-26-17.
High fever, 103 degrees Fahrenheit lasting from approximately 10pm on the day of vaccination to the following morning at 5am.
Temperature of 100.7, chilling, tired, brain fog, runny/stuffy nose. Took Tylenol and rested.  Felt fine the next morning.
Patient was given Pfizer comirnaty 12yrs and old. Patient is 7yrs old at time of vaccination
After second Moderns COVID -19 vaccine, along with fever and body aches,  individual also experienced chest pain, which he called 911 for. He was kept in hospital for observation x 24 hours, and released with dx of chest pains  r/t body aches from vaccine. He states no long-term concerns.
Pt recvd 3 doses of Engerix-B vax & did not seroconvert; booster dose was adminstered; no tx was given;
Breakthrough case admission after 3 vaccines Pfizer 3/12/21 Lot# EN6206;  Pfizer 4/5/21 Lot# Ew0150;  Pfizer 10/21/21 Lot# 32030BD
Within 1-2 minutes of receipt of his immunizations patient exhibited a pattern of cutis marmorata involving all extremities, as well as several (half dozen) small urticarial lesions located over the lower legs and ankles and over the upper chest and back and one or two over the extremities. No treatment was given. The lesions disappeared within 20 minutes.
Sore Arm immediately and throughout the day/night following Muscle Pain in larger muscles, 24 hours after injection Headache feels like I am very dehydrated, ibuprofen Extreme Chills the first night, lasted 2 hours, took 4 ibuprofen for pain Nausea lack of appetite started 24 hours later Profuse Sweating after extreme chills  Itching all over started 24 hours later - claritan
Patient on cycle of Cefdinir, finished last dose on 12/31/2020. On 1/2/2021 patient broke out in a bad rash, hives, patches of red all over body. Went to ED. Patient reports same type of reaction after receiving shingles and pneumonia vaccines.
Adverse event started 1/20/2015 as itching over the left arm where she received her Td shot on 1/14/2015.  This was followed by redness over the same area which cause the patient to start scratching and applying ice on it.  On 1/21/15, patient noted that the redness was larger and the itching increased which prompted her to seek medical attention.
whole edge of my tongue all the way around turned bright red is sore kind of like burning, looked a little inflamed; tongue is hurting everywhere; whole edge of my tongue all the way around turned bright red is sore kind of like burning, looked a little inflamed; tongue is hurting everywhere; whole edge of my tongue all the way around turned bright red is sore kind of like burning, looked a little inflamed; tongue is hurting everywhere; This is a spontaneous report from a contactable consumer (patient).   A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: Unknown) at single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that "four hours after I took the vaccine the whole edge of my tongue all the way around turned bright red is sore kind of like burning, looked a little inflamed. It is like you drink a hot drink and you burn you tongue but I did not even realized when I was speaking and I was like my tongue is hurting everywhere." Outcome for events was unknown.   No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Left arm became painful, lost range of motion. Throbbing, stabbing pain. Lost ability to drive, lost ability to dress, and shower. Pain lasted longer than 6 days, loss of sleep.
BODY ACHE; SENSATION OF DIZZINESS; LACK OF ENERGY; FEELING SICK; HEADACHE ON ONE SIDE OF HEAD; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included acetylsalicylic acid for high blood pressure.  On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced sensation of dizziness. On APR-2021, the subject experienced lack of energy. On APR-2021, the subject experienced feeling sick. On APR-2021, the subject experienced headache on one side of head. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache on one side of head, and sensation of dizziness and the outcome of feeling sick, lack of energy and body ache was not reported. This report was non-serious. This same reporter case is linked to 20210440215.
Patient is a 40-year-old G2P1 female who received a hepatitis B immunization earlier today.  Several hours after the immunization, she noticed a itching red rash on her forehead and arms.    She was given diphenhydramine 25 mg of orally x 1 dose.   She was discharged in good condition.  She was told to take over-the-counter Benadryl 25 mg every 4 hours as needed for itching.   The ultrasound showed a 15 week viable intrauterine pregnancy. Blood type = B positive
This case was received from a health professional on 30 July 2007. An allergist reported that a 4-year-old patient with a history of allergies to milk, nuts, seeds, peanuts, eggs, and shellfish, had received dose four of Daptacel (lot number not provided, administration date unknown). The patient subsequently developed urticaria, swelling lips, itchy tongue, and slight wheezing, which lasted five hours. The patient was seen by a pediatrician and treated with antihistamines. The reporter did not have any additional information.
tired; This case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a 62-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st June 2022, the patient received the 2nd dose of Shingles vaccine. On 22nd June 2022, 1 days after receiving Shingles vaccine, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was not recovered/not resolved.   It was unknown if the reporter considered the tiredness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-JUN-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that she was a healthy person and received second dose of Shingles vaccine Tuesday afternoon (the day before reporting) and felt horribly tired all day on Wednesday (the day before reporting) and then on Thursday she felt okay and then today (Friday) on the day of reporting she really tired again. The reporter asked would this tired feeling subside soon.  Additional Supportive Information: The follow-up would not possible as no contact details were available.
Information has been received from a physician concerning a 61 year old female who on 10-JUL-2007 at 15:00 was vaccinated SC with a 0.65 ml dose of Zostavax (Oka/Merck)(lot # "3039U").  On 12-JUL-2007 at 15:00 the patient experienced redness and warmth around the injection site.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information from the administering health care professional indicated that the patient was going to watch the affected are. The patient's outcome was not reported. No further information was provided. Additional information has been requested.
This is a 22y.o. female with a past medical history of depression who intially presented for chief complaint of suicidal ideation with plan.  Patient reported that she lost her father this past fall and had worsening depression since this time.  She has had intermittent suicidal ideation with worsening suicidal thoughts for the preceding 2 to 3 days.  Patient's mother removed sharp objects in the home as she was contemplating cutting her wrists open. Patient denies any significant past medical history or surgical history. Patient has prior history of admissions for similar complaints.  In the ED, vitals stable.  Labs largely unremarkable. Patient was initially admitted to inpatient psych, however on 8/2 patient noted to have temperature of 103F with tachycardia in the 130's. She also noted HA, cough, and sore throat. Patient was found to be COVID positive and was transferred to medical floor. She is vaccinated against COVID.  Patient was treated supportively and did not require supplemental oxygen, antiviral therapy, or steroids.  Patient reported improvement in her mood and denied suicidal ideations.  Psychiatry was following.  Patient is cleared for discharge at this time with recommendations to follow-up with psychiatry as an outpatient.  Social work provided psychiatric follow-up resources to patient. COVID dc info provided.
At time of injection, pt had extremity twitch, eye dilation and became pale - after 3rd injection felt nauseous, had pulse of 60. Was kept supine and given juice. By 5 min felt improved.
Patient here to get Flu shot, shot given, patient felt fine. Patient checking out and said he didn't feel a thing. I was documenting immunization and a thump was heard, went to see and patient was surrounded by doctors. Patient taken back to room, where examined by doctors.
No additional AE details were provided and no additional AE's were reported; The HCP reports that the patient received a dose of PNEUMOVAX 23 after it was involved in a temperature excursion. .; This spontaneous report was received from a medical assistant referred to a patient of unknown age and gender.  The patient's medical history, pertinent medical history and drug reaction/allergies were not reported.  On 03-JAN-2023, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 ml, lot #U035117, expiration date: 18-AUG-2023, administered intramuscularly for prophylaxis (strength was not provided) (product storage error).  It was reported that the suspect vaccine was exposed to a temperature of minus 0.4 F for a time frame of 1 hour and 10 minutes, minus 14 F for a time frame of 5 minutes, minus 33 F for a time frame of 30 minutes, minus 27 F for a time frame of 25 minutes, minus 2 F for a time frame of 5 minutes, 16.7 F for a time frame of 5 minutes. The total time frame was 2 hours 20 minutes. There were no previous temperature excursions.   No additional adverse event (AE) details and no additional AE were provided (no adverse event).
Fever; chest pain, tighness in chest; shoulder, back, neck pain, body aches; shoulder, back, neck pain, body aches; shoulder, back, neck pain, body aches; headache and muscle spasms; headache and muscle spasms; This made it difficult for her to hold her bladder; short of breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 59-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6202, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 01Apr2021 09:30 (at the age of 59 years old) as Dose 2, Single for covid-19 immunisation. Medical history included High Blood Pressure and Asthma from an unknown date and unknown if ongoing. No concomitant medications were reported. Historical vaccine included first dose of bnt162b2 (COMIRNATY, Solution, for injection batch/Lot Number EM9809, Expiry date was not reported) via an unspecified route of administration, administered in Arm Left as Dose 1, Single for covid-19 immunisation. The patient had not tested COVID post vaccination. The patient had not received any other vaccine within 4 weeks. On 01Apr2021,(at 21:30) the patient experienced, ever, chest pain, tightness in chest, shoulder, back, neck pain, body aches, headache and muscle spasms, this made it difficult for her to hold her bladder and short of breath. As a treatment patient received Toradol through her intravenous site and sodium chloride flush. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood culture: negative on 02Apr2021, blood culture: normal on 02Apr2021, body temperature: 102 on unspecified date, body temperature: 103 on unspecified date, electrocardiogram: normal on 02Apr2021, x-ray: normal on 02Apr2021. The outcome for the events was unknown.  No follow up attempts are possible. No further information is expected
RUNNY NOSE, SLIGHT SORE THROAT TIRED, HIGH BLOOD PRESSURE
pt recv vax;unconsolable persistent cry for 50 minutes;erythematous rash on fore head;
constant headache and eye watering.  Feels like my eyes are being pulled out of their socket with severe headache pain behind my eyes and temples.  Symptoms began within 24 hours of 2nd dose.  Dr. has prescribed 2 rounds of antibiotics, steroids, and tamiflu to treat as sinus infection.  None of them have worked.  Tried over the counter headache medication and nothing will ease the pain.
Case number PHHY2011US65527 is an initial spontaneous report received from a pharmacist on 19 Jul 2011 with a follow-up from the pharmacist on 04 Aug 2011. This report refers to an 18-year-old male patient. He was given only the MenCYW lyophilized liquid component of MENVEO (batch number: M100053) intramuscularly at a dose of 0.5 ml on 15 Jul 2011. No other adverse reaction was reported. Follow-up received from the pharmacist on 04 Aug 2011: Updated information about vaccination details.
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were unknown. On multiple unspecified dates, the patients were vaccinated with improperly stored ROTATEQ (dose unknown, lot# L047185, expiration date: 17-SEP-2017) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Made all dormant illnesses/infections flare-up (etc. Hashimoto's, Epstein Barr, HSV-1) also affected menstrual cycle and symptoms. Experiencing extreme fatigue and weakness, headaches and brain fog, menstrual irregularities, and discomfort.
Patient fully vaccinated (J&J) but not boosted admitted to the hospital with COVID-19 associated symptoms
Initial unsolicited report received from physician (Practitioner) on 17-JUL-2018. This case is linked with case 1-1431861995 (2018SA198341) (same reporter). This case involves a four-month old male patient who was vaccinated with an expired dose of PENTACEL in left thigh (Batch number: C5400AA, expiration date: 24 June 2018, dose, route of administration was not reported) on 17 July 2018. Package: NDC: 4928151005, Lot: C5400AA, exp date: JUN242018, DTAP IPV: NDC 4928156005, LOT: 64999AB, exp. date: 24JUN2018, HIB vial: NDC 4928154515, LOT: C5400AA, exp date: 24JUN2018. It was an actual medication error due to expired vaccine used. It was not reported whether any adverse events occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
104.3 highest temp, only went down to 102.3 after Tylenol and Motrim regimen. Fever lasted a week. Finally broke after 3rd dose of an antibiotic. Very lethargic, lowest temp before antibiotic 101.3. Mother reported that visit was made to emergency room on 11-18-03 and doctor visit was made on 11-20-03 for unresolved fever and lethargy. Antibiotic prescribed. Fever returned to normal on 11-21-03.
Patient developed left shoulder pain approximately 48 hours after the second dose of Moderna. She then noted an enlarged lymph node just above her left collarbone. Node is about the size of a penny.
significant tinnitus on both ears; tingling fingers; fatigue; pain behind left knee; localize pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (significant tinnitus on both ears), PARAESTHESIA (tingling fingers), FATIGUE (fatigue), ARTHRALGIA (pain behind left knee) and VACCINATION SITE PAIN (localize pain on injection site) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced TINNITUS (significant tinnitus on both ears), PARAESTHESIA (tingling fingers), FATIGUE (fatigue), ARTHRALGIA (pain behind left knee) and VACCINATION SITE PAIN (localize pain on injection site). On 24-Feb-2021, PARAESTHESIA (tingling fingers), FATIGUE (fatigue), ARTHRALGIA (pain behind left knee) and VACCINATION SITE PAIN (localize pain on injection site) had resolved. At the time of the report, TINNITUS (significant tinnitus on both ears) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Patient called the pharmacy to report adverse reaction to administered vaccine. Vaccine was administered on Thursday. Patient reported that Friday morning she woke with a "very sore" arm that had limited range of motion and was "extremely painful" during the days following vaccine administration. Patient said it was not tender to the touch but has been sore. It showed slight improvement by Saturday afternoon and had improved more as of Tuesday. All symptoms indicate typical injection site reaction.
Baseball size rash on left arm that appeared 10 hours post vaccine.  She states it hurts a little bit but reports no other symptoms.  Recommended ice 4 to 5 times per day for about 20 minutes each time.  Oral pain relievers such as apap, ibuprofen if needed.  I mentioned Apap is preferred over Ibuprofen.
12 minutes post vaccination, the patient was sitting down and attempted to stand up to tell the observing health care staff that he was feeling "woozy." When he stood up, the patient fainted and fell to the ground. He appeared to be unconscious for 5-10 seconds and then came to. While he was confused for a few minutes, he was able to orient himself to place, time, and date. No treatment was administered. Patient's blood pressure was monitored throughout recovery time.
About 5 hours post vaccine arm was very sore. Applied ice 12-20 min. x 3 that pm.  11/19 About 1 1/2x more swollen than R arm and reddened. Also warm to touch. Reddened from deltoid area to elbow. Ice applied periodically next several days. Arm back to normal by 11/23/20
The day after vaccination I felt extremely lightheaded to the point of almost passing out. I also developed a welp at injection site that lasted a week a grew in size. It was beat red and hit to touch. It is just now starting to becoming lighter and decreasing in size
#2 vaccine given R. arm 3/31/2021 Left side of face red noticed  4/8/21, today 4/14/21 very red all r side of face and neck
Memory problems, joint pain, rib and chest pain, ulcers on fingers, bad circulation, Raynaud's, back and leg pain, extreme tiredness, loss of appetite, weight loss, strands of grey hair, panic attack, depression - more symptoms continued to pop-up - nothing has been cured.
Received vaccine-told me (mother) it was very painful when given. Several days later began complaining of fever (noted at night), fatigue, back hurting, joint pain. Then developed an unusual, productive cough. The cough and other symptoms lasted longer than 7-10 days. (We treated at home with analgesics, rest, nebulizer treatments).