chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about patient's medical history, concurrent conditions and concomitant therapy provided. On 06-APR-2012, the patient was vaccinated with the first dose of RECOMBIVAX HB with strength 5 mcg/0.5 ml (lot number, expiration date, dose and route of administration were not reported). Subsequently, on 24-NOV-2015, the patient was vaccinated with the second dose of RECOMBIVAX HB (lot number, expiration date, dose and route of administration were not reported). This dosing schedule was outside the labeled recommendations in the RECOMBIVAX HB prescribing information. No adverse effect was reported. Additional information has been requested.
no adverse event; The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine) and NO ADVERSE EVENT (no adverse event) in a 9-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 25-Mar-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine) and NO ADVERSE EVENT (no adverse event) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The patient received a Moderna Monovalent vaccine instead of a Moderna bivalent vaccine).    No concomitant medications were reported.  No other adverse reactions were reported.  No treatment medications were reported.
Maculopapular rash of face, thorax, arms and proximal legs. Exanthem of palate and buccal mucosa. Posterior cervical adenopathy.
Pt presented to ER early the following am, with seizures. Pt reports having a small reactions immediately after vaccine administration. Pt reports muscle stiffness, eyes rolling back, shaking, diaphoretic. Pt also reports having a second episode of syncope when she arrived home.
Pt presented to ED with weakness, diarrhea, afib with RVR. Pt started on xeloda a month prior by oncology and had be told 2 days prior to stop medication d/t GI side effects including nausea and vomiting. Pt tested positive for COVID and was started on remdesivir as presentation was unsure of drug side effect vs. COVID involvement. Diarrhea persisted and pt was tried on imodium and lomotil. GI effects seem to be improving.
I had chills and tachycardia, very elevated heart rate and just palpitations enough to get me scared to go to the ER. They a series of test to check that I didn't have a heart attack. Things were fine and they said it was probably reaction to the vaccine. Sadly it's happened a lot after. Now I have heart arrhythmia which I never had before.
I had a break through case of COVID 4 months after receiving my vaccine after being exposed to someone who learned they were positive about 12 hours after speaking with me without masks. I am still recovering from this case of COVID after taking a course of prednisone.
no adverse event; VARIVAX was stored in the refrigerator since 15-NOV-2021,  the refrigerator had an excursion with maximum temperautre.; This spontaneous report was received from a vaccine coordinator referring to an unknow age and gender patient. Information regarding the patient's medical history, concurrent conditions and concomitant therapies was not provided.   On 19-JAN-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at a dose of 0.5 milliliter, lot #U015678, expiration date: 18-MAY-2023, administered subcutaneously for prophylaxis (strength, anatomical site injection were not provided) (Product storage error). it was mentioned that varicella virus vaccine live (oka/merck) (VARIVAX) was stored in the refrigerator since 15-NOV-2021, and the administered dose of the vaccine experienced a temperature excursion of minus 51 Degree Fahrenheit. Information regarding time frame was reported as unknown.  it was reported that no previous temperature excursion was occurred.   No additional adverse event (AE) information was provided (no adverse event).
Diarrhea; Upset stomach; Chills - just shaking; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (Chills - just shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (Chills - just shaking). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (Upset stomach) and CHILLS (Chills - just shaking) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD21-077983, US-MODERNATX, INC.-MOD-2021-080116 (E2B Linked Report).; Sender's Comments:  MOD21-077983:Crossed linked as per source doc US-MODERNATX, INC.-MOD-2021-080116:Crossed linked
Pt's wife reported that pt's last dose of OPSUMIT was yesterday (12/22/2022). pt did not order on time. right now pt is in the hospital. he was unwell on monday, went to complete covid test, and he was vaccinated for covid on monday (12/19/2022). unknown if covid positive. 2 days later (12/21/2022) he didn't fell well again and when he stood up from the bed he collapsed and couldn't breathe. right now pt admitted to the hospital for pneumonia since wednesday(12/21/2022). unknown if hospital can provide opsumit. no other information provided.
Period completely stopped. I was very heavily bleeding on the day of my period but the next day (today) after my period no blood at all. Has never happened before. Maybe just a coincidence.
This is a breakthrough covid case. Patient completed series 1/18/21 and became positive 5/22/21
In February I started to get these bazaar muscle spasm in my legs especially in my right leg. The spasms would move from my foot to my knees and my thighs. If i wasn't careful I would hunch down and get a charlie horse. So I decided to go see my physical therapist for the muscle spasm that were getting out of control. In the month of April in my right eye my vision started to get blurry and my eyelid started to get droopy.  So I decided to go to the eye doctor Dr. who decided to run a few eye test and she said the results came back fine. I will be receiving an mri on 05/27/2021. Ptosis was the diagnostic they gave me for the droopy eye.
FLEXERIL 10 mg 3 x day 800 Ibuprofen 2 x day. Light headed evening of 11-6-09 next morning 11-7-09 woke up with all over body ache then the ache became more intense in muscles worst in arms, between shoulder blades, nervousness in legs and spasms in my sides. I have dropped things extreme fatigue and have also lost my balance.
pretty sick from the last vaccine; like having a bad case of the flu for 24 hours; felt kind of queasy after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS, INFLUENZA, and NAUSEA in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 089A21A and 095A21A) for COVID-19 vaccination. No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS, INFLUENZA, and NAUSEA. At the time of the report, ILLNESS and NAUSEA outcome was unknown and INFLUENZA had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-370422, MOD-2021-370441, MOD-2021-370435 (Patient Link).
Cannot taste what he is eating and it is followed by a metallic/soapy aftertaste.  This started one day after the vaccine and continues.
Fever, body aches, joint pain, cough, congestion, nausea, vomiting lasting more than 5 days after vaccine administered
Patient received 2 vaccines in right arm. We believe MMR and DTaP. IPV given in left arm. Four hours after administration, right arm began to be erythematous and swollen. Worsened over the next  24 hours. Mother called ER - they told her to watch progression abd use ice and Tylenol. The third day after vaccine, swelling extended from deltoid to below elbow with marked erythema and warmth. No fevers or respiratory symptoms.
a patient received a dose of Fluzone High Dose which had expired on 11May2018/No AE; on 07Oct2019, opened new box of 10 prefilled syringes and two syringes were missing and on 11Oct2019, they opened another box which had three syringes missing/ no AE; Initial and additional information received on 11-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of an unknown demographics who received an expired dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UI871AN/UI871AB, expiry date: 11-May-2018) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to expired vaccine used.  It was also a case of Product packaging quantity issue  At the time of report, no adverse event was reported.  It was reported that when last flu season ended, the reporter shipped all remaining vaccine out of the facility. They purchased a new refrigerator this year specifically for the new flu vaccine. There was no way anything was left behind. She maintains that the expired vaccine was part of a new shipment. She does not know in which box of other prefilled syringes that the expired prefilled syringe was located. She has alerted everyone to be diligent and check all the expiration dates. She believes the expired vaccine was given on a weekend and she does not work weekends.  Last week on 07Oct2019, the medical assistant informed the caller they opened new box of 10 prefilled syringes and two syringes were missing. The lot was UJ284AB expiry 25May2020. Then today, 11Oct2019, they opened another box which had three syringes missing. The lot is UJ252AA expiry 01May2020. Both boxes with missing syringes were sealed upon receipt. No other information is available, as the call disconnected when the caller was looking for more information and the consultant was holding.  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.
Post vaccine - pt developed fever. Mother took child to MD, he suggested possible reaction to DTAP. Child treated with motrin and tylenol.  F/U call 3/5/99 indicated continued fever with temp of 101.
SICK; CHILLS; FEVER; ADVERSE EVENT; This spontaneous report received from a physician concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received ustekinumab (solution for injection, subcutaneous, batch number: Unknown) 90 mg, frequency was not reported from 25-FEB-2021 to 11-JUN-2021, and dose and frequency were not reported from 29-JAN-2021 for crohns disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccoination. The batch number was not reported. Per procedure, no follow-up will be requested for this case as no permission to contact HCP.  No concomitant medications were reported. On 11-JUN-2021, the subject experienced adverse event. On an unspecified date, the subject experienced sick, chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of ustekinumab was not changed. The patient recovered from adverse event on 11-JUN-2021, and the outcome of fever, chills and sick was not reported. This report was non-serious.
pt recvd vax 29MAY92 & 31MAY92 5-6PM t100 ax shortly p/sz- to ER t104.2 given APAP 1/2 hr later t105.2; given Ceclor; cxr neg; ER MD dx ?OM-febrile sz; f/u dx rxn to DTP;
When child wake up L arm was hot to the LQ touch, swollen, hard and a bright red color. Child complained arm hurt, mom night before didn't notice anything till the morning, gave child MOTRIN for pain.
Second shot hurt and it was bleeding; Second shot hurt and it was bleeding; I got a very stiff neck on my left side and I cannot look over my shoulder on my left side; It hurts to hold my head up; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My tongue is swollen and I end up biting and that is hurting; My teeth even hurt; my eyes hurt; I have a headache in my temple area; My skin hurts when touched; I have weakness all over and it hurts to talk; My back hurts; my hips hurt/my joint hurts; I have a gland swelled right underneath my chin under my jaw; My hands hurt; Nauseated; My diaphragm also hurts, it feels like I did 100 pushups or something; This is spontaneous report received from a contactable consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6205), via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunisation. The patient medical and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6201) for covid-19 immunisation. The patient experienced she had both the shots in her left arm her shoulder and second shot hurt and it was bleeding. She didn't know blood came out from the vaccine for what but it hurt. She got a very stiff neck on her left side and she could not look over her shoulder on her left side, her tongue was swollen and she end up biting and that is hurting. It hurts to hold her head up, her teeth even hurt, her eyes hurt, she had a headache in my temple area, her skin hurts when touched, she had weakness all over and it hurts to talk. Her back hurts, her hips hurt, her joint hurts and she had a gland swelled right underneath her chin under her jaw. Her hands hurt, and she had nauseated also. This was awful, it seems like she had a disease or something. Her diaphragm also hurts, it felt like she did 100 pushups or something. The event onset date was Mar2021. The outcomes of events were unknown.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021412713 same reporter/drug, different patient/event
patient received empty syringe  follow by shingrix vaccine. however patient did not experience side effect
Immediately after vaccination it triggered a sharp shooting pain (nerve like pain) that went down her left arm. I contacted patient 1 hr after vaccination now it's tender but still feels heaviness in her arm.
Multiple Myeloma/diagnosed INGUS which is one of the indicators for multiple myeloma.; Glaucoma got worst; Mild neuropathy on the legs/it's mild and shouldn't cause the continuous weakness; Difficulty walking; Still has extreme weakness in the legs; Joint pain; Muscle pains; Extreme fatigue; Severe weakness/continuous weakness; Hypoglycemia; Nauseated; Serious side effects; This spontaneous case was reported by a consumer and describes the occurrence of PLASMA CELL MYELOMA, GLAUCOMA, and NEUROPATHY PERIPHERAL in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycemia, High cholesterol, and Glaucoma. Concomitant products included LATANOPROST for Glaucoma, PRAVASTATIN for High cholesterol, ASPIRIN, VITAMIN D, SIMBRINZA, and MULTIPLE VITAMINS for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION COMPLICATION (Serious side effects). On 30-Mar-2021, the patient experienced NAUSEA. On 31-Mar-2021, the patient experienced HYPOGLYCAEMIA, ASTHENIA, and FATIGUE. On an unknown date, the patient experienced PLASMA CELL MYELOMA (seriousness criterion medically significant), GLAUCOMA (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (seriousness criterion medically significant), GAIT DISTURBANCE, MUSCULAR WEAKNESS, ARTHRALGIA, and MYALGIA. In May 2021, FATIGUE and NAUSEA had resolved. At the time of the report, PLASMA CELL MYELOMA, NEUROPATHY PERIPHERAL, HYPOGLYCAEMIA, GAIT DISTURBANCE, VACCINATION COMPLICATION, ASTHENIA, ARTHRALGIA, and MYALGIA outcome was unknown and GLAUCOMA and MUSCULAR WEAKNESS had not resolved.            Concomitant medication given as Lovage 2g twice a day. Treatment information was not provided.  The patient said that nothing occur after the first dose.   The patient reported that he went to several specialist and that a Neurologist diagnosed the patient with a mild neuropathy on the legs.     The patient was sent also to an oncology and was diagnosed with multiple Myeloma, have to watch it because it might never occur but sometimes it does. The patient then said it was diagnosed INGUS which is one of the indicators for multiple myeloma.   Patient is hesitant to receive the booster dose.  Temporary report number 666967  Company Comment: This case concerns a patient with no previous relevant medical history, who experienced the unexpected events of plasma cell myeloma, glaucoma, neuropathy peripheral. The events occurred after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since events occurred after second dose. The medical history of sulfonamide remains a confounder. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Patient's Left arm became deep red, warm to touch and swollen. On 11/08/2016 He presented with raised, pustules the spread on torso, and legs. Patient complained of itching and discomfort.
gave 17 year old vaccine; A sontaneous report was received from a health care professional concerning a 17-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273).    The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event,was not provided.   On unknown date , prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, was considered as recovered.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old) for mRNA-1273 (lot number unknown) with no associated AEs reported.
The first night after injection I had significant muscle soreness and stiffness, chills, achiness, and severe headache. Symptoms subsided next day w TYLENOL, although felt lethargic. Last night I noticed small bumps along the lymph's of the left arm, which is where I received the injection. I do not feel any swollen in arm pit or neck, just upper arm. I did receive a senior dose of flu vaccine at the same time as the shingles vaccine in the same arm.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. information regarding the patient's current condition and medical history was not provided. On 15-APR-2015 the patient was vaccinated with GARDASIL, 120Y). On 03-MAR-2015 the patient was vaccinated with GARDASIL 9) (interchange of vaccine products, product name confusion). No adverse symptoms reported. No product quality complaint (PQC) was involved. No further information was provided.  Additional information has been requested.
Was fine until May 7 - got so nauseated, violently throwing up - emptied stomach - could not talk, stand up - called ambulance and went to ER. I am totally convinced that if I had heart trouble or high BP - or was in delicate health - this could have killed me. My husband was scared to death; I was totally helpless both times. I didn't correlate being so sick with vaccine until the second (and last) vaccine.
pts wife came in today to get shingrix shot and indicated that husband developed a fever and headache from either the shingrix vaccine or flu vaccine. when i talked with pt he indicated that the after taking naproxen and tylenol his fever was going down from 99.2 f and his headache was gone. dr suggested going to er to be evaluated. pt says he's getting better and didn't think it was necessary
After first J&J shot, I noticed tinnitus started a couple of weeks after and is still with me today. A week or two after the Moderna shot, been suffering IBS which continues to give me GI distress today.
Participant complained of "funny feeling", light-headed, and nausea. BP and P 136/88, P72. Sat in chair w/legs lifted and given ice pack, face pale, pulse strong. 12:45 BP 118/78, P 64 strong. Stated at 12:40 that she felt like she did when she had anaphylactic shock before- carries epi w/her. 1:00 BP 110/78, P 64, color still somewhat pale. Said she felt better, insisted she go "2 doors down" for a mtg but would check back in an hour and also would take her benedryl. 1:40 color had completely returned and pulse strong. Said she felt completely better.