chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to two unspecified patients patients of unknown age and gender. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On multiple unspecified dates, patients were vaccinated with improperly stored (temperature: -8.3 degree Celsus for 11 hours, because of data logger), VARIVAX lot #L019124, expiry date 27-MAY-2017, (dose and frequency not reported). There was no previous temperature excursion. No adverse effect reported. No product quality complaint (PQC) was involved. The outcome of the events was unknown. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Given Covid Vaccine on Left Arm no symptoms or no reactions given expired vaccine on child 1-2 days late
abnormal mammogram; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MAMMOGRAM ABNORMAL (non-serious), outcome "unknown", described as "abnormal mammogram". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
not been feeling good; stomach sick; bloated stomach; feverish; aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not been feeling good), ABDOMINAL DISCOMFORT (stomach sick), ABDOMINAL DISTENSION (bloated stomach), PYREXIA (feverish) and MYALGIA (aches) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M201A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PROBIOTICS NOS for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced MALAISE (not been feeling good), ABDOMINAL DISCOMFORT (stomach sick), ABDOMINAL DISTENSION (bloated stomach), PYREXIA (feverish), MYALGIA (aches) and NAUSEA (nausea). At the time of the report, MALAISE (not been feeling good), ABDOMINAL DISCOMFORT (stomach sick), ABDOMINAL DISTENSION (bloated stomach) and PYREXIA (feverish) outcome was unknown, MYALGIA (aches) had resolved and NAUSEA (nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug included blood pressure medications and vitamins.  Treatment information was not provided.
This spontaneous report as received from a physician via company representative refers to a female patient in her 60's years old. On 24-OCT-2012 the patient was vaccinated with standard ZOSTAVAX (lot number not provided). On 03-NOV-2012, the patient experienced lumbar plexopathy after receiving ZOSTAVAX. Unspecified treatment was given for adverse event. EMG test was performed and results was not provided. The patient had sought medical attention via doctor's visit. The outcome of lumbar plexopathy was unknown. The causality was not provided. Additional information has been requested.
t98.1;pt had routine immun on 17JAN96, afeb;19JAN96 local MD called & said pt had convuls & didn't need DTP;seemed to think convuls d/t inc temp p/having shots;hospitalized x 3d
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 35-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Nov2022 at 15:30 as dose 4 (booster), single (Lot number: GJ6738) at the age of 35 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Apr2021 at 13:30 as dose 1, single (Lot number: ER8737), in left arm, on 29Apr2021 at 13:30 as dose 2, single (Lot number: ER8736), in left arm and on 17Dec2021 at 13:30 as dose 3 (booster), single (Lot number: FE3594), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZOLPIDEM TARTRATE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.
2 hrs after vaccines - developed hives over body. Responded well to oral BENADRYL.
Late/no period, irregular PMS symptoms. Loss of appetite and weight. No desire to drink the amount of liquids normally consumed.
Tiredness, muscular pain in the joints, ankles, shoulders, neck and upper back on the left side. Anxiety and depression.
Severe Pain @ injection site lasting 10 hours, pain @ injection site lasting 3 days, severe  joint and muscle pain lasting 10hours, joint and muscle pain lasting 3 days, severe fatigue for 10 hours, severe headache for 10 hours, chills for 2 days, fever, axillary swelling - ongoing
Couldn?t sleep til 4:30 pm after falling out of bed twice.  Couldn?t get off floor. Extreme weakness. Slept the entire next day. After that didn?t recover strength for five/six days. Couldn?t eat.
1/14 vaccination 1/15 sore arm, redness, and 3 bumps Seven days later,  the bumps has 'bloomed' like hives; puffy, raised. itchy.  I put cortisone cream for couple of days.
5:40-5:55 AM: Almost passed out, black zig-zag lines in eyes, loss of vision, almost fell to ground, dizziness, weakness in both arms and both legs, brief period of profuse sweating, chills lasting throughout the day, fever, headache in area just above forehead and around eyes (a lot of pressure, pounding headache), rapid heart beat, ringing in ears, loss of balance and strength. 7:10 AM: Admitted to ER. Approx. 11:00 AM: Diagnosed with adverse reaction/allergy to pneumonia vaccine and diphtheria/tetanus/pertussis vaccine, given Tylenol and Ibuprofen for pain. Late in evening, approx. 9:00 PM: discovered redness, swelling, and blotches on right arm in area of vaccine. Late on 08/04/12 through present: severe pain on right arm at pneumonia vaccine site.
Rash generalized. A non-serious, spontaneous report of full body rash has been received from a physician concerning a four year old male patient, which occurred one day after receiving FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. The patient's medical history and concomitant medications were not provided. The patient received FLUMIST on 05-Oct-2009. On 06-Oct-2009, the patient developed a full body rash. The event outcome was not reported.
no adverse event; Monovalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient).    Patient ID was reported. Concomitant medications details were not reported by the reporter. It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Reportedly, the patient was eligible for COVID-19 vaccine. Treatment details were not reported by the reporter.
Started experiencing Diverticulitis symptoms the morning following the 4th shot.  I started antibiotics on 5/18 & have improved considerably since then but not 100% yet.    I also had Diverticulitis symptoms following the 1st shot but did not believe it was vaccine related at the time.  After the 1st shot it was the first time that I need to be treatment for Diverticulitis.  The situation resolved itself after taking antibiotics.
About an hour after vaccine (1st dose) my left cheek and lips were numb, had headaches. Numbness were on and off and lasted for 2 days. At exactly 72 hours I felt like myself again. Not sure if I should get 2nd dose.
Sx. chills, fatigue, Lt. arm swollen from elbow to shoulder. OTC - ADVIL with effect, elevated (L) arm at HS with good effect. Pt. states she had PNEUMOVAX years ago without difficulty. Physical exam today with minimal finding of very faint erythema.
Pain at injection site around 4 hours after injection. Fever at night (12 hours after injection). Fatigue, slight headache, some aching around wrists and joints, mild nausea. Side effects began to subside around morning next day (24 hours later).
About 10 hours after receiving my first Moderna COVID 19 vaccine, I was in bed trying to sleep when a very weird and painful sensation spread throughout my entire body. It felt as though my entire body was on fire. I immediately removed my clothes and tried to sleep, but even the blanket was too painful. I could not move. I could not have any article of clothing on me. It felt like my skin was going to fall off. I could not see any visual marks on my body from the pain. My husband, on the other hand, did not have this side effect, which is how I knew something was wrong. Thankfully, the pain went away the following morning.
Sore throat  Coughing  Headache Nausea Body aches Tiredness Loss of taste & smell
Site: Pain at Injection Site-Medium, Additional Details: Patient complains of very painful arm, with some difficulty in movement. Arm discomfort has not resolved 3 weeks since receiving the shot. Patient has treated with ice receiving temporary relief. Patient is following up with primary care for additional care.
Pt recvd 3 Engerix-B vax on 20NOV90, 22DEC90, 28MAY91; pt recvd HBIG on 15APR91 for needle stick; 22OCT91 pt had no titer; will give two more doses of vax;
Patient due for Hep B, given Hep A in error.  Physician aware of error and parents notified.  No adverse reaction to vaccine.
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 87-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis. On 27th March 2018, the patient received SHINGRIX. In April 2018, 30 days after receiving SHINGRIX, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown. It was unknown if the reporter considered the shingles and pain to be related to SHINGRIX. Additional details reported as follows: The healthcare professional reported that after receiving the SHINGRIX the patient developed Shingles 1 month later. The patient had pain but no rash for 3 months. No additional information provided.
Got flu vaccine on Wed 9/28/16. On 9/29 in am began vomiting, horrible stomach ache, stiff neck and horrible body aches. As day went on, on 9/29 all symptoms got worse vomiting at work all day. Nausea all the time and body aches . Had to take 9/30 off because I was so sick.
She passed away the next evening. She stated that she was feeling unwell and I encouraged her to go to bed and rest. A while later I noticed our bathroom light was still on which was odd, I went to turn it off and saw her on the toilet. It looked like she had fallen asleep on the toilet. After getting closer to her I realized that she had died. No autopsy was done as she was given for scientific research.
10-8-13 Pt given MMRV (R) and varicella (L) at same visit to HD. 10-11-13 spoke with mom and understands vaccination error. Child asym. Mom and child's school teacher will observe for increased fever and febrile seizure. On 10-8-13 pt came to clinic with parents for shots. In discussion with parents what shots were needed, ask questions about child's health etc., explained to parents child could have MMRV which was MMR and varicella together in one shot or could have MMR and varicella in separate shots. Parents seemed undecided what they wanted so I said lets do MMR and varicella separate. Mother said that was what she wanted. I told RN we would do MMR and varicella separate. She got the immun from frig. Child was given immun. I have varicella and KINRIX. RN gave another immu which was supposed to be MMR. Earlier in the day a 10--13 RN gave a MMR prior to this pt. I had already gone over MMRV and MMR with her before this child ever arrived. On 10-9-13 secretary questioned me about the lot number of immu given to pt on 10-8-13. I checked lot number which was for MMRV. I reported this to director.
Donor stated approx. 5hrs after shot was given he began to experience it. Arm pain going down left side of body with it. Thumb pain, mild dizziness, nausea, paleness, and numbness tingling in shoulder. Donor states symptoms lasted approx 12 hours and resolved on their own with no treatment required.
Initial report received from a non-health care professional on 14 September 2012. This is a cluster report for 10 patients. Ten patients with no reported medical history and concomitant medications had received FLUZONE on an unspecified date (batch number UH745AC) (route and anatomical site of administration not reported). It was reported that 45 patients were immunized from the above lot number and about 10 patients complained of "1/2 dollar size knots on their arm", fever, redness, swelling and achy feeling on an unspecified date. Laboratory investigations and corrective treatment was not reported. The overall outcome was not reported. Documents held by sender: None.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt has history of passing out after shots. passed out brief;y after adminstration. did not fall or hit head. was given water and ice pack while mom attended to him. EMTs were called and took blood pressure did not bring to hospital
Tapping sensation in left ear (intermittent), which I had never experienced before - it continues over 1 week later.  Left arm at injection site swollen, tender, and red for 1 week.  This doesn't occur after flu shot.  After 1 week, there's just a slightly tight feeling in shoulder.
About two months after my third dose I developed ongoing and persistent elbow inflamation that skill has not resolved. With radiating elbow pain.
Systemic: Fainting / Unresponsive-Mild, Systemic: panic attack-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Mild, Systemic: Weakness-Mild, Additional Details: patient went through anxiety/panic attack. resolved within 15 minutes with no complications.
Patient is a 30 y.o. female who presents to the ED with concern of reaction to her second vaccine.  She received the vaccine on Wednesday and that evening he developed nausea, vomiting and diarrhea.  She states she has mild, intermittent coughing, fevers body aches and fatigue.  She she states that she has been having difficulty keeping any food or fluids and as she will have episode of vomiting or diarrhea shortly after eating or drinking.  On her left arm area of the injection site she has area of redness that is irregularly shaped approximately 10 cm in length by 6 cm in width.  The area is mildly warm to palpation.  She has been applying ice packs.  She has been taking acetaminophen to control the fever no other medications taken.  She states she has been attempting to stay hydrated with sips of fluids.
other zoster-related conditions; herpes zoster; Information has been received from a lawyer referring to an elderly patient of unknown gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 02-NOV-2013 (at 67 years old), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) by a healthcare provider at a school for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by healthcare providers at a hospital for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster and other zoster-related conditions (Ill-defined disorder). The outcome of both events was unknown.
Cause of Death: SENILE DEGENERATION OF THE BRAIN, CHRONIC SACRAL PRESSURE ULCER, DEPRESSION
The evening p/vax pt had severe pain in arm that was injected & had a fever to 101;pt went to ER for eval;pt was sent home;seen in clinic the next day w/very tender arm but no erythema/edema or fever;
Patient received both vaccines in his left arm approx an inch apart on 10/16/18. On 12/11/18 he stated that his arm was still sore/ in pain from the vaccines and that he went to his primary care doctor and received a "steroid injection" to help reduce the pain. He did not state specifically when this happened or what time of injection he received.
Information has been received from a certified medical assistant concerning a 62 year old male who at 10:00 on Sept 21 2005 was vaccinated intramuscularly in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 649988/0692P). It was reported that the patient had since developed pain, redness, swelling, and warmth at and around the injection site. On Sept 23 2005, the patient developed an allergic reaction with some erythema in the posterior part of the arm and around the elbow possible cellulitis. The patient sought medical attention and was treated with gatifloxacin (Tequin) 400 mg daily. On Sept 24 2004, the patient was admitted to the hospital. On Sept 26 2004, the patient recovered and was discharged. No additional information is expected.
Left shoulder/arm pain, aching and throbbing after receiving immunization. Pain, decrease ROM and sleep disturbance persist despite use of ibuprofen/naproxen, ice 2 weeks after immunization. Pain 12 hr later. Started with decrease ROM 10/5/10.
This spontaneous report as received from a health professional via a company representative refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concomitant medications, allergies and pertinent medical history reported. On an unknown date, the patients were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, strength, route of administration, lot#, expiry date were not reported). On an unknown date, the patients experienced mumps. The outcome of mumps was unknown. The relatedness between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) was not reported. Additional information has been requested.
2 days p/vax mom brought in pt;site rt leg edematous, red w/bruising, warm to touch;mom took baby to MD, given ATB;instructed mom to give DPH & APAP;
12 days after the vaccination noted erythema, swelling and tenderness at the injection site, about 2-3 inches diameter.
Gradual eruption of hives with worsening itching, almost all on the right side of my body, with eventual swelling of my face, mostly on the right side, to the point of nearly closing my right eye.
CHEMOTHERAPY INDUCED PERIPHERAL NEUROPATHY, SUBSEQ 10/1/2021 OTH PULMONARY EMBOLISM W/O ACUTE COR PULMONALE
Child with birth asphyxia and history of questionable previoius seizure with no abnormalities on previous EEG.  Had fever of 101 possible unilakial seizure 2 days after administration of above vaccines.  Child also has history of recurrent high fevers without previous febrile seizure. The medical record received on 3/23/04 states staring, jerking of arm, and shivering.
In for 15 mo check up on 10/25/10 rec'd 3 vaccines, parent called approx 3 hours later hives noted on forehead with (R) eye swelling, no resp S Sx- BENADRYL given with improvement in hives. Immune site (L) thigh reported red with small bumpy rash.
FELT TASTE OF BLOOD IN MOUTH; FELT SORENESS; FEELING OF PAIN IN CHEST; NO ENERGY; DIZZINESS; This spontaneous report received from a consumer concerned a 37 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and gout, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-JUN-2021, the subject experienced dizziness. On 25-JUN-2021, the subject experienced no energy. On 26-JUN-2021, treatment medications included: paracetamol. On 27-JUN-2021, the subject experienced felt soreness. On 27-JUN-2021, the subject experienced feeling of pain in chest. On 29-JUN-2021, the subject experienced felt taste of blood in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and no energy, and the outcome of felt soreness, feeling of pain in chest and felt taste of blood in mouth was not reported. This report was non-serious.
It started out with the size of a silver dollar. It was red, itching, burning and very hot. I went and seen a doctor and he gave me a steroid for it. By the end of the day it had doubled in size. The next day I had three doses of the steroid and it had double in the size the night before. I went and seen Dr. and he gave me a prescription for Prednisone cream and antibiotics. As I was using them it went away and when I stopped using them it came back. It became red and blotchy like hives. I went back in and they refilled my prescription. After that it was fine.
After vaccine was given, patient was cleaned up after having a bowel movement and shortly after, patient became tachypneic with nasal flaring and verbalized the words "can't breathe." Dr. was notified and came to the bedside to assess. Patient had audible upper airway wheezes and orders obtained for Epi, benadryl and solumedrol. RT also came to bedside to assist.  1mg Epi x2 given 25mg Benadryl given 125mg Solumedrol given   Anesthesia was called for intubation due to continuing low sats. -7.5 ETT noted at 22@lip -OG@60  Both were cleared via CXR.  -0307: patient sedated and resting comfortably.