chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of a 63-year-old male subject testing hepatitis B antigen positive following vaccination with Engerix B (GlaxoSmithKline) for prophylaxis.  Concurrent medications included Zemplar, allopurinol, Nexium, Serevent, Colace, Epodil, thalidomide, VFEND, albuterol, Singulair, Kytril, lorazepam, EPO, and Renagel.  On 21 October 2006 the subject received 1st dose of Engerix B, two 20 mcg injections, one in each arm (40 mcg, intramuscularly).  In September 2006, the subject tested hepatitis antigen negative.  On 24 October 2006, the subject had a positive antigen test result.  The subject had a negative test result again on 02 November 2006.
This spontaneous report was received from a register nurse concerning a 16 year old male patient. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with two doses of (oka-merck) PROQUAD (dose, dose number, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. Register nurse reported that while in another state, a 16 year old male patient was given a (oka-merck) PROQUAD twice, one month apart. No adverse effects were noted. Additional information has been requested.
Numbness and weakness ascending from feet to pelvis. Follow-up Information 20-JAN-2010: I was treated at the hospital from January 8, 2010 until January 12, 2010. The attending physician was Neurologist.
I woke up with chills and shaking, which subsided after a few hours. Felt like I had the flu for a few hours, followed by muscle aches. I felt weak the next day, but was much recovered by the day after.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced high fever 102-104°F and headache. The outcome of the events was unknown.
+ COVID TEST ON 3/20/2021  HOUSEHOLD EXPOSURE  FULLY COVID 19 VACCINATED.
Patient given DTAP #5, IPV#4, PCV#4 at approx 2:50 pm.  Pt was back in clinic with new onset cough and urticarial rash on face, torso, scalp, neck, both ears were bright red.  On exam had near O2 Sat 98% but bibasilar fine wheezing.  He was given IM BENADRYL, 25mg & srepinehrine 1:10du/ml.  Responded within minute.  Rash and wheeze cough were gone-discharged 1 minute later with by mouth BENADRYL.
After the first shot on 03242021 I experienced overall fatigue.  Though I drove the 30 minutes to the first shot, I could not drive the same distance to the second due to fatigue.   After the second shot, the fatigue worsened. Pain in my joints and muscles increased. My inability to walk beyond a few steps resulted in my using a cane at all times.  My grip worsened and I dropped most objects I picked up. The pain had continued to increase throughout my body.  I could not sleep, I became depressed.  My thought processes became confused and my memory cloudy. I spoke to the Rheumatologist on June 3 out of concern and he scheduled Xrays.  By 06232021 the confusion symptom started to wane.
09Jan91 pt splashed MMR in eye.  Rinsed eye in water and exp mild stinging + redness for next few hrs.  Sx remitted w/in 24 hrs.
PATIENT EXPERIENCE FEVER & MUSCLE ACHE AND  ADDITIONALLY HE EXPERIENCE  NOSE BLEEDING DROPS (CLOT ALIKE AS PATIENT DESCRIBED)
Head was burning; Ringing in her ear; her tongue was burning; This spontaneous case was reported by a health care professional and describes the occurrence of BURNING SENSATION (Head was burning), TINNITUS (Ringing in her ear) and TONGUE DISCOMFORT (her tongue was burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Head was burning), TINNITUS (Ringing in her ear) and TONGUE DISCOMFORT (her tongue was burning). At the time of the report, BURNING SENSATION (Head was burning), TINNITUS (Ringing in her ear) and TONGUE DISCOMFORT (her tongue was burning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment was given.
Left deltoid red and swollen. TYLENOL/MOTRIN 3-4 x a day as needed.
Rash appeared 9 days after receiving the shot, red in area of shot, warm to touch, slight swelling.  Keeping an eye on it and will see if it goes away after 48 hours- (read online that some patients have experienced the rash and it went away in 24-48 hours)
client received 1st dose pfizer covid vaccine at age 10. Client did not report any adverse reactions.
10/7/07-10/10/07: Fever (102-103.5), lack of appetite and fussiness.  10/12/07: Rash on neck,back,stomach and diaper area-some on face, still lack of appetite and fussiness.
Patient presented with swelling and redness of about 8cmx 8cm in diameter, where flu shot had been administered. Warm to the touch. Treated with 500mg PO BID for 10 days
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Patient should not take anything with aspirin in it.
Severe headaches, fever, tiredness, nausea, burning rash all over body, stiff neck during the early morning and all day after the shot. Rash is worse 2 days later, still fever and mild headache.
Case number PHEH2014US018546, is an initial spontaneous report from a nurse received on 12 Sep 2014. This report refers to a 20-year-old female patient. Past medical history and concomitant medications were not reported. She was administered an intramuscular dose of MENVEO (batch number: M13015) on 12 Sep 2014. It was reported that the vaccine administered was exposed to 1 degree Celsius four times overnight on 12 Sep 2014. No adverse reactions were reported following the medication error.
C/o headache, nausea, chills pain in Rt arm & neck. BP 112/78, P96 Temp 37.7 degrees C. Dizziness also present. Military transported to ER.
Administration Error - patient signed up for first dose Moderna mass vaccination clinic provided by Hospital on 3/31/2021. Patient marked "NO" on Pre-vaccination checklist for COVID-19 Vaccine. Patient received what we believed to be her first dose of Moderna vaccine. When entering the patient information, we found that she had been fully vaccinated at another facility. Patient did not experience any immediate reactions. Upon follow up, patient did not have any known side effects to receiving a 3rd dose in error.
4 am: 2 hours of chills and violent trembling. My teeth were clenched so tight for so long, my jaw ached. 6 am: I couldn?t lift a glass of water. Someone brought my cup and straw, which I nestled between my face and pillow. I sipped what I could. 6:30: Sleep 8:am: Woke up thinking it was 6pm. I couldn?t roll over. Dizzy and weak, I collapsed back into bed from trying to stand.  Someone walked me to the bathroom. Once there, I wheezed and gasped for air. Then I got scared and cried, which made it even harder to breathe. It felt like my body wasn?t absorbing the oxygen it took in. 8:05:  Sleep 9 am: Woke up hoping the day was almost over and I slept through it. The cruelest part is sleeping what felt like the deepest sleep only to wake up an hour later ? over and over again. My spine and neck ached, which made my head hurt ? or my head hurt all on its own.  12 pm: Sharp abdominal pains with any movement. If I did move, I had fits of gasping for air. Had to ask Someone for the phone sitting just a foot away. I couldn?t look at the screen. My eyeballs were too sore, head too achy, and brain too fogged. The phone was only to ask for help while someone worked in the other room. 12:30: Abdomen sore to touch. Hard to talk. My bowels became so shut down it hurt(s) to move straight water through them.  The rest is kind of a blur. Lots of sleep. In the afternoon, someone walked me to the bathroom. Back in bed, I had another breathing fit. My abdominal pain felt inescapable. Through was happy for his company, I think I fell asleep during our conversation. At some point, someone brought me broth but I didn?t get much down. By evening, I could walk to the bathroom alone, albeit hunched like a 120 year old in need of a walker. My guts just hurt too much to stand upright.  Day 2: I still suffer from abdominal pain, a headache and muscle aches, but I CAN roll over, lift a glass of water, and focus on a screen for short stints. (I documented this in stages.) I can walk slowly but still painfully to the bathroom without help, but I get winded beyond that. I?m afraid to eat with my digestive tract so inflamed, but I have far more energy today, 32 hours after my last meal, than I did yesterday. I?ve also lost 6 pounds. Day. 3: 10 pounds down, still with diarrhea, but eating again. Restless sleep. Significantlt winded and dizzy after mild activity, like walking from one side of the house to the other.
Mom called and reported to this writer that 3 hours after vaccine administration that patient was having behavioral changes. He was having "spurts of rage episodes".
Fell hitting her head on the tile floor at check-out. Patient was transferred back to patient room to lay down and rest total time of roughly 30 min post episode. Reevaluated and diagnosed with mild concussion although exam findings were reassuring.  Initial BP  110/74, BP Post episode 122/80, BP at discharge 112/80.
PTSD; This is a spontaneous report from a contactable consumer (patient). A 36-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly, administered in Arm Left on 18May2021 (Lot Number: EW0161, expiration date unknown) at age of 36 years old as a single dose for covid-19 immunisation. Medical history included ongoing celiac disease (onset date: Childhood  Patient Details: Maintains a gluten free lifestyle as much as possible). Concomitant medication included sertraline taken for antidepressant from an unspecified start date and ongoing.  The patient experienced PTSD (post-traumatic stress disorder) on 18May2021 with outcome of recovering. Therapeutic measures were taken as a result of event. The event was reported as being medically significant.   Follow-up attempts are completed. No further information is expected.
sore arm; lethargic; weak; tired; achy; not feel well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), ASTHENIA (weak), FATIGUE (tired) and PAIN (achy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), ASTHENIA (weak), FATIGUE (tired), PAIN (achy) and MALAISE (not feel well). At the time of the report, PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), ASTHENIA (weak), FATIGUE (tired), PAIN (achy) and MALAISE (not feel well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
gastrointestinal pain/discomfort, lower back pain, urinary incontinence, pressure in stomach area, constipation, diarrhea, abnormal stool. All symptoms occurred off and on every day for weeks beginning 5/5/21
Patient received Infant/Moderna (6 months to 5 years), rather than the Bivalent Moderna that was intended. No adverse effects were reported when patient left clinic. Patient will return in 4 weeks to receive the correct vaccine.
sore injection site, rib pain headache, body aches, flushed fatigued,
Extreme Brain Fog, Lapses in time, episodes of stuttering and slurred speech, difficulty with cognitive thinking.
Information has been received from a licensed practical nurse (L.P.N) through the Merck pregnancy registry concerning a 22 year old female with cardiac murmur with a history of 2 pregnancies and 2 live births and a history of hypothyroidism who on 27-FEB-2008 was vaccinated with the first dose of GARDASIL (lot # 659653/1448U). Concomitant therapy included FLINTSTONES Multivitamin. The patient was pregnant. The reporter stated that the patient's last menstrual period was 16-FEB-2008. The estimated conception date was 02-MAR-2008. The patient was in for first obstetrics (OB) visit on 10-JUN-2008 and urine pregnancy test was positive and ultrasound due date was 24-NOV-2008. On 02-JUL-2008 ultrasound was performed for size and dating. The result was within normal limits (MNL) and the estimated delivery date was 23-NOV-2008. No product quality complaint was involved. Follow-up information on 19-DEC-2008 was received from a licensed practical nurse (L.P.N) concerning a 23 year old patient who was a smoker, on 27-FEB-2008 at 1535 was vaccinated intramuscularly into left deltoid with the first dose of GARDASIL (lot # 659653/1448U). Ferrous sulfate, FLINTSTONES Multivitamin and omeprazole were used during pregnancy. On 12-NOV-2008, the patient delivered a female baby with congenital anomaly weighing 3103gm (weeks from LMP: 38). Length: 20 inch. Apgar score: 8/9. The baby had a cleft palate. There were no other complications or abnormalities. The complications during pregnancy included gestational diabetes and anemia. Ferrous sulfate was taken for the treatment of anemia. At the time of reporting, the outcomes for cleft palate, gestational diabetes and anemia were unknown. Additional information has been requested.
Severe fatigue, muscle fatigue, cough and chest pain developed 9 days later.
rash on my left wrist on the outside; large cold sore; This is a spontaneous report from a contactable consumer (patient). A 84-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 10Feb2021 (Batch/Lot number was not reported) at a SINGLE DOSE for COVID-19 immunisation.  Medical history included atrial fibrillation and thyroid condition from an unknown date and unknown if ongoing. No known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL0140), on 20Jan2021 04:00, right arm at single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has not tested positive for COVID-19 since having the vaccine. The patient had not tested positive for COVID-19 since having the vaccine. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROXIN) 50mg. About a week after the second dose, patient developed a rash on her left wrist on the outside. It has been about a week and it is finally going away but not completely and patient experienced a large cold sore that is still there. The events were considered as non-serious. No treatment was given for the event. The outcome of the event rash on left wrist was recovering, while the outcome of the event large cold sore was not recovered.   Information on the lot/batch number has been requested.
Information has been received from a pharmacy tech concerning a female patient in her late 60s who on approximately 01-JAN-2009, "approximately 2 weeks ago", was vaccinated with ZOSTAVAX (Oka/Merck) (lot # not provided). After vaccination, patient experienced excessive pain at injection site. Ibuprofen and ice were suggested as treatment. This is one of several reports received from the same source. Additional information has been requested.
the patient developed a red, sore, swollen rash from her elbow up to the injection site on her arm; the patient developed a red, sore, swollen rash from her elbow up to the injection site on her arm; the patient developed a red, sore, swollen rash from her elbow up to the injection site on her arm; the patient developed a red, sore, swollen rash from her elbow up to the injection site on her arm; This spontaneous report was received from a pharmacist and concerns to a 66 year old female patient. The patient's historical condition, and drug reactions or allergies were not reported. Concomitant therapies included: influenza virus whole virion 3v vaccine inactivated (FLUZONE (INFLUENZA VIRUS WHOLE VIRION 3V VACCINE INACTIVATED)).     On 13-SEP-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, intramuscular, lot # R012976 and expiration date 25-JAN-2020, for prophylaxis (dosage schedule, and anatomical location were not reported).      On 14-SEP-2019 (reported as within 24 hours), the patient developed a red (erythema), sore (pain in extremity), swollen rash (rash and peripheral swelling) from her elbow up to the injection site on her arm. The patient received treatment with diphenhydramine hydrochloride (BENADRYL). No laboratories were performed. The patient sought for medical attention with the pharmacist.   The outcome of pain in extremity, rash, peripheral swelling and erythema was reported as recovered/resolved.   The causality between the aforementioned event and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA002594: US-009507513-1910USA002818: US-009507513-1910USA002780:
Rotarix was administered intramuscularly rather than orally; This case was reported by a physician via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 5th July 2022, the patient received the 2nd dose of Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On 5th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's comment: Physician reported that the Rotarix was administered intramuscularly rather than orally to the patient. The reporter did not have the lot or expiration date of vaccine at the time of the call. The reporter consented to follow-up. Additional Supportive Information: The patient received Rotarix intramuscularly rather than orally, which led to Inappropriate route of vaccination.
Hives and inflammation all over the body. The hives move locations of the body. Right now it's in both of my arms and they are swollen and inflamed and hot. I am itchy! This happened after I took the Moderna booster shot. I have never had allergies and never broke out into hives like this. This is different. This is scary.
After 2nd Pfizer shot of 2 on 2/27/21 I had minor issues with breathing, went to the emergency room at hospital and had a catherization to make sure it wasn't my heart.  The symptom disappeared on its own after 7 months (Sept 2021). After the Pfizer  booster on October 12, 2021 within 3 days I had difficulty breathing when I walked or climbed stairs and had to stop constantly to catch my breath.  I was also unable to twist my upper body to the right when I was attempting to exercise
13AUG95 t104 lasted 12 days-temp range 101-104; 14AUG94 MD dx tonsils & sinus infectt; 15AUG95 rash started face, stomach; 17AUG95 rash all over body & blotchy;rash lasted 12 dasy rash has bumps;pt did not eat well;
Left thigh red and warm. Afebrile, was fine until this AM 10/28.  No pain, alert, active.  Dad outlined a 3x4cm, warm, nontender, not to indurated lesion. Local immunization reaction call 10/29.  Seems better, fainter in color.
patient presented to the pharmacy today (8-9) and stated that one week after she received her Tdap vaccine, she started to get hard nodules that felt like marbles under her skin. She believes this is a vaccine reaction. She also got a tattoo around the same time. The lumps I felt were above her tattoo but she stated that started at the injection site and moved down her arm and then to her other arm. Her doctor is referring her to a specialist but she has not had that appt yet.
bumps on anterior lateral thighs mid day Saturday;increased Sunday & by Monday entire thighs (both);saw PMD Monday morning;felt it was from IPV;given med;
Patient has these extremely painful raised spots all over his back. It is spaced out but is all over his back. Some of the affected areas are scabbed as well. Patient also went to see a specialist and even his specialist said in all his years he has never seen anything like that and thinks that it could be attributed to the vaccine and gave the patient antiviral therapy.
pt recv vax & head became red in color & blotchy, redness from head to neck & torso;called MD for tx orders to give DPH 1/2tsp q 6-8hr PRN;rxn almost completely resolved by 1105AM;
Approximately 2 days after receiving my 3rd Covid-19 Pfizer shot (left arm), I began experiencing tinnitus in my right ear.  Since the tinnitus began, it has been uninterrupted.  I stil (11/16/2021) have it.
Headache, chills, nausea, body aches Narrative: employee states: 2nd vaccine, symptoms started as a dull headache, however, by the evening progressed to a throbbing headache, chills, nausea, and body aches Woke up with still a headache and some nausea has come back
This spontaneous report was received from a certified medical assistant and refers to a 9 year old male patient. Information on the patient's concurrent conditions, medical history or concomitant medications was not reported. On 16-APR-2016 at 09:59, the patient was vaccinated intramuscularly in the right arm with his first dose of GARDASIL 9 (lot # L044475 and expiration date 12-MAY-2017, dose was not reported). The temperature of excursion was 34F and the time frame was 65 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse events, signs or symptoms were reported. No product quality complaint (PQC) was involved. The patient had no illness at the time of vaccination. This is one of several reports received from the same source. Additional information is not expected as all required correspondence has been received.