chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lack of efficacy - tested positive for COVID; Lack of efficacy - tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 17Feb2021 12:00 (Lot number: EL3247) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1,Lot No: EL3247, Location of injection: Arm Right,Time: 12:00, Route of Administration: Intramuscular), administration date: 27Jan2021, when the patient was 24 years old, for Covid-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Dec2021 12:00, outcome "recovered" and all described as "Lack of efficacy - tested positive for COVID". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course:No other vaccine was received in four week. No other medications received in two week. No covid prior vaccination.
24 hrs later - Rapid heart rate (150 resting) exhaustion, Swollen red arm, body aches, low grade fever
Within 22 Hours of second dose, she heard a loud noise in her right Ear and then suddenly she could not hear anything. She also experienced dizziness and severe headaches.
1/15 12:15 pm covid vaccine with moderna 6:16pmtook singular 7:16 pm itchy and tingling of left side of tongue 8:05 Benadryl 50mg 11:00 Benadryl 50 mg  1/16 10am patient first still feeling itching and tingling of left side and tip of tongue with left side of throat. Given prednisone 60mg daily for 5-7 days  1/18 still feeling itching and tingling. Tongue still feels weird. Some dizziness
6th day of off/on low grade fever, fatigue, muscle aches, joint aches, headache.
Nausea, lightheaded, dizzy, weak, itchy face, lower lip swollen.  Taken to ER. IV started, given Benadryl, Pepcid, steroid IV, Oxygen.  Watched for 2 hours, then discharged with resolution of symptoms
Patient states sore arm and could not move it the night of the shot, pain has now radiated into her neck and back, patient went to primary care for care.
Vaccine was given to a 15 year old for first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was given to a 15 year old for first dose) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was given to a 15 year old for first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine was given to a 15 year old for first dose) outcome was unknown.        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.   No concomitant products were reported. No treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2022: Follow up received contains no new information
Vaccination site pruritus/covid-19 vaccines felt itchy after first one; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Vaccination site pruritus/covid-19 vaccines felt itchy after first one) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    There was no reported medical history.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus/covid-19 vaccines felt itchy after first one). At the time of the report, VACCINATION SITE PRURITUS (Vaccination site pruritus/covid-19 vaccines felt itchy after first one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication details were provided. No treatment medication details were provided.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna
CELLULITIS; INDURATION; WARM TO TOUCH; Vaccine administered at inappropriate site; This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a 3-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2018-2019 season) (batch number 2277M, expiry date 24th June 2020) for prophylaxis.   On 26th August 2019, the patient received the 1st dose of FluLaval Quadrivalent 2018-2019 season (intramuscular) .5 ml. On 26th August 2019, unknown after receiving FluLaval Quadrivalent 2018-2019 season, the patient experienced vaccine administered at inappropriate site. On 28th August 2019, the patient experienced cellulitis (serious criteria GSK medically significant), induration and skin warm. The patient was treated with cephalexin (Keflex) and mupirocin (Bactroban (Mupirocin)). On an unknown date, the outcome of the cellulitis, induration, skin warm and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the cellulitis, induration and skin warm to be related to FluLaval Quadrivalent 2018-2019 season.  Additional details were provided as follows: The patient received FluLaval Quadrivalent 2018-2019 season on right thigh, which led to vaccine administered at inappropriate site. The patient had not received any other vaccines while receiving FluLaval Quadrivalent 2018-2019 season. The patient experienced cellulitis, induration and was warm to touch. The patient was treated with Keflex and Bactroban. It was not necessary for the reporter to follow-up. This case has been linked with case US2019AMR164419 reported by the same reporter. Clarification has been raised to confirm the time to onset of event, as of now it was considered as 2 days.
HYPOTENSION (SARASOTA EMS RESPONDED TO PHARMACY); CLAMMY/SOB, EXTREMITY TINGLES; DEATH WITHIN 6-7 HRS
12 hours after receiving first dose of Moderna, Chills, temp of 103, intractable nausea and vomiting and severe headache lasting for 30 hours.
Extreme diarrhea - started with typical bowel movement, bowel movement changed to a pale/clay color, and then changed to pale/clay with a green tint and became diarrhea. My diarrhea became completely green. I spent 3 hours on the toilet.  Nausea
Severe rigors, myalgias, fever of ~8hrs duration, headache, dizziness
Developed hives on torso and back about 4-5 days after 2nd dose. Symptoms have not resolved.
Patient received 1st dose of  Pfizer Covid 19 vaccine.  Was monitored in-office 15 minutes with no issue. Mother reported he left the building and went to the car where he vomited and had near syncopal event, lowering himself to ground.  Then he vomited again.  Patient was brought into office and laid supine on exam table. Vitals were taken within 5 minutes of event and were within normal range.  After 10 minutes patient sat up and was given water.  He sat for additional 10 minutes.  After finishing water, patient denied symptoms, was back to baseline and was released to go home with mother with instruction to seek emergency care at ED if symptoms returned and follow up with primary care physician as this was a vaccine clinic visit and he is not our patient.   Vitals: BP 106/58, PR 74, RR 22, O2 Sat 99, Temp 99.0F, denied pain
I woke up with a cough and I was tired. My throat hurt but I thought I was because of a cough. I had a little bit of headache. It was a dry cough. The tiredness and the dry cough lasted about three to four days. People said that I sounded like a man when I talked. It never really left my sinuses but by Thursday I could blow my nose and stuff would come out and that is when I realized it was turning into a sinus infection. The congestion stopped except that I still have remnants of it, but mostly stopped on Monday of this week. I was out of work from the 19th - 22nd. I didn't have a fever, but I was really tired. No treatment as far as medications. A doctor at my workplace had urgent care have me do a COVID test. They wanted to make sure I was okay. It was the first test I've had to have, and I work there at the Urgent care. I was lazy because I was so tired, so I rested. I still have to blow my nose but now my mucous that had been greenish/yellowish is now clear.
Hours after vaccination my right harm became red about 3-4 inches around injection, swollen and hot. My whole right arm become incredibly itchy. Those symptoms lasted at least 4 weeks.
Pt recvd 1st dose of Hep B vax w/no noted problem; pt recvd 2nd dose of Hep B vax 18AUg92 w/in an hr following vax pt exp sore arm w/pain @ the inject site; sx resolved w/in 24 hrs; No further details were provided;
Moderate pain days 1-3. Sudden onset pain above injection site day 7.  Near shoulder. Painful enough to wake me in night. Unable to sleep on that side. Gradual improvement by day 11.
Vomiting every half hour 12/12/14 and 12/13/14, Diarrhea 12/14/14 and 12/15/14.
Narrative:  Patient called into call center day after receiving first dose of vaccine - experiencing body aches, fever (101 F) and vomiting. Patient reported no symptoms consistent with allergic reaction, drinking fluids and eating well despite emesis. Patient contacted for follow up phone call on 3/29 and symptoms had resolved.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication reported.   This case was linked to (Patient Link).
Tdap and MMR given left arm on 4-17-13, pt reports to HD on 4-24-13 with c/o pain/soreness in right arm and redness at site and below. Pt reports last Td in 2011.
The morning after his second dose he developed severe myalgias and stiffness. Later he was found to have high inflammatory markers and diagnosed with polymyalgia rheumatica. He was treated with prednisone 80mg  and experienced robust improvement. Subsequently he has tapered down to 15mg daily without recurrence to date.
Headache. It's a stuffy heavy feeling. Great lack of energy. Tiredness. Body aches. Joint Aches. My hands have hurt. I have had very, very intense pain in the kidney area of my back and also the lower abdomen area in the front of my body. I'm not eating a lot. I just don't want to eat. I'm hungry, but I just don't want to eat. I want this to be over with...the whole feeling here.
Information has been received from a male patient of unknown age, referring to himself. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On an unknown date, the patient received a dose of shingles vaccine (manufacturer unknown) (strength, frequency, route, lot#, expiration date unknown) for prophylaxis. On 13-SEP-2018, the patient received a second dose of shingles vaccine (manufacturer unknown) (in his arm, strength, frequency, lot#, expiration date unknown) for prophylaxis (inappropriate schedule of vaccine administered). No Adverse effects reported. It is not confirmed if either the first vaccine or the second vaccine was ZOSTAVAX or another company's product.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 71-year-old female patient who received SHINGRIX (batch number FJ578 ?, expiry date 30th January 2020). Concomitant products included folic acid, meloxicam and methotrexate. On 16th January 2018, the patient received SHINGRIX. In January 2018, 12 hours after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling, injection site warmth, general body pain and sleepiness. In January 2018, the outcome of the injection site erythema, injection site swelling, injection site warmth, general body pain and sleepiness were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site warmth, general body pain and sleepiness to be related to SHINGRIX. Additional details were provided as follows: The reporting pharmacist stated there were no concomitant vaccines, and was not aware of any other medical history for the patient. The patient was administered SHINGRIX in the right deltoid and experienced pain head to toe, sleepiness, and injection site redness, swelling, and warmth to touch. The events lasted for 36 hours. The reporting pharmacist stated that she was not aware of the patient seeking medical attention for symptoms. The reported batch number FJ578, was not available in sales data sheet.
Tested positive on 9/13/22 for first time.  Continue to have Covid related sinus infection and lung issues, filling with fluid.
Starting 1 week after vaccination my left arm at the site of vaccination became itchy. No rash or swelling developed. Level of itch was similar to a mosquito bite. Itchiness lasted 3 days. No treatment was needed.
pt recv vax; generalized pruritic hives all over body; giant hives; dph & medrol given;
25OCT97 body aches, cold, chills;2NOV97 hives head to toe everything was puffy;3NOV97 joint swelling-elbows, waist, knees;4NOV97 seen by MD vax rxn pred given;
Approximately 10 minutes after administration of Moderna vaccine (second dose) patient complained of onset of throat swelling, shortness of breath and dry cough. Epinephrine 0.3mg IM was given due to concern for early anaphylaxis
Injection site has red lump, warm to touch, painful. No new chills or fever. Tried warm/cold compress, ibuprofen, TYLENOL.
my arm has a big bump it is hot to the touch and painful. It started as 2 bumps that looked like a bee sting or bite. Then by Saturday 4/10/21 it was one big bump. I believe it is called the covid arm.
DIZZINESS; NAUSEA; EXHAUSTION; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 75 year old female. The patient's weight was 138 pounds, and height was 64 inches. The patient's past medical history included food allergy, and migraine, and concurrent conditions included mitral valve prolapse, iodine allergy, contrast allergy, and sulfa allergy. The patient experienced drug allergy when treated with bupivacaine hydrochloride, and lidocaine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. On 07-APR-2021, the subject experienced headache. Treatment medications included: paracetamol. On 09-APR-2021, the subject experienced exhaustion. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and headache on 08-APR-2021, and had not recovered from exhaustion, nausea, and dizziness. This report was non-serious.
Low grade fever 100F, severe headache, muscle aches, tenderness at injection site, left arm/neck/shoulder is hard to move because it is stiff and hurts, diarrhea
#2  vaccine in series:   High fever (101- 104 ear thermometer) confirmed with oral mercury thermometer (1 degree lower)lasting 24 hours;  tx'd with Tylenol; headache, body aches, extreme lethargy- slept for long periods of time with brief waking to drink and medicate  # 3 booster :  High fever 101-104 ear thermometer) confirmed with oral  mercury thermometer (~ 1 degree lower) lasting  ~48 ;  day 2 fever up to 101 @ 48 hrs post vax- same with HA, body aches and extreme lethargy; slept for long periods of time with brief waking to drink and medicate; day 2 lethargy improved  but fever 101 remained ; last recorded fever was @ ~ 48 hours post vax
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 18-JUL-2012, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-JAN-2017, the patient was treated by a physician for the onset of severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
08/18/21 The patient presents with 48 year old female with a medical Hx of bipolar disorder presents to the ED Altered mental status, patient reports of recently not taking her  Vistaril and Depakote. Pt on physical examination also reported of weakness and dysuria symptoms. Patient has been urinating on herself. Pt is a limited historian but reported that her roommate called 911 for concerns in her mental status. 08/28/21 : Mild distress, just diagnosed with COVID-19
wife called this morning at ~ 9:00 a.m. to report that he woke up with a fever of 101, has been throwing up, is dizzy and disoriented since he woke up this morning.  I advised that he remain seated or lying down, to give Tylenol per dosage on pkg/bottle.  To call 911 if symptoms worsen.  Wife stated that  did have COVID infection in Sept. 2020.  He walks with walker.  I called wife back at 1:50 pm.  States  took Tylenol, fever went down to 99, and he has been able to keep small amt of fluid down.  He has remained seated to avoid risk of falling.  Wife has him urinating in bucket.  Re-emphasized calling PCP to consult, or 911 if symptoms worsen.  To continue Tylenol per pkg instructions.  Wife voiced understanding.
Patient verbally reports she received both vaccines on 9/23/20. The week of October 4-10 (unclear which specific day), she developed symptoms of Bells Palsy. She was diagnosed with Bells Palsy on 10/13/20 by her Primary Care Provider. Patient has had Bells Palsy in the past. She reports her symptoms are worse on the left side, which is where she received the Shingles vaccine dose. She reports that she Is stable and being followed by her Primary Care Provider, however she was not evaluated or managed at this facility for the adverse event.
I had the flu shot administered and a few hours later I felt tingling in my hand like pins & needles and numbness.  It has been that way ever since, I cant do much without it getting like that & my job requires me to type a lot.  It does not hurt but it does bother me a lot.
injection site pain from time of injection, lasting 48hrs; lethargy (lasting 48hrs); occasional diarrhea (lasting 72hrs); feeling feverish (lasting 72hrs); a feeling that of activation of immune response
Significant fatigue, headaches, GI upset, arm soreness that lasted 3 days. Fatigue continues to last.
headquarters contacted me by voice mail and said to call the local pharmacy about the vaccine. I called and was told there was a refrigeration issue and to see a doctor. pharmacy refused to provide any more details nor would they give me any written information. My doctor asked what he supposed to do since it's been nearly 7 weeks since the vaccine was administered and pharmacy will not provide guidance. They said a pharmacist would call me and talk to me but it has not happened (they have not called me).
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of hepatitis b vaccine recombinant (yeast). Subsequently, the patient experienced hair loss. Additional information has been requested.
29JUL97 diarrhea x 3-4d, runny & odorous;no blood noted;30JUL97 fever 103.8R, cont until 2AUG97 between 101R & 103R;2AUG97 measles-like rash, face body, still has on 4AUG97 itchy;MD dx summer virus & 2AUG97 eyes watery & sl inflamed;
REDDEN RASH APPROXIMATELY  THE SIZE OF A SODA CAN BELOW THE INJECTION SITE AND WARM TO THE TOUCH, APPEARED 2 DAYS FOLLOWING INJECTION
Pt diagnosed with epilepsy (partial seizures) after administration. No history or family history. States she knows 4 other people that have been diagnosed with epilepsy after vaccination.
Pt presented to student health for Varivax #2 today. He stated that he had a low grade fever, ecchymosis, and swelling and generalized feeling of discomfort x 2 weeks after Varivax #1 given on 02-27-08. Varivax #2 not given today.
Pt's subjective complaint, 12 hours, post vax, of lip swelling. Presents to medical, 2 days, post vax, with possible lip swelling but no distress. Treated with Benadryl and educated.
Patient was 17 years old at time of vaccination; This spontaneous case was reported by an other caregiver and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 17 years old at time of vaccination) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included Asthma (chronic).    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 17 years old at time of vaccination). On 09-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient was 17 years old at time of vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.