chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Second primary dose administered almost 2 months after the 1st one; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second primary dose administered almost 2 months after the 1st one) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second primary dose administered almost 2 months after the 1st one). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second primary dose administered almost 2 months after the 1st one) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2022, SARS-CoV-2 test: (Positive) Positive.      Patient had no Allergies medications, food and other products   Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination information were not reported.   On October 2021, patient received Pneumonia shots.   No treatment medications were reported.   This case was linked (Patient Link).
Seen in office 3-18-04- Rash on abdomen and legs 3 weeks earlier had varicella vaccine. Vesicular lesions on legs and diaper area.
PATIENT STATED THAT SHE IS NOT ABLE TO LIFT HER LEFT ARM WELL.
Bronchitis; had an allergic reaction on Saturday; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The caller stated that she experienced bronchitis and has taken an antibiotic regarding her condition and wanted to know how long she needs to wait to get the COVID 19 vaccine second shot after this since she was originally scheduled on 12May2021 or would it be fine for her to take the vaccine. Caller stated she received an antibiotic on Thursday and had an allergic reaction on Saturday and she stopped taking it so she has lost two days not being on an antibiotic and so she probably will not be ready on Wednesday to get the vaccine. Caller stated all she wanted to know was what is the time frame for her to get the second shot and how can she reschedule her appointment. Therapeutic measures were taken as a result of bronchitis in the form of antibiotic. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
gen rash 1hr p/vax;parents carried pt to ER where recv epi;
viral infect, settled in joints;c/o feet hurting again & wouldn't walk;Ibuprofen for swelling;
hives - within 5 minutes of receiving vaccine developed hive on right forearm, then developed several others on both left and right arms; This is spontaneous report from a contactable consumer (patient). A 59-year- old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199), via an unspecified route of administration on 06Mar2021 18:30 at left arm as a single dose for COVID-19 immunisation. The patient medical history included allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefalexin monohydrate (KEFLEX) and ciprofloxacin (CIPRO) and had allergy with both the drugs. It was stated that the patient experienced hives- within 5 minutes of receiving vaccine developed hive on right forearm, then developed several others on both left and right arms on an unknown date in 2021. Therapeutic measures received for the event included that within 60 mins the patient took 12.5 mg antihistamine. The outcome of hives was recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
I felt achy and had a horse voice and experienced tiredness, congestion and had pressure in my ears. I contacted the Dr. the next day and told him the results of my home Covid test and he prescribed Molnupiravir for my infection. I would say that I was sick for a total of nine days.
(R) arm swelling and redness started 9/11/13 the day after vaccination. Today seen in urgent care, swelling is decreasing. Treatment: ZYRTEC and cold packs.
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, Fatigue Narrative:
10/27 swelling of arm slightly below site of vaccine administration; 10/28 sent to ED for worsening symptom; 10/31 seen in Primary Care Center for f/u ED visit for cellulitis L arm, improving; placed on keflex 250 mg for 10 days at time of ED visit
Pruritic maculopapular rash; Itching; vaccination site rash; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULO-PAPULAR (Pruritic maculopapular rash), PRURITUS (Itching), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PAIN (COVID arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012629A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced RASH MACULO-PAPULAR (Pruritic maculopapular rash), PRURITUS (Itching), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PAIN (COVID arm). On 26-Feb-2021, RASH MACULO-PAPULAR (Pruritic maculopapular rash), PRURITUS (Itching), VACCINATION SITE RASH (vaccination site rash) and VACCINATION SITE PAIN (COVID arm) had resolved. Not Provided          No concomitant drug information was provided. Treatment information included Benadryl and Tylenol. Action taken with Moderna COVID-19 Vaccine was not applicable    Most recent FOLLOW-UP information incorporated above includes: On 24-Apr-2021: Email On 24-Apr-2021: Patient demographics added, vaccine dosage details added, event stop date added, outcome updated from unknown to recovered.
pt recv 2nd dose of vax;subsequently devel urticaria;following the third dose of vax,failed to seroconvert;
This case was reported by a pharmacist via call center representative and described the occurrence of muscle soreness in a 67-year-old male patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) for prophylaxis. On 5th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced muscle soreness and pain in arm. On an unknown date, the outcome of the muscle soreness and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the muscle soreness and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The pharmacist relaying information regarding adverse event on behalf of the patient. The patient received 1st dose of SHINGRIX at the pharmacy. The patient came on the date of reporting and stated that his left arm still hurts since receiving the first vaccination. The patient was hesitant to receive next dose as the muscle soreness was still present. No further information was provided as patient was unavailable. The patient was not available to provide permission to contact the physician.
Bad cramps in legs; bad headache in his eyes; chills; Temperature of 102; nauseous; Vomited a little bit; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Bad cramps in legs), HEADACHE (bad headache in his eyes), CHILLS (chills), PYREXIA (Temperature of 102) and NAUSEA (nauseous) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 025J202A) for COVID-19. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 28-Jan-2021, the patient experienced MUSCLE SPASMS (Bad cramps in legs), HEADACHE (bad headache in his eyes), CHILLS (chills), PYREXIA (Temperature of 102), NAUSEA (nauseous) and VOMITING (Vomited a little bit). At the time of the report, MUSCLE SPASMS (Bad cramps in legs), HEADACHE (bad headache in his eyes), CHILLS (chills), PYREXIA (Temperature of 102), NAUSEA (nauseous) and VOMITING (Vomited a little bit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 102 (High) for about a day and a half.         No relevant concomitant medications were reported. No treatment information was provided.    This case was linked to MOD-2021-151679, MOD-2021-151679 (Patient Link).
Sore shoulder pessisted many months after shot.  Now getting PT for it.  My physical therapist says I'm the 3rd person she's seen who has reported long term muscle soreness after this year's flu shot
Mom states pt started w/rash & fever 2 days p/last shot; took to ER & was told reaction from Hep B vax;
I woke up at 3 AM, about 12 hours after the vaccination, with shivers and leg pain.  My legs were shaking.   I had great difficulty walking to the bathroom - my legs were very weak, I had to lean on walls and furniture to get to bathroom. I never experienced something like this before in my entire life.  I got out of bed a few hours later and walked to the kitchen with difficulty and collapsed on the floor, where I stayed the entire next day.  I checked my temperature - first it was 100.6 and later it was 101.0 degrees. My legs were weak the entire day and  I could not eat much.  I slept on the kitchen floor for most of the day.  I slept OK the following night.  The next day I did not have a fever, but was very tired. I could not function in normal activity until late in the afternoon of the next day.  The vaccination prevented me from normal functioning for one and one half days.
Vomited at 12:30 am, 2am,  and 3am the following morning after receiving vaccine. Extreme lethargy and muscle soreness throughout body.
Arm is a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is a little sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021 at 2:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm is a little sore). At the time of the report, PAIN IN EXTREMITY (Arm is a little sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Event outcome was updated.
PT PHONE THIS PHN R.N. ON 4/29/04 AND STATED SHE HAD HAD MMR ON 4/1/04 AND APPROX 3 WKS AFTER SHE STARTED HAVING SWELLING AND PAIN IN R KNEE, THEN L KNEE THEN EVENTUALLY WRISTS WERE SORE AND THEN HER ANKLES, HANDS AND NOW HER INDEX FINGER IS SWOLLEN. PAIN AND EDEMA ROTATE SITES.   THIS SN ADVISED HER TO MAKE APPT C HER DR, AND GAVE HER ALL THE INFO I HAD OUT OF PACKAGE INSERT, AND EPI BOOK, I THEN PHONED DEPT OF PUB HEALTH, VACCINE LINE AND WAS ADVISED TO PHONE THE MANUFACTURER.  I CONTACTED THE MANUFACTURER AND INFORMED THEM OF ABOVE AND THEY STATED THEY HAD FILLED OUT A VAERS. AND THAT I COULD FILL OUT ONE AS WELL.  ON 5/3/04 I CONTACTED PT AND SHE STATED SHE HAD PAIN IN HANDS THIS WKEND AND THAT MD HAD PUT HER ON CELEBREX AND SHE WAS WITHOUT PAIN THIS AM, AND DR. WAS HOPING IT WAS FROM MMR AND TO CHECK WITH DR IN 2 WK, IF JOINT PAIN CONTINUED THEY WOULD RUN MORE TESTS THEN.
ELEVATED C-REACTIVE PROTEIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced elevated c-reactive protein. Laboratory data included: C-reactive protein (NR: not provided) 12 mg/L. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of elevated c-reactive protein was not reported. This report was non-serious.; Sender's Comments: V0. medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Swelling under eyes and chin. (Also,temporary headaches and eye irritation, tiredness.) 4 trips to doctors offices on 6/14/21, 12/20/21, 6/9/22 & 7/13/22. No issues or symptoms until after taking the vaccine.
Information has been received from a healthcare worker who worked at a state immunization program referring to multiple unspecified patients of unknown age and gender. On multiple unspecified dates these patients were vaccinated with doses of improperly stored GARDASIL (dose was not reported, lot# K009482 with expiration 06-MAR-2017; lot # K009482 with expiration 06-MAR-2017; lot # K006124 with expiration 02-FEB-2017). No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.
This is a 87y.o. male  Patient has an extensive past medical history which includes BPH coronary artery disease status post catheterization congestive heart failure with preserved ejection fraction COPD diabetes mellitus hyperlipidemia which the patient recently had a below-the-knee amputation the patient was then sent to in-patient rehab which the patient was working with physical therapy occupational therapy the patient's chest x-ray that was obtained has some vague symptoms in which prompted a COVID swab in which the patient has been COVID positive and transferred back to general medical floor
Patient received her 1st Pfizer vaccine on 3/21/21 around 2:30. She states she started to feel numbness over her face and some slight difficulty swallowing within minutes after receiving her vaccine. She sat in the observation area for 15 minutes but never reported her symptoms to the staff. She also states that she started to feel anxious as well and wasn't sure if it contributed to her symptoms. She said she felt like she just needed to get some fresh air. When she got home she took Zyrtec 10mg and had relief of her throat symptoms and some improvement of the numbness over her face. She did not have complete numbness until 3/25/21. She notified her physician of this event and he advised her to return to the clinic and report it.
Hospitalization for hypoxic respiratory failure, COVID pneumonia. Treated with dexamethasone 6 mg IV twice daily
Client was signed up for the Moderna shot by his program facility and clicked he was 18 years old, signed all the paperwork stating he was eligible, he received the Moderna shot , and after he received the shot it was discovered he was 16 years 8 months old. Patient had no actual adverse event, no reactions, no medical needs, family was notified of the issue and opted to get him vaccinated with Pfizer later on instead.
patient fainted during the 15 minute monitoring period and hit his head on the floor, when pharmacy staff rushed out he was conscious and was able to speak, patient was instructed to lie on the floor and prop his feet up onto a chair and remained this way for about 15 minutes. When questioned he stated he was ok but his head hurt a little bit from when he fell.   After awhile the patient was feeling ok and went home.
Continues Body And verbal TICS. Shaking, Jerking, Vocal all ongoing today.
swelling, erythema about the size of silver dollar w/itching @ inject site; 22DEC93 f/u called pt to request more info about provider; 30DEC93 spoke w/pt would not give info about provider; states devel flu on 22NOV93 & pneumonia 29NOV93;
INJECTION SITE REACTION; This spontaneous report received from a patient concerned a 53 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021 11:09, Laboratory data included: Body temperature (NR: not provided) 98.1 F. On an unspecified date, the subject experienced injection site reaction. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from injection site reaction. This report was non-serious.
Pt recv vax on 7/13/95; on 11/18/98 pt exp varicella disease
This spontaneous report as received from a physician refers to a 16 year old female patient. On 30-AUG-2011 the patient was vaccinated with GARDASIL, 0.5 ml, intramuscular. The dose number, the lot number and expiration date of the vaccine, the route of administration and anatomical location of the vaccination were not reported. On 10-SEP-2011, reported as 11 days after the date of vaccination the patient experienced celiac disease (disability, medically significant upon internal review), tripping down the stairs because her legs were so weak (disability), muscle pain (disability), extreme fatigue (disability), myasthenia gravis (disability, medically significant upon internal review) and being so weak that she had issue lifting her arms (disability). Disability was reported as serious criterion, the event(s) to which this referred however were not specified. Treatment for the myasthenia gravis included MESTINON, IVIG and Prednisone. The outcome of celiac disease, tripping down the stairs, muscle pain, extreme fatigue and myasthenia gravis was reported as not recovered/not resolved. The physician reported that all adverse effects were progressing. No causality statement was reported for any of the events in relation to GARDASIL. Additional information has been requested.
This spontaneous report was received from a nurse practicioner and a reporter (role unspecified) from the nurse's healthcare facility and refers to a 38 year old patient of unknown gender. No information about the patient's medical history, concomitant medications or concurrent conditions was provided. On 22-NOV-2016, the patient was vaccinated with an improperly stored dose of M-M-R II injection, 0.5 ml, subcutaneously in right upper arm (lot # K024825, expitarion date: 02-DEC-2016). The dose of M-M-R II was reported to be stored on unknown dates at 8.6 degrees Fahrenheit (F) for 1 minute, 6.5 F for 1 minute and 47 F for 1 hour and 40 minutes. The temperature excursion was detected with a data logger. No previous excursions were reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information is not expected, as the reporter has no further data.; Sender's Comments: US-009507513-1610USA013766:
Patient was administered 3 vaccines (MMR, Varivax, and flu). About 10-15 minutes after the vaccination patient experienced syncope. Patient was alert and refused EMS. Ice pack, smelling salts/alcohol pads given to help with alertness. Patient monitored for additional 15-20 minutes and was okay to leave
10/29-101 degree fever, achy 5:30-11:30 PM. 11/1-single croup-like cough (night before Halloween). 11/2-11:15 PM began wheezing. Nebulizer at ER 3:00 AM, sent home. 11/3-follow up visit to doc. 2 dosages of ORAPRED.
muscle and bone pain; teeth chattering, like she was cold; nausea; dry heaving; headache; fever of 103; muscle and bone pain; According, to the consumer the doctors from the hospital told her she was being treated for sepsis; arm started to blow up like a red balloon and spread everywhere; arm started to blow up like a red balloon and spread everywhere; injection site pain; This spontaneous report was received from a 67-year-old female, referring to herself.  The patient's medical history included COVID-19 and kidney stones. The patient's concurrent conditions were not reported. Historical drugs included codeine (causes nausea) and benadryl (causes somnolence). Concomitant medications included gabapentin, montelukast, escitalopram oxalate (LEXAPRO) and omeprazole (PRILOSEC).   On 07-JUL-2022, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (reported as "to stay out of the hospital with pneumonia") in upper right arm (strength, exact dose, lot #, expiry date and route of administration were not provided).  On 07-JUL-2022, the patient experienced injection site pain. On 08-JUL-2022, the patient experienced teeth chattering, like she was cold, which quickly led to a headache, muscle and bone pain, nausea and dry heaving and a fever of 103. On 08-JUL-2022, the patient was admitted to the hospital and reported the hospital performed urine and blood cultures, COVID testing and a viral screen; all of these tests came back negative or clear according to the patient. The patient was administered pain medication and an antibiotic. On 09-JUL-2022, the arm she received the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in, started to "blow up like a red balloon and spread everywhere". According to the patient, the doctors from the hospital told her, she was being treated for sepsis and would not listen to her regarding a reaction to the vaccine, stating "there was a lot of paperwork involved." The patient reports, that she was home now and was still red and swollen, "just not as bad as before". On 11-JUL-2022, the patient was discharged from the hospital. At the time of reporting, the patient had not recovered from the events.  The reporter considered events of teeth chattering, headache, muscle and bone pain, nausea, dry heaving, fever, injection site pain and arm started to blow up like a red balloon and spread everywhere to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The causal relationship between sepsis and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.  Upon the internal review, the event of sepsis was considered to be medically significant.
9JUN98 11PM arms itching, then progressed all of body x/palm of hands, soles of feet & testicular area;given aveeno oatmeal bath, DPH, curel lotion;
Patient came in for a Pfizer COVID Vaccine booster. Received Janssen by mistake.
This spontaneous report as received from a clinical/medical assistant refers to a 16 years old patient of unknown gender. On 23-JUN-2014 the patient was vaccinated with (Oka/Merck) PROQUAD (dose, lot # and expiry date were not reported) by mistake. No adverse effect was reported. Additional information is not expected because there is no consent to contact the reporter.