chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2021 as dose 1, single (Lot number: EP7534), in right arm and on 12Apr2021 as dose 2, single (Lot number: ER8731) at the age of 40 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Dec2021 as dose 3 (booster), single (Lot number: 033F21A), in right arm and on 21Oct2022 as dose 4 (booster), single (Lot number: 061F22A), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 10Dec2021, outcome "recovering", described as "Interchange of vaccine products administered"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (04Jan2023) Negative, notes: home test was negative; (10Jan2023) Positive, notes: positive at home test 6 days after. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rebound symptoms and a positive at home test 6 days after an at home test was negative. Total of 7 days after completing Paxlovid. The outcome of the events was recovering.
Case number PHEH2015US002052, is an initial spontaneous report from a medical assistant (MA) received on 27 Jan 2015 and with a follow up report received on 23 Mar 2015. This report refers to an 11-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered MenCYW-135 liquid component of MENVEO (batch number: M14044) without being reconstituted with MenA, intramuscularly on 19 Jan 2015. No adverse event was reported following the administration error (inappropriate preparation of medication). Follow up report received from MA on 23 Mar 2015: Added patient demographic details.
chest pain & weakness Narrative:  Pt received his covid vaccine dose #1 on 1/29/2021. On 1/30/2021 he experienced a fever, chest pains and weakness. Pt reported this at his appointment to receive his 2nd dose of covid vaccine on 2/26/2021. Nurse administering vaccine informed pharmacist pt reported he was still feeling weak from the first vaccine dose, so weak he could not perform ADLs without assistance. Pharmacist recommended pt be sent to the ER evaluation, possibly pt has an illness unrelated to the vaccine and another dose may cause worsening of symptoms. Upon further investigation pt was seen at outside hospital ER on day after his dose #1 covid vaccine for chest pain, pleural effusion and weakness and low grade fever. Pt was evaluated and transferred to ER dept. ER gave him morphine iv, magnesium iv, & furosemide 40mg iv. Pt was admitted on 01/31/2021. Pt evaluated by cardiology, internal medicine & given a course of antibiotics. Pt was diagnosed with Chronic Right side pleural effusion, POA. Pt was discharged on 2/3/2021 with the following medication discharge instructions: "SUMMARY OF MEDICATION CHANGES NEW meds: -Start cefdinir 300mg by mouth twice a day for infection - take first dose evening of 2/3/2021 and last dose evening of 2/4/2021 - Start ferrous sulfate (iron) 325mg by mouth every other day - Start pantoprazole 40mg by mouth daily 30 to 60 minutes before breakfast CHANGED meds: -Metoprolol succinate 50mg by mouth daily changed to metoprolol tartrate 12.5mg (=1/2 25mg tablet) by mouth twice a day STOPPED meds: -Stop taking lisinopril until follow-up with your primary care provider -Stop taking omeprazole Of note pt's medical history includes the following comorbidities: *Gastroesophageal reflux disease *Coronary arteriosclerosis *Carotid atherosclerosis *Carcinoma of colon * Colostomy present *Hyperbilirubinemia On 2/26/2021 vaccine dose #2 was held. Pt was encouraged by nurse to follow up with PCP or to report to ER for further evaluation. Pt was given phone # to reschedule dose#2 if appropriate.
Patient started getting sick around 9 hours after receiving the vaccine. Patient had never been sick before, not even a cold. Her symptoms included fever, diarrhea, loss of appetite & not sleeping very well.
Three to four hours after shots were administered, the baby awoke from her nap screaming and then turned pale and unresponsive/limp.  She felt cold and was perspiring.  She appeared to have fainted for a period.  After about 5 minutes she seemed to get a little color back and nursed a little.  She did not have a fever according to our thermometer.  Temp was 96.8 (underarm).  We gave her some Tylenol anyway.  We did not take her to the doctor but called the nurse at the clinic.  She did not seem too concerned, but of course we were.  Since the baby seemed better after a few minutes, we thought it best to let her rest at home instead of taking to the ER.
It was reported that a pt (6 of 10) received a TD Adult that was inadvertently administered intradermal. The pt developed a large local red, hard area at the injection site. Further information is being requested.
I was intolerant to my first Shingrix injection; This case was reported by a consumer via call center representative and described the occurrence of drug intolerance in a 73-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug intolerance. On an unknown date, the outcome of the drug intolerance was unknown.   It was unknown if the reporter considered the drug intolerance to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was intolerant after first Shingrix injection. The patient asked whether to get the 2nd dose as the patient was intolerant to the first injection.
Severe long-lasting Nerve pain from my neck down to my toes. Chest pains
arm was sore a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore a little bit) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm was sore a little bit). At the time of the report, VACCINATION SITE PAIN (arm was sore a little bit) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-075278 (Patient Link).
PT PRESENTS BY WHEELCHAIR WITH C/O OF FALLS. PT REPORTS 2ND COVID VACCINE TUESDAY. PT REPORTS TODAY HAS BEEN HAVING INCREASED WEAKNESS. PT REPORTS WHEN HE STANDS HAS INCREASED WEAKNESS IN LEFT LEG. PT REPORTS DECREASED FEELING IN LEGS. PT DENIES SOB OR CHEST PAIN. PT DENIES PAIN IN LEGS. PT REPORTS "I CAN STAND AND TRY TO WALK THEN MY LEGS GIVE OUT". NO S/SX OF DISTRESS NOTED. PT IS AFEBRILE. PT DENIES ANY PAIN. NO FURTHER COMPLAINTS, COMMENTS OR CONCERNS REPORTED AT THIS TIME.
Approximately 8cm x 8cm, flat, smooth, warm to touch area at left bicep about 3 days post vaccination, resolving without treatment.
Initial report was received 08 March 2012 from a consumer, who is also the patient. A male patient (age and date of birth not reported) who had cellulitis of the foot (cause unknown) at the time of vaccination, had received an intramuscular injection of DECAVAC, lot number U369BA (lot number invalid) on 01 August 2011. The patient had been taking KEFLEX and BACTRIM concomitantly. On 10 August 2011 (also reported as 10 days later), the patient reported "feeling weird" which resulted in blurred vision, paresthesia, left arm paralysis, trouble walking and dizziness. He was evaluated by several neurologists and rheumatologists, also reported as 19 doctors. He received spinal taps and brain scans (unspecified) which showed a 1cm brain lesion on the temporal lobe. The patient was diagnosed with Chronic Fatigue Syndrome and Sjogren's Syndrome five months post vaccination. Outcome was not reported. Documents held by sender: None.
I received my second Moderna booster for COVID-19 on 5/9/2022. While I was on vacation on 8/10/2022, I went to lunch with my grandmother. When I got back from lunch, I felt extremely tired and had nasal dryness. On 8/11/2022, I felt increasingly tired and my throat was scratchier. I took an antigen test that night and got a negative result. When I woke up the morning of 8/12/2022, I had a major headache; I almost never get headaches, so this was unusual. Also, my ears hurt and everything sounded like I was underwater, and I could even almost hear my heartbeat. Not only that, but my eyes felt hot and watery. I knew that something was going on, so I took another antigen test that day and got a positive result. I took a PCR test at a clinic later that day and got another positive result. I self-isolated for about 10 days and took OTC medicines for body aches, congestion, and fever. When 8/22/2022 or 8/23/2022 rolled around, I felt like I had a made a full recovery. On 8/22/2022, I took another antigen test and got a negative result.
Pt. received only the diluent on 9/16/13 of Menveo not the powdered Serotype, revaccinated 10/2/13.
Initial case report received from a consumer via a lawyer on 23 OCT 2009. A female patient of unknown age was vaccinated with FLUVIRIN (batch no. unknown) on 31-OCT-2007. The patient developed pleurisy after vaccination and was hospitalized. The outcome was unknown at time of this report.
An 18 year old male patient who was administered the first dose of GARDASIL 9 on 25-MAR-2019, the second dose on 27-AUG-2019 and the third dose on 22-OCT-2019.; This spontaneous report was received from a Registered Nurse via company representative referring to a 18 year old male patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  The Registered Nurse reported that about an 18 year old male patient was administered the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown)  on 25-MAR-2019, the second dose on 27-AUG-2019 and the third dose on 22-OCT-2019 for phrophylaxis.
Information has been received from a licensed practical nurse concerning a 34 month old white female with no past medical history and no known drug allergies who on 30Nov2001 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live. There was no illness at the time of vaccination. Concomitant vaccinations included a first dose in the right anterior thigh of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  and a fourth dose in the left anterior thigh of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (PREVNAR).   On 21Oct 2003 the pt presented to the Dr's office with chickenpox, described as 10 to 15 itchy, papular vesicular lesions on the chest and right leg. The child was also noted to have a fever. In addition, it was noted that the child had an ear infection which was being treated with amoxicillin.  Unspecified medical attention was sought.  There was no product quality complaint. Follow up information indicated that the adverse event onset was 17Oct2003. On 21Oct2003, the pt presented to the physician's office with 10-15 lesions (first lesions spotted 4 days prior) and was afebrile. The pt was also diagnosed with left otitis media. She was treated with amoxicillin. No further information was available as of 05Nov2003. Follow up information from the nurse indicated that as of 18Nove2003 no further information was available.
Arm began to ache shortly after injection as per usual. Days went on and it did not subside. I reached out to local heath care providers for advice. I was told it should subside. It didn't. When it was time for my second dose I couldn't bare to have another injection in my arm. I had the second in my right thigh. Started with similar pain, but subsided quickly, and was completely gone in a couple of days. My shoulder has never recovered. It's been two months and my arm has neve stopped aching. I've lost strength in my arm, and a deep throb is always present that keeps me from sleeping.
Pt had syncopal episode. Placed patient laying down on mat on floor with feet elevated. BP: 121/68, P 50 in Left arm, BP: 110/61, P 56 in Right arm. Pt responded quickly after laying on floor and able to stand up after 5minutes. Patient sat in chair for 15min before leaving. She was AAOX4.
Information has been received from a pediatrician concerning a 19 month old male with asthma, food allergies and warts on his abdomen who on 12/4/00, at 15 months, was vaccinated with a first dose of varicella virus vaccine live (lot # 635454/1144K). On 2/27/01, at 18 months old, he was vaccinated with the second dose of varicella virus vaccine live. Concomitant therapy included alum, potassium (+) diphtheria toxoid (+) pertussis vaccine (+) tetanus toxoid (TRIPEDIA) (lot # U029915A), poliovirus vaccine (IPOL) (lot # R0692), cromolyn sodium (INTAL), diphenhydramine HCl (BENADYRL), and albuterol nebulizer (manufacturer unknown). On 3/11/01, at 19 months old, the patient had an acute muscle weakness with flaccid muscle tone. Upon waking from his nap, he was found by his mother to be unable to sit or stand up. It was reported that the child was extremely floppy, although he was still able to suckle. Roughly 6 hours after the onset of the incident, the patient crawled out of his mothers lap and walked across the floor and appeared fine. It was noted that over the next couple of months the patient appeared increasingly clumsy and weak. Follow up information received from a nurse indicated that the child has severe handicaps and has several problems. It was also noted that the child was autistic. The patient's severe handicaps, several problems, and autism were considered to be incidental findings. The reporter felt that the patient's experience was possibly disabling. Additional information has been requested.  Reported on 03/26/2003: "Follow up information received from a physician indicated that on 03/11/2001, the office received a phone call from the parents of the child stating that the child was not able to sit up, was "dizzy" when he sat up, and cried when he went up to sit.  The child was seen in the office and was diagnosed with right otitis media and tonsillitis.  On 03/21/2001, the mother reported that the patient was "much better."  It was noted that the patient recovered.  Follow up information received from a physician indicated that the patient's experience was not disabling.  This report no longer meets the criteria for expedited submission because of follow up information indicated that the events were non-serious.  Additional information has been requested. A 15-day follow report received 03/26/2003 adds no new info.
No adverse reaction. This was just administered to a pediatric patient. Several days worth of follow up calls reported no adverse reaction.
This spontaneous report was received from the patient's mother via a company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with GARDASIL (dose, frequency, route of administration, lot # and expiration date were not reported). The patient received three doses of GARDASIL, each dose on a separate unspecified date. On an unknown date, an unspecified time after receiving GARDASIL (it was unspecified if this occurred after the first dose, the second dose, or the third dose) the patient was diagnosed with an unspecified reproductive cancer. The outcome of the event was unknown. The relatedness between the event and GARDASIL was not reported. Upon internal review, the event of unspecified reproductive cancer was considered to be medically significant. Additional information is not expected because there was no consent to contact a physician.
Within a couple hours severe pain in left arm at injection site and deltoid; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees; Pain remains 7/10 in shoulder blade and arm; Still do not have full AROM 23+ hours after injection; muscle spasms around left shoulder blade 4-5 hours later; 130 resting heart rate 6 hours after; burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees/ Pain remains 7/10 in shoulder blade and arm; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), intramuscular in the left arm on 21Dec2020 13:15 at a single dose for COVID-19 immunization. Medical history included partial motor seizures face. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication included lisdexamfetamine mesilate (VYVANSE 40 mg), escitalopram oxalate (LEXAPRO 10 mg), brivaracetam (BRIVIACT, 100 mg).  On 21Dec2020 4pm, within a couple hours severe pain in left arm at injection site and deltoid, muscle spasms around left shoulder blade 4-5 hours later, 130 resting heart rate 6 hours after, burning in left scapula to left side of chest, by midnight was unable to lift arm away from body more than 25 degrees. On 22Dec2020, by 9 am this morning back to 90 degrees shoulder flexion and abduction with pain. Pain remains 7/10 in shoulder blade and arm. Still do not have full AROM 23+ hours after injection. The patient was not hospitalized for the events and did not receive any treatment for the events. The events were reported as non-serious. The vaccine was administered in a workplace clinic. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.  Information regarding lot/batch number has been requested.
Pt recvd Engerix-B on 27APR90, 31MAY90, & 26OCT90 subsequently found neg anti-HBS p/3 doses @ 1mo, 2mo, & 6mo intervals;
A lot of headache; Little bit nauseous; Rash on face; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247; Expiration Date: 31May2021), via an unspecified route of administration on 27Jan2021 at SINGLE DOSE for covid-19 immunisation. The same day, which was a Wednesday, the patient was having a couple of symptoms., kind of have like a headache and then a little bit nauseous but then this morning woke up with the rash on my face. The patient hasn't read anything about that being kind of a side effect and it was just a little bit strange to me that happened a few days to me after being already vaccinated. So, was enquiring what was to be done.  The outcome of the events was unknown.   Follow-up (30Jan2021): This is a Follow-up spontaneous report from a contactable consumer. Limited information was obtained.  Follow-up attempts are completed. No further information is expected.
expired DAPTACEL dose was administered to a patient with no reported adverse event; Initial information received on 14-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient for whom expired Diphtheria-15/Tetanus/5 AC Pertussis Vaccine [Daptacel] dose was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Jul-2023, the patient received a dose of 0.5 ml 1x (total) expired suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine suspension for injection of standard strength (frequency: once) (lot: C5893AA, Expiry date: 21-Jun-2023) via unknown route in unknown administration site for Immunization with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Bruising surrounded by redness/swelling on left thigh. 12.5cm by 10cm. Prescription for Keflex TID x 10 days.
Almost immediately began to experience nausea and some mild lightheadedness.   Within an hour began to feel like I had taken a sedative (reminded me of how klonopin made me feel when I was taking it for anxiety).  Sedative type feeling lasted for approximately 4 hours.  Headache developed approximately 2 hours after receiving vaccination.  Headache and nausea persisted until bedtime.  Had major issues sleeping and had night sweats all night.  Nausea is gone this morning but headache is still present.  Some mild tenderness at injection site that is still present this morning.
Patient presented with bilateral lower extremity pain and edema. Patient says that the pain started in the morning while she was getting ready for work. She had just gone to the bathroom and she bent over to get some of the lint off of her pants and then got up. The pain came on all of a sudden. It is described as a burning and throbbing pain that she rates as a 10/10 when it first started. At exam she stated it is 8/10 since she had been given some medicine. She was unable to walk and had numbness in her toes and was unable to move them. She stated that she was able to move them earlier. She had some nausea and vomiting and with the vomiting she did have some incontinence. She had never had this pain before and she is a foster child and does not know her family history. She is a nonsmoker and denies any illegal drug use. She does not drink either. She denies any injury or trauma.  Patient was subsequently admitted to Hospital. She underwent an urgent MRI on admission which showed no evidence for acute fracture. No cord impingement or abnormal cord signal. There was spinal stenosis at cervical levels related to a combination of disc degenerative change at C3-C4 and C5-C6 superimposed upon a low normal caliber spinal canal. Cord impingement, but no myelomalacia. Neurology was consulted as patient was experiencing paralysis of her lower extremities and numbness, along with pain upon urination. Neurology completed a lumbar puncture which was positive for protein but negative for white cells. Also completed EMG/NCS of the left limbs which revealed very early neuropathy with primarily motor findings. Neurology diagnosed the patient with Guillain Barre Syndrome, likely related to administration of the flu vaccine. Patient was treated with 0.4g/kg of IVIG x 5 doses. After treatment she has considerably less tingling but unchanged weakness. She is being discharged to a rehab facility.