chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a company representative concerning her father a 78 year old male with diabetes, asthma and seasonal allergy who in August 2007, was vaccinated with a dose of ZOSTAVAX (Oka/Merck). In August 2008, the patient was diagnosed with herpes zoster. Herpes zoster was affecting his bowels and the patient was experiencing nerve pain. The patient's herpes zoster and nerve persisted. The patient did not seek medical attention. No product quality complaint was involved. Herpes zoster, affecting bowels and nerve pain were considered to be disabling. No further information is available.
During a public event I became somewhat disoriented. That afternoon my family and I noticed that I was slurring my words somewhat and shuffling my feet as a I walked, and sometimes I could not complete a thought or, when I spoke, a sentence  My affect was also affected: I wept more readily than usual. They also noticed that my eyes were bloodshot.  I resisted a suggestion that I go to an Urgent Care Center or an ER.  We did not take my blood pressure. Those conditions persisted into the next morning. When a neighbor, an RN, came over, she insisted we call an ambulance. The EMTs insisted I be taken to an ER for assessment, not treatment. At the Hospital ER I received a CT of the brain, a heart X-Ray and a blood work up. I was told there was no reason to keep me, given a low dose of a mild blood pressure medication, and told to see my doctor the next day. I did and was referred to a physical therapist, a speech therapist and a cardiologist.
Light headed and aches within two hours. At 2am next morning, I could hardly stand due to muscle pain and weakness, neck to toes, with associated nausea and low-grade fever of 99/100 the rest of the day.  I took Advil and Tylenol every 4-6 hours. Some pain and weakness and nausea remain on 2/4/2021 but fever is gone and feeling well enough to return to work.
This spontaneous report was received from a medical assistant and refers to an unknown number of unspecified patients. The patients' pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the unknown number of patients were vaccinated with improperly stored  M-M-R II, for prophylaxis (dose, units, lot number and expiration date were not provided). Concomitant therapy included (STERILE DILUENT) (lot number and expiration date were not provided) used for reconstitution of M-M-R II. Administered vaccine reached temperature excursion high of 15.9 Celsius degrees and lasting for 2 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA007629: US-009507513-1705USA007630:
in the interim I had Covid; in the interim I had Covid; This is a spontaneous report from a Pfizer sponsored program. A Contactable consumer (patient) reported that a 63-year-old female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration, administered in Arm Right on 15Mar2021 at a single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient reported that today was my second dose of Pfizer vaccine but in the interim I had Covid on an unspecified date in 2021, so I spoke with my healthcare provider and they told me to wait 90 days and then I have to start it all over again. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested
fever; soreness in right arm; headache; shingles outbreak on her back and tooth; tooth (described as 'like having a cavity"); This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (shingles outbreak on her back and tooth), DENTAL CARIES (tooth (described as 'like having a cavity")), PYREXIA (fever), MYALGIA (soreness in right arm) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 01-Apr-2021, the patient experienced PYREXIA (fever), MYALGIA (soreness in right arm) and HEADACHE (headache). In April 2021, the patient experienced HERPES ZOSTER (shingles outbreak on her back and tooth) and DENTAL CARIES (tooth (described as 'like having a cavity")). On 03-Apr-2021, PYREXIA (fever) and MYALGIA (soreness in right arm) had resolved. On 05-Apr-2021, HEADACHE (headache) had resolved. At the time of the report, HERPES ZOSTER (shingles outbreak on her back and tooth) and DENTAL CARIES (tooth (described as 'like having a cavity")) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient  took one Tylenol on 27Apr2021 at 14:00 and 28Apr2021 at 03:00.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA302269, 2018SA313496 and 2018SA302120. This case involves child patient who was vaccinated with 0.5 ml IPOL (batch number, expiration date was not reported) via intramuscular route in right thigh on 17-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE, PREVNAR 13 and HEPATITIS B VACCINE for Immunisation. It was an actual medication error due to incorrect product storage. It was reported that an open IPOL was administered following 2 excursions. It was unknown whether the patient had any adverse event. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
At an unspecified time in 1999, the received the first injection with Lymerix. Sometime thereafter, she experienced an exacerbation of her arthritis. The second dose of Lymerix was given in 1999 while the symptoms were ongoing.  The information received on 3/21/00, reports the symptoms remain ongoing.
This case was reported by a physician and described the occurrence of rash under eyes in a 3 week old subject of female who was vaccinated with hepatitis B vaccine recombinant Engerix B for prophylaxis. The subject had no known allergies. Concurrently the subject received no medications. On May 6 2005, the subject received the 1st dose of Engerix B. On may 12 2005, 6 days after vaccination with Engerix B, the patient experienced an allergic reaction manifested as a rash beneath the eyes and was seen at a physicians office. The physician described the rash as a rash bilaterally beneath the eyes with micropustles, macro papules, coalescing under the eyes. The physician also reported that he, usually sees this type of rash with topical application of products. As of June 3 2005 the rash had improved. In the reporters opinion, the rash was possibly related to the use of Engerix B.
Student c/o feeling dizzy and frontal, NKA, headache, symptoms, palor and skin, clammy, decreased B/P 1:00pm- V/S 80/58, 18, S2; 1:05pm: 92/60,84,20. 1:10pm: 102/72,32,88. 1:16pm 96/70,86,28. 1:27pm 98/70, 80, 24. 1:30pm 96/70, 80,24. (Recovered and released in stable condition).
Information was received from a registered nurse regarding an unknown number of patients. The unknown number of patients were inadvertently administered GARDASIL, and PEDVAXHIB (dosages and routes of administration not provided) on 30-OCT-2013 and 31-OCT-2013, that had been improperly stored. No adverse effects reported. The nurse was unable to confirm the exact number of identifies of the patients at the time of this report. Additional information has been requested.
rash all over body; This case was reported by a physician via sales rep and described the occurrence of generalized rash in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB35AA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero with an associated reaction of pyrexia (1st dose received on 23rd August 2021, for tolerance, refer case US2021AMR225344).   On 25th October 2021, the patient received the 2nd dose of Bexsero .5 ml and Bexsero Pre-Filled Syringe Device. In October 2021, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced generalized rash. The patient was treated with prednisone and allergy medication {nos} (Allergy Medication). On an unknown date, the outcome of the generalized rash was unknown.   It was unknown if the reporter considered the generalized rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash all over body, no swelling of tongue.  The patient was prescribed with Prednisone and allergy medications. On the date of reporting (29th October 2021), the patient was going to visit the physician. It was reported that on next day, reported event on website. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR225344:same reporter
devel rt anterior thigh & rt buttocks shingles @ side on which vax recv;lesions extended from rt knee to rt groin & around rt buttocks;vesicles were dried & unable to grow zoster on cult;
Pt came in on 9/20/17-injection site on left MT was raised, warm to touch. Pt was given cephalexin 250 mg/5ml 10 mL 2x a day for 10 days. Pt came in 9/21/17, left thigh with 2 marked lines 16cm x 13cm. Medial side more erythematous. Pt was given ROCEPHIN inj 1 ml R MT, 1.1 ml R buttocks 750 mg 2.1 mL total.
This spontaneous report was received from a nurse referring to an unspecified number of patients of unspecified gender and age. Information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapy was not provided. On unknown dates in 2017, reported as since 26-JAN-2017, the unspecified number of improperly stored doses of M-M-R II (lot number M028130, expiration date 03-JUN-2018, lot number M022407, expiration date 02-MAY-2018 and lot number M022408, expiration date 02-MAY-2018) (dose, route of administration and were not reported) were administered to the patients. The reporter did not have access to the lot number and expiration date of the sterile diluent (MRK) (dose and route of administration were not reported) that was used to reconstitute the doses. The doses were stored in temperatures from 47F Fahrenheit degrees to 77 Fahrenheit degrees for 1 hour and 42 minutes.  Data logger was involved. There was no previous excursion reported. No adverse effects have been reported. Product quality complaint was not involved. Additional information has been requested.
Injection pain was intense and felt like it hit something. Said it was painful injection and by evening she couldnt move arm at all and couldnt sleep due to pain. By next morning it was quite a bit better, sore bur much improved. Pt feels shot was too high. Some days are worse than others, some days not so bad. Pt did see her PA 3 weeks later and she said they could do PT. Pt denied because she didnt have time.  It is really bad now in shoulder and has decided to do therapy.
7-18-11: ZOSTAVAX given; 7-19-11: Pt had swelling in the injection area, redness, hot to touch & itching -> told her to take TYLENOL, BENADRYL and apply ice. 7-23-11: Only slightly swollen and itching -> feeling better.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed) and DIZZINESS (Dizzy spells) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Herniated disc (lower).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed), DIZZINESS (Dizzy spells), GAIT INABILITY (Could not walk without a walker), LIMB DISCOMFORT (Unsteady on her feet), CHILLS (horrible chills), PYREXIA (Fever) and ARTHRALGIA (sharp pains in her knees). At the time of the report, PAIN IN EXTREMITY (Horrible leg pain/ horrible pain in the legs), FALL (Falling/ fell/had fallen six times), BALANCE DISORDER (Loss of balance/ she loss balance/ Could not maintain her balance), DYSSTASIA (legs collapsed), DIZZINESS (Dizzy spells), GAIT INABILITY (Could not walk without a walker), LIMB DISCOMFORT (Unsteady on her feet), CHILLS (horrible chills), PYREXIA (Fever) and ARTHRALGIA (sharp pains in her knees) outcome was unknown.            No concomitant product information was provided. No treatment information was provided. Patient reported that She had been to eye, hearing, and orthopedic specialists, and all said they could not find anything and her bloodwork was also fine. The neurologist was scheduled to do magnetic resonance imaging (MRI) scans of her head in Sep/2021.   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Added Patient demographics(date of birth), Medical history, Dose 1 information, Anatomical location for dose 2 and new events(Dizzy spells, pain in her knees, unsteady on her foot, could not walk without a walker). Updated dose 2 batch number and event verbatim (fall, balance disorder). On 25-Aug-2021: Follow up received contains no new information
This spontaneous report was received from a nurse refers to unspecified multiple patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had lot # L025738, expiry date: 14-AUG-2017, lot # L029631, expiry date: 14-AUG-2017 and lot # L044694, expiry date 04-FEB-2018 (route, dose and anatomical place of vaccination were not provided). The vaccines were exposed to temperature of 74 degree Fahrenheit for 10 hours. The temperature excursion was detected by a data logger. No adverse effects were reported. At the time of this report, the vaccines were back in range. No product quality complaint (PQC) involved and no further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient originally told us that he had not had any previous COVID vaccine doses and that this would be his first dose entirely.  He also confirmed this in the immunization room prior to vaccination and which time we discussed when he would return for his second dose. Patient chose to get Moderna after an explanation on both Pfizer and Moderna that we had in stock. After the vaccination was complete, the patient's wife came to the pharmacy stating we gave him a new card which he doesn't need because he already has one. We discussed that he indicated he had no previous doses so I asked her to have him return to the pharmacy with his card so we could take a look at it. When he returned we discovered he had received one previous dose of the Pfizer vaccine on 2/11/22 from a different facility. Per protocol, patient does not need to re-dose and both he and his wife were advised that he will need to return when he is eligible for his first booster dose.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and unknown gender. Patient's concurrent conditions and relevant medical history was not reported. On 05-FEB-2015, the patient was vaccinated with GARDASIL (lot number: K007264 with unspecified expiration date) (dose, frequency and route unspecified) that had underwent temperature excursion. Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issues was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
On post vaccination day 99, patient began to complain of neurologic symptoms: diplopia, ptosis, leg paresis, dysphagia, and blurred speech.  Saw a neurologist 3 days later who gave a diagnosis of multiple sclerosis.  Clinical team in process of obtaining documentation.
Patient presented to pharmacy for the Moderna COVID-19 vaccination on 3/10/21. We ran it through her insurance. We followed up with the second dose in the series on 4/7/21. Our team recently found out that the patient had received the first and second Moderna COVID-19 vaccine already at pharmacy on 2/6/21 and 3/5/21. Pharmacy says they billed the patient's insurance. That is why when we billed the vaccine, insurance didn't pick up that the patient had already received the vaccine. We have tried multiple times per day to reach the patient to see why they received 4 doses of the Moderna COVID-19 vaccine, but no one answers the phone.
Felt fuzziness in head - kind of like congestion (2 days after shot). On 2/24/11 - became completely paralyzed for approx. 1/2 an hour.
I received my first vaccine on April 1, 2021 and my second one on April 22, 2021. Prior to this my menstrual cycles have been between 28-31 days. My menstrual cycle started on April 9 and then I didn't start my next cycle until May 15 (37 days later!). The next cycle I had only 18 days in between my period. The next cycle was 33 days. The next one (current) is 28 days. I thought it was very strange to have a 37 day,  then an 18 day cycle, then a 33 day cycle. I'm hoping I'm back to my 'normal self' with my cycles, but thought the information was worth passing along.
after 24 hours - fatigue which lasted 3 days.  next had muscle and joint aches for 1 week moderate to severe.  pronounced in neck, wrists, fingers, ankles.  head ache moderate for 5 days which still slight after a week.
sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) had resolved.       Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.
redness and swelling in the face; rash along her side; redness and swelling in the face; fever; This spontaneous report as received from a physician via a company representative, refers to a 21 month old female patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.     On an unknown date, the patient received only her first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot# and expiration date  were not provided). On approximately 25-APR-2019 (reported as 4 to 5 days ago), the patient experienced a rash along her side, redness and swelling in the face, and a fever. The patient was brought to the clinic. No treatment was given for the events. The outcome of erythema, pyrexia, swelling face and rash was reported as not recovered/not resolved. Causality assessment was not provided.
Hives, tightness in throat. Patient took Benadryl with relief of symptoms.
c/o sore throat, fever of 103 orally & stomachache on 30MAY-11 days p/vax; seen by MD had a throat culture & WBC (nl);
pt recv vax; localized redness; tx w/ ice compresses x 15mins; apap given;
rash developed on arm opposite of injection immediately after getting vaccine, denies resp sxs, any facial edema.  was monitored for 30 additional minutes after getting vaccine and released home.  reports no increase in rash size since it appeared.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 06-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Mom states patient developed joint pain, after the vaccine, which included her arms/shoulder and knees.