chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEARTBURN; NAUSEA; FEVER 100 DEGREES; HEADACHE; MODERATE DISCOMFORT; 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, intramuscular, batch number: Unknown, and batch number: UNKOWN expiry: UNKNOWN) .5 ml, administered on 04-MAR-2021 03:00 for prophylactic vaccination. No concomitant medications were reported. On 04-MAR-2021, the subject experienced nausea. On 04-MAR-2021, the subject experienced heartburn. On 04-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced fever 100 degrees. On 05-MAR-2021, the subject experienced moderate discomfort. Laboratory data included: Body temperature (NR: not provided) 100 DEGREES. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, heartburn, headache, and fever 100 degrees, and the outcome of moderate discomfort was not reported. This report was non-serious.
24 hours after receiving vaccination started getting what was a start of migraines, which would come to a peak, and just stop. Over the past month still getting migraines at random times of the of the day, but symptoms have become worse. For the past three days have been experiencing soreness this in my throat, and Mucus.
Patient experienced Tinnitus on one ear two days after receiving the vaccine. As of 03/20/21 about a month later, patient still has the same symptom.
broke out in shingles/a large 6x2 inch swath; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (broke out in shingles/a large 6x2 inch swath) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (broke out in shingles/a large 6x2 inch swath). At the time of the report, HERPES ZOSTER (broke out in shingles/a large 6x2 inch swath) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No relevant concomitant medications were reported.   The patient got moderna vaccine 6 weeks ago  in order to keep her job. 2 weeks ago she broke out in shingles, a large 6x2 inch swath, and was in significant pain for days. She never previously had nor been exposed to shingles.  The event significant pain was subsumed under diagnosis of shingles.  No treatment information was provided.
Received KINRIX on 7/21/09, parent noted localized reaction 24 hrs later.  Called to office 7/23/09 to report that arm was red, swollen, warm to touch, 0 fever, good ROM.  Recommended Motrin and cool compresses prn.  Call with fever worsening.  Symptoms rash, etc.
Child was given the Adult Pfizer but dosage 0.2ml  instead of the child Pfizer. No signs or symptoms noted at this time.
2/26/21?1400, a temp of 99.5.  Felt real agitated.   2/27/21?0830, agitation.  Chills at 1045.  .   3/2/2021?0900, continuing agitation.    3/3/2021?1220, anxiety.   3/4/21?1530, kind of anxious now.     3/9/21?0930, agitation.  3/11/2021?2000, anxiety.   3/12/2021?2 week mark.  Increased anxiety in the evening.    3/13/2021?0800, near panic on awakening.  Struggling to function.
BLURRINESS; RASH; DIZZINESS; DRY MOUTH; COUGHING; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight was not reported. The patient's concurrent conditions included allergic to many medications including flu vaccination. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A22A expiry: UNKNOWN) dose was not reported, administered 1 total on 09-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that few minutes after administration she started feeling dizzy, dryness in mouth, coughing, felt like there is a cotton ball in mouth, slight rash all over and blurriness. Then she was transferred to the emergency room where they used intravenous (IV) Benadryl and Epipen and they monitored her. Ever since then she still has headaches and tiredness. Treatment medications (dates unspecified) included: Benadryl (diphenhydramine hydrochloride), and Epipen (epinephrine) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, and tiredness, and the outcome of rash, dizziness, dry mouth, coughing and blurriness was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-Covid-19 vaccine ad26.cov2.s-Blurring, Coughing, dizziness, dryness of mouth. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. V0:-Covid-19 vaccine ad26.cov2.s-Rash. This events is labeled per RSI and is therefore considered potentially related.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 28-AUG-2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster with complications. On or about 20-APR-2016, the patient was treated by a physician at a hospital for a persistent vesicular outbreak accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient was prescribed valacyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
knee pain has gotten worse in the last few days; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee pain has gotten worse in the last few days) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) injection for COVID-19 vaccination.     The patient's past medical history included Knee pain. Concomitant products included PARACETAMOL (TYLENOL), GABAPENTIN, METOPROLOL, HYDROCHLOROTHIAZIDE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On an unknown date, the patient started mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (knee pain has gotten worse in the last few days). At the time of the report, ARTHRALGIA (knee pain has gotten worse in the last few days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
An initial report was received from a nurse on 06-Sep.2012 and concerns a 40-year-old male patient, who on 28.Aug.2012, received the first oral dose of VIVOTIF (batch no.: 3000132). The patient's medical history was not reported. Vaccinations given on the on 16.Aug.2012 included, other manufacturers, Yellow fever vaccine (batch no.: not reported), Polio vaccine (batch no.: not reported), TWINRIX (batch no.: not reported), and MMR (batch no.: not reported). On 28.Aug.2012, following administration of the first dose of vaccination, the patient broke out in rash - hives. The patient also experienced the same event after the second dose. The vaccination was discontinued. The patient was treated with BENADRYL. On an unspecified date, the patient recovered from the event. The event was considered non-serious.
Patient received vaccination approximately 5-10 min after vaccine patient reported feeling nauseated. Upon observation patient was pale, diaphoretic and dizzy. Immediately laid patient on the ground and elevated legs.  Pulse ox was applied to patients finger with oxygen saturation at 90%. Mother reported patient had not eaten anything since lunch, provided waters and cracker to patient. Patient felt much better and symptoms resolved.
"Covid Arm" About 8-9 days after injection, itchiness and redness occurred at injection site, increasing each day.  Redness is about 2.5 inches in diameter at 13 days.
Could not sleep; Sore; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood cholesterol increased" (ongoing), notes: Verbatim: High cholesterol. The patient's concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 13Feb2021, outcome "recovered" (14Feb2021), described as "Could not sleep"; PAIN (non-serious) with onset 13Feb2021, outcome "unknown", described as "Sore".  Additional information: Caller mentioned her husband also could not sleep. It was like they did a whole bunch of cocaine, a lot of tossing and turning. It was after the first shot they could not sleep. Caller stated her and her husband got their doses on the same dates one after the other. After the first dose he was very sore. It was later that same day. He was more sore than she was. The soreness lasted a day or two. States he's having physical therapy on his right arm. Caller says he has gone like 3 different times. He goes to therapy every Thursday for his right arm. However, she has never put the two and two together regarding physical therapy until now. No prior vaccinations within 4 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mostl likely vasovagal syncope. patient fainted and woke up very quickly disoriented. was sweaty for about 10 minutes. He was given reeses candy bar and water and monitored for an additional 15 minutes after his beginning time. was released about 40 minutes after his vaccine/reaction.
a 15 months old male patient was given a 0.5 ml dose of Act-Hib vaccine which was incorrectly reconstituted with sterile water instead of the diluent provided with the vaccine/No AE; Initial information received on 11-May-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old male patient was given a 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] which was incorrectly reconstituted with sterile water instead of the diluent provided with the vaccine (lot UJ183AAA, expiry date: 12-FEB-2021) via unknown route in the left vastus lateralis on 11-May-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for prophylactic vaccination.   It was an actual medication error case due to wrong solution used in drug reconstitution.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
I know this vaccine is inherently good for the population as a whole. I was recommended to receive this vaccine as a registered nurse because it had been over 3 months since I had Covid. However, I was a Covid long hauler with lingering symptoms until 12/23/20 that never really fully resolved completely. I believe I received the Moderna vaccine too soon after my long term symptoms mostly resolved and hence the immediate and severe reaction that my doctors and specialists are still trying to figure out and how to treat properly.   There was a nurse that reported some similar symptoms to mine after receiving the Moderna vaccine and this was on national news. However, I am not sure she ever had Covid or the long term symptoms I had from the virus before getting the vaccine and that sets us apart. However, both I and this nurse were on depress medicine when receiving the vaccine and unsure if there is a possible correlation or interaction between the vaccine and depression meds.
This spontaneous report as received from a registered nurse refers to his brother of unknown age. In November 2007 the patient was vaccinated with a dose of ZOSTAVAX (lot number not provided). On 02-APR-2013 the patient came down with shingles. He had one of the worst cases the reporter had seen over the years working as a nurse. It was on his left mid back wrapping around the front of his rib cage about 12 inch wide. The areas were finally healing but he was still having to take a narcotic for pain every six hours with not a whole lot of relief. They had tried the xylocaine patches but they had not helped at all. They thought it supposed to be a one dose vaccine but obviously for the patient it was not effective after five years. At the time of the report the outcome of shingles was recovered and pain was not recovered. Additional information has been requested.
2 weeks of Menstrual flow, followed by spotting daily for 2 months.
Tinnitus noticeably increased to the threshold that intermittently I was not able to understand what people were saying to me. I am a member of hospital and hospital does not have audiologist trained in Tinnitus, therefore I have no treatment.
pt exp acute cerebellar ataxia-partially but not fully resolved >1yr later;wobbly;unable to walk or stand;pt exp ataxia, devel delay, rt exotropia;hypotonic in trunk & extremities;sleeping problem;eye drifting off line;diminished appetite;
BOOSTRIX given in (L) deltoid on 4-9-09. On 4-12-09 swelling of deltoid noted, no redness - (+) tender. Swelling resolved by evening 4-13. Also had area of red bumps around injection site - fading by P.M. 4-14. On 4-13 noticed identical area of redness about 1" diameter, pruritic L antecubital.
This spontaneous prospective pregnancy report as received from a consumer refers to a female patient of unknown age. Medical history or currents conditions were not reported. In 2014, (reported as whiting the last three months) the patient was vaccinated with M-M-R II injection, dose number unknown. Concomitant therapies were not reported. The consumer reported that the patient feels she may be pregnant. No confirmed by an physician. No other adverse symptoms were reported. Additional information is not expected.
Pt recvd 1st dose of Recomb 19DEC90 & on 7JAN91 pt devel sinus infect, dizziness &  yeast infect that was so bad pt could hardly void;10JAN91 MD noted ear infect & UTI; On 18JAN91 pt reported dizziness that persisted & pt passed out x 5;
Missed second dose, more than 36 days difference from first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose, more than 36 days difference from first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose, more than 36 days difference from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose, more than 36 days difference from first dose) 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.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-Jun-2021 and does not contain any new information. Updated reporter E-mail; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot #: Not provided) with no associated AEs.
Got both shingles shot, now have shingles/Suspected vaccination failure; Shingles on thigh; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 62-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (patient received shingles shot in his/her 50s).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he got the original shingles shot in his/her 50s. The patient stated that then the new shingles 2 dose shot came out and his/her doctor had asked him/her to get both the doses. The patient was 62 years and now he got the shingles on his thigh. Additional supportive information: This case was considered as suspected vaccination failure as details regarding, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
50 mg Benadryl 20 mg Pepsid. Pt presented with chest tightness; difficulty breathing initial POx 100% %98. Subsequently c/o nausea; some gagging, this subsided on its own. was given 50 mg Benadryl; 20 mg Pepcid; juice. able to swallow w/o problems, continued to c/o feeling shakey; reported H/O fear of needles. observed for 40 min. symptoms resolved.
The patient received the Pfizer COVID19 vaccine on 03/30/2021. The patient reports that two (2) weeks after receiving the vaccine he experienced numbness and tingling in both feet. He reports the numbness and tingling progressed up both legs resulting in pain in the knees and thighs. The patient reports having sought medical attention for the progressing symptoms, however, it is unknown what the cause of the adverse reaction. The patient has reported these adverse reactions to me on 05/14/21. The patient reports he currently is still feeling muscle fatigue and nerve pain.
9-13-08 mother noticed red blotchy rash on arms, legs and trunk of child. Rush turned to bruising mostly on arms and legs. Examined by Dr on 09-22-08. Mother stated Dr suspected ITP. Follow up visit scheduled for Oct 1, 08
4-6 hrs after shot arm started to hurt worse than a tetanus shot. By evening I couldn?t lay on it or touch it. Day two:  site is raised and red, constant headache, muscle soreness (all over), nausea and chills
Pt recvd DTP/OPB 9SEP91 & exp severe pain @ inject site, would not eat & was crying, arm very swollen, hot, red & painful from inject site to elbow; t99.7 very tender to touch; lethargic, t100; Mom to see MD;
Extreme nausea; vomiting; fatigue; fever 101 (unspecified units); This is a spontaneous report from a non-contactable consumer, the patient.  A 26-year-old female patient received unknown dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VAACINE; Lot/batch no: Unknown) via unspecified route of administration and anatomical site on 17Mar2021 at 03:45 PM as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medication included vaccine (Active substance and Manufacturer Unknown) within 4 weeks prior to the COVID vaccine for which indication and start date was not reported. The patient was not tested for COVID-19 after having vaccination. On 17Mar2021, the patient experienced extreme nausea, vomiting, fatigue and developed fever of 101(unspecified unit). The patient did not receive any treatment for the events. The clinical outcome for the events extreme nausea, vomiting, fatigue and fever 101 were resolving. Information about lot/batch number cannot be obtained. No further information is expected.
Narrative: 1025- Patient c/o being lightheaded, tunnel vision, dizzy feels like he is going to pass out. BP 127-87 HR 65 RR 18. Patient assisted to a stretcher feet elevated. 1030 - Patient reports tunnel vision is resolving, no longer feel dizzy 1035 - Patient reports feeling normal - no c/o - no longer diaphoretic or clammy skin. BP 122/23 HR 59 RR 16 1040 - Patient carrying on conversation no c/o 1046- BP 129/86 HR 60 RR 16 1050 - Patient assisted to sitting position on the side of the stretcher 1052 - BP 122/84 HR 66 RR 16 1055 Patient continues to have no c/o was dc'd from the auditorium states he was going to the first floor canteen. Provided Patient with the location of the ED and instructed to report there if symptoms return.
The pt developed respiratory distress and was not feeding well. She required intubation in ER. The pt had a history of myotonic dystrophy.
Post-dose 1 of COVID-19 Pfizer vaccine, pt started feeling lethargic and lightheaded. Lightheadedness start 12/18(post-dose Day1) and it became more significant 12/19-12/20.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 18-MAY-2015 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II 0.5ml (rHA (recombinant human albumin), lot # J014876, expiration date 21-NOV-2015, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.