chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lost her sense of smell again; got sick,stayed in bed rest of Saturday and Sunday; some pain in lower back right side neck area; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got sick,stayed in bed rest of Saturday and Sunday), NECK PAIN (some pain in lower back right side neck area) and ANOSMIA (lost her sense of smell again) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in March 2020. Concomitant products included ZINC, VITAMIN D [VITAMIN D NOS] and ASCORBIC ACID (VIT C) for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced ILLNESS (got sick,stayed in bed rest of Saturday and Sunday) and NECK PAIN (some pain in lower back right side neck area). On an unknown date, the patient experienced ANOSMIA (lost her sense of smell again). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, ILLNESS (got sick,stayed in bed rest of Saturday and Sunday), NECK PAIN (some pain in lower back right side neck area) and ANOSMIA (lost her sense of smell again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Side-effects begain that evening 12/28:  fever of 101.9, chills waking her up at 11 pm, pain in arm that lasted until 12/31, severe & pulsating headache lasting until 12/29 severe enough to cause nausea and the inability to get out of bed, fatigue. Resolution of symptoms:  12/31. TM set up for testing 1/3 at medical office.
Per mother - on 11/25/10 approximately 3:00 am pt. woke up with rapid heartbeat, mother calmed him down & went back to bed. At approximately 8:00 am pt c/o tiredness, dizzy. At approximately 10:00 pt dizzy, H/A, temp 100.3, "seeing stars". At approximately 12:00 seen in ER, told "possible reaction to medication", but per mother, not taking any meds.
No reported side effects; accidently gave PROQUAD and VARlVAX instead of MMR-II and VARlVAX; accidently gave PROQUAD and VARlVAX instead of MMR-II and VARlVAX; This spontaneous report was received from a licensed practical nurse and refers to a 1-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-MAY-2021, the patient was accidently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (PROQUAD) 1 dose, 0.5 milliliter, lot # T030479, expiration date 07-MAR-2022 (injection site and route of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose, 0.5 milliliter (injection site, route of administration, lot # and expiration date were not reported), both for prophylaxis instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and vaccine live (oka/merck)(VARIVAX).  It was not discovered until vaccine reconciliation on 28-MAY-2021 (reported as "today"). There was no reported side effects. The nurse confirmed this was not a product confusion or product quality complaint, it was a medication error as she was new to pediatric office.
Patient presented to pharmacy 2 days after receiving Zostavax with erythematous rash with solid borders, appoximately 2 inches in diameter, and pruritis at the site of injection.
persistent headache; constructed, scratchy throat; constructed, scratchy throat; This is a spontaneous report from a contactable consumer. This consumer (Patient) reported that, a 61-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 26Mar2021 13:30 (Batch/Lot Number: ER8727) as dose 2, single (at age of 61-years old) for covid-19 immunization. The patient did not have Known allergies and other medical history. No covid prior vaccination and no covid tested post vaccination. There was no other vaccine in four weeks and other medications in two weeks. The patient previously took first dose of BNT162B2, Solution for injection via an unspecified route of administration, administered in Right arm on 05Mar2021 12:30 PM (Batch/Lot Number: EN6206) as single dose (at age of 61-years old) for covid-19 immunization. The patient experienced persistent headache, constructed, scratchy throat on 27Mar2021 22:30. It was reported that, she has had a persistent headache since 36 hours after the shot. It was sometimes worse (splitting). Her husband and she both have had a constructed, scratchy throat since taking the shot. Really should warn people. It was now over 30 days. The patient did not receive any treatment for events. The outcome of the events was not resolved at time of reporting.  No follow-up attempts are possible. No further information is expected.
Chills; Fever; Nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A 15-year-old patient of an unspecified gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: EIH0183), dose 1 via an unspecified route of administration on 17May2021 at 14:00 as dose 1, single for covid-19 immunization. It was reported that patient had no underlying conditions. The patient medical history and concomitant medications were not reported. On 18May2021 at 11:30, the patient developed chills, fever, nausea and dizziness. The outcome of events was unknown.   No follow-up attempts are possible. No further information is expected.
Pt's mother stated pt's L arm started tingling around the wrist area about 10 minutes after receiving the vaccine.
Initial information received on 14-Aug-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 16 years old patient who was given expired MENACTRA. This is actual medication error case as the patient received expired vaccine. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of HPV Vaccine for Immunisation on 14-August-2018. On 14-Aug-2018, the patient received a dose of suspect 0.5 ml of Meningococcal A-C-Y-W135 (D Conj) Vaccine lot U5567CA, exp date: 28-June-2018 via intramuscular route in the right arm. It was not reported if the patient experienced any adverse event. Lab data, corrective treatment: not applicable. Outcome: not applicable. 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. Documents held by sender: none.
Developed redness and warmth and some swelling at injection site that began about 7 hours after injection and grew in size to about 3 inches the next day.  It did itch but otherwise some discomfort pain to area.  By day 5 the area had almost healed entirely.
Swelling and rash/redness for at least three days (still experiencing this) Fever of 99-101 for 48 hours (I usually run about a 96-96.5) Soreness soon after up until 3 days after
Lethargy, Fever of 101 degrees, Night Sweats, Nausea, Congestion, Cough, Feeling Dehydrated; Eventually Diagnosed with Pertussis (Whooping Cough).
pt complaining of red, swollen warm to the touch injection site maybe the size of a baseball or so
sore arm with redness and swelling which resolved after 3 days and then on day 9 post vaccine (1/5/21) developed redness, warmth; raised rash and itching at injection site  (3 inch diameter) which has not yet resolved.
After patient had waited the 15 minutes-upon post vaccine check in patient stated that her are felt funny. I asked her to explain and she said kind of numb and tingly. Told patient to watch make sure no swelling/redness/or spots at injection site or around that area and also to watch and make sure are doesn't get hot. If so or symptoms worsen patient need to go to ER immediately. I told patient if he symptoms were concerning enough she needed to go to er and patient stated that she did not feel they were that bad at this time.
Patient had requested a tdap vaccine but was administered a COVID vaccine.  Patient had already completed a COVID series with Pfizer and was now receiving a Moderna dose in error.
Pt was at prom and developed fever, headache, vomiting & diarrhea. No known ingestion. Symptoms lasted about 1 day & resolved with IVF.
4 weeks after flu shot & PNEUMOVAX shot decreased vision (R) eye, both optic nerves swollen.
Right arm got red, like a rash; Rash on right arm expanding and the center is lighter and the borders are reddish; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Right arm got red, like a rash) and VACCINATION SITE ERYTHEMA (Rash on right arm expanding and the center is lighter and the borders are reddish) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20F) for COVID-19 vaccination.     Concurrent medical conditions included Neuropathy. Concomitant products included ATORVASTATIN for Cholesterol, GABAPENTIN for Neuropathy.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE RASH (Right arm got red, like a rash) and VACCINATION SITE ERYTHEMA (Rash on right arm expanding and the center is lighter and the borders are reddish). At the time of the report, VACCINATION SITE RASH (Right arm got red, like a rash) and VACCINATION SITE ERYTHEMA (Rash on right arm expanding and the center is lighter and the borders are reddish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
It started out with headache and fatigue in a day I had a headache and was nauseous I started having congestion both nose and then cough I eventually had a fever and diarrhea this lasted seven days and I had a fever that lasted eight days I could not bring it down so I called my doctor and started on an antibiotic..
Developed facial and lip swelling about an hour later which prompted visit to PF. Treated with Prednisone and Benadryl. No tongue swelling or difficulty breathing. BP at PF was 200/108 and she had a headache. She increased her Lisinopril dose to 40mg.
Very large lump at the injection site (thigh). The swelling was the size of a grape fruit with a very red, hot to the touch rash in a bulls eye shape. I gave her Motrin for pain and fever and Benadryl for the itching and kept an ice pack on her leg for swelling.
A non-serious spontaneous report of gave H1N1 LAIV to person >49 years old was received from a registered nurse/healthcare professional concerning a 61-year-old male. No relevant medical history was reported for this patient. On 23-Nov-2009 the patient inadvertently received H1N1, Intranasal. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Muscle pain, behind my legs and knees, shortness of breath , headaches, back pain,
23APR98 (for 3 days) temp 100-102;vomiting/diarrhea;
Received 5 shots in afternoon, that evening was vomiting, lethargic, the body went limp and body temp dropped extremely low, bundled him up, rushed to local hospital. By time got there, his temp was back up. I told the RN he had shots and said that was not the problem. Was still sick when shots were administered.
Severe headache almost immediately after shot, so I took 1 extra strength Tylenol for pain. Was woken up at approximately 4:00am with symptoms of a racing heart, severe anxiety & panic (worse than I have ever felt in my life), severe dizziness, and a un-quench-able thirst. Also felt cold inside my body, but skin was hot. I felt extremely confused. I also felt like I was literally going to go insane. Touching objects felt unreal. My brain did not feel like it was mine if that makes sense. I felt in complete lack of control of my body and mind. I also have severe nausea. It?s 1:15pm the next day, and the symptoms are not as bad, but all still there like a dog in my head
Prolonged, severe itching began 4 days following vaccination. Antihistamines not effective.
Dizziness, Headache, Myalgia, Fever,  NauseaVomiting,  chills, stomach cramps Narrative:  Other Relevant History:
Pt had Pfizer vaccine for Dose 1. Pt was inadvertently given Moderna vaccine for Dose 2.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender, whose medical history, concurrent conditions and concomitant medications were not known. On an unknown date, the patients may have been vaccinated with VARIVAX (lot number L000456, expiry date 06-JAN-2017) that was improperly stored (temperature 8.4F for 36 hours (doses may have been given). There were no previous exposures and no adverse effects were reported. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of joint pain in a female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was unknown. It was unknown if the reporter considered the joint pain to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The reporter asked how to treat joint pain from Shingrix shot.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-MAR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 "10PK 0.5mL SD-PFS LLokwTip 10Pk" and  lot # L014876 with expiration date 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.777777778 Celsius)for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
soreness at injection site; pain; swollen arm; itching; headache; could not sleep on side; injection site is hot; fever of 102 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site), PAIN (pain), PERIPHERAL SWELLING (swollen arm), PRURITUS (itching) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included TOPIRAMATE and CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) for an unknown indication.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site), PAIN (pain), PERIPHERAL SWELLING (swollen arm), PRURITUS (itching), HEADACHE (headache), SLEEP DISORDER (could not sleep on side), VACCINATION SITE WARMTH (injection site is hot) and PYREXIA (fever of 102 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at injection site), PAIN (pain), PERIPHERAL SWELLING (swollen arm), PRURITUS (itching), HEADACHE (headache), SLEEP DISORDER (could not sleep on side), VACCINATION SITE WARMTH (injection site is hot) and PYREXIA (fever of 102 degrees Fahrenheit) 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.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On an unknown date, the patient missed a dose of ZOSTAVAX (lot #, expiry not reported) because the diluent was under filled. No adverse event was reported. PQC reported because of the under fill. Additional information has been requested.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the shingles was not reported. The reporter considered the shingles to be related to zoster vaccine live (ZOSTAVAX).
Itching and red spots on the hands; Itching and red spots on the hands; Bump under the lips; Hard time swallowing; Skipping steps/ balance issue; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (62-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced a bad reaction, itching and red spots on the hands, bump under the lips, hard time swallowing, skipping steps/ balance issue. Patient wanted to know should she get the second dose or not. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
As weather turned warm in the summer I started having extreme reactions to the heat and bug bites (skin irritation, large bug reactions that became swollen, full of pus and lasted weeks. I had. Ever had reactions like this before. The frequency was at least 4x/ week.  In September 2021 had a full body reaction to heat that resulted in hives from shoulders to knees. Have seen doctor multiple times. Treatments have included: 10 days prednisone, Pepcid, Zyrtec; Allegra; Benadryl; anti steroid creams. Diagnosed with chronic urticaria in Nov 2021. Hives will return ( rating in severity) within 24 hours of stopping  medication. I am currently just taking Zyrtec daily with good success. But hives will return after 24 hours if I stop.
LOSS CONSCIOUSNESS AND FELL TO FLOOR HITTING HEAD ON FLOOR.  AWOKE WITHIN 15 SECONDS. PLACED SUPINE WITH FEET ELEVATED,  STAFF MEMBER CALLED AMBULAN B/P 100/60.  HR UPPER 50S REACHED 70S WITHIN A MINUTE OR TWO.  SAO2 100% RR 20.
Have a sore arm; Swelling in the arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Have a sore arm) and PERIPHERAL SWELLING (Swelling in the arm) in an 86-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Pfizer booster) and Pfizer (Pfizer vaccination). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Have a sore arm) and PERIPHERAL SWELLING (Swelling in the arm). At the time of the report, PAIN IN EXTREMITY (Have a sore arm) had not resolved and PERIPHERAL SWELLING (Swelling in the arm) was resolving.            Concomitant medications were not reported.  Treatment information was not provided.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. Patients' medical history and concurrent conditions were not reported. Since 19-NOV-2015 (vaccination start date approximated to 2015) the patients were vaccinated with improperly stored VARIVAX (Merck) (lot # K009756 exp: 09-JUL-2016 or lot# L021213 exp: 10-JUN-2017). VARIVAX (Merck) (lot # K009756) was stored at -10C for 15 hours and administered to the patient with in a time frame of 1 hour 36 minutes and VARIVAX (Merck) with lot# L021213 was stored at -5C for 16 hours and administered with in a time frame of 1 hour 36 minutes. No adverse effect reported. No product quality complaint (PQC) was involved. This is one of the two reports from the same source. Additional information has been requested.
erythema and skin breakdown, vesiculation, weeping within 24-48h of vaccine admin; presumed cellulitis vs erysipelas  treated with oral Keflex  outcome pending as pt actively being treated
Patient states 2-3 days after vaccination developed shingles rash with pain under armpit. Also reports headache and flu-like symptoms. Pt states rash then progressed to across the chest. Patient states pain has decreased a little.
Patient states he has a history of becoming "faint" when he receives any injections/vaccines. Two minutes after receiving his vaccine, he felt lightheaded. He denied any other complaints. After lying recumbent, symptoms resolved without further issue. Of note, vital signs showed elevated BP. Advised patient to follow up with primary care physician for recheck.
No data entered A follow up report received 10/19/2001 adds: Became "sick", weak, dizzy, lightheaded and feverish (temp 100) evening of 10/4/01. Ached all over. Took Ibuprofen before going to bed-felt much better in AM. Arm black and blue for 2 weeks.
Headache, Arthralgia, Fever,  fatigue Headache, fatigue, Arthralgia, fever; taking ibuprofen