chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of COVID-19 (contracted COVID-19) and product dose omission issue (unable to receive her 2nd dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 045A21A) for COVID-19 immunization. No medical history reported. On Mar 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 13, 2021, patient experienced COVID-19 (contracted COVID-19). On an unknown date, patient experienced product dose omission issue (unable to receive her 2nd dose). At the time of the report, COVID-19 (contracted COVID-19) and product dose omission issue (unable to receive her 2nd dose) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. Most recent follow-up information incorporated: On Jul 12, 2021: Follow-up received on Jul 12, 2021 contains non-significant information. Patient identifier (patient initials) added.
This spontaneous report was received from a registered nurse and refers to a 1 month old patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 24-SEP-2015, the patient was inadvertently administered an adult dose of RECOMBIVAX HB, first dose, injection, 10/1.0 microgram/ml, 1.0ml, lot # L016427 and expiration date 13-APR-2017. There were no concomitant medications provided. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
lumbar pain; Muscle pain; aches; This case was reported by a nurse via call center representative and described the occurrence of lumbar pain in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a day after receiving Shingrix, the patient experienced lumbar pain, muscle pain and pain. On an unknown date, the outcome of the lumbar pain, muscle pain and pain were unknown.   It was unknown if the reporter considered the lumbar pain, muscle pain and pain to be related to Shingrix.  Additional details were provided as follows: The batch number was not reported. The nurse reported through online chat that the patient had Shingrx vaccine before the date of reporting. The patient know muscle pain was a common side effect. Since last PM the patient had symptoms, including pronounced lumbar pain.  The patient asked was that to be expected. Some other aches intermittently. But, constant lumbar pain. The reporter did not consent to follow up. Related to Patient.  The reporter reporting about herself.  The reported declined to provide address at time of online chat.
This case was reported by a physician via call center representative and described the occurrence of injection site hives in a adult patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site hives. On an unknown date, the outcome of the injection site hives was recovering/resolving. The reporter considered the injection site hives to be possibly related to FLUARIX QUADRIVALENT.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of FLUARIX QUADRIVALENT in an unknown deltoid. The patient had hives over the injection site. The physician did not have the charts at the time of reporting. The physician denied any serious criteria concerns. The physician had limited information, but would have nurse call back with more details. This case was linked to case, US2016155827 as reported by the same reporter.
Vesicles crops about 3 cm diameter erythema 6 cm around vesicle Lt ant/lateral upper thigh 10 days after vaccination. No fever, no itch.
Patient came in for Moderna booster. Patient reports itchiness on her left arm. Vitals signs were done. Patient was given Benadryl for itchiness. Checked vitals signs 5 minutes after the first check. Patient stayed for and extra 30 minutes. Patient states itchiness was relieved. Instruct the patient to call ED for developing reactions and/or seek medical attention from their healthcare provider. Patient left observation site at 10:50am with no reports of worsening or other symptoms.  Vital signs #1: Temperature 97.1, Pulse 66, Respiration Rate 18, Blood pressure 131/90, O2 98 Vital signs #2: Temperature 98.0, Pulse 66, Respiration Rate 17, Blood pressure 126/86, O2 100
Pain and swelling on both arms. Red welts/hives on both arms. Dizziness and weakness. Fever for 48 hours at 102+. Headache. Nausea. Vomiting (ER doctor gave three doses of anti-nausea medicine to get me to stop throwing up).
expired dose with no adverse event; Initial information received on 18-Feb-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who took expired dose with no adverse event while receiving vaccine Meningococcal A-C-Y-W135 (D Conj) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  First time product used: Yes  Concomitant medications included Meningococcal Vaccine B (Meningococcal Vaccine B) ; Hpv Vaccine (Hpv Vaccine) for ; and Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) all for Immunisation.  On 17-Feb-2022, the patient received dose of 0.5 ml once a day for suspect Menactra (Batch number U6828AA expiry 09-Jan-2022) via intramuscular route in the right deltoid for immunisation.  On 17-Feb-2022, it was reported that patient was administered an expired dose with no adverse event (expired product administered) of Menactra.  Action taken was not applicable  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 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.
Developed redness and swelling with pain at injection site within 24 hours of receiving injection in left deltoid.
pt recv vax 1SEP95 & 2AUG96 pt devel shingles on lt shoulder, upper back & down arm, fever;tx w/med & healed quickly; dx herpes zoster;
Right thigh and 1" below puncture site of immunization Nickel size, red warm, some swelling, advised to apply alternate cool and warm compress and Tylenol.
Loss of taste and smell, still currently ongoing. Nausea and vomiting, stopped after a day. Arm pain and red elevated area where vaccine was administered, has stopped. Low grade fever, stopped after 3 days. Lung pain still ongoing. Swollen face for 2 days.
Vaccine given 11am 10/21/09 that afternoon developed shaking chills, did not check temp. Developed abd pain 2 am that resolved on its own by morning, no intervention needed.
Received dose #1 at 0830. Severe pain at and around injection site by 1000. Unable to abduct arm by 1030. Took Tylenol 650 mg po around 1130. Pain eased but never went away. On the night of the injection, chills, inability to warm up, sweating, and GI upset started and lasted into the next day. Injection site pain remained until day 3.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, the patients might have received doses of improperly stored VAQTA (lot # L015460 with expiration date 20-JUL-2017; dose and route were not reported). The vaccine was exposed to 31 Fahrenheit for 40 minutes. There was no prior excursion. Data logger was unknown. No adverse effects were reported. At the reporting time, the reporter did not sure if the vaccine was administered. This is one of several reports received from the same reporter. Additional information has been requested.
12:00 PM loss of appetite, 2:00 low energy, 3:30 complaining of sore leg and acting lethargic, 4:00 fever, 5:00 PM vomited once, 5:30 gave Ibuprofen, 6:00 fever gone and energy slowly returning, appetite remained low the rest of the night.
Mom and Dad state patient has run fever 9 hs between 100-101 (R) since vaccine were administered on10-12-16. Temp is normal during the day- 98.6 (R). Dad has hx of allergy to nectuaria component of vaccine.
Dizziness started two days ago and is ongoing.; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness started two days ago and is ongoing.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced DIZZINESS (Dizziness started two days ago and is ongoing.). At the time of the report, DIZZINESS (Dizziness started two days ago and is ongoing.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.
Second vaccine on March 1, 2021 - Sore arm, chills, fever just under 103 for 2 days, very tired.  Took Tylenol.  This went away after a few days and then on March 8, 2021 one week  after vaccine developed a large rash on my right arm which was very sore.  Also had very bad migraine headache.  Tylenol or Motrin did not help.   Eventually the rash and soreness went away.  On April 1, 2021 called my doctor's office because soreness came back.  They told me to take advil or mortin which did not help. On April 6, 2021 I went to see my doctor because right arm was extremely sore and I could barely move it.  Doctor put me on prednisone for a week and muscle relaxants as needed,  After that week with medication I felt fine and still do.
It was August 1st and I felt chest congestion coming on with headache issues and on the 2nd I requested appointment at the Dr. office and that appointment they did a COVID-19 test it was negative and they treated me for bronchitis and I self COVID-19 tested on the 7th it came back positive for COVID-19 and on the 10th and my COVID-19 test was negative. I had a little fuzziness in the head but that was probably related to the headache. They prescribed me albuterol inhaler when I went to the doctor. I didn't seek treatment for the COVID-19 but they did mention if I did test positive that I could call and they would provide treatment. I have developed a rash on my body since testing negative around my eye and forehead and spread to the right side of my waist and left forearm and that was rather itchy. The PA thought that was an allergic reaction to something and gave me two injections and that didn't help and I went to see another doctor and they gave me a couple of creams for eczema and she stated that COVID-19 may have been a trigger for the reaction.
Extreme headache, nausea, body aches, flushed skin, swelling of face, diarrhea
Pt developed severe headache w/ neck stiffness about one day after receiving vaccine--suspicious for meningitis, so hospitalized for one day (but with negative workup).
got fever (highest recorded of 101.4) and chills (was like a short duration flu) ; gave aspirin to reduce fever. felt better 36hours after shot
Patient described feeling very dizzy and in a dream like state. Patient states felt like she was dreaming in the middle of the night that her throat was swelling shut and her husband informed her she was actually awake. She said she was unable to get off the couch for 3 days, felt very dizzy and felt unable to swallow.
Information has been received from a physician's assistant concerning a 22 year old Caucasian female cardio technician with no allergies and no past medical history who on 21-Dec-1995 and 30-Jan-1996 was vaccinated with a first and second 0.5 ml dose of varicella virus vaccine live, respectively. Subsequently, the reporter was performing a pre-employment physical on the patient. On 16-Dec-2003, a varicella titer was negative for IgG antibody. On 16-Dec-2003, the patient was positive for rubella IgG antibody and measles IgG antibody. Unspecified medical attention was sought, but prescription drug treatment was not required. A product quality complaint was not involved. Additional information is not expected.
index was itching on lt arm; pain, swelling & inc warmth occurred on the lt arm on 12SEP94; index also stated that a rash appeared on the same arm & it was papular; rash also on the trunk of the body;  fatigued; rash lasted x 2 wks
This spontaneous report as received from a Doctor of pharmacy refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (Lot # not reported). No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unknown date, the patient experienced welt associated with ZOSTAVAX administration site. The outcome of welt associated with ZOSTAVAX administration site was unknown. This is one of several reports received from the same source. Additional information has been requested.
tested positive for covid; first dose of the Moderna COVID-19 vaccine on 25Mar2021 (Lot # 044A21A) and the second dose on 23Apr2021 (Lot # 001C21A). On 03Jan2022 she tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid) and DRUG INEFFECTIVE (first dose of the Moderna COVID-19 vaccine on 25Mar2021 (Lot # 044A21A) and the second dose on 23Apr2021 (Lot # 001C21A). On 03Jan2022 she tested positive for covid) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jan-2022, the patient experienced COVID-19 (tested positive for covid) and DRUG INEFFECTIVE (first dose of the Moderna COVID-19 vaccine on 25Mar2021 (Lot # 044A21A) and the second dose on 23Apr2021 (Lot # 001C21A). On 03Jan2022 she tested positive for covid). On 13-Jan-2022, COVID-19 (tested positive for covid) had resolved. At the time of the report, DRUG INEFFECTIVE (first dose of the Moderna COVID-19 vaccine on 25Mar2021 (Lot # 044A21A) and the second dose on 23Apr2021 (Lot # 001C21A). On 03Jan2022 she tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. On 13-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative.         Company comment: This is a spontaneous case concerning a 54-year-old female patient with no reported medical history, who experienced the non-serious AESI COVID-19, more than 8 months after receiving  the second dose of mRNA-1273.  Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medications reported. No treatment reported.; Sender's Comments: Company comment: This is a spontaneous case concerning a 54-year-old female patient with no reported medical history, who experienced the non-serious AESI COVID-19, more than 8 months after receiving  the second dose of mRNA-1273.  Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Red patch at injection site- recovered/resolved Hot patch at injection site- recovered/resolved Itchy patch at injection site- recovered/resolved  A report was received from a health professional on 05 November 2003, concerning a 59 year old female vaccinee who developed a 6cm x 3cm red, hot and itchy patch at the site of injection the same evening after receiving Fluvirin vaccine on 04 November 2003. On 04 November 2003 the vaccinee developed a 6cm x 3cm red, hot and itchy patch at the site of injection. It was reported as being similar to an allergic reaction such as that observed during an allergy test. The rash was treated with a topical corticostaroid cream and the patient recovered on 05 November 2003. There was insufficient information to determine the reporter's causality assessment. Follow-up pending.
Information has been received from a physician concerning a patient who was vaccinated with MMR. Subsequently, the patient experienced rash and fever 4-5 days post vaccination. The patient sought unspecified medical attention. No further information is available.
onset w/in few hr of fever to 102, chills, whole body aching, listlessness;APAP given;pt took liquids & slept;24 hr later temp still 101 but pt awake, hungry, & feeling better;Thimerosol? advised consult w/PMD;Thimerosol & adverse rxn
Shortness of breath lasted about a minute.  Recipient took her mask off and felt better within a minute.
This case was reported by a physician via sales rep and described the occurrence of arthralgia in a adult patient who received BEXSERO. On 9th August 2016, the patient received the 1st dose of BEXSERO. In August 2016, less than a week after receiving BEXSERO, the patient experienced arthralgia (serious criteria other: serious as per reporter), headache and myalgia. On an unknown date, the outcome of the arthralgia, headache and myalgia were unknown. The reporter considered the arthralgia, headache and myalgia to be almost certainly related to BEXSERO. Additional details were reported as follows: The age at vaccination was not provided. This case was previously reported to a doctor. The patient was about 16 to 18 year old. The patient received a BEXSERO vaccine at the request of the parents. A day before the reporting date, the physician received a phone call noting the patient was experiencing the noted adverse events and the appointment was scheduled for that day afternoon. The patient visited emergency room.
ER trip evening after received FLUMIST - Croup - Racemic Epi Decadron.
Child seen for well child exam on 4/13/00. She had a hx of mild URI symptoms starting the day before, but was not having any difficulty, fever or nasal congestion. She was given MMR that day and she developed fever and was seen on 4/15/00 with bronchiolitis. Treated with Amoxicillin and Tylenol.
Pain left arm and lateral side left breast, intermittent lateral  left breast pain still occurs , was more painful first 1-2 weeks now much milder but still occurs frequently lasting 1-2 min,
AFTER TALKING TO THE CDC, THEY SAID SHOULD CAUSE NO HARM, SHOULD ONLY HAVE A SORE ARM LIKE ANY OTHER VACCINE
second dose within 26 days of first dose/second dose given at day 24; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 26 days of first dose/second dose given at day 24) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021 at 8:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 26 days of first dose/second dose given at day 24). On 31-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose within 26 days of first dose/second dose given at day 24) had resolved.            No concomitant medications was provided. No treatment medications was provided.  Patient had taken second dose within 26 days of first dose, second dose given at day 24.
Information has been received from a technician at a physician's office concerning a 36 year old female, with allergies to steroids, who in 1998 or 1999 was vaccinated with a first dose of hepatitis B virus vaccine (route and lot # unknown). In 1998 or 1999, 2 to 3 days post vaccination, the patient experienced hives, welts, swollen throat, joint aches, and erythema. The patient self treated with 20 tablets of 50mg diphenhydramine hydrochloride and 20 tablets of 180mg of fexofenadine hydrochloride. Unspecified medical attention was sought. No product quality complaint was involved. The report indicates the patient continues to experience hives every 2 to 3 months; and therefore, has not recovered. The hives, welt, swollen throat, joint aches, and erythema were considered to be other important medical events (OMIC). Additional information has been requested.
Patient here c/o sore throat for 3 d, then started getting a rash on face and body yesterday. Noted a little light headedness briefly last night. He did have 3 immunizations yesterday: HPV, men B and hep B. He had some congestion 4 and 5 d ago, sl chills, no fever, rare cough. No throat closing, no resp distress, no GI sx. + rash (diffuse erythematous, macular rash on chest and back, coalesced on neck, alittle on face, some on upper arms). Take Zyrtec, Claritin or similar for rash for the next few days. RTC if any worsening sx, or if antihistamines not helping. ER prn sudden change for the worse, difficulty breathing, etc. Lukewarm showers. Rest, increase fluids, can take decongestant if needed for URI sx.
Patient vaccinated under the age stated in FDA EUA for Moderna COVID-19 vaccine.  No reported adverse outcome by parent.
On 5/2/03 complained of left deltoid pain and swelling - upon observation 3 x 5 area of increased induration and increased color in left arm (-) adenopathy - good, ROM - instructed to apply ice, given reassurance, if problem to ER or RTC.
SkinRash, Rash, UrticariaPruritus & NauseaVomiting Narrative: