chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pink; Arm hurting the three days after the shot; A lot more body aches; it was warm; deep severe itch; arm was in pain and she could see the injection site; It was swollen; I t was red; Very sore arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Pink), PAIN IN EXTREMITY (Arm hurting the three days after the shot), PAIN (A lot more body aches), VACCINATION SITE WARMTH (it was warm) and VACCINATION SITE PRURITUS (deep severe itch) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis, Osteoporosis, Fibromyalgia, Hypertension, Hyperthyroidism since 1981, Osteoarthritis (Experienced much more pain than usual.) since 2019, Reactive airways disease and Drug allergy (Amoxicillin). Concomitant products included VITAMINS NOS for Vitamin supplementation, LEVOTHYROXINE, PRAVASTATIN from 12-Feb-2021 to an unknown date, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) and METOPROLOL for an unknown indication.   On 26-Feb-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 3:25 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Pink), PAIN IN EXTREMITY (Arm hurting the three days after the shot), PAIN (A lot more body aches), VACCINATION SITE WARMTH (it was warm), VACCINATION SITE PRURITUS (deep severe itch), VACCINATION SITE PAIN (arm was in pain and she could see the injection site), VACCINATION SITE SWELLING (It was swollen), VACCINATION SITE ERYTHEMA (I t was red), MYALGIA (Very sore arm) and HEADACHE (Slight headache). At the time of the report, VACCINATION SITE DISCOLOURATION (Pink), PAIN IN EXTREMITY (Arm hurting the three days after the shot), PAIN (A lot more body aches), VACCINATION SITE WARMTH (it was warm), VACCINATION SITE PRURITUS (deep severe itch), VACCINATION SITE PAIN (arm was in pain and she could see the injection site), VACCINATION SITE SWELLING (It was swollen), VACCINATION SITE ERYTHEMA (I t was red), MYALGIA (Very sore arm) and HEADACHE (Slight headache) had resolved.            Treatment Used anti-itch cream on arm and went to sleep. Took nothing for the pain   This case was linked to MOD-2021-186809 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Mar-2021: Follow-up document was received with Initial receipt date retained as 11-MAR-2021 and safety received date on 26-MAY-2021. Patient's information including height, weight, race, ethnicity,dosage details, medical history, concomitant medications, additional event and event outcome were updated. It contains significant information.
Day 1 - Fever, chills, rash; day 2 "hives" - seen day 2 and treated with Diphenhydramine 25mg q 6 hours, Ranitidine 75mg q 12 hours. Patient had fine maculo-papular rash over trunk and proximal limbs and erythematous patches, irregular and up to 6-8 cm diameter. Day 3 Patient reported Benadryl ineffective prescribed hydroxyzine in past was effected - patient switched to Hydroxyzine 25mg q 6 and day 4 almost completely resolved.
Rn administered 1ml instead of 0.5 ml of Moderna Vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Rn administered 1ml instead of 0.5 ml of Moderna Vaccine) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included OXYCODONE, HYDROXYZINE (ATARAX [HYDROXYZINE]), MILK OF MAGNESIA, MELATONIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AMLODIPINE, ATORVASTATIN CALCIUM (LIPITOR), BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), GABAPENTIN (NEURONTIN), LISINOPRIL, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]), VITAMIN D3, PARACETAMOL (TYLENOL), SALBUTAMOL SULFATE (VENTOLIN HFA) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 06-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (Rn administered 1ml instead of 0.5 ml of Moderna Vaccine). On 06-Apr-2021, ACCIDENTAL OVERDOSE (Rn administered 1ml instead of 0.5 ml of Moderna Vaccine) had resolved.        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.   Registered nurse administered 1 milliliter instead of the 0.5 milliliter of the Moderna COVID-19 vaccine.   Per reporter, the patient had not reported any adverse events.   Treatment information was not provided.  This report refers to a case of accidental overdose for mRNA-1273, lot # 044A21A with no associated AEs.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up received o 27-May-21. ADR form - non-significant; Sender's Comments: This report refers to a case of accidental overdose for mRNA-1273, lot # 044A21A with no associated AEs.
Fever over 101, body aches, back pain, tiredness and fatigue, sweats and chills simultaneously
Patient's father (D/O/B: 12/20/1971) provided consent for his son to be vaccinated.  At the time of administration, the father provided an incorrect DOB (07/15/2004) for his son to make his age 16 at the time of vaccination. The patient was actually born 7/15/2005 which would have made him 15 at the time his 1st dose was administered.  At that time eligibility was for 16 years of age and older.  This was discovered 5/23/2021 when the patient presented for his 2nd dose .
4 x 1 1/2 cm, wheal, posterior, left arm and small papules, left shoulder. NO SOB or choking.
This 41 year old received her second Moderna covid vaccine on 2/5/2021.  She had no immediate issues the first 15-30 min post vaccination.  During her drive home (about 30 -40 min post vaccination) she noticed her throat felt full and kept trying to clear it.  She tried drinking but this did not ease the reaction.  She called her MD but was sent to local ER which was closer.  She denied any SOB, fever, rash, itching, HA, swelling to throat, tongue or body, and had no dizziness, GI distress or other systemic reactions.   She presented to a specific hospital and was treated with epi pen, IV benadryl, solumedrol and pepcid and released on 5 day predinisone taper
The patient presented to our pharmacy on 6/12/21 to pick up a prescription for Ketoconazole 2% topical cream.  At the consultation window the patient mentioned that this was to treat a rash on her neck that she believes was caused by the Moderna vaccine.  She received her first dose on 1/29/21 and reported that two days later she had a rash on her neck. She stated that the rash burned and was itchy, and that it gradually spread to her inner left forearm and face.  At the pharmacy on 6/12/21, her neck was visibly red, along with her face and left forearm.  The patient saw her primary care doctor in Februrary, but she states that she was not given any thing for the rash and was told by her doctor to monitor the rash.  The patient saw Doctor again in May and was prescribed a cream for the rash, but the patient does not recall the name of the cream and there is no history of that prescription at our pharmacy. The patient reports that the cream did not help, so she saw her allergist in June.   She saw Provider and was prescribed ketoconazole 2%.
Arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79-year-old female patient received BNT162B2 (BNT162B2), administration date 01Mar2021 (Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "Arm soreness".  Additional information: The patient reported having arm soreness 1.5 days after the receiving the dose. She was told by her son that the Pfizer vaccine is not safe and is a biological agent. She wants any and all information regarding the safety of getting the vaccine. She read in the news and online that (name) reports that the vaccine is experimental and not approved and that AstraZeneca COVID vaccine causes blood clots. She also read that one mother (38 y/o) in (Name) died and she told her daughter before she died that it was the vaccine that contributed to her illness.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Low level ache, pain 1 out of 10 /continued slight ache outside elbow; around the top and side of his elbow around to the tendon; around the top and side of his elbow around to the tendon; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2023, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, 1 day after receiving Shingrix, the patient experienced pain (Verbatim: Low level ache, pain 1 out of 10 /continued slight ache outside elbow), tendon pain (Verbatim: around the top and side of his elbow around to the tendon) and pain in elbow (Verbatim: around the top and side of his elbow around to the tendon). The outcome of the pain, tendon pain and pain in elbow were not resolved.   It was unknown if the reporter considered the pain, tendon pain and pain in elbow to be related to Shingrix.     It was unknown if the company considered the pain, tendon pain and pain in elbow to be related to Shingrix.   Additional Information: GSK Receipt date:08-APR-2023 and 11-APR-2023. The reporter was the patient.  The patient received his first dose of Shingrix on left upper arm.  The following day, he began to experience a low level ache around the top and side of his elbow around to the tendon.  He had been experiencing this ache every day since the vaccine.  The ache begins when he first wakes up in the morning, and lasts for about an hour.  The pain intensity was described as 1 out of 10. Patient awaken every morning with a slight ache on the outside of my elbow that diminishes in about a couple of hours.  Pharmacists stated that about 1 in one hundred people get this, but it is over in a few days, and then look surprised at patient's complaint of continued aches.
Extreme soreness, swelling and welts covered most of upper arm, hot and itchy.
An expired Jynneos vaccine was accidently administered to a patient; An expired Jynneos vaccine was accidently administered to a patient; Case reference number US-BN-2023-000104 is a spontaneous case report initially received from a health care professional via Communications (reference number: USBAV23-0124) on 20-Jan-2023 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On 13-Jan-2023, the patient was vaccinated with the first dose of expired Jynneos vaccine (batch number: FDP00014; refrigerator expiration date: 05-Jan-2023), at a dose of 0.5 mL, subcutaneously, at an unknown site of administration, for unknown indication (explicitly coded as 'expired vaccine used' and 'product administration error'). As reported, the patent received vaccine 64 days after the vaccine was moved from freezer to refrigerator and eight days after the refrigerator expiration date.   At the time of this report, it was unknown if the patient experienced any adverse event due to Jynneos.  Additional information received on 20-Jan-2023 included the local case ID.; Reporter's Comments: A patient of unknown demographics was vaccinated with the first dose of expired Jynneos vaccine on 13-Jan-2023 and expiration date was 05-Jan-2023, for unknown indication, which is considered as expired product administered and product administration error. No associated adverse events were reported. Expired product administered and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the first dose of expired Jynneos vaccine on 13-Jan-2023 and expiration date was 05-Jan-2023, for unknown indication, which is considered as expired product administered and product administration error. No associated adverse events were reported. Expired product administered and product administration error are listed per company convention. The patient's medical history and concomitant medication details were not provided. Expired product administered and product administration error are not related to Jynneos, but to a human factor. The case is non-serious.
Patient developed clots/DVT in the RUE over 1-2 weeks after the Meningococeal injection.  She presented to my office with large swollen arm and was sent to ED where an ultrasound showed large Subclavian DVT's on the right
feel chilled like for 2 hours; This is a spontaneous report from a contactable consumer. This female consumer (patient) reported that:  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feel chilled like for 2 hours. The patient assessed the event as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Covid-19/Congestion headache and dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19/Congestion headache and dry cough) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029k2oa) for COVID-19 vaccination.     The patient was not taking any other medications or products within 2 weeks of starting COVID-19 treatment. The patient had received previously a COVID-19 vaccine.  the patient had allergic reaction on unknown drugs.     On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient experienced COVID-19 (Covid-19/Congestion headache and dry cough). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 06-May-2022 to 10-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Covid-19/Congestion headache and dry cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. company comment This spontaneous case concerns a 43-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred on an unknown date, about 2 months after receiving a dose of mRNA-1273 Vaccine. The patient was treated with paxlovid from 06-May-2022 to 10-May-2022 for 5 days for COVID-19 treatment. Four days after stopping paxlovid, on 14-May-2022, the patient experienced cough (dry cough) and headache (Congestion headache). On an unknown date, SARS-CoV-2 test was positive. Outcome of covid 19 was unknown.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 43-year-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse event of special interest COVID-19 (with a positive SARS-CoV-2 test) that occurred on an unknown date, about 2 months after receiving a dose of mRNA-1273 Vaccine. The patient was treated with paxlovid from 06-May-2022 to 10-May-2022 for 5 days for COVID-19 treatment. Four days after stopping paxlovid, on 14-May-2022, the patient experienced cough (dry cough) and headache (Congestion headache). On an unknown date, SARS-CoV-2 test was positive. Outcome of covid 19 was unknown.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
I tested positive for COVID19 on 01/05/2022 despite being fully vaccinated. I started feeling sick around 12/30/2021 but never got tested until 01/05/2022. Symptoms were mild and I still had my sense of smell and taste.
Information has been received from a physician concerning a 26 year old licensed practical nurse with asthma and hypertension and allergies to phenytoin, carbamazepine, IV contrast dye, and meiricaine who on 2/8/01 and 3/23/01 was vaccinated with the first and second doses of varicella virus vaccine live (lot # unknown), each given six weeks apart. There was no illness at the time of vaccination. It was noted that a titer was drawn on 4/14/03 and the patient was non-immune and failed to seroconvert. The varicella zoster IgG was <0.91 (negative). A repeat vaccination and a recheck of the titer was recommended. Unspecified medical attention was sought. There was no product quality complaint. There were no adverse events following prior vaccinations of the patient or her siblings. No further information is expected.
Right after leaving the facility I started itching on my left arm . When I got home I had a red raised lump on the injection site. It was very hot, it itched and it hurt
pt had 2 szs while @ school approx 2PM; ambulance transported pt to ER due to 2 min-long apnea; brought to ER, 14OCT93 parents took  to MD;
9/22/21 Arm felt weird and heavy right after J&J vaccine  injection at 3:08pm  Fever 99.7-3:25pm Ears face and neck hot-3:33pm Splitting Headache-4:00pm Pain on right side of abdomen-4:03pm Left side of chest pain-4:07pm Nauseous-4:56pm Fever 101-5:12pm Pain in left side of neck-5:49pm Fever 101-6:25pm Feeling weak and shaky-6:30pm Nausea intensified-6:44pm 9/23/21 Puked-1:55am Fever 100.6-2:00am Left ankle and calf pain-2:10am Diarrhea-2:22am Body aches and weak stomach-2:30am Extreme lower back and abdomen pain-2:33am Diarrhea-2:37am Puked-3:00am Fever 100.6-9:10am Right side chest pain-9:53am Diarrhea-10am Fever 100.1-10:18am Headache-11:45am Numb toes-12:15pm Hospital until 8pm for chest pain, extreme back pain, chills, nausea, fever of 101 9/24/21 Woke up with headache, nausea, fever of 99.9, and pain at injection site. Chest pain later in the day. 9/25/21 Woke up with headache, nausea, fever of 99.2, and pain at injection site. 3:15 chest pressure. Right side chest pain occasionally throughout the night. 9/26/21 Woke up with headache, upset stomach, fever of 99.6, and pain at injection site. Persistent pain in left side of neck-9:25am Fever of 99.4-12:48p Still persisting pain in left side of neck. Fever of 99.8-5:35pm 9/27/21 Woke up with upset stomach and fever of 99.8. Fever of 100.2-8:00am 9/28/21 Woke up with headache and fever of 99.2-6:15am Still have pain in left side of neck. Fever of 100.0-1:51pm Headache, radiating left arm and side of neck pain-2:16pm 9/29/21 Woke up with fever of 99.6 Fever of 99.9-6:35pm 9/30/21 Woke up with fever of 99.9 Fever of 100.8-12:45pm Fever of 99.9-3:40pm
A non-serious spontaneous report of child got a portion of H1N1 LAIV dose in the eye was received from a nurse/health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications were reported for this patient. On 14-Dec-2009, the patient received the H1N1, Intranasal. The child leaned back during the administration of the H1N1 LAIV, causing a portion of the vaccine to be administered to his eye. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable, and the event was considered resolved.
A little fever, muscle pain, tiredness. (All of the above expected); A little fever, muscle pain, tiredness. (All of the above expected); A little fever, muscle pain, tiredness. (All of the above expected); Chest pain and sudden changes in heart rate (totally unexpected); Chest pain and sudden changes in heart rate (totally unexpected); This is a spontaneous report from a contactable consumer (patient).  A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, in Arm Left on 04Jun2021 12:30 (Batch/Lot Number: EW0191) as single dose for covid-19 immunisation. There was no relevant medical history reported. The patient's concomitant medications were not reported. On 05Jun2021 13:00, patient experienced a little fever, muscle pain, tiredness. (all of the above expected), chest pain and sudden changes in heart rate (totally unexpected).  The patient reported that events resulted in visit to a doctor's office, Emergency or urgent care department/room, Hospitalization, Disability or permanent impairment. Outcome of the events was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent nasal swab on 28May2021 and on 05Jun2021 pending result.   Information on Lot/Batch number was available. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 67-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD TIV vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius (explicitly coded as incorrect product storage). On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250802, expiry date: 30-Jun-2019 and dose: not reported] which underwent temperature excursion (explicitly coded as drug administration error). At the time of this report, no adverse event was reported. This case 201805409 was crossed linked to original case 201804863 due to same reporter.
Seen in urgent care for diffuse urticaria. No new soaps/detergents/lotions/pets/foods. No recent illness. No recent vaccinations besides Moderna COVID-19 vaccine. Lot number and expiration date was not listed on patients vaccine information card. Given IM solu-medrol 125 mg and sent home with prescriptions for diphenhydramine and steroid taper. ED precautions given.
About three months after I received my first dose  of the Moderna Covid vaccine and two months after my second dose I started having irregular menstrual cycles. I had a normal menstrual cycle in March and four days after it ended I started menstruating again for an additional 2 to 3 days. Since then each menstrual cycle that I have is completed and then a day or two later followed by several days of light spotting.
MMR injection given 4/28/14. Parent called clinic on 4/30/14 reporting that injection site was red, tender and warm to touch. Red area was larger than previous day. Patient was seen in clinic 5/1/14 by P.A. Patient also examined by Dr who agrees likely a reaction to MMR. Given the quick spread overnight, will treat for cellulitis (about 5 x 4, mild self blanching around injection site warm, erythematous, no firmness - treated with amoxicillin 960 mg by mouth 2 times daily x 10 days.