chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the person who took out the vaccine accidentally took out the FLUZONE HIGH DOSE QIV instead of the regular FLUZONE QIV with no adverse event; Initial information was received on 18-Nov-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves 64 years old female patient who took out the vaccine accidentally took out the influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] instead of the regular fluzone qiv with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ELASOMERAN (MODERNA COVID-19 VACCINE).  On 19-Oct-2022, the patient received 0.7 ml once dose of suspect influenza quadrival A-B high dose HV vaccine (lot number: UJ924AB, expiration date, formulation: unknown) via intramuscular route in the left deltoid for prophylactic vaccination (Immunisation) instead of the regular fluzone qiv with no adverse event (wrong product administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  Outcome was Unknown for the event the person who took out the vaccine accidentally took out the fluzone high dose qiv instead of the regular fluzone qiv with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Patient was given an IM shot of DTap (4th dose too early). No symptoms at time of vaccine administration. Was seen an hour after vaccine was given and remained asymptomatic.
Swollen; Itching; Redness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), ERYTHEMA (Redness), HEADACHE (Headache) and PERIPHERAL SWELLING (Swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (Headache). On 27-Jan-2021, the patient experienced PRURITUS (Itching) and ERYTHEMA (Redness). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen). On 28-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, PRURITUS (Itching), ERYTHEMA (Redness) and PERIPHERAL SWELLING (Swollen) outcome was unknown. Not Provided      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.   concomitant medications included medicines for cholesterol (10mg), Remicade injection and Prolia for the bones (injection every 6 months). No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: Concomitant medications were updated.
A mother reported that her 13 month old daughter developed a fever following post-exposure rabies vaccination with RabAvert. The child received RabAvert (quantity and route of administration not reported) and HRIG at 17:30 in 8/01 (exact date unk). The child developed a fever of 101F at 03:30, the following morning. The child was treated with Tylenol and the fever resolved in 2 hours. Additional information has been requested.
It started from an extensive rash on the tummy, around ears, neck and face and significant facial swelling especially in between eyes. It all happened in a matter of a few hours. The patient was taken immediately to the pediatrician. Doctor ordered to do a Strep Throat test and immediately decided that it's a common viral infection that presents with hives. She didn't want to even consider the possibility of the adverse vaccine reaction even though the patient's mother clearly stated that she is sure that it's from that. She didn't perform any viral test, nor checked the patient's blood. Prescribed steroids for hives, asked to get topical Benadryl and liquid Zyrtec. Next day the child was feeling worse. The rash started going to the limbs and he started complaining of the pain in his joints, especially knees. Patient started limping and his fever spiked to 102 Fahrenheit. The mother took the patient to the Hospital Pediatric ER after calling Doctor's office to confirm that it's what they recommend.  Doctor, after long battling the mother's opinion regarding the post-vaccine reaction admitted that the patient is having the actual measles following the vaccination 10 days. The patient started feeling nauseous and turned all yellow while in the ER and complained of the tummy ache. The doctor checked his belly and held off releasing the patient for an hour. Nurses performed a strep throat test, ran CBC Blood Test and performed nasal virus test. Told the patient to take Benadryl and Motrin at home The patient continues to be very sick and the sickness seems to be consistent with the symptoms of measles. His upper and lower limbs are all swollen, his whole body is covered in a rash, he has a high fever and feels nauseous.
This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a 44-year-old female patient who received FLUARIX QUADRIVALENT (batch number B9G34, expiry date 20th May 2017). Previously administered products included FLUARIX QUADRIVALENT (received vaccine in last year and had no reaction). On 3rd October 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 4th October 2016, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced swelling arm (serious criteria disability), pain in arm (serious criteria disability) and injected limb mobility decreased (serious criteria disability). On an unknown date, the outcome of the swelling arm, pain in arm and injected limb mobility decreased were unknown. The reporter considered the swelling arm, pain in arm and injected limb mobility decreased to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were reported as follows: On 3rd October 2016 at 8:47 hours, the patient received the FLUARIX QUADRIVALENT. On the next day, the patient reported a swollen left arm which ached and she was not able to raise her left arm. The reporter stated that the patient felt both these adverse events were somewhat disabling to the patient.
Information has been received concerning a pt who was vaccinated on 10/17/00 and on 10/18/00 she developed cellulitis at the injection site, with redness, edema, and warmth. The pt was seen by a physician and treated with Zithromax and she recovered.
Symptoms thus far have included headache, increased fatigue, increased weakness, increased shortness of breath especially dyspnea on exertion, myalgias, sore throat, coughing congestion.  Mentions that the reason she presented to the clinic was the notable increased shortness of breath which has been worsening over the past few days.
52 year old female with hx of bipolar disorder and alcohol dependence who was brought to the ER for evaluation altered mental status and possible overdose. The patient tested COVID positive 3 days ago without any symtoms after being exposed to a covid positve family member. Patient states she received 2 dose Moderna vaccine few months ago ( dose not remember the month and date).
No adverse event, but error: wrong vaccine product administered.  Pfizer vaccine received at day 0 (2/25/21), Moderna given as second dose at day 21 (3/18/21).
Pain in affected arm. Injection site pain, redness, burning, itching, feeling hot at 4:00 PM. Swelling of the arm 5:00 PM. On 04/24/2015 low grade fever redness, swelling and pain spread up and down arm (6" x 3") defined area, nausea, dizziness, fatigue, malaise which continued to worsen. Visited Urgent Care on 04/26/2015 and was treated for possible allergic reaction/cellulitis. Medications prescribed were Zyrtec 10mg Tablets daily and Cipro 500mg Tablets twice daily for 7 days. Swelling improved but not resolved 04/28/2015. Itchiness, redness, pain, burning, nausea, fatigue, dizziness and malaise still on-going.
Oct 22-Inability to concentrate, couldn't drive. Sever pain in arm from shot, swollen, red and hot to the touch. Oct. 23-Muscles in legs, arms and back all are painful. Oct. 24- Mild dizziness, aches and pains all over body, dry mouth, fingers were locking up/cramping, feet were cramping. Muscles are twitching, weakness, fatigue. Oct. 25- Taken to emergency room, extremely dizziness. muscles aching in legs, back and arms, dry mouth. Emergency room doctor said I was slightly dehydrated, but she said they couldn't do anything because of the adverse reactions to the flu shot. Wrote me prescription for dizziness meclizine 25 mg and sent me home.
The left side of my face became numb and my neck was stiff.  It went away by the next day
flu symptoms.  Pt received J&J vaccine this morning 0900. At 1400, started having a HA, chills, dizziness, chest pain cramps, and n/v. History:  Pt had J&J COVID-19 vaccine this morning and after noon, pt started developing chills, non-thunderclap headache, felt light-headed like passing out while standing, having to sit down, sweating, with N/V x 2, here for eval.  Also had muscle aches, in chest, thigh, and other parts of muscles, not isolated to chest.  Felt not quite 100% when pt woke up this morning but otherwise didn't have any other symptoms before the vaccine and denies recent sick contact, recent travel, recent illness/surgery/procedures/abx use, diarrhea, rash, COVID-19 hotspot visit, sore throat, ear pain
severe body ache; headache; fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe body ache, headache and fever. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe pain in neck and behind shoulder blade on left side, weakness in grip strength and forearm. Numbness in left thumb and tracing  up arm to forearm.
Local pain and discomfort to her L arm; Local pain and discomfort to her L arm; 16 year female patient Given Dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (Local pain and discomfort to her L arm), VACCINATION SITE PAIN (Local pain and discomfort to her L arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year female patient Given Dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE DISCOMFORT (Local pain and discomfort to her L arm), VACCINATION SITE PAIN (Local pain and discomfort to her L arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year female patient Given Dose). On 06-May-2021, VACCINATION SITE DISCOMFORT (Local pain and discomfort to her L arm) and VACCINATION SITE PAIN (Local pain and discomfort to her L arm) had resolved. At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year female patient Given Dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications was reported. Treatment medications was not provided.   This case was linked to MOD-2022-458050 (Patient Link).
cold sweat; Bruise-like soreness at the injection site; chills; trouble sleeping which lasted for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping which lasted for 2 days), COLD SWEAT (cold sweat), VACCINATION SITE PAIN (Bruise-like soreness at the injection site) and CHILLS (chills) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    On 28-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 29-Sep-2023, the patient experienced COLD SWEAT (cold sweat), VACCINATION SITE PAIN (Bruise-like soreness at the injection site) and CHILLS (chills). On an unknown date, the patient experienced INSOMNIA (trouble sleeping which lasted for 2 days). On 02-Oct-2023, COLD SWEAT (cold sweat), VACCINATION SITE PAIN (Bruise-like soreness at the injection site) and CHILLS (chills) had resolved. At the time of the report, INSOMNIA (trouble sleeping which lasted for 2 days) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   The patient had no concomitant disease or risk factor. Treatment information was not provided.
Approx. 20 minutes after booster was received, subject started to feel ill.  He became tense and passed out for a short time.
Immediately (within seconds) after receiving the Pentacel vaccination, he had a 10 x 10cm raised wheal and erythema and swelling to his L thigh.  He was moving a lot as the shot was given but my MA felt like she gave it IM as per normal protocol.  He was crying continuously, but observed for 30 minutes at the clinic and did not develop signs of anaphylaxis.   Ice and topical diphenhydramine were applied.  He had difficulty walking on this leg for the first day and then the reaction improved over several days.  He had previously tolerated both Daptacel and Pentacel without any major reactions.
Worsening pain at the injection side of his Left arm that radiates down to his elbow; difficulty raising his right arm over shoulder level; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Worsening pain at the injection side of his Left arm that radiates down to his elbow) and VACCINATION SITE PAIN (difficulty raising his right arm over shoulder level) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN), LOSARTAN, ATORVASTATIN and MELOXICAM for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (Worsening pain at the injection side of his Left arm that radiates down to his elbow) and VACCINATION SITE PAIN (difficulty raising his right arm over shoulder level). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Worsening pain at the injection side of his Left arm that radiates down to his elbow) and VACCINATION SITE PAIN (difficulty raising his right arm over shoulder level) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-114498 (Patient Link).
At 12:10 PM RN administered 0.1cc of Jynneos vaccine intradermally to the right forearm and a wheal was not produced. RN notified lead clinic nurse RN and was instructed to give a 2nd dose of 0.1cc to the left forearm. The patient was educated. The dose of 0.1 cc was given on the left forearm and a wheal was produced. Patient was educated to observe for adverse reactions.
Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; Nausea; Feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) on 17Mar2021 at 09:00 at left arm as first single dose for COVID-19 immunisation. (Age at vaccination: 51 Years). Concomitant medications included Wellbutrin (MANUFACTURER UNKNOWN) 150mg and Estadiol (MANUFACTURER UNKNOWN) 5mg; all for unknown indications from unknown dates. Prior to the vaccination, the patient was diagnosed with COVID-19 and since having the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has tested positive for COVID-19 prior to vaccine. Patient was allergic to penicillin and oxy. On 17Mar2021 at 22:00, the patient experienced tiredness, headache, muscle pain, chills, joint pain, fever, nausea and felt unwell. No therapeutic measures were taken as a result of events. The clinical outcome of the events tiredness, headache, muscle pain, chills, joint pain, fever, nausea and feeling unwell were resolved. Information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a female patient with allergic reaction to monosodium L-glutamate who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported). After receiving the vaccine she had been unable to sleep. It was unknown if the patient sought medical attention. At the time of the report the outcome of unable to sleep was unknown. No further information is available.
Type 1 diabetes (diagnosed in March of 1997, but getting sick in fall of 1996)
Unable to walk, hurts "all over," loss of appetite. The medical records state sore throat, rash, weakness and headache. The medical record received on 1/28/04 states leg pain, rash and viral myalgias.
Tinnitus started about 1 1/2 weeks after vaccination with initial dizziness. Tinnitus is increasing steadily. Suspecting vaccine adverse event since nothing else in my medical history or environment changed. Tinnitus is now pretty significant and increasing.
Information has been received from a physician concerning a 7 or 8 yr old pt who was vaccinated with a dose of varicella virus vaccine live. In approx June 2005, the pt was seen in the office with break through varicella. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
Left arm swelling, redness including circle around vaccination site, high level of soreness/pain and itching of the left arm. Patient stated that they received two vaccines in the left arm, but that was not what was documented on file. Follow-up to occur with immunizer regarding this. Patient was told to consult doctor upon worsening symptoms and counseled that potentially Benadryl could assist with itching symptoms. This has occurred since receiving vaccination on Friday, October 6th, 2023.
Within 15-minutes of vaccination, the patient reported a headache. EMS managed patient's care on-site.
Instant swelling to about a gumball size, red patches/blotches on arm, pain, shortness of breath, burning sensation from center of chest up to throat but no throat closure, slight dizziness.
Chills; FEVER; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (FEVER) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (FEVER). At the time of the report, CHILLS (Chills) and PYREXIA (FEVER) outcome was unknown.     Treatment medication was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Patient was seen in the office on 3/17 for worsening of arm redness and swelling.  Was given Keflex for possible cellulitis.  Docotor's option was a vaccine reaction.
UNKNOWN TO US, PATIENT HAD RECEIVED JANSSEN j&j ON 04/06/21 FROM ANOTHER FACILITY.
Chills, persistent bilateral flank pain, fluctuating in severity throughout the day, mild-moderate to moderate
After a few hours received pneumonia vaccine I had severe pain to injected site, unable to lift arm with intermittable pain, some numbness.  It didn't relieve pain after taking extra strength TYL 500mg + NICODIN 5mg + BENADRYL 25mg, so I went to ER with family member's assist.  Pain lasted for 10-12 days after shot.
Swelling and redness on right upper arm with induration about 5cm X 5cm.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 9:28 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 9:28 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 78.35.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34 and total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
High fever, shaky, hard to breathe.  Felt like throat was swelling, hoarse.