chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache achiness, sinus pressure Narrative:  1/20/21 in the evening HA, achiness, sinus congestion, coughing, chills that lasted in to the morning sel care with otc acetaminophen and feeling better today 1/21/21
ARM FEELS A BIT OF PAIN; HUGE FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 24-AUG-2021, the patient experienced arm feels a bit of pain. On 24-AUG-2021, the patient experienced huge fever. The action taken with covid-19 vaccine was not applicable. The outcome of the huge fever and arm feels a bit of pain was not reported. This report was non-serious.
Swelling in top right arm and shoulder. Exteme pain in that area, Extreme hardened around the injection site, about four-five inches wide. Hight fever, chills, while blood count high. Tired and lethargic.
sore arm for about 3 days, then started feeling weaker and weaker.  By about a week and a half out from his vaccine he states he was "sleeping all the time."  At 2 weeks he had a bad nose bleed that lasted an hour and was extremely hard to stop.  A week later he had another bad nose bleed and couldn't stop it so went to the ER where they treated it with a "plug."  The next day the ER removed the plug because it was bothering him so much.  Mid week on the 4th week he had another bad nose bleed and saw an ENT who cauterized it.  ENT advised he not receive dose 2 of the Covid vaccine in case the vaccine contributed to his severe nose bleeds.  No history of nosebleeds.
A single seizure; Headache; Chills; A spontaneous report was received from a consumer who is a 71 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced headaches, chills, and seizure.  The patient's medical history was not reported.  Concomitant medicine reported included metoprolol. The patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection on unknown date.   On 27 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Batch number: 014M20A] intramuscularly in the right dominant arm for prophylaxis of COVID-19 infection.   On 27 Feb 2021, the patient experienced headache and chills. On the morning of 01 March 2021, patient experienced a single seizure and transported to hospital. Emergency department discharged the patient stated that her magnesium levels were low and was given magnesium supplements and advised to follow up with PCP. Later the patient followed up with her PCP and they concluded her magnesium levels were normal then. Treatment for the event included Magnesium Supplements.   The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the events is not applicable.  The outcome of events, headaches, chills, and seizure were resolved on 28 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Patient tested positive for COVID-19 on 8/7/2021 with symptoms starting on 8/4/2021.  Patient is now hospitalized.
Vesicular rash on face, chest, back Treated with Benadryl, Calamine lotion. Tylenol prn fever
Pt recvd vax woke up 11PM crying, screaming, c/o extreme pain gerneralized fever >101, vomiting started p/APAP which was given Q4 @ 2AM fever >103; pt had redness & swelling @ inject site & advised MD call/visit;
Muscle soreness and lethargic in general.  I took two naps the day after shot and one nap the day after that. Was unable to hike very far or work outside for more than 30 minutes before I needed to rest.  Also felt depressed the third day after but not sure that is due to the shot.
One hour subsequent to receiving third dose of Lymerix pt experienced fever of 100 degrees and chills. Pt was seen in the ER, treated with Tylenol and discharged. The most recent information reports the outcome of the event as resolved.
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 02-JAN-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 60 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a 6 year old female who on 28-SEP-2000 was vaccinated subcutaneously in the arm with the first dose of Varivax (Lot # 635208/0076K). On 30-MAY-2006 the patient was diagnosed with chickenpox. Subsequently, the patient recovered from the chickenpox. No further information is expected.
I got a fever of 101.5; Chills; Body ache; This is a spontaneous report from a contactable healthcare professional (patient). A 60-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included Graves' disease, hypothyroidism, cholesterol, thyroid problems, hyperthyroidism, and had COVID in July (year unspecified). Concomitant medications included atorvastatin (generic) and atorvastatin calcium (LIPITOR) for cholesterol, and levothyroxine sodium (SYNTHROID). The patient had first vaccine and then next evening on an unknown date she got a fever of 101.5 and then had the chills and body ache and everything and she was scheduled to have her next one on 25 (not clarified). Patient had blood test before the end of the year 2020 but nothing new now. Patient took TYLENOL as treatment for the events. The outcome of the events was unknown.
pt recv vax & devel full-blown chicken pox;MD reported 10 to 20 patients;
Myalgia, Arthralgia, Fever, "chills, SOB, nerve pain in previous injuries"
Redness Left Deltoid - injection site treated as cellulitis with Clindamycin 150mg 1 tid x 1 week
This spontaneous report was received from a medical assistant refers to a patient of unknown gender and age. The patient's relevant medical and past drug histories and concomitant medications were unknown. On an unknown date, the patient was vaccinated with VARIVAX (lot # M008173, expiry date: 16-FEB-2018) via subcutaneous route in the back of the arm. Medical assistant reported that the vaccine underwent a temperature excursion, but the patient did not experience any adverse reactions. It is unknown if there were any relevant laboratory data. This is one of the three reports received from the same reporter. Additional information has been requested.
Local size reaction, swelling w/o itchiness or excessive pain. Large amount of bleeding. Advised cold compress, NSAIDS if needed.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient's daughter was translating on site at the time of occurence. pt complaint of diffuculty breathing in the waiting room and observed redness on the chest. tongue was not swollen. took patient into separate room and continue to observe patient. patient stated she can breath much better after taking off mask and doesn't want us to call 911 yet. informed that if patient were to leave and having diffuculty breathing at home, she must call 911. she can take benadryl 2 of 25mg Q 6-8 h if rash ob
Seriousness criteria other medically significant (OMIC). Initial report received from the patients parents on 4/18/2006. A four year old male patient, with possible allergies, had received, on 8/4/2005, an injection of IPOL, lot number X12402, and injection of MMR vaccine, lot number 0348P, and an injection of Infanrix, lot number AC14B002AA. Routes and sites of administration were not provided. Fifteen minutes post vaccination, the patients face, lips and palms of his hands became swollen and red. He also experienced difficulty breathing and elevated blood pressure. He was examined by a physician and treated with steroids. At the time of this report, the patient had recovered from the event.
Warmth, Redness and Swelling arm at the site of injection, pain 8/10.
Complaint of left arm redness and swelling after receiving TD on 3/3/03. Returned on 3/9/03 for check of left arm.
Shivering, fever for x 2 days. Treated with over the counter acetaminophen 4x daily
No additional AE/; HCP reported a 2-month 2-day old patient received GARDASIL 9. The operator of the device was a nurse. No additional AE/no PQC.; Information has been received from a licensed practical nurse, referring to a 2 month- old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 25-SEP-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 1 dose, lot #W026152, expiration date: 29-JAN-2025 (also reported on 09-JAN-2025), administered for prophylaxis (strength, and route of administration were not provided) (Inappropriate age at vaccine administration).  the reporter stated that the 2-month 2-day old patient received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the operator of the vaccine was a nurse. No additional adverse events were reported.
Rash like pimples; pimples burned a bit; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ACNEIFORM (Rash like pimples) and BURNING SENSATION (pimples burned a bit) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced DERMATITIS ACNEIFORM (Rash like pimples) and BURNING SENSATION (pimples burned a bit). At the time of the report, DERMATITIS ACNEIFORM (Rash like pimples) and BURNING SENSATION (pimples burned a bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Initial unsolicited report received from a Pharmacist via other company (Pfizer, Manufacturer report number: 2017092318) on 13 March 2017. This case involves a female patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu Vaccine) on an unknown date in 1971 (while she was in hospital) and a dose of PREVENAR 13 (batch number, dose and expiration date unknown for both the vaccines) on an unknown date. Patient's medical history and concomitant medications were not reported. On an unknown date in 1971, following the vaccination, the patient passed out. Lab data and corrective treatment were not reported. On an unknown date, patient recovered completely from the event. Upon internal review the case was considered as serious because of important medical event passed out. Patient was instructed never to get flu vaccine by her physician and was told her the reason she passed out was probably due to the chicken feathers that was part of the vaccine (reported as related). List of documents held by sender: none. Sender's Comments: Time to onset is unknown. Loss of consciousness may occur as the result of traumatic brain injury, brain hypoxia, severe poisoning with drugs that depress the activity of the central nervous system, severe fatigue and other causes. It was suspected that patient unconscious due to chicken or chicken feathers that part of the vaccine. More details regarding exact time to onset, name of the vaccine administered, patient was in contact with chicken, history of allergy, concomitant medication and investigation reports are needed for complete assessment of the case. As 2 vaccines were administered before the onset of events, making it difficult to assess the role of each vaccine.
Around 10 days after the vaccine, around 4/19/2021 I had a vertigo attack. I had spinning and nausea, I was hugging the toilet vomiting. That lasted for 2 hours, after that I had to go to sleep because it wiped me out. About every 3 weeks like clockwork, that same situation happened through 9/13/2021. I was diagnosed with Meniere?s disease on 7/2021. They put me on a diuretic to decrease the pressure in my ear. I took it in July through August 2021, but I stopped taking it because it was not helping. I was assigned to a Physical therapist, and she had me doing eye exercises, but that did not seem to help. So, I did not keep it up. I was told to limit my sodium, but no change with that either. I am not saying the vaccine caused the vertigo to reappear, but I am saying that it did not cause it either. During 4/2021 I was having a lot of stresses. I do not know if the vertigo was triggered by the stresses or the vaccine. I had had a history of vertigo for the past 18 years. This was different than what I had experienced before. Prior to April 2021, they were isolated events with several years between attacks, but beginning in April, 10 days after the vaccine, they were every 3 weeks. They vertigo attacks are back to what they were before the vaccine, as opposed to what they were in 4/2021- 9/13/2021.
Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025D21A, 001A21A and 030L20A) for COVID-19 vaccination.     Patient had no allergies.  Previously administered products included for Product used for unknown indication: Flu vaccine (past month). Past adverse reactions to the above products included No adverse event with Flu vaccine. Concurrent medical conditions included Hypertension and Type I diabetes mellitus. Concomitant products included LOSARTAN for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2022, the patient experienced COVID-19 (Covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at a dose of for 5 days. At the time of the report, COVID-19 (Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medications also included insulin pump.   This case was linked to MOD-2022-670551 (Patient Link).
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 15-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006486: US-009507513-2106USA006487: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Severe dizziness with onset at 12 to 14 hours after injection Moderate to severe headache  Moderate overall body ache, and fatigue
diff breathing x 2wk, heavy neck swelling 3-4wk, stiffness in back; recovering
Fainted; Sweating; Vision was blurry; It went "black; Whole skin feels cold; Felt something weird on her body; vision was sparkly; Chills; A spontaneous report was received from a Consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events felt something weird on her body, sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird.  The patient's medical history was not provided. Products known to have been used by patient, with in two weeks prior to the event, included levothyroxine, lisinopril, amlodipine, omeprazole, atorvastatin, baby-aspirin, lisinopril hydrochlorothiazide.  On 2-Jan-2021, patient received the first of two planned doses of mRNA-1273 (lot/batch: 037K20A) intramuscularly at right arm . On 28-Jan -2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly at right arm for prophylaxis of COVID-19 infection.   On 21-Feb-2021, the patient experienced the events felt something weird on her body. sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird. Treatment information was not provided.   The patient received both scheduled dose of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable   The outcome of events, felt something weird on her body, sweating, chills, vision was blurry, vision was sparkly, it went black, she fainted, whole skin feels cold, just feels weird were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On day 11 I woke up with a 4 inch, large, red, itchy, warm welt at injection site
Deltoid muscle sore, which was expected. But pain went up into my clavicle and my lymphnodes feel very swollen. Having pain radiate up my neck and down my arm.
gen urticaria immed p/vax;resolved w/DPH in 24hr;
Patient received his second Moderna shot at approximately 11:45am.  He waited for 15 minutes at the pharmacy, then went shopping.  He later came back around 12:20 and said he felt a little short of breath.  He did not appear to be in distress and was talking normally.  I had him sit down and remove his mask.  I got him some cold water and his sister asked him if he was just nervous.  He replied no.  She said he had heart issues and that she was going to take him to the urgent care to just make sure he was ok.  He  was able to walk and talk normally and did not appear to be in distress.  I called him later to check on him and he said the urgent care said it was probably an allergic reaction and they gave him prednisone and benadryl and he felt fine now.
He is be vomiting, ever since Saturday.; This is a spontaneous report received from a contactable consumer reported for patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Reporter enquired that the new virus is out. The delta, could you tell what the signs and symptoms are there because reporter's nephew might have it because he is be vomiting ever since saturday, five days later. Reporter's nephew might have the strain because he has kept vomit ever since then so, need to contact somebody as soon as possible. Reporter stated you are pharmacist, let me ask you the same. What could have make him vomiting since saturday and he can't stop it. He has been vomiting since saturday he cannot hold anything on his stomach not even water. We tried soup we tried everything, to come to emergency room he vomit come around out there and he still doing the same thing, so what could have happen to him that made him vomit like this. Did you know anything that possibly happen to the person make them vomiting, while you being a pharmacist, you know medicine and you know lot of other stuff may be you may have some suggestions, It could be poisonous or what could it be could it be tummy ache or what. The outcome of event was unknown.  Information about batch/Lot number has been requested.