chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High on fever, 108ºF; This spontaneous case was received on 28-Sep-2020 from a pharmacist (reference number SEQW-02494) and concerned a 60-year-old, male patient.  The patient's medical history and concomitant medication deatels were not provided.  On 26-Sep-2020, around 11:00 am, the patient was vaccinated with Flucelvax QIV (Influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: right arm) for influenza prophylaxis. The batch number reported was 279836, expiration date: 30-Jun-2021.   On the same day, in the afternoon, the patient developed high fever, 108°F and was hospitalized.  On an 28-Sep-2020, reported as today, the patient called to the pharmacy saying that he was discharge from hospital.  The outcome of the event was unknown.  The reporter did not provide causality assessment.  Company comment: The patient developed pyrexia on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient was hospitalized. No information regarding medical history and concomitant medications was provided. Considering all above mentioned, causal relationship is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).  The reporter assessed the case as serious.; Sender's Comments: The patient developed pyrexia on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is suggestive. Reportedly, the patient was hospitalized. No information regarding medical history and concomitant medications was provided. Considering all above mentioned, causal relationship is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
2.5 inc area of swelling and redness. Tx ice x 30 min Benadryl 25mg tb x 2. Observation x 1.5 hrs. Follow up next morning.
my left arm was extremely painful, swollen and red. can't lift it. this started about 4 hours after 2nd dose. Around 8pm that night started with chills, body aches, headache and nausea. This lasted for about 36 hours. I developed some tingling in my legs. I'm on day 3 post vaccine. I feel better but still have some weakness, hot flashes and headaches. Arm is still swollen and red and hot to touch.
Sore & swelling L shoulder to wrist which was severe temp. hot higher than 99.8. Felt cold, hand white on Fri. in bed 1/7 & 1/8 felt drained. L arm throbbed red upper arm. 1/10 numerous fever blisters (about 10) on bottom lip & had one on top lip applied ice, elevation, ibuprofen, swelling gradually decreased  & was gone after a wk.
Delayed / doses / first doses in Nov 2019 / second doses yesterday, 4/22/21; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2019).   On 22nd April 2021, the patient received the 2nd dose of Shingrix. On 22nd April 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The age at vaccination was not reported. Initially, the pharmacist inquired about delayed shingrix doses for a patient and asked should he receive his second dose or restart the series. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up. This case has been linked with case US2021090834, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090834:Same reporter. Wife's case.
localized swelling 12 hours after vaccine.  had diarrhea, sweating, nausea ("lasted 15 minutes").  Client reports these S & S and also stated her MD recommended Benadryl po before and after Twinrix.  (Client called MD.)  Vaccine not given today (8/5/08); client referred back to PMD.
Injection site swelling, left arm and axillary swelling, palpable and painful lymph nodes. Left arm numbness comes and goes.  Difficult to reach above head at times.  Monday 10/10/2011 right arm lymph nodes are painful, not as swollen.
hives over entire body 7hr post inj;no SOB;no swelling of lips or tongue;
Covid-19 vaccine was administered to individual < 18 years of age in error. No adverse event was observed or reported.
Patient state on the 8th and 9th day after the vaccine was given her arm had a red spot about "3 inches in diameter" and she felt nauseated.  Then on the 10th day she felt achy, like the flu.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 19-AUG-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, 0.5 ml, (lot # K009105, expiration date 21-JAN-2016) (route and dose were not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the first time excursion was 24, 34 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree) and the type of excursion (R/F) for the second excursion was 176, 48 and R.The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
8 patients got expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) in a 56-year-old male 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) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine). On 28-Sep-2021, EXPIRED PRODUCT ADMINISTERED (8 patients got expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
positive COVID test on 11/17/21; pt in SNF; DNR; pt found deceased in bed in facility; per death certificate pt died of Failure to Thrive, Dysphagia, COVID 19, Alzheimer's dementia
Around 3 hours after injection some difficulty breathing/fully catching breath, chills, shakes, fever (100 degree). The next day had general aches and weakness.
Information has been received from a doctor of science, the author of an article published in the journal in June 2011, who reported that the analysis of side effects of GARDASIL (lot numbers not reported) showed that there were "236 cases of pregnant women who were stricken, most of them suffering miscarriages or bleeding". The patients' outcomes were unknown. Upon internal review, miscarriages were considered to be other important medical events. No further information is available.
3-12-21: Lower back muscle pain/cramping.  Slight fatigue. 3-13-21: Dull headache, fatigue,  3-14-21: Headache, chills, nausea, muscle fatigue, fever, night sweats.
Presented with dizziness and falling, developed progressive weakness, sensory loss, dysmetria.  Was hospitalized and diagnosis made by neurologist with EMG confirmation - acute sensory neuronopathy (Guillain Barre Variant).  Received IVIG without significant improvement at follow up.  She is now nonambulatory and resides at long term acute care facility.
Patient returned about 2 hours after receiving vaccine complaining of chest tightness, shortness of breath and arm and chest pain.  Patient declined rapidly and could not breath. Called 911 and administered 1 dose of Epipen 0.3mg. Patient's breathing improved immediately. Patient went to ER for further workup.
lump under her armpit in the same arm of injection; some soreness under her armpit; armpit feels uncomfortable; tired; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (lump under her armpit in the same arm of injection), AXILLARY PAIN (some soreness under her armpit), AXILLARY PAIN (armpit feels uncomfortable) and FATIGUE (tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced AXILLARY PAIN (armpit feels uncomfortable) and FATIGUE (tired). On 24-Mar-2021, the patient experienced AXILLARY PAIN (some soreness under her armpit). On 25-Mar-2021, the patient experienced AXILLARY MASS (lump under her armpit in the same arm of injection). At the time of the report, AXILLARY MASS (lump under her armpit in the same arm of injection), AXILLARY PAIN (some soreness under her armpit), AXILLARY PAIN (armpit feels uncomfortable) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment details include half a Mobic pill   This case was linked to MOD-2021-121332 (Patient Link).
Macular lesions within watery centers surrounded by red areas. Began 06/23/2002 on back, Progressed to crusted area ands another outbreak of lesions 06/25/2002.
Patient states she was advised by nurse that because it was intermuscular (triceps), it may be because she is experiencing a headache that lasted 36 hours, also fatigue for 5 days, also joint stiffness for 7 days and she states she felt very sore and stiff and had a hard time walking up and down stairs without feeling shortness of breath. Said she felt "run down". On day 8 (12/31) she felt a lump like a mosquito bite. Day 9 the injection site became red and became very hot to touch. No fever reported. She was advised to see a nurse and was advised it could be hypersensitivity and to report this. This happened on 01/02/2021
Coroner stated that 3 weeks after patient received 2nd dose of COVID-19 Moderna vaccine, patient collapsed from cardiac arrest, which lead to death.
No side effects; incorrect product storage; This spontaneous report has been received from a vaccine provider referring to a 2 month-old male infant.  Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.  On 17-NOV-2020 , haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB)(lot #T001206 with expiration date: 03-JUN-2022, dose details and frequency were unknown)  was administered to the patient intramuscularly in left thigh for prophylaxis, after a temperature excursion (product storage error). No side effects was reported. The vaccine was stored at maximum 50 degrees Farenheit (F), but they were moved to transport containers in frozen packs at 47.2 degrees Farenheit (F) for a time frame of 30 minutes. Then they were moves to another fridge. Malfunction was identified, fixed and the vaccines were moved back to original fridge, where the temperature was appropriate. There was digital data logger involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2011USA013815: US-009507513-2012USA007336:
Skin Erythema - Information has been received from a physician concerning a male who on 31 Oct 2000 was vaccinated with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation.  Subsequently, the patient developed a red, erythematious streak on the right arm a little further down than injection site.  The physician reported that the streak was above the anticubitial fossa.  The patient sought unspecified medical attention and his outcome was unknown.  Additional information has been requested.
07/21/16: nausea, vomiting; 07/22/16: body aches, headache, nausea, chills/cold, hot feeling, fever; 07/23/16: nausea, vomited 1 time; Ongoing headache today since 07/21/16.
whole face swelled up; lips swollen up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (whole face swelled up) and LIP SWELLING (lips swollen up) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00TFU4, 031A21A and 042LFCA) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (whole face swelled up) and LIP SWELLING (lips swollen up). At the time of the report, SWELLING FACE (whole face swelled up) and LIP SWELLING (lips swollen up) had not resolved.            No concomitant medications reported. No treatment information was provided.   This case was linked to MOD-2021-378271 (Patient Link).
screamed 45 mins p/vax then cried 3 days w/brief moments of calmness; low grade temp; no site rxn; difficult to console;
Patient started experiencing pain in muscle and bones in left arm; Patient started experiencing pain in muscle and bones in left arm; Neck pain (with radiation); Patient reported sore arm after receiving 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient reported sore arm after receiving 1st dose), BONE PAIN (Patient started experiencing pain in muscle and bones in left arm), NECK PAIN (Neck pain (with radiation)) and MYALGIA (Patient started experiencing pain in muscle and bones in left arm) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE and LOVASTATIN for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Patient reported sore arm after receiving 1st dose). On 22-Feb-2021, the patient experienced NECK PAIN (Neck pain (with radiation)). On 02-Mar-2021, the patient experienced BONE PAIN (Patient started experiencing pain in muscle and bones in left arm) and MYALGIA (Patient started experiencing pain in muscle and bones in left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Patient reported sore arm after receiving 1st dose), BONE PAIN (Patient started experiencing pain in muscle and bones in left arm), NECK PAIN (Neck pain (with radiation)) and MYALGIA (Patient started experiencing pain in muscle and bones in left arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, X-ray: normal (normal) MD did x-ray and couldn't find anything.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Swollen lymph nodes in left and right arm pit. Left was swollen and fluid was in pectoral muscle area.
3/24 04:00 : full-body aches 3/24 20:00 : chills 3/24 22:00 : 3/25 04:00 : sweating, more chills 3/25 08:00 : no symptoms  No treatment, just rest, food and fluids.
Vomiting, lightheadedness, floating feeling, nausea, tachycardia within 15 minutes of vaccination
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 17 years old female patient received the first single dose of TRUMENBA on an unspecified date for immunization. Medical history and concomitant medications were not provided. On an unspecified date after vaccination the patient experienced fever at 101.2, sore neck, congestion, cough, localized arm swelling extreme with heat and redness. Events outcome was unknown.
1-2 days following injection a rash at site of injection noted. No discomfort. Rash resolved within 24 hrs. 3 wks at one day later redness, swelling and discomfort at site of injection (about 50 cent piece size in redness and spot in center appeared swollen (seen by phone picture).
pt recv vax on 6MAR97 & pt presented to clinic on 8MAr97 w/lt deltoid redness @ complete circle site of inj (under circular bandage);no c/o pain or swelling;exam w/no tenderness, no induration, no vesicle;only blanching erythema;
Reconstituted Pfizer with 0.18 ml of normal saline instead of 1.8 ml of normal saline. Provider notified. She feels patient will be fine. Manager to be notified in am as it is evening clinic now. Patient to be notified after nurse manager notified of event and further instructions provided.
Tingling og tongue and itchy eyes at 10min post admin Swelling/redness and flushing of head 20mins post admin Shortness of breath at 20mins Whole body hives and itching at 40min pot admin Swelling under the jaw and tightness/burning in chest at 40min After treatment in er...symptoms resolved after 5hrs. 14hrs later, symptoms reoccurred, with increasing severity. Went back to the ER for treatment.  Again symptoms resolved after 5hrs. Now on 25mg benadryl 4x/day, 40mg prednisone 1x/day, zertec 20mg 1x/day and 20mg famotidine 1x/day for the next 4 days. Still being treated.
No patients experienced symptoms; unspecified patients may have been administered improperly stored doses of PEDVAX HIB, GARDASIL 9, RECOMBIVAX HB and ROTATEQ; This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On unknown dates, the patients were vaccinated with improperly stored doses of the following vaccines: Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # R036178 with expiration date on 09-OCT-2021, and lot # R027329 with expiration date on 12-JUL-2021; HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # S026372 and expiration date on 01-APR-2022, and lot # R029507 with expiration date on 10-JUL-2021; Hepatitis B Vaccine (Recombinant) (RECOMBIVAX HB) lot # R031056 with expiration date on 04-JUN-2021, and lot # R031055 with expiration date on 04-JUN-2021; and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally, lot # 1660685 with expiration date on 21-MAR-2021, and lot # S005875 with expiration date on 30-NOV-2020, (strength, dosing details were not reported) via unknown route, all vaccines for prophylaxis.  It was reported that the vaccines were exposed to a temperature of 47.6-degree Fahrenheit for 41 minutes and 31.9-degree Fahrenheit for 6 hours and 58 minutes. There was not previous temperature excursion. It was reported that digital data logger was involved. No symptoms were reported.  This is a non-valid case due to the lack of patient's identifiers.  Follow-up information was received on 03-MAR-2020 from a nurse supervisor.  The nurse referred to a 13-year-old male patient (previously considered non-valid).  On 17-JAN-2020, the patient was vaccinated with improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength not reported) lot # R029507 with expiration date on 10-JUL-2021 for prophylaxis (product storage error).  The reporter confirmed that there had been no reports of adverse event following the administration of the vaccinations. She also reported that no patients received the Merck vaccination Hemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB). Additional information has been requested.  This is one of the several reports by the same reporter.; Sender's Comments:  US-009507513-2003USA001374: US-009507513-2001USA006732: US-009507513-2003USA001376: US-009507513-2003USA001377: US-009507513-2003USA001378: US-009507513-2003USA001379:
ADVERSE EVENTS NOS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: unknown, expiry: unknown) dose not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced adverse events nos (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse events nos was not reported. This report was non-serious. This case, involving the same patient is linked to 20220112515.
Student received nasal vaccine and within 1 minute had a seizure like episode with no response to verbal stimuli, eye rolling, head tilted to side while seated upright this lasted 3 minutes. Student recovered and became alert and oriented.
2 pts who recvd 3 doses of Engerix-B did not respond;
rash on the trunk and the face; pharyngitis like reaction on the throat; erythema at the injection site; Route of Administration: IM; This spontaneous report as received from a physician refers to a 12 month old male patient. He had no known allergies.     On 16-OCT-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # T016145 has been verified to be a valid lot number, expiration date: 07-NOV-2021, recombinant Human albumin (rHA)), via intramuscular route (dose was not reported) for prophylaxis. On 17-OCT-2020, the patient experienced erythema at the injection site. On 27-OCT-2020, he experienced rash on the trunk and the face and pharyngitis like reaction on the throat. Medical attention was sought for the patient. He received a treatment with acetaminophen (TYLENOL).  The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was not provided.
Headache; Body aches; Nausea; Fatigue; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unspecified date (reported event took place after use of product), the patient experienced headache, body aches, nausea, and fatigue. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.