chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 (Batch/Lot number: unknown) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Body aches".  Additional information: The patient had no known allergies. The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 4/7/00 the mother reported that the pt broke out in hives. Had one welt on leg on 3/31/00 and spread to extremities, chest and back and face. Looked like mosquito bites. No pustule discharge or scabs. No fever, no diarrhea, no seizure activity. Rash not irritated by water or heat. Pt went to hospital on 4/8/00 since she still had a rash and was told she had hives and given Benadryl. Was told could be a reaction to the vaccinations. Called mother and was informed that the child needed to have the vaccines given by PMD for possible monitoring of side effects.
A spontaneous report has been received from Physician via medical representative concerning a patient of unknown gender. Patient's relevant history, concurrent diseases and concomitant drugs were not provided. It was reported that child was administered nasal FLUMIST (intranasal) for flu vaccine during 2015 and developed A strain flu (Preferred Term: Influenza). FLUMIST was continued. The outcome of the event of flu was unknown. The company physician assessed the event of flu to be non serious. Corrected Report 10-Mar-2017: Trade name corrected for FLUMIST from FLUMIST to FLUMIST QUADRIVALENT. Key ingredient corrected from FLUMIT to Q/LAIV. Additional reporter added. Patient age group added as child.
Severe skin rash in abdominal area, lower back and upper legs. Was prescribed Triamcinolone 0.1% cream for affected areas.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8° (10 mins); This non-serious spontaneous report was received by partner (reference: 02197725) on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.   FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003725, MCM-003726, MCM-003724, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
At 1:16PM patient complaints of pruritus, but patient said feeling ok. At 1:35PM continue with pruritus Benadryl 50ml IM were administrated. Vital signs Oxygen saturation 95%,  HR 85bpm, BP 155/91mmHg, Dxt 119 and RR 12 rpm. At 1:45pm patient complaint of fatigue, an Rapid Response (RR) code for anaphylactic reaction was activated. Patient received  Epinephrine 0.3mg IM (1 dose), Solu-Cortef 200mg IM (1 dose) and was transferred to the ER per anaphylactic shock protocol. Vitals signs at ER were 132/76mmHg, RR 14rpm, Osat 99% and HR 83bpm.
rash. Generalized body rash x 10 days with stiff joints developing 2-3 days ago, after receiving J&J vaccine on 15MAR21; states seen in ED 4-5 days ago and Rx Famotidine and Benadryl with no relief. 60 yo M w/ no known chronic medical conditions, presents w/ 10 days papular, flesh-colored rash to extremities; started 8 days after receiving J&J vaccine. Most prominent on the extensor surfaces of his MCPs, PIPs, elbows, but also extends up both of his arms. 2 days joint stiffness. No facial rash, mucosal involvement, systemic sx, weight changes. No personal or family h/o autoimmune dz.   VS w/o acute abn. Well-appearing, NAD. Papular rash as described above. No desquamating rash, mucosal involvement.   I spoke to Dr.
Feeling awful; Headache; Nausea; Very tired; Cold arm; Painful arm; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2020, the patient received the 1st dose of Shingrix. On 15th November 2020, 1 days after receiving Shingrix, the patient experienced feels awful, headache, nausea, tiredness, cold extremities and pain in arm. On an unknown date, the outcome of the feels awful, headache, nausea, tiredness, cold extremities and pain in arm were unknown.   It was unknown if the reporter considered the feels awful, headache, nausea, tiredness, cold extremities and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and woke up feeling awful. The patient had headache nausea, very tired, cold and painful arm.
Individual's father tested covid positive on 9/8/21.  Individual isolated away in a hotel and tested on 9/9/21 (positive result).  He later returned home and continued to isolate.  He's symptomatic with sore throat, pink eye, and HA.  Advised individual to continue to isolate from family in separate rooms until 9/19/21 and to callback hotline for further instruction and also to callback when DOH contacts him.
Immediately post vacciantion pt felt dizzy.  Pt taken to triage area. Vitals: 104/58, 65, 95%. Pt was observed for an additional time.  Pt stable and released from the vaccination site w/ a family member.
This spontaneous report was received from a physician via company representatives from a support services director concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. Concomitant therapies were not provided. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (10Pk-0.5mL SD-PFS LLokwTip) lot number K010466, expiration date of 23-MAR-2016 (route of administration was not reported). The vaccine had two temperature excursions: one for 24 hours and another one for 32 hours. The lowest recorded temperature for the first excursion was 34 degrees Fahrenheit (1.111111111 Celsius) and the highest recorded temperature for the second excursion was 48 degrees Fahrenheit (8.888888889 degrees Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Redness, swelling at injection site left arm. Treatment: Prelone oral suspension 5 mg every 10 hours for 2 days, Twice daily for 2 days, daily for 2 days Atarax oral susp. 10 mg three times daily as needed.
vasovagal sx: sweating, weak pulse;vomiting w/in 30min of vax;pt held in clinic for observation;sx resolved w/o tx;
Flu symtems for 3 days. Body aches, fever, weakness.  After that, low grade fever from May 8 to present (May22)
The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021; 606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13OCT2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13OCT2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 13OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 29OCT2021 beyond expiration date 13OCT2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Patient recived the booster dose. It was mentioned that the vial was placed in the refrigerator on 29-Oct-2022, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment information was provided.
Comvax given on 7/17/00, leg swollen, went to ER on 7/19/00 evening and mother states nothing was done. Pt checked by MD on 7/20/2000 an had swollen right outer thigh. Treated with warm packs. To recheck in 2 months for well baby check.
This spontaneous report as received from a pharmacist via company representative refers to four patients of unknown age and gender. Patient's medical histories were not reported. On an unknown date the patients were vaccinated with ZOSTAVAX (dose, frequency, route of administration and anatomical location: unknown) (lot # K000995, exp date: 16-MAR-2015). On an unknown date, the patient experienced a mild injection site reaction of redness at injection site. The adverse reaction resolved on its own (date unknown). The relatedness between the events and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. After receiving Flu shot, the patient experienced very sore arm.
Serious drop in glucose level causing lethargic, non responsive and unsteadiness which lasted for several days.  Same thing happened after the 2nd does.  But glucose dropped to 25, which caused a visited to the ED.
Giant hive in left Arm of if injection site one week prior To injection. Hard lump; hot to the touch
The patient received 0.25mL Moderna for his 2nd vaccine. This was discovered by the nurse who  administered another 0.25mL of Moderna, so the patient could receive his full dose.
Severe vomiting; Chills; Fever; Sweats; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 20Apr2021 at 08:15 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 20Apr2021 at 22:30, the patient experienced severe vomiting, chills, sweats and fever. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe vomiting, chills, sweats and fever was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & devel herpes zoster 3 different groups of lesions on rt side of chest along dermatome;lesions were painful & pruritic;pt did not have a hx of chickenpox or varicella exposure;
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccines on 02/05/21 and 03/05/2021. COVID + on 1/20/22. Presented to ED 1/20/22 with hypotension, generalized weakness, fatigue, and 2 falls within the 10 days previous. Admitted for acute hypoxemic respiratory failure due to Covid PNA.  Started on 2L of O2. Treated with rocephin, decadron, remdesivir. On 1/29/21 noted on telemetry to become more bradycardic. Code blue called and ACLS protocol was initiated. Given 3 rounds of epinephrine and CPR without ROSC. Patient expired on 1/29/22.
Sore arm starting evening of injection, continued through second day (at time of report) Extreme dizziness starting morning after injection.
Dad phoned 7-16-15 said night after vaccines pt had face swelling and face felt heavy. No trouble breathing. Rash on back of shoulder not where vaccines were given-went to ER 7-15-15. Face not as swollen and rash some better. No trouble breathing.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 35 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Treatment was Paxlovid. Treatment start date was 30Aug2023 and stop date was 04Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2-18-03-Swollen tender area noted at left neck area by the collar bone by RN. Clinic and health department notified. 2-25-03 Same area noted but more firmer than last week. DOH was informed and a recommendation was made for the patient to she her provider. Patient was examined at the clinic by PA on 2-25-03 and he said it was a swollen lymph node and if it doesn't resolve in 2 weeks to return to the clinic.
Ringing in my ears; Had a little bit of feeling under the weather; Sore arm for 1 day; I have acute hearing loss. My hearing is down to about 80 percent; This spontaneous case was reported by a physician and describes the occurrence of TINNITUS (Ringing in my ears), HYPOACUSIS (I have acute hearing loss. My hearing is down to about 80 percent), MALAISE (Had a little bit of feeling under the weather) and PAIN IN EXTREMITY (Sore arm for 1 day) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced MALAISE (Had a little bit of feeling under the weather) and PAIN IN EXTREMITY (Sore arm for 1 day). On 03-Nov-2021, the patient experienced TINNITUS (Ringing in my ears). In November 2021, the patient experienced HYPOACUSIS (I have acute hearing loss. My hearing is down to about 80 percent). The patient was treated with METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. On 02-Nov-2021, PAIN IN EXTREMITY (Sore arm for 1 day) had resolved. At the time of the report, TINNITUS (Ringing in my ears) had not resolved and HYPOACUSIS (I have acute hearing loss. My hearing is down to about 80 percent) and MALAISE (Had a little bit of feeling under the weather) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On 03-Nov-202, day three, patient had ringing in ears and it progressively got worse. On 10-Nov-2021, patient went to urgent care. They gave a cortisone shot (solumedrol) and a prescription for prednisone. Patient had acute hearing loss. His hearing was down to about 80 percent.   This case was linked to MOD-2021-385149, MOD-2021-385158 (Patient Link).
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022 at 2:02 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient ethnicity as withheld. The patient had received the vaccine dose number as second booster. No concomitant medications were reported. It was reported that a series of an approximately 540 patients had received lot number of 066H21A in past and had an its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed. No treatment medications were reported.   This case was linked to MOD-2022-542869 (Patient Link).
High fever 2 days... Uncomfortable shaking. A few hours Couldn't hold a glass of water to drink. It would still half full. Fatigue for 3 days
shipment is delayed by more than 2 days, product was administered to the patient /no AE; shipment is more than 2 days not to use and to obtain a replacement of the products/no AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA308920, 2019SA308921 and 2019SA308846 (same reporter).  This case involves a 68 years old male patient who received a 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UT6695JA, Exp. Date: 30-Jun-2020) via intramuscular route at an unknown site on 04-Nov-2019 that had a shipment delay.  Relevant medical history and concomitant medication were unknown.  It was an actual medication error case due to incorrect product storage and Product shipment delay.  It was reported that the vaccines were shipped 30-Oct-2019 and were delivered this morning 04-Nov-2019. She has taken care of the replacements. Before they received the email, one dose of FLUZONE QUADRIVALENT had been administered to this patient.  It was reported that no adverse event was experienced.  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 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.