chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash was shingles-like i.e. on only one side, wrapping around side of body in fingers.; This case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included diclofenac sodium (Voltaren Arthritis Pain Gel) (batch number 879V, expiry date 30th September 2023) for arthritis.   Previously administered products included Shingrix (received 1st dose in February 2019).   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, the patient started Voltaren Arthritis Pain Gel 130 Bq 4 times daily (520 Bq daily). On an unknown date, unknown after receiving Shingrix, the patient experienced rash. Voltaren Arthritis Pain Gel was discontinued. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. The patient was also using Voltaren Arthritis Pain 1 percent gel 4 times/day upto 21 days to his/her right foot. On day 3 of using gel with beneficial effects, the patient developed rash. The patient stated that in pamphlet mentioned the possibility of a rash, but did not mention a location. The rash was on the right side of the patient's midriff and was shingles-like, i.e., on only one side and wrapping around the side of his/her body in fingers. The patient discontinued using the gel upon appearance of the rash. After 2 to 3 days, the rash subsided and the patient had not resumed the gel.  The patient appreciate any guidance you might provide. The patient was treated by health care professional. The reporter authorized follow-up with health care professional. It was unknown if the reporter considered the rash to be related to Voltaren Arthritis Pain 1 percent gel. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2019, not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix in May 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient never received the second dose, which led to incomplete course of vaccination. Consent to follow up was denied.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Photophobia
Clinical narrative: Arm Soreness; Eyes became very sensitive to light/ Light Sensitivity (eyes); This case was reported by a consumer via call center representative and described the occurrence of photophobia in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th January 2022, the patient received the 1st dose of Shingrix. In January 2022, 24 hrs after receiving Shingrix, the patient experienced photophobia. On 25th January 2022, the patient experienced pain in arm. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the photophobia and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the photophobia and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix on Tuesday.   The patient stated that her eyes became very sensitive to light starting the next day on 26th January 2022 (approximately 24 hours after she received the vaccine).   The patient stated she took Benadryl and laid down.   The patient stated she still had light sensitivity, but it was not as bad as it was the day before.    The patient also stated that she still had left arm soreness which began less than a day after vaccination with Shingrix. The reporter gave consent to follow up with health care professional (pharmacy).
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Completed series of Twinrix with Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 23-year-old female patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Previously administered products included Twinrix (1st and 2nd dose received on an unknown date).   On 27th January 2022, the patient received Engerix B. On 27th January 2022, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The reporter stated that the patient came in to office stating she needed to get her third dose of Hepatitis B vaccine. The reporter administered dose of Engerix-B, however the first two doses of the series the patient received were Twinrix, which led to wrong vaccine administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. HCP gave permission for follow-up.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Dark circles under eyes, Periorbital swelling, Skin discolouration, Swelling of eyelid, Yellow skin
Clinical narrative: dark circles under eyes; eyelids appeared purple; eyes look puffy; eyes look swollen; skin appears yellowish; This case was reported by a consumer via call center representative and described the occurrence of dark circles under eyes in a male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 26th January 2022 18:00, the patient received Boostrix (intramuscular) .5 ml. In January 2022, less than a day after receiving Boostrix, the patient experienced dark circles under eyes, skin discoloration, puffy eyes, swelling of eyelid and yellow skin. On an unknown date, the outcome of the dark circles under eyes, skin discoloration, puffy eyes, swelling of eyelid and yellow skin were not recovered/not resolved.   It was unknown if the reporter considered the dark circles under eyes, skin discoloration, puffy eyes, swelling of eyelid and yellow skin to be related to Boostrix.  Additional details were provided as follows: The case was reported by patient himself. The patient received a dose of Boostrix into his left arm  around 6pm at his pharmacy.  Last night after receiving the dose, the patient developed dark circles under his eyes and that his eyelids appeared to turn purple in color.  In morning of the day of reporting, patient's eyes look swollen and puffy and that looked like patient was in a car accident or beat up, and that his skin appears to be yellowish.  The reporter did not provide the lot or expiration date of the vaccine given. The patient was contacting his health care professional(Hcp). The reporter consented to follow up with hcp.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered
Clinical narrative: HIBERIX at 15 months and a second at 18 months; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 18-month-old female patient who received Hib (Hiberix) (batch number PJ7ER, expiry date 13th November 2022) for prophylaxis.   Concomitant products included haemophilus B conjugate vaccine (tetanus) (Hiberix).   On 27th January 2022, the patient received the 2nd dose of Hiberix (intramuscular) .5 µl. On 27th January 2022, unknown after receiving Hiberix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter stated that, the patient received a Hiberix injection at 15 months old and a second Hiberix injection on the day of reporting, which led to extra dose administered. The reporter stated, the patient was supposed to receive the Hepatitis A vaccine on the day of reporting. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: seizures; This case was reported by a consumer via call center representative and described the occurrence of seizure in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA12AZ, expiry date 1st February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th June 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th July 2021, 13 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced seizure (serious criteria GSK medically significant). The patient was treated with zonisamide (Zonisamide). On 28th January 2022, the outcome of the seizure was recovered/resolved.   It was unknown if the reporter considered the seizure to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: Consumer reporting patient having seizures after Bexsero administration. The patient had been taking Zonifamide since having seizures.  As per consumer, seizures developed on after Bexsero administration.  Consumer reported patient was still having seizures. It was ok for safety to follow up.  The reporter consented to follow up. This case has been linked to US2021151007, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022016259:Same reporter-Deleted case US-GLAXOSMITHKLINE-US2021151007:Same reporter
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo with sterile water administered; Menveo with sterile water administered; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 14-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amva580a, expiry date 31st August 2022) for prophylaxis.   On 5th January 2022, the patient received Menveo (intramuscular) .5 ml. On 5th January 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The HCP (health care professional) inadvertently reconstituted Menveo with sterile water instead of the MenCYW-135 liquid conjugate and administered the dose to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow-up. This case had been linked with case US2021249278, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021249278:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Oxygen saturation, Speech disorder, Thrombosis
Clinical narrative: BLOOD CLOT; HARD TO TALK; This spontaneous report received from a patient of an unspecified age, sex, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 total, dose was not reported administered on an unspecified date for prophylactic vaccination.  On 20-DEC-2021, the patient experienced suspected covid-19 infection, suspected clinical vaccination failure and oxygen saturation decreased (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) 1 total, dose was not reported administered on 16-DEC-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot number. No concomitant medications were reported.  On 20-DEC-2021 four days after the vaccine, the patient got very sick. Because of the vaccine after 4 days the patient went to the hospital and got Omicron and was in the hospital for 3 nights. The patient's blood was clotted and received shoot to thin blood at the hospital. The patient's oxygen was 87. The patient can walk are talk. For 10 days it was hard for the patient to talk and stayed in bed for 12 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hard to talk on 30-DEC-2021 and the outcome of blood clot was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220152367.; Sender's Comments: V0:20220161291-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Blood clot, hard to talk -This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pharyngitis
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: period disorder, low iron, and allergy NOS. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. It was unknown if patient had any adverse reaction after Janssen vaccine (dose number in series 1). Non-company suspect vaccine included: Pfizer (dose number in series 2) (batch number: 33036BD, form of admin, route of admin was not reported) dose was not reported, administered on 21-JAN-2022 at 16:00 in left arm for prophylactic vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Pfizer vaccine. It was reported that patient was not tested and diagnosed with Covid-19. Concomitant medications included ascorbic acid for drug used for unknown indication, and iron for drug used for unknown indication. On 23-JAN-2022 at 07:00, the patient experienced sore throat and felt inflammation on her throat (dose number in series 2). Treatment medications (dates unspecified) included: paracetamol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammation in throat, and sore throat. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Interchange of vaccine products, Oropharyngeal pain
Clinical narrative: This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: period disorder, low iron, and allergy NOS. The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry date: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. It was unknown if patient had any adverse reaction after Janssen vaccine (dose number in series 1). Non-company suspect vaccine included: Pfizer (dose number in series 2) (batch number: 33036BD, form of admin, route of admin was not reported) dose was not reported, administered on 21-JAN-2022 at 16:00 in left arm for prophylactic vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Pfizer vaccine. It was reported that patient was not tested and diagnosed with Covid-19. Concomitant medications included ascorbic acid for drug used for unknown indication, and iron for drug used for unknown indication. On 23-JAN-2022 at 07:00, the patient experienced sore throat and felt inflammation on her throat (dose number in series 2). Treatment medications (dates unspecified) included: paracetamol. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammation in throat, and sore throat. This report was non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Contusion, Eye pain, Heart rate irregular, Hypertension
Clinical narrative: This spontaneous report received from a patient concerned a 58 year old female. The patient's height and weight were not reported. The patient's past medical history included: blood clot. Patient had blood clot previously. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609 and expiry: 07-SEP-2021) dose was not reported, 1 total, administered on 04-APR-2021 for prophylactic vaccination. The patient didn't have any problem with the primary vaccine. She woke up at 4 AM with night sweats when treated with Covid-19 vaccine ad26.cov2.s (Dose number in series was 1). The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 29-JAN-2022 on left arm for prophylactic vaccination. No concomitant medications were reported. On 29-JAN-2022, the patient had her blood pressure elevated and had flu like symptoms (felt nauseated, bone aches, shaking, incontrollable freezing then body felt hot and headache). Her heart rate was unstable, her body felt like it did when she had a blood clot previously. The patient felt like throat was starting to close, the back of her neck hurt and eye felt like they were going to burst from eye pain and were red and watery. Her fingers since were swollen and having a hard time moving them. On 30-JAN-2022, the patient went to emergency room (urgent care) and did tests at the urgent care. In JAN-2022, the patient had bruising, veins looked budging green and painful. The patient went to urgent care (Dose number in series was 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure on JAN-2022, was recovering from heart rate was unstable, felt like throat was starting to close, and back of neck hurt, had not recovered from watery eye, swollen fingers, bruising, veins looking budging green, eye feels like they were going to burst from eye pain and were red, and painful veins, and the outcome of flu like symptoms was not reported. This report was non-serious. This case, involving the same patient is linked to 20220208604 (Dose number in series 1 case).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Laboratory test, Lacrimation increased, Neck pain, Peripheral swelling
Clinical narrative: This spontaneous report received from a patient concerned a 58 year old female. The patient's height and weight were not reported. The patient's past medical history included: blood clot. Patient had blood clot previously. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609 and expiry: 07-SEP-2021) dose was not reported, 1 total, administered on 04-APR-2021 for prophylactic vaccination. The patient didn't have any problem with the primary vaccine. She woke up at 4 AM with night sweats when treated with Covid-19 vaccine ad26.cov2.s (Dose number in series was 1). The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 29-JAN-2022 on left arm for prophylactic vaccination. No concomitant medications were reported. On 29-JAN-2022, the patient had her blood pressure elevated and had flu like symptoms (felt nauseated, bone aches, shaking, incontrollable freezing then body felt hot and headache). Her heart rate was unstable, her body felt like it did when she had a blood clot previously. The patient felt like throat was starting to close, the back of her neck hurt and eye felt like they were going to burst from eye pain and were red and watery. Her fingers since were swollen and having a hard time moving them. On 30-JAN-2022, the patient went to emergency room (urgent care) and did tests at the urgent care. In JAN-2022, the patient had bruising, veins looked budging green and painful. The patient went to urgent care (Dose number in series was 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure on JAN-2022, was recovering from heart rate was unstable, felt like throat was starting to close, and back of neck hurt, had not recovered from watery eye, swollen fingers, bruising, veins looking budging green, eye feels like they were going to burst from eye pain and were red, and painful veins, and the outcome of flu like symptoms was not reported. This report was non-serious. This case, involving the same patient is linked to 20220208604 (Dose number in series 1 case).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Vascular pain, Vein discolouration
Clinical narrative: This spontaneous report received from a patient concerned a 58 year old female. The patient's height and weight were not reported. The patient's past medical history included: blood clot. Patient had blood clot previously. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808609 and expiry: 07-SEP-2021) dose was not reported, 1 total, administered on 04-APR-2021 for prophylactic vaccination. The patient didn't have any problem with the primary vaccine. She woke up at 4 AM with night sweats when treated with Covid-19 vaccine ad26.cov2.s (Dose number in series was 1). The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) dose was not reported, 1 total, administered on 29-JAN-2022 on left arm for prophylactic vaccination. No concomitant medications were reported. On 29-JAN-2022, the patient had her blood pressure elevated and had flu like symptoms (felt nauseated, bone aches, shaking, incontrollable freezing then body felt hot and headache). Her heart rate was unstable, her body felt like it did when she had a blood clot previously. The patient felt like throat was starting to close, the back of her neck hurt and eye felt like they were going to burst from eye pain and were red and watery. Her fingers since were swollen and having a hard time moving them. On 30-JAN-2022, the patient went to emergency room (urgent care) and did tests at the urgent care. In JAN-2022, the patient had bruising, veins looked budging green and painful. The patient went to urgent care (Dose number in series was 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure on JAN-2022, was recovering from heart rate was unstable, felt like throat was starting to close, and back of neck hurt, had not recovered from watery eye, swollen fingers, bruising, veins looking budging green, eye feels like they were going to burst from eye pain and were red, and painful veins, and the outcome of flu like symptoms was not reported. This report was non-serious. This case, involving the same patient is linked to 20220208604 (Dose number in series 1 case).
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients of an unspecified age and sex. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 01 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that "I have known people having J&J vaccine get COVID (suspected covid-19 infection, suspected clinical vaccination failure), my family they have been vaccinated." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0- 20220200536-Covid-19 vaccine ad26.CoV-2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity, Sensory disturbance
Clinical narrative: 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, batch number: 043AZ1A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced trouble breathing, rush of chemicals going through arm, chest and neck, and felt arm pain. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from trouble breathing on APR-2021, and was recovering from felt arm pain, and rush of chemicals going through arm, chest and neck. This report was non-serious. This case is associated with product quality complaint (PQC): 90000214889. The suspected product quality complaint has been confirmed to be this report indicated a medical adverse event for the patient after the product was administered. There is no product quality issue described in the information reported. This record was approved as void as no PQC identified based on the PQC evaluation/investigation performed. Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate irregular, Laboratory test
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient takes care of himself, had no high blood pressure and walk on a treadmill. The patient did not have any history of heart issues. On an unspecified date, the patient was previously treated with Covid-19 vaccine ad26.cov2.s from an unspecified manufacturer (dose number in series: 1) (suspension for injection, route of admin, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on for prophylactic vaccination. The reporter did not report any adverse events following vaccination with Covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received Covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 10-DEC-2021 for prophylactic vaccination. Concomitant medications included vitamins. On an unspecified date, the patient experienced irregular heart beats. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) not reported (dose number in series: 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of irregular heart beats was not reported. This report was non-serious. Sender's Comments: V0- Medical assessment comment is not required as per standard procedure as case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced very sick. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Heart rate increased, Rash
Clinical narrative: DIFFICULTY BREATHING; FAST HEARTBEAT; DIZZINESS; SWELLING OF FACE AND THROAT; FACE TURNED RED AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; RASH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was unknown if the patient had drug abuse or illicit drug usage, consumed alcohol or smoked. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 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 difficulty breathing, fast heartbeat, dizziness, swelling of face and throat, face turned red after receiving the janssen covid 19 vaccine, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty breathing, fast heartbeat, rash, dizziness, swelling of face and throat and face turned red after receiving the janssen covid 19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: DIFFICULTY BREATHING; FAST HEARTBEAT; DIZZINESS; SWELLING OF FACE AND THROAT; FACE TURNED RED AFTER RECEIVING THE JANSSEN COVID 19 VACCINE; RASH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: It was unknown if the patient had drug abuse or illicit drug usage, consumed alcohol or smoked. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 02-APR-2021 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 difficulty breathing, fast heartbeat, dizziness, swelling of face and throat, face turned red after receiving the janssen covid 19 vaccine, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty breathing, fast heartbeat, rash, dizziness, swelling of face and throat and face turned red after receiving the janssen covid 19 vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; LIGHTHEADED/DIZZY; This spontaneous report received from a consumer  via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced lightheaded/dizzy, and patient got covid (suspected covid-19 infection and suspected clinical vaccination failure). Consumer reported that, "Never had the shot my father has a heart problem he gets the shot after dad comes home dizzy and lightheaded everybody in my family got covid had it for 2 days its the flu with respiratory issues." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure and lightheaded/dizzy was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000215711.; Sender's Comments: V0:20220204846-Covid-19 vaccine ad26.cov2.s- suspected clinical  vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Blood disorder, General physical health deterioration
Clinical narrative: SERIOUS HEALTH ISSUES; BLOOD PROBLEMS; This spontaneous report received from a patient via social media via a company representative concerned a male 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced serious health issues, and blood problems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from serious health issues, and blood problems. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Off label use, Product administered to patient of inappropriate age
Clinical narrative: STROKE; 17 YEAR OLD MALE PATIENT GOT THE VACCINE; OFF LABEL USE; This spontaneous report received from a consumer via agency via a company representative concerned a 17 year old male. 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, and batch number were not reported) 1 total, dose, start therapy date were not reported, administered for prophylactic vaccination which was an off label use as 17 year old male patient got the vaccine. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stroke. The reporter reported that, "Strokes are way up among my extended acquaintance including a 17 year old boy. All vaccinated for covid". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, 17 year old male patient got the vaccine and off label use was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220207981.; Sender's Comments: V0:20220207120-COVID-19 VACCINE AD26.COV2.S-Stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN RIGHT LUNG; This spontaneous report received from a patient through a company representative concerned a patient 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, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clot in right lung. Patient was on eliquis (apixaban). As per reporter, "I took the J&J vaccine and ended up with a blood clot in my right lung. Now on Eloquis". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clot in right lung was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220207350-JANSSEN COVID-19 VACCINE Ad26.COV2.S- BLOOD CLOT IN RIGHT LUNG. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Illness, Oropharyngeal pain
Clinical narrative: SICK; BAD SORE THROAT; BODY ACHES; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a consumer via a company representative 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sick, bad sore throat, body aches, chills, fever, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, bad sore throat, body aches, chills, fever, headache, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: SICK; BAD SORE THROAT; BODY ACHES; CHILLS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a consumer via a company representative 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sick, bad sore throat, body aches, chills, fever, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, bad sore throat, body aches, chills, fever, headache, and fatigue. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ADVERSELY AFFECTED; This spontaneous report received from a consumer via a company representative concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adversely affected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adversely affected was not reported. This report was non-serious.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: MENSTRUAL CYCLE DISRUPTED (BREAKTHROUGH MENSTRUAL BLEEDING); This spontaneous report received from a patient concerned a 33 year old female. The patient's weight was not reported and height was 165 centimeters. Patient had 1 gravida. Patient's Expected due date (EDD) was 20-Aug-2022. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced menstrual cycle disrupted (breakthrough menstrual bleeding). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from menstrual cycle disrupted (breakthrough menstrual bleeding) on 12-APR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: This spontaneous report received from a health care professional 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021 expiry: UNKNOWN) dose was not reported, administered on 01-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On 01-FEB-2022, the patient experienced administration of vaccine from a vial that was opened on 28-Jan-2022. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine from a vial that was opened on 28-Jan-2022 was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKES; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical histories or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose were not reported, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number were not reported. The company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patients experienced strokes. Reporter stated that "Strokes are way up among my extended acquaintance." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of strokes was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220207120.; Sender's Comments: V0: 20220207981-COVID-19 VACCINE AD26.COV2.S- strokes. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 42 year old male. Initial information was processed with the additional information received on 03-FEB-2022. 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, batch number: 201A21A, expiry: 21-SEP-2021) dose was not reported, 1 total, administered to right arm on 31-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-FEB-2022, the patient experienced runny nose, slight headache, cough (suspected covid-19 infection) and tested positive for covid-19 using a binax now take home antigen test (suspected clinical vaccination failure). Laboratory data included: COVID-19 antigen test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000216067.; Sender's Comments: V0: 20220208065-- suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous report received from a patient via a company representative via social media concerned a male 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced felt drained for 2 days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt drained for 2 days. This report was non-serious.