chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 at 17:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 41 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Feb2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 09Mar2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 17Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 15Jul2022 at 17:30 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate-to-severe asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300231719 same patient, different drug/ event;
pain in the back; pain in the bones; Still in bed; Pain in the arm of the injection; Could not touch the arm; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in the back), BONE PAIN (pain in the bones), ASTHENIA (Still in bed), PAIN IN EXTREMITY (Pain in the arm of the injection) and VACCINATION SITE DISCOMFORT (Could not touch the arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced BACK PAIN (pain in the back), BONE PAIN (pain in the bones), ASTHENIA (Still in bed), PAIN IN EXTREMITY (Pain in the arm of the injection), VACCINATION SITE DISCOMFORT (Could not touch the arm) and HEADACHE (Severe headache). On 02-Mar-2021, PAIN IN EXTREMITY (Pain in the arm of the injection), VACCINATION SITE DISCOMFORT (Could not touch the arm) and HEADACHE (Severe headache) had resolved. At the time of the report, BACK PAIN (pain in the back), BONE PAIN (pain in the bones) and ASTHENIA (Still in bed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medications included high blood pressure medications and diabetes medications. No treatment information was provided.
Patient is a 70-year-old male who just tested positive for covid presenting with cough. He does occasionally have sputum production that is pink tinged/blood-tinged. No gross blood. He denies having chest pain, shortness of breath, back pain. He is complaining of lack of smell, body aches, fatigue, myalgias. Patient denies having any history of COPD, CHF. Patient is vaccinated. For covid. Chest X ray with no evidence of an acute process.  Patient will be discharged with cough medicine. Patient instructed to return if this worsens in severity per Patient is interested in monoclonal antibody treatment he was given referral to clinic and informed that they will be in touch with him.
symptom of more nauseous feeling; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (symptom of more nauseous feeling) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included PRAVASTATIN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced NAUSEA (symptom of more nauseous feeling). At the time of the report, NAUSEA (symptom of more nauseous feeling) outcome was unknown. Not Provided          Concomitant products included Acid reflux medication for an unknown indication. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not applicable.
Rotator cuff issues; Skin on his arms and back bleeding; Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms; noticed more allergy symptoms; can't sleep; Had upset stomach/stomach is still woozy; Nausea; Shivering; Fever; aches and pain in his joints; This spontaneous case was reported by a patient and describes the occurrence of ROTATOR CUFF SYNDROME (Rotator cuff issues), SKIN HAEMORRHAGE (Skin on his arms and back bleeding), PRURITUS (Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms), INSOMNIA (can't sleep) and ABDOMINAL DISCOMFORT (Had upset stomach/stomach is still woozy) in a 67-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis and Eczema.    The patient's past medical history included Fall in January 2022.   On 27-Jan-2022, the patient started DUPILUMAB (DUPIXENT) (unknown route) 300 milligram. On 11-Apr-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced INSOMNIA (can't sleep), ABDOMINAL DISCOMFORT (Had upset stomach/stomach is still woozy), NAUSEA (Nausea), CHILLS (Shivering), PYREXIA (Fever) and ARTHRALGIA (aches and pain in his joints). On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (Rotator cuff issues), SKIN HAEMORRHAGE (Skin on his arms and back bleeding), PRURITUS (Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms) and HYPERSENSITIVITY (noticed more allergy symptoms). The patient was treated with MELOXICAM for Rotator cuff syndrome, at an unspecified dose and frequency. At the time of the report, ROTATOR CUFF SYNDROME (Rotator cuff issues) had not resolved, SKIN HAEMORRHAGE (Skin on his arms and back bleeding), PRURITUS (Skin on arms and back itching/experienced itchiness on his knees, elbows and under arms), INSOMNIA (can't sleep) and NAUSEA (Nausea) outcome was unknown, ABDOMINAL DISCOMFORT (Had upset stomach/stomach is still woozy) and CHILLS (Shivering) was resolving and PYREXIA (Fever), ARTHRALGIA (aches and pain in his joints) and HYPERSENSITIVITY (noticed more allergy symptoms) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report was received from a registered nurse referring to an adult patient of unknown age and gender. Concurrent condition and medical history were not reported. On 24-JUL-2015, the patient was inadvertently vaccinated with the first expired dose of RECOMBIVAX HB 10/1.0 mcrg/ml, lot # H017018, expiration date on 11-JUL-2015 (dose, route of administration and anatomical location were not reported). It was unknown if the patient sought medical attention. There was not a quality product complaint involved. No adverse effects were reported. Additional information is not expected because the physician cannot be contacted.
This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported similar events for two patients. This is the second of two reports. An elderly patient (over 65 years of age) of an unspecified gender received a dose of PREVNAR 13, on an unspecified date at 0.5 ml single in arm for pneumonia pneumococcal.  The patient medical history was not reported.  There were no concomitant medications.  The patient had soreness in the arm of the injection for a month after vaccination. The final outcome of the events was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2016537674 Same reporter/drug/event, different patient.
Patient reports after receiving 3rd dose (booster) to left upper extremity the injection site became painful, red, warm to touch, raised knot over injection site, pain to axilla, tingling to left fingertips.  Reports pain near injection site/armpit with range of motion of left upper extremity.  Reports she has taken Ibuprofen and iiced the injection site without relief.  States the redness to injection site has increased in size over night.
This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in arms), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE SWELLING (Swollen  arm) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04EAQ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 13-Mar-2021. Concomitant products included METFORMIN and ETHINYLESTRADIOL, NORETHISTERONE ACETATE (LOESTRIN) for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced RASH (Rash in arms), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE SWELLING (Swollen  arm), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency and HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash in arms), VACCINATION SITE INDURATION (Hardness), VACCINATION SITE URTICARIA (hives on arm), VACCINATION SITE SWELLING (Swollen  arm), NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, SARS-CoV-2 test: unknown (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Other medications include birth control. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up information received on 21-Jun-2021 contains non-significant information.
COVID-19; COVID-19; This is a spontaneous report from a contactable consumer reporting same event under the same suspect product for 28 patients. This is one of 28 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN,SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced COVID-19 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on unknown date. The reporter stated that 28 people from a certain location tested positive.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101237061 Same reporter/product/events, different patient
disorientated; significant depression; mental acuity; spaced out; This spontaneous case was reported by a physician and describes the occurrence of DISORIENTATION (disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (spaced out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 053E21A, 029K20A and 011J20A) for COVID-19 vaccination.     The patient's past medical history included Dementia. Previously administered products included for Product used for unknown indication: flu vaccine (She received a flu vaccine simultaneously with the 3rd dose of the vaccine.) on 20-Aug-2021. Past adverse reactions to the above products included No adverse event with flu vaccine.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced DISORIENTATION (disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (spaced out). On 05-Apr-2022, DISORIENTATION (disorientated), DEPRESSION (significant depression), MENTAL DISORDER (mental acuity) and FEELING ABNORMAL (spaced out) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported. Patient stated that She was not pyretic.  No medications or treatments have been provided for her current symptoms.   This case was linked to MOD-2022-532755 (Patient Link).
AFTER RECEIVING VACCINE CLERICAL STAFF CHECKED MEDICAL RECORD AND DISCOVERED PATIENT'S FIRST DOSE WAS OF MODERNA, AND PFIZER WAS ADMINISTERED AT THIS VISIT BECAUSE CLIENT REPORTED TO CLERICAL STAFF THAT SHE WAS HERE FOR HER SECOND DOSE OF PFIZER.  PATIENT TOLERATED DOSE FINE AND WAS INFORMED THAT THE SERIES WAS CONSIDERED COMPLETE AND DOSE SHOULD NOT BE REPEATED PER CDC INTERIM CLINICAL CONSIDERATIONS.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old female patient who received SHINGRIX (batch number ER5ZB, expiry date 9th June 2021) for prophylaxis. On 2nd March 2019, the patient received SHINGRIX (intramuscular) .5 ml. On 3rd March 2019, 1 days after receiving SHINGRIX, the patient experienced fever and chills. On 4th March 2019, the patient experienced swelling arm. On an unknown date, the outcome of the fever and chills were recovered/resolved and the outcome of the swelling arm was not recovered/not resolved.  It was unknown if the reporter considered the fever, chills and swelling arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The pharmacist reported the patient had fever and chills and at the time of reporting had swelling or a large circular bump three inches below the injection site. The reporter stated she thought that the fever and chills were started the next day following the injection, but they have resolved. The reporter did not know when they resolved.
At injection site for Zoster vaccine, area became bright red, swollen, and hot approximately two days post vaccination. Affected area is approximately 3" x 4". As of 10/7/2017 area is still slightly red, swollen, tender to the touch and itchy. OTC Benedryl gel was applied to affected area. No medical treatment was sought.
Pt exhibited seizure-like symptoms following vaccine. Turned head to right side, with fixed grimace-like facial expression, remained seated and in fixed position with muscle rigidity; episode lasted 30 sec., approximately. Immediate return to prior level of functioning.
Reoccurrence of shingles; skin rash, skin rash on neck and forehead; Hot; swelling of arm at the injection site; Red; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (Reoccurrence of shingles), RASH (skin rash, skin rash on neck and forehead), VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (swelling of arm at the injection site) and VACCINATION SITE ERYTHEMA (Red) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (swelling of arm at the injection site) and VACCINATION SITE ERYTHEMA (Red). On 09-Apr-2021, the patient experienced HERPES ZOSTER (Reoccurrence of shingles) and RASH (skin rash, skin rash on neck and forehead). On 05-Apr-2021, VACCINATION SITE WARMTH (Hot), VACCINATION SITE SWELLING (swelling of arm at the injection site) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown. At the time of the report, HERPES ZOSTER (Reoccurrence of shingles) and RASH (skin rash, skin rash on neck and forehead) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  Treatment information included Ibuprofen, Lotrimin antifungal, Hydrocortisone, Destin and valacyclovir 1g every 8 hours for 7 days.  Action taken with mRNA-1273 in response to the event was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Translation received and does not contain any new information.
I didn't know I was pregnant when getting the vaccine. Roughly 2-3 week pregnant when getting the first dose. The due date early but baby was born by induction. The baby was born missing one toe of the right foot. Other wise the baby is developing fine.
pt says she had soreness and achiness throughout her body that lasted a couple of days.  She developed a red 3 x 1 1/2 itchy rash on her upper left arm that starts near the injection site that is sore and hot to the touch.  She is using cortisone cream and ice which seems to help.  Pt called her PCP regarding her symptoms.
Hot rash on upper back, still present on day two but no longer feels hot and did not spread
Patient stated that when she had her period (menstrual cycle) following the vaccine her symptoms were much worse/more severe than they normally are. Did not provide any more specific details.
Pt had immediate dizziness, followed by fever of 101 the next day, followed by intermittent dizzinesss since, which it now has been about a week, as well as nausea.
Feels kind of hung over/ feels like he's getting over the flu; All his broken bones hurt like hell now/bone aches; Lightheaded; Left arm is really sore more than the first time; Headache; Body aches / lower back has been really achy; Horribly sick/really sic/feeling sick; Sick to his stomach/still feel poopy; Low energy/still in bed; Couldn't sleep last night; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Horribly sick/really sic/feeling sick), ABDOMINAL DISCOMFORT (Sick to his stomach/still feel poopy), ASTHENIA (Low energy/still in bed), INSOMNIA (Couldn't sleep last night) and FEELING ABNORMAL (Feels kind of hung over/ feels like he's getting over the flu) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Ankle reconstruction (Reconstructive surgeries on ankle and knee). Concurrent medical conditions included Thyroid disorder NOS and Back pain.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced ILLNESS (Horribly sick/really sic/feeling sick), ABDOMINAL DISCOMFORT (Sick to his stomach/still feel poopy), BONE PAIN (All his broken bones hurt like hell now/bone aches), DIZZINESS (Lightheaded), HEADACHE (Headache) and MYALGIA (Body aches / lower back has been really achy). 07-Sep-2021, the patient experienced ASTHENIA (Low energy/still in bed), INSOMNIA (Couldn't sleep last night) and PAIN IN EXTREMITY (Left arm is really sore more than the first time). On 08-Sep-2021, the patient experienced FEELING ABNORMAL (Feels kind of hung over/ feels like he's getting over the flu). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and TRAMADOL ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (Horribly sick/really sic/feeling sick), ABDOMINAL DISCOMFORT (Sick to his stomach/still feel poopy), ASTHENIA (Low energy/still in bed), INSOMNIA (Couldn't sleep last night), FEELING ABNORMAL (Feels kind of hung over/ feels like he's getting over the flu), BONE PAIN (All his broken bones hurt like hell now/bone aches), DIZZINESS (Lightheaded), PAIN IN EXTREMITY (Left arm is really sore more than the first time), HEADACHE (Headache) and MYALGIA (Body aches / lower back has been really achy) outcome was unknown.            Concomitant medication provided include thyroid medication and tramadol for mild narcotic for pain in back.  Patient took half of a marihuana brownie for his symptoms.   This case was linked to MOD-2021-313212 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow-up was received on 9-SEP-2021 and Updated relevant medical history, added treatment medication, added event; lightheaded, updated event verbatim.
Client was not eligible for 2nd booster yet due to age and not immune compromised. Client did not report any adverse side effects after administration.
Long time healthy individual, with normally lower (not-low) blood pressure.   Vaccinated Sep 2021.   Unexpected onset of severe chest pains and cardiac event occurred Oct 1, 2022.  Rushed to ER via ambulance.  Diagnosis: Bradycardia.  Heart rate far too low.   At one point while coconscious,  rate 37 beats per minute.   Pacemaker judged required and implanted to maintain nominal heart rate.
Patient received both Zoster (Shingrix) and Flublok quad 2022-2023 PFS on 9/27/22 intramuscularly in her left deltoid.  She called the pharmacy on 6/1/23 to make aware that she experienced immediate swelling and hives on 9/27/22 and the hives have remained on her skin ever since.  She said her doctor has had her on steroids, allegra, and pepcid AC for awhile but she still has the swelling.  She asked about the inactive ingredients in the vaccines because she was concerned they may have had an effect.