chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At around 10 minutes he started with a headache after a few minutes (around 20 min post vaccination) he was associated with intense abdominal pain in the left skin after a sensation of chest tightness. his throat started to burn and he started feeling like he had something stuck in his throat, and he said it was as if his throat was closing. Pale skin with cross-links on arms and chest. He felt that he could not swallow his saliva well and then that it was difficult for him to get air. 911 arrived I took him to Hospital, on the way he was injected with a BENDARYL IM. Corticosteroids were used urgently. I arrived with stable hemodynamics but a sensation of pain, burning in the throat plus a sensation of closure or a foreign body in the throat, (which did not become complete) plus a sensation of having to make an effort to breathe well.
Diarrhea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.   Reporter did not allow further contact
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 69-year-old male patient who received SHINGRIX (batch number 5CYXDMC P1C?, GSK note the reported batch number did not match with any GSK lot number expiry date unknown,) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (For tolerance of 1st dose, refer case US2019GSK055185 ). On 20th March 2019, the patient received the 2nd dose of SHINGRIX. On 20th March 2019, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On 21st March 2019, the patient experienced injection site pain, fever, fatigue and chills. Rechallenge with SHINGRIX was positive. On 22nd March 2019, the outcome of the injection site pain was recovering/resolving and the outcome of the fever, fatigue and chills were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown. The reporter considered the injection site pain, fever, fatigue and chills to be probably related to SHINGRIX. Additional details were provided as follows: Within 24 hours patient was seen by a doctor due to fever 101.4 Degree F, chills, extreme fatigue and injection site pain beyond what would be expected for a vaccination. The patient was instructed to not return to work. The condition was greatly improved after 24 hours of rest.
1st dose 2018, 2nd dose 12Oct2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 7742Z, expiry date 25th March 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 9th November 2018).   On 12th October 2021, the patient received the 2nd dose of Shingrix. On 12th October 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows:  The reporter stated that a patient received the first dose of Shingrix on 9th November 2018 and the second dose on 12th October 2021, which led to lengthening of vaccination schedule. The lot and expiration was not available for the first dose, but the lot and expiration of dose 2 was as follows: 7742Z, 25th March 2023 .  The reporter noted the lot number was difficult to read, so it might not be accurate, but that was what the numbers appear to be.  The reporter consented to follow up from safety.
Patient tested COVID+ on  11/13/2020 following household exposure. Received first COVID vaccine 12/23/2020. Symptoms of sore throat, N/V/D started on 1/12/21 prior to receiving her 2nd vaccine dose.  COVID test on 1/13/21 resulted as positive.
Face felt flush; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face felt flush) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 25-Jan-2021 at 6:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced FLUSHING (Face felt flush). On 25-Jan-2021, FLUSHING (Face felt flush) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
redness and swelling in right upper arm to elbow crease. he also received Pneumoccocal vaccine at the same time.
pt recvd vax;exp severe pain at inject site;pain got progressively worse;next day could only dress with 1 arm
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 07-NOV-2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Presents to the ED c/o coffee ground emesis starting today. She also notes constipation. She also tested positive for COVID-19 2 days ago and her facility has put her on NC for low SpO2.  shortness of breath.   Lives in Nursing Home since hip fracture.  Tx.ocontinue isolation/ quarantine precautions. + mucinex  ,Decadron tx given.
Two weeks after the first shot I couldn't walk on my left leg without very bad pain,. Ended up going to see othro doctor and have gotten bursitis in there which has been on going still to this day and on restricted duties at work for my job I am on my feet for 7.5 hours of the day walking, running up and down, bending and lifting.  Five days days into my second shot which was on 02/03/2021 I woke up and could not lift my left arm. Went and had an X-ray done to find I have a strained shoulder which still pops and gets sore. Back to the ortho doctor for that also. Sent to PT for both arm and leg and still seeing ortho doctor to this day . Not sure what they need to do to release the bursitis. There was no injury in either arm nor leg for this to happen except for the only connection is the shots.
Reports having symptoms of COVID after exposure with a positive case. Tested positive for COVID; Reports having symptoms of COVID after exposure with a positive case. Tested positive for COVID; This is a spontaneous report from a contactable nurse.    A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 29Jan2021 intramuscular at single dose (first dose at 44 years; Lot Number: EN5318) and on 19Feb2021 intramuscular at single dose (second dose at 44 years ; Lot Number: EN5318) for covid-19 immunisation. Medical history included exposure with a positive case on an unknown date in 2021. The patient's concomitant medications were not reported.  The patient reported having symptoms of covid on 11Apr2021 after exposure with a positive case. He was tested positive for COVID on 12Apr2021 via Nasal Swab. The outcome of the event was recovering.; Sender's Comments: Based on the information provided, the contributory role of the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), to reported events and tested positive for COVID via Nasal Swab is probable.
This spontaneous report as received from a physician via a company representative refers to a 56 year old female patient. Her medical history was not provided. Her concurrent conditions included seasonal allergies, arthritis, diabetes, high cholesterol, unspecified thyroid problems, sleep apnea and hypertension. None drug reactions/allergies were reported. On 30-OCT-2015, the patient was vaccinated with the dose of PNEUMOVAX 23 (0.5 ml, intramuscularly; lot # and expiration date were not reported). Concomitant therapies included FLONASE, hydrocodone, ketorolac tromethamine, metformin, SOLU-MEDROL, VICTOZA, ZETIA and an unspecified medication reported as gabapentin. On an unknown date, the patient experienced severe pain in her shoulders that hurt to touch. She also could not move her arms. The patient sought medical attention - she returned to the office a few days later and she received the treatment with diphenhydramine hydrochloride and the symptoms seemed to subside. On an unknown date, the patient went to the orthopedist who stated that she likely had chronic shoulder pain and referred her to a pain specialist. The pain specialist performed a magnetic resonance imaging (MRI) on an unknown date and stated that the patient had torn tendons in her rotator cuff in her arms. It was also provided that the patient was suing the practice. The outcome of the adverse event was unknown. The relatedness between the adverse event and PNEUMOVAX 23 was not provided. Additional information has been requested.
I woke up the next day with a pounding heart.  It continued over the course of the day, sometimes rising into the low 100s even though I am taking meds to decrease my heart rate and is normally in the 60s.  Symptoms continued for about 24 hours.
Drastic vision change.  Could not focus on anything up close.  For example unable to read a large computer screen for five weeks.  Able to see long  distance much better and no longer required glasses to see far away.  Have worn glasses all of my adult life.  Gradual improvement in process.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (She felt like she was going to die) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (She felt like she was going to die). At the time of the report, FEELING ABNORMAL (She felt like she was going to die) outcome was unknown. No concomitant products were reported. No treatment information was reported by the reporter.
Hives on her neck; red all over"; Itching all over; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on her neck), ERYTHEMA (red all over") and PRURITUS (Itching all over) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided.).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced URTICARIA (Hives on her neck), ERYTHEMA (red all over") and PRURITUS (Itching all over). At the time of the report, URTICARIA (Hives on her neck), ERYTHEMA (red all over") and PRURITUS (Itching all over) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient did not received treatment.
28 hours post injection painful small vesicular rash on left palm.  Like any bites (no exposure to ants). Rash progressed in pain, distribution,  and number of bumps (>80) entire palm only over next 3 days.   Possible dx pompholyx eczema?
fever; pain at injection site; This is a spontaneous report from a Regulatory Authority. A non-contactable female consumer reported for herself that.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, and pain at injection site on an unspecified date. It was reported that Caller received first vaccine and had fever and pain at injection site. Wanted to know should she return to work with fever. The outcome of events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Narrative:  Patient is a 67yo male with a PMH significant for myasthenia gravis, hyperlipidemia, obesity who presented to PCP on 3/15 after receiving his second COVID vaccine on 3/5. He reported dyspnea, dizziness and diaphoresis on exertion for the next two days. His son called an ambulance on 3/7, but patient refused transport. EMTs reportedly did rhythm strip and patient was told that "everything looked okay." On 3/15, patient endorsed a non-productive cough x3 weeks. He also stated that he was still "breathing heavier than normal" and that HR was increased. D-dimer was elevated at 11192, and he was referred to the ED. In the ED on 3/16, ultrasound found DVT on R side with extension into femoral vein, and CT chest positive for bilateral proximal PEs. Vital signs remained stable, oxygen saturation remained in mid 90s ORA. Patient was initiated on heparin drip and admitted for further care.
Mild fatigue, soreness and warm red rash at injection site for several days,  muscle and joint pain
Miscarriage - 6/18/21 Positive pregnancy test in early May, EDD was January 9th, 2022 Last dose received on 3/31
This spontaneous prospective pregnancy report as received from a physician refers to a 17 year old female patient with medical history of mild asthma and no allergies. On 03-JUN-2014, the patient was vaccinated with third dose of GARDASIL (dose, frequency, route of administration: not reported) (lot #, exp date: unknown) for HPV prevention. No concomitant medication was reported. On 03-JUN-2014 reported as "on this date", a pregnancy test was given with negative results. The patient sought medical attention on 05-JUL-2014. She visited an unspecified emergency room and released the same day. The patient had been experiencing abdominal pain on unspecified dates. On an unknown date in approximately 2014, the patient was given an ultrasound and determined to be pregnant on an unknown date. The Last Menstrual Period (LMP) and Estimated date of delivery (EDD) were unknown. The patient was also diagnosed with ovarian cysts on an unknown date. No treatment was given to the patient for the adverse events. The outcome of ovarian cysts and abdominal pain was unknown. Relatedness between ovarian cysts and abdominal pain and GARDASIL was not reported. Additional information has been requested.
Patient received SP vac.  He was deployed.  He experienced a chest pain episode while deployed sometime after unremarkably receiving the SP vac.  He was medically evacuated to hospital.  A cardiac work-up was negative for cadiac pathology.  His diagnosis was non-cardiac chest pain.  He was also newly diagnosed with hypertension and hypercholesterolemia.  No other cardiac event noted.  Redeployed and sent home.
Pt developed temperature of 101-102 the following day along with dizziness and headache. The fever lasted 6 days. Pt also developed minor non-productive cough. Pt experienced soreness at injection site.
Pain in arm; Headache; Tired; Muscle Aches; Shivering; coldness; Upset Stomach; Hives; Weakness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th March 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 19th March 2022, 1 days after receiving Shingrix, the patient experienced injection site pain, headache, tiredness, muscle pain, shivering, coldness, upset stomach, hives and weakness. On an unknown date, the outcome of the injection site pain, headache, tiredness, muscle pain, shivering, coldness, upset stomach, hives and weakness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, headache, tiredness, muscle pain, shivering, coldness, upset stomach, hives and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-MAR-2022 Reporter's Comments:  The patient self-reported this case. The patient received Shingrix on left deltoid and on next day after, the patient began experiencing headache, tiredness, pain in arm, muscle aches, shivering, coldness, upset stomach, hives and weakness. Till the time of reporting, the patient was still experiencing these symptoms as they had not resolved.   The reporter asked how long side effects last. The reporter consented to follow up.
Initial information received on 19-Mar-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a nine-years-old female patient who was vaccinated with a 0.5 ml dose of DAPTACEL instead of ADACEL lot C5254AA expiry date 18-Sep-2019 via unknown route in the left deltoid, on 01-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included IPOL POLIO VACCINE for Immunisation; and PROQUAD for Immunisation. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was reported that the patient got DAPTACEL DTaP instead of ADACEL Tdap on 01MAR2019. She states that they had checked the State database and the child was flagged for a DTAP because she did not get the full 5 in the series and that it was also their fault because they did not check the age viability before giving the DAPTACEL. Plan is to offer booster Td in 10 years. It was unknown whether patient experienced any adverse reaction. 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
received second dose >37 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose >37 days after first dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose >37 days after first dose). On 31-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second dose >37 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.   This case was linked to MOD-2021-416481, MOD-2021-416211 (Patient Link).
@0940 patient c/o anxiety, felt like she was having a rapid pulse, v/s 137/91 (her normal is 120s), 95-96% RA, rr 22, hr 84, temp of 97.2, Reports feeling dizzy and light headed. Patient has a history of allergies, swelling. @1004 repeat vitals 123/81y, 98% RA, hr 77, RR 21, denies pain, remains anxious and light headed. About 15 minutes later, she reports feeling better, less anxious, no more light headedness.
Came into office with red splotches behind legs, woke from nap with them. Plan to treat with Atarax and call mom for F/U.
Migraine with visual aura.  Visual aura bright light artifacts, starts small and then increase in intensity.  Within about 10-20 mins will have intense headache pain.  Had 1 on 10/27/21, 1 10/29/21 early pm and another, separate event on 10/29/21 at 11pm, then 10/30/21 at 5pm.  On 10/31/21 early pm had visual aura and no following migraine. Visual aura symptoms lasted 20-30 minutes followed by migraine that lasted 1-2 hours while awake and resolved during sleep.  Lingering headache/discomfort when awake later, but not migraine headache.  I have had migraines before but never more than 1 in a 3 month period and have gone as long as 3 years between events.
Chills, High Fever, Muscle Fatigue, Headaches, Can't raise left arm