chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ALMOST KILLED/A LONG LIST OF SIDE EFFECT; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; LITTLE HEAT AT THE SITE OF INJECTION; LOW GRADE FEVER; FATIGUE REOCCURENCE; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic fatigue syndrome, non-alcohol user, non-smoker, fibromyalgia, panic and anxiety disorder (genetic), heart burn (occasional), not sleep good, and drug allergy (Azithromycin), and other pre-existing medical conditions included: The patient had no COVID infections after vaccination. The patient experienced fatigue and little heat at the site of injection when treated with influenza vaccine for prophylactic vaccination.  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total administered on 19-MAR-2021 to left arm for covid-19 prophylaxis. On an unspecified date in 2021, the patient experienced low grade fever for 2-3 days, little heat at the site of injection, and fatigue reoccurence (Dose number in series 1). Patient reported that adverse events were minor with no diarrhea and no vomiting. The patient additionally received non-company suspect vaccine Moderna covid-19 vaccine (Spikevax) (elasomeran), (Dose number in series 2), (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 29-OCT-2021 for covid-19 prophylaxis which was revaccination with different COVID-19 vaccine (Dose number in series 2). Concomitant medications included alprazolam, and naproxen.  On an unspecified date, the patient experienced a long list of side effect following her Moderna covid-19 vaccine (Spikevax) which almost killed her that means patient had lot of adverse events. (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient recovered from low grade fever on 2021, and the outcome of little heat at the site of injection, fatigue reoccurence, almost killed/a long list of side effect and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
HEARING LOSS; TINNITUS; DECREASED VISION; HEADACHE; This spontaneous report received from a patient concerned a 74 year old male. The patient's weight was 175 pounds, and height was 68 inches. The patient's past medical history included tinnitus (increase in intensity and had to increase the strength of reading glasses), and concurrent conditions included diabetes type 2, non-smoker, and non alcohol user. The patient did not have drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 and expiry: 09-JUL-2021) dose was not reported, 1 total administered on 09-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the patient experienced hearing loss, decreased vision, headache and tinnitus.  On 10-MAR-2021 Hearing test (NR: not provided) hearing loss 70 dB on a auditory exam which was different from two years ago, Laboratory data (dates unspecified) included: Hearing test (NR: not provided) 20 dB. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from tinnitus, hearing loss, and decreased vision. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210664144-COVID-19 VACCINE AD26.COV2.S-HEARING LOSS. 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).
Woke up with stabbing pain in upper arm on the injection arm and her hand on the same arm felt numb. As time progressed the hand is less numb but her lower arm and elbow still feel "weird". She doesn't think she needs to go the Dr or a hospital today, but if she is still experiencing problems tomorrow she may as a precaution.
5ml syringes that had been provided were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/23/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
He was diagnosed with a double ear infection on August 22 and hand foot& mouth disease on August 24. Not sure if this is related to the COVID vaccine, but I'm reporting it just in case.
This case was reported by a other health professional and described the occurrence of injection site erythema in a female patient who received Influenza vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent (unknown). On an unknown date, an unknown time after receiving Influenza vaccine Quadrivalent, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. It was unknown if the reporter considered the injection site erythema to be related to Influenza vaccine Quadrivalent. Additional information received on 14 November 2014: The patient experienced redness at the injection site, described as wider spread than expected. It was unknown if the patient received FLUARIX QIV or FLULAVAL QIV. Follow-up information received on 25 November 2014: The reporter information was updated. This is one of the 2 cases reported by the same reporter for the same vaccine.
She was sick for over a month now after getting the booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "vivid dreams", "pain on her right head", "she got sick for 22 days for the first and second shot of the Pfizer Covid-19 Vaccine", "nausea"; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "vivid dreams", "pain on her right head", "she got sick for 22 days for the first and second shot of the Pfizer Covid-19 Vaccine", "nausea". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She was sick for over a month now after getting the booster".  Additional Information: It was reported that the patient was sick for over a month now after getting the booster and she got sick for 22 days for the first and second shot of the Pfizer Covid-19 Vaccine. She also experienced vivid dreams, pain on her right head and nausea over and over.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. had a fever of 101.5F around 24 hours after vaccine around 48 hour vaccine, the arm left where he received the vaccine became hard and warm to the touch, it was hard from his armpit down to his elbow. It was red as well. It took around 48-72 to completely go away.
1/29 (R) Lateral shoulder greater than or equal to softball size, indurated, tender and warm to touch. No GI/resp/cardiac symptoms. IM-Diphenhydramine 50mg and dexamethasone 6mg 1/30 improvement in skin reaction.
burp; was hypersensitive in the area which lasted until 2 days after the 2nd dose/is still having hypersensitivity in the right side of my face; itchy arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 11:48 (Lot number: EN6206) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autoinmune Hashimoto" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Right Eye Proptosis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "she had a similar sensation in her face approximately 11 year ago" (unspecified if ongoing). Family history included: "Prostate Cancer" (unspecified if ongoing), notes: Father had Prostate Cancer & Heart Disease; "Heart Disease" (unspecified if ongoing), notes: Father had Prostate Cancer & Heart Disease. The patient's concomitant medications were not reported. Past drug history included: Benadryl, reaction(s): "Could not go to the bathroom (childhood)", notes: Benadryl Side Effect Could not go, to the bathroom (childhood). Vaccination history included: Bnt162b2 (PFIZER/BIONTECH COVID-19 VACCINE DETAILS:, Dose: 1st, Time (24hr): 11:25 AM., Anatomical Site of injection: Left Arm, Batch/Lot number: EL9266), administration date: 18Feb2021, for covid-19 immunisation.  The following information was reported: HYPERAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "was hypersensitive in the area which lasted until 2 days after the 2nd dose/is still having hypersensitivity in the right side of my face"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itchy arm"; ERUCTATION (non-serious) with onset Mar2021, outcome "unknown", described as "burp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, eructation.  Additional Information: The patient had not received any other vaccine within 4 weeks prior to the vaccination. Relevant tests: Test: BW prior 1-2 weeks before the vaccine. BW 8 days after. Narrative: Consumer stated 15 minutes after the 1st dose she started with numbness sensation on the right side of my neck and face. It then started to go away, but she was hypersensitive in the area which lasted until 2 days after the 2nd dose. She mentioned she started to burp within 5 minutes after the 2nd dose and therefore she was administered Pepcid. She also experienced itchy arm which normal.  No follow-up attempts are possible. No further information is expected.
Severe headache, hive like redness surrounding injection site, severe malaise, chills lasting approximately 24 hrs.
"slight tightening in throat for several days.  Not a sore throat but almost like my throat was closing a little.  Not enough to be alarmed"
fever 102 for 2 days;swelling/redness @ inj site for 2 days;civilian MD prescribed ATB;
got sick on both of them; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (got sick on both of them) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick on both of them). At the time of the report, ILLNESS (got sick on both of them) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were provided.   This case was linked to MOD-2021-428257 (Patient Link).   Reporter did not allow further contact
Sinus congestion and draining; Sinus congestion and draining; Significant achiness in my neck and upper back; Significant achiness in my neck and upper back; Low fever; Significant fatigue; This spontaneous case was received on 17-Nov-2022 from other non-healthcare professional (consumer) via Communications (reference number: SEQW22-05900) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On 16-Nov-2022, around 3 pm, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, anatomical location: not reported) for active immunisation for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. The batch number was not reported.  On the same date, within three hours after receiving Flucelvax Quadrivalent, the patient began to experience significant achiness in neck and upper back. Around 7:30 pm, the patient began to have a low fever and significant fatigue, and into the night began to experience sinus congestion and draining.   At the time of initial reporting on 17-Nov-2022, the patient had not recovered from the events of sinus congestion, 'nasal sinus discharge', 'neck pain', 'upper back pain' and fatigue. As reported, sinus congestion and draining continued on into the second day, and the patient was still experiencing achiness, fatigue and sinus congestion after 24 hours.  The outcome of the event of fever was unknown.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A patient of an unreported age experienced fatigue, fever, upper back pain, neck pain, and sinus congestion and hypersecretion on the same day after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.; Sender's Comments: A patient of an unreported age experienced fatigue, fever, upper back pain, neck pain, and sinus congestion and hypersecretion on the same day after receiving the suspect product Flucelvax Quadrivalent. Based on suggestive temporal relationship, causality for the reported events is assessed as possibly related.
body aches; Earache; Fever; headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (body aches), EAR PAIN (Earache), PYREXIA (Fever) and HEADACHE (headache) in a 72-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 058A22A) for COVID-19 prophylaxis.     The patient's past medical history included CPAP. Previously administered products included for Product used for unknown indication: J&J ((Lot# & Exp. Date: unknown)) on 17-Mar-2021 and J&J ((Lot# & Exp. Date: unknown)) on 28-Oct-2021. Past adverse reactions to the above products included No adverse event with J&J and J&J. Concurrent medical conditions included Diabetes, Atrial fibrillation, Congestive heart failure, Blood pressure high and Sleep apnea. Concomitant products included LISINOPRIL, CARVEDILOL, FUROSEMIDE, INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N), INSULIN HUMAN (NOVOLIN R), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN C [ASCORBIC ACID], CHONDROITIN SULFATE SODIUM, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE]), MACROGOL 3350 (MIRALAX), SENNOSIDE A+B (SENOKOT), HYDROXYZINE HCL, VITAMIN D3, CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and TART CHERRY for an unknown indication.    On 17-Jun-2022, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), EAR PAIN (Earache), PYREXIA (Fever) and HEADACHE (headache). At the time of the report, PAIN (body aches), EAR PAIN (Earache), PYREXIA (Fever) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient wife was stated that both had satisfaction vaccination in the past. Little things like the body aches and fever. Patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient did not receive any other vaccine at the same time as the Moderna Spikevax or within 4 months. No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-742491 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742491:Master case for Spikevax 6th Dose (2023-2024 formula)
Initial report was received 06 November 2009 from a health care professional, who is also the patient. Of note, this event involved a case of misuse (i.e., inappropriate dose administered). A 67-year-old female patient with a history of a penicillin allergy, hypertension and osteoporosis, had received a "half dose" first dose injection of H1N1 (lot number, route and site not reported) "two weeks ago", and two hours later, she developed nausea, loss of appetite and malaise. The symptoms lasted 36 hours. The patient had previously received her seasonal influenza vaccine (manufacturer, lot number, route and site not reported) three weeks before: however that vaccine had been administered in two doses (dosage amounts not reported) separated by four days. Concomitant medications included Lisinopril, propranolol, LIPITOR and EVISTA. At the time of the report, the patient had recovered. Documents held by sender: None.
Vaccination  administered.  Within about 1 hour she reported itching and rash to right arm, no shortness of breath, no swelling.  Rash continued to itch and she reported at about  4 pm that day that the rash was now on her thigh.
Patient received vaccine at 2PM. Around 2:20 patient reports she is having some anxiety and difficulty breathing. She has found out her tire on her car is flat and she states that is making her worried. I observed patient and she appears to be shaking but no distress noted in breathing. Blood pressure is checked at 2:32 and was 152/92. Patient now states that she normally takes Xanax three times daily and a blood pressure pill daily and she has not taken these medications today because she was coming for her vaccine. At 2:35 she reports her throat feels like it is swelling. 911 is immediately called. Epinephrine 0.5 mg/0.5 ml is given IM in patients right deltoid at and patient is placed on 4 liters of 02 by nasal cannula at 2:39.  Patient reports at 2:43 that her throat does not feel as tight. Blood pressure is re-checked at 2:44 and is 148/86. Patient states she feeling dizzy, but her throat does not feel like it is closing. Ambulance arrived at 2:50 and resumed care of patient. Patient denies transport and leaves with grandson walking to their personal vehicle and appears in stable condition.
w/in 1 hr of vax pt devel shrill, high pitched inconsolable constant screaming which lasted 4-4 1/2 hrs; pt became fussy; t98;
About 4 hours post vax, her babysitter was in the process of changing her diaper, holding her legs up when the the child began screaming so the babysitter thought she hurt the leg which received the shot. When she looked at the child's face she had 'mucus and 'milk' in her mouth and nose and was having a hard time catching her breath. 911 was called and mother was instructed to have patient visit.
On April 11 at 1AM I noticed the light coming through the window was unusually dim.  I glanced at the smoke detector light and noticed it was dim.  Normally this light illuminated the nearby wall but I was barely able to see the light.  My illuminated clock also was clearly dimmer than usual.  It was as if my pupils were not adjusting to the dark.  This symptom subsided last night and my night vision is now normal.
Fever, fatigue, nausea, headache 3-4 days after administration of Hepatitis A #2. Received Hep A #1 5/10/11.
This spontaneous report was received from a, currently 70 years old, female patient. On an unknown date (reported as "two years or so" and "about 2011 or so" also reported as 2009 or 2010) before having a shingles outbreak, the patient was vaccinated with a dose ZOSTAVAX, 1 injection, (Lot # and expiration date were not reported). Concomitant therapies included SYNTHROID. On an unknown date (reported as about 2011 or so"), the patient experienced shingles outbreak that landed her in Hospital "for about a week" (dates unspecified). When the shingles started, she did not feel well overall and was very lethargic and eventually developed a rash. The physician did not think it was shingles originally because the patient had already had the ZOSTAVAX (unspecified date) a few years before her outbreak. Symptoms were treated with an unknown prescription medication. The outcome of shingles outbreak was unknown. Additional information has been requested.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 008B21-2A) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Healthy without cold or anything the month of December.  Concurrent medical conditions included Hypothyroidism since 2013, Allergy (she 5 years old) and Asthma (she 5 years old). Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Allergy to animal, LEVOTHYROXINE for Hypothyroidism.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 12-Jan-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2021, SARS-CoV-2 antibody test: SARS COV2 total AB value 1615.0, standard- 0.0 to0.7 SARS COVID total interep value positive, standard negative. On 10-Jan-2022, SARS-CoV-2 test: (Negative) Negative, deep runny nose. On 12-Jan-2022, SARS-CoV-2 test: (Positive) Positive. On 17-Jan-2022, SARS-CoV-2 test: (Positive) Positive.         It was reported that patient's toddler got covid and slept in her bed with her fever and sneezed on us. Patient hoped Pfizer quickly starts trials on 0 to 5 ages with a new formula to address omnicron better now that hers had omnicron. It was reported that got booster due to travel and as she had a toddler.  Treatment information was not provided.  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 case was linked to US-MODERNATX, INC.-MOD-2022-625499 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Live follow-up received with no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-625499:Husband case