chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He was given 0.5mL of the Moderna COVID vaccine in error, though 0.25mL was documented.  ( I am a pediatrician mom, so I am certain it was 0.5mL b/c I was surprised that the volume was different this year)  At 2AM, he woke up with abdominal pain.  It started periumbilical.  Over the course of the day he developed fever.  Fever and abdominal pain became severe (temp 104) guarding/splinging with abdominal pain.  He was brought to Emergency department where his exam was suspicious for appendicitis.  Labs and Ultrasound were done.  Ultrasound did not identify the appendix. Lab were notable for a CRP of 30, but otherwise non-remarkable. Hospitalization for observation was considered, but he was observed and discharged from the ED.  The next AM he was markedly improved.   Of note, my other son also received the 0.5mL dose and did fine with minimal if any symptoms.
One week it was extremely mild upset tight feeling and pain in lower abdomen. The GI upset feeling was there and sometimes not. I ignored it at first. It lingered for weeks, like over a month. It was quick that the symptoms change around the 8th or 10th day. My stools became too soft and barely formed. It was not diarrhea, it was not there to that point.  I called my GI doctor, and got a appointment a month later and the symptoms continued. It last easily a month. I had done nothing or different than ever before.  The pain was not consistent, just like upset stomach. I ate more fiber to make it go away.  Now I am fine, I made my appointment and had a telehealth appoint and the symptoms were gone by the time I had the appointment. I was recommended to take Metamucil, but did not. I had a colonoscopy and my symptoms were fine and there was nothing unusual found, but a poly that was a 3 millimeters. I was good to go.
The patient reports itching all over her body, which was actually present the day before she got the shot but she states worsened after receiving the vaccine.
sweaty; tired; bone muscle in body achy; injection site hurts; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweaty), FATIGUE (tired), MYALGIA (bone muscle in body achy) and VACCINATION SITE PAIN (injection site hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweaty), FATIGUE (tired), MYALGIA (bone muscle in body achy) and VACCINATION SITE PAIN (injection site hurts). At the time of the report, HYPERHIDROSIS (sweaty), FATIGUE (tired) and MYALGIA (bone muscle in body achy) outcome was unknown.            Concomitant medication was not provided Treatment information was not provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable    This case was linked to US-MODERNATX, INC.-MOD-2021-074706 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-074706:CROSSLINKED WITH DOSE 1
feel sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 41-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feel sick ".  Additional Information: It was reported that the patient feels sick getting them at the same time. The patient considered the event as caused by suspect product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Four days after receiving vaccine I experienced severe shortness of breath and passed out.  In the next week I had 3 more syncope  episodes after severe dyspnea.  Went to the emergency room and in hospital was diagnosed with stage 3 heart block with LONG pauses (one was 23 seconds).  I needed an emergency pacemaker.  I was also diagnosed with atrial fibrillation.  Eliquis and Bisoprolol added to my medications.   I also was diagnosed with pneumonia of unknown origin and unknown type (viral vs. bacterial). Speculation is I aspirated when I passed out.
extremely sick; low grade fever of 100.5 to 103; bad chills; Pounding on the front of the head/  Headaches; Felt nauseated - without throwing up; This spontaneous case was reported by an other caregiver and describes the occurrence of ILLNESS (extremely sick), CHILLS (bad chills), HEADACHE (Pounding on the front of the head/  Headaches), NAUSEA (Felt nauseated - without throwing up) and PYREXIA (low grade fever of 100.5 to 103) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (bad chills), HEADACHE (Pounding on the front of the head/  Headaches) and NAUSEA (Felt nauseated - without throwing up). On 12-Feb-2021, the patient experienced PYREXIA (low grade fever of 100.5 to 103). On an unknown date, the patient experienced ILLNESS (extremely sick). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 12-Feb-2021, CHILLS (bad chills) and NAUSEA (Felt nauseated - without throwing up) had resolved. On 13-Feb-2021, PYREXIA (low grade fever of 100.5 to 103) had resolved. On 16-Feb-2021, HEADACHE (Pounding on the front of the head/  Headaches) had resolved. At the time of the report, ILLNESS (extremely sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 100.5 - 103 (High) 100.5 to 103 degrees.         No concomitant medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-016797 (Patient Link).
Information has been received from a 41 year old female with Graves disease and an allergy to cephalexin who in April 1998, was vaccinated with the second dose of VARIVAX (Oka/ Merck). In July 2008, the patient went to her primary care physician for a regular check up. Since the patient received VARIVAX (Oka/Merck) about 10 years ago, she asked the physician if she needed to be revaccinated or if she was protected for life. The physician stated that she could do a titer test to find out. The titer test demonstrated that the patient was not immune to varicella (chicken pox). No further information available.
Headache back of neck and under both ears (mastoid area). Highest fever was 101.2. Rash on both hands. Rash and bumps on right arm where injection was given.
MODERNA COVID-19 EUA Received shot at hospital at 2:30 pm on Jan. 5th.  Had a mildly sore arm that evening and next day at work.  I did notice I had a hard, reddened welt area around injection site, about an inch and half in diameter.  At 8:15 pm on Jan. 6th, I became increasingly achy, and by 9 pm, I could barely stand without my entire body aching.  I took 600 mg of Ibuprofen along with my usual nightly meds of Ambien, Trazodone, and 50 mg benadryl.  It was very hard to sleep that night, as no position was comfortable, and even the weight of the blanket hurt my skin all throughout my body.  I called in sick to work Jan 7th.  I continued to take Ibuprofen and benadryl as directed on the label throughout the day.  Around 4 pm on the 7th, I finally started to feel some relief from the body aches.  My upper left arm remains slightly itchy and has an even larger reddened area now, that measures 3 inches as of today, Jan. 16th.  It remains warm to the touch, and slightly hardened under the skin.  I do have pictures of my arm from January 6th, the day after receiving the injection, but prior to becoming achy, and from today, January 16th, that I would be willing to share.
feeling unwell; dizziness/lightheadedness; Generalized aching; This spontaneous case was reported by an other and describes the occurrence of MALAISE (feeling unwell), DIZZINESS (dizziness/lightheadedness) and PAIN (Generalized aching) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    No Medical History information was reported.   In November 2020, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg every two weeks. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PAIN (Generalized aching). On 26-Mar-2021, the patient experienced MALAISE (feeling unwell) and DIZZINESS (dizziness/lightheadedness). On 26-Mar-2021, PAIN (Generalized aching) had resolved. At the time of the report, MALAISE (feeling unwell) and DIZZINESS (dizziness/lightheadedness) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-101973 (Patient Link).
experiencing some mid-axillary pain radiating to my breast on the injection site arm; Low grade fever; This is a spontaneous report from a contactable nurse.  A 44-years-old female patient received the second dose of bnt162b2 (BNT162B2; Lot # EK4176) vaccine  , via an unspecified route of administration  on 19Jan2021 at 0.3 mL, single for covid-19 immunisation .  Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing.  Concomitant medication included omeprazole (OMEPRAZOLE).  On 29Dec2020, the patient received the first dose of BNT162B2 vaccine without any problem. The patient experienced  some mid-axillary pain radiating to the breast on the injection site arm and low grade fever  on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included body temperature: low grade   on unknown date.   The reported events were considered non serious. The patient received treatment with Tylenol.  Follow up information has been requested.
Breakthrough case admission after 4 vaccines Modena 2/18/21 Lot# 023M20A;  Moderna 3/18/21 Lot# 002B21A;  Moderna 11/22/21 Lot# 012H21B;  Moderna 5/1/22 Lot# 059M21A
Patient explains immediate pain at time of administration. Loss of range of motion and physical therapy to regain motion.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   Our Vaccine Task Force, after speaking with CDC and PA, decided to offer the employee an additional COVID-19 vaccine dose. Thanks.
whooping cough; She just didn't get out of bed; sick; Her temp was 100.4; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for immunisation. Medical history included ongoing lung cancer. There were no concomitant medications. Clinical course: The first of Jan2021, she was extremely sick, with what felt to her like whooping cough. Her temp was 100.4. Her normal resting temperature is 96.5. 100.4 is a really high temperature for her. It lasted for a week. It felt like she was going to cough up her lungs. She just didn't get out of bed, it was horrible. Finally, at the end of 5 or 6 days, she was able to get up and got herself to the drug store. She got a bottle of Robitussin, which helped somewhat with the coughing. She hadn't been that sick in 40 years. It was that awful. She had wondered about that. The outcome of events was unknown.  Information on the lot/batch number has been requested.
suffering the discomfort; sent me to bed, it is horrible; This case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced discomfort and bedridden. On an unknown date, the outcome of the discomfort and bedridden were recovered/resolved.   It was unknown if the reporter considered the discomfort and bedridden to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR012339   Additional Information: GSK Receipt Date: 26-JAN-2023 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient got the shingles vaccine in October and in December the booster, both of them sent him/her to bed for three days it was horrible. The patient said it was worth suffering the discomfort for three days than to suffer the sequelae for all life, please get the vaccine. Additional supportive information: As per narrative shingles vaccine seems to have been administered in 2022, hence conservatively 2022 year was captured. This case had been linked with case US2023AMR012339, reported by the same reporter. The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR012339:same reporter - 2nd dose
weepy; pruritus; urticaria; covered with hives on the arms, torso, stomach and legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (covered with hives on the arms, torso, stomach and legs), CRYING (weepy), PRURITUS (pruritus) and URTICARIA (urticaria) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 020B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN for an unknown indication.   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced URTICARIA (covered with hives on the arms, torso, stomach and legs). On an unknown date, the patient experienced CRYING (weepy), PRURITUS (pruritus) and URTICARIA (urticaria). The patient was treated with Zyrtech at an unspecified dose and frequency. At the time of the report, URTICARIA (covered with hives on the arms, torso, stomach and legs) had resolved and CRYING (weepy), PRURITUS (pruritus) and URTICARIA (urticaria) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was prescribed steroid cream by HCP. patient used Zyrtech as a treatment daily   This case was linked to MOD-2021-098164 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: ADR receivedmobole no. updated ,
Extreme chest pain (10/10). From shoulder to shoulder, neck to abdomen, front to back. Extreme pain lasted at least one hour.
Pfizer-BioNTech COVID-19 Vaccine EUA Fever, chills, severe body aches. Fever resolved with ibuprofen
pt recvd vax 22NOV93 & w/in 4 hrs became irritable; irritability cont through noc; 28NOV93 devel fever 101.8 & swelling of inner rt leg from groin area to knee; sx remained thru 26NOV93; could not straighten rt leg; seen in ER 26NOV93;
started slightly pinkish dot rash from left ankle  area (below knee) --not too large area--, starting 10pm on the day she received shot. not itch
Erythema and swelling of right thigh, almost circumferenced swelling, induration noted at injection site. Erythema is patchy in pattern
Chronic fatigue and feeling cold like I can't get warmed up, but no fever, tense, jittery feeling with the coldness and fatigue gets worse as day goes by.  Hard to rest and relax because of the cold and tense feeling  This lasted the entire 3 weeks between dose 1 and dose 2.  I got dose 2 on Feb. 19 and have had same fatigue that isn't going away.  Fatigue and coldness is not worse with 2nd dose, but I heard that side effects were only supposed to last a few days.  To get warmed up I feel like I have to take a hot bath which also helps the tension.  Also later in the day I feel like I can't move properly, I just have to stay still, moving is too much of an effort.
chills, fever, fatigue, muscle aches, nausea, pain at injection site, swollen lymph nodes;
fever; weakness in her head; blood pressure was down/blood pressure went down to 80; her heart rate went down; every time she got down, she was definitely ill; she couldn't even lift her head or lift her arms; she couldn't even lift her head or lift her arms; she couldn't even lift her head or lift her arms; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 83-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization, reaction(s): "Weakness in her head", "blood pressure was down/blood pressure went down to 80", "she couldn't even lift her head or lift her arms", "her heart rate went down", "she couldn't even lift her head or lift her arms", "every time she got down, she was definitely ill", "she couldn't even lift her head or lift her arms", "Fever". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; ASTHENIA (non-serious), outcome "unknown", described as "weakness in her head"; BLOOD PRESSURE DECREASED (non-serious), outcome "unknown", described as "blood pressure was down/blood pressure went down to 80"; HEART RATE DECREASED (non-serious), outcome "unknown", described as "her heart rate went down"; ILLNESS (non-serious), outcome "unknown", described as "every time she got down, she was definitely ill"; HYPOKINESIA (non-serious), outcome "recovered", HEAD DISCOMFORT (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "she couldn't even lift her head or lift her arms". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller was calling on behalf her mom that had received 4 doses of the Pfizer-BioNTech COVID 19 Vaccine. However in these previous shots, her mom had fever, weakness in her head and also her blood pressure was down. She wanted to know if this have been reported in order to make a decision if her mom can receive the bivalent formulation. Every time she got down, she was definitely ill and it means her blood pressure went down to 80 and her heart rate went down and then it was like, she couldn't even lift her head or lift her arms or anything like that and it lasted like a 24 hours period and the caller wanted to even get her the booster (Unspecified Booster Shot) but too scared of it. So, it wasn't like it was a single incident, it was every time she got the Pfizer Vaccine. NDC number of COVID-19 Vaccine: Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201293068 same patient/drug/event; different dose;US-PFIZER INC-202201293434 same patient/drug/event; different dose;US-PFIZER INC-202201293435 same patient/drug/event; different dose;
She is not doing too well this time; she doesn''t feel great/Not feeling well, felt funky; Muscle aches; Chills; It is red where it was put in/Redness around where she got the shot; It is still swollen and warm.; It is still swollen and warm./Arm was hot; The arm hurts/arm pain/sore arm/soreness; little tingly in my arm; Arm was swollen; Fever; tired/little tired/Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2) (Lot number: 3P1358) 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 (Second dose), administration date: 16Mar2021, for COVID-19 immunization, reaction(s): "She maybe had a sore arm for 2 days, 3 days max with the second one", "With the second one maybe a little tired", "arm hurt a little more"; Bnt162b2 (First dose, She did fine with the other two Pfizer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "She is not doing too well this time; she doesn''t feel great/Not feeling well, felt funky"; MYALGIA (non-serious), outcome "unknown", described as "Muscle aches"; CHILLS (non-serious), outcome "unknown", described as "Chills"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "It is red where it was put in/Redness around where she got the shot"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "It is still swollen and warm."; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "It is still swollen and warm./Arm was hot"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The arm hurts/arm pain/sore arm/soreness"; PARAESTHESIA (non-serious), outcome "unknown", described as "little tingly in my arm"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Arm was swollen"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; FATIGUE (non-serious), outcome "unknown", described as "tired/little tired/Tiredness". Therapeutic measures were taken as a result of vaccination site erythema, vaccination site swelling, vaccination site warmth, pain in extremity.  Additional information: She got it on Friday around 4:30 or 5:00 and she squeezed her arm pretty hard and put it in. Caller is not sure if that is the normal way. They grabbed 3 inches of flesh and then put the needle in. She didn't feel the needle at all. It was a little disturbing. It is now Tuesday and she doesn't feel great yet. It was reported that patient was alright for a couple of hours, then she felt tired, had chills, her arm was sore and swollen, she had redness around where she got the shot, and her arm was hot. She applied ice and took a homeopathic T-relief Arnica.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101324870 Same patient and drug, different event separated in time
Hives and itching.  Broke out on hives on my left arm near injection - hives/rash broke out on my back and down my right arm and legs.