chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles like reaction on back; Swelling on Arm; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 30th May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 11 days after receiving Shingrix, the patient experienced shingles and swelling arm. On an unknown date, the outcome of the shingles and swelling arm were unknown.   It was unknown if the reporter considered the shingles and swelling arm to be related to Shingrix.  Additional details were provided as follows: The pharmacist stated that the patient was administered Shingrix vaccine and about 11 days later the patient experienced a shingles like reaction on her back.  The patient visited her physician before the date of reporting and as per the physician it was Shingles.  Less than a month after receiving Shingrix, the patient also experienced swelling on the arm which was almost gone. No further details were provided.
Patient received fluzone on Tuesday, Oct 9. Called pharmacy on Wednesday complaining of swelling and pain at injection site. Advised to take tylenol and possibly use some ice for swellling. Phoned again Thursday and complained swelling and pain had become worse. Asked patient to come down for an assessment. Swelling present on shoulder. Also had pain on top of arm and under arm. Skin appeared spotty with red patches. No other areas of body involved. Patient feels fine except for pain in shoulder. Phoned family physician for patient, and requested that she be seen. Physician did not believe it was a serious reaction and that swelling would subside soon.
Woke up w/ headache approx. 12 hours after vaccine administered. Fever started that morning (99 degrees). Rose to 100 degrees that afternoon w/ headache. Took 2 Tylenols & it slowly dropped back down. Normal temp  by 6pm. Headache gone. No further side effects, except for sore spot from injection. No swelling or discoloration on arm.
Adverse reaction to COVID-19 vaccine     2. Microcytic anemia  Retic Count   Iron and Iron Binding Capacity   Ferritin   CBC no Differential   Doing well following adverse reaction.  Advised to let us know of any recurrent symptoms.  Anticipating possible booster doses of COVID-19 vaccine down the line, advised that they should stay tuned for information about whether he would be a candidate.    Mild anemia with significant microcytosis.  Will check iron studies, follow up with results.  Consider thalassemia if iron studies normal.
This spontaneous report was received from a healthcare worker refers to a patint of unknown demographics. On 10-MAR-2014 the patient was vaccinated with VARIVAX (Merck) (dosing regimen unspecified). Other suspect therapies included on 10-MAR-2014, M-M-R II and VAQTA (dosing regimen unspecified). No concomitant medications were reported. On an unknown date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported No product quality complaint involved. The outcome of medication error was unknown. This case is linked to : 1403USA005417, 1403USA011256, 1403USA011262, 1403USA011268, 1403USA011301, 1403USA011335, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011420, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427 (same reporter link). Additional information has been requested.
5 mins after receiving vaccine I felt a strong sense of heat within the muscles in my back. Soon after felt anxiety and scared so I ran to the front of pharmacy to get the pharmacist?s attention for them to call 911. I began feeling weak and started hyperventilating, feeling like I was going to die. Almost felt difficult to gasp for a full breath of air. As I got on the floor due to feeling weak, I began sweating profusely in my face, while at the same time, seeing my sweat drip on the ground like I just ran a full sprint mile. I was begging the pharmacist for some water but she refused to give me water because she thought I would choke. I was able to breathe but hyperventilating made it difficult. A couple mins passed, and I began to try my best to control my breathing by taking deeper breaths. I say about 5 mins, the paramedics arrived, but by then, all the side effects went away. Lastly, I felt the chills and very cold by the time the medics came. I got up on my own accord, went outside in the sun and felt normal again.
Sore throat; Runny nose; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 06May2021, outcome "unknown", described as "Sore throat"; RHINORRHOEA (non-serious) with onset 06May2021, outcome "unknown", described as "Runny nose"; HEADACHE (non-serious) with onset 06May2021, outcome "unknown", described as "Headache".  Additional information: The caller got his first dose on 16Apr2021 and will be getting the second dose by tomorrow, 07May2021. The caller currently has a sore throat, runny nose, and headache. The caller wants to know if it is okay to get the second dose tomorrow as scheduled?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was planning to get 3 vaccines, these two and a flu Vaccine. After the second vaccine, the patient passed out and was shaking.  Patient came back in about 60 seconds.  The patient vomited within a few min of waking up and complained of a burning sensation in her arms and legs. Paramedics came and checked BP. BP was fine. Pt stayed here for about 30 min and then her mother picked her up to go home. Pt felt fine once she left.
I felt fine all day and that evening but over night while sleeping l developed severe chills. It resolved over the course of the next day.
Arm soreness started on May 18 @ 3:30pm.  Went to sleep with same arm soreness at 11pm.  Woke up at 1:15am on May 19, walked approximately 12 feet started experiencing cold chills.  At 1:20am, while standing and holding cellphone in right hand, started experience of convulsive seizure to the point of cellphone health stats saying i walked 103 steps while standing still convulsing.  After calming down enough to sit, i sat on couch to sleep.  Heart rate was still registering in 200 bpms for next couple hours. May 20, 2021 started experiencing sore throat at 5:30am.  As day progresses am experiencing flu type symptoms.
2/17/21 - Chills at 2:30am; increasing fever - peaked at 103.8 at 2:30pm while taking acetaminophen and ibuprofen. Muscle aches. Joint pain. Excruciating headache.  2/18/21 - Chills, Fever peaked at 102.5 while taking acetaminophen and ibuprofen. Muscle aches. Joint pain. Excruciating headache.  2/19/21 - Chills, Fever peaked at 101.3 while taking acetaminophen and ibuprofen. Muscle aches. Joint pain. Headache was gone. 2/20/21 - Fever peaked at 99.8 while taking acetaminophen and ibuprofen. 2/21/21 - No symptoms
Headache fatigue, arm soreness Narrative:  Arm soreness, headache, fatigue; took  tylenol
Patient received Moderna COVID vaccine on 4/10/21 and 5/8/21. On 1/16/22, patient admitted to our inpatient facility with acute encephalopathy, volume overload, and COVID positive status. During hospitalization, patient is clinically asymptomatic for COVID19, she continued to be oxygenated at 2L. As of today (1/21/22), patient is still admitted in our med/surg unit.
Hospital Course: Patient admitted, and cardioverted in ED. And admitted for remdesivir for asymptomatic COVID. After discussion with Cardiologist and ID, final recommendation was to treat fore 3 day course given immune status.  Patient remains asymptomatic, and heart rate improved after cardioversion. Recommendation per cardiology team on the phone was to start metoprolol xl 25mg daily and can be adjusted outpatient.     BP 124/84  | Pulse 110  | Temp 97.7 °F (36.5 °C)  | Resp 18  | Wt 99.7 kg (219 lb 12.8 oz)  | SpO2 95%  | Breastfeeding No  | BMI 32.46
On 5/2/2018 mom reported he had fever and the skin near the injection site became erythematous, edematous and tender. Mom returned to the clinic 05/04/2018 with erythematous, edematous, tenderness measuring 13cm X 8cm in right thigh. Cellulitis was treated with Cephalexin 250mg/5ml 5ml twice a day for 10 days, returned the following morning 5/5/2018 cellulitis improved and erythema, edema and tenderness decreased.
The Saturday morning following my booster shot, I started experiencing an elevated heart rate along with body aches, body chills, and moments of overheating. I have a fitbit, and while my resting heart rate is generally  high, in the mid 80s - low 90s, my heart rate reached 140 while sitting down. This elevated heart rate fluctuated throughout the day, but stayed above 110 (unless sleeping when it would return to resting) and lasted for about 5 days before returning to normal. I did not have any shortness of breath, fever, or major fatigue. I notified my primary care provider at my school the following Monday. I was scheduled and rescheduled for an ECG on 11/30 and to monitor my symptoms in the meantime. My elevated heartrate subsided after 5-6 days, but I still went and got the ECG performed and it was normal. I also had bloodwork done with came back normal. I received a referral to a cardiologist in order to receive clearance for any potential future COVID-19 vaccinations.
The day after my arm was sore and I felt a bit listless. On 10/05/22 I was fasting as I was observing one of my holidays, I thought that is why I was fatigued but I took a home COVID-19 test. It came back negative. On 10/06/22, temperature went up to 102.0F and I had body aches, headache, chill so I took another home COVID-19 test. This test came back positive, I called my PCP and had a telehealth visit. She called in Paxlovid that I started taking immediately after I picked it up from the pharmacy. Today 10/07/22 I am feeling better with the exception of a lingering cough.
Expired dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 06-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided   This case was linked to MOD-2022-449303 (Patient Link).
Vomiting; 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 VOMITING (Vomiting) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.
Fast heart beat; tight stomach; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Fast heart beat) and MUSCLE TIGHTNESS (tight stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced TACHYCARDIA (Fast heart beat) and MUSCLE TIGHTNESS (tight stomach). On 08-Mar-2021, TACHYCARDIA (Fast heart beat) had resolved. At the time of the report, MUSCLE TIGHTNESS (tight stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Approximately 8 days after receiving the first Moderna dose, I experienced a sudden onset of intense arm pain across the entire arm where vaccine dose was received after having been recovered for several days from initial soreness immediately after injection. Pain and discomfort radiated up into the shoulder as well and lasted for approximately 24 hours. Advil helped relieve some of the pain. Felt like an intense pulled muscle, radiating for hours. It was intense enough to interfere with normal sleep schedule.
seems to get the flu right after getting the shot; Initial information regarding an unsolicited valid non-serious case received from a consumer on 16-Oct-2020.   This case is linked to cases 2020SA293120, 2020SA293225, 2020SA293330, 2020SA293473, 2020SA293507, 2020SA293522, 2020SA293345, 2020SA293379, 2020SA293395, 2020SA293409, 2020SA293461 and 2020SA290167 (cluster).  This case involves a female patient of unknown age who seemed to get the flu right after getting the shot (influenza), while she received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the reporter stated that the patient seemed to get the flu right after getting the shot (influenza).  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for seems to get the flu right after getting the shot.   It was not reported if the patient received a corrective treatment.  Outcome of both the events were unknown, at the time of reporting.  Information on the batch number was requested.      The reporter assessed the causal relationship with suspect vaccine as related.
pt recvd vax 15DEC92; this was pt's 5th DTP shot; pt had no reactions to any prev shots; that evening devel a fever w/trembling; the following morning had fever; t104
I had something that felt like I was punched in the stomach so my stomach is real sore; so I do have pain already in that area but now it is like worse; I have had one that was really bad in my arm but at the injection point it went all the way down my arm to my fingers; This spontaneous report has been received from a consumer, concerning herself a 76-years-old white female patient. The patient's concurrent conditions included osteoporosis, mitral valve prolapse, neuropathic pain, and non-ulcer dyspepsia. Her medical history, previous drug reactions, and allergies were not provided.   On an unspecified date in 2012, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (conflicting information reported as Prevnar 23) injection, as prophylaxis (strength, dose, frequency, vaccination scheme, route of administration, anatomical location, lot number, and expiration date were not provided). On the same date she was vaccinated with pneumococcal vaccine conj 13v (PREVENAR 13) (formulation, strength, dose, frequency, vaccination scheme, route of administration, anatomical location, lot number, and expiration date were not provided). Later, on an unspecified date in 2022 (reported as "in 10 years"), when she went to receive her flu shot (not specified) she also received another dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23).  On an unknown date, the patient experienced really bad pain at the site of injection (vaccination site pain) in her arm which went all the way down to her fingers and noted she had never had that. In addition, she felt like she was "punched in her stomach" so her stomach was sore (abdominal pain upper). Moreover, the reporter mentioned that due to her current condition of neuropathic pain, she presented with pain in the area, however now it has gotten worse (neuralgia). She also mentioned she was "pretty healthy" for her age and was inquiring if having received an extra dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) could cause her any side effects. At the time of reporting, the patient had not recovered from neuralgia and abdominal pain upper, as for vaccination site pain the outcome was unknown.   The causal relationship between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) and the events was not provided.
FEVER 102, MUSCLE ACHE, LEG CRAMPS HARD TO WALK, HEADACHE, CHILLS, TIRED.
Narrative: Patient received Pfizer dose #1 08/20/21 and developed left-sided chest pain/tightness, as well as brain fog/fatigue/dizziness. She had onset of symptoms about 3 days she received the Pfizer Covid19 vaccination and they persisted for weeks including when she went to the ER 09/09/21 for evaluation. She had benign findings about 10day s/p PFIZER #1 with no therapeutic intervention required. Patient had minimal/no symptoms with PFIZER #2 in SEPT 2021. Notable, patient was diagnosed with COVID-19 several months prior to vaccination.
Got the 2nd moderna vaccine and immediately passed out. Got incredibly sweaty and lightheaded. Had blurred vision and had trouble hearing directly after shot was administered. Effects subsided within about 30 min.
Patient who is only 17 years old was administered Moderna vaccine first dose. will be 18 years in 2 months but has not reached 18, the age requirement. Left voicemail for patient on 5-11-21, waiting to hear back.
Very mild, but unexpected nose bloody nose from left nostril. Only noted when blowing nose. With 1 clot.
a nurse reported tha a 74 year old male received his second dose of Pnu-Imune 23on 03/15/01. Within 48 hours post vax, the pt developed an injection site reaction characterized by redness and swelling which extended to his elbow. The pt was treated "symptomatically" and he recovered. No further info was available at the date of this report. Manufacturer's Comment: This is 1 of 2 pts from this facility who developed an injection site reaction following receipt of Pnu-Imune 23, lot #470-592. See related report HQ1201422MAY2001. FOLLOW-UP information was received from the nurse on 07/13/01. On 03/16/01, the patient experienced injection site pain which kept him awake for two nights following vaccine administration. The patient remained recovered.
12/27/2021  iNADVERENTLY MIXED VIAL OF PFIZER PEDIATRIC AND PFIZER ADULT TOGETHER AND ADMINISTERED .3 ML IM TO PATIENT. Patient was called and had no adverse events at 6pm a12/27/2021 - called am of the Dec.28th -c/o fever body aches chills .  Pt.instructed she could take Tylenol /ibuprofen. Talked with pt. yesterday pm - feeling little better - continuing to take ibuprofen . 12/29/2021 - Pt. c/o soreness in axillary are - no fever - body aches better.
ON 1-25-22  TUESDAY AT 4:30PM PATEINT CALLED AND SAID SHE WAS COUGHING HAD SOME BREATHNG PROBLEMS AND SLEPT IN TILL  3PM.  SHE TOOK 4 PUFFS OF ALBUTEROL INHALER WITH LITTLE RELIEF. HER 02 LEVEL WAS 97% AND SHE WAS WAITING FOR HER DOCTOR TO REFILL HER NEBULIZER MEDICATION. I ADVISED TO GO TO THE HOSPITAL IF CONDTION PERSISTS. I FOLLOWED UP WITH HER ON  1/27/22 AND SHE WAS DOING GREAT. SHE GOT HER MEDICATION THAT NIGHT AND WAS FEELING GOOD THE NEXT DAY .
Havrix - Administration to a 11 month-old patient.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female patient who received HAV (Havrix) (batch number 3397T, expiry date 30th November 2023) for prophylaxis.   On 26th October 2022, the patient received Havrix. On 26th October 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 26-Oct-2022 Reporter's comment: The reporter asked about safety information and how to proceed with the patient. The reporter consented to follow-up. Additional supportive information: The patient received Havrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Sore Arm; No Energy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and ASTHENIA (No Energy) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm) and ASTHENIA (No Energy). On 15-Apr-2021, PAIN IN EXTREMITY (Sore Arm) and ASTHENIA (No Energy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication, treatment information provided.   This case was linked to MOD-2021-128099 (Patient Link).
Felt tired next day. 4 days later very tired, muscle and joint pain, headache, shooting pains in head, nausea, skin sensitivity.
1/9 vaccination 2.5 hours later, my arm was swollen, itchy, raised, heated, increased HR, chills, weakness. Symptoms lasted for 2 days. Fatigue lasted for 4-5 weeks after; 'washed out' 1/13 days later, I could barely walk due to the swelling. I thought my foot was going to collapse due to the crackling sound. Sent to urgent care for xray, swelling and inflation, no breaks.  1/21 I had to go to a foot and ankle specialist 1/25 I was referred to have a doplar to make sure I didn't have a clot.  I had to get fitted for a special foot brace, had to get a second one.  My retina, on my L side, started to see flashes of light. Dr. stated it was prob going to tear. The specialist said could be a autoimmune; fighting off the vaccine.  1/28 urgent care. Foot was infected. Prescribed 500 mg x3 Cycler x 7 day; probiotic, as well.  I removed my name for 2nd vaccine.  Swelling lasted till March 13.  Told body was fighting off vaccine.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On 02-DEC-2013 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # reported as G016512 expiry date 23-NOV-2013) (dose and route not reproted). Concomitant medication was not reported. No adverse symptoms reported. Additional information has been requested.