chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Walking pneumonia; Cough worse; Wheezing; This serious case was reported by a nurse via sales rep and described the occurrence of pneumonia in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced pneumonia (Verbatim: Walking pneumonia) (serious criteria GSK medically significant), cough aggravated (Verbatim: Cough worse) and wheezing (Verbatim: Wheezing). The patient was treated with azithromycin (Z-Pak). The outcome of the pneumonia, cough aggravated and wheezing were not resolved.   It was unknown if the reporter considered the pneumonia, cough aggravated and wheezing to be related to Arexvy.     It was unknown if the company considered the pneumonia, cough aggravated and wheezing to be related to Arexvy.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that the rheumatologist's mother received the RSV vaccine but not sure if it was GSK or Pfizer vaccine and subsequently developed walking pneumonia.  The patient experienced cough 1 to 3 days prior to receiving the vaccine, then after receiving the vaccine the patient became worse. Patient was prescribed a Z-pack but symptoms did not improve so she presented to her PCP and PCP diagnosed her with walking pneumonia due to wheezing on exam and no CXR was performed. The reporter consented to follow up.
About 14 hours after injection, I awoke with extreme lethargy, tired muscles over entire body, and moderate chills.  Within about 24 hours after that, symptoms had mostly subsided.  We took my temperature but I did NOT have a fever.
Tongue swelling after 30 minutes of Moderna injection.  at 1:00 PM Benadryl 50 mg given by mouth and at 1:11 PM Pepcid 20 mg given by mouth.  at 1:55 PM EMS called.  Patient evaluated by EMS and vitals stable.  Patient declined transport but did not drive herself home.
I had extreme fatigue, headaches and tired and sore arm. It went away after a couple days.
Myocarditis with chest pain and ST segment elevation. Elevated troponin. Runs of ventricular tachycardia. Hospitalization to pediatric cardiac intensive care unit.  Presented to ED 6/9 and currently in  the intensive care unit.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Seven minutes after her 1st Pfizer shot, she passed out, looked pale & sweating. I gave her one Benadryl 5 mg capsule with plenty of water. We called 911, they came in but she still very pale and tired. They brought her to nearby hospital.
This case was reported by a other health professional via sales rep and described the occurrence of stomach pain in a 14-year-old male patient who received FLUARIX QUADRIVALENT (batch number BM577, expiry date 30th June 2017). On 12th October 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced stomach pain. On an unknown date, the outcome of the stomach pain was unknown. It was unknown if the reporter considered the stomach pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient remained for 15 minutes following injection. On the drive home, patient experienced stomach pain without vomiting and was driven to the emergency room. The patient was not admitted to hospital. The reported lot number (VM577) for FLUARIX QUADRIVALENT did not exist and was updated to BM577 as per the sales database. GSK representative called to report adverse event as taken from health case professional's office.
Patient experienced swelling, redness, and extreme pain in the left arm near the injection site.  Patient started taking Tylenol and then consulted the pharmacist on duty on Saturday, 8/27/16.  Per pharmacist instructions, patient continued to take Tylenol and also took Benadryl as well as applying ice to the affected area.  Reaction was resolved by Monday, 8/29/16.
Nausea; Migraine headache; Chills; Joint pain; This is a spontaneous report from a contactable Nurse. A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 30Dec2020 10:30 at Left arm at single dose for covid-19 immunization. Vaccine was administered at hospital and not administered at military site. Medical history included ongoing spondylolisthesis diagnosed 15-20 years ago and overweight. Her vertebrae were not in physical alignment. The patient was given steroids, but it didn't help. Steroids didn't do anything. There was no name or NDC/Lot/Exp of steroids. The patient no longer has steroids. Her back will hurt when she gains weight. Height was now under 5 feet 5 inches (164 cm). The patient had no family medical history. There were no concomitant medications. No additional vaccines administered on same date of pfizer suspect and no prior vaccinations within 4 weeks. No adverse events follow prior vaccinations. The patient experienced multiple side effects 10 hours after the vaccine and lasted 20 hours. Side effects started 20:00 - 21:00 on 30Dec2020. Side effects were classified as: Nausea, migraine headache, chills, and joint pain. The events was waxing and waning. On 31Dec2020, side effects were 75% gone by 16:00. Joint pain was completely going by 22:00-23:00 on 31Dec2020. Chills were gone between 08:00-09:00 on 31Dec2020. Nausea and migraine headache stayed until 16:00-17:00 on 31Dec2020 and then it went away. At the time of vaccination, there was a low-pressure center coming through. There was also an ice and snowstorm. She was wondering if the headaches and joint pain were due to the weather. The patient took no medication or treatment for spondylolisthesis and wondered if that had something to do with it. The patient really want to have second shot in two weeks. Investigation assessment was no. The outcome of the events was recovered on 31Dec2020. Causality assessment by primary reporter via global introspection was unknown.
Stroke like symptoms, left hemiparesis, numbness and paresthesia of feet and hands, left dropfoot, loss of coordination, loss of proprioception,  loss of mobility. Arthritic left knee in February walking with assistive device to complete loss of mobility and wheelchair bound by march. Expressive aphasia in March, resolving
he has been having a low grade headache; little pain on his injection site and it went away; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (he has been having a low grade headache) and INJECTION SITE PAIN (little pain on his injection site and it went away) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (He said the injection site pain was worst than when he had Pfizer. He had 5 or 6 Pfizer shots previously.). Past adverse reactions to the above products included Injection site pain with Pfizer vaccine.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 16-Nov-2023, the patient experienced HEADACHE (he has been having a low grade headache) and INJECTION SITE PAIN (little pain on his injection site and it went away). In November 2023, INJECTION SITE PAIN (little pain on his injection site and it went away) had resolved. At the time of the report, HEADACHE (he has been having a low grade headache) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 16-Nov-2023, the patient went to his local pharmacy and they did not have Pfizer COVID-19 shots, so they administered Spikevax to the patient. He stated that since 16-Nov-2023, he had been having a low-grade headache. He had a little pain on his injection site and it went away. He said that the injection site pain was worst than when he had Pfizer vaccine.  No treatment medications were reported.   Reporter did not allow further contact
Initially patient has been admitted because of COVID-19 infection with multifocal pneumonia leading to acute respiratory failure with hypoxia. Patient was started on broad-spectrum intravenous antibiotics and intravenous Decadron. Patient required supplemental oxygen initially and eventually patient's respiratory status got worse and so patient was intubated and patient required mechanical ventilator support. Life support has been withdrawn on 19th September 2021 and subsequently patient expired at 10:45 a.m..
0.2ml of undiluted COVID vaccine given to patient. RN unaware of medication error until patient left. Pt was observed for 15 minutes just in case of any reaction. No reaction observed. Attending notified. Attending informed parent and called parent to check for any reactions. Parent states patient was okay with no reaction.
Enlarged right lymph node (opposite of injection arm), Headaches, Fever, Body aches, Chills, Sweating ,Fatigue, Tiredness,
1/26 - arm pain, body aches  1/27-  fever, chills., body aches , headache 1/28, low grade temperature, headache, itchiness at injection site,  swelling and warmnsss at injections site.
cough; mucous in lungs; phlegm and mucous in nose; This is a spontaneous report from a contactable consumer (daughter).   A 88-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 06Mar2021 (at the age of 88-years-old) as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient historical vaccine included BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 13Feb2021 12:40 (at the age of 88-years-old) as dose 1, single for covid-19 immunisation and experienced Leg pain, Numbness in leg and Limbs stiffness. Patient experienced phlegm and mucous in her nose after second dose and had a cough. Reporter adds that the phlegm started that Monday following the vaccination and patient called her to tell her this information. Reporter told her to suck on lemons and she was feeling better, the mucous was still there but phlegm is not in her nostrils. There was mucous in her mother lungs but not a lot of it.  Caller adds that as treatment she told her mother to drink something warm to help. Caller adds that she believes the vaccine was given to her mother around 12-o-clock but maybe not quite 12 pm as that was the scheduled appointment time. Patient had taken lemon as treatment for the events. The outcome of event phlegm and mucous in nose was recovered on an unknown date, the outcome of cough and mucous in lungs was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
2 hours later, food tasted funny and I got extremely tirec and took nap. Woke up 4 hours later with severe headache, hot and cold flashes, skin hurt, nausea, brain fog. Strong immune response with fever.  Next day, using tylenol for pain and still quite lethargic.
TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-2526) was received from a pharmacist on 09-Oct-2019. It described a 67-year-old female consumer who "took unrefrigerated doses" (PT: Product storage error), while being on oral Vivotif capsule for typhoid prophylaxis.  Case report: The consumer did not refrigerate Vivotif doses and she took all the doses.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Fatigue; Muscle cramps; Neck is a little sore; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for covid-19 immunization. The patient reported feeling a lot of fatigue again and some muscle cramps and their neck is a little sore on an unspecified date, so they have been isolating a lot. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
On day following vaccine administration, patient experience total sensory loss from the left ear within the course of an hour resulting in complete deafness and vertigo. ENT-prescribed oral corticosteroids failed to resolve the deficit as had worked in prior episodes of partial hearing loss. Diagnostics from rheumatologist and neurologist failed to discover any cause. Patient has recovered only slightly in the intervening months, with less vertigo and returned perception of pressure changes but no hearing within normal frequency ranges.
Fever of up to 101.1-took Ibuprofen for < than 24 hours Fatigued with fever Swollen lymph node in right armpit -my vaccine was given in right arm
pt recv vax FEB98 & 17FEB98 pt exp a rash & was taken to ER;
Left thigh erythematous and swollen 48 hours after Pediarix given.
A staph infection; An allergic reaction (hives and swollen lips); Hives; swollen lips; Cellulitis; This spontaneous case was reported by a pharmacist and describes the occurrence of CELLULITIS (Cellulitis), STAPHYLOCOCCAL INFECTION (A staph infection), HYPERSENSITIVITY (An allergic reaction (hives and swollen lips)), URTICARIA (Hives) and LIP SWELLING (swollen lips) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criteria hospitalization and medically significant), STAPHYLOCOCCAL INFECTION (A staph infection) (seriousness criteria hospitalization and medically significant), HYPERSENSITIVITY (An allergic reaction (hives and swollen lips)) (seriousness criterion hospitalization), URTICARIA (Hives) (seriousness criterion hospitalization) and LIP SWELLING (swollen lips) (seriousness criterion hospitalization). The patient was hospitalized for 5 days due to CELLULITIS, HYPERSENSITIVITY, LIP SWELLING and URTICARIA. At the time of the report, CELLULITIS (Cellulitis), STAPHYLOCOCCAL INFECTION (A staph infection), HYPERSENSITIVITY (An allergic reaction (hives and swollen lips)), URTICARIA (Hives) and LIP SWELLING (swollen lips) outcome was unknown.        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.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the 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 the events, a causal relationship cannot be excluded.
At apprx. 7:00 PM on 01/15/2021, subtle itch occurred. Throughout the rest of the evening, redness and intense itching occured. Two red patches appeared, above and below the injection site, resembling a venn diagram. Rash was hot to the touch, however no fever was present throughout the weekend, or into Monday the 18th of Jan. Saturday morning, received word from MD that it eas okay to trial triamcinolone acetonide .1% BID on red, itchy area. Immediately applied at 8AM. Following that, there was a relief from the itching, but redness persisted. Reapplied in the evening, and Sunday morning as well. Sunday evening, applied a layer of TAC, a layer of eucerin cream and wrapped site in plastic wrap. Monday morning, redness had resolved very, very slightly, itching persists. Prescribed 12 day course of prednisone (40mg QD x3 days, 30mg QD x3 days, 20mg QD x3 days, 10mg QD x3 days) and given samples of ultravate lotion to use topically until rash resolves.
Few seconds after given vaccine to patient, he started slumping down, with pale and sweaty face. Oxygen was administered, V/S take B/P 110/62, pulse 62, resp 20. Patient became alert and oriented X 4, but mother insisted that paramedic will called because of the paleness and sweaty appearance the patient. Paramedic was called and the patient was taken to Hospital for further evaluation.
"Cold" symptoms. Stuffy nose, sore throat, chest congestion. Aches, especially base of neck. Couldn't turn head. Chills. Headache.
C/o sorethroat and mild cough. no CP,SOB,N,V,D.
taste issues/taste was very muted/pasty or nondescript; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 09Nov2023 at 11:00 as dose 1, single (Lot number: HJ7221) at the age of 65 years, in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TASTE DISORDER (non-serious) with onset 11Nov2023, outcome "not recovered", described as "taste issues/taste was very muted/pasty or nondescript". Therapeutic measures were not taken as a result of taste disorder.  Additional information: Patient had no past drug allergy. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Three days after injection, patient developed taste issues.  First, sense of smell seemed normal.  When patient consumed food, patient could taste it with the first-third of  tongue, then as patient continued to chew working the food to the rear two-thirds of tongue the taste was very muted.  Everything, no matter what patient consumed, tasted pasty or nondescript.  It's kind of maddening.
Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored ROTATEQ (lot # M004883 with expiration date 02-OCT-2017; lot # M014318 with expiration date 30-SEP-2017, strength, dose, frequency and route were not reported). No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
Pt. given vaccine, was in the process of checking out and became fainty, clammy, poor skin color, would not acknowldege questions asked or instructions. BP at that time was 70/40, with a pulse of 50. Cold compresses applied to forehead, fan was turned to pt.,coke and saltines to pt. BP 10 minutes later was 86/58 , pulse 74. Pt. continued to rest and vitals again taken after 10 minutes-BP 90/60 and pulse 74. Pt. was no longer clammy, was speaking when spoken to, color good.Stated that she had not eaten anything this am. Felt better and was told to call the office prn.
coughing and throwing up green stuff which was mucus; felt dizzy; couldn't get my head right because my neck was hurting; Felt like my body was on fire; My whole body was red; my glands swelled up, lymph nodes between my shoulder and neck are still swollen; fever up to 100.1 -100.4degF; aches and pain; really bad headache; felt like I lost all my energy; A spontaneous report was received from a consumer concerning a 72-years old, female patient who experienced the events coughing, myalgia, pyrexia, dizziness, neck pain, headache, erythema, feeling hot, fatigue and lymphadenopathy.  The patient's medical history was not provided.  Concomitant product use was not reported.  On 25 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 002A21A) in the left arm for prophylaxis of COVID-19 infection.    On 25 Feb 2021, few hours after vaccination the patient was coughing and throwing up green stuff which was mucus. The patient experienced aches and pain, fever up to 100.1  100.4 deg F, dizziness. The patient also reported neck pain, really bad headache, whole body was red, felt like her body was on fire, glands swollen, lymph nodes between her shoulder and neck got swollen and she felt loss of energy. The patient took Tylenol for headache.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events coughing, myalgia, pyrexia, dizziness, neck pain, headache, erythema, feeling hot, fatigue and lymphadenopathy are still ongoing.
6/15 Headache, swelling L axilla, by 6/18 - chest pain, pressure.  ED visit:  testing revealed increased troponin and pos D Dimer. Cardiologist consulted, hospitalized on telemetry while waiting for transfer. Diagnosis myocarditis.  Medicated with toradol, ativan initially with good response.  Later dexamethasone for  myocarditis and metoprolol for tachycardia.  Hospitalized, still awaiting transfer at the time of this report.
Fever and headache with sniffles. Tylenol every 6-8 hours for 2 days
1hr p/vax pt devel an incapacitating h/a;h/a worse lying down;could feel a throbbing in head that matched hear beat;h/a lasted 1hr;fever (did not take temp) devel 6hr p/vax gone by next day;red rash area @ yellow fever site;
shot's after effect is a sore arm for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 27-JUL-2022 Reporter's comments: This case was reported by consumer via interactive digital media. The patient had the 2-dose vaccine too. It was reported that patient knew that after the shot's after effect was a sore arm a few days. This would go away. The reporter mentioned that there is a need to take second shot to insure the protection. The disease of shingles is not anything that patient would wish on anyone. The follow up would not be possible as contact details were not provided. Additional Supportive Information: For tolerance of 2nd dose refer case US2022AMR112182.; Sender's Comments:  US-GSK-US2022AMR112182:Same reporter
Realized after the fact that we administered the first dose in a Moderna series to a 17 year old.  Patient not yet 18 years of age.
"after first I had a lot of stiffness in right arm.  I couldnt move it"
The vaccine received was Influenza, but I don't have the information about the brand name and manufacturer. Adverse reactions: shivers, temperature (102F), nausea, headaches, nasal congestion, profuse sweating.
3/24/00 Vax given @ 8am and pt broke out with rash on entire body. By 9 am pt was seen in ER and told it was an allergic reaction. Treatment with Tylenol.