chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 100.4F; Injection site arm hurts a lot; Chills; Feeling sick; Headache; A spontaneous report was received from a physician, who was a female patient who received Moderna's COVID-19 vaccine and experienced feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot.    The patient's medical history included Covid-19 in March 2020. Concomitant medications were not provided.    On 22 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On the evening of 22 Dec 2020, the patient experienced a fever of 100.4 degrees Fahrenheit.   On 23 Dec 2020, the patient called and stated that her injection site arm hurt a lot. She denied redness at the injection site. She stated she was having side effects including feeling sick, chills, and headache and still felt symptomatic. Treatment included paracetamol.   Action taken with mRNA-1273 in response to the events feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot, was not reported.   The events, feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot, were considered not resolved.  The reporter assessed the events, feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot as related to the study drug.; Reporter's Comments: This case concerns a female patient who experienced events of feeling sick, fever of 100.4 F, chills, headache, and injection site arm hurts a lot. The events occurred 1 day after the first dose of COVID-19 vaccine administration. Due to possible temporal relationship, the events are considered as related to the vaccine.
Bleeding from belly button - extreme headache within an hour of the shot - very sore and tired - felt like an extreme hangover headache while still drunk - my balance was gone - could barely walk for two days.
Generalized muscle weakness, lethagy, body aches, headache, injection site erythema, redness, and moderate pain. Injection site reaction is approximately 2cm x 3cm.
Case number PHEH2015US023677, is an initial spontaneous report from a physician received on 11 Nov 2015. This report refers to a 48 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number not reported) on 25 Aug 2015. Two weeks after vaccination the patient developed pain at the injection site that was radiating to her neck and arm on the right side. The pain was getting worse. Seriousness and causality of the events were not reported.
Pain in gallbladder; This spontaneous case was reported by a consumer and describes the occurrence of BILIARY COLIC (Pain in gallbladder) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Gallstones.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced BILIARY COLIC (Pain in gallbladder). At the time of the report, BILIARY COLIC (Pain in gallbladder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
new onset cardiac murmur; fever; petechial rash; This is spontaneous report received from a contactable nurse. A 25-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via intramuscular route on 11Mar2021 as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication received within two weeks included birth control. No other vaccine was received within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 23Mar2021, the patient experienced new onset cardiac murmur, fever, and petechial rash. The events resulted in doctor or other healthcare professional office/clinic visit, life threatening illness (immediate risk of death from the event). The patient had been tested for COVID-19 since the vaccination. She underwent COVID-19 nasal swab test on 23Mar2021 with negative result. Outcome of events was not recovered.   Information on the lot/batch number has been requested.; Sender's Comments: The information provided is limited and does not allow for a complete medical assessment.  Based on temporal association a contributory role of BNT162B2 to the reported events  cannot  be totally excluded.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
high amount or arm throbbing and alot of hand / fingering numbness.  this has taken place after both injections
Patient experienced, redness and swelling  in entire upper arm. It was very painful and hard to move.  She saw a PA that prescribed and antibiotic and diagnosed cellulitis.  She is feeling better since she started the antibiotics.
Myocardial infarction treated with multiple (3) angioplasties to coronary arteries
Felt head pressure / very cold almost chills for about 4-6 hours same time.
No adverse effects reported; the patient was inadvertently administered one dose of PNEUMOV AX 23, which had expired on 10/24/2019; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-JAN-2020, the patient was inadvertently vaccinated with expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot # R006465 and expiration date 24-OCT-2019 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects were reported.
Exertion; Chills; Body ache; fever of 103.8; Congestion; Left cervical lymph nodes were swollen and firm/Left axillary lymphadenopathy; Mild dry cough; This is a spontaneous report from a contactable physician (patient). A female patient of an unspecified age received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at 17:00 to at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. On 07Jan2021, she woke up with a fever of 103.8, severe chills, body ache and congestion. She said her left cervical lymph nodes were swollen and firm. She took Tylenol 500 mg every four hours. In the evening, she skipped the dose of Tylenol and her temperature went up to 103.9. She took another dose of Tylenol and again after a few minutes it was 105 with chills, body ache and a mild dry cough. She put a cold compressor on her head and went to sleep. The next morning, on 08Jan2021, her temperature was 102.1 and she had developed left axillary lymphadenopathy and she no longer had chills. So, she took one dose of Tylenol in the morning and her temperature came down to 100 throughout that day, no chills. On Saturday, 09Jan2021, her temperature came down to 99 to 98. On Sunday, 10Jan2021, was the first day that she had no fever but just exertion. So she ultimately was totally fine but her left neck lymph node were slightly swollen and firm but lesser than before and she was imagining that it will gradually resolve. Therapeutic measures were taken as a result of chills, body ache, fever. The patient had a COVID test on an unspecified date with unknown result. The outcome of event chills was resolved on 08Jan2021, outcome of event fever was resolved on 10Jan2021, outcome of event exertion was unknown, outcome of other events was resolving.   Information on the Lot/Batch number has been requested.
Postmenopausal breakthrough bleeding began approximately 12 hours post-vaccination and has continued for seven months depending on food intake (soy, dairy, corn, or almonds) or asthmatic trigger.
Broke out in generalized hyperemic maculopapular rash 2 days after receiving DTaP/Hib.
Vaccine was injection into the bursa rather than the deltoid. It caused bursitis and tendinitis. Wrong administration site (e.g, gluteus maximus rather than the deltoid).
Pt syncopized and fell forward from seated position falling from exam table to ground.  Woke after 60 seconds and reoriented well.
*Pain down left arm through elbow & wrist - 10 min after injection, still sore 1-1/2hrs later *Nausea & vomiting while driving home approx 25-30 minutes after vaccine.  Vomiting lasted 30-45 minutes, nausea continues 1-1/2hrs later *Lightheaded- 45min after & still continues 1-1/2hrs later *Headache
I got both of mine painful but not as painful as the Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose received on an unknown date, refer case US2023AMR118278.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: I got both of mine painful but not as painful as the Shingles).  Rechallenge with Shingrix was positive. The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.     It was unknown if the company considered the pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR118278   Additional Information: GSK Receipt Date: 29-AUG-2023 The case was received from the patient via interactive digital media. The patient received both her Shingrix vaccine which was painful. It was not as painful as Shingles. She stated that the people she knew had shingles were like it was so painful. The patient asked to get vaccinated.  The follow-up would not required per process; Sender's Comments:  US-GSK-US2023AMR118278:Same patient / Shingrix dose 1st
Initial report received from a healthcare professional on 11 June 2013. A 37-year-old female patient had received an intramuscular first dose of ADACEL (Lot number: U4612AA, anatomical site of administration was not reported) on 11 June 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 15 November 2012. The estimated date of delivery was reported as 16 August 2013. The patient's health during pregnancy, concomitant medications, medical history and risk factors were not reported. As of 11 June 2013, the patient had not experienced any adverse event. Documents held by sender: none.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe, Systemic: Tachycardia-Severe, Additional Details: within 2 minutes of receiving the moderna covid 19 vaccine patient notified pharmacist she felt like her throat was closing, she said it felt like a brick was on her neck. she was also experiencing the symptoms checked above.  following initial assessment pharmacist administered one dose (0.3mg) or epinephrine and called 911. pharmacist monitored patient symptoms and blood pressure and pulse until paramedics arrived.  Patient was taken to local emergency department by ambulance.
tested positive for Covid/began serious symptoms late 07Nov2023; tested positive for Covid/tested positive for Covid/began serious symptoms late 07Nov2023; a slightly sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Oct2023, outcome "unknown", described as "a slightly sore arm"; VACCINATION FAILURE (medically significant) with onset 07Nov2023, outcome "unknown", described as "tested positive for Covid/began serious symptoms late 07Nov2023"; COVID-19 (medically significant) with onset 07Nov2023, outcome "unknown", described as "tested positive for Covid/tested positive for Covid/began serious symptoms late 07Nov2023". The events "tested positive for covid/began serious symptoms late 07nov2023" and "tested positive for covid/tested positive for covid/began serious symptoms late 07nov2023" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Nov2023) Positive. The patient received booster Oct2023 with no side effects as usual other than a slightly sore arm. On 08Nov2023 the patient tested positive for Covid, the patient began serious symptoms late 07Nov2023 but by 08Nov2023 afternoon when the patient saw the dr the patient was only showing mild symptoms, no fever ever, so the patient was still grateful. Those the patient was close to during incubation period all tested negative.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
during counseling before the shot and reviewing her consent form she stated she had a reaction to a flu shot when she was a baby but has not had any reactions to vaccines since-she does not get a yearly flu shot but other vaccines were stated as no incident.  she received the shot without incident and sat with me for a few minutes in the counseling room and was fine.  several minutes after that she  told one of my technicians who was leaving the pharmacy she was going to pass out.  we laid her down on the floor and proceeded to call 911.  she said her heart rate was up and she self monitored with her apple watch.  she never lost consciousness and was ok when the ems arrived.  she chose not to go with ems and left with her husband who had been called.
Pt received his single vaccination of Janssen, and fainted while waiting in waiting area after receiving his vaccination.  Pt says he has a needle phobia, and was hesitant to get the vaccine. He had a muffin to eat earlier in the day, and nothing since. The tech, called  me when she saw him fall. when I saw him, he was standing up. He sat back on his chair. I got his to rest with his head lowered. He appeared to be dizzy and cold and clammy. When I took his Blood Pressure, it was 95/46. He had a 1 cm cut below his right eyebrow. He did not want to go for stitches, because he hates needles. After resting up for about 30 minutes, he told me that he felt better, then left.
After doing routine activity on May 4, cutting grass and then playing Pickleball, on morning of May 5th woke in extreme debilitating pain in hands, arms and feet and lower legs. Went to ER but they found nothing. Also had issue with stomach that may have contributed to 10 pounds of weight loss in April that started after 2nd vaccination. Went to ER on May 19th to try to assess issues with pain, found nothing. Entered Hospital on May 21 to have neurologist evaluate issue. Nothing found.   Dr. advised to report this issue to you.
Never had panic attacks or anxiety untill received first dose. With nausea. Now won't go away. Life is hell.; Never had panic attacks or anxiety untill received first dose. With nausea. Now won't go away. Life is hell.; Never had panic attacks or anxiety untill received first dose. With nausea. Now won't go away. Life is hell.; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 68-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm (reported as left shoulder) on 19Aug2021 12:00 as dose number unknown, single (at the age of 68-years-old) for COVID-19 immunization. Vaccination facility type was reported as Pharmacy or Drug Store. Patient was not pregnant at the time of vaccination. Patient did not have COVID-19, prior to vaccination and was not tested for COVID-19 post vaccination. Patient did not receive any other vaccine in four weeks. Patient medical history included known allergies with Lopressor, effient and statins. The concomitant medications were not reported. Patient never had panic attacks or anxiety until received first dose, with nausea on 21Aug2021. Now would not go away. Life was hell. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The therapeutic measures taken as a result of the events included Anxiety medication. The outcome of the event was not resolved.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This case was reported by a pharmacist and described the occurrence of an injection site reaction in an adult patient who received hepatitis B vaccine recombinant (Engerix B). The physician reported that multiple patients experienced injection site reactions with Engerix B, however patient identifiers were not provided. On an unspecified date on or before 4/13/2005, the patient received a dose of Engerix B into the deltoid muscle (dose number not provided, lot AHBVB034BB). the pharmacist referred to the Engerix B as the adult formula. The pharmacist stated that, the patient complained about a lot of pain as the vaccine was going into the muscle. The injection site reaction resolved on an unspecified date after 4/13/2005 and on or before 5/20/2005. The pharmacist considered the injection site reaction to be related to vaccination with Engerix B. The pharmacist reported that he observed, no pain with Engerix B from lot ENG5588A4. The pharmacist also reported that , at another employer, I regularly administered the ENG lot without any untoward reaction reported by the patient. On 05/20/2005. Two Engerix B immunizations were given from lot AHBVB005AA with no pain reported.
Per patient's mother, patient was very sleepy and "lethargic" within a few hours of vaccine administration and remained this way for 1 to 2 days. This occurred with 2, 4, and 6 mo vaccines.
pt had a positive COVID test on 2/22/22; pt passed away at home on 2/27/22; no medical records
No adverse effect noted as of this time.  The reason for this submission is to document that the patient was accidentally given Flublok, which is only indicated for patient 18 years of age and up.  The patient is 15 years old.
Fatigue, sore throat, bruising, body aches, nausea, fever, swollen lymph nodes. The symptoms continue until present.
One week after Moderna vaccine red, itchy, painful rash appeared at injection site.   Approximately 4"x3"   Although it seems to be lightening a tiny bit in color,  the rash is growing.  Now, approximately  5"x3"    Upon my own investigation (via Google) learned this is called COVID arm.  It is not typically listed as a side effect.  It is most commonly seen in 30-40 y/o women (I'm 72).  I want to make sure it is safe to receive the 2nd vaccine.
first it was on the 18th and then I came down with COVID; first it was on the 18th and then I came down with COVID; This is a spontaneous report from a  Non-contactable consumer (patient) of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration on 18Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient stated that she received first dose was on the 18Jan2021 and then she came down with covid on an unspecified date. she is wondering if she could get her second shot this Thursday. The patient underwent lab tests and procedures which included covid test: came down with covid on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist via a company representative referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced cellulitis at unspecified location an unspecified amount of time after administration of PNEUMOVAX 23. The reporter stated that he had reported this adverse event to Vaccine Adverse Event Reporting System (VAERS) (no VAERS number was provided). At the time of the report, the outcome of cellulitis was unknown. Additionally, the reporter did not provide causality assessment between the event and vaccination with PNEUMOVAX 23. Upon internal review, cellulitis was determined to be medically significant. This is one of the two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA000894:
no adverse effects; The primary reporter reported that the patient was "administered the first, second and third dose in the GARDASIL series". The primary reporter reported that the patient was then "inadvertently administered a dose of GARDASIL 9.; The primary reporter reported that the patient was "administered the first, second and third dose in the GARDASIL series". The primary reporter reported that the patient was then "inadvertently administered a dose of GARDASIL 9.; This spontaneous report was received from a nurse and refers to a 17-year-old male patient. The patient's concurrent conditions,   medical history, drug allergies/reactions and concomitant medications, if any, were not reported.  On 06-AUG-2013, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) first dose and on 21-NOV-2013, he received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration and anatomical site of vaccination were not provided; lot number and expiration date were unknown); then on 24-APR-2014, with the third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (dose, route of administration and anatomical site of vaccination were not provided; lot number H020901; expiration date not reported, but upon internal validation established as 05-JUL-2015); all administered for prophylaxis.  On 29-JUL-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration and anatomical site of vaccination were not reported; lot number R036914 and expiration date on 23-SEP-2021) for prophylaxis (interchange of vaccine products and extra dose administered). In addition, no adverse effects were reported.