chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 44 years old female patient with allergy to every antibiotic. No Medical History reported. On 25-JAN-2013 the patient was vaccinated with the first dose of GARDASIL (Lot # 06524E, expiration date November-2014) intramuscularly. No other co-suspects were reported. No concomitant medications were reported. On 27-JAN-2013 the patient developed a high fever, swollen lymph nodes in her neck and under her arms, malaise, a rash and itching. The patient sought unspecified medical attention. The patient was treated with TYLENOL. At the time of the report the physician stated that all symptoms have resolved and now the patient only reported having erosion in the back of her throat. At the time of the report the patient was recovering from erosion in the back of her throat. There were no laboratories diagnostic studies performed. The relationship between high fever, swollen lymph nodes in her neck and under her arms, malaise, a rash, itching and erosion in the back of her throat with GARDASIL was unknown. Additional information has been requested.
Patient fainted about 3-4 minutes after receiving the vaccine.  Patient was very pale and sweaty.  We laid the patient down and gave him an ice pack and water.  He quickly came back and felt better within 5-10 minutes.
burning sensation; Sensitive skin; swelling; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation), SENSITIVE SKIN (Sensitive skin) and SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning sensation), SENSITIVE SKIN (Sensitive skin) and SWELLING (swelling). At the time of the report, BURNING SENSATION (burning sensation), SENSITIVE SKIN (Sensitive skin) and SWELLING (swelling) outcome was unknown.            Treatment information was not provided.  Upon in internal review on 21 May 2021, the age was corrected to an unknown age
Patient has experienced excessive soreness, redness, discoloration, and knot in the muscle since receiving her shingrix vaccine
Scratchy throat; itching lips; This is a spontaneous report from a non-contactable nurse. A 36-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EK5730, via an unspecified route of administration on Right arm from 22Dec2020 to 22Dec2020 as single dose for COVID-19 immunization. Medical history included food allergy (Shrimp). The patient's concomitant medications were not reported. The patient experienced scratchy throat and itching lips for approximately 1.5 hours starting 20 mins post vaccine on 22Dec2020. The event caused prolonged hospitalization. The outcome of the events was recovered on 22Dec2020.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 vaccine cannot be excluded for reported events throat irritation and lip itching.   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.
Patient complained of neck pain approximately 4 hours after vaccine administered on 5/24/2022 at 11:45 am. Client went to the ER in the evening on 5/24/2022 and was given muscle relaxant. Patient followed up with clinic on 5/27/2022 stating that her neck pain was significantly improved after taking the muscle relaxant medication.
This is a spontaneous report from a contactable consumer. A 22-year-old female patient received the first dose of TRUMENBA (lot number: S56026; expiration date: 28Feb2019), intramuscularly in the left deltoid on 14Jun2018 at 0.5 ml, single as required for work physical at the physician's office. The patient had no medical and family medical history. Concomitant medication included GARDASIL (lot number: N029069, expiration date: 17May2020) on 14Jun2018 for immunization. The patient received her first meningococcal group b rlp2086 vaccine yesterday (14Jun2018) and noticed all of her symptoms this morning of 15Jun2018. The patient came back to the office today (15Jun2018) with a local reaction. She had redness at the area with swelling, the site was hot to the touch and painful and she had a low grade fever of 99.1. The patient was advised to use a cold compress to the site and use TYLENOL as needed for pain. The outcome of the adverse events was not recovered.
Information has been received from a pharmacist concerning a patient who on an unknown date was vaccinated with ZOSTAVAX (Merck) (lot # not reported). One week later the patient developed shingles. The outcome of shingles was unknown. The patient was treated with unknown antivirals. It was unknown if the patient sought medical attention. Additional information has been requested.
Rash, fever, joint pain, body aches. Being transferred to higher echelon of care.
Swelling of neck - CAT scan revealed mass - please contact patient's PCP with any questions. Still experiencing swelling in arm and neck - probable allergic reaction.
patient had swelling on her neck under her ear starting day after vaccination (5/8/21). Patient states it is painful to touch, and has increased in size over the first few days but now seems to be staying at the same size.  No drainage from the ear, not hot to the touch.  Recommended tylenol or motrin and to follow up with doctor to get evaluated. only other symptom is a runny nose starting day after vaccination also
Patient received the Moderna Bivalent vaccine within 90 days of  having Covid and of treatment with Paxlovid
This case was reported by a pharmacist via sales rep and described the occurrence of injection site in a male patient who received FLUARIX quadrivalent. On 17th September 2015, the patient received FLUARIX quadrivalent .5 ml. On 17th September 2015, several hours after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On 18th September 2015, the patient experienced arthralgia and fatigue. On an unknown date, the outcome of the injection site pain, arthralgia and fatigue were recovered/resolved. The reporter considered the injection site pain, arthralgia and fatigue to be related to FLUARIX quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. This case was reported by a pharmacy director. On 17th September 2015, the patient experienced pain at the injection site within a few hours of vaccine administration. On 18th September 2015, 1 day after receiving the vaccine, the patient experienced fatigue and arthralgia. The patient's birth date, age as well as lot number and expiration date of the vaccine were unknown. The concomitant medication or the other vaccines that might had been administered by the patient were unknown.
Patient reports that he was in another state at the end of December, 2010, when he first began having nosebleeds, and he also noticed that his gums would bleed after brushing his teeth. He returned home to a foreign country and he then began to notice a "red rash" on his chest and upper back. He returned to school on January 24th and continued playing sports. He first noticed a bruise on the left side of his abdomen, then his right arm, left knee and right wrist. He would still continue to have nosebleeds, but was not seen for these symptoms. Patient went home around March 11th for break and he had a blood test that showed that his platelets were low. He had another test the next day, and the platelets were lower. He was referred to a Hematologist and was seen in the ER and admitted to the hospital. He was treated with IV Dexmethasone. He returned to school on March 27th and was feeling better. He is now on oral steroids.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medications and medical history were not provided. On 23-MAR-2016 the patient was vaccinated with an improperly stored dose of MMR II (lot # K0051110, expiry date 04-APR-2016, dose, route and dose number were unspecified). The excursion details were as follows: temperature: 49F; time frame: 16 hours, 30 minutes; previous temperature excursion No adverse effect was reported. Additional information has been requested.
104 degree temp evening of 5-06-10.  No redness or swelling of shot site but arm painful and difficulty in using it.  99.9 degree temp this am and will talk with physician.  5-11-10 Mom states fever remained til evening 5-8-10.  Is moving arm over head now.
Myalgia, Fever & NauseaVomiting Narrative:   Other Relevant History:
CHIEF COMPLAINT:   Fall at home. Pt states she had become dizzy and  had asyncopal episode in the kitchen and hit front of head on counter. No bloodthinners. Hx Afib. FSBS 111   HISTORY OF PRESENT ILLNESS:     Patient presenting to the emergency department with a near syncopal episode.  Patient states that she believes she hit her head slightly on the edge of the table.  Patient states that she was cooking when she felt lightheaded she does recall the event denies ever having chest pain shortness of breath.  Patient states that this time she feels very well.  Patient's only history is Crohn's disease as well as CKD.  Patient denies any other issues and feels well at this time.
profuse Swelling in the area and fever. Then like burning sensation accompanied by water bubbles in the skin area, like when you get burned by fire. Now I am peeling my upper left arm skin.
started with headache, next day a slight cough, then as the days went on the cough got worse, and at times like I cant' catch my breath.  this a week now and starting to feel some improvements .  Still very  tired and throat a little scratchy, not raw like it had been.  I didnt go to doc. just treated the systems
Patient states one week after the vaccine, he woke up and his left arm was swollen from the shoulder to the hand, and without pain.He did not report this until 8/26. His elbow was swollen with a pocket of fluid, he has full use of the arm. He f/u with an md 8/29 who said he is unsure if it is from the vaccine or not. This doctor did xrays, and has referred him to an orthopedic dr. to drain the elbow.
This case is 1 of a cluster of 2 patients' who experienced similar adverse events following vaccination with ADACEL. The event for the second patient was captured in case number 2011-06220. Initial report received from a health care profession on 03 August 2011. A female patient (age reported as in 30's and birth date reported as 15 December 1965) received a left deltoid intramuscular injection (dose 1) of ADACEL, sanofi pasteur Ltd. lot number C3927AA, on an unknown date (reported as one week ago). The patient's medical history was not reported. The patient had no other vaccines within 4 weeks of the ADACEL and had no known allergies. The patient complained of left deltoid redness and hotness at the injection site and one week later still has hard firm lump at the site. On patient examination, the patient had an induration (described as grape-size cyst) with no signs of inflammation (cold abscess?). On application of warm compresses (no antibiotic were used), the patient reported quick resolution of symptoms. The outcome was reported as recovered. Follow-up information was received from a health care professional on 19 September 2011. The patient had received the ADACEL vaccine on 26 July 2011 (previously reported as one week ago). She has a history of colon cancer "OEOD". No further information was available at the time of the report. The outcome remained recovered. Documents held by sender: None.
Received Flu vax nasal beginning of October. Have had severe sinusitis ever since. Had subsequent sinus infection - 2 courses of Abx. As of today Dec 10 2014, I am still dealing with sinus pain, congestion. Also have had weakness, joint pain and malaise the entire time.
pt given vax 29JUL92 @ approx 1020AM & mom had said might faint; p/vax pt was allowed to sit for about 3 mins; pt not feeling well appeared pale around mouth, skin cool, clammy, p52 weak;
This case was reported by a healthcare professional and described the occurrence of burning pain in a subject of unspecified age and gender who was vaccinated with TWINRIX. On an unspecified date the subject received unspecified dose of TWINRIX. At an unspecified amount of time following injection with TWINRIX, the subject experienced burning pain that seemed to shoot down the arm lasting 2 to 3 minutes after the injection. The reporter consulted with the rep for this vaccine and was told that there have been other reports of "pain" during injection associated with this vaccine/ Since there has been no change in the formulation of  the TWINRIX used, the reason for this type of reaction in the last 4 to 5 months is unclear. This was considered to be a product complaint. The outcome of the events was unknown. These events occurred in a number of different subjects from the same source, but with different contacts. Linked cases include A0732483A, A0732491A, A0732492A, A0732500A, A0732501A, A0732515A, A0732528A, A0732533A, A0732539A, A0732936A and A0732944A.
I experienced pain and nerve damage in my left leg from thigh up which made it difficult to walk, shortness of breathe, chest pain/tightness, foggy brain at random including losing my train of though i.e. where I am or what I'm doing, loss of smell which is still muted as of now. I am still experiencing shortness of breath and loss of smell, with the brain fog last occurring 2 months ago. I was prescribed an alvesco mcg inhaler for the shortness of breathe and told to smell items i.e. flowers 5 times daily to help regain my sense of smell.
Patient had a local reaction after her flu shot. The area where she got the shot became red and warm to the touch. She wasn't sure if she had a fever. She said she had a bump where she got the shot. This bump became smaller over time. She felt better after 3 days.
Post observation period, patient reported sensation of tongue/throat swelling, in addition to excess thirst and a cold sensation to her chest.  Patient requested to wait longer in observation. 5 minutes later patient continues to report sensation of throat swelling. Patient worried about possible exposure at work with a work mate that tested positive today.   MD STAT called and team responded to vaccine clinic.  VS as follow  BP 135/95 HR 87 Oxygen saturation of 100% on RA.  Patient speaking in full sentences with a clear speech. Respirations are even and non labored.   MD  evaluated patient and discussed symptoms with her. After evaluation, MD determines that this is not a vaccine adverse reaction, patient reports that she was feeling "very anxious" about receiving vaccine today and about the news of her co workers COVID + status.  MD  gives approval for patient to go home and completes teaching with patient for when to call emergency or be seen in ED if she experiences worsening symptoms. At the time of departure from clinic patient reports " feeling much better". Patient ambulated out of the clinic with a strong and steady gait. Respirations are even and non labored. Speaking in full sentences with a clear speech.
After six (6) days of getting my 1st Muderna vaccination  I'm still having bad headaches all day with chills on & off during the day. Also I seem to be in a fog at times & having trouble paying attention. I'm taking Tylenol Extra Strength medicine twice a day, not helping.
Case number PHEH201500089, is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 59 years old male patient. Medical history and concomitant medications were not reported. On 18 Nov 2014, the patient received FLUVIRIN, (batch number: 145205) at a dose of 0.5 ml intramuscularly. It was reported that the patient received FLUVIRIN that reached below 36 F for 3.5 non-consecutive days; vaccine reached 33.1 F for less than 12 hours. Reporter did not believe that the vaccine was frozen. She thought it might be due to thermometer malfunction. The case was assessed non-serious. No adverse event was reported following this medication error (incorrect storage of drug).
Headache, malaise, chills, myalgia starting 24 hours after vaccination. no vaccine site reaction, lymphadenopathy.
pt recvd vax & devel pyelonephritis, a cold & oth unspecified symptoms;
Administered after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect product storage in a 41-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 997K5, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect product storage. On an unknown date, the outcome of the incorrect product storage was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comments: Registered nurse reports that a patient was vaccinated with Boostrix on 30th August 2022 that had been undergoing a temperature excursion on and off since 23rd August 2022 (highest temperature reached was 47.9 F).  The reporter was currently doing an analysis to determine the total time outside of range and to see if other patients were possibly administered GSK vaccines during the 54 days of on and off excursions.  At this time only this one patient was identified.  To the RN's knowledge, there were no prior excursions. The reporter consented to follow up. The reporter was confirmed presentation was PFS via lot number. Additional Supportive Information: the patient received vaccine, which had been undergoing a temperature excursion on and off, which led to incorrect product storage.
pt recv vax 6JUN97 & the following day pt exp a large local rxn the size of a golf ball accompanied by soreness & sloughing of skin;
Pain in left arm within a few hours of vaccine. Worsening, deep pain in the shoulder starting that night. Progressive worsening pain and inability to lift anything with left arm.  Progressed and not relieved by OTC meds.  Saw urgent care provider, three different ortho provider. 3 steroid injections, oral NSAIDS for pain and inflammation, 5 weeks of PT, recurring follow ups with third ortho provider, EMG test, and MRI. Pain is still off and on, but starting to worsen again.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-332638 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Non-significant follow up appended.
A report was received from a health care professional on 11/11/03 concerning an unspecified number of vaccinees who inadvertently received 1ml of Fluvirin on an unspecified date. On an unspecified date an unspecified number of vaccinees received 1ml of Fluvirin. No adverse symptoms were exhibited at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 12/4/03: An update report was received from a health care professional concerning a 93 year old female vaccinee who inadvertently received 1ml Fluvirin SC on 10/31/03. On 10/31/03 the vaccinee inadvertently received Fluvirin SC. No adverse symptoms were exhibited at the time of reporting. No follow up pending.
104F fever; Sharp headache; Nausea; Chills; Stomach pain; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history included sjogren's and achenbach syndrome. The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 12:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021 at 23:00, the patient experienced 104F fever, sharp headache, nausea, chills and stomach pain. Therapeutic measures were taken as a result of these events and included treatment with TYLENOL and ADVIL. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 23Apr2021, the patient had underwent body temperature test and the result was 104 Fahrenheit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stomach pain, 104F fever, sharp headache, nausea and chills was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recvd vax on 14APR92 pt came back for 2nd shots mom states pt had t103 & persistent, inconsolable crying p/1st set of shots; also had high-pitched cry; sx lasted 7 hrs; APAP was given; pt was not taken to ER;
The day following the vaccine, I experienced extreme fatigue and body aches. I took naps several times during the day.  A red rash appeared just below the injection site.   The next day I did not experience the fatigue and body aches.  The red rash is still present.  There is some itching, but not severe.  I have been applying  Benadryl Cream two to three times a day.
patient reported chest pain, lightheadedness and difficulty breathing 15 minutes after vaccine was given. chest pain was like pressure rated 9/10. she said she had a history of asthma and that she hadn't needed to use an inhaler in years. resp 26, pulse 113 and O2 98%