chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via patient support programs and described the occurrence of allergic reaction in a adult male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. Co-suspect products included salbutamol sulphate (Ventolin Hfa) inhaler for chronic obstructive pulmonary disease. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose and Ventolin Hfa 90 µg daily. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season and Ventolin Hfa, the patient experienced allergic reaction. The action taken with Ventolin Hfa was unknown (Dechallenge was unknown). Rechallenge with Ventolin Hfa was unknown. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season and Ventolin Hfa. Additional details were provided as follows: This case was received from the non healthcare provider via the patient assistance program. The age at vaccination was not reported. The patient stated that he went to the hospital on 6th July 2018 because he had allergic reaction from the Flu shot. The patient stated he was taking the Ventolin HFA at the time of the reaction. No further details regarding hospital visit was provided. The reporter agreed to be contacted for follow up.
"Covid Arm" ... very sore, growing round bullseye ... the spot is now the size of a grapefruit... the spot if feverish.... left side of body itches.
Pt developed induration, redness, swelling and warmth on right deltoid muscle vaccine placed 36 hrs prior.
a little bit of a Headache; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Eisai (manufacturer control number: EC-2021-088274). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) as single dose (unknown if first or second dose) for COVID-19 immunisation and lenvatinib mesilate (LENVIMA) via an unspecified route of administration from 15Feb2021 at 20 mg daily for endometrial uterine cancer. Relevant medical history included ongoing malignant hypertension (blood pressure still runs high), 2 brain aneurysms, left thyroid lobe enlarged a number of years and endometrial uterine cancer. Concomitant medications were not reported. On 18Feb2021, the patient experienced a little bit of a headache. The patient stated she got a "COVID vaccine" last week (before starting LENVIMA) and patient's Doctor told her the "headache" cold be from the vaccine too. Cause unknown but occurred while on LENVIMA. The patient reported that her blood pressure was 149/82 on 18Feb2021 and it was 132/66 on 17Feb2021, which was low for her. The patient was instructed by her Doctor to notify her Doctor if blood pressure was ever "160/100, or higher." At the time of the report, the action taken with lenvatinib mesilate and  the outcome of the event were unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
had a lump at the injection site; Initial information received on 03-Aug-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who had a lump at the injection site while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (formulation, strength: unknown) lot number not reported in unknown administration site as Immunization.Lot number is requested.  On an unknown date the patient had a lump at the injection site (vaccination site mass) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT.He had the injection site for four months.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had a lump at the injection site).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event had a lump at the injection site.
12/03/21 patient presents to ED for "rectal bleed". PMHx of "A. fib on Eliquis, CAD status post CABG ×2, diastolic heart failure with EF of 55%, hypertension, sick sinus syndrome status post pacemaker placement, hemorrhoids, PUD"
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unspecified age. On an unknown dates the patients were vaccinated with GARDASIL (lot number was not reported), which was improperly stored since 28-OCT-2014. No adverse effects were reported. Follow up information has been received from the nurse on 10-NOV-2014. The nurse reported that an additional excursion has affected the same doses of GARDASIL (lot# J009788, exp 17-MAR-2016) and of ROTATEQ (capture in MARRS # 1411USA003388), and multiple patients have been administered both products. No adverse effects reported. This is one of several reports from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Hives on the left arm 24 hours after the second dose. I am currently still getting hives 2 months after.
Pt received anthrax and smallpox vaccines on Jul 18 and 20.  Presented to facility on 30 Jul brought in by ambulance.  Developed chest pain (cardiac pain ruled out with cardiac studies), papular rash on flexural areas of upper and lower extremities and headache.
Same day post vax, the pts experienced red, warm, and inflamed elbows. The pts were treated with ice packs and the swelling reportedly began to go away.
Starting on October 5, 2021, I started suffering from a continuous headache in the lower back of my head. This has now been going on for more than three months and doctors are still unsure of the cause or how to treat. Imaging scans and bloodwork have all come back clear.  On January 1, 2022, I suffered from a bout of vertigo for the first time ever in my life. Doctors are unsure of the cause. It lasted for about a week. Physical therapy was used to manage it while it was going on.
Narrative:  76yr admitted with dyspnea in the setting of COVID + and likely COPD exacerbation. Patient was exposed to COVID one week prior to admission developed sx of SOB, cough, wheeze along with lost taste and smell. Tested positive 8/24 admitted 8/27. PMH: COPD (s/p R thoracotomy w/ lung resection), HTN, HLD, AAA, CKD, CVA (residual L hand weakness), mild cognitive impairment, and current tobacco use. Hospital course: Sats on RA did not drop below 92%, did not require oxygen or COVID medications. Was given albuterol MDI and prednisone 40mg for COPD exacerbation. Spent 1 day in ICU then discharged (8/27 to 8/28).
Seconds min after shot flushed red, & felt dizzy. My arm, neck shoulder, under arm & breast swole up with enlarged lymph nodes & glands. Had chills, low fever. After it did not clear up in 2 weeks- calmed doc- referred to allergy specialist. Still have swelling. Not as bad. Has not completely gone down.
Information has been received from a physician's assistant concerning a girl who on an unspecified date was vaccinated with a first dose of VARIVAX (Oka/Merck). On 12-FEB-2009, the 9 year old patient should have received her second dose, however she was vaccinated with ZOSTAVAX (Oka/Merck) due to human error. No adverse effects reported. Follow up information was received from a Practice Manager concerning the patient who on 13-MR-2009 received the first dose of VARIVAX (Oka/Merck). The patient was inadvertently given ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) for second dose. It was a case of human error and not product confusion. The nurse pulled the VARIVAX (Oka/Merck) box out of the freezer and there was a loose vial of ZOSTAVAX (Oka/Merck) in the VARIVAX (Oka/Merck) box. The ZOSTAVAX (Oka/Merck) was given by mistake. The office has now initiated a process whereby the two vaccines will be stored in different sections of the freezer. And the nurse will ask another person to verify the bottle before withdrawing the vaccine. No further information is available.
23MAR91 pt had sz which lasted 8-10 min per mom; no fever & "not sick" & did not stop breathing;
Initial report received on 20/Sep/2006 from a health care professional.  A 51-year-old female patient, with no past medical history, had received a left deltoid injection of Adacel, lot number unknown, on 15/Sep/2006.  The next day, she noticed a "lump".  Two days later, her upper arm became red and swollen from the elbow to the shoulder, and she developed blistering. The patient was examined by a physician and diagnosed with cellulitis. She was treated with KEFLEX. The patient was not certain of the needle size used during administration or the date of her prior Tetanus/Diphtheria vaccination (most likely 5-10 years ago).  At the time of this report, the patient had not recovered.  Information received on 04 December 2006: The reported lot number was and upon internal review, it was confirmed to a TRIPEDIA product. The vaccine was administered intramuscularly. The onset of the "blistering" was 16 September 2006 and it was 2" wide and 1" long. The "lump" was confirmed to be a lymphadenopathy. The diagnosis of cellulitis was clinical and the reported symptoms were limited to the injection site. The patient was treated with antibiotics, OTC BENADRYL/TYLENOL and cold compresses. The cellulitis resolved on 04 October 2006 and the patient recovered.
Swelling, joint pain, violent vomiting, fever, chills, head aches, difficulty breathing, cough has developed
Patient received vaccine without incident, sat in waiting room with mother for 15 minutes.  After 15 minutes, patient got in line at register with mother to pick up a prescription but kept trying to sit on floor.  patient became very pale and was going to faint .We had patient lay on mom lap in waiting room.  Once he was able to sit up he was given Powerade and recovered and left with mother.
Information has been received from a physician, via a company representatives, concerning a 65 year old female, with asthma and immunocompromised, who in 1997 was vaccinated 9route unknown) with a first dose of pneumococcal 23v polysaccharide vaccine (lot unknown).  Concomitant therapy included (therapy unspecified) for asthma.  In 1997 the patient developed cellulitis after the vaccination and was hospitalized.  In December 2005, the patient was vaccinated intramuscularly in the right deltoid 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot unknown).  The patient developed cellulitis in vaccinated arm.  Her arm became red, painful, and swollen down to the elbow.  She also had a fever.  She was treated with intravenous antibiotics, ceftriaxone sodium (ROCEPHIN) and moxifloxacin hydrochloride (AVELOX).  It took her 5 weeks to recover completely.  No product quality compliant was involved.  Additional information has been requested.
Can this vaccine cause diarrhea; 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 DIARRHOEA (Can this vaccine cause diarrhea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     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 DIARRHOEA (Can this vaccine cause diarrhea). At the time of the report, DIARRHOEA (Can this vaccine cause diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
I was pregnant at the time of vaccination and gave birth to a healthy baby(7lb 5 oz) at 39weeks + 4days  gestation. When my baby was about 10 weeks old I developed mastitis and sought care from my primary doctor, who prescribed antibiotics.
Diarrhea, Fussy, and has to be held. Occasionally wakes up suddenly and stomach seems to be bothering him.  Seems to be precursor to diarrhea. Similar side effects after first dose of Rotateq.
pt brought to hosp via EMS with increasing SOB; O2 saturation 50% on RA; c/o nausea and vomiting; O2 supplementation; CXR showed bilateral pneumonia; transferred to ICU; given Remdesivir, dexamethasone, baricitinib, zinc, vitamin D, ABX; pt transitioned to DNR and eventually comfort care; pt passed away in the hospital
14 hours after injection, I experienced prickling sensations and tightness around my windpipe and prickling, tingling sensations in my back behind my shoulder blades.  These were mild and lasted for 2 hours.
headache; arm pain; arm was really hot; nauseous/nausea; diarrhea; body aches; feel bad/she wasn't feeling well; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171, Expiration date: unknown) intramuscular, administered in left arm on 04May2021 in the morning around 10:00 am (age at vaccination was 48 years) as dose 2, single for COVID-19 immunization. The patient did not have any medical history. The patient did not receive any concomitant medications and she hasn't been on any medicines. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8732, Expiration date: unknown) intramuscular, administered in left arm on 01Apr2021 in the evening between 15:30-16:00 pm (age at vaccination was 48 years) as dose 1, single for COVID-19 immunization and experienced headache, arm pain and her arm was warm at the site, her body was aching and she was really tired. No additional vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that after the first dose, the symptoms lasted 3 days and on the 4th day, she started to feel better. For the second dose, it seems like it was doing the same thing and she was feeling the same way. The patient received the second dose of Pfizer COVID vaccine on Tuesday, 04May2021 and she was okay on Tuesday. On 05May2021, Wednesday night around 22:00 pm, the patient experienced headache, arm pain, her arm was really hot, nauseous/nausea, had diarrhea and body aches/her body was achy. The patient was at work and she started to feel bad and she wasn't feeling well. She confirmed those symptoms were still ongoing and persisting. She clarified she just felt her arm and it felt not as hot as it was. She mentioned she started taking some Tylenol and it seems like the hotness went down, her arm was just warm. She clarified that she referred to her left arm. The patient asked how long those symptoms typically last and if anyone had reported that. The adverse events did not require a visit to Emergency Room or Physician Office. No relevant tests were done. There was a Product Complaint. The outcome of the events arm pain and arm was really hot was resolving. The outcome of the other events was not resolved.  No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning his son, with no pertinent medical history and no known drug allergies, who in February 1991, was vaccinated with MMR II (lot# not provided) and subsequently developed autism. There was no concomitant medication. Patient sought unspecified medical attention. No lab diagnostic studies were performed. Patient autism persisted. Upon internal review, autism was considered an other important medical event. No further information is available.
At approximately 8 pm on 12/29/20, I became very itchy on my bilateral arms.  Little bumps were noticed.  As the night when on the area of redness spread to the torso and down to the toes.  I was up all night due to the rash being extremely itchy.  I only had cortisone cream in my house at that time.  I applied the cream to bilateral arms.  At 11:00 am on 12/30 I bought Benedryl and took my first dose.  I had soreness at the insertion site and my arm was extremely sore.
sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Flu shots and had very sore arm. No other information was available. The information regarding consent to follow up was not reported.
Within 36 hrs of vaccination broke out in rash on lower back and abdomen. Hives on upper thighs, both legs. Private physician said it allergic reaction. Prescribed Allegra and Elocon.
Sore throat, Body aches, Phlegm for 7 days post shot.
Muscle pain in arm; This case was reported by a consumer via call center representative and described the occurrence of myalgia upper extremities in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13th July 2020, the patient received Shingles vaccine. In July 2020, less than a week after receiving Shingles vaccine, the patient experienced myalgia upper extremities. On an unknown date, the outcome of the myalgia upper extremities was not recovered/not resolved.   It was unknown if the reporter considered the myalgia upper extremities to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and had muscle pain in arm. The reporter asked was it ok to take Tylenol for the muscle pain in arm.
It felt like there was water in the ear; The right cheek was swollen; lymph nodes were swollen; He felt a pressure in the right ear; It impaired his hearing due to the pressure/trouble hearing; The face felt achy with hives; The face felt achy with hives; This is a spontaneous report from a contactable pharmacist (patient's wife).   A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL9262), via an unspecified route of administration injection in the left upper arm on at a single dose on 21Jan2021,10:00 for covid-19 immunization. Relevant medical history included blood pressure (unspecified), diabetes, stomach acidity, lipid lowering all from an unknown date and unknown if ongoing. Ongoing concomitant medications included irbesartan blood pressure, metformin for diabetes, famotidine for stomach acidity, atorvastatin for lipid lowering colecalciferol (vitamin D) for unknown indication. The patient experienced lymph nodes were swollen, felt a pressure in the right ear, felt like there was water in the ear, right cheek was swollen on 21Jan2021 17:00; impaired hearing due to the pressure/trouble hearing, face felt achy with hives on 21Jan2021. The events were mild, thought it would go away by itself. The events did not require a visit to emergency room and physician's office. It was further reported that around 5-6 hours after getting the vaccine, in the evening, he started to have the lymph nodes on the right side of his face swelling. Along with that he had trouble hearing. It was like swimming and lots of water got in the ear and that water could not come out. He also had hives. He had hives under his eye. It was like on his cheek between his eye. It was red and about the size if a finger nail. She would like to speak to someone about him taking the second dose. She wanted to know if there was any concern in him getting the second dose. The issues with trouble hearing is getting better, he is almost back to normal. When he touches his ear it still feels sensitive. The hives is still there, but it is like paler, but still there. It is like weaker at this point . Outcome of the event lymph nodes were swollen, impaired hearing due to the pressure/trouble hearing, face felt achy with hives was recovering, while unknown outcome for the event pressure in the right ear, felt like there was water in the ear, right cheek was swollen was unknown.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 8 days after receiving SHINGRIX, the patient experienced muscle pain, fever and red rash. On an unknown date, the outcome of the muscle pain, fever and red rash were unknown. It was unknown if the reporter considered the muscle pain, fever and red rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter asked whether it was possible to develop a fever with muscle aches 8 days after the SHINGRIX injection. The fever was gone after about 24 hours, but no other symptoms accompanied the fever such as cold, cough, or any stomach symptoms. Also, then 2 to 3 days, 10 days after vaccination the fever, the patient developed a red rash. The patient wanted to know whether these symptoms match the possible symptoms of side effects of the SHINGRIX injection.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity started to receive PREVNAR, intramuscular from 08Jan2016 to 08Jan2016 at 1 DF, single. The patient medical history was not reported. There were no concomitant medications. The patient experienced numbness and tingling in both hands, coldness of whole body, fever, chills, fatigue and "not been able to hold anything" on an unspecified date with outcome of unknown. The action taken in response to the events for PREVNAR was not applicable. Follow-up (09MAR2016): Follow-up attempts completed. No further information expected.
Took pill #1 & after had headache & eye pain, pill #2, 3 & 4 eye pain & headache increased with each one.
Hands and arm dermatitis rash 3 weeks after vaccination, possibly a delayed reaction to vaccine.  Has topical steroid cream to apply to dermatitis sites from doctor staff member visited as well as zyrtec tablet for allergies once a day. Dermatitis sites have pruritus and are red and raised patchy rash areas. Large patch on left hand, small "spot" like raised red bumps on arms and right hand - diffuse, not many bumps.