chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bilateral viral eye infection; This case was reported by a nurse via call center representative and described the occurrence of eye infection viral in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included MEASLES VIRUS VACCINE LIVE ATTENUATED (MEASLES VACCINE).   On 21st May 2019, the patient received the 2nd dose of Shingrix .5 ml. On 28th May 2019, 7 days after receiving Shingrix, the patient experienced eye infection viral (serious criteria clinically significant/intervention required). The patient was treated with Eye Drops (Nos). On an unknown date, the outcome of the eye infection viral was not recovered/not resolved.   It was unknown if the reporter considered the eye infection viral to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on right deltoid and developed bilateral viral eye infections. She went to her optometrist and was being treated with prescription eye drops. She did not have vaccine information for this adverse event  She had a measles vaccine a week before the Shingrix dose 2, administered subcutaneous. Emergency visit was required. The reporter was consented to follow up
She didn't have a bad reaction to it.; This year she took both of the shingles vaccines. 24Jan2020 she took the first shingles vaccine and then on 25Mar2020 the second shingles vaccines.; This spontaneous report was received from 71-year-old female patient, who was referring to herself. The patient's concurrent conditions included pressure headaches from storms, melanoma (found in December 2003), thyroid disorder and diabetes. Concomitant therapies included levothyroxine sodium (SYNTHROID), colesevelam hydrochloride and metformin hydrochloride. She was divorced. The patient was allergic to pollen from every tree except cottonwood, to every pain medication in the world (codeine, morphine, ibuprofen, naproxen (reported as "naproysyn"), acetaminophen, sulindac (CLINORIL), tramadol, anaphylaxis to opioids; she was able take aspirin - she limited herself to 6 tablets per year), also allergic to fluoride, synthetic tetanus, band aid adhesive and sulfa drugs, to night shade family (tomatoes, eggplant, potatoes and bell peppers; bell pepper and egg plant caused anaphylaxis to her; she could walk into the produce department and the oil got in the air from a bell pepper and she would start having a reaction), tobacco, ants, bees and wasps and insect bites (she got anaphylaxis if she got stung by ants, bees, wasp and insect bites), carbon paper, cleaning chemicals, dust, eucalyptus (the scent of it in the air caused her eyes to start swelling; she has not been able to wear make up), mold, pesticides, smoke, synthetic fabrics (like polyester) and synthetic perfumes, tree sap (the saps from Evergreen and tropical varieties of plants, like palm trees, caused rashing). She could eat eggs and was not allergic to eggs. She could eat tree nuts like pecans and walnuts, yet she was allergic to the pollen from the tree. On an unknown date in September 1967 (reported as in the fall of 1967), she received her first flu vaccine. She had the flu vaccine again the next year in 1968. She had a big goose egg, rashing, and problems breathing. She had a reaction again. She has never had another flu vaccine and has not had the flu either. On an unknown date in approximately 2012 (8 years ago, also reported as the last time), she had an opioid, which was from a dentist. He said she would not be allergic to it. She believed him and took it. In less than 15 minutes, she was projectile vomiting into the toilet. Those are some of her symptoms.   On 24-JAN-2020, the patient was vaccinated with the first dose of a shingles vaccine (manufacturer unknown) (strength, dose, route of administration, lot number and expiry date were not reported) for prophylaxis. On 25-MAR-2020, the patient received the second dose of shingles vaccine (manufacturer unknown). The patient did not had any bad reaction to the vaccines.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-2012USA004558:
4:38 pm rx note: PATIENT HAS SOME SWELLING IN THE ARM FOLLOWING PNEUMOVAX SHOT; CALLED IN TO ASK IF SHE COULD USE ICE PACK.
localized red rash w/swelling & induration w/ c/o itching @ site of MMR; area iced & pt was given DPH & observed in office x 30min & sent home w/instructions to call in inc problems;
Initial and follow up information has been received from a physician concerning a 14 month old female child who inadvertently was vaccinated IM in to left thigh with a dose of Gardasil lot #656371/0181U.  In follow up the physician reported that the child was experiencing nausea, vomiting, fever and decreased appetite following vaccination.  The outcome was unknown.  Additional information has been requested.
Pain/decreased range of motion that has persisted after flu vaccine given in (L) arm. Pain/discomfort has continued in (L) shoulder since vaccine given 4-5 weeks ago.
I received the 1st dose of Pfizer vaccine on July 20th, 2021. I had muscle ache for  the first two days and couldn't sleep during nights. Starting on July 24th afternoon, I noticed left eyelid slightly swelling with no pain nor itchy. On July 25th morning, the swelling got a little bit worse. On following Monday (July 26th), the swelling started spreading and tenderness, but no pain. On Tuesday (July 27th) morning, the swelling further spread to the bridge of the nose and down to the upper lip. My boss, who is a physician, told me to take Claritin on July 26th, I did so. But, the swelling didn't get well today.
4 patients were inadvertently given the expired vaccine, NO AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.   This case involves four patients of an unknown demographics who received an expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
This spontaneous report was received from a certified medical assistant who reported that an unspecified number of patients received doses of PROQUAD (Merck) and VARIVAX (Merck) that underwent a supported temperature excursion. The patients received these doses on unspecified dates. No adverse experiences were reported. No further information was provided. Additional information has been requested.
5/23/2022  2:51am Resident declining, BP 102/54, P 61, R 39, O2 Sats 83 % on 4 LPM of O2, no pedal pulse X 2, legs bluish purple to knees, Resident sent to Hospital.  Resident admitted to hospital dx kidney failure and A FIB . resident currently on hospital at this time
Patient states her left arm was very sore for about a week after administration. She then reports arm pain that "flares up" frequently when using her left arm that has persisted after 1 month since that vaccination.
Feels very fatigued. C/O joint pain and cramping. C/O joints burning and hurting in right arm and hand. Feels fine mentally.
With in 20mins of vax had episode where vision were blurred.  8:30pm had another episode of blurred vision. Lasted 15mins then went to sleep.
Patient received Pfizer COVID vaccine on 2/10/21 and 3/8/21. On 10/31/21, patient admitted to our facility for GI Bleed, acute blood loss anemia with a known history of noncirrhotic portal hypertension associated with splenomegaly and thrombocytopenia. He's also found to be COVID positive per external result from 10/29/21, but is completely asymptomatic from respiratory standpoint. As of today (11/2/21), patient is still hospitalized in our med/surg unit for the acute blood loss anemia secondary to upper GI bleed and underwent upper endoscopy earlier in the day.
Feels first dose may have affected sciatic nerve as it was painful; This spontaneous case was reported by a patient and describes the occurrence of SCIATIC NERVE INJURY (Feels first dose may have affected sciatic nerve as it was painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. C12A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SCIATIC NERVE INJURY (Feels first dose may have affected sciatic nerve as it was painful). At the time of the report, SCIATIC NERVE INJURY (Feels first dose may have affected sciatic nerve as it was painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-622718.
Pain at the spot of the injection; This is a spontaneous report from a non-contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, in left arm on 10Mar2021 at 09:45AM (at the age of 38-years-old) (Lot Number: Et 3247) as 1st dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. The patient was not pregnant. The patient did not have COVID prior to vaccination. The patient did not receive other vaccines in four weeks. On 10Mar2021 at 16:00 (also reported as about 6 hours after the injection), the patient experienced pain at the spot of the injection and lasted for about 16 hours. No treatment was received for the events. The patient was not tested for COVID post vaccination. The outcome of the event was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.
pt was irritable p/sleeping; became very pale; some high pitched crying; was irritable but consolable; t99 R; was seen by MD;
I don't have the lot information.  My BP skyrocketed after I got the vaccine.  I ended up in the emergency room 59 days after the vaccine.
sick; nauseated; fever; heart rate went up from 60 to high 100s/heart rate went up; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart rate went up from 60 to high 100s/heart rate went up), ILLNESS (sick), NAUSEA (nauseated) and PYREXIA (fever) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arrhythmia (it was controlled) and Suspected COVID-19 in March 2021. Concomitant products included METOPROLOL for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (heart rate went up from 60 to high 100s/heart rate went up). On 01-Jan-2022, the patient experienced ILLNESS (sick), NAUSEA (nauseated) and PYREXIA (fever). The patient was treated with METOPROLOL for Heart rate increased, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (heart rate went up from 60 to high 100s/heart rate went up), ILLNESS (sick), NAUSEA (nauseated) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, Heart rate: high (High) went up from 60 to high 100s. On 01-Jan-2022, Heart rate: high (High) heart rate went up.         It was reported that on 01 Jan 2022,the heart rate went up again which she took metoprolol again.Patient reported that being blind and not being able to provide certain information at this time.
Redness, swelling and itchiness on left arm at vaccine site. Recommended to apply ice and take ibuprofen or Benadryl as needed.
Received 2nd dose of Covid vaccine yesterday. Woke up at 4AM with chills, a mild headache, and arm pain. Ibuprofen helped to relieve symptoms. Still feels chills, arm pain, and now fatigue.
First Day:   Slight pain in arm. Slight headache. Second Day:   Very tired. Slept most of the day. Third Day:   Woke up with a bad back pain. Felt tired. Around 2:00 pm had a severe stabbing pain in       back. The pain went to ribs and then right lung. Took Tylenol and rubbed CBD oil on back. Pain subsided in 30 minutes, but hard to breath deeply. The rest of day had less severe stabbing pain in lung off and on. Fourth Day:  Very tired , light headed . Pain in right lung when breathing deep. Oxygen saturation was low when walking around. Brain fog. Feel uncomfortable. Fifth Day: Only slight pain in lung when breathing deeply. Feel much better.
Red warm swelling around injection site day 9 after injection.  Itchy and sore.  Slowly going away
Shaking uncontrollably and cold from 4:30-5:30 AM.  Fatigue and tired for the next 24 hours.  Brain fog when I woke up at 10:30 AM the next day.  Fever coming and going until ~6 PM.  Diahrea at 7 PM.
Severe chest pain, tightness, and shortness of breath. Heavy heart palpitations.
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 21-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No treatment medications were reported.  This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient, unknown age and gender, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on the same day after unspecified dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
allergist confirmed it was an anaphylaxis reaction; both sides of her throat started swelling; lingering residual swelling in lymph nodes, upper chest, and throat 67 days after vaccination; ears were really affected in the beginning with throbbing ear pain; headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (allergist confirmed it was an anaphylaxis reaction) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Reaction to food coloring.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced ANAPHYLACTIC REACTION (allergist confirmed it was an anaphylaxis reaction) (seriousness criterion medically significant), PHARYNGEAL SWELLING (both sides of her throat started swelling), LYMPHADENOPATHY (lingering residual swelling in lymph nodes, upper chest, and throat 67 days after vaccination), EAR PAIN (ears were really affected in the beginning with throbbing ear pain) and HEADACHE (headaches). At the time of the report, ANAPHYLACTIC REACTION (allergist confirmed it was an anaphylaxis reaction), PHARYNGEAL SWELLING (both sides of her throat started swelling), LYMPHADENOPATHY (lingering residual swelling in lymph nodes, upper chest, and throat 67 days after vaccination), EAR PAIN (ears were really affected in the beginning with throbbing ear pain) and HEADACHE (headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 29 Jan 2021, 45 minutes after administration of the second dose, both sides of her throat started swelling and she was taken to the Emergency Room (ER) Treatment medications in the ER included Epipen (epinephrine), unspecified steroids, and Benadryl (diphenhydramine). At home, she took loratidine, famotidine and two rounds of a 5-day tapering regimen of prednisone. The allergist confirmed it was an anaphylaxis reaction, and thought she was allergic to the base, polyethylene glycol, which has not been tested. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-073672, MOD21-14991, MOD-2021-002300, MOD21-00576 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Developed a rash on right arm, chest, neck, and face with redness and small raised bumps.
Child with new onset diabetes type 1. Seen on 12/27/21 but had symptoms for 1 week of increased urination, thirst, weight loss. Glucose >444 and 3+ glucose on urine. Child was stable and sent to hospital for further evaluation and management.
uncontrollable diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 19Aug2021 (Lot number: FA7485) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "type 2 diabetic" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE taken for type 2 diabetes mellitus, start date: 16Aug2021 (ongoing). The following information was reported: DIARRHOEA (non-serious) with onset 20Aug2021, outcome "not recovered", described as "uncontrollable diarrhea". Additional information: The reporter reported for her husband. The patient had injection on 19Aug2021, and her husband had experienced uncontrollable diarrhea in morning on 20Aug2021, he didn't realize it was happening and there was no indication for it. This was unusual for him.  No follow-up attempts are possible. No further information is expected.
Exactly one week after first dose my arm started to itch, a huge lump quickly formed, the morning after it formed it became hot to the touch. Day 2- still hot to the touch, hard lump on injection site arm. History of a anaphylaxis to Zithromax has me worried about second dose or any long term  effects.
L leg with firm discolored, 1 cm area at outer side of (L) leg - the site of PEDIARIX given. Tenderness to palpation.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 27th April 2020) for prophylaxis.   On 28th April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The healthcare professional stated that patient received 1st dose and was treated for shingles. The reporter asked whether patient need the 2nd dose. The reporter consented to follow up.
Reporting post vaccination tingling, itchiness, and swelling of the tongue. Taken to Urgent Care for continued treatment and monitoring.
Narrative:  COVID infection following COVID vaccine series 03/27 Pfizer, dose #1 04/16, Pfizer, dose #2 07/14 PT ADMITT to medicine dx: Atypical chest pain r/o ACS LOS; 1 day 07/14 CXR impression: No acute abnormality or change since September 2019. 08/08 pt cc: loss of taste or smell, cough, rhinorrhea, headache, exposure: unknown 08/08-08/17 Pt symptoms continue 08/11 COVID swab, result: detected 08/11 SARS-COV-2 LINEAGE result: AY.4 08/11 SARS-COV-2 CLADE result: 21A 08/18 clinically resolved
This spontaneous report was received from a registered nurse refers to a patient of unknown age. The medical history, concurrent condition and concomitant medications were not reported. On 18-JUN-2015, the patient was vaccinated with GARDASIL 9 dose 1. On 21-JAN-2016, the patient was vaccinated with GARDASIL 9 dose 2 which was later than the recommended schedule. No adverse effects were reported. Additional information has been requested.