chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 85 year old mother with penicillin allergy and a history of lymphoma who in July 2007, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included blood pressure medicines. In July 2007, 2 days after vaccination the patient developed fever and had an on and off temperature for a week after vaccination. The patient "recently" had tests done and it showed her thyroid was not working and her kidney function went down and she became anemic. The patient had lymphoma 10 or 11 years ago. Unspecified medical attention was undertaken. A product quality complaint was not involved. Additional information has been requested. This is in follow-up to report (s) previously submitted on 12/21/2007.  Information has been received from a consumer concerning her 85 year old mother with penicillin allergy and a history of lymphoma who in July 2007, was vaccinated with a dose of ZOSTAVAX vaccine (Merck). Concomitant therapy included blood pressure medicines. In July 2007, 2 days after vaccination the patient developed fever and had an on and off temperature for a week after vaccination. The patient "recently" had tests done and it showed her thyroid was not working and her kidney function went down and she became anemic. The patient had lymphoma 10 or 11 years ago. Unspecified medical attention was undertaken. A poduct quality complaint was not involved. Additional information was received from the physician. On 08-AUG-2007 the physician was told by the patient's daughter that she wasn't sure was wrong but the patient had been "real sick" for this last few days. She stated that the patient "got the shot, had a med change, got stung by a bee and was at the street fair in the heat all in the same week so it could be any combination of those things". The physician did not feel that ZOSTAVAX vaccine (Merck) was the cause of the patient's symptoms. No further information was provided. Additional information has been requested.
Pt was admitted on 12/1/2021 because of fatigue, cough and rhinorrhea found to have right upper lobe pneumonia with pleural effusion.  He came in contact with a person who had COVID 19 about 2 weeks. He has been having weakness, cough and runny nose for a week (11/25/21). He was tested positive for COVID 19 infection on 12/1/21. He also complaints of diarrhea. CTA chest at admission negative for PE, but suggestive of right upper lobe pneumonia and right pleural effusion. CRP 1.80. Pro calcitonin - 0.07. Admitted for further care.  Underwent thoracentesis, as aspirin/Eliquis were held, 750 cc pleural fluid removed. Transudate per light's criteria. Aspirin, Eliquis restarted. Breathing better. On room air. On Doxy, decadron and Remdisivir.  patient discharged on Decadron.
Felt like I swallowed sand paper, a bad headache, weak feeling, now today I feel feverish, raw throat, no swollen glands in my throat, feels like sand paper feeling all the way to lungs a low grade fever, have coughed up some mucus, sticky stuff in my eyes they watery.
Swelling; Covid arm; Had a rash; Can I please have the AE document sent to me in paper form mailed to me? They sent it to me in email, but I'm not technologically savvy, & I had a hard time trying to complete it.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), VACCINATION SITE REACTION (Covid arm), VACCINATION COMPLICATION (Can I please have the AE document sent to me in paper form mailed to me? They sent it to me in email, but I'm not technologically savvy, & I had a hard time trying to complete it.) and RASH (Had a rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced VACCINATION COMPLICATION (Can I please have the AE document sent to me in paper form mailed to me? They sent it to me in email, but I'm not technologically savvy, & I had a hard time trying to complete it.). On an unknown date, the patient experienced SWELLING (Swelling), VACCINATION SITE REACTION (Covid arm) and RASH (Had a rash). At the time of the report, SWELLING (Swelling), VACCINATION SITE REACTION (Covid arm), VACCINATION COMPLICATION (Can I please have the AE document sent to me in paper form mailed to me? They sent it to me in email, but I'm not technologically savvy, & I had a hard time trying to complete it.) and RASH (Had a rash) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  I did get both shots of Moderna in March 2021.  Can I please have the AE document sent to me in paper form mailed to me? They sent it to me in email, but I'm not technologically savvy, & I had a hard time trying to complete it.  Crosslinked with MOD21-041140 (AE case)
Gastrointestinal discomfort; This is a spontaneous report from a contactable consumer (patient's daughter). An 88-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6202, Expiration Date: Jun2021), via an unspecified route of administration, on 26Feb2021 (at the age of 88 years), as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was administered the second dose of Pfizer COVID-19 vaccine on 26Feb2021. Starting today, 01Mar2021 around 11:30 (about 70 hours after the patient was administered the vaccine), she had onset of gastrointestinal discomfort. The patient's daughter asked if there have been any late adverse events reported like gastrointestinal discomfort with the vaccine. Gastrointestinal discomfort was described as being generalized, abdominal discomfort with no nausea and no diarrhea. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Vaccine administered 10/5/12, patient later experienced left arm tenderness, pain, mild erythema, & warmth. Patient was treated for cellulitis potentially related to vaccine administration with vancomycin. Improved prior to discharge on 10/9.
~4 hours post-dosage administration, mild muscle aches and mild headache.  Awoke ~11 hours post-dosage administration with severe muscle aches, continuous chills, elevated heart rate, dry mouth and mucose membranes lasting 5 hours, after which symptoms subsided.  ~24 hours post-dosage administration all symptoms had resolved.
Hospitalization: admitted 8/26/22; discharged 8/27/22. Presentation to the ED: vague intermittent chest pain describing it as cramping or tightness-precordial for the past few weeks, without any associated shortness of breath.   COVID-19 + date: 8/26/22. Treatment: No indication of any immunomodulator or antiviral at this time. Paxlovid was offered, but the patient declined the treatment.  Discharge to: Home or Self Care
Around 3 days after receiving my second dose of Pfizer, my legs began to hurt, specifically in my calf. I experienced similar pain after my first dose but attributed it to normal leg pain and it went away after a few weeks. However, this pain did not go away and lasted until December of 2021. In January, the pain came back. In March the pain began to spread to other muscles like arms and back. I went to my doctor in July, as the pain was still persisting. They ran blood tests and other tests for lupus, diabetes, and other illnesses but were unable to find anything. My doctor advised that the only thing they could think of was that I was developing fibromyalgia. I have never had issues with pain in the past and have been a fairly active and healthy person. I have not been able to work out or be very active at this point.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown dates, the patients received improperly stored PEDVAXHIB (dose, route, lot numbers and expiration dates were not provided). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Pt c/o swollen neck glands fever of 101 degrees facial swelling, sore puffy rt arm, sleepiness.
This spontaneous report was received from licensed vocational nurse, concerning a 2 year old twin patient of unknown gender (twin experience reported on 1403USA003555). The patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, the patient received an expired dose of vaccinated with MMR II (dose and route not provided), Lot # 1732AA, expiry date on 04-NOV-2013. No adverse effects reported. This is one of several reports received from a same source. Additional information has been requested.
Parents state two short-lived < 3 minutes with eyes in back of head without GTC movement but sporadic arm movement. Vaccines given 05/22/2014 with report 06/10/14 with concern.
Irritable, red at site of injection with hard lump under the skin noted on 03/08/2002 at appt. 11:10am.
Information has been received form a health professional concerning a female who was vaccinated on an unspecified date with GARDASIL. Subsequently the patient experienced extreme swelling and redness at the injection site. It was reported that the site "looked infected." Subsequently, the patient recovered from extreme swelling and redness at the injection site. The patient sought unspecified medical attention.
No additional AE reported.; The vaccine expired on December 1, 2020 and was administered on December 14, 2020.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not provided.    On 14-DEC-2020, the patient was vaccinated with an expired dose (expired product administered) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter (ml), as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number S017250 which has been verified to be valid, expiration date reported and validated as 01-DEC-2020). No additional adverse events were reported.
Breakthrough case admission after 3 vaccines Moderna 3/2/21 Lot# 007B21A;  Moderna 4/19/21 Lot# 043B21A ; Moderna 1/26/22 Lot# 007J21A
One day I woke up and I started to have an uncomfortable feeling in my vaginal area. It started with a little soreness then it grew and grew to a sore itch. I became more uncomfortable so on Easter Sunday I got some vaginal cream for it. It helped a little bit. Then I went to see a gynecologist. There was no smell and no discharge. The doc came to a conclusion that it was a possible cause of the vaccine that affected my nerve endings. The vaginal itch come and goes, but it is not as strong as it was before. It becomes weaker and weaker each time it comes back. I was prescribed a vaginal cream but I never took it because it was so expensive. A couple of times I have had a sharp pain that would start in my neck then go down to my shoulder blades. It was a sharp pain that would come and go a few times. It would last for a day then go away. In September I had COVID. I had fatigue that came and went. I had it for possibly 2 weeks before I got tested.
Patient was given the incorrect vaccine. Opening a VAERS as directed by our company policy. Patient should have gotten the primary series.
Information has been received from a physician concerning an 18 year old male patient who in April 2011, was vaccinated with the first dose of GARDASIL intramuscularly, ( lot number not reported). There was no concomitant medication. The physician stated that the patient smoked marijuana "after the administration". In approximately April 2011, two weeks after the administration of GARDASIL, the patient had a seizure with tonic clonic activity and had an over night hospital stay. The patient received unspecified treatment. At the time of the report the event improved, although, the patient's status was not reported. Additional information has been requested.
Patient fainted after feeling dizzy. She remained in her chair and was uninjured.  We placed her on her back and gave her fluids and food upon her regaining consciousness.  She remained in the pharmacy area for another 30 minutes and was fine.
Perceived numbness at beginning on left leg and now occasional and neuropathy type pain in feet. Heaviness in legs. Sensitivity to hot and cold in feet.
Right shoulder is more tender and achy; 2nd shot made him worse, shot might have flared up symptoms; Every part of body is achy; Tender shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Right shoulder is more tender and achy), CONDITION AGGRAVATED (2nd shot made him worse, shot might have flared up symptoms), PAIN (Every part of body is achy) and ARTHRALGIA (Tender shoulder blade) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033A21A) for COVID-19 vaccination.     The patient's past medical history included Concussion, Whiplash injury, Shoulder injury and Back surgery. Concomitant products included VITAMINS NOS for an unknown indication.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Right shoulder is more tender and achy), CONDITION AGGRAVATED (2nd shot made him worse, shot might have flared up symptoms), PAIN (Every part of body is achy) and ARTHRALGIA (Tender shoulder blade). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Right shoulder is more tender and achy), CONDITION AGGRAVATED (2nd shot made him worse, shot might have flared up symptoms), PAIN (Every part of body is achy) and ARTHRALGIA (Tender shoulder blade) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes Blood pressure Tablets.  The patient spoke with his doctor and his doctor could not pinpoint if the side effects were from the vaccine. The vaccine might have flared up the symptoms the patient had from the concussion and whiplash he had years ago.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up will be processed with the initial report. Follow-up information included the patient contacting his doctor regarding his adverse events.
ongoing sinus/uri sx that have been intermittent but got worse on 11/6 with dry cough. Yesterday she started feeling a lot of fatigue.
This spontaneous report has been received from a licensed practitioner nurse (L.P.N.) and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The nurse reported that on unspecified dates since 15-FEB-2017, an unspecified number of patients were vaccinated with improperly stored doses of PROQUAD (lot # M042499, expiration date 17-APR-2018; lot # M035144, expiration date 30-JAN-2018; lot # M017334, expiration date 05-OCT-2017; doses, routes of administration, and frequencies were not reported) for prophylaxis which were reconstituted with an sterile diluent (DILUENT MRK) injection (lot numbers and expiration dates were not reported). The vaccine data logger measured a temperature range from 15°F to 46°F for a total time frame of 10 hours and 4 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA001635.
3/30/21 - Vaccination administered 0645, minor soreness at injection site. 3/31/21 -  Upon awakening at 0600, minor soreness at injection site with additional minor pain in right trapezius muscle.  Later, 400 p.m. feeling of minor weakness, 900 p.m. more noticeable pain (muscle soreness) in right trapezius. 4/1//2 - Awaken at 3:00 a.m. by more severe pain in right trapezius.  Upon getting out of bed at 6:00 a.m. found pain expanded to full right trapezius, partial extension to middle of right pectoral, fully up right side of neck, and partially in right armpit.  Right side of face experiencing numbness along right cheek bone and right side of right eye.  Experiencing increased pain when raise right arm elbow above shoulder.  Typing this is difficult.
Pt recvd vax & adm to hosp 17JAN94 w/dx pertussis;
UNPLEASANT SIDE EFFECTS; MAJOR CALF PAIN IN BOTH LEGS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced unpleasant side effects, and major calf pain in both legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unpleasant side effects and major calf pain in both legs was not reported. This report was non-serious.
Patient was given dose with a 1/2" needle instead of the recommended 1" needle. This error occurred due to the syringes we had received for the Pfizer vaccine and our TB syringes appearing almost identical and were in the same location, so staff member grabbed the wrong one. Patient was notified via phone call 2 days after date of vaccination of potential for more robust local reaction. Patient stated that she had not experienced any kind of reaction.
Within about 5 minutes of receiving her first Pfizer Covid19 vaccine, the patient passed out and hit her head on the floor. She regained consciousness quickly (within seconds) after I got to her. She stated she had felt nauseas and tingly before fainting. She has not experienced this before with other vaccines. Ambulance was dispatched due to her hitting her head. Parents and paramedics determined she was ok to go home.
This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (throat started swelling), HYPOAESTHESIA (he started feeling numbness), PARAESTHESIA (he started feeling tingling), INJECTION SITE PAIN (arm soreness at the injection site) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension, Anxiety, COPD and Cardiovascular disorder. Concomitant products included ALPRAZOLAM (XANAX) for Anxiety, TADALAFIL (CIALIS) for Hypertension, APIXABAN (ELIQUIS) for an unknown indication. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PHARYNGEAL SWELLING (throat started swelling), HYPOAESTHESIA (he started feeling numbness) and PARAESTHESIA (he started feeling tingling). On 28-Jan-2021, the patient experienced INJECTION SITE PAIN (arm soreness at the injection site). On 01-Feb-2021, the patient experienced NAUSEA (nausea), DIARRHOEA (diarrhea) and SWELLING (my lower legs are swelling). On 31-Dec-2020, PHARYNGEAL SWELLING (throat started swelling), HYPOAESTHESIA (he started feeling numbness) and PARAESTHESIA (he started feeling tingling) had resolved. At the time of the report, INJECTION SITE PAIN (arm soreness at the injection site), NAUSEA (nausea), DIARRHOEA (diarrhea) and SWELLING (my lower legs are swelling) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was given a "shot" of diphenhydramine and the event resolved. This case was linked to MOD-2021-017705.
Cellulitis had spread across the top of her arm; warm to touch; itchy; Chills; red blotch on arm; A spontaneous report was received from a nurse who was an 54-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, itchy, red blotch on arm, warm to touch, and cellulitis spread across the top of her arm.  The patient's medical history was not provided. No concomitant medications were reported.  On 28 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly for prophylaxis of COVID-19 infection.   On 05 Jan 2021, the patient woke up experiencing chills, was itchy, and had a red blotch on her arm that was warm to touch.   On 06 Jan 2021, the patient reported the cellulitis had spread across the top of her arm. Treatment for the event included cefalexin.  On 07 Jan 2021, the patient reported that the redness was still there, but it was getting better and had not spread.  Action taken with mRNA-1273 in response to the events was not provided.  The events, chills, itchy, red blotch on arm, warm to touch, and cellulitis spread across the top of her arm, were considered resolving.; Reporter's Comments: This case concerns a 54 year-old, female patient, who experienced events of chills, itchy, red blotch on arm, warm to touch, and cellulitis spread across the top of her arm. The events of chills, itchy, red blotch on arm, warm to touch occurred 9 days after the first dose and the event of cellulitis occurred 10 days after the first dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related.
Patient received a PPSV 23 in left arm and FLuzone HD in right arm around noon on 10/24/2020. Patient presented back at the pharmacy on 10/25/2020 and reported that he had an adverse reaction to the PPSV23. Patient reported that he developed swelling and redness that he had noticed around 4 or 5 pm on the day of the administration. Redness/rash had extended to the elbow crease when he presented to the pharmacy on 10/25/20 but the swelling had gone significantly according to the patient.