chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 5/28/00 or in June, 2000, the pt had her first dose of Lymerix. Within hours, post vax, she noted pain at injection site. The next day, she noted a 5cm X 10cm area of erythema, swelling, induration and tenderness around the injection site. There were a vague febrile sensation. The injection site symptoms persisted for about 7-10 days. During the last 1-2 days of this local site reaction, she had bilateral ankle pain and stiffness which resolved in a day or two. There may have been mild nausea during this period. On the day she returned to work, she reported nausea, anorexia, headache, photophobia and arthralgias. Joint swelling or erythema was not reported. These symptoms waxed and waned, but never completely disappeared. On 7/24/00, the pt presented to her PMD. He examined her (results unavailable). The pt was prescribed NSAIDS and instructed to return as needed. On 8/8/00, the symptoms were worse; headache had become more severe and persistent and a feeling of "unsteadiness" with fast movement. She was referred to reporting MD and his differential dx included a possible vax reaction and aseptic meningitis. He has prognosis for recovery to be excellent. He has advised against a 2nd dose of Lymerix. As of 8/18/00, the outcome of the event is improving.  Follow up on 03/15/2001: "The patient has no allergies and was taking no concurrent medications.  She was "basically healthy" per the physician.  The day of the vaccination, the patient reportedly experienced pain and a moderate rash at the injection site.  The physician reported that she also developed mild ankle pain, swelling, and stiffness that began on the day of immunization and resolved by 05/30/2000.  The injection site reaction persisted until 06/06/2000. The physician reported that on 06/15/2000, the patient developed sinusitis pain and a "syndrome typical of aseptic meningitis"; these were of moderate intensity.  On 07/24/2000, symptoms included intermittent nausea, anorexia, headache, photophobia, asthenia, tiredness, occasional fevers.  Cytomegalovirus IgM Titer was negative.  Epstein-Barr virus titer indicative of "past infection", and negative antinuclear antibody titer.  The vaccinee was prescribed doxycycline (07/28/2000-08/11/2000). Sinus x-rays were interpreted as normal.  The physician prescribed azithromycin on 08/11/2000.  The vaccinee's symptoms continued to wax and wane into 10/2000.  The vaccinee was referred to a neurologist on 10/31/2000.  The reporting physician did not have information regarding the outcome of this referral. However, on 03/07/2001, the physician indicated that the injection site rash was related to LYMErix administration, and the ankle pain and swelling, sinisitis pain, and "syndrome typical of aseptic meningitis" were possibly related to LYMErix administration.  The most recent information received on 03/07/2001, reported the outcome of the events as resolved..  Ankle swelling and "syndrome typical of sceptic meningitis" do not meet ICH serious criteria, but are being submitted as an expedited report by special request."
varicella like lesions @ ankle next day 2 more lesions appeared on upper thigh; crusted over by 21AUG95
Chief Complaint: Covid Like Symptoms (pt reports covid s/s w epigastric x 10 days PTA).  Patient COVID-19 screen also came positive. This diarrhea could be superimposed with COVID-19.  discharged  to home
pt recvd vax & devel f w/ t 103.8 & some anorexia;
This case was initily reported by a consumer and described the occurrence of injection site induration in a 4 month old male subject who was vaccinated with Pediarix for prophylaxis. Follow up for this case was received from a physician. The consumer had initially reported that the subject received Infanrix. Follow up received from the physician indicated that the subject had actually received Pediarix. The subject had no relevant medical history. Concurrent medications included Zantac for an unspecified drug indication. At eight weeks of age, on 24 May 2006 at 1:00pm the subject received the 1st dose of Pediarix in the right thigh (lot number not provided). The subject also received other immunizations on 24 May 2006; however, the specific vaccinations received were not reported. One day following receipt of the 1st dose of Pediarix, on 25 May 2006, the subject experienced injection site infection. The subject was seen by a surgeon for incision and drainage of the injection site infection and was treated with an unspecified oral medication. The event resolved on an unspecified date on or before 26 July 206. On 26 July 2006, the subject received the 2nd dose of Pediarix in the left thigh (lot number not provided). On the same day as receipt of the 2nd dose of Pediarix, 26 July 2006, the subject experienced injection site induration and injection site cyst. The subject was again seen by a surgeon for incision and drainage of the injection site cyst and was treated with an unspecified oral medication. The events resolved on an unspecified date after 26 Jul 2006 and on or before 08 September 2006. The physician considered the events to be related to vaccination with Pediarix.
A dose of Tdap was given in error to a 5 year old for his 3rd DTaP dose by mistake. The error was noted while the patient and his mother were still in the clinic. Mother was informed that this dose was given in error and would not count for school shots. She agreed to have him receive his 3rd dose of DTaP immediately in his other thigh and it was explained that this may cause more soreness. Comfort measure were taught and all VIS forms were provided to this parent.
Pain on sternum O 5 mins P no R to right side of chest Q dull, pressure S 3
feel very tired after 4 days; 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 FATIGUE (feel very tired after 4 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced FATIGUE (feel very tired after 4 days). At the time of the report, FATIGUE (feel very tired after 4 days) outcome was unknown.            Concomitant Medications were not provided by the reporter. Treatment Information was not provided by the reporter.   Reporter did not allow further contact
Non-stop pain at injection site. (And I have never had a problem with injections, including prior flu-shots. Over the next few days post-injection, (and increasing over the next several months), the pain spread throughout my tricep. The pain was at the surface of my skin and deep in the tissue. Even a normal shower was too painful to bear at the site for many months. Eventually, the pain radiated to my left shoulder. Now I have chronic pain in deep in my tricep and in my left shoulder. I cannot sleep on that side of my body.
Narrative:  COVID infection after completion of COVID vaccine series: 01/07/2021 COVID vaccine dose #1 02/01/2021 COVID vaccine dose #2 07/16/2021 Pt reported spouse tested COVID positive and wanted to get tested as well. COVID positive per nasopharyngeal swab. 07/17/2021 Pt reported onset of cough and rhinorrhea 07/19/2021 Pt reported cough resolved and "doing pretty good." 07/20/2021 Pt reported that other symptoms resolved 07/21/2021 Pt reported symptoms have maintained resolution 07/22/2021 Clinical resolution of COVID infection per CDC guidelines
On day after vaccine (2/4/2021) pt reports chills and subjective fever and increased heart rate. Reports hospitalization from 2/16- 2/22 for increased HR., chest pain but no shortness of breath. Discharged on 2/23 on beta blockers. Reports echo showed fluid around heart during 3/6-3/8 hospitalization. Reports no pneumonia.
Thrombocytopenia; Vaccinators are vaccinating very high up on the shoulder; A spontaneous report was received from a nurse concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Vaccinators are vaccinating very high up on the shoulder, thrombocytopenia.  The patient's medical history, was not provided by the reporter.No Concomitant medications were  reported.  On an unknown date, the patient received their planned dose of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   The reporter stated that Vaccinators are vaccinating very high up on the shoulder. They need to go down on the deltoid. She also reported the event of thrombocytopenia of which one involved a doctor who died.  Action taken with mRNA-1273 in response to the events was not applicable.   The  outcome of the event, vaccinators are vaccinating very high up on the shoulder was resolved . The outcome of the events thrombocytopenia is fatal.; Reporter's Comments: This report refers to a patient who experienced non-serious of vaccinating very high up on the shoulder, (Vaccine administered at inappropriate site). There were no reported AEs associated with this case of vaccine administered at inappropriate site.; Reported Cause(s) of Death: Thrombocytopenia
Slow onset itchiness including head and all over body. No visible rashes and injection site looks fine.
Sx onset 7/15/21 with cough, chills & muscle aches. Visited son, his wife & newborn in another location. Son and one other are both + cases. Tested on 7/26/21 which resulted as positive.
Woke up with 102.5 temp at 1230 am took two Tylenol woke up again at 145 temp was up to 103.8 felt like I was going to pass out.  Couldn?t call for help I was pumping (as I am a breastfeeding mom).  I did pass out at that time came back to with the pump bottles laying on my lap and the pump time read 12minutes and 48 seconds.  Loss of consciousness was probably about 10minutes.  Did not feel well all day the next day with extreme muscle pain, dizziness and chest pain/discomfort.  Still had dizzy episodes the next day and today.
Information has been received from a published article. This literature case was initially reported on 29-MAR-2010. This article concerned 32 patient's (8 male and 24 female) aged between one to 57 years (mean age of patients was 29 years). The patients received a RECOMBIVAX HB, manufacturer, batch number, route and site not reported, on unreported dates. This report concerns patient #15 of 32, a 29 year old male. On an unreported date between 1982 and 2009, one to fifteen days post vaccination, the patient experienced uveitis (mean time to onset of three days). The uveitis was reported to occur after the first vaccination in 15 patients, after the second vaccination in three patients and after the third vaccination in three patients. The duration of the uveitis was not reported for nine patients. One patient had recurrent uveitis after the first and second doses of vaccine. one patient had recurrent uveitis after both the second and third doses. Patient outcome had not been reported. A 29 year old male on an unspecified date was vaccinated with the first dose of RECOMBIVAX HB (lot number, route and site not reported). There was no concomitant medication. Two days after vaccination, the patient developed uveitis. At the time of the report, the patient's outcome was not reported. The authors stated the RECOMBIVAX HB may have a possible association with the development of uveitis in some patients. Immune complex deposition and adjuvant effects are potential pathogenic mechanisms. Uveitis was considered to be an other important medical event. Other business partner numbers include E2010-02312. Additional information has been requested. The article also discussed the experience of an additional 31 patients while on therapy with RECOMBIVAX (WAES # 1004USA01716, WAES # 1004USA02327 to WAES # 1004USA02339, WAES # 1004USA02341 to WAES # 1004USA02357). A copy of the published article is attached as further documentation of the patient's experience.
Mother phones reporting symptoms of vomiting, nausea, sweating beginning at 11:00 AM one day post vax.
1) Severe chest congestion. 2) Severe nasal congestion. 3) Conjunctivitis (pink eye) full onset 8 hrs.
If I have 1st shingrix and get covid; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced covid-19. The patient was treated with MONOCLONAL ANTIBODY (NOS) (MONOCLONAL ANTIBODY). On an unknown date, the outcome of the covid-19 was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had 1st shot of Shingrix and experienced Covid. The patient received monoclonal antibodies shot. The patent asked if could get 2nd shingrix shot and how long did have to wait for monoclonal shots.
muscle pain; joint pain; headache; tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tired). In February 2021, MYALGIA (muscle pain), ARTHRALGIA (joint pain), HEADACHE (headache) and FATIGUE (tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant  medications were reported. No Treatments were reported.
After Dose 2: 08/31/2021, a few days after 09/02/2021 started to feel unwell and he was lethargic tired and sleepy. He also had slight pigmentation. Called the physician and insurance would not approve the annual check up until Jan. 2022. Appointment was on 01/12/2022 for AIC an Heart evaluation was done and then specialist appointment. Results can back with positive for Diagnosed with type 2. A1C 7.8 and Heart test came out okay. Thought the inflammation but it was not an issue. Heart specialist, Peds Heart specialist. EKG normal. New Diagnosis of Type two diabetes was not reflected in prior annual exam.
Seizures for unknown reason while at school.limited memory. Advised at urgent care to go to er. Went to er and was admitted for monitoring and neurology consult
covered with hives; metal taste in her mouth; allergic reaction within 30 minutes following the administration of the vaccine; tongue /started to swell; her face, /started to swell; ears started to swell; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a 54-year-old female patient who received Flu Seasonal TIV Quebec (FluLaval 2011-12 season) for prophylaxis.   Concurrent medical conditions included drug allergy (allergic reaction to calcium pills).   On 25th October 2011, the patient received FluLaval 2011-12 season. On 25th October 2011, less than an hour after receiving FluLaval 2011-12 season, the patient experienced allergic reaction, swollen tongue, facial swelling, ear swelling and taste metallic. In November 2011, the patient experienced hives. The patient was treated with benadryl (nos) (Benadryl) and prednisone. On an unknown date, the outcome of the allergic reaction, swollen tongue, facial swelling, ear swelling, hives and taste metallic were recovered/resolved.   It was unknown if the reporter considered the allergic reaction, swollen tongue, facial swelling, ear swelling, hives and taste metallic to be related to FluLaval 2011-12 season.  Additional details were provided as follows: The patient had an allergic reaction within 30 minutes following the administration of the vaccine.  She had a metal taste in her mouth and her face, tongue and ears started to swell. She took benadryl immediately and then was given prednisone for a month.  When prednisone ran out, the patient was covered with hives. She took 2 more prednisone pills to resolve the hives. The reporter did not consent to follow up.
Information has been received from a nurse referring to a patient of unknown age and gender. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot number, dose and route were unknown). On an unknown date the patient experienced pain. The patient was still experiencing pain 5 months after the vaccine was administered. At the time of report, the outcome of the pain was unknown. The causality between the event and PNEUMOVAX 23 was unspecified. No PQC was involved. This is one of two reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse practitioner referring to a 15 month old patient (gender unspecified). No pertinent medical history and concurrent condition reported. On 07-JUL-2014 VARIVAX (Merck) [lot # J011125, expiry date 02-SEP-2015] dose 1, 0.5 ml, subcutaneous stored at 22C for 72 hours was administered to the patient. No other concomitant therapies reported. The action taken was unknown. The outcome of the event was unknown. No PQC reported. Additional information has been requested.
Roughly 5 minutes after vaccine patient lost awareness, became red in the face, eyes rolled to back, seizure like activity for about 1 to 2 minutes. 911 was called and the patient was assessed and released.
12 hrs p/receiving HBOC pt devel generalized hives (1030PM) seen @ clinc given DPH;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 04-SEP-2018, the patient was vaccinated with VARIVAX lot # R011808 with expiration date on 23-APR-2020 via intramuscular instead of subcutaneous for prophylaxis (dose not reported). Nonetheless, no adverse effects were reported.
Tingling  and "pins-and-needles" sensation in the right forearm and hand.
Syncope; This is a spontaneous report from a contactable health care professional via Pfizer Sales Representative. This health care professional reported similar events for 3 patients. This is 2nd of 3 reports.  A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced syncope on an unspecified date. Event took place after use of product. The outcome was unknown.  The information on the batch number has been requested.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported event syncope.,Linked Report(s) : US-PFIZER INC-2019341772 same drug/event/reporter, different patient;US-PFIZER INC-2019341788 same drug/event/reporter, different patient
1 hr sore, hardened, red, started draining, green, yellow drainage; rx w/Vantilin;
Redness and swelling right deltoid only lasting 3 days, mild pain and itching at site of injection lasting one day. Advised Ibuprofen q 6-8 hrs prn, cold compress prn for swelling.
covid vaccine breakthrough case  dose 1 Moderna 2/12/21 015M20A dose 2 Moderna 3/12/21 010A21A
This spontaneous report as received from a medical assistant refers to a 25-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 05-JUL-2018, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not reported) for prophylaxis. The patient received her second dose of GARDASIL 9 intramuscularly (dose, lot # and expiration date were not reported) for prophylaxis on an unknown date in November 2018. On 04-FEB-2019, the patient received the third dose of GARDASIL 9 intramuscularly, lot #: 1581027, expiration date: 03-JUN-2021 (dose was not provided) for prophylaxis. There was no adverse event reported.
Patient started coughing so bad that she threw up. This happened several times. Loss of appetite. Would only eat 2-3 ounces of bottle compared to 7 oz. Eyes were red and swollen and pouring over with tears. Nose was running constantly with clear snot. Injection site was very red and swollen. Very fussy and screaming. Lethargic and sleeping much more than usual. Diarrhea. Symptoms worsened as night went on and into Sunday. Monday morning (07-19-20) woke up with croup like cough and congestion. Those symptoms lessened as day continued. Went to Doctor on 07-19-10 and doctor stated it was probably viral; however, patient had been perfectly healthy prior to vaccine, was not introduced to any new environments, not in daycare, never had a fever and symptoms were improving within only 2 days.
Information has been received from a female who "yesterday," on 20-MAY-2008, was vaccinated with zoster vaccine live (Oka/Merck) and stated she experienced one of the common side effects listed in the prescribing information. The patient stated she had headaches and injection site reaction like warmth, redness and swelling. The patient outcome with regard to headache and injection site warmth, redness and swelling was unknown. No further information is available.
Information has been received from a physician, concerning a 17 year old female patient with a history of seizures up until 8 years old, who on 16-JUL-2008 was vaccinate with the first dose of GARDASIL (lot # 660557/0072X). Concomitant therapy included DEPO-PROVERA two days before GARDASIL. On 16-JUL-2008, the patient experienced fainting 15 minutes later after vaccination. The patient hit her head when she fainted. The patient recovered on an unspecified date. Th patient sought medical attention. There was no product quality complaint. Additional information is expected.
I was on a bus tour and there was a man sitting behind us, who I believe exposed me to COVID-19, but I was also in multiple airports and was overseas. My flight was delayed, and I had to take a different airport than expected. Around the night of 03/30/2023 is when I really started to feel badly. I'm sure all of the stress of travel and inadequate sleep had something to do with me being more susceptible. My symptoms began as lethargy, malaise, no energy, needing to blow my nose more often. My symptoms got worse as my trip went on. When we returned home from our trip, I took an at home COVID-19 test, which was positive. I was treating myself with vitamin supplemented lozenges and as the symptoms got worse, I began taking over the counter cold and flu medication. At one point, I had a huge temperature spike. That day, it felt like my fever broke, but I was still feverish. I did call my doctor once we returned from our trip. Since it was too late for me to be prescribed Paxlovid, he prescribed Prednisone. I took the Prednisone and began taking a regimen of vitamins. I stayed quarantined until I was no longer feverish, which was about another week.
Information has been received from a physician concerning a female who on 17-NOV-2007 was vaccinated with her first dose of Gardasil.  On 18-NOV-2007 the patient experienced severe stomach cramps.  Subsequently, the patient recovered from severe stomach cramps and sought unspecified medical attention.  Additional information has been requested.
Moderna COVID-19 Vaccine EUA.............approx 2 weeks later, feeling nauseated with diahrea for 3 days. This is happening after BOTH injections just like clockwork. on the 15th day after injection. Only other side effect was the sore arm on the second injection