chrisvoncsefalvay/vaers-outcomes huggingface dataset:
5 days post vax, maculo pap over whole body, temp 101-102; f/u  no further adverse effects noted; exam WNL's;
On the morning of 3/21/2021 I awoke to skin pain on my LEFT side (Bilateral mastectomy lymph glands only on right) from midsternal through the left scapula. Any touch was painful, sheets clothing etc. It felt like Shingles but no rash was there. day 3-7 terrible spleen pain with pressure under my left ribs radiating to my back to the base of my scapula. On day 8 the shingles rash appeared on my RIGHT side and I was put on Valtrex. Because of the sternal and rib pain I thought perhaps I was constipated so I took several laxatives to no avail. The rib pain was crushing even to the touch. It finally slowly dissipated staring day 9
Patient was experiencing paleness and trouble swallowing saliva shortly after administration of the vaccine. She was fine a couple minutes later.
shingles; This is a spontaneous report from a contactable consumer (patient's son) reported that a 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 05Feb2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was asking for his father who received the 1st dose of the vaccine on 05Feb2021. He was scheduled to take the 2nd dose on 26Feb2021 but has developed shingles on an unspecified date. He was asking whether if it would be safe if he can still take the vaccine on the scheduled date. The consumer mentioned that his father did not experience any side effects of the vaccine and that it went great. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with a dose of improperly stored GARDASIL 9 with lot number M023169 and expiration date of 13-JUN-2018 (strength, route of administration, anatomical location and dose were unknown), which was stored at 23.4 Fahrenheit degrees for 8 hours and 44 minutes (1 cycle). There was no previous temperature excursion. The temperature excursions were not detected by a data logger. No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Pt reported feeling lightheaded about 10 minutes after receiving his vaccine dose as well as witnessing another pt have a syncopal event. Pt lost consciousness and was gently lowered down to the floor by a bystander. The patient regained consciousness a few seconds after being aroused. The patient was A&Ox3 and was feeling better after 30 additional minutes of monitoring. The patient declined EMS evaluation when they arrived and felt comfortable going home. He believed his anxiety watching the previous event unfold may have caused his syncope.
Initial unsolicited report received from a pharmacist on 26 October 2015. This case involves a 69-year-old male patient who was vaccinated with a intramuscular [series not reported] dose of FLUZONE HD (batch number UI434AA, expiry date 04 April 2016) in left arm on 18 October 2015. Patient had no illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medications were not reported. On 18 October 2015, few hour following the vaccination patient had started sneezing for hours, had asthma like s/s and a nasal drip. Patient laboratory investigation and corrective treatment were not reported. On an unspecified date, patient had recovered. Upon medical review, the case was considered as serious due to important medical event asthma like s/s. List of documents held by sender: none.; Sender's Comments: Asthmatic attack is listed following INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE administration. Time to onset is compatible with a role of the vaccination; however it is not known whether asthma was well controlled in this patient with medical history of asthma. Complementary information regarding the frequency, severity and triggering factors of previous asthmatic attacks, as well as history of any previous allergies and information on any treatment adjustment following this episode would be helpful to further assess the case.
Guillain Barre? Eye got droopy, blurry vision. April 1st started double vision. 4/15/13 - broke out with rash. 4/17/13 was seen at clinic and placed on meds for shingles. Had on torso chest and back. 4/30/13 saw MD locally sent to see a neurologist and admitted to hospital on 5/8. Released on 7/3. In rehab. Wife called on 9/12/13 to report. She thought hospital had already notified of reaction.
Had trouble sleeping due to pain at injection site. Could not roll onto arm without waking up (this happened repeatedly). Woke up with a slight fever, body aches, extreme fatigue. Headache started around 10 AM. Continued all day. Temp is 99.6 at 3:30 PM.
Pt felt fine so she started to walk around the store while she waited her 15 minutes.  She started to lose her hearing, then collapsed.  Her family brought her back to me.  When I got to her she said she was very lightheaded, very sweaty, no strength.  She was not having difficulty breathing or talking.  But, she couldn't sit up on her own. After 5 minutes she felt better and sat up.  The EMTs arrived 5 minutes later and checked her out.  Her BP was a little low and so was her heartrate.  But she seemed ok.  They told her they could take her to the hospital or she could go home.  So she stood up and said she felt ok.  We watched her for a couple of minutes.  Then she started to collapse again.  The EMTs rechecked her heartrate and BP and it had not changed.  They put in an IV for a saline drip, gave her oxygen, hooked her up to an EKG machine and rolled her out to the ambulance.  I do not know what happened after that.
was called to inform me that he had "flu like" sx on Thursday 6/14-the day he rec. vaccines-Stayed home from work (6/15) felt tired, flushed in the face, tingling down arms and legs off and on, HA a little nausea (no rash, no joint pain) on Sunday felt short of breath (6/17) went to urgent care "O2 Sat. and BP normal-Given Prednisone-did not start-"waited to talk to me req. recommendation"
the mouth just swelled up; it was a very funny feeling, a weird sensation; This spontaneous case was reported by a consumer and describes the occurrence of MOUTH SWELLING (the mouth just swelled up) and FEELING ABNORMAL (it was a very funny feeling, a weird sensation) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced MOUTH SWELLING (the mouth just swelled up) and FEELING ABNORMAL (it was a very funny feeling, a weird sensation). At the time of the report, MOUTH SWELLING (the mouth just swelled up) and FEELING ABNORMAL (it was a very funny feeling, a weird sensation) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  The patient received treatment with homeopathic- rescue remedy and it seemed to calm down the symptoms.  Reportedly, the patient stated that the swelling happened right away and it began to go down within a fairly short period of time. The patient stated that it didn't go down to the throat and that she has been in getting in touch with her .doctor she is concerned about second dose.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up information received on 02-JUL-2021 and contains non significant information: Contact information updated- email address and fax number added.
Information has been received from a physician concerning a 5 year old male with no known allergies or pertinent medical history who on 05-JUN-2007 was vaccinated SC with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck) (lot # 657195/0366U). Concomitant therapy included the "regular vaccines for a kindergarten visit". On 07-JUN-2007, the patient developed chickenpox on his neck, abdomen and chest. There were only a few (less than 50) lesions. Unspecified medical attention was sought, there were no labs performed. The patient's status at the time of the report was unknown. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Acheness; 100.8 degrees; Slightly nauseated; Site is sensitive; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Site is sensitive), PAIN (Acheness), PYREXIA (100.8 degrees) and NAUSEA (Slightly nauseated) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 93990S) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Thyroid disorder, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), LISINOPRIL and ROSUVASTATIN for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, the patient experienced VACCINATION SITE REACTION (Site is sensitive), PYREXIA (100.8 degrees) and NAUSEA (Slightly nauseated). On an unknown date, the patient experienced PAIN (Acheness). At the time of the report, VACCINATION SITE REACTION (Site is sensitive), PAIN (Acheness), PYREXIA (100.8 degrees) and NAUSEA (Slightly nauseated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and Treatment medication were reported.
Woke up 14 days later (Feb 4th) and there is a red itchy circle around my vaccine injection site. 3.5 inches X 3.5 inches and blotchy in color.
pt recv vax;@ home mom reports difficulty breathing;to er;full arrest;CPR adm;resuscitated;P=159;felt warm;;thought to be chocking;pupils small; pt's VS full;pt intubated;epi given;pt died,suspected SIDS;
Pleurisy-type symptoms in left, upper chest; severe body aches all over; lethargic and difficulty getting a deep breath. Lasted several days. Happened after 2nd shot as well.
Within 10-15 minutes patient fainted and woke up with no other issues. Breathing was normal throughout this time period. Some sweating.
Patient fainted shortly after receiving covid vaccination. He was seated. 911 was called.  He revived quickly and consulted with emergency personnel . He stated he was feeling better but  he did not want to drive.  He remained at the pharmacy until he transportation arrived.
Woke up at 2 AM on 04/10/2021 with "severe joint pain & skin pain", joint pain especially in bilateral hips, bilateral knees & lower extremity skin pain.    Woke up at 6 AM on 04/10/2021 & felt very nauseated, dizzy & felt like she was going to pass out.  Throughout the day on 04/10/2021 had no energy & felt like she had the flu all day with Temperature 100.9 degrees F in AM.   Has had mild fatigue since the injection on 04/09/2021 that continues.
No adverse symptoms reported; an unspecified 2 year old patient inadvertently received a dose of GARDASIL 9; This spontaneous report was received form a nurse, regarding a 2-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions/allergies were not reported.  On 25-FEB-2020 , the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis (product administered to patient of inappropriate age). No adverse symptoms were reported.
Initial and follow up information has been received from a physician concerning a 65 year old female, with a history of childhood chickenpox, lipids, hypothyroidism and osteoporosis and no known drug allergies who was vaccinated into the left arm on 12 NOV 2007 at 11:15 with a first dose of ZOSTAVAX (Merck) (Lot # 658361/1090U). Concomitant therapy included ZOCOR, SYNTHROID, alendronate sodium (MSD), ezetimibe (+) simvastatin (MSD) and PREVACID, PROMETRIUM, VIVELLE-DOT. On 15-NOV-2007 the patient stated that the outer edge of her right eye was red, itchy and sensitive and her eyelids bothered her. The patient developed a single vesicle at the lateral margin of her eye. The patient also developed numbness of the cheek below the effected eye. No treatment was initiated. On 16-NOV-2007 the patient reported that the pain around her eye had worsened and she has a blister on the outer edge. The consumer stated that the pain moved from her eye to her mouth. Unspecified medical attention was sought. The consumer reported that on 16-NOV-2007 her eye was starting to get better and the pain was starting to subside. The consumer also reported that in approximately September 2007 she went to another country and was vaccinated with hepatitis A virus vaccine inactivitated (manufacturer unknown) (which she took before and after the trip). The physician stated that "the patient was diagnosed with shingles since the vesicle was located in the dermatomal distribution of the trigeminal nerve (maxillary)". The physician reported that the patient had no recent exposure to chickenpox or shingles. There was no reported illness at the time of vaccination. VZV1P program information was provided, though at the time of reporting the physician was unable to obtain a specimen. No lab diagnostic studies were performed. There was no product quality complaint. At the time of reporting the patient was considered recovered on 21 NOV 2007. This is one several reports received from the same source. Additional information is not expected. This is a consolidation of two reports concerning the same patient. Follow up information has been received on 15-JAN-2008 from a consumer who reported that she developed a mild case of shingles in her right eye and numbness in her right cheek. No further information provided. This is a consolidation of two reports concerning the same patient.
3 hours after getting the high dose injection I began coughing with  a tickle like cough that also felt  like there was congestion in my chest.  It was almost like an asthma cough although I wasn't wheezing but couldn't stop.  It lasted about 45 minutes and my throat was very sore after but I was able to have hot tea and a cough drop which seemed to help calm things down.  Spoke to a 24hr nurse at Insurance during this and we accessed that my  reaction was not a severe allergic reaction during that time (no other symptoms)and if it got any worse I should go to a nearby clinic.  These symptoms did not continue during the night. Just thought this reaction should be included on possible reactions.  I have gotten flu shots for many years and maybe the stronger dose caused this reaction.  I am not sick or fighting a cold or any type of illness at this time.
Fever 103, Swelling to left axillary, sore throat, cough, body aches, headache.
SOB & unable to sleep are reported in a pt who recvd flu vax; pt exp insomnia for 1 wk following flu vax; exp SOB;
arm is sour; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had 2 times).   On 14th December 2021, the patient received the 2nd dose of Shingles vaccine. In December 2021, less than a week after receiving Shingles vaccine, 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 Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had stated of having shingles twice. The patient got shot on Tuesday and his/her arm was sour, but no pain.
Feels better for a few days then it comes back; Really tired; Muscle pain; Joint pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (Feels better for a few days then it comes back), FATIGUE (Really tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced FATIGUE (Really tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills). On 11-Feb-2021, the patient experienced SYMPTOM RECURRENCE (Feels better for a few days then it comes back). At the time of the report, SYMPTOM RECURRENCE (Feels better for a few days then it comes back), FATIGUE (Really tired), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were rescue inhaler for asthma.
received call from mother of client reporting that client had swelling on right side of jaw that started on saturday (8/20/22) after receiving vaccinations on 8/17/22. she reports that swelling is still present in right side of jaw. She took client to dentist for exam and he told her to contact Health Department that gave immunizations. Dentist prescribed amoxicillin for swelling in jaw. Mother reports she will set up apt with PCP. clients mother reports low grade fever of 99.3 also on Saturday after vaccinations. she denies any other symptoms. client was not taking any medications at time of vaccinations and does not have any allergies. client does not have any preexisting conditions.
Vaccine received in my left arm. Within 48 hours of the dose,  I noticed substantial swelling in the breast tissue under my armpit and actual swelling in my left breast.  My left breast kind of burns and tingles. The breast is softer than usual to the touch, so it appears there is some fluid in my breast and in my armpit. The breast is also bulging out of my bra, which is extremely unusual. I had my mammogram earlier this year and had no issues. I have not noticed any swelling in the lymph nodes in my left armpit.
Parosmia affecting both smell and taste, starting after second dose (April 30) and lasting since
Developed suspected vaccinia lesions after exposure (wrestling) to an individual who received Smallpox vaccine.
Severe chronic joint pain in right knee, left ankle, and left hip. Also, severe chronic swelling in right knee and left ankle. Has lasted for over five months. Still no official diagnosis or cause.  Have had breast implants (silicon) for three years. Just had them removed a couple of weeks ago. Believe it's from the implants, not the vaccine, but am unsure at this time.
A bright red rash has appeared down my sternum and under my breasts. It has since spread to my my neck and spots on my back. The rash is not raised or painful.
No problem but sore arm  tom1st 2 vaccines. 3rd vaccine- sore arm next Eve broke out in hives  over body and day after on face. Went to Dr he didn?t think it was from shot since I was ok after first two but didn?t know.
Swelling & tenderness noted in (R) arm. Pt saw her MD and was diagnosed with cellulitis & treated with antibiotics: Sulfamethoxazole-trimethoprim.
Rash at injection site; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site). The patient was treated with HYDROCORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (Rash at injection site) and VACCINATION SITE SWELLING (swelling at injection site) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient last previous booster was 6 months ago, Each time, patient gotten rash and swelling at injection site, to treat these issues, (She used hydrocortisone).   This case was linked to US-MODERNATX, INC.-MOD-2023-742904 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-742904:Monovalent case
p/vax small red patches on arm just below inj site (lt deltoid);pt states that felt bad & slept all day;pt took APAP;pt states this AM 10/21/99 arms has raised area w/redness & warm to touch, but not as uncomfortable as on 10/20/99;
7/20/2021 developed pain and swelling in right lower leg. Seen by APRN 8/3/2021. Diagnosed with DVT
70-year old female with a PMH of T2DM (on empagliflozin) received her booster on 10/1/2021. She experienced frequent urination right after getting the vaccines in medical facility. No further details documented in patient notes.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 14-OCT-2015 00:52, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 5 (6hours and 41mins) and 0.7 (6hours 41mins) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Muscle soreness, beginning in lower back and extending throughout the back, shivering, tiredness, fever. After the vaccination, I worked out at the gym (weightlifting and running, followed by steam room), and noticed some soreness in lower back (about 1-2 hours after vaccination). Tiredness began later in the afternoon. By 7pm, I had muscle soreness throughout the back, a low-grade headache, and by 9 pm extreme shivering. Later that evening, I also had a low-grade fever. Took  hot shower for the shivering, stretched for the muscle soreness, and took acetaminophen for fever and then went to bed about 10:30pm. Slept for about 11 hours, waking up about every 3 hours.  The following day (today) I have felt like I'm recovering from a cold, with continuing headache, but receding soreness and no recurrence of shivering.
Patient had nausea onset of 2 hours after shot and resolved after 2 days. No treatment was required.